S.I. No. 78/2001 - Safety, Health and Welfare At Work (Carcinogens) Regulations, 2001

1.	Citation and Commencement.
2.	Interpretation.
3.	Employer/Self-employed.
4.	General Duties of Employer.
5.	Information made available to the Authority.
6.	Unforeseen Exposure.
7.	Foreseeable Exposure.
8.	General Measures.
9.	Duty not to make Charges for Personal Protective Equipment.
10.	Information and Training of Employees.
11.	Consultation.
12.	Health Surveillance.
13.	Exposure Record.
14.	Revocation.

S.I. No. 078 of 2001

SAFETY, HEALTH AND WELFARE AT WORK (CARCINOGENS) REGULATIONS, 2001

I, Tom Kitt, Minister of State at the Department of Enterprise, Trade and Employment, in exercise of the powers conferred on me by section 28 of the Safety, Health and Welfare at Work Act, 1989 (No. 7 of 1989), in relation to the matters set out in paragraphs (1), (2) to (7), (9) to (16), (17), (21), (22), (25), (26), (28)(a), (28)(c), (29), (30), (32), (33) and (36) of the Fourth Schedule of that Act, the Labour (Transfer of Departmental Administration and Ministerial Functions) Order, 1993 ( S.I. No. 18 of 1993 ) (as adapted by the Enterprise and Employment (Alteration of Name of Department and Title of Minister) Order, 1997 ( S.I. No. 305 of 1997 )), and the Enterprise, Trade and Employment (Delegation of Ministerial Functions)(No. 2) Order, 1997 ( S.I. No. 330 of 1997 ) and after consultation with the National Authority for Occupational Safety and Health, and for the purpose, amongst other things, of giving effect to Council Directive 90/394/EEC¹ as amended by Council Directives 97/42/EC² and 99/38/EC³ hereby make the following regulations:

These Regulations may be cited as the Safety, Health and Welfare at Work (Carcinogens) Regulations, 2001.

• (1) In these Regulations

“Act” means the Safety, Health and Welfare at Work Act, 1989 (No. 7 of 1989);

“carcinogen” means:

• (a) a substance which meets the criteria for classification as a category 1 or 2 carcinogen set out in Annex VI of Directive 67/548/EEC⁴ ,

• (b) a preparation composed of one or more substances referred to in subparagraph (a) where the concentration of one or more of the substances meets the requirements for concentration limits for the classification of a preparation as a category 1 or 2 carcinogen set out in either:

• (i) Annex I to Directive 67/548/EEC, or

• (ii) Annex I to Directive 88/379/EEC⁵ where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

or

• (c) a substance, preparation or process referred to in Schedule 1 and a substance or preparation released by a process referred to in Schedule 1;

“employer” means, for the purposes of these Regulations, an employer of employees who are, or who are likely to be, exposed to carcinogens or mutagens as a result of their work;

“exposure” means, unless otherwise specified, an exposure to a carcinogen or mutagen;

“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 reference period as set out in Schedule 2;

“mutagen” means:

• (a) 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;

• (b) a preparation composed of one or more substances referred to in subparagraph (a) 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:

• (i) Annex I to Directive 67/548/EEC, or

• (ii) 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;

“responsible medical practitioner” means the registered medical practitioner employed, or otherwise engaged, by an employer to be responsible for health surveillance of employees covered by these Regulations.

• (2) A word or provision used in these Regulations and also used in Council Directive 90/394/EEC as last amended by Council Directive 99/38/EC shall have the same meaning in these Regulations as it has in that Directive.

• (3) In these Regulations a reference to a paragraph or subparagraph is to a paragraph or subparagraph in the provision in which the reference occurs, unless it is indicated that reference to some other provision is intended, and a reference to a Regulation or a Schedule is to a Regulation of, or a Schedule to these Regulations, unless it is indicated that reference to some other Regulation or Schedule is intended.

• (4) These Regulations shall apply in addition to the European Communities (Protection of Workers) (Exposure to Asbestos) Regulations, 1989 ( S.I. No. 34 of 1989 ), the European Communities (Protection of Workers)(Exposure to Asbestos)(Amendment) Regulations, 1993 ( S.I. No. 276 of 1993 ), and the European Communities (Protection of Workers)(Exposure to Asbestos)(Amendment) Regulations, 2000 ( S.I. No. 74 of 2000 ), where such application will result in an improvement of the conditions of health and safety of every person at work at the workplace who is, or who may be exposed to asbestos or dust containing asbestos.

• (1) These Regulations shall apply to a self-employed person as they apply to an employer and as if that self-employed person was an employer and his own employee.

• (2) These Regulations shall apply to an employer in respect of the use by him of the services of a fixed-term employee or a temporary employee, taking into account the provisions of Regulation 4 of the Safety, Health and Welfare at Work (General Application) Regulations, 1993 ( S.I. No. 44 of 1993 ).

• (3) Where duties, however expressed, are placed by these Regulations on an employer in respect of any of his employees at a workplace, he shall be under a like duty in respect of every other person at work at that workplace who is or may be exposed at that place to a carcinogen or a mutagen as defined in Regulation 2 (1), except that the duties under Regulations 12 and 13 shall not apply to persons who are not his employees.

It shall be the duty of every employer-

• (a) to apply the measures specified in Schedule 3 wherever a carcinogen or mutagen is used at that employer's place of work,

• (b) to assess any risk to any employee's health or safety resulting from any activity at that employer's place of work likely to involve a risk of exposure of any employee to carcinogens or mutagens, and for that purpose to determine the nature, degree and duration of any employee's exposure to carcinogens or mutagens, and to lay down the resulting measures to be taken to ensure the safety and health of employees,

• (c) to renew the assessment required by paragraph (b) regularly and in any event whenever there is a change in conditions at the place of work which may affect any employee's exposure to carcinogens or mutagens,

• (d) to take account of all other routes of exposure to carcinogens or mutagens, including absorption either into or through the skin or both, when assessing a risk of exposure,

• (e) to give particular attention to any effects concerning the health or safety of employees at particular risk and to take account of the desirability of not having such employees present in areas where they may be exposed to carcinogens or mutagens,

• (f) to prevent exposure of employees to carcinogens or mutagens at a place of work where the results of the assessment required by paragraph (b) reveal a risk to employees' health or safety,

• (g) to 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 eliminates or reduces the risk to an employee's health or safety,

• (h) to ensure that any carcinogen or mutagen is (in so far as is technically possible) used in a closed system whenever it is not technically possible to replace a carcinogen or mutagen in accordance with the provisions of paragraph (g),

• (i) to ensure that the level of exposure of employees is reduced to as low a level as is technically possible where it is not technically possible to use a system referred to in paragraph (h),

• (j) to ensure that exposure shall not exceed the limit value of a carcinogen or mutagen as set out in Schedule 2,

• (k) to ensure, in the case of areas where an assessment under paragraph (b) reveals a risk to employees' safety and health, that only those employees are permitted to enter who must do so in order to perform their work or duties, and

• (l) to ensure that all containers, packages and installations containing carcinogens or mutagens are labelled clearly and legibly and display clearly visible warning and hazard signs.

• (1) The employer shall provide the Authority when requested with the findings of any assessment carried out under Regulation 4 (b).

• (2) Where an assessment carried out under Regulation 4 (b) reveals a risk to any employee's health or safety, the employer shall provide the Authority, when requested, with information relating to-

• (a) the activities 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 employees exposed to carcinogens or mutagens,

• (d) the preventive measures taken to prevent or reduce such exposure,

• (e) the type of personal protective equipment used for the purpose of such measures,

• (f) the nature and degree of exposure of employees to carcinogens or mutagens, and

• (g) the replacement substances or preparations used to reduce such exposure.

• (1) An employer, wherever a carcinogen or mutagen is used at that employer's place of work, shall inform the employees in the event of any unforeseeable event or an accident which is likely to result in an abnormal exposure of employees to carcinogens or mutagens.

• (2) An employer shall ensure that until the situation referred to in paragraph (1) has been restored to normal and the cause of abnormal exposure has been eliminated-

• (a) only employees who are essential to the carrying out of repairs and other necessary work shall be permitted to work in an area of abnormal exposure,

• (b) employees so employed shall be provided with protective clothing and individual respiratory protection equipment,

• (c) such exposure of employees is not permanent and is kept to the minimum time necessary, and

• (d) unprotected employees shall not be allowed to work in an area of abnormal exposure.

• (3) Taking account of the provisions of Regulation 6 of the Safety, Health and Welfare at Work (General Application) Regulations, 1993, the employer shall ensure that the provisions of paragraphs (1) and (2) are applied in relation to the employees of such other persons and self-employed persons who may be associated with such abnormal exposure to carcinogens or mutagens.

• (4) It shall be the duty of every employee to wear personal protective equipment provided by an employer in compliance with subparagraph (2)(b) and taking account of Regulation 14 of the Safety, Health and Welfare at Work (General Application) Regulations, 1993.

• (1) It shall be the duty of every employer in respect of any activity where there is a potential for a significant increase in exposure of employees to carcinogens or mutagens, and in respect of which all scope for further technical preventive measures for limiting employees' exposure has already been exhausted, to-

• (a) consult with the employees or their representatives on measures for limiting exposure by reducing the duration of exposure,

• (b) provide employees with individual respiratory equipment and protective clothing during any period of abnormal exposure,

• (c) ensure that exposure is not permanent and is kept to a minimum for each employee, and

• (d) take appropriate measures to ensure that the areas in which abnormal exposure prevails are clearly demarcated and indicated or that unauthorised persons are prevented by other means from having access to such areas.

• (2) It shall be the duty of an employee to wear personal protective equipment provided by an employer in compliance with subparagraph (1)(b) and taking account of Regulation 14 of the Safety, Health and Welfare at Work (General Application) Regulations, 1993 ( S.I. No. 44 of 1993 ).

• (3) Taking account of the provisions of Regulation 6 of the Safety, Health and Welfare at Work (General Application) Regulations, 1993, the employer shall ensure that the provisions of paragraphs (1) and (2) are applied in relation to the employees of such other persons and self-employed persons where there is a potential for a significant increase in exposure to carcinogens or mutagens.

• (1) It shall be the duty of every employer, in the case of any activity in relation to which there is a risk of contamination by carcinogens or mutagens, to take appropriate measures to ensure that-

• (a) employees do not eat, drink or smoke in any working area where there is such a risk,

• (b) employees are provided with appropriate protective or other appropriate special clothing,

• (c) separate storage places are provided for working or protective clothing and for ordinary clothes,

• (d) personal protective equipment is properly stored in a designated place, and cleaned where possible and checked before use and in any case after each use, and

• (e) such equipment found to be defective is repaired or replaced, as may be appropriate.

Taking account of the provisions of Regulation 7 of the Safety, Health and Welfare at Work (General Application) Regulations, 1993, it shall be the duty of every employer to provide personal protective equipment required to be provided by these Regulations free of charge.

• (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) the wearing and use of protective equipment and clothing,

• (e) steps to be taken by employees including those to be taken during rescue operations, in the case of incidents and to prevent incidents,

• (f) the consequences for employees' safety and health of the selection, wearing and use of protective clothing and equipment, and

• (g) installations and related containers containing carcinogens or mutagens and the significance of the labelling, warning and hazard signs referred to in Regulation 4 (1).

• (a) can check the means by which these Regulations are applied,

• (b) can be involved in the implementation of these Regulations,

• (c) are informed of the measures determined for limiting employee exposure referred to in Regulation 7, and

• (d) are informed as quickly as possible of the type of exposure referred to in Regulation 6 (1), of the causes thereof and of the measures taken or to be taken in relation thereto.

• (a) keep an up-to-date list of the employees engaged in the activities in respect of which the results of the assessment referred to in Regulation 4(b) reveal a risk to employees' health and safety, indicating, if the information is available, the exposure to which they have been subjected and this list shall be made available on request to the responsible medical practitioner or the Authority for inspection,

• (b) ensure that each employee has access to the information on the list which relates to him personally, and

• (c) ensure that the employees or their safety representatives, or both, in the undertaking have access to anonymous collective information.

It shall be the duty of every employer to ensure that consultation of employees or their safety representatives (or both) as regards the requirements of these Regulations, takes place in accordance with the provisions of Regulation 12 of the Safety, Health and Welfare at Work (General Application) Regulations, 1993.

• (1) It shall be the duty of every employer-

• (a) to make provision for relevant health surveillance to be made available, under the responsibility, where appropriate, of a responsible medical practitioner, for those employees for whom the results of an assessment carried out under Regulation 4(b) reveal a risk to their health or safety,

• (b) to ensure that the health surveillance required by subparagraph (a), where appropriate includes health surveillance made available prior to exposure and at regular intervals thereafter, and that these arrangements are such that it is directly possible to implement individual and occupational hygiene measures,

• (c) to ensure that where an employee is found to be suffering from an abnormality, which is suspected to be the result of exposure to carcinogens or mutagens, health surveillance is made available to other employees, who have been similarly exposed, whenever requested by a responsible medical practitioner or the Authority,

• (d) to ensure that, where the surveillance required by subparagraph (c) is undertaken, a further re-assessment of the risk of exposure is made in accordance with Regulation 4 (b),

• (e) to ensure that where an employee receives health surveillance under this Regulation that an individual health record is kept of such matters,

• (f) to ensure that any employee may request a review of the results of any health surveillance he may undergo.

• (2) It shall be the duty of any responsible medical practitioner, under whose responsibility an employee receives health surveillance under this Regulation-

• (a) to keep an individual confidential medical record, and

• (b) to propose any protective or preventive measures necessary in respect of any individual employee.

• (3) An employer shall ensure that employees are provided with information and advice regarding any health surveillance which they may undergo following the end of exposure.

• (4) It shall be the duty of the responsible medical practitioner in respect of paragraph (2)(a) and the employer in respect of paragraph (1)(e) to give access to an employee to the results of his own health surveillance.

• (5) It shall be the duty of the responsible medical practitioner to allow access to individual confidential medical records to an occupational medical adviser who is designated under section 34 (4) (a) of the Act.

• (6) It shall be the duty of a responsible medical practitioner when carrying out relevant health surveillance required by this Regulation to take account of the recommendations in Schedule 4.

• (7) It shall be the duty of an employer who becomes aware of, or of any registered medical practitioner including a responsible medical practitioner who diagnoses a case of cancer resulting from occupational exposure, to notify such case to the Authority.

• (8) In this Regulation “health surveillance” means the periodic review, for the purpose of protecting health and preventing occupationally related disease, of the health of employees, so that any adverse variations in their health which may be related to working conditions are identified as early as possible.

The list referred to in Regulation 10(4)(a), the health record referred to in Regulation 12(1)(e) and the medical record referred to in Regulation 12(2)(a) shall be kept for at least 40 years following the end of the relevant exposure, and shall be deposited with the Authority if an employer ceases to be an employer for the purposes of these Regulations.

The Safety, Health and Welfare at Work (Carcinogens) Regulations, 1993 ( S.I. No. 80 of 1993 ), are revoked.

SCHEDULE 1

Regulation 2(c)

List of Substances, Preparations and Processes referred to in Regulation 2 (c)

• (1) Aflatoxins

• (2) Arsenic

• (3) Auramine manufacture

• (4) Isopropyl alcohol manufacture (strong acid process)

• (5) Leather dust arising during preparation and finishing in boot and shoe manufacture

• (6) Magenta manufacture

• (7) Mustard gas (β,β ' -dichlorodiethyl sulphide)

• (8) Rubber manufacturing and processing giving rise to rubber process dust and rubber fume

• (9) Work involving exposure to aromatic polycylic hydrocarbons present in coal soot, coal tar or coal pitch.

• (10) Work involving exposure to dusts, fumes and sprays produced during the roasting and electro-refining of cupro-nickel mattes.

(11)⁶ Work involving exposure to hardwood dusts.

(Note - Entries at points (1),(2),(5),(6),(7) and (8) are from the British HSE EH40 list)

SCHEDULE 2

Regulations 2 and 4 (b)(j)

Limit Values for Occupational Exposure

Name of Agent	Einecs7	CAS8	Limit Values	Limit Values	Notation	Transitional Measures
			mg/m39	ppm10
Benzene	200-753-7	71-43-2	3.25 11	1 12	Sk 6	Limit value: 3 ppm (= 9.75 mg/m3) until 27^th June, 2001
Vinyl chloride monomer	200-831-0	75-01-4	7.77 14	315	-	-
Hardwood Dusts	-	-	5.0 16 7	-	-	-

SCHEDULE 3

Regulation 4

Measures required under Regulation 4 (a)

• (1) Limitation of the quantities of a carcinogen or mutagen at the place of work.

• (2) The keeping as low as possible of the number of employees exposed or likely to be exposed to a carcinogen or mutagen.

• (3) Design of work processes and engineering control measures so as to avoid or minimise the release of carcinogens or mutagens into the place of work.

• (4) The use of appropriate systems for the extraction of carcinogens or mutagens at source compatible with the need to protect health and the environment.

• (5) The use of appropriate procedures for the measurement of carcinogens or mutagens, in particular for the early detection of abnormal exposures resulting from an accident or other unforeseen event.

• (6) The use of suitable working procedures and methods.

• (7) The use of collective protection measures and where exposure cannot be avoided by other means, individual protection measures.

• (8) The use of hygiene measures, in particular regular cleaning of floors, walls and other surfaces.

• (9) The provision of information for employees.

• (10) The demarcation of risk areas and the use of adequate warning and safety signs, including “no smoking” signs, in areas where employees are exposed or are likely to be exposed to carcinogens or mutagens.

• (11) The drawing up of plans to deal with emergencies likely to result in abnormally high exposure.

• (12) The means for safe storage, handling and transportation, in particular by using sealed containers which are clearly and visibly labelled.

• (13) The means for safe collection, storage and disposal of carcinogenic or mutagenic waste by employees, including the use of sealed containers which are clearly and visibly labelled.

SCHEDULE 4

Regulation 12

Practical Recommendations for the Health Surveillance of Employees

• keeping records of an employee'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 employee when he is the subject of health surveillance, in the light of the most recent knowledge available to occupational medicine.

	GIVEN under my hand this 8th day of March, 2001.
	TOM KITT, T.D.
	Tom Kitt
	Minister of State at the Department of Enterprise, Trade and Employment

EXPLANATORY NOTE

(This note is not part of the instrument and does not purport to be a legal interpretation.)

These Regulations give effect to Council Directive 90/394/EEC of 28 June, 1990 as amended by Directives 97/42/EC of 27 June 1997 and 1999/38/EC of 29 April 1999 on the protection of workers from the risks related to exposure to carcinogens and mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC).

Under the Regulations employers must carry out an assessment of the risks associated with the use of a carcinogen or mutagen in the workplace, and take steps to control such risks by eliminating or minimising exposure.

Employers must also ensure that employees who are at possible risk of exposure to carcinogens or mutagens are consulted and provided with information and training on the nature of the hazards and risks of carcinogens or mutagens. Employees must also be provided with the facility to undergo health surveillance if desired.

The Regulations require employers to maintain records on the results of assessments, measurements of exposure and health surveillance. Such records must be available to the National Authority for Occupational Safety and Health.

Footnotes