Safety, Health and Welfare at Work (Biological Agents) Regulations 2013

• Jurisdiction: Ireland

ARRANGEMENT OF REGULATIONS

PART 1

Preliminary and general

1. Citation and commencement.

2. Interpretation.

3. Application.

4. Prohibitions.

PART 2

Duties of employers and employees

5. Duties of employers.

6. Duties of employees.

PART 3

Protective and preventive measures

7. Risk assessment.

8. Information, training and consultation of employees.

9. Hygiene.

10. Individual protection.

11. Vaccination.

12. Health surveillance.

13. Emergency plans.

PART 4

Notification and record keeping

14. Information and notification to be provided to the Authority.

15. Occupational exposure lists.

PART 5

Special measures

16. Health care and veterinary care facilities other than diagnostic laboratories.

17. Laboratories, industrial processes and animal rooms.

PART 6

Revocations

18. Revocations.

SCHEDULE 1

Indicative list of activities.

SCHEDULE 2

Prevention and risk reduction measures.

SCHEDULE 3

Biohazard sign.

SCHEDULE 4

Matters relating to vaccination practice.

SCHEDULE 5

Matters relating to health surveillance of employees.

S.I. No. 572 of 2013

SAFETY, HEALTH AND WELFARE AT WORK (BIOLOGICAL AGENTS) REGULATIONS 2013

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 3rd January, 2014.

I, RICHARD BRUTON, Minister for Jobs, Enterprise and Innovation, in exercise of the powers conferred on me by section 58 of the Safety, Health and Welfare at Work Act 2005 (No. 10 of 2005), and for the purpose of giving effect to Directive 2000/54/EC of the European Parliament and of the Council of 18 September 20001 and after consultation with the Health and Safety Authority, hereby make the following regulations:

PART 1

Preliminary and general

Citation and commencement

1. These Regulations may be cited as the Safety, Health and Welfare at Work (Biological Agents) Regulations 2013.

Interpretation

2. In these Regulations, save where the context otherwise requires—

“Act” means the Safety, Health and Welfare at Work Act 2005 (No. 10 of 2005);

“biological agent” 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, classified into 4 risk groups according to their level of risk of infection, as follows (if the biological agent to be assessed cannot be classified clearly in one of the following groups, it shall be classified in the highest risk group among the alternatives):

(a) a “group 1 biological agent” means one that is unlikely to cause human disease to employees;

(b) a “group 2 biological agent” means one that can cause human disease and might be a hazard to employees, although it is unlikely to spread to the community and in respect of which there is usually effective prophylaxis or treatment available;

(c) a “group 3 biological agent” means one that can cause severe human disease and presents a serious hazard to employees and that may present a risk of spreading to the community, though there is usually effective prophylaxis or treatment available;

(d) a “group 4 biological agent” means one that causes severe human disease and is a serious hazard to employees and that may present a high risk of spreading to the community and in respect of which there is usually no effective prophylaxis or treatment available;

“cell culture” means the in-vitro growth of cells derived from multicellular organisms;

“exposure” means exposure of an employee at a place of work to a biological agent;

“hazard” means a potential source of injury or damage to health from exposure;

“incident” means an occurrence which involves the risk of exposure;

“micro-organism” means a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material;

“occupational medical adviser” means a person designated under section 63 of the Act;

“relevant code of practice” means a code of practice, relating to these Regulations, published under section 60 of the Act;

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

Application

3. (1) Subject to paragraph (2), these Regulations, and any relevant code of practice, apply to activities in a place of work where existing or potential, whether deliberate or incidental, exposure to a biological agent has occurred or may occur.

(2) Where the results of a risk assessment under Regulation 7 show that there is exposure or potential exposure (or both) to a group 1 biological agent, including attenuated vaccines, with no identifiable health risks to employees, Regulations 5(b)(ii) to (iv) and (vi) to (xiv), 6, 7(1)(c) and (f), 7(2)(a) and (b), 8, 9, 10, 11, 12, 13, 14(1)(b) to (f), 14(2) to (4), 15, 16 and 17 shall not apply in relation to such exposure, but the principles of good occupational safety and hygiene shall be observed.

(3) Obligations and duties arising under these Regulations are in addition to obligations and duties arising under any other enactment.

(4) In this Regulation, “enactment” means—

(a) an Act of the Oireachtas,

(b) a statute that was in force in Saorstát Éireann immediately before the date of the coming into operation of the Constitution and that continues in force by virtue of Article 50 of the Constitution, or

(c) an instrument made under—

(i) an Act of the Oireachtas, or

(ii) a statute referred to in subparagraph (b).

Prohibitions

4. The Authority, on receipt of a notification referred to in Regulation 14(1)(e), may prohibit the use of the biological agent or agents referred to in the notification or require the application of additional controls to safeguard the safety, health and welfare of employees from exposure to the said notified agent or agents.

PART 2

Duties of employers and employees

Duties of employers

5. Where an employee is, or is likely to be, exposed to biological agents as a result of his or her work activities, his or her employer shall—

(a) apply these Regulations and any relevant code of practice,

(b) without prejudice to paragraph (a)—

(i) complete a risk assessment as required under Regulation 7 and apply, if appropriate, the special measures specified in Regulations 16 and 17,

(ii) avoid the use of a harmful biological agent, if the nature of the activity so permits, by replacing it with a biological agent which, under its conditions of use and in the present state of knowledge, is not dangerous or is less dangerous, as the case may be, to the health of employees,

(iii) prevent the exposure of employees to a biological agent at a place of work where the results of the risk assessment under Regulation 7 reveal a risk to employees health and safety,

(iv) where the results of the risk assessment under Regulation 7 reveal that it is not technically possible to prevent exposure, apply the prevention and risk reduction measures specified in Schedule 2, in order to ensure that, as far as technically practicable, the level of exposure of employees is reduced to as low a level as necessary in order to adequately protect the health and safety of the employees concerned,

(v) where the results of the risk assessment under Regulation 7 show that the exposure or potential exposure (or both) is to a group 1 biological agent, including live attenuated vaccines, with no identifiable health risk to employees, ensure that the principles of good occupational safety and hygiene are applied,

(vi) where a risk assessment under Regulation 7(1)(f) shows that the activity may result in exposure to a biological agent, as in the course of the activities for which an indicative list is given in Schedule 1, comply with the provisions of these Regulations, unless the results of such assessment show such compliance to be unnecessary,

(vii) provide information and training and consult with employees as required under Regulation 8,

(viii) make available facilities and put in place procedures as specified in Regulation 9,

(ix) provide for the supply of suitable work clothing, special protective clothing and personal protective equipment as required under Regulation 10,

(x) make effective vaccines available as required under Regulation 11,

(xi) provide, as required under Regulation 12, relevant health surveillance prior to exposure and at such intervals as are necessary,

(xii) establish and maintain safety precautions, emergency procedures and plans as appropriate and required under Regulation 13,

(xiii) provide information and notification to the Authority as specified in Regulation 14, and

(xiv) maintain, as required under Regulation 15, for the purposes of this subparagraph, a list of the employees who have been or may be exposed to any or all of—

(I) a group 2 biological agent specified in a relevant code of practice,

(II) a group 3 biological agent, and

(III) a group 4 biological agent.

Duties of employees

6. An employee shall report immediately to his or her employer, or to the person responsible for safety and health at work in the employers undertaking, any accident or incident of which he or she becomes aware, involving exposure, or risk of exposure, to, or release of, a biological agent involving, or likely to involve, a risk to the health or safety of an employee.

PART 3

Protective and preventive measures

Risk assessment

7. (1) Subject to Regulations 16 and 17, an employer shall—

(a) assess any risk, whether existing or potential, to the health and safety of employees resulting from any activity at that employers place of work likely to involve a risk of exposure and for that purpose determine the nature, degree and duration of any such risk and apply—

(i) the prevention and risk reduction measures specified in Schedule 2 to be taken, and

(ii) any special...