Biological Agents
Biological agents
Exposure to biological agents may arise in a host of industries and settings. It is a particular risk in hospitals, laboratories, waste disposal, farming and veterinary. It may also arise in prisons, post offices and other settings.
The regulations in relation to biological agents implement EU Directives. They apply to a wide range of biohazards which are classified in accordance with a number of groups and types. They include certain types of bacteria, viruses, parasites, fungi and other agents. Over 300 types are listed.
Group 1 agents are unlikely to cause human disease. Group 2 agents may cause human disease and might be hazardous, although it is unlikely to spread generally. Group 3 agents can cause severe human disease and present a serious hazard, which may spread. Group 4 biological hazards cause severe human diseases and are at high risk of spreading in the community.
Different categories of biological agent are identified, depending on their potential impact. The categorisation into risks groups determines the requisite precautions. The extent of duties applicable depend on the group to which the agent belongs.
A written risk assessment must be undertaken in relations to exposure to biological agents. Preventative measures must be taken. Risks are to be avoided entirely or are to be taken, only where they can be properly managed. Specific preventative measures are required.
Requirements
Employers must avoid the use of harmful biological agents. The agent must be replaced if possible.
A risk assessment is required. It must be kept and maintained in written form. Where several agents are present, the assessment must be on the basis of all of them. The risk assessment must be revised and reviewed periodically based on updated information and any reclassification of the particular biological agents present.
The regulations require that steps are to be taken on foot of the risk assessment. Where the risk assessment reveals a risk to health and safety, the employer must reduce exposure to as low a level as necessary to protect health and safety, if the exposure cannot be prevented.
The regulations set out required measures, including the minimisation of exposure, the design of work systems, precautionary measures, hygiene measures, bio-hazard signs, emergency response plans, testing for the presence of agents, safe systems of collection and storage and safe handling. Employees are also obliged to deploy precautionary and preventative measures.[ihc-hide-content ihc_mb_type=”show” ihc_mb_who=”4″ ihc_mb_template=”3″ ]
Specific Obligations
There are particular requirements in respect of certain activities which carry potential exposure to biological agents. They include certain food production and agricultural activities, contact with animal food products, health care, post-mortem units, veterinary, refuse disposal plants and sewage purification.
Special obligations apply to certain areas of work involving specific risks from biological agents. They include, in particular, sewage treatment and disposal, working in laboratories, working in healthcare including hospitals, work connected with food production, work in agriculture and work involving contact with animals.
Specific obligations apply to employers in the area of healthcare and veterinary work. Decontamination and disinfection requirements and procedures apply. Containment measures are required in respect of group 4 agents. Employers operating laboratories with animals who have been infected with biological agents or suspected to be so are subject to specific obligations.
In the case of works with certain categories of biological agents, one of more of the following requirements may apply
- prior notification to the HAS;
- hygiene and protective equipment;
- the use of vaccines;
- health surveillance by employers.
HSA Notice
The HSA is to be furnished on request with information on which the risk assessment is based.
Prior notice of certain types of work must be given. 30 days’ prior notice is required to the HSA of the works including
- works involving the use of group 2 to 4 agents;
- works with certain particular agents;
- first time works with agents in particular classes;
- circumstances where previous notifications require to be updated
The notification must give particulars of the business, persons responsible, risk assessments and particulars of the biological agents involved. Accidents and incidents must be notified to the HSA.
Personal Protective Equipment
Where there is a risk from biological agents, employees must have the appropriate personal protective equipment. There must be suitable washing and cleaning facilities. There must be a clear separation from where food and drink are consumed or stored.
Personal protective equipment must be properly maintained, cleaned and checked as required. Working clothes and protective equipment which may be contaminated must be removed at the end of the working period and separated. It must be decontaminated. The protective clothing and equipment must be cleaned, decontaminated or disposed of, as required. This includes disposal of defective clothing, masks and gloves for healthcare workers.
Training / Information
There are requirements for training and information, in the context of biological agents. Comprehensive information on the risks, the required measures by way of hygiene and protective measures, equipment and procedures must be communicated in advance. Written instructions must be given.
Where necessary, signs must be displayed in respect of procedures in the case of accidents and incidents. There is an obligation on employees to notify supervisors, where appropriate.
An employee must have access to the relevant information on the risks which relate to him or her. They must be made available for inspection by the HSA and certain other parties, including the safety representative. On termination of business, the employer must give particulars of exposed employees to the HSA.
Records
The employer must compile lists of employees who may be exposed to group 3 and group 4 agents. They must include particulars of the agents concerned. They must be maintained for at least 10 years after the termination of exposure, or longer in certain cases.
If there is a continuing risk to human health, the records must be maintained for up to 40 years, depending on the nature of the risks involved. Longer periods of retention are required in relation to agents which involve persistent or latent infections, evolving diagnosis and toxicology and generally, agents whose effects may manifest themselves over a longer period.
Health Surveillance
Employees must undertake health surveillance measures. They must be undertaken and periodically reviewed under the supervision of a medical practitioner. There are matters of which the medical practitioner must take account. There are obligations on medical practitioners in relation to proposals for countermeasures and records.
An employer may be obliged to assess whether vaccines are appropriate or necessary. Vaccines may only be used in accordance with guidelines. Employees should be informed of the benefits and risks. They must be offered free of charge. Certification is required which must be furnished to the employee and the HSA on request.
Civil Claims
Many civil claims have involved injuries from hypodermic needles, in the course of employment. In some cases, the employer has been found liable on common law principles of negligence on the basis of failure to provide a safe system of work.
Some cases have involved employees who have lifted up waste, which has caused infection and injury. A number of claims have made by employees who have been posted abroad, to countries in which particular diseases are prevalent or rampant. Some cases have involved security personnel and Gardaí, who have been stabbed with syringes with blood of unknown origin.
Some cases have been brought on the basis of claimed reaction to the prospect of disease, from accidental skin pricks and cuts. Claims based on needle injuries from syringes containing substances of unknown origin with an apprehended risk of infection have been accepted in principle. However, the courts have not readily allowed such claims, in the absence of sufficient evidence of demonstrable psychological injury.
References and Sources
Irish Books
Safety, Health and Welfare and at Work Law in Ireland 2nd Ed 2008 Byrne Ch.9
Safety & Health Acts Consolidated & Annotated 2013 Byrne
Health, Safety & Welfare Law in Ireland 2012 Kinsella
Health & Safety: Law and practice 2007 Shannon
Health & Safety at Work 1998 Stranks Ch.6
Civil Liability for Industrial Accidents 1993 While
Websites
The Health and Safety Authority www.hsa.ie
Health and Safety Executive (UK) www.hse.gov.uk
UK Books
Tolleys Health and safety at work, 2017 29th ed Bamber,
Corporate liability: work related deaths and criminal prosecutions 3rd ed. Author FORLIN, G.
Health and safety at work: European and comparative perspective Author ALES, E., ed.
Health and Safety Law 5th Ed 2005 Stranks
Principles of Health and Safety at Work (8th ed) Holt, Allan St. John; Allen, Jim;
The Law of Health and Safety at Work 2014/15 (23rd ed) Moore, Rachel; Winter, Hazel;
Statutes
Safety, Health and Welfare at Work Act 2005
Safety, Health and Welfare at Work (General Application) (Amendment) (No. 3) Regulations 2016 (S.I. No. 370 of 2016)
Safety, Health and Welfare at Work (General Application) (Amendment) (No. 2) Regulations 2016 (S.I. No. 70 of 2016)
Safety, Health and Welfare at Work (General Application) (Amendment) Regulations 2016 (S.I. No. 36 of 2016)
Safety, Health and Welfare at Work (General Application) (Amendment) Regulations 2012 (S.I. No. 445 of 2012)
Safety, Health and Welfare at Work (General Application) (Amendment) Regulations 2010 (S.I. No. 176 of 2010)
Safety, Health and Welfare at Work (General Application) (Amendment) Regulations 2007 (S.I. No. 732 of 2007)
Safety, Health and Welfare at Work (General Application) Regulations 2007 (S.I. No. 299 of 2007)
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 protective measures which may be required,
to ensure the safety and health of such employees,
(b) keep the risk assessment referred to in subparagraph (a) in written form as required by section 19 of the Act,
(c) when carrying out the risk assessment required by subparagraph (a), assess the risk, in the case of activities involving exposure to biological agents from 2 or more of the risk groups in paragraphs (b), (c) and (d) of the definition of “biological agent” in Regulation 2, on the basis of the hazards presented by all biological agents present,
(d) as often as necessary and, in any event, whenever there is a change in conditions at the place of work which may affect any employees exposure to a biological agent, review and, as appropriate, amend the risk assessment required by subparagraph (a),
(e) conduct the risk assessment referred to in subparagraph (a) on the basis of all available information, including—
(i) the classification of each biological agent which is or may be a hazard to human health as specified in a relevant code of practice,
(ii) information on diseases which may be contracted as a result of the work of the employees,
(iii) potential allergenic or toxigenic effects as a result of the work of the employees,
(iv) knowledge of a disease from which an employee is found to be suffering and which has a direct connection with his or her work, and
(v) any recommendations which have been made by the Authority indicating that a particular biological agent should be controlled in order to protect employees health where employees are or may be exposed to such a biological agent as a result of their work,
and
(f) where the results of the risk assessment show that the activity does not involve a deliberate intention to work with or use a biological agent but may result in exposure, 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.
(2)(a) Certain biological agents classified as group 3 biological agents which may be specified in a relevant code of practice may present a limited risk of infection for employees because they are not normally infectious by the airborne route. Subject to subparagraph (b), an employer may, for biological agents so specified, having completed an appropriate risk assessment and taking account of the nature of specific activities in question and of the quantity of the agent involved, dispense with such group 3 containment measures as may be specified in a relevant code of practice.
(b) The Authority may, where necessary, publish in a relevant code of practice the minimum containment measures which shall be applied in cases to which subparagraph (a) applies.
Information, training and consultation of employees
8. (1) An employer, in the case of any activity in relation to which there is a risk to the health or safety of an employee due to work with a biological agent, shall take appropriate measures to ensure that each such employee or his or her safety representative (or both) 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 suitable work clothing, special protective clothing and personal protective equipment, and
(e) steps to be taken by employees in the case of incidents and to prevent incidents.
(2) Prior to the commencement of work involving contact with a biological agent, an employer shall give the training referred to in paragraph (1) and ensure that such training is adapted to take account of new or changed risks and is repeated as often as is necessary.
(3) An employer shall provide written instructions at the place of work, and, if appropriate, display notices which shall, at 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, and
(b) the handling of a group 4 biological agent.
(4) An employer shall ensure that employees or their safety representative (or both) are or is—
(a) informed, immediately, 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),
(b) informed, 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, and
(c) consulted in relation to the matters referred to in Regulation 7.
(5) An employer shall provide information in accordance with paragraph (1) to—
(a) any other employer whose employees, or
(b) any self-employed person who,
may be affected by exposure to a biological agent arising from the conduct of the employers undertaking.
Hygiene
9. 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 take appropriate measures to ensure that—
(a) employees do not eat or drink in any location within a place of work where there is a risk of contamination by a biological agent,
(b) employees are provided within the place of work with appropriate and adequate washing and toilet facilities, which may include eye washes and skin antiseptics, and
(c) procedures are specified for taking, handling and processing samples of human or animal origin.
Individual protection
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.
SCHEDULE 1
Regulations 5(b)(vi) and 7(1)(f)
Indicative list of activities
1. Work in food production plants.
2. Work in agriculture.
3. Work in biotechnology, including the production of pharmaceutical products.
4. Work activities where there is contact with animals and products of animal origin (or both).
5. Work in health care, including isolation and post mortem units, funeral and cremation undertakings.
6. Work in clinical, veterinary and diagnostic laboratories, excluding diagnostic microbiological laboratories.
7. Work in refuse disposal plants.
8. Work in sewage purification installations.
SCHEDULE 2
Regulations 5(b)(iv) and 7(1)(a)(i)
Prevention and risk reduction measures
(Measures to be taken where it is not technically possible to prevent exposure)
1. The keeping as low as possible of the number of employees exposed or likely to be exposed to a biological agent.
2. The design of work processes and engineering control measures so as to avoid or minimise the release of a biological agent into the place of work.
3. The use of both collective protection measures and individual protection measures where exposure cannot be avoided by other means.
4. The use of hygiene measures compatible with the aim of preventing or reducing the accidental transfer or release of a biological agent from the place of work.
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 4
Regulation 11(b) and Regulation 12(4)(a)
Matters relating to vaccination practice
1. If the risk assessment referred to in Regulation 7 reveals that there is a risk to the health and safety of an employee due to his or her exposure to a biological agent for which effective vaccines exist, the employer shall offer vaccination to each such employee.
2. Vaccination shall be carried out in accordance with any current best medical practice and employees should be informed of the benefits and drawbacks of both vaccination and non-vaccination.
3. Vaccination shall be offered free of charge to employees.
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
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.
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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).
S.I. No. 70/2016 –
Safety, Health and Welfare at Work (General Application) (Amendment) (No. 2) Regulations 2016.
“Iris Oifigiúil” of 23rd February, 2016.
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) (as adapted by the Enterprise, Trade and Innovation (Alteration of Name of Department and Title of Minister) Order 2011 ( S.I. No. 245 of 2011 )), and to give effect to Articles 1, 2 and 3 of Directive 2014/27/EU of the European Parliament and of the Council of 26 February 20141 , and after consultation with the Health and Safety Authority, hereby make the following regulations:
1. (1) These Regulations may be cited as the Safety, Health and Welfare at Work (General Application) (Amendment) (No. 2) Regulations 2016.
(2) The Safety, Health and Welfare at Work (General Application) Regulations 2007 to 2016 and these Regulations may be cited together as the Safety, Health and Welfare at Work (General Application) Regulations 2007 to 2016.
2. (1) In these Regulations “Principal Regulations” means the Safety, Health and Welfare at Work (General Application) Regulations 2007 ( S.I. No. 299 of 2007 ).
(2) A word or expression that is used in these Regulations and is also used in Articles 1, 2 and 3 of Directive 2014/27/EU of the European Parliament and of the Council of 26 February 20141 has, unless the contrary intention appears, the same meaning in these Regulations and the Principal Regulations as it has in those Articles.
3. Regulation 2 of the Principal Regulations is amended in paragraph (1) by the insertion of the following definitions:
“ ‘group 2 biological agent’ has the meaning assigned to it by Regulation 2 of the Regulations of 2013;
‘group 3 biological agent’ has the meaning assigned to it by Regulation 2 of the Regulations of 2013;
‘group 4 biological agent’ has the meaning assigned to it by Regulation 2 of the Regulations of 2013;
‘Regulations of 2013’ means the Safety, Health and Welfare at Work (Biological Agents) Regulations 2013 ( S.I. No. 572 of 2013 );”.
4. Regulation 159 of the Principal Regulations is amended by the substitution of the following paragraphs for paragraph (2):
“(2) This Chapter shall not apply to signs used for the placing on the market of hazardous substances and mixtures, products and equipment (or either of them) except to the extent that any other enactment concerning a European act makes specific reference to such signs.
(2A) In paragraph (2), ‘European act’ has the same meaning as it has in the European Communities Act 2007 (No. 18 of 2007).”.
5. Schedule 7 to the Principal Regulations is amended—
(a) in Part A, by the substitution of the following paragraph for paragraph 2:
“2.
Biological agents
Biological agents of—
(a) group 3 biological agent, and
(b) group 4 biological agent.”,
(b) in Part A, in paragraph 3, by the substitution of the following subparagraph for subparagraph (a):
“(a) Substances and mixtures which meet the criteria for classification under Regulation (EC) No. 1272/2008 of the European Parliament and of the Council in one or more of the following hazard classes and hazard categories with one or more of the following hazard statements:
(I) acute toxicity, category 1, 2 or 3 (H300, H310, H330, H301, H311, H331);
(II) skin corrosion, category 1A, 1B or 1C (H314);
(III) flammable gas, category 1 or 2 (H220, H221);
(IV) flammable aerosols, category 1 (H222);
(V) flammable liquid, category 1 or 2 (H224, H225);
(VI) explosives, categories “Unstable explosive”, or explosives of Divisions 1.1, 1.2, 1.3, 1.4, 1.5 (H200, H201, H202, H203, H204, H205);
(VII) self-reactive substances and mixtures, type A, B, C or D (H240, H241, H242);
(VIII) organic peroxides, type A or B (H240, H241);
(IX) specific target organ toxicity after single exposure, category 1 or 2 (H370, H371);
(X) specific target organ toxicity after repeated exposure, category 1 or 2 (H372, H373);
(XI) respiratory sensitisation, category 1, subcategory 1A or 1B (H334);
(XII) skin sensitisation, category 1, subcategory 1A or 1B (H317);
(XIII) carcinogenicity, category 1A, 1B or 2 (H350, H350i, H351);
(XIV) germ cell mutagenicity, category 1A, 1B or 2 (H340, H341);
(XV) reproductive toxicity, category 1A or 1B (H360, H360F, H360FD, H360Fd, H360D, H360Df);”,
(c) in Part A, in paragraph 3 by—
(i) the deletion of subparagraph (b),
(ii) the deletion of subparagraph (c), and
(iii) the deletion of subparagraph (d),
(d) in Part A, in paragraph 3, in subparagraph (e), by—
(i) the substitution of “mixtures” for “preparations”, and
(ii) the insertion of “(amended by the Safety, Health and Welfare at Work (Carcinogens) (Amendment) Regulations 2015 ( S.I. No. 622 of 2015 ))” after “2001)”, and
(e) in Part B, in paragraph 1, by the insertion of “(amended by the Safety, Health and Welfare at Work (Carcinogens) (Amendment) Regulations 2015 ( S.I. No. 622 of 2015 ))” after “2001)”.
6. (1) Schedule 8 to the Principal Regulations is amended in Part A in paragraph 1—
(a) in subparagraph (b)—
(i) by the substitution of “group 2 biological agent, group 3 biological agent and group 4 biological agent (within the meaning of Regulation 2 of the Regulations of 2013),” for “risk groups 2, 3 and 4 within the meaning of relevant statutory provisions relating to biological agents,” and
(ii) by the substitution of “and in so far as they do not yet appear in Part B, or Part C, of this Schedule” for “but excluding those referred to in Part B of this Schedule”,
(b) in subparagraph (c), by the insertion of “, or Part C,” after “Part B”,
(c) in subparagraph (c), by the substitution of the following clause for clause (i):
“(i) substances and mixtures which meet the criteria for classification under Regulation (EC) No. 1272/2008 of the European Parliament and of the Council2 in one or more of the following hazard classes and hazard categories with one or more of the following hazard statements, in so far as they do not yet appear in Part B, or Part C, of this Schedule:
(I) germ cell mutagenicity, category 1A, 1B or 2 (H340, H341),
(II) carcinogenicity, category 1A, 1B or 2 (H350, H350i, H351),
(III) reproductive toxicity, category 1A, 1B or 2 or the additional category for effects on or via lactation (H360, H360D, H360FD, H360Fd, H360Df, H361, H361d, H361fd, H362), and
(IV) specific target organ toxicity after single exposure, category 1 or 2 (H370, H371),”, and
(d) in subparagraph (c)—
(i) in clause (ii) by—
(I) the substitution of “mixtures” for “preparations”, and
(II) the insertion of “(amended by the Safety, Health and Welfare at Work (Carcinogens) (Amendment) Regulations 2015 ( S.I. No. 622 of 2015 ))” after “2001)”, and
(ii) in clause (iii) by—
(I) the substitution of “mixtures” for “preparations”, and
(II) the insertion of “(amended by the Safety, Health and Welfare at Work (Carcinogens) (Amendment) Regulations 2015 ( S.I. No. 622 of 2015 ))” after “2001)”.
(2) Schedule 8 to the Principal Regulations is amended in Part A, in paragraph 2, by the insertion of “(amended by the Safety, Health and Welfare at Work (Carcinogens) (Amendment) Regulations 2015 ( S.I. No. 622 of 2015 ))” after “2001)”.
7. Schedule 9 to the Principal Regulations is amended—
(a) in Part A, in paragraph 11 by—
(i) the substitution of “hazardous” for “dangerous”,
(ii) the substitution of “mixtures” for “preparations”, and
(iii) the insertion of the following paragraph after paragraph 11:
“11A. For the purposes of paragraph 11, if there is no equivalent warning sign in paragraph 3.2 of Part B to warn about hazardous chemical substances or mixtures, the relevant hazard pictogram, as set out in Annex V to Regulation (EC) No. 1272/2008 of the European Parliament and of the Council, must be used.”,
(b) in Part B, in paragraph 3.2 by—
(i) the deletion of the warning sign “Harmful or irritant material”,
(ii) the deletion of the Note for the warning sign “Harmful or irritant material”, and
(iii) the insertion of the following Note for the warning sign “General danger” after the Note for the warning sign “Flammable material or high temperature”:
“Note: The warning sign “General danger” shall not be used to warn about hazardous chemical substances or mixtures, except for cases when the warning sign is used in accordance with the second subparagraph of paragraph 5 of Part C to this Schedule to indicate the stores of hazardous substances or mixtures.”,
(c) in Part C, by the substitution of the following paragraph for paragraph 1:
“1. Containers used at work for chemical substances or mixtures classified as hazardous according to the criteria for any physical or health hazard class in accordance with Regulation (EC) No. 1272/2008, and containers used for the storage of such hazardous substances or mixtures, together with the visible pipes containing or transporting such hazardous substances and mixtures, shall be labelled with the relevant hazard pictograms in accordance with that Regulation.
This paragraph does not apply to containers used at work for brief periods nor to containers whose contents change frequently, provided that alternative adequate measures are taken, in particular for information or training (or both of them) which guarantee the same level of protection.
The labels referred to in this paragraph may be—
(a) replaced by warning signs as provided for in Part B of Schedule 9, using the same pictograms or symbols, and where there is no equivalent warning sign in paragraph 3.2 of Part B of this Schedule, the relevant hazard pictogram set out in Annex V of Regulation (EC) No. 1272/2008 shall be used,
(b) supplemented by additional information, including the name or formula (or both of them) of the hazardous substance or mixture and the details of the hazard, and
(c) used for the transporting of containers at the place of work, supplemented or replaced by signs that are applicable throughout the European Union for the transport of hazardous substances or mixtures.”, and
(d) in Part C, in paragraph 5, by—
(i) the substitution of “hazardous” for “dangerous” in each place where it occurs, and
(ii) the substitution of “mixtures” for “preparations” in each place where it occurs.
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GIVEN under my Official Seal,
18 February 2016.
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.)
Directive 2014/27/EU seeks to amend five EU Directives on health and safety at work as a result of the adoption of the EU “CLP” Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures in 2008.
The Safety, Health and Welfare at Work (General Application) (Amendment) (No. 2) Regulations 2016 amend S.I. No. 299 of 2007 in order to transpose Articles 1, 2 and 3 of Directive 2014/27/EU.
1 O.J. No. L65, 5.3.2014, p.1
2 O.J. No. L353, 31.12.2008, p.1