exposure to carcinogens or mutagens at work, 2003

L.N. 122 of 2003

OCCUPATIONAL HEALTH AND SAFETY

AUTHORITY ACT

(CAP. 424)

Regulations on the protection of workers from the risks related to

exposure to carcinogens or mutagens at work, 2003

IN EXERCISE of the powers conferred by article 12 of the

Occupational Health and Safety Act, the Deputy Prime Minister and

Minister for Social Policy, in consultation with the Occupational Health

and Safety Authority, has made the following regulations:-

(1) The title of these regulations is the Regulations on the

protection of workers from the risks related to exposure to carcinogens

or mutagens at work, 2003.

(2) These regulations aim to protect workers against risks

to their health and safety, including the prevention of such risks, arising

or likely to arise from exposure to carcinogens or mutagens at work,

and lay down minimum requirements in this area, including limit values.

(3) These regulations shall apply to activities in which

workers are or are likely to be exposed to carcinogens or mutagens as a

result of their work.

(4) As regards asbestos, insofar as any provisions in these

Regulations are more favourable to safety and health at work than any

other provision contained in regulations dealing with asbestos, these

regulations shall apply.

(5) These Regulations shall not apply to workers exposed

only to radiation insofar as such issue is regulated under any other

regulation or legislative provision.

List of substances, preparations and processes (Regulation 2 (c))

1. Manufacture of auramine.

2. Work involving exposure to polycyclic aromatic hydrocarbons present in coal

soots, coal tar or coal pitch.

3. Work involving exposure to dusts, fumes and sprays produced during the roasting

and electro-refining of cupro-nickel mattes.

4. Strong acid process in the manufacture of isopropyl alcohol.

5. Work involving exposure to hardwood dust.

B

In these regulations, unless the context otherwise requires

“Act” means the Occupational Health and Safety Authority

Act; Cap. 424

“Authority” means the Occupational Health and Safety

Authority established by article 8 of the Act;

“carcinogen” means

(i) a substance which meets the criteria for

classification as a category 1 or 2 carcinogen‘set out in Annex

VI of Directive 67/548/EEC;

(ii) a preparation composed of one or more substances

referred to in point (i) where the concentration of one or more

of the individual substances meets the requirements for

concentration limits for the classification of a preparation as

a category 1 or 2 carcinogen set out either

- in Annex I to Directive 67/548/EEC, or

- in Annex I to Directive 88/379/EEC where the

substance or substances do not appear in Annex I to

Directive 67/548/EEC or appear in it without

concentration limits;

(iii) a substance, preparation or process referred to in

Annex I as well as a substance or preparation released by a

process referred to in Annex I;

“doctor” means a medical practitioner, specialised in internal

or oncological medicine, who is appointed by an employer to

examine workers exposed to carcinogens or mutagens;

“limit value” means, unless otherwise specified, the limit

of the time-weighted average of the concentration for a “carcinogen

or mutagen” in the air within the breathing zone of a worker in

relation to a specified period as set out in Schedule III;

“mutagen” means

(i) a substance which meets the criteria for

classification as a category 1 or 2 mutagen set out in Annex

VI to Directive 67/548/EEC;

(ii) a preparation composed of one or more substances

referred to in (i) where the concentration of one or more of

the individual substances meets the requirements for

concentration limits for the classification of a preparation as

a category 1 or 2 mutagen set out in either

-

Annex I to Directive 67/548/EEC, or

- Annex I to Directive 88/379/EEC where the

substance or substances do not appear in Annex I to

Directive 67/548/EEC or appear in it without

concentration limits.

Practical recommendations for the health surveillance of workers

(Regulation 14 (7))

1. The doctor must be familiar with the exposure conditions or circumstances of

each worker.

2. Health monitoring 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 personal interview,

- where appropriate, biological monitoring, as well as detection of early

and reversible effects.

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

health monitoring, in the light of the most recent knowledge available to occupational

medicine.

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

exposure to carcinogens or mutagens, 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.

The assessment must be renewed regularly and in any event when

any change occurs in the conditions which may affect workers’ exposure

to carcinogens or mutagens.

The employer must supply the Authority at its request with the

information used for making the assessment.

(2) When assessing the risk, account shall be taken of all

other routes of exposure, such as absorption into and/or through the

skin.

(3) When the assessment referred to in this regulation is

carried out, an employer shall give particular attention to any effects

concerning the health or safety of workers at particular risk and shall,

inter alia, take account of the desirability of not employing such workers

in areas where they may come into contact with carcinogens or mutagens.

Limit values and other directly related provisions (Regulation 16)

A. Limit values for occupational exposure

EINECS ( 1 )

CAS ( 2 )

Name of

Limit values

Notation

agent

mg#m ( 3 )

ppm ( 4 )

3.25 ( 5 )

1 ( 5 )

Skin ( 6 )

Benzene

200-753-7

71-43-2

7.77 ( 5 )

Vinyl

200-831

75-01-4

chloride

monomer

5.0 ( 5 ) ( 7 )

Trab ta’ injam

-

-

-

-

hardwood

( 1 ) EINECS: European Inventory of Existing Chemical Substances.

( 2 ) CAS: Chemical Abstract service Number.

( 3 ) mg/m 3 = milligrams per cubic metre of air at 20 ∞ C and 101.3kPa (760 mm

mercury pressure).

( 4 ) ppm = parts per million by volume in air (ml/m 3 ).

( 5 ) Measured or caluclated in relation to a reference period of eight hours.

( 6 ) Substantial contribution to the total body burden via dermal exposure possible.

( 7 ) Inhalable fraction; if hardwood dusts are mixed with other wood dusts, the

limit value shall apply to all wood dusts present in that mixture.

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

(1) The employer shall reduce the use of a carcinogen or

mutagen at the place of work, in particular by replacing it, in so far as is

technically possible, by a substance, preparation or process which, under

its conditions of use, is not dangerous or is less dangerous to workers’

health or safety, as the case may be.

(2) The employer shall, upon request, submit the findings of his

investigations to the Authority.

(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 it is not technically possible to replace the

carcinogen or mutagen by a substance, preparation or process which,

under its conditions of use, is not dangerous or is less dangerous to

health or safety, the employer shall ensure that the carcinogen or the

mutagen is, in so far as is technically possible, manufactured and used

in a closed system.

(3) Where a closed system is not technically possible, the

employer shall ensure that the level of exposure of workers is reduced

to as low a level as is technically possible.

(4) Exposure shall not exceed the limit values as set out in

Schedule III

(5) Wherever a carcinogen or mutagen is used, the employer

shall apply all the following measures

(a) limitation of the quantities of a carcinogen or mutagen

at the place of work; (b) keeping as low as possible the number

of workers exposed or likely to be exposed;

(c) design of work processes and engineering control

measures so as to avoid or minimize the release of carcinogens or

mutagens into the place of work;

(d) evacuation of carcinogens or mutagens at source, local

extraction system or general ventilation, all such methods to be

appropriate and compatible with the need to protect public health

and the environment;

(e) use of existing appropriate procedures for the

measurement of carcinogens or mutagens, in particular for the early

detection of abnormal exposures resulting from an unforeseeable

event or an accident;

(f) application of suitable working procedures and methods;

(g) collective protection measures and/or, where exposure

cannot be avoided by other means, individual protection

measures;

(h) hygiene measures, in particular regular cleaning of

floors, walls and other surfaces;

(i)

information for workers;

(j) demarcation of risk areas and use of adequate warning

and safety signs including ‘no smoking’ signs in areas where

workers are exposed or likely to be exposed to carcinogens or

mutagens;

(k) drawing up plans to deal with emergencies likely to result

in abnormally high exposure;

(l) means for safe storage, handling and transportation, in

particular by using sealed and clearly and visibly labelled

containers;

(m) means for safe collection, storage and disposal of waste

by workers, including the use of sealed and clearly and visibly

labelled containers.

Where the results of the assessment referred to in regulation 3

reveal a risk to workers’ health or safety, an employer shall, when

requested, make available to the Authority appropriate information on

(a) the activities and/or industrial processes carried out,

including the reasons for which carcinogens or mutagens are used;

(b) the quantities of substances or preparations

manufactured or used which contain carcinogens or mutagens;

(c)

the number of workers exposed;

(d) the preventive measures taken;

(e)

the type of protective equipment used;

(f)

the nature and degree of exposure;

(g) the cases of replacement.

(1) In the event of an unforeseeable event or an accident

which is likely to result in an abnormal exposure of workers, the

employer shall inform the workers thereof. Unforeseen exposure

(2) Until the situation has been restored to normal and the

causes of the abnormal exposure have been eliminated

(a) only those workers who are essential to the carrying out

of repairs and other necessary work shall be permitted to work in

the affected area;

(b) the workers concerned shall be provided with protective

clothing and individual respiratory protection equipment which

they must wear; the exposure may not be permanent and shall be

kept to the strict minimum of time necessary for each worker;

(c) unprotected workers shall not be allowed to work in the

affected area.

(1) For certain activities such as maintenance, in respect of

which it is foreseeable that there is the potential for a significant increase

in exposure of workers, and in respect of which all scope for further

technical preventive measures for limiting workers’ exposure has already

been exhausted, the employer shall determine, after consultation of the

workers and/or their representatives in the undertaking or establishment,

without prejudice to the employer’s responsibility, the measures

necessary to reduce the duration of workers’ exposure to the minimum

possible and to ensure protection of workers while they are engaged in

such activities.

(2) Pursuant to the first sub-article (1), the workers

concerned shall be provided with protective clothing and individual

respiratory protection equipment which they must wear as long as the

abnormal exposure persists; that exposure may not be permanent and

shall be kept to the strict minimum of time necessary for each worker.

(3) Appropriate measures shall be taken to ensure that the

areas in which the activities referred to in the sub-article (1) take place

are clearly demarcated and indicated or that unauthorized persons are

prevented by other means from having access to such areas.

Appropriate measures shall be taken by employers to ensure Access to risk areas

that access to areas in which the activities in respect of which the results

of the assessment referred to in regulation 3 reveal a risk to workers’

safety or health take place are accessible solely to workers who, by

reason of their work or duties, are required to enter them.

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

for which there is a risk of contamination by carcinogens or mutagens, and

protection

to take appropriate measures to ensure that

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

where there is a risk of contamination by carcinogens or mutagens;

(b) workers are provided with appropriate protective

clothing or other appropriate special clothing;

(c) separate storage places are provided for working or

protective clothing and for street clothes;

(d) workers are provided with appropriate and adequate

washing and toilet facilities;

(e) protective equipment is properly stored in a well-defined

place; it is checked and cleaned if possible before, and in any case

after, each use; defective equipment is repaired or replaced before

further use.

(2)

Workers may not be charged for the cost of these

measures.

(1) Appropriate measures shall be taken by the employer

to ensure that workers and, or 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, including the additional risks

due to tobacco consumption;

(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, including rescue workers,

in the case of incidents and to prevent incidents.

The training shall be

- adapted to take account of new or changed risk, and

- repeated periodically if necessary.

(2) Employers shall inform workers of installations and

related containers containing carcinogens or mutagens, ensure that all

containers, packages and installations containing carcinogens and

mutagens are labelled clearly and legibly, and display clearly visible

warning and hazard signs.

Appropriate measures shall be taken to ensure that

(a) workers and, or any workers’ representatives in the

undertaking or establishment can check that these Regulations are

applied or can be involved in its application, in particular with

regard to

(i) the consequences for workers’ safety and health of

the selection, wearing and use of protective clothing and

equipment, without prejudice to the employer’s responsibility

for determining the effectiveness of protective clothing and

equipment;

(ii) the measures determined by the employer which

are referred to in the first sub-paragraph of regulation 8(1),

without prejudice to the employer’s responsibility for

determining such measures;

(b) workers and, or any workers’ representatives in the

undertaking or establishment are informed as quickly as possible

of abnormal exposures, including those referred to in regulation 8,

of the causes thereof and of the measures taken or to be taken to

rectify the situation;

(c) the employer keeps an up-to-date list of the workers

engaged in the activities in respect of which the results of the

assessment referred to in regulation 3 reveal a risk to workers’

health or safety, indicating, if the information is available, the

exposure to which they have been subjected;

(d) the doctor and, or the Authority as well as all other

persons who have responsibility for health and safety at work at

the employer’s workplace have access to the list referred to in

subparagraph (c);

(e) each worker has access to the information on the list

which relates to him personally;

(f) workers and, or any workers’ representatives in the

undertaking or establishment have access to anonymous collective

information.

(1) Employers shall consult workers and, or their Consultation and

participation of

representatives and allow them to take part in discussions on all questions workers.

relating to safety and health at work. This presupposes

L.N. 36 of 2003.

- the consultation of workers,

- the right of workers and/or their representatives to make

proposals,

- balanced participation in accordance with the General

Provisions for Health and Safety at Work Places Regulations, 2003.

(2) Workers or workers’ representatives with specific

responsibility for the safety and health 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 safety and

health;

(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 safety and health 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 safety and health 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 safety and health of

workers, or workers’ representatives with specific

responsibility for the safety and health 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 safety and health.

(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 undertakingand/or

establishment;

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

worker regarding adequate safety and health 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 safety and health 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 paragraph (2) and the workers’

representatives referred to in paragraphs (2) and (3) may not be placed

at a disadvantage because of their respective activities referred to in

paragraphs (2) and (3).

(5) Employers must allow workers’ representatives with

specific responsibility for the safety and health of workers adequate

time off work, 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 to the Authority if they consider that the measures taken and the

means employed by the employer are inadequate for the purposes of

ensuring safety and health at work. Workers’ representatives must be

given the opportunity to submit their observations during inspection

visits by the Authority.

(1) The employer shall make arrangements for carrying out

relevant health surveillance of workers for whom the results of the

assessment referred to in regulation 3 reveal a risk to health or safety.

(2) The arrangements referred to in paragraph (1) shall be

such that each worker shall be able to undergo, if appropriate, relevant

health surveillance

-

prior to exposure,

-

at regular intervals thereafter.

Those arrangements shall be such that it is directly possible to

implement individual and occupational hygiene measures.

(3) If a worker is found to be suffering from an abnormality

which is suspected to be the result of exposure to carcinogens or

mutagens, the doctor or the Authority may require other workers who

have been similarly exposed to undergo health surveillance. In that event,

a reassessment of the risk of exposure shall be carried out in accordance

with regulation 3.

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

individual medical record shall be kept and the doctor or the Authority

shall propose any protective or preventive measures to be taken in respect

of any individual workers.

(5) Information and advice must be given to workers

regarding any health surveillance which they may undergo following

the end of exposure.

(6) Workers shall have access to the results of the health

surveillance which concern them, and 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 II.

(8) All cases of cancer identified in accordance with

applicable laws and, or practice as resulting from occupational exposure

to a carcinogen or mutagen shall be notified to the Authority.

(1) The list referred to in regulation 12 (c) and the medical Record keeping.

records referred to in regulation 14(4) shall be kept for at least 40 years

following the end of exposure.

(2) Those documents shall be made available to the

Authority in cases where the undertaking ceases activity.

Limit values and other directly related provisions are set out Limit values.

in Schedule III.

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 Offences.

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

an offence.