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S.I. No. 146/1994:
SAFETY, HEALTH
AND WELFARE AT WORK (BIOLOGICAL AGENTS) REGULATIONS, 1994.
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SAFETY, HEALTH AND WELFARE AT WORK (BIOLOGICAL AGENTS) REGULATIONS, 1994.
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INDEX OF
REGULATIONS
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Regulation
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1. Short Title and Commencement.
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2. Interpretation.
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3. Duties of Employers.
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4. Risk Assessment.
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5. Information and Notification to be provided
to the Authority.
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6. Hygiene, Individual Protection and
Vaccination.
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7. Information, Training and Consultation of
Employees.
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8. Duties of employees to report accidents and
incidents.
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9. Keeping of lists of exposed employees.
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10. Health Surveillance.
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11. Health care and veterinary care.
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12. Laboratories, industrial processes and
animal rooms.
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SCHEDULES
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FIRST SCHEDULE
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Indicative
list of activities.
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SECOND SCHEDULE
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Measures to
be taken where it is not technically possible to prevent exposure.
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THIRD SCHEDULE
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Biohazard
Sign.
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FOURTH SCHEDULE
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Classification
of Biological Agents.
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FIFTH SCHEDULE
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Recommendations
on Vaccination Practice.
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SIXTH SCHEDULE
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Recommendation
for the Health Surveillance of Employees.
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SEVENTH SCHEDULE
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Indications
concerning Containment Measures and Containment Levels.
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EIGHTH SCHEDULE
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Containment
Measures and Containment Levels for Industrial Processes.
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S.I. No. 146 of 1994.
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SAFETY, HEALTH AND WELFARE AT WORK
(BIOLOGICAL AGENTS) REGULATIONS, 1994.
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I, RUAIRÍ QUINN, Minister for Enterprise 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), and the Labour
(Transfer of Departmental Administration and Ministerial Functions) Order,
1993 ( S.I. No. 18 of 1993 ), and for the purpose of giving effect to
Council Directive 90/679/EEC1 of 26 November, 1990 as amended by
Council Directive 93/88/EEC2 of 12 October, 1993, after consulation with the National Authority for Occupational
Safety and Health, hereby make the following Regulations:—
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Short Title
and Commencement.
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1. (1) These Regulations may be cited as the Safety, Health and
Welfare at Work (Biological Agents) Regulations, 1994.
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(2) These Regulations shall come into operation on the 23rd day of May,
1994.
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Interpretation.
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2. (1) In these Regulations:—
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"the Act" means the Safety, Health and Welfare at Work Act,
1989 (No. 7 of 1989);
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"biological agent" means a micro-organism, including those
which have been genetically modified, a cell culture and a human endoparasite, which may be able to provoke any
infection, allergy or toxicity, classified into four risk groups according
to their level of risk of infection, as follows:—
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— a "group 1 biological agent", that is one that is
unlikely to cause human disease;
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— a "group 2 biological agent", that is one which 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;
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1O.J. No. L 374 of 32/12/1990, pp. 1-12.
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2O.J. No. L 268 of 29/10/93
pp. 71-82.
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— a "group 3 biological agent", that is one which can
cause severe human disease and presents a serious hazard to employees and
which may present a risk of spreading to the community, though there is
usually effective prophylaxis or treatment available;
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— a "group 4 biological agent", that is one which causes
severe human disease and is a serious hazard to employees and which may
present a high risk of spreading to the community and in respect of which
there is usually no effective prophylaxis or treatment available;
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"cell culture" means the in-vitro growth of cells derived from multicellular organisms;
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"containment level" means the containment level specified in
columns 2, 3 and 4 of the Seventh and Eighth Schedules as appropriate;
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"employer" means, for the purpose of these Regulations, any
employer of employees who are in contact with or at risk of being exposed to
a biological agent as a result of work;
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"micro-organism" means a microbiological entity, cellular or
non-celular, capable of replication or of
transferring genetic material;
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"responsible medical practitioner" means the registered medical
practitioner employed, or otherwise engaged, by an employer to be
responsible for health surveillance of employees under these Regulations;
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"the Principal Regulations" means the
Safety, Health and Welfare at Work (General Application) Regulations, 1993 (
S.I. No. 44 of 1993 ).
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(2) In these Regulations a reference to a paragraph is to a paragraph in
the Regulation in which the reference occurs, unless it is indicated that
reference to some other Regulation 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.
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(3) The provisions of Regulations 2 and 4 and of Part II of the Principal
Regulations shall apply to the application of the provisions of these
Regulations.
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Duties of
Employers.
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3. It shall be the duty of every employer—
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( a ) to 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, eliminates or reduces the risk to the
health of employees,
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( b ) to prevent the exposure of employees to a biological
agent at a place of work where the results of the risk assessment under
Regulation 4 reveal a risk to employees' health and safety,
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( c ) to ensure that the level of exposure of employees is
reduced to as low a level as necessary in order to protect adequately the
health and safety of the employees concerned, where it is not technically
possible to prevent exposure,
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( d ) to apply the measures specified in the Second Schedule
where the results of the risk assessment under Regulation 4 reveal that it
is not technically possible to prevent exposure,
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( e ) where the results of the risk assessment under
Regulation 4 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 to provide that where a biological
agent is being handled as part of an industrial process, to ensure that the
principles of good occupational safety and hygiene are applied,
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( f ) where the results of the assessment under Regulation 4
show that the activity does not involve a deliberate intention to work with
or use a biological agent but may result in employees being exposed to a
biological agent, as in the course of the activities for which an indicative
list is given in the First Schedule, to comply with Regulations 3 (a),
5, 6, 7 (iii), 7 (iv), 8, 9 and 10, unless the results of such assessment
show such compliance to be unnecessary,
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( g ) to apply these Regulations to
activities in which employees are likely to be exposed to biological agents
as a result of their work.
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Risk
Assessment.
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4. It shall be the duty of every employer—
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( a ) to assess any risk to the health and safety of
employees resulting from any activity at that employer's place of work
likely to involve a risk of exposure of any employee to a biological agent
and for that purpose to determine the nature, degree and duration of any
employee's exposure to a biological agent and to lay down the measures to be
taken to ensure the safety and health of such employees,
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( b ) to keep the risk assessment referred to in paragraph (a)
in written form as required by Regulation 10 of the Principal Regulations,
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( c ) when carrying out the risk assessment required by
paragraph (a), to assess the risk, in the case of activities
involving exposure to several groups of a biological agent, on the basis of
the danger presented by all hazardous biological agents present,
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( d ) to renew the risk assessment required by paragraph (a)
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 a biological
agent, and
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( e ) to conduct the risk assessment referred to in paragraph
(a) on the basis of all available information, including—
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(i) the classification of a biological
agent which is or may be a hazard to human health referred to in the Fourth
Schedule,
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(ii) information on diseases which may be contracted as a result of
the work of the employees,
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(iii) potential allergenic or toxigenic
effects as a result of the work of the employees,
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(iv) knowledge of a disease from which an employee is found to be
suffering and which has a direct connection with his work, and
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(v) any recommendations which may be 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.
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Information
and Notification to be provided to the Authority.
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5. It shall be the duty of every employer—
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( a ) to provide the Authority when requested with the
information used for making any risk assessment carried out under Regulation
4 and with the findings of any such assessment,
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( b ) where the risk assessment carried out under Regulation
4 reveals a risk to any employee's health or safety, to provide the
Authority, when requested, with appropriate information in writing relating
to—
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(i) the results of the risk assessment,
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(ii) the activities in which employees have been exposed or may have
been exposed to a biological agent,
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(iii) the number of employees exposed,
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(iv) the name and capabilities of the person responsible for safety
and health at work,
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(v) the protective and preventive measures taken, including working
procedures and methods,
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(vi) an emergency plan for the protection of employees from exposure
to a group 3 or a group 4 biological agent which might result from a loss of
physical containment,
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( c ) without prejudice to Part X of the Principal
Regulations, to inform the Authority of any accident or incident which may
have resulted in the release of a biological agent and which could cause
both severe human infection and human illness or both,
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( d ) to deliver the list required by Regulation 9 to the
Authority in cases where he ceases to be an employer,
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( e ) to notify the Authority—
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(i) thirty days prior to the commencement
of work involving the use for the first time of a group 2 or 3 or 4
biological agent,
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(ii) subject to subparagraph (i), thirty
days prior to the commencement of work involving the use for the first time
of each subsequent group 4 biological agent and any subsequent new group 3
biological agent, where the employer himself provisionally classifies that
biological agent,
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(iii) for the first time only, as required by subparagraph (i), in the case of laboratories providing a purely
diagnostic service in relation to a group 4 biological agent, and
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(iv) in any case where there are substantial changes of importance
to safety and health at work to processes or procedures which render the
notifications required by subparagraph (i), (ii)
or (iii) out of date,
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( f ) to include in the notification required by paragraph (e)—
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(i) the name and address of the
undertaking or the establishment (or both),
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(ii) the name and capabilities of the person responsible for safety
and health at work,
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(iii) the results of the risk assessment under Regulation 4,
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(iv) the species of the biological agent, and
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(v) the protective and preventive measures that are envisaged,
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( g ) To make available to the
Authority the list referred to in Regulation 9 in cases where the
undertaking or the establishment (or both) ceases activity.
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Hygiene,
Individual Protection and Vaccination.
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6. (1) It shall be the duty of every employer, 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, to take appropriate
measures to ensure that—
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( a ) employees do not eat or drink in any place of work
where there is a risk of contamination by a biological agent,
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( b ) employees are provided with suitable personal
protective equipment,
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( c ) employees are provided with suitable washing and toilet
facilities, which may include eye washes and skin antiseptics (or both),
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( d ) any necessary personal protective equipment is—
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(i) properly stored in a designated place,
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(ii) checked and cleaned if possible, before, and in any case after
each use, and
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(iii) repaired, where defective, or replaced, before further use,
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( e ) procedures are specified for taking, handling and
processing samples of human or animal origin,
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( f ) working clothes and personal protective equipment,
referred to in subparagraphs (b) and (d), which may be
contaminated by a biological agent, are removed on leaving the working areas
and, before taking the measures referred to in subparagraph (g), kept
separately from other clothing, and
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( g ) the working clothes and
personal protective equipment referred to in subparagraph (f) are
decontaminated and cleaned or, if necessary, destroyed.
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(2) It shall be the duty of every employer to—
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( a ) apply any special protective measures to employees
identified as requiring these by the risk assessment under Regulation 4,
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( b ) 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, taking account of the Fourth
Schedule, and
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( c ) take account of the
recommendations set out in the Fifth Schedule when making vaccines available
to employees.
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Information,
Training and Consultation of Employees.
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7. It shall be the duty of every employer 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—
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(i) without prejudice to the provisions of
Regulations 11 and 13 of the Principal Regulations, to take appropriate
steps to ensure that employees or their safety representative (or both)
receive sufficient and appropriate training and information concerning—
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( a ) potential risks to health,
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( b ) precautions to be taken to prevent exposure,
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( c ) hygiene requirements,
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( d ) the wearing and use of personal protective equipment,
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( e ) the steps to be taken by employees in the case of
incidents and to prevent incidents,
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(ii) to provide information in accordance with paragraph (i) to any employer of other employees or to any self
employed person who may be affected by exposure to a biological agent
arising from the conduct of his undertaking,
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(iii) to give, at the beginning of work involving contact with a
biological agent, the training referred to in paragraph (i)
and to ensure that such training is adapted to take account of new or
changed risks and, if necessary, is repeated periodically,
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(iv) to provide written instructions at the place of work, and, if
appropriate, display notices which shall, as a minimum, include the
procedure to be followed in the case of—
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( a ) a serious accident or incident involving the handling
of a biological agent, or
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( b ) the handling of a group 4 biological agent, and
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(v) to ensure, without prejudice to the provisions of Regulation 9
of the Principal Regulations, that his employees or their safety
representative (or both)—
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( a ) are informed as quickly as possible 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),
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( b ) are informed, as quickly as possible, when a serious
accident or incident occurs of the causes thereof and of the measures taken
in relation thereto,
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(vi) without prejudice to the provisions of
Regulation 12 of the Principal Regulations, to consult his employees or
their safety representative (or both) in relation to the matters referred to
in subparagraphs (a) to (e) of paragraph (i)
and in the Schedules.
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Duties of
employees to report accidents and incidents.
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8. It shall be the duty of every employee to report to his
employer or his immediate supervisor any accident or incident, of which he
becomes aware, involving the exposure to, or release of, a biological agent
likely to involve a risk to the health and safety of employees.
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Keeping of
lists of exposed employees.
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9. It shall be the duty of every employer to—
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( a ) keep a list of the employees who may be exposed to a
group 3 or a group 4 biological agent (or both), indicating the type of work
done by each employee, and, whenever possible, the biological agent to which
they have been exposed, as well as records of exposures accidents and
incidents, as appropriate,
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( b ) keep the list referred to in paragraph (a) for
at least ten years following the end of exposure,
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( c ) keep the list referred to in paragraph (a) for a
longer period not exceeding forty years, depending on the likely duration of
risk to the health and safety of employees determined during the risk
assessment referred to in Regulation 4, following the last known exposure in
the case of those exposures which may result in infections—
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(i) with a biological agent known to be
capable of establishing persistent or latent infections,
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(ii) that in the light of present knowledge, are indiagnoseable
until illness later develops,
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(iii) that have particularly long incubation periods before illness
develops,
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(iv) that result in an illness which recrudesce at times over a long
period despite treatment, and
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(v) that result in illnesses that may have serious long-term sequelae,
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( d ) ensure that each employee has access to the information
on the list which relates to him,
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( e ) ensure that the employees or their safety
representative (or both) have access to collective information which does
not identify information relating to any individual employee,
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( f ) ensure that the list is made available, on request, to
the responsible medical practitioner or the Authority or person designated
under Regulation 8 of the Principal Regulations for inspection,
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( g ) ensure that the employees or
their safety representative (or both) have access, on request, to the
information provided for in Regulation 5.
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Health
Surveillance.
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10. (1) It shall be the duty of every employer—
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( a ) to make provision for relevant health surveillance as
defined in Regulation 15 (3) of the Principal Regulations, to be made
available, under the responsibility of a responsible medical practitioner
where appropriate, for those employees for whom the results of any of the
risk assessment under Regulation 4 reveal a risk to their health or safety,
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( 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,
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( c ) to 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 to a biological agent, health surveillance is made
available to other employees, who have been similarly exposed, whenever
requested by a responsible medical practitioner or by the Authority,
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( d ) to ensure that where the health surveillance required
by subparagraph (c) is undertaken, a further reassessment of the risk
of exposure is made in accordance with Regulation 4 (a),
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( e ) to ensure that, where an employee receives health
surveillance under this Regulation, an individual record is kept of such
matters, and
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( f ) to ensure that any employee
may request a review of the results of any health surveillance he undergoes.
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(2) It shall be the duty of every employer to ensure that employees are
provided with information and advice regarding any health surveillance which
they may undergo following the end of exposure.
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(3) It shall be the duty of the responsible medical practitioner in
respect of paragraph (4) (a) and the employer in respect of paragraph
(1) (e) to give access to an employee to the results of his own
health surveillance.
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(4) It shall be the duty of any responsible medical practitioner under
whose responsibility an employee receives health surveillance under this
Regulation when carrying out relevant health surveillance required by this
Regulation—
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( a ) to keep an individual confidential medical record and
to retain that record for the appropriate period, taking account of the
periods referred to in Regulation 9 (b) and 9 (c),
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( b ) to take account of the recommendations in the Sixth
Schedule,
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( c ) to propose any protective or preventive measures to be
taken in respect of any individual employee,
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( d ) to allow access to the individual confidential medical
record to an occupational medical adviser who is designated under section 34
(4) (a) of the Act, and
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( e ) to make available to an
occupational medical adviser who is designated under section 34 (4) (a)
of the Act, the individual confidential medical record in cases where the
undertaking or establishment (or both) ceases activity.
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(5) 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 disease or death resulting from
occupational exposure to a biological agent to notify such case to the
Authority.
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Health
care and veterinary care.
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11. It shall be the duty of every employer when carrying out a
risk assessment under Regulation 4 to—
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( a ) pay particular attention to the risks posed by the
nature of the work,
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( b ) pay particular attention to uncertainties about the
presence of a biological agent in human patients or animals and the
materials and specimens taken from them,
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( c ) pay particular attention to 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,
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( d ) 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—
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(i) specifying appropriate decontamination
and disinfection procedures,
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(ii) implementing procedures enabling contaminated waste to be
handled and disposed of without risk, and
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( e ) to apply appropriate containment measures in accordance
with the Seventh Schedule 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 a
group 3 or a group 4 biological agent.
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Laboratories,
industrial processes and animal rooms.
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12. (1) It shall be the duty of every employer at a place of work
which is a laboratory, including diagnostic laboratories and in rooms for
laboratory animals which have been deliberately infected with a group 2, 3
or 4 biological agent or which are, or are suspected to be, carriers of such
agent, to—
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( a ) determine containment measures in accordance with the
Seventh Schedule, in order to minimise infection, in laboratories carrying
out work which involves the handling of a group 2, 3 or 4 biological agent
for research, development, teaching or diagnostic purposes,
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( b ) carry out activities involving the handling of a
biological agent having fixed the physical containment level required for
that biological agent in accordance with the Seventh Schedule, following the
risk assessment required by Regulation 4, only in—
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(i) working areas corresponding to at
least the containment level specified in column 2 of the Seventh Schedule
for a group 2 biological agent,
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(ii) working areas corresponding to at least the containment level
specified in column 3 of the Seventh Schedule for a group 3 biological
agent,
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(iii) working areas corresponding to at least the containment level
specified in column 4 of the Seventh Schedule for a group 4 biological
agent, and
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( c ) adopt—
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(i) at least containment level specified
in column 2 of the Seventh Schedule in laboratories handling materials in
respect of which their exists uncertainties about the presence of a
biological agent which may cause human disease, but which do not have as their
aim working with a biological agent including cultivating or concentrating a
biological agent,
|
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|
(ii) containment levels specified in
columns 3 or 4 of the Seventh Schedule, as and when appropriate, where it is
known or it is suspected that it is necessary.
|
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|
|
(2) It shall be the duty of every employer at a place of work where
industrial processes using a group 2, 3 or 4 biological agent are carried
out to—
|
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|
( a ) apply the containment measures and containment levels
set out in paragraph (1) (b) taking account of the Eighth Schedule,
|
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|
( b ) apply whatever measures are considered necessary in
accordance with the risk assessment required by Regulation 4 linked to the
industrial use of a group 2, 3 or 4 biological agent,
|
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|
|
( c ) apply at least the containment level specified in
column 3 of the Seventh Schedule to 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
|
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|
( d ) where appropriate to apply
combined containment measures and containment levels in the Eighth Schedule
on the basis of the risk assessment required by Regulation 4.
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FIRST SCHEDULE
|
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|
|
Indicative
List of Activities
|
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|
|
Regulation 3 ( f )
|
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1. Work in food production plants.
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2. Work in agriculture.
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3. Work activities where there is contact with animals and products
of animal origin (or both).
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4. Work in health care, including isolation and post mortem units.
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5. Work in clinical, veterinary and diagnostic laboratories,
excluding diagnostic microbiological laboratories.
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6. Work in refuse disposal plants.
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7. Work in sewage purification installations.
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SECOND
SCHEDULE
|
|
|
|
Measures to
be taken where it is not technically possible to prevent exposure
|
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|
|
Regulation 3 ( d )
|
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|
|
1. The keeping as low as possible of the number of employees exposed
or likely to be exposed to a biological agent.
|
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|
|
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.
|
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|
3. The use of both collective protection measures,
and individual protection measures where exposure cannot be avoided by other
means.
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|
|
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 workplace.
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5. The use of the biohazard sign depicted in the Third Schedule, and
other relevant warning signs.
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6. The drawing up of plans to deal with accidents involving a
biological agent.
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7. The testing, where it is necessary and technically possible, for
the presence, outside the primary physical confinement, of a biological
agent used at work.
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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.
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9. The making of arrangements for the safe handling and transport of
a biological agent within the workplace.
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THIRD SCHEDULE
|
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|
Biohazard
Sign
|
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Second Schedule
|
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FOURTH
SCHEDULE
|
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|
|
Classification
of Biological Agents
|
|
|
|
Regulation 4 (e) (i) 6 (2) (b)
|
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|
|
1. Certain biological agents classified in group 3 which are
indicated in the list by an asterisk (*), may present a limited risk of
infection for workers because they are not normally infectious by the
air-borne route.
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|
2. The list also gives a separate indication in cases where the
biological agents are likely to cause allergic or toxic reactions, where an
effective vaccine is available, or where it is advisable to keep a list of
exposed employees for more than ten years.
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|
These indications are shown by the following letters:
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A: Possible allergic effects.
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D: List of workers exposed to this biological agent to be kept for
more than ten years after the end of last known exposure.
|
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T: Toxin production.
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|
V: Effective vaccine available.
|
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|
N.B. For biological agents appearing on this list, "spp" refers to other species which are known
pathogens in humans.
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|
|
|
|
|
|
Biological Agent
|
Classification
|
Notes
|
|
BACTERIA and similar organisms
|
|
|
|
Actinobacillus actinomycetemcomitans
|
2
|
|
|
Actinomadura madurae
|
2
|
|
|
Actinomadura pelletieri
|
2
|
|
|
Actinomyces gerencseriae
|
2
|
|
|
Actinomyces israelii
|
2
|
|
|
Actinomyces pyogenes
|
2
|
|
|
Actinomyces spp.
|
2
|
|
|
Arcanobacterium haemolyticum (corynebacterium
haemolyticum)
|
2
|
|
|
Bacillus anthracis
|
3
|
|
|
Bacteroides fragilis
|
2
|
|
|
Bartonella baciliformis
|
2
|
|
|
Bordetella brochiseptica
|
2
|
|
|
Bordetella parapertussis
|
2
|
|
|
Bordetella pertussis
|
2
|
V
|
|
|
|
|
|
|
|
|
|
Biological Agent
|
Classification
|
Notes
|
|
Borrelia burgdorferi
|
2
|
|
|
Borrelia duttonii
|
2
|
|
|
Borrelia recurrentis
|
2
|
|
|
Borrelia spp.
|
2
|
|
|
Brucella abortus
|
3
|
|
|
Brucella canis
|
3
|
|
|
Brucella melitensis
|
3
|
|
|
Brucella suis
|
3
|
|
|
Campylobacter fetus
|
2
|
|
|
Campylobacter jejuni
|
2
|
|
|
Campylobacter spp.
|
2
|
|
|
Cardiobacterium hominis
|
2
|
|
|
Chlamydia pneumoniae
|
2
|
|
|
Chlamydia trachomatis
|
2
|
|
|
Chlamydia psittaci (avian
strains)
|
3
|
|
|
Chylamydia psittaci (other strains)
|
2
|
|
|
Clostridium botulinum
|
2
|
T
|
|
Clostridium perfringens
|
2
|
|
|
Clostridium tetani
|
2
|
T, V
|
|
Clostridium spp.
|
2
|
|
|
Corynebacterium diphtheriae
|
2
|
T, V
|
|
Corynebacterium minutissiumum
|
2
|
|
|
Corynebacterium pseudotuberculosis
|
2
|
|
|
Corynebacterium spp.
|
2
|
|
|
Coxiella burnetii
|
3
|
|
|
Edwardsiella tarda
|
2
|
|
|
Ehrlichia sennetsu
(Rickettsia sennetsu)
|
2
|
|
|
Ehrlichia spp.
|
2
|
|
|
Eikenella corrodens
|
2
|
|
|
Enterobacter aerogenes/cloacae
|
2
|
|
|
|
|
|
|
|
|
|
|
Biological Agent
|
Classification
|
Notes
|
|
Enterobacter spp.
|
2
|
|
|
Enterococcus spp.
|
2
|
|
|
Erysipelothrix rhusiopaethiae
|
2
|
|
|
Escherichia coli (with the exception of non-pathogenic
strains)
|
2
|
|
|
Flavobacterium meningosepticum
|
2
|
|
|
Fluoribacter bozemanae (Legionella)
|
2
|
|
|
Francisella tularensis (Type A)
|
3
|
|
|
Francisella tularensis (Type B)
|
2
|
|
|
Fusobacterium necrophorum
|
2
|
|
|
Gardnerella vaginalis
|
2
|
|
|
Haeomophilus ducreyi
|
2
|
|
|
Haemophilus influenzae
|
2
|
|
|
Haemophilus spp.
|
2
|
|
|
Helicobacter pylori
|
2
|
|
|
Klebsiella oxytoca
|
2
|
|
|
Klebsiella pneumoniae
|
2
|
|
|
Klebsiella spp.
|
2
|
|
|
Legionella pneumophila
|
2
|
|
|
Legionella spp.
|
2
|
|
|
Leptospira interrogans (all serovars)
|
2
|
|
|
Listeria monocytogenes
|
2
|
|
|
Listeria ivanovii
|
2
|
|
|
Morganeila morganii
|
2
|
|
|
Mycobacterium africanum
|
3
|
V
|
|
Mycobacterium avium/intracellulare
|
2
|
|
|
Mycobacterium bovis (except BCG strain)
|
3
|
V
|
|
Mycobacterium chelonae
|
2
|
|
|
Mycobacterium fortuitum
|
2
|
|
|
Mycobacterium kansasii
|
2
|
|
|
Mycobacterium leprae
|
3
|
|
|
|
|
|
|
|
|
|
|
Biological Agent
|
Classification
|
Notes
|
|
Mycobacterium maimoense
|
2
|
|
|
Mycobacterium marinum
|
2
|
|
|
Mycobacterium microti
|
3(*)
|
|
|
Mycobacterium paratuberculosis
|
2
|
|
|
Mycobacterium scrofulaceum
|
2
|
|
|
Mycobacterium simiae
|
2
|
|
|
Mycobacterium szulgai
|
2
|
|
|
Mycobacterium tuberculosis
|
3
|
V
|
|
Mycobacterium ulcerans
|
3(*)
|
|
|
Mycobacterium xenopi
|
2
|
|
|
Mycobacterium pneumoniae
|
2
|
|
|
Neisseria gonorrhoeae
|
2
|
|
|
Neisseria meningitidis
|
2
|
V
|
|
Nocardia asteroides
|
2
|
|
|
Nocardia brasiliensis
|
2
|
|
|
Nocardia farcinica
|
2
|
|
|
Nocardia nova
|
2
|
|
|
Nocardia otitdiscaviarum
|
2
|
|
|
Pasteurella multocida
|
2
|
|
|
Pasteurella spp.
|
2
|
|
|
Peptostreptococcus anaerobus
|
2
|
|
|
Plesiomonas shigelloides
|
2
|
|
|
Porphyromonas spp.
|
2
|
|
|
Prevotella spp.
|
2
|
|
|
Proteus mirabilis
|
2
|
|
|
Proteus penneri
|
2
|
|
|
Proteus vulgaris
|
2
|
|
|
Providencia alcaifaciens
|
2
|
|
|
Providencia rettgeri
|
2
|
|
|
|
|
|
(*) As appropriate some measure required by classification as group 3 may
be dispensed with.
|
|
|
|
|
|
|
|
|
Biological Agent
|
Classification
|
Notes
|
|
Providencia spp.
|
2
|
|
|
Pseudomonas aeruginosa
|
2
|
|
|
Pseudomonas mallei
|
3
|
|
|
Pseudomonas pseudomallei
|
3
|
|
|
Rhodococcus equi
|
2
|
|
|
Rickettsia akari
|
3(*)
|
|
|
Rickettsia canada
|
3(*)
|
|
|
Rickettsia conorii
|
3
|
|
|
Rickettsia montana
|
3(*)
|
|
|
Rickettsia typhi (Rickettsia mooseri)
|
3
|
|
|
Rickettsia prowazeki
|
3
|
|
|
Rickettsia Rickettsii
|
3
|
|
|
Rickettsia tsutsugamushi
|
3
|
|
|
Rickettsia spp.
|
2
|
|
|
Rochalimaea quintana
|
2
|
|
|
Salmonella Arizonae
|
2
|
|
|
Salmonella Enteritidis
|
2
|
|
|
Salmonella Typhimurium
|
2
|
|
|
Salmonella Paratyphi A, B, C
|
2
|
V
|
|
Salmonella Typhi
|
3(*)
|
V
|
|
Salmonella (other serovars)
|
2
|
|
|
Serpulina spp.
|
2
|
|
|
Shigella boydii
|
2
|
|
|
Shigella dysenteriae
(Type 1)
|
3(*)
|
T
|
|
Shigella flexneri
|
2
|
|
|
Shigella sonnei
|
2
|
|
|
Staphylococcus aureus
|
2
|
|
|
Streptobacillus moniliformis
|
2
|
|
|
Streptococcus pneumoniae
|
2
|
|
|
|
|
|
(*) As appropriate some measure required by classification as group 3 may
be dispensed with.
|
|
|
|
|
|
|
|
|
Biological Agent
|
Classification
|
Notes
|
|
Streptococcus pyogenes
|
2
|
|
|
Streptococcus spp.
|
2
|
|
|
Treponema carateum
|
2
|
|
|
Treponema pallidum
|
2
|
|
|
Treponema pertenue
|
2
|
|
|
Treponema spp.
|
2
|
|
|
Vibrio cholerae
(including El Tor)
|
2
|
|
|
Vibrio parahaemolyticus
|
2
|
|
|
Vibrio spp.
|
2
|
|
|
Yersinia enterocolitica
|
2
|
|
|
Yersinia pestis
|
3
|
V
|
|
Yersinia pseudotuberculosis
|
2
|
|
|
Yersina spp.
|
2
|
|
|
VIRUS
|
|
|
|
Adenoviridae
|
2
|
|
|
Arenaviridae
|
|
|
|
Junin virus
|
4
|
|
|
Lymphocytic choriomeningitis virus (neurotropic
strains)
|
3
|
|
|
Lymphocytic choriomeningitis virus (other strains)
|
2
|
|
|
Machupo virus
|
4
|
|
|
Mopeia virus and other Tacaribe viruses
|
2
|
|
|
Astroviridae
|
2
|
|
|
Astroviridae
|
2
|
|
|
Bunyaviridae:
|
|
|
|
Bunyamwera virus
|
2
|
|
|
Oropouche virus
|
3
|
|
|
California
encephalitis virus
|
2
|
|
|
Hantaviruses:
|
2
|
|
|
Hantaan (Korean haemorrhagic
fever)
|
3
|
|
|
|
|
|
|
|
|
|
|
Biological Agent
|
Classification
|
Notes
|
|
Seoul virus
|
3
|
|
|
Puumala virus
|
2
|
|
|
Prospect Hill virus
|
2
|
|
|
Other hantaviruses
|
2
|
|
|
Nairoviruses:
|
|
|
|
Crimean-Congo haemorrhagic fever
|
4
|
|
|
Hazara virus
|
2
|
|
|
Phleboviruses:
|
|
|
|
Rift Valley fever
|
3
|
V
|
|
Sandfly fever
|
2
|
|
|
Toscana virus
|
2
|
|
|
Other bunyaviridae known to
be pathogenic
|
2
|
|
|
Calciviridae:
|
|
|
|
Norwalk
virus
|
2
|
|
|
Other Caliciviridae
|
2
|
|
|
Coronaviridae
|
2
|
|
|
Filoviridae:
|
|
|
|
Ebola virus
|
4
|
|
|
Marburg
virus
|
4
|
|
|
Flaviviridae:
|
|
|
|
Australia
enciphalitis (Murray
Valley encephalitis)
|
3
|
|
|
Central European tick-borne encephalitis virus
|
3(*)
|
V
|
|
Absettarov
|
3
|
|
|
Hanzalova
|
3
|
|
|
Hypr
|
3
|
|
|
Kuminge
|
3
|
|
|
Dengue virus type 1 - 4
|
3
|
|
|
Hepatitis C virus
|
3(*)
|
D
|
|
Japanese B encephalitis
|
3
|
V
|
|
|
|
|
(*) As appropriate some measure required by classification as group 3 may
be dispensed with.
|
|
|
|
|
|
|
|
|
Biological Agent
|
Classification
|
Notes
|
|
Kyasanur
Forest
|
3
|
V
|
|
Louping ill
|
3
|
|
|
Omsk
(*)
|
3
|
V
|
|
Powassan
|
3
|
|
|
Roccio
|
3
|
|
|
Russian spring-summer encephalitis (TBE)
(*)
|
3
|
V
|
|
St Louis encephalitis
|
3
|
|
|
Wesselbron virus
|
3(*)
|
|
|
West Nile fever virus
|
3
|
|
|
Yellow fever
|
3
|
V
|
|
Other flaviviruses known to
be pathogenic
|
2
|
|
|
Hepadnaviridae:
|
|
|
|
Hepatitis B virus
|
3(*)
|
V, D
|
|
Hepatitis D virus (Delta) (b)
|
3
|
V, D
|
|
Herpesviridae
|
|
|
|
Cytomegalovirus
|
2
|
|
|
Epsteir-Barr virus
|
2
|
|
|
Herpesvirus simiae (B virus)
|
3
|
|
|
Herpes simplex viruses types 1 and 2
|
2
|
|
|
Herpesvirus varicella-zoster
|
2
|
|
|
Human B-lymphotropic virus
(HBLV-HHV6)
|
2
|
|
|
Orthomyxoviridae
|
|
|
|
Influenza viruses types A, B and C
|
2
|
V(c)
|
|
Tick-borne orthomyxovirdae:
Dhori and Thogoto viruses
|
2
|
|
|
|
|
|
(a)Tick-borne encephalitis.
|
|
|
|
(b)Hepatitis D virus is pathogenic in workers only in the
presence of simultaneous or secondary infection caused by hepatitis B virus.
|
|
|
|
Vaccination against hepatitis B virus will therefore protect workers who
are not affected by hepatitis B virus against hepatitis D virus (Delta).
|
|
|
|
(c) Only for types A and B.
|
|
|
|
|
|
|
|
|
Biological Agent
|
Classification
|
Notes
|
|
Papovaviridae
|
|
|
|
BK and JC
viruses
|
2
|
D(d)
|
|
Human papillomaviruses
|
2
|
D(d)
|
|
Paramyxovirdae
|
|
|
|
Measles virus
|
2
|
V
|
|
Mumps virus
|
2
|
V
|
|
Newcastle
disease virus
|
2
|
|
|
Parainfluenza viruses types 1
to 4
|
2
|
|
|
Respiratory scncytial virus
|
2
|
|
|
Parvoviridae
|
|
|
|
Human parvovirus (B19)
|
2
|
|
|
Picornaviridae
|
2
|
|
|
Acute haemorrhagic conjunctivitis virus (AHC)
|
2
|
|
|
Coxsacki viruses
|
2
|
|
|
Echo viruses
|
2
|
|
|
Hepatitis A virus (human enterovirus
type 72)
|
2
|
V
|
|
Polioviruses
|
2
|
V
|
|
Rhinoviruses
|
2
|
|
|
Poxvirdae
|
|
|
|
Buffalopox virus (e)
|
2
|
|
|
Cowpox virus
|
2
|
|
|
Elephantopox virus (f)
|
2
|
|
|
Milkers' node virus
|
2
|
|
|
Molluscum contagiosum
virus
|
2
|
|
|
Monkeypox virus
|
3
|
V
|
|
Orf virus
|
2
|
|
|
|
|
|
(d) Recommended for work involving direct contact with these
agents.
|
|
|
|
(e) Two viruses are identified: one a Buffalopox
type and the other a variant of the vaccinia
virus.
|
|
|
|
(f) Variant of cowpox virus.
|
|
|
|
|
|
|
|
|
Biological Agent
|
Classification
|
Notes
|
|
Rabbitpox virus (g)
|
2
|
|
|
Vaccinia virus
|
2
|
|
|
Variola (major and minor)
virus
|
4
|
V
|
|
White pox virus ("Variola
virus")
|
4
|
V
|
|
Yatapox virus (Tana and Yaba)
|
2
|
|
|
Reoviridae
|
|
|
|
Coltiviruses
|
2
|
|
|
Human rotaviruses
|
2
|
|
|
Orbiviruses
|
2
|
|
|
Reoviruses
|
2
|
|
|
Retroviridae (h)
|
|
|
|
Human immunodeficiency viruses
|
3
|
D
|
|
Human T-cell lymphotropic
viruses (HLTV)
|
|
|
|
types 1 and 2
|
3
|
D
|
|
Rhabdoviridae:
|
|
|
|
Rabies virus
|
3(*)
|
V
|
|
Vesicular stomatitis virus
|
2
|
|
|
Togaviridae
|
|
|
|
Alfaviruses:
|
|
|
|
Eastern equine encephalomyelitis
|
3
|
V
|
|
Bebaru virus
|
2
|
|
|
Chikungunya virus
|
3(*)
|
|
|
Everglades virus
|
3(*)
|
|
|
Mayaro virus
|
3
|
|
|
Mucambo virus
|
3
|
|
|
Ndumu virus
|
3
|
|
|
O'nyong-nyong virus
|
2
|
|
|
Ross River
virus
|
2
|
|
|
|
|
|
(*) As appropriate some measure required by classification as group 3 may
be dispensed with.
|
|
|
|
(g) Variant of Vaccinia.
|
|
|
|
(h) At present there is no evidence of disease in humans
caused by retroviruses of simian origin.
|
|
|
|
As a precaution containment level 3 is recommended for work with them.
|
|
|
|
|
|
|
|
|
Biological Agent
|
Classification
|
Notes
|
|
Semlike
Forest virus
|
2
|
|
|
Sindbis virus
|
2
|
|
|
Tonate virus
|
3(*)
|
|
|
Venezuelan equine encephalomyelitis
|
3
|
V
|
|
Western equine encephalomyelitis
|
3
|
V
|
|
Other known alfaviruses:
|
2
|
|
|
Rubivirus (rubella)
|
2
|
V
|
|
Toroviridae
|
2
|
|
|
Unclassified viruses
|
|
|
|
Blood-borne hepatitis viruses not yet identified
|
3(*)
|
D
|
|
Hepatitis E virus
|
3(*)
|
|
|
Unconventional agents associated with(i):
|
|
|
|
Creuzfeld-Jakob disease
|
3
|
D (j)
|
|
Gerstmann-Sträussler-Scheinker
syndrome
|
3
|
D (j)
|
|
Kuru
|
3
|
D (j)
|
|
PARASITES
|
|
|
|
Acanthamoeba castellani
|
2
|
|
|
Ancylostoma duodenale
|
2
|
|
|
Angiostrongylus cantonensis
|
2
|
|
|
Angiostrongylus Costaricensis
|
2
|
|
|
Ascaris lumbriocoides
|
2
|
A
|
|
Ascaris suum
|
2
|
A
|
|
Babesia divergens
|
2
|
|
|
Babesia microti
|
2
|
|
|
Balantidium coli
|
2
|
|
|
Brugia malayi
|
2
|
|
|
Brugia pahangi
|
2
|
|
|
|
|
|
(*) As appropriate some measure required by classification as group 3 may
be dispensed with.
|
|
|
|
(i)There is no evidence in humans of
infections caused by the agents responsible for bovine spongiform
encephalitis. Nevertheless, containment level 2 is recommended at least as a
precaution for laboratory work.
|
|
|
|
(j) For work involving direct contact with these agents.
|
|
|
|
|
|
|
|
|
Biological Agent
|
Classification
|
Notes
|
|
Capillaria philippinensis
|
2
|
|
|
Capillaria spp.
|
2
|
|
|
Clonorchis sinensis
|
2
|
|
|
Clonorchis viverrini
|
2
|
|
|
Cryptosporidium parvum
|
2
|
|
|
Cryptosporidium spp.
|
2
|
|
|
Dipetalonema streptocerca
|
2
|
|
|
Diphyllobothrium latum
|
2
|
|
|
Dracunculus medinensis
|
2
|
|
|
Echinococcus granulosus
|
3
|
|
|
Echinococcus multilocularis
|
3
|
|
|
Echinococcus vogeli
|
3
|
|
|
Entamoeba histolytica
|
2
|
|
|
Fasciola gigantica
|
2
|
|
|
Fasciola hepatica
|
2
|
|
|
Fasciolopsis buski
|
2
|
|
|
Giardia lamblia
(Giardia intestinalis)
|
2
|
|
|
Hymenolepis diminuta
|
2
|
|
|
Hymenolepisnana
|
2
|
|
|
Leishmania brasiliensis
|
3
|
|
|
Leishmania donovani
|
3
|
|
|
Leishmania ethiopica
|
2
|
|
|
Leishmania mexicana
|
2
|
|
|
Leishmania peruviana
|
2
|
|
|
Leishmania tropica
|
2
|
|
|
Leishmania major
|
2
|
|
|
Leishmania spp.
|
2
|
|
|
Loa Loa
|
2
|
|
|
Mansonello ozzardi
|
2
|
|
|
Mansonella perstans
|
2
|
|
|
|
|
|
|
|
|
|
|
Biological Agent
|
Classification
|
Notes
|
|
Naegleria flowleri
|
3
|
|
|
Necator americanus
|
2
|
|
|
Onchocerca volvulus
|
2
|
|
|
Opisthorchis felineus
|
2
|
|
|
Opisthorchis spp.
|
2
|
|
|
Paragonimus westermani
|
2
|
|
|
Plasmodium falciparum
|
3
|
|
|
Plasmodiums spp (human and simian)
|
2
|
|
|
Sarcocystis suihominis
|
2
|
|
|
Schistosoma haematobium
|
2
|
|
|
Schistosoma intercalatum
|
2
|
|
|
Schistosoma japonicum
|
2
|
|
|
Schistosoma mansoni
|
2
|
|
|
Strongyloides stercoralis
|
2
|
|
|
Strongyloides spp.
|
2
|
|
|
Taenia saginata
|
2
|
|
|
Taenia solium
|
3
|
|
|
Toxocara canis
|
2
|
|
|
Toxoplasma gondii
|
2
|
|
|
Trichinella spiralis
|
2
|
|
|
Trichuris trichiuria
|
2
|
|
|
Trypanosoma brucei brucei
|
2
|
|
|
Trypanosoma brucei gambiense
|
2
|
|
|
Trypanosoma brucei rhodesiense
|
3
|
|
|
Trypanosoma cruzi
|
3
|
|
|
Wuchereria bancrofti
|
2
|
|
|
FUNGI
|
|
|
|
Aspergillus fumigatus
|
2
|
A
|
|
Blastomyces dermatitidis (Ajellomyces dermatidis)
|
3
|
|
|
Candida albicans
|
2
|
A
|
|
|
|
|
|
|
|
|
|
Biological Agent
|
Classification
|
Notes
|
|
Coccidioides immitis
|
3
|
A
|
|
Cryptococcus neoformans var. neoformans (Filobasidiella neoformans var. neoformans)
|
2
|
A
|
|
Cryptococcus neoformans var. gattii (Filobasidiella bacillispora)
|
2
|
A
|
|
Emmonsia parva
var. parva
|
2
|
|
|
Emmonsia parva
var. crescens
|
2
|
|
|
Epidermophyton floccosum
|
2
|
A
|
|
Fonsecaea compacta
|
2
|
|
|
Fonsecaea pedrosoi
|
2
|
|
|
Histoplasma Capsulatum var. Capsulatum (Ajelomyces Capsulatus)
|
3
|
|
|
Histoplasma capsulatum duboisii
|
3
|
|
|
Madurella grisea
|
2
|
|
|
Madurella mycetomatis
|
2
|
|
|
Microsporum spp.
|
2
|
A
|
|
Neotestudina rosatii
|
2
|
|
|
Paracoccidioides brasiliensis
|
3
|
|
|
Penicillium marneffei
|
2
|
A
|
|
Sporothrix schenckii
|
2
|
|
|
Trichophyton rubrum
|
2
|
|
|
Trichophyton spp.
|
2
|
|
|
|
|
|
FIFTH SCHEDULE
|
|
|
|
RECOMMENDATIONS
ON VACCINATION PRACTICE
|
|
|
|
Regulation 6 (2)
(c)
|
|
|
|
(1) If the risk assessment referred to in Regulation (4) (a), (b)
and (c) reveals that there is a risk to the health and safety of
employees due to their exposure to a biological agent for which effective
vaccines exist, the employer should offer them vaccination.
|
|
|
|
(2) Vaccination should be carried out in accordance with any guideline
issued or approved by the Authority and employees should be informed of the
benefits and drawbacks of both vaccination and non-vaccination.
|
|
|
|
(3) Vaccination must be offered free of charge to employees.
|
|
|
|
(4) A vaccination certificate may be drawn up which should be made
available to the employee concerned and, on request, to the Authority.
|
|
|
|
SIXTH SCHEDULE
|
|
|
|
RECOMMENDATIONS
FOR THE HEALTH SURVEILLANCE OF EMPLOYEES
|
|
|
|
Regulation 10 (4) (b)
|
|
|
|
1. Where appropriate the responsible medical practitioner should be
familiar with the exposure conditions or circumstances of each employee.
|
|
|
|
2. Health surveillance of employees must be carried out in accordance
with the principles and practices of occupational medicine; it must include
at least the following measures:
|
|
|
|
— keeping records of an employee's medical and occupational history,
|
|
|
|
— a personalised assessment of the employee's state of health,
|
|
|
|
— 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.
|
|
|
|
SEVENTH
SCHEDULE
|
|
|
|
INDICATIONS
CONCERNING CONTAINMENT MEASURES AND CONTAINMENT LEVELS
|
|
|
|
Regulations 11 (e)
and 12 (1)
|
|
|
|
The measures contained in this Schedule shall be applied according to the
nature of the activities, the assessment of risk to employees, and the nature
of the biological agent concerned.
|
|
|
|
|
|
|
|
|
Containment
Measures
|
Containment
Levels
|
|
|
2
|
3
|
4
|
|
1. The workplace is to be separated from any other
activities in the same building
|
No
|
Recommended
|
Yes
|
|
2. Input air and extract air to the workplace are to
be filtered using HEPA or likewise
|
No
|
Yes, on extract air
|
Yes, on input and extract air
|
|
3. Access is to be restricted to nominated workers
only
|
Recommended
|
Yes
|
Yes, via airlock
|
|
4. The workplace is to be sealable to permit
disinfection
|
No
|
Recommended
|
Yes
|
|
5. Specified disinfection procedures
|
Yes
|
Yes
|
Yes
|
|
6. The workplace is to be maintained at an air
pressure negative to atmosphere
|
No
|
Recommended
|
Yes
|
|
7. Effective vector control e.g. rodents and insects
|
Recommended
|
Yes
|
Yes
|
|
8. Surfaces impervious to water and easy to clean
|
Yes, for bench
|
Yes, for bench and floor
|
Yes, for bench, walls, floor and ceiling
|
|
9. Surfaces resistant to acids, alkalis, solvents,
disinfectants
|
Recommended
|
Yes
|
Yes
|
|
10. Safe storage of a biological agent
|
Yes
|
Yes
|
Yes, secure storage
|
|
11. An observation window, or alternative, is to be
present, so that occupants can be seen
|
Recommended
|
Recommended
|
Yes
|
|
12. A laboratory is to contain own equipment
|
No
|
Recommended
|
Yes
|
|
13. Infected material including any animal is to be
handled in a safety cabinet or isolator or other suitable containment
|
Where appropriate
|
Yes, where infection is by airborne route
|
Yes
|
|
14. Incinerator for disposal of animal carcases
|
Recommended
|
Yes (available)
|
Yes, on site
|
|
|
|
|
EIGHTH
SCHEDULE
|
|
|
|
CONTAINMENT
MEASURES AND CONTAINMENT LEVELS FOR INDUSTRIAL PROCESSES
|
|
|
|
Regulations 12 (2) (a) and 12 (2) (d)
|
|
|
|
The measures contained in this Schedule shall be applied according to the
nature of the activities, the assessment of risk to employees, and the
nature of the biological agent concerned.
|
|
|
|
|
|
|
|
|
Containment
Measures
|
Containment
Levels
|
|
|
2
|
3
|
4
|
|
1. Viable organisms should be handled in a system
which physically separates the process from the environment
|
Yes
|
Yes
|
Yes
|
|
2. Exhaust gases from the closed system should be
treated so as to:
|
Minimise release
|
Prevent release
|
Prevent release
|
|
3. Sample collection, addition of materials to a
closed system and transfer of viable organisms to another closed system,
should be performed so as to:
|
Minimise release
|
Prevent release
|
Prevent release
|
|
4. Bulk culture fluids should not be removed from the
closed system unless the viable organisms have been:
|
Inactivated by validated means
|
Inactivated by validated chemical or physical means
|
Inactivated by validated chemical or physical means
|
|
5. Seals should be designed so as to:
|
Minimise release
|
Prevent release
|
Prevent release
|
|
6. Closed systems should be located within a
controlled area
|
Optional
|
Optional
|
Yes and purpose built
|
|
( a ) Biohazard signs should be posted
|
Optional
|
Yes
|
Yes
|
|
( b ) Access should be restricted to nominated
personnel only
|
Optional
|
Yes
|
Yes, via an airlock
|
|
( c ) Personnel should wear protective clothing
|
Yes, work clothing
|
Yes
|
A complete change
|
|
( d ) Decontamination and washing facilities should be
provided for personnel
|
Yes
|
Yes
|
Yes
|
|
( e ) Personnel should shower before leaving the
controlled area
|
No
|
Optional
|
Yes
|
|
( f ) Effluent from sinks and showers should be
collected and inactivated before release
|
No
|
Optional
|
Yes
|
|
( g ) The controlled area should be adequately
ventilated to minimise air contamination
|
Optional
|
Optional
|
Yes
|
|
( h ) The controlled area should be maintained at an
air pressure negative to atmosphere
|
No
|
Optional
|
Yes
|
|
( i ) Input air and extract
air to the controlled area should be HEPA
filtered
|
No
|
Optional
|
Yes
|
|
( j ) The controlled area should be designed to
contain spillage of the entire contents of the closed system
|
No
|
Optional
|
Yes
|
|
( k ) The controlled area should be sealable to permit
fumigation
|
No
|
Optional
|
Yes
|
|
( l ) Effluent treatment before final discharge
|
Inactivated by validated means
|
Inactivated by validated chemical or physical means
|
Inactivated by validated chemical or physical means
|
|
|
|
|
GIVEN under my
Official Seal, this 17th day of May, 1994.
|
|
|
|
RUAIRÍ QUINN,
|
|
|
|
Minister for Enterprise
and
|
|
|
|
Employment.
|
|
|
|
EXPLANATORY
NOTE.
|
|
|
|
These Regulations implement Council Directives 90/679/EEC of 26 November, 1990, and 93/88/EEC
of 12 October, 1993, on
the protection of workers from risks related to exposure to a biological
agent at work. The Regulations define biological agents. Biological agents
thus include bacteria, viruses and fungi. The Regulations draw a distinction
between incidental exposure to a biological agent and exposure arising from
their deliberate use (Regulation 3 (f)). Employers must identify the
biological agent to which workers are, or may be, exposed. They must assess
the risk, making use of the classification referred to in Regulation 2 and
the Fourth Schedule, and proceed in accordance with the remaining
Regulations where appropriate. Specific Regulations set out action to be
taken in Veterinary and Health Care facilities and in industrial processes.
|
|
|
|
|