CELEX: 51989PC0404
Language: en
Date: 1989-07-28
Title: AMENDED PROPOSAL FOR A COUNCIL DIRECTIVE ON THE PROTECTION OF WORKERS FROM THE RISKS RELATED TO EXPOSURE TO BIOLOGICAL AGENTS AT WORK

24. 8. 89                            Official Journal of the European Communities                            No C 218/5
                                                            II
                                                    (Preparatory Acts)
                                               COMMISSION
             Amended proposal for a Council Directive on the protection of workers from the risks related
                                       to exposure to biological agents at work (')
                                             COM(89) 404 final — SYN 129
             (Submitted by the Commission pursuant to the third paragraph of Article 149 of the EEC Treaty on
                                                      2 August 1989)
                                                      (89/C 218/04)
             0) OJ No C 150, 8. 6. 1988, p. 6.
Seventh   individual Directive within the meaning of             Individual Directive within the meaning of Article 16 of
           Article 8 of Directive 80/1170/EEC                                      Directive 89/391/EEC
                     ORIGINAL PROPOSAL                                               AMENDED PROPOSAL
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                         THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European            unchanged
Economic Community, and in particular article 118A
thereof,
Having regard to the proposal from the Commission,
established following consultation with the Advisory
Committee on Safety, Hygiene and Health Protection at
Work,
In cooperation with the European Parliament,
Having regard to the opinion of the Economic and
Social Committee,
Whereas Council Directive 80/1107/EEC of 27                      Whereas this Directive is an individual Directive within
November 1980 on the protection of workers from the              the meaning of Article 16 of Council Directive
risks related to exposure to chemical, physical and bio-         89/391/EEC (2) on the introduction of measures to
logical agents at work (2), as amended by the Act of             encourage improvements in the safety and health of
Accession of Spain and Portugal, provides for directives         workers at work; whereas the provisions of the latter are
for certain agents;                                              therefore fully applicable to the exposure of workers to
                                                                 biological agents without prejudice to more stringent
                                                                 and/or specific provisions contained in the present
                                                                 Directive;
O OJ No L 327, 3. 12. 1980, p. 8.                                O OJ No L 183, 29. 6. 1989, p. 1.
 ---pagebreak--- N o C 218/6                          Official Journal of the European Communities                               24. 8. 89
                     ORIGINAL PROPOSAL                                               AMENDED PROPOSAL
Whereas, under the terms of the said Directive, such            deleted
protection should as far as possible be ensured by
measures to prevent exposure or to keep it at as low a
level as is reasonably practicable;
Whereas more precise knowledge of the risks involved in         unchanged
exposure to biological agents at work can be obtained
through the keeping of records;
Whereas employers must keep abreast of new devel-               unchanged
opments in, technology with a view to improving the
protection of workers' health and safety;
Whereas it is necessary, in order to ensure the highest         unchanged
degree of protection reasonably practicable, that workers
and their representatives be informed about the risks
which biological agents can pose for their health, and the
measures necessary to lessen or eliminate those risks and
that they should be in a position to ensure that the
necessary protective measures are taken,
Whereas, preventive measures should be taken for the            unchanged
protection of the health and safety of workers exposed
to biological agents,
HAS ADOPTED THIS DIRECTIVE:                                     HAS ADOPTED THIS DIRECTIVE:
                         Objective
                          Article 1                                                      Article 1
 1.   The purpose of this Directive, is to protect workers      1.    This Directive, which is an individual Directive
against risks to their health and safety, and to prevent        within the meaning of Article 16 of Directive
such risks, arising or likely to arise from exposure to         89/391/EEC, has as its aim the protection of workers
biological agents at work.                                      against risks to their health and safety, including the
                                                                prevention of such risks, arising or likely to arise from
                                                                exposure to biological agents at work. It lays down
                                                                particular minimum provisions in this area.
2.    This Directive shall apply to all workers with the        deleted
exception of workers engaged in sea transport and in air
transport.
For the purposes of this Directive 'workers engaged in          deleted
sea transport and in air transport' means personnel on
board.
                                                                2.    Member States shall take the necessary steps to
                                                                ensure that employers, workers and workers' represen-
                                                                tatives are subject to the legal provisions necessary for
                                                                the implementation of this Directive.
                                                                3.    In particular, Member States shall ensure adequate
                                                                controls and supervision.
 ---pagebreak--- 24. 8. 89                             Official Journal of the European Communities                No C 218/7
                     ORIGINAL PROPOSAL                                           AMENDED PROPOSAL
                        Definitions
                          Article 2                                                  Article 2
For the purposes of this Directive:
(a) 'Biological agents' are microorganisms including             unchanged
    those which have been genetically manipulated, cell
    cultures and multicellular human endoparasites.
(b) A 'Group 1' biological agent is one that is most             unchanged
    unlikely to cause human disease. It does not produce
    infection and is unlikely to spread in the community.
    This definition includes any genetically modified
    biological agent which fulfils the criteria for good
    microbiological practice as laid down in Annex I.
(c) A 'Group T biological agent is one that may cause            unchanged
    human disease and might be a hazard to workers. It
    rarely produces infection. It is unlikely to spread in
    the community and there is usually effective
    prophylaxis or treatment available.
(d) A 'Group 3' biological agent is one that may cause           unchanged
    severe human disease and presents a serious hazard
    to workers. It may present a risk of spread in the
    community but there is usually effective prophylaxis
    or treatment available.
(e) A 'Group 4' biological agent is one that causes severe       unchanged
    human disease and is a serious hazard to workers. It
    may present a high risk of spread in the community
    and there is usually no effective prophylaxis or
    treatment available.
(f) 'Micro-organism' is any microscopic unicellular or           unchanged
    subcellular biological entity capable of replication.
(g) 'Genetically modified biological agent'           is an      unchanged
    organism derived by the techniques of            genetic
    manipulation.
(h) 'Genetic manipulation' is the formation of a new             unchanged
    combination of genetic material by the insertion of
    nucleic acid molecules produced by whatever means
    outside the cell, into any virus, bacterial plasmid or
    other vector system so as to allow their incorporation
    into a host organism in which they do not naturally
    occur but in which they are capable of continued
    propagation.
 ---pagebreak--- N o C 218/8                            Official Journal of the European Communities                                   24. 8. 89
                     ORIGINAL PROPOSAL                                                 AMENDED PROPOSAL
(i) 'Cell culture' is the in vitro growth of cells isolate        unchanged
    from multicellular organisms.
(j) 'Incidental exposure to biological agents' is any work       unchanged
    activity or sector of activity in which there is no
    deliberate intention to handle or use biological
    agents but where the work activity may result in
    workers being exposed to biological agents,
    including contact with animals and animal products
    where there may be a risk of exposure to zoonotic
    agents, and sewage and health care activities where
    they may be a risk of exposure to persons or patho-
    logical material with infectious disease.
(k) 'Conscious decision to work with biological agents'           unchanged
    is any work activity or sector of activity in which the
    purpose of the work biological agents, including
    work in research laboratories or industrial processes
    employing biological agents.
                        Assessment
                          Article 3                                                         Article 3
1.    This Directive shall apply to work activities in            unchanged
which workers are or are potentially exposed to bio-
logical agents as a result of their work activities.
2.    In the case of any activity or sector of activity likely    2.    In the case of any activity or sector of activity likely
to involve a risk of exposure to biological agents the risk       to involve the risk of exposure to biological agents the
must be assessed. Member States shall fix the conditions          risk must be assessed. Member States shall fix the
of this assessment and of any further assessment, if              conditions of this assessment and of any further
necessary, and shall determine by whom it is to be                assessment, if necessary, and shall determine by whom it
conducted. The assessment shall be conducted so as to             is to be conducted. The assessment should furthermore
determine the nature and degree of the:                           allow the classification of the biological agents to Groups
                                                                  1 to 4 (Article 2 (b) to (e)). Pending a Community classi-
                                                                  fication (Annex V) this classification shall be made by
                                                                  the Member States. The assessment shall be conducted
                                                                  so as to determine the nature and degree of the:
— inherent hazard of a biological agent to health,                unchanged
— risk of workers' exposure or potential exposure,                unchanged
    including a determination of whether this involves
    either incidental exposure, or a conscious decision to
    work with biological agents,
                                                                  — effectiveness      of prophylactic and          therapeutic
                                                                      measures in the event of infections of other health
                                                                      hazards,
 ---pagebreak--- 24. 8. 89                             Official Journal of the European Communities                           No C 218/9
                      ORIGINAL PROPOSAL                                              AMENDED PROPOSAL
— risk of transfer        from    the  workplace     to  the     unchanged
     community,
— risk of further spread within the community.                  unchanged
This assessment shall not apply to genetically modified         unchanged
biological agents which have been notified in accordance
with the provisions of Council Directive . . . / . . ./EEC.
3.     The identification of a biological agent as being        3.    The assessment of a biological agent as being
hazardous to health shall be based on all available infor-      hazardous to health shall be based on all available infor-
mation including:                                               mation including:
                                                                    diseases which may be caused          through    direct
                                                                    connection with a work activity,
     a disease from which a worker is found to be                   a disease from which a worker is found to be
    suffering which has a direct connection with his work           suffering which has a direct connection with his work
     activity and/or epidemiology which indicates that a            activity and/or epidemiology which indicates that a
    biological agent has been a source of human                     biological agent has been or may be a source of
     infection and/or illness,                                      human infection and/or illness,
     guidelines issued by a responsible authority which             guidelines issued by a responsible authority, to be
     indicate that a biological agent should be controlled          designated by the Member State in consultation with
     in some way in order to prevent human infection                the Commission, which indicate that the biological
     and/or illness when workers are or are potentially             agent should be controlled in some way in order to
    exposed to such an agent as a result of their work              prevent human infection and/or illness when workers
     activity.                                                      are or are potentially exposed to such an agent as a
                                                                    result of their work activity.
4.     Biological agents shall be assessed on the basis of      4.    Biological agents shall be assessed on the basis of
the maximum degree of hazard, unless there is evidence,         the maximum degree of hazard unless there is evidence,
in individual cases, that the degree of hazard is lower.        exceptionally and in individual cases, that the degree of
                                                                hazard is lower.
The assessment of a genetically modified biological agent        unchanged
shall be made, when appropriate, on the same basis.
                                                                Where biological agents cannot be clearly assigned to
                                                                one of the groups set out in Article 2 (b) to (e), they
                                                                shall be assigned to the group presenting the greatest
                                                                degree of hazard.
5.     This Directive shall apply without prejudice to the      unchanged
provisions of Council Directive . . . / . . ./EEC on the
contained use of genetically modified micro-organisms.
6.     Articles 4 to 17, with the exception of the first        6.    Articles 4 to 17, with the exception of the first
indent of Article 9, shall not apply if the assessment          indent of Article 9, shall not apply if the assessment
referred to in paragraph 2 shows that the exposure              referred to in paragraph 2 shows that the exposure
and/or potential exposure is to a Group 1 biological            and/or potential exposure is to a Group 1 biological
agent or to a biological agent which causes disease only        agent with no identifiable health risk to workers.
in animals and/or in plants and that there is no ident-
ifiable health risk to workers.
 ---pagebreak--- N o C 218/10                         Official Journal of the European Communities                                24. 8. 89
                     ORIGINAL PROPOSAL                                              AMENDED PROPOSAL
7.     Articles 6 to 14 shall not apply if the assessment      Articles 6 to 14 shall apply if the assessment referred to
referred to in paragraph 2 shows that the work activities      in paragraph 2 shows that the work activities involve a
involve only incidental exposure to biological agents.         conscious decision to work with biological agents.
                                                               If the assessment referred to in paragraph 2 shows that
                                                               the activities involve only incidental exposure to bio-
                                                               logical agents, the provisions of Articles 6 to 14 shall
                                                               become applicable from the moment they are shown to
                                                               be necessary.
General provisions applicable to work activities which         unchanged
involve both incidental exposure to biological agents and
   a conscious decision to work with biological agents
                          Article 4                                                      Article 4
The risk of workers' exposure must be avoided. Where            1.   The risk of workers' exposure must be avoided.
this is not reasonably practicable, having regard to the       Where this is not practicable, having regard to the work
work activity and the risk assessment referred to in           activity and the risk assessment referred to in Article 3
Article 3 (2) exposure shall be reduced to as low a level      (2) exposure shall be reduced to as low a level as
as is necessary in order to protect adequately the health      necessary in order to protect adequately the health and
and safety of the workers concerned, in particular by the      safety of the workers concerned, in particular by the
following measures which are to be applied when appro-         following measures which are to be applied in the light
priate :                                                       of the result of the risk assessment referred to in Article
                                                               3 (2):
(a) the limitation of the number of workers exposed or          unchanged
     potentially exposed;
(b) the prevention of exposure or its adequate control by       unchanged
     the appropriate design of work processes and/or the
     use of engineering control measures;
(c) collective protection measures including the use and        unchanged
     maintenance of adequate equipment;
(d) personal protection measures, where exposure               (d) personal protection measures and equipment, where
     cannot reasonably be avoided by other means;                   exposure cannot be avoided by other means;
(e) hygiene measures designed to prevent the accidental         unchanged
     transfer or release of a biological agent from the
     workplace;
(f) the provision of up-to-date information on biological      deleted
     agents which are or may be present at the workplace
     together with a continuing programme of adequate
     training for workers;
(g) use of a biohazard sign (Annex II) and other               (becomes f) use of the biohazard sign depicted in Annex
     warning signs;                                            II and other warning signs;
(h) emergency procedures designed to minimize                  unchanged (becomes g)
     workers' exposure resulting from a serious accident
     or incident.
 ---pagebreak---   24. 8. 89                             Official Journal of the European Communities                           No C 218/11
                       ORIGINAL PROPOSAL                                               AMENDED PROPOSAL
                                                                   2.    Employers shall take the appropriate measures to
                                                                   ensure that workers and/or their representatives in the
                                                                   undertaking or establishment receive appropriate and
                                                                   up-to-date information, based on all available infor-
                                                                   mation, concerning, biological agents which are or may
                                                                  be present at the workplace, together with appropriate
                                                                  instruction where necessary, and a continuing
                                                                  programme of appropriate training.
                           Article 5                                                       Article 5
 1.    At the beginning of employment and at regular              unchanged
 intervals thereafter, the workers shall receive up to date
information together with adequate instruction, so that
they are made aware of all the requirements laid down in
Article 4.
2.     Appropriate measures shall be taken to ensure that         2.    Employers shall take appropriate measures to
workers and/or any workers' representatives in the                ensure that workers and/or workers' representatives in
undertaking or establishment can receive explanations on          the undertaking or establishment receive explanations on
the potential risks to health from exposure to biological         the potential risks to health from exposure to biological
agents, the hygiene requirements, and the emergency               agents, the hygiene requirements, and the emergency
procedures designed to minimize workers' exposure                 procedures designed to minimize workers' exposure
resulting from a serious accident or incident.                    resulting from a serious accident or incident.
Additional provisions applicable to work activities which           Hygiene measures, protective clothing and equipment
involve a conscious decision to work with biological
                            agents
                           Article 6                                                       Article 6
1.     Appropriate measures shall be taken so far as is           1.    Employers shall be required to take the following
reasonably practicable for the protection of the health           measures for all work activities in which there is a safety
and safety of workers by providing that:                          and health risk to workers:
(a) areas are set aside where workers can eat and drink           unchanged
     without risking contamination by biological agents;
(b) workers are provided with appropriate protective              unchanged
     clothing or other appropriate special clothing;
(c) separate storage places are provided for working or           unchanged
     protective clothing and for street clothes;
(d) protective respiratory equipment is placed in a well-         unchanged
     defined place and is checked, if possible before, and
     in any case after each use; defective equipment shall
     be repaired or replaced before further use.
 ---pagebreak--- N o C 218/12                           Official Journal of the European Communities                               24. 8. 89
                      ORIGINAL PROPOSAL                                               AMENDED PROPOSAL
2.     Working      clothes     and   personal    protective      unchanged
equipment, including protective clothing which may be
contaminated by biological agents, must be removed on
leaving the working area and stored separately from
other clothing. The employer must ensure that such
clothing and personal protective equipment are disin-
fected, cleaned or, if necessary, destroyed.
3.     Workers who handle biological agents must be               unchanged
provided with skin and eye antiseptics, suitable washing
facilities and, if appropriate, showers.
4.     Workers may not be charged for the cost of                 unchanged
measures taken pursuant to paragraphs 1, 2 and 3.
                                                                                 Records of exposed workers
                            Article 7                                                      Article 7
 1.    Employers shall keep a record of workers exposed           unchanged
or potentially exposed to Group 3 and/or Group 4 bio-
logical agents indicating the type of work done, and
whenever possible the biological agent to which they
may have been exposed, as well as records of accidents
and incidents, as appropriate.
2.     The records referred to in paragraph 1 shall be kept       2.   The research referred to in paragraph 1 shall be
for at least 10 years following the end of exposure, in           kept for at least 40 years following the end of exposure,
accordance with national laws and practice.                       in accordance with national laws and practice.
3.     The doctor and/or the authority responsible for            3.    The doctor and/or the authority responsible for
health and safety at work shall have access to the records        health and safety at work, and any other person
referred to in paragraph 1.                                       responsible for health and safety at work, shall have
                                                                  access to the records referred to in paragraph 1.
4.     Each worker shall have access to information in the        unchanged
records which relates to him personally.
5.     Workers and/or any workers' representatives in the         unchanged
undertaking or establishment shall have access to
anonymous collective information in the records.
 ---pagebreak--- 24. 8. 89                             Official Journal of the European Communities                           No C 218/13
                     ORIGINAL PROPOSAL                                               AMENDED PROPOSAL
                          Article 8                                                       Article 8
 1.   The use of a Group 3 or 4 biological agent shall be        1.    The use of a Group 3 or 4 biological agent must be
avoided, as far as is reasonably practicable by its             avoided      by substituting     a less hazardous       or
replacement by a less hazardous or non-hazardous                non-hazardous agent, where this is technically prac-
agent.                                                          ticable.
2.    Suppliers or importers of a Group 3 or 4 biological       2.     Suppliers or importers of a Group 3 or 4 biological
agent for use at work shall ensure that they are                agent for use at work shall ensure:
adequately described, packed and transported.
                                                                 (a) the safe handling and transport of such agents, in
                                                                     particular through the use of airtight containers
                                                                     which are clearly and visibly labelled;
                                                                 (b) the safe collection, storage and disposal of waste,
                                                                     through, inter alia, the use of airtight containers
                                                                     which are clearly and visibly labelled.
                                                                           Worker consultation and participation
                          Article 9                                                       Article 9
Employers shall on request make available to            the     Employers shall on request make available to the
responsible authorities appropriate information on:             responsible authorities, and to workers and/or workers'
                                                                representatives, appropriate information on:
— the results of the assessment referred to in Article 3        unchanged
    (2),
— the activities in which workers have been exposed or          unchanged
    potentially exposed to biological agents,
— the number of workers exposed,                                unchanged
— the name of the person responsible for safety and             — the name and qualifications of the person responsible
    health at work,                                                  for safety and health at work,
— the protective and preventive measures             taken      unchanged
    including working procedures and methods,
— an emergency plan for the protection of workers               unchanged
    from exposure to a Group 3 or 4 biological agent
    which might result from a loss of physical
    containment.
                                                                                    Worker information
                         Article 11                                                  Becomes Article 10
1.    Employers shall display written instructions at the        1.    Employers shall display written instruction at the
workplace which shall include the procedure to be used          workplace which shall, as a minimum, include the
in the case of:                                                 procedure to be followed in the case of:
— a serious accident or incident,                               unchanged
— work with a Group 4 biological agent.                         unchanged
 ---pagebreak--- N o C 218/14                         Official Journal of the European Communities                                  24. 8. 89
                     ORIGINAL PROPOSAL                                                 AMENDED PROPOSAL
2.    A serious accident or incident shall be reported         2.     Any accident or incident shall be reported
immediately to and recorded by the person responsible          immediately to the person responsible for safety and
for the work.                                                  health at work.
3.    Workers and/or any workers' representatives in the       unchanged
undertaking or establishment shall be 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.
                                                                Specific provisions applicable to the use of genetically
                                                                                    modified biological agents
                         Article 10                                                    Becomes Article 11
1.    Without prejudice to Directive . . . / . . ./EEC on the   1.    Without prejudice to Directive 8 9 / . . ./EEC on the
deliberate release of genetically modified organisms,           deliberate release of genetically modified organisms, and
employers shall give a prior notification to the                Directive 8 9 / . . ./EEC on the use of genetically modified
responsible authority, at least 60 days before:                 micro-organisms in contained systems, employers shall
                                                                give a prior notification to the responsible authority and
                                                                to the workers and/or their representatives, at least 90
                                                                days before work is planned to commence, of:
— an intention to carry out genetic manipulation work           — an intention to carry out genetic manipulation work
    or to work with a genetically modified biological               or to work with a genetically modified biological
    agent in Group 2, 3 or 4,                                       agent,
— an intention to introduce substantial changes to a            unchanged
    procedure which has already been notified,
— work with a Group 4 biological agent, or if there is          unchanged
    an intention to handle, store or transport such an
    agent.
2.    In the case of genetic manipulation work, or work         2.    The prior notification shall include:
with a genetically modified biological agent, prior notifi-
cation shall include the name and address of the under-
taking and/or establishment and the name of the person
responsible for safety and health at work.
                                                                — the name and address of the undertaking and/or
                                                                    establishment,
                                                                — the name and qualifications of the person responsible
                                                                    for safety and health at work.
In the case of a Group 4 biological agent this prior noti-      unchanged
fication shall include:
— the result of the assessment referred to in Article 3         unchanged
    (2),
— the name of the biological agent,                             — the name and taxonomic description of the biological
                                                                    agent,
    the protection and preventive measures that are
    envisaged,                                                  unchanged
    the name of the person responsible for safety and
    health at work.                                             deleted
 ---pagebreak--- 24. 8. 89                             Official Journal of the European Communities                           No C 218/15
                     ORIGINAL PROPOSAL                                               AMENDED PROPOSAL
3.     Employers shall inform forthwith the responsible          3.   Employers shall inform forthwith the responsible
authority of any accident or incident that may have              authority and workers of any accident or incident that
resulted in the release of any biological agent such that it    may have resulted in the release of any biological agent
could cause severe human infection and/or illness.              which could cause severe human infection and/or illness.
                                                                                    Medical surveillance
                         Article 12                                                      Article 12
1.    The specific rules for the health surveillance of         unchanged
workers shall be established by the Member States in
accordance with national law and practice.
2.    Members States shall make arrangements to ensure           2.   Member States shall make arrangements to ensure
that, where relevant, each worker can undergo an                that each worker can undergo an assessment of his state
assessment of his state of health prior to potential             of health prior to potential exposure. This assessment
exposure. This assessment should be such that it is              should be such that it is directly possible to implement
directly possible to implement individual and hygiene           individual and hygiene measures.
measures.
3.    Where relevant, the assessment referred to in              3.   The assessment referred to in paragraph 2 should
paragraph 2 should identify those workers for whom              identify those workers for whom special protective
special protective measures may be required. When                measures may be required. When appropriate, effective
appropriate, effective vaccines should be made available        vaccines should be made available for those workers who
for those workers who are not already immune to the              are not already immune to the biological agent to which
biological agent to which they are exposed or are poten-        they are exposed or are potentially exposed.
tially exposed.
4.    If a worker is found to be suffering from an              unchanged
infection and/or illness which is suspected of being the
result of exposure, the doctor or authorities responsible
for health surveillance may decide that other workers
similarly exposed shall undergo assessments of their state
of health, and may require a reassessment of the risk of
exposure as referred to in Article 3 (2).
5.    When the assessments referred to in this Article           5.   When the assessments referred to in this Article
have been made, an individual health record shall be            have been made, an individual health record shall be
kept for at least 10 years following the end of exposure,       kept for at least 40 years following the end of exposure,
in accordance with national laws and practice.                   in accordance with national laws and practice.
The doctor or authority responsible for health                  The doctor or authority responsible for health
surveillance may propose protective measures to be taken        surveillance may propose protective measures to be taken
in respect of any individual worker.                            in respect of any individual worker under certain circum-
                                                                stances, but without identifying the individual in question
                                                                to third parties.
6.    The worker concerned or the employer may                  unchanged
request a review of the assessments referred to in this
Article, in accordance with national laws and practice.
 ---pagebreak--- N o C 218/16                           Official Journal of the European Communities                24. 8. 89
                      ORIGINAL PROPOSAL                                           AMENDED PROPOSAL
Special measures for health care facilities and diagnostic        unchanged
                          laboratories
                           Article 13                                                Article 13
1.     Specific measures shall be taken for health care          unchanged
facilities, in particular isolation and post-mortem units,
and clinical, veterinary and diagnostic laboratories.
2.     For the purposes of the assessment referred to in          unchanged
Article 3 (2), particular attention shall be paid to:
— uncertainties about the presence of biological agents           unchanged
    in the materials and specimens being investigated,
— the hazard of biological agents known or suspected              unchanged
    to be present in the materials or specimens,
— the risk posed by the nature of the work activity.              unchanged
3.     The specific measures listed in Annex III for the          unchanged
physical containment of biological agents shall be
applied, when appropriate.
Special measures for industrial processes, laboratories and       unchanged
                         animal rooms
                           Article 14                                                Article 14
1.     Specific measures shall be taken for industrial            unchanged
processes, animal rooms and laboratories, excluding
clinical, veterinary and diagnostic laboratories in order
to ensure the physical containment of a Group 2, 3 or 4
biological agent.
For this purpose Member States shall classify biological          unchanged
agents using the definitions in Article 2 (c), (d) and (e)
relating respectively to a Group 2, 3 or 4 biological
agent.
2.     Following the assessment referred to in Article 3 (2)      unchanged
special measures shall be taken as laid down in Annex III
after matching the physical containment level for bio-
logical agents with the degree of risk.
For this purpose work activities involving:                       unchanged
— a Group 2 biological agent may be carried out only              unchanged
    in working areas corresponding to at least the
    physical containment level 2,
 ---pagebreak---  24. 8. 89                              Official Journal of the European Communities                           No C 218/17
                      ORIGINAL PROPOSAL                                                AMENDED PROPOSAL
     a Group 3 biological agent may be carried out only           unchanged
     in working areas corresponding to at least the
     physical containment level 3,
     a Group 4 biological agent may be carried out only           unchanged
     in working areas corresponding to the physical
     containment level 4.
 3.    When the volume of the biological agents which             3.    When the volume of Groups 2 and/or 3 biological
are being handled in Groups 2 and/or 3, justifies it, the         agents handled justifies it, the physical containment level
physical containment level' shall be increased, when              shall be increased, when appropriate, to at least level 3
appropriate, to at least the level 3 or 4 respectively, in        or 4 respectively, in order to ensure that the health and
order to ensure that the health and safety risks are              safety risks are minimized, taking into account the
minimized.                                                        containment levels.
4.     In an industrial process in which there is adequate        unchanged
physical containment of biological agents by means of a
closed system, the specific measures listed in points 1 and
2 of Annex III shall be applied only when appropriate.
5.     In the case of a biological agent in respect of which      unchanged
a conclusive assessment has not yet been possible as
referred to in Article 3 (2), but the indications are that a
risk to health might arise from the proposed use, then
work activities may be carried out only in working areas
corresponding to at least the physical containment level
3.
6.     The additional measures required for laboratories           unchanged
and animal rooms are listed in Annex IV.
                       Final provisions
                          Article 15                                                       Article 15
The Annexes to this Directive may be adapted to                   The procedure described in Article 17 of Directive
technical progress in accordance with the procedure set           89/391/EEC shall be used:
out in Article 10 of Directive 80/1107/EEC.
                                                                      for the establishment of Annex V as mentioned in
                                                                      Ai-tiVl» 3,
                                                                      Article  \
                                                                  — for the regular adaptation to technical progress of the
                                                                      Annexes to this Directive.
                          Article 16                                                      Article 16
Member States shall ensure that workers and/or                    unchanged
workers' representatives where they exist in an under-
taking or establishment are consulted on the provisions
referred to in this Directive and that they can be
involved in their application.
 ---pagebreak--- N o C 218/18                            Official Journal of the European Communities                                     24. 8. 89
                     ORIGINAL PROPOSAL                                                   AMENDED PROPOSAL
                         Article 17                                                           Article 17
1.    Member States shall keep national statistics of              1.     Member States shall keep and publish national stat-
recognized cases of serious illness or death due to                istics of cases of illness or death due to exposure due to
exposure to biological agents at work.                             biological agents at work and shall regularly
                                                                   communicate these statistics to the Commission.
2.    Member States shall publish up-to-date and appro-            unchanged
priate information on occupational diseases caused by
biological agents.
                         Article 18                                                           Article 18
1.    Member States shall adopt the laws, regulations               unchanged
and administrative provisions necessary to comply with
this Directive before 1 January 1992. They shall
immediately inform the Commission thereof.
2.    Member States shall communicate to the                        unchanged
Commission the provisions of national law which they
adopt in the field governed by the Directive.
                         Article 19                                                           Article 19
This Directive is addressed to the Member States.                   unchanged
                          ANNEX I                                   unchanged
                         ANNEX II                                                             ANNEX II
         Biohazard sign as referred to in Article 4 (g)                      Biohazard sign as referred to in Article 4 (f)
                         ANNEX III                                  unchanged
                         ANNEX IV                                   unchanged
 ---pagebreak--- 24. 8. 89                           Official Journal of the European Communities                      N o C 218/19
                                                       ANNEX     K(new)
                                        Classification of biological agents (Article 3)
          'Group 1' biological agents:                                               To be completed
          'Group 2' biological agents:                                               T o be completed
          'Group 3' biological agents:                                               To be completed
          'Group 4' biological agents:                                               To be completed