IE
S.I. No. 572/2013 - Safety, Health and Welfare at Work (Biological Agents) Regulations 2013.
Table of Provisions (18)
Statutory Text (18 Articles)
1. A responsible medical practitioner shall be familiar with the exposure conditions or circumstances of each employee.
2. Health surveillance of employees shall be carried out in accordance with the principles and practices of occupational medicine; it shall include at least the following measures
(
a
) keeping records of an employees medical and occupational history;
(
b
) a personalised assessment of the employees state of health;
(
c
) where appropriate, biological monitoring as well as detection of early and reversible effects.
3. Further tests may be decided upon for each employee, when he or she is the subject of health surveillance, in the light of the most recent knowledge available to occupational medicine.
GIVEN under my Official Seal,
20 December 2013.
RICHARD BRUTON,
Minister for Jobs, Enterprise and Innovation.
EXPLANATORY NOTE
(This note is not part of the Instrument and does not purport to be a legal interpretation.)
These Regulations transpose Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work. This is a codified Directive which repealed and replaced Council Directive 90/679/EEC of 26 November 1990 as amended by Council Directive 93/88/EEC of 12 October 1993, Commission Directive 95/30/EC of 30 June 1995, Commission Directive 97/59/EC of 7 October 1997, and Commission Directive 97/65/EC of 26 November 1997.
These Directives were previously transposed in Ireland through the Safety, Health and Welfare at Work (Biological Agents) Regulations 1994 (
S.I. No. 146 of 1994
) and the Safety, Health and Welfare at Work (Biological Agents) (Amendment) Regulations 1998 (
S.I. No. 248 of 1998
). The 1994 and 1998 Regulations are repealed and replaced by these Regulations which transpose Directive 2000/54/EC.
These Regulations enable the publication of some aspects of the Biological Agents Directive (i.e. the list of biological agents and their classification, together with indications concerning containment measures and levels) in a relevant Code of Practice, rather than in the Regulations themselves.
These Regulations define biological agents and apply to activities in which workers are or potentially are exposed to biological agents as a result of their work. Employers must identify the biological agent to which workers are, or may be, exposed. They must assess the risk, making use of the list of biological agents, their classification, containment levels and measures provided for in the relevant Code of Practice, and proceed in accordance with the remaining Regulations where appropriate.
These Regulations permit the Health and Safety Authority to prohibit a specific use of a Biological Agent or request that additional control measures are put in place (Regulation 4).
1 O.J. No. L 262, 17.10.2000, p.21.
4. A vaccination certificate may be drawn up which shall be made available to the employee concerned and, on request, to the Authority.
SCHEDULE 5
Regulation 12(4)(a)
Matters relating to health surveillance of employees
5. The use of the biohazard sign depicted in Schedule 3, and other relevant warning signs which are in compliance with Regulations 158 to 162 of and Schedule 9 to the Safety, Health and Welfare at Work (General Application) Regulations 2007 (
S.I. No. 299 of 2007
).
6. The drawing up of plans to deal with accidents involving a biological agent.
7. The testing, where necessary and technically possible, for the presence, outside the primary physical confinement, of a biological agent used at work.
8. The use of means for the safe collection, storage and disposal of waste by employees, including the use of secure and identifiable containers, after suitable treatment where appropriate.
9. The making of arrangements for the safe handling and transport of a biological agent within the place of work.
SCHEDULE 3
Schedule 2(5)
Biohazard sign
SCHEDULE 4
Regulation 11(b) and Regulation 12(4)(a)
Matters relating to vaccination practice
10. (1) In the case of any activity in relation to which there is a risk to the health or safety of employees caused by working with a biological agent, an employer shall provide all employees so at risk with—
(
a
) suitable work clothing,
(
b
) special protective clothing, and
(
c
) personal protective equipment.
(2) An employer shall ensure that—
(
a
) suitable work clothing, special protective clothing and personal protective equipment, referred to in paragraph (1), which may be contaminated by a biological agent, are removed on leaving the working area and, before taking the measures referred to in subparagraph (
b
), are kept separately from other clothing in a well defined place, and
(
b
) the suitable work clothing, special protective clothing and personal protective equipment referred to in subparagraph (
a
) are checked before and after each use and cleaned and decontaminated or, if necessary, destroyed.
Vaccination
11. In the case of any activity in relation to which there is a risk to the health or safety of employees caused by working with a biological agent, an employer shall—
(
a
) make effective vaccines available, when necessary, to those employees who are not already immune to the biological agent to which they are exposed or are likely to be exposed, and
(
b
) comply with the matters set out in Schedule 4 when making vaccines available to employees.
Health surveillance
12. (1) In the case of any activity in relation to which there is a risk to the health or safety of employees due to work with a biological agent, an employer shall—
(
a
) make provision for appropriate health surveillance as provided for in section 22 of the Act to be made available, and undertaken by a responsible medical practitioner, for each employee for whom the results of a risk assessment under Regulation 7 reveal a risk to his or her health or safety as a result of exposure,
(
b
) ensure that, where appropriate, the health surveillance required under subparagraph (
a
) includes health surveillance made available prior to exposure and at such intervals as are necessary thereafter and that these arrangements are such that it is directly possible to implement appropriate individual and occupational hygiene measures,
(
c
) ensure that, where an employee is found to be suffering from an infection or illness (or both) which is suspected to be the result of exposure, health surveillance is made available to all other employees who have been similarly exposed, whenever requested by the responsible medical practitioner or by the Authority,
(
d
) ensure that where the health surveillance required under subparagraph (
c
) is undertaken, the risk assessment is reviewed and, as appropriate, amended in accordance with Regulation 7(1)(
d
),
(
e
) ensure that, where an employee receives health surveillance under this Regulation, an individual health record of such matters is kept by such employer for at least 10 years following the end of exposure of that employee, and
(
f
) in the case of an employee referred to in paragraph (
c
) of Regulation 15, keep an individual health record for such employee for an appropriately longer time, not exceeding 40 years, to be determined as provided for in that paragraph, following the last known exposure of the employee concerned.
(2) An employer shall ensure that each employee is provided with information and advice regarding any health surveillance which he or she may undergo following the end of exposure of such employee.
(3) A responsible medical practitioner and an employer, as appropriate, shall give access to an employee to the results of the health surveillance, or review of same, which concern that employee.
(4) A responsible medical practitioner, when carrying out relevant health surveillance under this Regulation, shall—
(
a
) comply with the requirements contained, and take account of the other matters specified, in Schedules 4 and 5,
(
b
) propose any protective or preventive measures to be taken, including any special protective measures which may be required, in respect of any individual employee, as appropriate,
(
c
) allow access to the individual confidential medical record of any individual employee to an occupational medical adviser,
(
d
) make available to the Authority or such person as the Authority directs, each individual confidential medical record of an individual employee held by him or her, in cases where—
(i) the employers undertaking ceases activity, or
(ii) he or she is ceasing to practice as a registered medical practitioner,
and
(
e
) keep an individual confidential medical record and retain that record for at least 10 years and, taking account of cases referred to in paragraph (
c
) of Regulation 15, keep an individual confidential medical record for an appropriately longer time, not exceeding 40 years, to be determined as provided for in that paragraph, following the last known exposure of the employee.
(5) An employer who becomes aware of, or a registered medical practitioner (including a responsible medical practitioner) who diagnoses, a case of disease or death of an employee resulting from occupational exposure to a biological agent, shall notify such occurrence to the Authority.
(6) An employer may request a review of the results of the health surveillance referred to in subparagraph (
a
) of paragraph (1).
(7) Where an individual confidential medical record of an employee is, pursuant to subparagraph (
d
) of paragraph (4), made available to the Authority or such person as the Authority directs, the Authority or such person, as the case may be, shall retain that record for a period of time equivalent to the length of time not yet elapsed of whichever of the periods referred to in subparagraph (
e
) of paragraph (4) is relevant in relation to the employee concerned.
Emergency plans
13. In the case of any activity in relation to which there is a risk to the health or safety of employees due to work with a biological agent, an employer shall establish and maintain safety precautions, emergency procedures and plans appropriate to the hazards in the place of work.
PART 4
Notification and record keeping
Information and notification to be provided to the Authority
14. (1) An employer shall—
(
a
) provide the Authority, when requested, with the information used for making any risk assessment carried out under Regulation 7 and with the findings of any such assessment,
(
b
) where the results of a risk assessment carried out under Regulation 7 reveal a risk to an employees health or safety, provide the Authority, when requested, with appropriate information relating to—
(i) the said results,
(ii) the activities in which employees have been exposed or may have been exposed,
(iii) the number of employees exposed,
(iv) the name and competencies of the person responsible for safety and health at work,
(v) the protective, preventive and risk reduction measures, and any special protective measures, taken, including working procedures and methods, and
(vi) an emergency plan for the protection of employees from exposure to a biological agent which might result from a loss of physical containment,
(
c
) provide employees or their safety representatives (or both), at their request, with the information referred to in subparagraph (
b
),
(
d
) immediately notify 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 or illness (or both),
(
e
) notify the Authority—
(i) at least 30 days prior to the commencement of work involving the use for the first time of biological agents from the risk groups in paragraphs (
b
), (
c
) and (
d
) of the definition of “biological agent” in Regulation 2,
(ii) subject to subparagraph (iii), at least 30 days prior to the commencement of work involving the use for the first time of each subsequent group 4 biological agent and each subsequent new group 3 biological agent, where the employer provisionally classifies that biological agent,
(iii) in the case of laboratories providing a purely diagnostic service in relation to a group 4 biological agent, only the initial intention to use for the first time the biological agent concerned, and
(iv) in any case where there are substantial changes of importance to safety and health at work to either or both processes and procedures which render the notifications required by clause (i), (ii) or (iii) out of date,
and
(
f
) include in the notification required by subparagraph (
e
)—
(i) the name and address of the employer and, where different, the place of work,
(ii) the name and competencies of the person responsible for safety and health at work,
(iii) the results of the risk assessment under Regulation 7,
(iv) the species of the biological agent, and
(v) the protection and preventive and risk reduction measures that are envisaged.
(2) Where an employers undertaking is to cease activity, the employer shall, before such cessation, deliver the list required by Regulation 15 and the individual health records required by Regulation 12(1)(
e
) to the Authority.
(3) Where an employer that is a body corporate fails, before the cessation referred to in paragraph (2), to deliver the list required by Regulation 15 and the individual health records as required by that paragraph, any person who was, at the time of such cessation, a director of the said body corporate shall be personally liable to ensure delivery of the said list and the said individual health records to the Authority.
(4) Where either or both a list required by Regulation 15 and the individual health records required by Regulation 12(1)(
e
) are delivered to the Authority, the Authority shall retain that list and those records for a period of time equivalent to the length of time not yet elapsed of whichever of the periods referred to in paragraphs (
b
) and (
c
) of Regulation 15 and subparagraphs (
e
) and (
f
) of Regulation 12(1) is relevant in relation to the employees concerned.
Occupational exposure lists
15. In the case of any activity in relation to which there is a risk to the health or safety of employees due to work with a biological agent, an employer shall—
(
a
) maintain a list (in this Regulation referred to as “the list”) of the employees who have been or may be exposed to any or all of—
(i) a group 2 biological agent specified, for the purposes of this paragraph, in a relevant code of practice,
(ii) a group 3 biological agent, and
(iii) a group 4 biological agent,
indicating the type of work done or to be done by each employee, and, whenever possible, the biological agent to which they have been or may be exposed, as well as records of exposures, accidents and incidents, as appropriate,
(
b
) keep the list for at least 10 years following the end of the last known exposure,
(
c
) keep the list for an appropriately longer period not exceeding 40 years following the last known exposure, depending on the likely duration of risk to the health and safety of employees determined during the risk assessment referred to in Regulation 7, following the last known exposure in the case of those exposures which may result in an infection—
(i) with a biological agent known to be capable of establishing persistent or latent infections,
(ii) that in the light of present knowledge is not diagnosable until illness develops many years later,
(iii) that has particularly long incubation periods before illness develops,
(iv) that results in illness that recrudesces at times over a long period despite treatment, or
(v) that results in illness that may have serious long-term sequelae,
(
d
) ensure that each employee has access to the information on the list which relates to him or her, personally,
(
e
) ensure that the employees or their safety representative (or both) have access to collective information from the list which does not identify information relating to any individual employee, and
(
f
) ensure that the list is made available, on request, to the responsible medical practitioner, the Authority or an occupational medical adviser.
PART 5
Special measures
Health care and veterinary care facilities other than diagnostic laboratories
16. In the case of health care and veterinary care facilities other than diagnostic laboratories, an employer shall—
(
a
) when carrying out a risk assessment under Regulation 7 pay particular attention to—
(i) the risks posed by the nature of the work,
(ii) uncertainties about the presence of a biological agent in human patients or animals and the materials and specimens taken from them, and
(iii) the hazard represented by a biological agent known or suspected to be present in human patients or animals and the materials and specimens taken from them,
(
b
) take appropriate measures to protect the health and safety of employees at a place of work which is either a health care facility or veterinary care facility including, in particular, by—
(i) specifying appropriate decontamination and disinfection procedures, and
(ii) implementing procedures enabling contaminated waste to be handled and disposed of without risk,
and
(
c
) apply appropriate containment measures, as specified in a relevant code of practice, in order to minimise the risk of infection at a place of work which is an isolation facility where there are either human patients or animals who are or who are suspected of being infected with—
(i) a group 2 biological agent specified, for the purposes of this paragraph, in a relevant code of practice,
(ii) a group 3 biological agent, or
(iii) a group 4 biological agent.
Laboratories, industrial processes and animal rooms
17. (1) This Regulation applies to an employer at a place of work which is either or both—
(
a
) a laboratory, including a diagnostic laboratory, and
(
b
) a room for laboratory animals, which animals—
(i) have been deliberately infected with—
(I) a group 2 biological agent,
(II) a group 3 biological agent, or
(III) a group 4 biological agent,
or
(ii) are, or are suspected to be, carriers of such an agent.
(2) An employer to whom paragraph (1) applies shall—
(
a
) as part of the risk assessment required by Regulation 7, where work is to be carried out which involves the handling of a biological agent from any of the risk groups in paragraphs (
b
), (
c
) and (
d
) of the definition of “biological agent” in Regulation 2 for research, development, teaching or diagnostic purposes, determine containment levels and implement containment measures, as specified in a relevant code of practice, in order to minimise the risk of infection,
(
b
) carry out activities involving the handling of a biological agent only in working areas corresponding to at least the containment level specified in a relevant code of practice for—
(i) containment level 2 for a group 2 biological agent,
(ii) containment level 3 for a group 3 biological agent, and
(iii) containment level 4 for a group 4 biological agent,
and, in determining the containment level required for the said biological agent, follow the risk assessment required by Regulation 7,
and
(
c
) adopt—
(i) at least containment measures specified for containment level 2 as specified in a relevant code of practice, where handling materials in respect of which there exists uncertainties about the presence of a biological agent which may cause human disease, but which laboratories do not have as their aim working with a biological agent including cultivating or concentrating a biological agent, and
(ii) containment measures specified for containment level 3 or 4, as specified in a relevant code of practice, as and when appropriate, where he or she knows or ought to know that it is necessary, except where a relevant code of practice shows that a lower containment level is appropriate.
(3) At a place of work where industrial processes using a group 2 biological agent, a group 3 biological agent or a group 4 biological agent are carried out, an employer shall—
(
a
) apply the containment measures and containment levels referred to in paragraph (2)(
b
) and take account of containment measures and containment levels for industrial processes specified in a relevant code of practice,
(
b
) apply the measures to be taken which are considered necessary in accordance with the risk assessment required under Regulation 7 linked to the industrial use of a group 2 biological agent, a group 3 biological agent or a group 4 biological agent,
(
c
) apply at least the containment measures for level 3 as specified in a relevant code of practice when carrying out any activity covered by this Regulation, where it has not been possible to carry out a conclusive assessment of a biological agent but where it appears that the use envisaged might involve a serious health risk for employees, and
(
d
) where appropriate, apply combined containment measures and containment levels specified in a relevant code of practice on the basis of the risk assessment required by Regulation 7.
PART 6
Revocations
Revocations
18. The Safety, Health and Welfare at Work (Biological Agents) Regulations 1994 (
S.I. No. 146 of 1994
) and the Safety, Health and Welfare at Work (Biological Agents) (Amendment) Regulations 1998 (
S.I. No. 248 of 1998
) are revoked.
SCHEDULE 1
Regulations 5(b)(vi) and 7(1)(f)
Indicative list of activities