Biological Agents at Work Regulations, 2003

L.N. 228 of 2003

OCCUPATIONAL HEALTH AND SAFETY AUTHORITY ACT

(CAP. 424)

Protection of Workers from Risks related to Exposure to

Biological Agents at Work Regulations, 2003

IN EXERCISE of the powers conferred by article 12 of the

Occupational Health and Safety Authority Act, the Deputy Prime

Minister and Minister of Social Policy, in consultation with the

Occupational Health and Safety Authority, has made the following

regulations:-

(1) The title of these regulations is the Protection of Workers Citation and scope.

from Risks related to Exposure to Biological Agents at Work

Regulations, 2003.

(2) The scope of these regulations is to 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.

(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.

INDICATIVE LIST OF ACTIVITIES

(Regulation 4)

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-mertem 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

Interpretation.

“Act” means the Occupational Health and Safety Authority

Act;

“Authority” means the Occupational Health and Safety

Authority established by section 8 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

risk groups, according to their level of risk of infection

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

unlikely to cause human disease;

(ii) 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;

(iii) 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;

(iv) 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.

BIOAZZARD 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.

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 15 of these

regulations.

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 agents where more than one species is know to be pathogenic to man, the list

will include those species which are know to be the most frequently responsible for

diseases, together with a more generic 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 know 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 shall be deemed to fall within 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 10 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 10

years after the end of last known exposure

T: Toxin production

V: Effective vaccine available

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, ‘spp.’ refers to other species which

are know pathogens in humans.

Biological agent

Classification

Notes

Actinobacillus actinomycetemcomitans

Actinomadura madurae

Actinomadura pelletieri

Actinomyces gerencseriae

Actinomyces israelii

Actino myces pyogenes

Actinomyces spp.

Arcanobacterium haemolyticum

(Corynebacterium haenolyticum)

Bacillus anthracic

Bacteroides fragilis

Bartonella bacillifonnis

Bartonella quintana (Rochalimaea

quintana)

Bartonella (Rochalinea) spp.

Bordetella bronchiseptica

Bordetella parapertussis

Bordetella pertussis

V

Borrelia burgdorferi

Borrelia duttonii

Borrelia recurrentis

Borrelia spp.

Brucella abortus

Brucella canis

Brucella melitensis

Brucella suis

Burkholderia mallei (Pseudomonas

mallei)

Burkholderia pseudomallei

(Pseudomonas pseudomallei)

Campylobacter fetus

Campylobacter jejuni

Campylobacter spp.

Cardiobacterium hominis

Chlamydia pneumoniae

Chlamydia trachomatis

Chlamydia psittaci (avian strains)

Chlamydia psittaci (other strains)

Clostridium botulinum

T

Clostridium perfringens

Clostridium tetani

T, V

Clostridium spp.

Corynebacterium diphtheriae

T, V

Corynebacterium minutissimum

Corynebacterium pseudotuberculosis

Corynebacterium spp.

Coxiella burnetii

Edwardsiella tarda

Ehrlichia sennetsu (Rickettsia sennetsu)

Ehrlichia spp.

Eikenella corrodens

Enterobacter aerogenes /cloacae

Enterobacter spp.

Enterococcus spp.

Erysipelothrix rhusiopathiae

Escherichia coli (with the exception of

non-pathogenic strains)

Escherichia coli, verocytotoxigenic

3 (**)

strains (e.g. O157:H7 or O103)

Flavobacterium meningosepticum

Fluoribacter bozemanae (Legionella)

Francisella tularensis (Type A)

Francisella tularensis (Type B)

Fusobacterium necrophorum

Gardnerella vaginalis

Haemophilus ducreyi

Haemophilus influenzae

Haemophilus spp.

Helicobacter pylori

Klebsiella oxytoca

Klebsiella pneumoniae

Klebsiella spp.

Legionella pneumophila

Legionella spp.

Leptospira interrogans (all serovars)

Listeria monocytogenes

Listeria ivanovii

Morganella morganii

Mycobacterium africanum

V

Mycobacterium avium/intracellulare

Mycobacterium bovis (except BCG strain

V

)

Mycobacterium chelonae

Mycobacterium fortuitum

Mycobacterium kansasii

Mycobacterium leprae

Mycobacterium malmoense

Mycobacterium marinum

Mycobacterium microti

3 (**)

Mycobacterium paratuberculosis

Mycobacterium scrofulaceum

Mycobacterium simiae

Mycobacterium szulgai

Mycobacterium tuberculsis

V

Mycobacterium ulcerans

3 (**)

Mycobacterium xenopi

Mycoplasma caviae

Mycoplasma hominis

Mycoplasma pneumoniae

Neisseria gonorrhoeae

Neisseria meningitidis

V

Nocardia asteroides

Nocardia brasiliensis

Nocardia farcinica

Nocardia nova

Nocardia otitidiscaviarum

Pasteurella multocida

Pasteurella spp.

Peptostreptococcus anaerobius

Plesiomonas shigelloides

Porphyromonas spp.

Prevotella spp.

Proteus mirabilis

Proteus penneri

Proteus vulgaris

Providencia alcalifaciens

Providencia rettgeri

Providencia spp.

Pseudomonas aeruginosa

Rhodococcus equi

Rickettsia akari

3 (**)

Rickettsia canada

3 (**)

Rickettsia conorii

Rickettsia montana

3 (**)

Rickettsia typhi (Rickettsia mooseri)

Rickettsia prowazekii

Rickettsia rickettsii

Rickettsia tsutsugamushi

Rickettsia spp.

Salmonella arizonae

Salmonella enteritidis

Salmonella typhimurium

Salmonella paratyphi A,B,C

V

Salmonella typhi

3 (**)

V

Salmonella (other serovars)

Serpulina spp.

Shigella boydii

Shigella dysenteriae (Type 1)

3 (**)

T

Shigella dysenteriae ,other than Type 1

Shigella flexneri

Shigella sonnei

Staphylococcus aureus

Streptobacillus moniliformis

Streptococcus pneumoniae

Streptococcus pyogenes

Streptococcus suis

Streptococcus spp.

Treponema carateum

Treponema pallidum

Treponema pertenue

Treponema spp.

Vibrio cholerae (including El Tor)

Vibrio parahaemolyticus

Vibrio spp.

Yersinia enterocolitica

Yersinia pestis

V

Yersinia pseudotuberculosis

Yersinia spp.

(**)See paragraph 8 of the introductory notes.

VIRUSES (*)

Biological Agent

Classification

Notes

Adenoviridae

Arenaviridae

LCM-Lassa-virus complex (old world

arena viruses)

Lassa virus

Lymphocytic (strains)

Lymphocytic choriomeningitis virus

(other strains)

Mopeia virus

Other LCM-Lassa complex viruses

Tacaribe-Virus-complex (new world

arena viruses)

Guanarito virus

Junin virus

Sabia virus

Machupo virus

Flexal virus

Other Tacaribe complex viruses

Astroviridae

Bunyaviridae

Belgrade (also known as Dobrava)

Bhanja

Bunyamwera virus

Germiston

Oropouche virus

Sin Nombre (formerly Muerto Canyon)

California encephalitis virus

Hantaviruses

Hantaan (Korean haemorrhagic

fever)

Seoul virus

Puumala virus

Prospect Hill virus

Other hantaviruses

Nairoviruses

Crimean-Congo haemorrhagic fever

Hazara virus

Phleboviruses

Rift Valley fever

V

Sandfly fever

Toscana virus

Other bunyaviridae known to be

pathogenic

Caliciviridae

Hepatitis E virus

3 (**)

Norwalk virus

Other Caliciviridae

Coronaviridae

Filoviridae

Ebola virus

Marburg virus

Flaviviridae

Australia encephalitis (Murray Valley

encephalitis)

Central European tick-borne

3 (**)

V

encephalitis virus

Absettarov

Hanzalova

Hypr

Kumlinge

Dengue virus type 1-4

Hepatitis C virus

3 (**)

D

Hepatitis G virus

3 (**)

D

Japanese B encephalitis

V

Kyasanur Forest

V

Louping ill

3 (**)

Omsk (a)

V

Powassan

Rocio

Russian spring-summer encephalitis

V

(TBE)(a)

St Louis encephalitis

Wesselsbron virus

3 (**)

West Nile fever virus

Yellow fever

V

Other flaviviruses known to be

pathogenic

Hepadnaviridae

Hepatitis B virus

3 (**)

V,D

Hepatitis D virus (Delta)(b)

3 (**)

V,D

Herpesviridae

Cytomegalovirus

Epstein-Barr virus

Herpesvirus simiae (B virus)

Herpes simplex virus types 1 and 2

Herpesvirus varicella-zoster

Human B-lymphotropic virus (HBLV-

HHV6)

Human herpes virus 7

Human herpes virus 8

D

Orthomyxoviridae

Influenza viruses types A,B and C

V (c)

Tick-borne orthomyxoviridae :Dhori

and Thogoto

Papovaviridae

BK and JC viruses

D (d)

Human papillomaviruses

D (d)

Paramyxoviridae

Measles virus

V

Mumps virus

V

Newcastle disease virus

Parainfluenza viruses types 1 to 4

Respiratory syncytial virus

Parvoviridae

Human parvovirus (B 19)

Picomaviridae

Acute haemorrhagic conjunctivitis virus

(AHC)

Coxsackie viruses

Echo viruses

Hepatitis A virus (human enterovirus

V

type 72)

Polioviruses

V

Rhinoviruses

Poxviridae

Buffalopox virus (e)

Cowpox virus

Elephantpox virus (f)

Milkers'node virus

Molluscum contagiosum virus

Monkeypox virus

V

Orf virus

Rabbitpox virus (g)

Vaccinia virus

Variola (major and minor)virus

V

Whitepox virus (‘Vari la virus’)

V

Yatapox virus (Ta a & Yaba)

Re viridae

Coltivirus

Human rotaviruses

Orbiviruses

Reuviruses

Retroviridae

Human immunodeficiency viruses

3 (**)

D

Human T-cell lymphotropic viruses

3 (**)

D

(HTLV), types 1 and 2

SIV (h)

3 (**)

Rhabdoviridae

rabies virus

3 (**)

V

Vesicular stomatitis virus

Togaviridae

Alphaviruses

Eastern equine encephalomyelitis

V

Bebaru virus

Chikungunya virus

3 (**)

Everglades virus

3 (**)

Mayaro virus

Mucambo virus

3 (**)

Ndumu virus

O'nyong-nyong virus

Ross River virus

Semliki Forest virus

Sindbis virus

Tonate virus

3 (**)

Western equine encephalomyelitis

V

Other know alphaviruses

Rubivirus (rubella)

V

Toroviridae

Unclassified viruses

Equine morbillivirus 4

Hepatitis viruses not yet identified

3 (**)

D

Unconventional agents associated with

the transmissible spongiform

encephalopathies (TSEs)

Creutzfeldt-Jakob disease

3 (**)

D (d)

Variant Creutzfeldt-Jakob disease

3 (**)

D (d)

Bovine spongiform encephalopathy

3 (**)

D (d)

(BSE) and other related animal

TSEs (i)

Gerstma -Sträussler-Scheinker syndrome

3 (**)

D (d)

Kuru

3 (**)

D (d)

(*) See paragraph 7 of the introductory notes.

(**) See paragraph 8 of the introductory notes.

(a) Tick-borne encephalitis.

(b) Hepatitis D 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 D virus (Delta).

(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.

(i) There is no evidence in humans of infections caused by the agents responsible for other

animal TSEs. Nevertheless, the containment measures for agents categorised in risk group 3

(**) are recommended as a precaution for laboratory work, except for laboratory work relating

to an identified agent of scrapie where containment level 2 is sufficient.

PARASITES

Biological agent

Classification

Notes

Acanthamoeba castellani

Ancylostoma duodenale

Angiostrongylus cantonensis

Angiostrongylus costaricensis

Ascaris lumbricoides

A

Ascaris suum

A

Babesia divergens

Babesia microti

Balantidium coli

Brugia malayi

Brugia pahangi

Capillaria philippinensis

Capillaria spp.

Clonorchis sinensis

Clonorchisviverrini

Cryptosporidium parvum

Cryptosporidium spp.

Cyclospora cayetanensis

Dipetalonema streptocerca

Diphyllobothrium latum

Dracunculusmedinensis

Echinococcusgranulosus

3 (**)

Echinococcusmultilocularis

3 (**)

Echinococcusvogeli

3 (**)

Entamoeba histolytica

Fasciola gigantica

Fasciola hepatica

Fasciolopsis buski

Giardia lamblia (Giardia

intestinalis)

Hymenolepisdiminuta

Hymenolepisnana

Leishmania brasiliensis

3 (**)

Leishmania donovani

3 (**)

Leishmania ethiopica

Leishmania mexicana

Leishmania peruviana

Leishmania tropica

Leishmania major

Leishmania spp.

Loa loa

Mansonella ozzardi

Mansonella perstans

Naegleria fowleri

Necator americanus

Onchocerca volvulus

Opisthorchis felineus

Opisthorchis spp.

Paragonimuswestermani

Plasmodium falciparum

3 (**)

Plasmodium spp.(human and

simian)

Sarcocystis suihominis

Schistosoma haematobium

Schistosoma intercalatum

Schistosoma japonicum

Schistosoma mansoni

Schistosoma mekongi

PARASITES (cont’d)

Biological agent

Classification

Notes

strongyloidesstercoralis

Strongyloides spp.

Taenia saginata

Taenia solium

3 (**)

Toxocara canis

Toxoplasma gondii

Trichinella spiralis

Trichuristrichiura

Trypanosoma brucei brucei

Trypanosoma brucei gambiense

Trypanosoma brucei

3 (**)

rhodesiense

Trypanosoma cruzi

Wuchereria bancrofti

(**)See paragraph 8 of the introductory notes.

FUNGI

Biological agent

Classification

Notes

Aspergillus fumigatus

A

Blastomycesdermatitidis(Ajellomyc

esdermatitidis)

Candida albicans

A

Candida tropicalis

Cladophialophora bantiana

(formerly:Xylohypha

bantiana,Cladosporium

bantianum or trichoides)

Coccidioidesinunitis

A

Cryptococcusneoformans

A

var.neofonnans(Filobasidiellaneofo

nnans var.neofonnans)

Cryptococcusneoformans var.gattii

A

(Filobasidiella bacillispora)

Emmonsia parva var.parva

Emmonsiaparva var.crescens

Epidermophyton floccosum

A

Fonsecaea compacta

Fonsecaea pedrosoi

Histoplasma capsulatum

var.capsulatum

(Ajellomyces capsulatus)

Histoplasmacapsulatum duboisii

Madurella grisea

Madurella mycetomatis

Microsporum spp.

A

Neotestudina rosatii

Paracoccidioides brasiliensis

Penicillium marneffei

A

Scedosporium apiospermum

(Pseudallescheria boydii)

Scedosporium prolificans

(inflatum)

Sporothrix schenckii

Trichophyton rubrum

Trichophyton spp.

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

various regulations

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

biological agent, with no identifiable health risk to workers, regulations assessment of risks.

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.

INDICATIONS CONCERNING CONTAINMENT MEASURES AND

CONTAINMENT LEVELS

(Regulations 15 and 16)

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.

A. Containment measures

B. Containment levels

1.The workplace is to be separated from

No

Recommended

Yes

any other activities in the same building

2.Input air and extract air to the workplace

No

Yes, on extract

Yes, on

are to be filtered using (HEPA)or likewise

air

input and

extract air

3.Access is to be restricted to nominated

Recommended

Yes

Yes, via

workers only

airlock

4.The workplace is to be sealable to permit

No

Recommended

Yes

disinfection

5.Specified disinfection procedures

Yes

Yes

Yes

6.The workplace is to be maintained at an

No

Recommended

Yes

air pressure negative to atmosphere

7.Efficient vector control, for example

Recommended

Yes

Yes

rodents and insects

8.Surfaces impervious to water and easy to

Yes, for bench

Yes, for bench

Yes, for

clean

and floor

bench,

walls, floor

and ceiling

9.Surfaces resistant to acids, alkalis,

Recommended

Yes

Yes

solvents, disinfectants

10.Safe storage of a biological agent

Yes

Yes

Yes,

secure

storage

11.An observation window, or, alternative,

Recommended

Recommended

Yes

is to be present, so that occupants can be

seen

12.A laboratory is to contain own

No

Recommended

Yes

equipment

13.Infected material, including any animal,

Where

Yes, where

Yes

is to be handled in a safety cabinet or

appropriate

infection is by

isolation or other suitable containment

airborne route

14.Incinerator for disposal of animal

Recommended

Yes (available)

Yes, on

carcasses

site

(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 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.

CONTAINMENT FOR INDUSTRIAL PROCESSES

(Regulation 4 and Regulation 16)

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.

Groups2, 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

1.Viable organisms should be handled in a system which

Yes

Yes

Yes

physically separates the process from the environment

2.Exhaust gases from the closed system should be treated so as

Minimise

Prevent

Prevent

to

release

release

release

3.Sample collection, addition of materials to a closed system and

Minimise

Prevent

Prevent

transfer of viable organisms to another closed system, should be

release

release

release

performed so as to

4.Bulk culture fluids should not be removed from the closed

Inactivated by

Inactivated

Inactivated

system unless the viable organisms have been

validated

by validated

by validated

means

chemical or

chemical or

physical

physical

means

means

5.Seals should be designed so as to

Minimise

Prevent

Prevent

release

release

release

6.Closed systems should be located within a controlled area

Optional

Optional

Yes, and

purpose-built

(a)Biohazard signs should be posted

Optional

Yes

Yes

(b)Access should be restricted to nominated personnel only

Optional

Yes

Yes, via an

airlock

(c)Personnel should wear protective clothing

Yes, work

Yes

A complete

clothing

change

(d)Decontamination and washing facilities should be provided for

Yes

Yes

Yes

personnel

(e)Personnel should shower before leaving the controlled area

No

Optional

Yes

(f)Effluent from sinks and showers should be collected and

No

Optional

Yes

inactivated before release

(g)The controlled area should be adequately ventilated to

Optional

Optional

Yes

minimise air contamination

(h)The controlled area should be maintained at an air pressure

No

Optional

Yes

negative to atmosphere

(i)Input air and extract air to the controlled area should be HEPA

No

Optional

Yes

filtered

(j)The controlled area should be designed to contain spillage of

No

Optional

Yes

the entire contents of the closed system

(k)The controlled area should be sealable to permit fumigation

No

Optional

Yes

(l)Effluent treatment before final discharge.

Inactivated by

Inactivated

Inactivated

validated

by validated

by validated

means

chemical or

chemical or

physical

physical

means

means

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

Authority

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 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.

RECOMMENDED CODE OF PRACTICE ON VACCINATION

(Regulation 14)

1. If the assessment referred to in regulation 3 reveals that there is a risk to the health

and safety of workers due to their exposure to biological agents for which

effective vaccines exist, their employers should offer them vaccination.

2. Vaccination should be carried out in accordance with the applicable legislative

and or other administrative provisions.

Workers should be informed of the benefits and drawbacks of both vaccination

and non-vaccination.

3. Vaccination must be offered free of charge to workers.

4. A vaccination certificate may be drawn up which should be made available to the

worker concerned and, on request, to the Authority.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

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

and individual

which there is a risk to the health or safety of workers due to work with protection.

biological agents, to take appropriate measures to ensure that

(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) is 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 the second

subparagraph, 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 Worker

in particular cases.

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 any workers’ representatives 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.

(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 paragraph 1 shall be kept for

at least 10 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 40 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 sub-paragraphs (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 sub-paragraphs (v) and (vi) above;

- the list and reports referred to in sub-paragraphs (iii)

and (iv) above;

- 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

(4) The workers referred to in subregulation (2) and the

workers’ representatives referred to in subregulation (2) and (3) may

not be placed at a disadvantage because of their respective activities

referred to in subregulations (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 law 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.

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

the Authority.

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 30 days before

the commencement of the work.

(c) Subject to subregulation (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) Renotification 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 date.

(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;

(e) the protection and preventive measures that are

envisaged.

(1) 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

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 reassessment 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 10 years following

the end of exposure.

(b) In the special cases referred to in paragraphs (a) to (e)

of regulation 11(2), an individual medical record shall be kept for

an appropriately longer time up to 40 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 Health and

veterinary care

regulation 3, particular attention should be paid to

facilities other than

diagnostic

laboratories.

(a) uncertainties about the presence of biological agents in

human patients or animals and the materials and specimens take

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

subparagraph of paragraph 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 paragraphs 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 Use of data.

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 Classification of

biological agents.

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 Onus of proof.

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 fact

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.