CELEX: 51988PC0165
Language: en
Date: 1988-04-05
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE PROTECTION OF WORKERS FROM THE RISKS RELATED TO EXPOSURE TO BIOLOGICAL AGENTS AT WORK

No C 150/6                           Official Journal of the European Communities                                  8. 6. 88
                                                            II
                                                    (Preparatory Acts)
                                               COMMISSION
              Proposal for a Council Directive on the protection of workers from the risks related to
                                          exposure to biological agents at work
                                                   COM(88) 165 final
                                    (Submitted by the Commission on 19 April 1988)
                                                      (88/C 150/05)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                        Whereas it is necessary, in order to ensure the highest
                                                                degree of protection reasonably practicable, that workers
                                                                and their representatives be informed about the risks
Having regard to the Treaty establishing the European           which biological agents can pose for their health, and the
Economic Community, and in particular Article 118A              measures necessary to lessen or eliminate those risks and
thereof,                                                        that they should be in a position to ensure that the
                                                                necessary protective measures are taken;
Having regard to the proposal from the Commission,
established following consultation with the Advisory            Whereas, preventive measures should be taken for the
Committee on Safety, Hygiene and Health Protection at           protection of the health and safety of workers exposed
Work,                                                           to biological agents,
In cooperation with the European Parliament,
                                                                HAS ADOPTED THIS DIRECTIVE:
Having regard to the opinion of the Economic and
Social Committee,                                                                       Objective
                                                                                         Article 1
Whereas Council Directive 80/1107/EEC of 27
November 1980 on the protection of workers from                 1.    The purpose of this Directive is to protect workers
the risks related to exposure to chemical, physical and         against risks to their health and safety, and to prevent
biological agents at work ('), as amended by the Act of         such risks arising or likely to arise from exposure to
Accession of Spain and Portugal, provides for Directives        biological agents at work.
for certain agents;
                                                                2.    This Directive shall apply to all workers with the
Whereas, under the terms of the said Directive, such            exception of workers engaged in sea transport and in air
protection should, as far as possible, be ensured by            transport.
measures to prevent exposure or to keep it at as low a
level as is reasonably practicable;
                                                                For the purposes of this Directive 'workers engaged in
                                                                sea transport and in air transport' means personnel on
                                                                board.
Whereas more precise knowledge of the risks involved in
exposure to biological agents at work can be obtained
through the keeping of records;
                                                                                        Definitions
Whereas employers must keep abreast of new devel-                                        Article 2
opments in technology with a view to improving the
protection of workers' health and safety;                       For the purposes of this Directive:
                                                                (a) 'Biological agents' are micro-organisms including
                                                                    those which have been genetically manipulated, cell
O OJ No L 327, 3. 12. 1980, p. 8.                                   cultures and multicellular human endoparasites.
 ---pagebreak--- 8. 6. 88                                Official Journal of the European Communities                                No C 150/7
(b) A 'Group 1' biological agent is one that is most                    agents, and sewage and health care activities where
     unlikely to cause human disease. It does not produce               there may be a risk of exposure to persons or patho-
     infection and is unlikely to spread in the community.              logical material with infectious disease.
    This definition includes any genetically modified
    biological agent which fulfils the criteria for good
     microbiological practice as laid down in Annex I.             (k) 'Conscious decision to work with biological agents'
                                                                        is any work activity or sector of activity in which the
                                                                       purpose of the work is to handle or use biological
                                                                        agents, including work in research laboratories or
(c) A 'Group 2' biological agent is one that may cause                  industrial processes employing biological agents.
     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.                                                    Assessment
                                                                                             Article 3
(d) A 'Group 3' biological agent is one that may cause             1.     This Directive shall apply to work activities in
     severe human disease and presents a serious hazard            which workers are or are potentially exposed to
     to workers. It may present a risk of spread in the            biological agents as a result of their work activities.
     community but there is usually effective prophylaxis
     or treatment available.
                                                                   2.     In the case of any activity or sector of activity likely
                                                                   to involve a risk of exposure to biological agents the risk
(e) A 'Group 4' biological agent is one that causes severe         must be assessed. Member States shall fix the conditions
     human disease and is a serious hazard to workers. It          of this assessment and of any further assessment, if
     may present a high risk of spread in the community            necessary, and shall determine by whom it is to be
     and there is usually no effective prophylaxis or              conducted. The assessment shall be conducted so as to
     treatment available.                                          determine the nature and degree of the:
                                                                   — inherent hazard of a biological agent to health,
(f) 'Micro-organism' is any microscopic unicellular or
     subcellular biological entity capable of replication.
                                                                   — risk of workers' exposure or potential exposure,
                                                                       including a determination of whether this involves
                                                                       either incidental exposure, or a conscious decision to
(g) 'Genetically modified biological agent'            is an
                                                                       work with biological agents,
     organism derived by the techniques of            genetic
     manipulation.
                                                                   — risk of transfer        from     the  workplace      to   the
                                                                       community;
(h) 'Genetic manipulation' is the formation of a new
     combination of genetic material by the insertion of
     nucleic acid molecules produced by whatever means             — risk of further spread within the community.
     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           This assessment shall not apply to genetically modified
     occur but in which they are capable of continued              biological agents which have been notified in accordance
     propagation.                                                  with the provisions of Council Directive . . . / . . ./EEC
                                                                   [on deliberate release into the environment of genetically
                                                                   modified organisms].
(i) 'Cell culture' is the in vitro growth of cells isolated
     from multicellular organisms.
                                                                   3.     The identification of a biological agent as being
                                                                   hazardous to health shall be based on all available infor-
                                                                   mation including:
(j) 'Incidental exposure to biological agents' is any work
     activity or sector of activity in which there is no
     deliberate intention to handle or use biological              — a disease from which a worker is found to be
     agents but where the work activity may result in                  suffering which has a direct connection with his work
     workers being exposed to biological agents,                       activity and/or epidemiology which indicates that a
     including contact with animals and animal products                biological agent has been a source of human
     where there may be a risk of exposure to zoonotic                 infection and/or illness,
 ---pagebreak--- No C 150/8                            Official Journal of the European Communities                                    8. 6. 88
— guidelines issued by a responsible authority which             (d) personal protection measures, where exposure
    indicate that a biological agent should be controlled             cannot reasonably be avoided by other means;
    in some way in order to prevent human infection
    and/or illness when workers are or are potentially
    exposed to such an agent as a result of their work           (e) hygiene measures designed to prevent the accidental
    activity.                                                         transfer or release of a biological agent from the
                                                                      workplace;
4.    Biological agents shall be assessed on the basis of
the maximum degree of hazard, unless there is evidence,          (f) the provision of up-to-date information on biological
in individual cases, that the degree of hazard is lower.              agents which are or may be present at the workplace
                                                                      together with a continuing programme of adequate
                                                                      training for workers;
The assessment of a genetically modified biological agent
shall be made, when appropriate, on the same basis.
                                                                 (g) use of a biohazard sign (Annex II) and other
                                                                      warning signs;
5.    This Directive shall apply without prejudice to the
provisions of Council Directive . . . / . . ./EEC on the
contained use of genetically modified micro-organisms.           (h) emergency procedures designed to              minimize
                                                                      workers' exposure resulting from a serious accident
                                                                      or incident.
6.    Articles 4 to 17, with the exception of the first
indent of Article 9, shall not apply if the assessment
referred to in paragraph 2 shows that the exposure and/                                    Article 5
or potential exposure is to a Group 1 biological agent or
to a biological agent which causes disease only in               1.     At the beginning of employment and at regular
animals and/or in plants and that there is no identifiable       intervals thereafter, the workers shall receive up-to-date
health risk to workers.                                          information together with adequate instruction, so that
                                                                 they are made aware of all the requirements laid down in
                                                                Article 4.
7.    Articles 6 to 14 shall not apply if the assessment
referred to in paragraph 2 shows that the work activities
involve only incidental exposure to biological agents.           2.     Appropriate measures shall be taken to ensure that
                                                                workers and/or any workers' representatives in the
                                                                undertaking or establishment receive explanations on the
                                                                potential risks to health from exposure to biological
General provisions applicable to work activities which           agents, the hygiene requirements, and the emergency
involve both incidental exposure to biological agents and       procedures designed to minimize workers' exposure
   a conscious decision to work with biological agents          resulting from a serious accident or incident.
                          Article 4
The risk of workers' exposure must be avoided. Where            Additional provisions applicable to work activities which
this is not reasonably practicable, having regard to the        involve a conscious decision to work with biological
work activity and the risk assessment referred to in                                        agents
Article 3 (2) exposure shall be reduced to as low a level
as is necessary in order to protect adequately the health                                  Article 6
and safety of the workers concerned, in particular by
the following measures which are to be applied when              1.     Appropriate measures shall be taken so far as is
appropriate:                                                    reasonably practical for the protection of the health and
                                                                 safety of workers by providing that:
(a) the limitation of the number of workers exposed or
     potentially exposed;                                        (a) areas are set aside where workers can eat and drink
                                                                     without risking contamination by biological agents;
(b) the prevention of exposure or its adequate control by
    the appropriate design of work processes and/or the          (b) workers are provided with appropriate protective
     use of engineering control measures;                             clothing or other appropriate special clothing;
(c) collective protection measures including the use and         (c) separate storage places are provided for working or
    maintenance of adequate equipment;                               protective clothing and for street clothes;
 ---pagebreak--- 8. 6. 88                               Official Journal of the European Communities                                  No C 150/9
(d) protective respiratory equipment is placed in a well-         2.    Suppliers or importers of a Group 3 or 4 biological
     defined place and is checked, if possible before, and        agent for use at work shall ensure that they are
     in any case after each use; defective equipment shall        adequately described, packed and transported.
     be repaired or replaced before further use.
                                                                                            Article 9
2.     Working      clothes     and   personal    protective      Employers shall on request make available to               the
equipment, including protective clothing which may be             responsible authorities appropriate information on:
contaminated by biological agents, must be removed on
leaving the working area and stored separately from
                                                                  — the results of the assessment referred to in Article 3
other clothing. The employer must ensure that such
clothing and personal protective equipment are disin-                 (2),
fected, cleaned or, if necessary, destroyed.
                                                                  — the activities in which workers have been exposed or
                                                                      potentially exposed to biological agents,
3.     Workers who handle biological agents must be
provided with skin and eye antiseptics, suitable washing          — the number of workers exposed,
facilities and, if appropriate, showers.
                                                                  — the name of the person responsible for safety and
                                                                      health at work,
4.     Workers may not be charged for the cost of
measures taken pursuant to paragraphs 1, 2 and 3.                 — the protective and preventive measures                 taken
                                                                      including working procedures and methods,
                            Article 7                             — an emergency plan for the protection of workers
                                                                      from exposure to a Group 3 or 4 biological agent
 1.    Employers shall keep a record of workers exposed               which might result from a loss of physical
or potentially exposed to Groups 3 and/or 4 biological                 containment.
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                                          Article 10
 incidents, as appropriate.
                                                                   1.    Without prejudice to Directive . . . / . . ./EEC on the
                                                                  deliberate release of genetically modified organisms,
                                                                  employers shall give a prior notification to the
 2.    The records referred to in paragraph 1 shall be kept       responsible authority, at least 60 days before:
 for at least 10 years following the end of exposure, in
 accordance with national laws and practice.
                                                                  — an intention to carry out genetic manipulation work
                                                                       or to work with a genetically modified biological
                                                                       agent in Group 2, 3 or 4,
 3.     The doctor and/or the authority responsible for
 health and safety at work shall have access to the records
                                                                  — an intention to introduce substantial changes to a
 referred to in paragraph 1.
                                                                       procedure which has already been notified,
                                                                  — work with a Group 4 biological agent, or if there is
 4.     Each worker shall have access to information in the            an intention to handle, store or transport such an
 records which relates to him personally.                              agent.
                                                                   2.    In the case of genetic manipulation work, or work
 5.     Workers and/or any workers' representatives in the
                                                                   with a genetically modified biological agent, prior
 undertaking or establishment shall have access to
 anonymous collective information in the records.                  notification shall include the name and address of the
                                                                   undertaking and/or establishment and the name of the
                                                                   person responsible for safety and health at work.
                            Article 8                              In the case of a Group 4 biological agent prior notifi-
                                                                   cation shall include:
  1.    The use of a Group 3 or 4 biological agent shall be
  avoided, as far as is reasonably practicable, by its
  replacement by a less hazardous or non-hazardous                 — the result of the assessment referred to in Article 3
  agent.                                                               (2),
 ---pagebreak--- N o C 150/10                           Official Journal of the European Communities                                   8. 6. 88
— the name of the biological agent,                               4.     If a worker is found to be suffering from an
                                                                  infection and/or illness which is suspected of being the
                                                                  result of exposure, the doctor or authorities responsible
— the protection and preventive measures that are                 for health surveillance may decide that other workers
    envisaged,                                                    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).
— the name of the person responsible for safety and
    health at work.
                                                                  5.     When the assessments referred to in this Article
3.    Employers shall inform forthwith the responsible
                                                                  have been made, an individual health record shall be
authority of any accident or incident that may have
                                                                  kept for at least 10 years following the end of exposure,
resulted in the release of any biological agent such that it
                                                                  in accordance with national laws and practice.
could cause severe human infection and/or illness.
                         Article 11                               The doctor or authority responsible for health
                                                                  surveillance may propose protective measures to be taken
1.    Employers shall display written instructions at the
                                                                  in respect of any individual worker.
workplace which shall include the procedure to be used
in the case of:
— a serious accident or incident,                                 6.     The worker concerned or the employer may
                                                                  request a review of the assessments referred to in this
                                                                  Article, in accordance with national laws and practice.
— work with a Group 4 biological agent.
2.    A serious accident or incident shall be reported
immediately to and recorded by the person responsible             Special measures for health care facilities and diagnostic
for the work.                                                                              laboratories
                                                                                            Article 13
3.    Workers and/or any workers' representatives in the
                                                                  1.     Specific measures shall be taken for health care
undertaking or establishment shall be informed as
                                                                  facilities, in particular isolation and post-mortem units,
quickly as possible when a serious accident or incident
                                                                  and clinical, veterinary and diagnostic laboratories.
occurs, of the causes thereof, and of the measures taken
or to be taken to rectify the situation.
                                                                  2.     For the purposes of the assessment referred to in
                         Article 12                               Article 3 (2), particular attention shall be paid to:
 1.   The specific rules for the health surveillance of
workers shall be established by Member States in
accordance with national law and practice.
                                                                  — uncertainties about the presence of biological agents
                                                                      in the materials and specimens being investigated,
2.    Members States shall make arrangements to ensure
that, where relevant, each worker can undergo an
assessment of his state of health prior to potential
exposure. This assessment should be such that it is               — the hazard of biological agents known or suspected
directly possible to implement individual and hygiene                 to be present in the materials or specimens,
measures.
3.    Where relevant, the assessment referred to in               — the risk posed by the nature of the work activity.
paragraph 2 should identify those workers for whom
special protective measures may be required. When
appropriate, effective vaccines should be made available
for those workers who are not already immune to the               3.     The specific measures listed in Annex III for the
biological agent to which they are exposed or are                 physical containment of biological agents shall be
potentially exposed.                                              applied, when appropriate.
 ---pagebreak--- 8. 6. 88                               Official Journal of the European Communities                          No C 150/11
Special measures for industrial processes, laboratories and       risk to health might arise from the proposed use, then
                        animal rooms                              work activities may be carried out only in working areas
                                                                  corresponding to at least the physical containment level
                          Article 14                              3.
1.     Specific measures shall be taken for industrial
processes, animal rooms and laboratories, excluding               6.    The additional measures required for laboratories
clinical, veterinary and diagnostic laboratories in order         and animal rooms are listed in Annex IV.
to ensure the physical containment of a Group 2, 3 or 4
biological agent.
                                                                                       Final provisions
For this purpose Member States shall classify biological
                                                                                          Article 15
agents using the definitions in Article 2 (c), (d) and (e)
relating respectively to a Group 2, 3 or 4 biological             The Annexes to this Directive may be adapted to
agent.                                                            technical progress in accordance with the procedure set
                                                                  out in Article 10 of Directive 80/1107/EEC.
2.     Following the assessment referred to in Article 3
(2), special measures shall be taken as laid down in
                                                                                          Article 16
Annex III after matching the physical containment level
for biological agents with the degree of risk.                    Member States shall ensure that workers and/or
                                                                  workers' representatives where they exist in an under-
For this purpose work activities involving:                       taking or establishment are consulted on the provisions
                                                                  referred to in this Directive and that they can be
— a Group 2 biological agent may be carried out only              involved in their application.
    in working areas corresponding to at least the
    physical containment level 2,
                                                                                          Article 17
— a Group 3 biological agent may be carried out only
     in working areas corresponding to at least the                1.   Member States shall keep national statistics of
    physical containment level 3,                                 recognized cases of serious illness or death due to
                                                                  exposure to biological agents at work.
— a Group 4 biological agent may be carried out only
     in working areas corresponding to the physical                2.   Member States shall publish up-to-date and appro-
     containment level 4.                                         priate information on occupational diseases caused by
                                                                  biological agents.
 3.    When the volume of the biological agents which
 are being handled in Groups 2 and/or 3 justifies it, the                                 Article 18
physical containment level shall be increased, when
 appropriate, to at least the level 3 or 4 respectively, in        1.   Member States shall adopt the laws, regulations
 order to ensure that the health and safety risks are              and administrative provisions necessary to comply with
 minimized.                                                        this Directive before 1 January 1992. They shall
                                                                   immediately inform the Commission thereof.
 4.    In an industrial process in which there is adequate
 physical containment of biological agents by means of a           2.   Member States shall communicate to the
 closed system, the specific measures listed in points 1 and       Commission the provisions of national law which they
 2 of Annex III shall be applied only when appropriate.            adopt in the field governed by this Directive.
 5.    In the case of a biological agent in respect of which
                                                                                           Article 19
 a conclusive assessment has not yet been possible as
 referred to in Article 3 (2), but the indications are that a      This Directive is addressed to the Member States.
 ---pagebreak--- N o C 150/12                              Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                         8. 6. 88
                                                                   ANNEX       I
           For genetically modified micro-organisms the criteria have to be established which permit a comparison of
           such micro-organisms with natural micro-organisms, in order to be able to determine to which group they
           belong and therefore which level of physical confinement should be applied.
           In this Annex the following definitions are given:
           — 'Host organism' is the organism into which donor DNA is inserted in rDNA constructions; it provides
                the major portion of the genome of the rDNA organism; same as recipient.
           — 'Vector' is an agent of transmission; for example a DNA vector is a self-replicating molecule of DNA
                that transmits genetic information from one cell or organism to another. Plasmids (and some viruses)
                are used as 'vectors' for DNA in bacterial cloning.
           The genetically modified micro-organism will have essentially the properties of the host, the genetic
           material of which is most often found integrated in the genetically modified micro-organism with only one
           foreign fragment more.
           The following table sets out the criteria for good microbiological practice (GMP) as referred to in Article
           2 (b) for a genetically modified biological agent:
                         Host organism                    rDNA engineered organism                               Vector/insert
           Non-pathogenic                           Non-pathogenic                              Well characterized and free from
                                                                                                 known harmful sequences
           N o adventitious agents                  As safe in industrial setting as             Limited in size as much as
                                                    host organism, but with limited             possible to the DNA required to
                                                    survival without adverse conse-             perform the intended function;
                                                    quences for human health                     should not increase the stability
                                                                                                 of the construct (unless that is a
                                                                                                requirement of the intended
                                                                                                 function)
           Extended        history    of     safe                                                Should be poorly mobilizable
           industrial use; or
           Built-in limitations       permitting                                                 Should not transfer any resistance
           optimal growth in industrial                                                          markers to micro-organisms not
           setting     but    limited    survival                                                known to acquire them naturally
           without adverse consequences                                                          (if        such    acquisition could
           outside the industrial setting                                                        compromise use of drug to
                                                                                                control disease agents)
           There are two clear examples of other classes of organisms that warrant the GMP designation unless they
           are pathogenic:
            (i) those constructed entirely from a single prokaryotic host (including its indigenous plasmids and
                 viruses) or from a single eukaryotic host (including its choroplasts, mitochondria or plasmids — but
                 excluding viruses — ) ; and
           (ii) those consisting entirely of DNA segments from different species that exchange DNA by known physi-
                 ological processes.
           For the purpose of this table, 'non-pathogenic' means an agent which does not cause human disease.
 ---pagebreak--- 8. 6. 88                               Official Journal of the European Communities                                    N o C 150/13
                                                           ANNEX II
                                          Biohazard sign as referred to in Article 4 (g)
                                                          ANNEX III
         The specific measures required at each of the three physical containment levels, as referred to in Articles 13
                                                 (3) and 14 (2), (3), (4) and (5)
                                                                                   Containment levels
                             Specific measures
                                                                          1                2                  3
          1. The workplace is to be in an isolated part of         Recom-           Yes               Yes
             a building and separated by an anteroom with          mended
             two doors
          2. Input air and extract air to the workplace are        No               Yes, on extract   Yes, on input
             to be filtered using HEPA or similar                                   air               and extract air
          3. Access is to be restricted        to nominated        Recom-           Yes               Yes, via an
             workers only                                          mended                             airlock
          4. The workplace is to be sealable to permit             No               Recommended       Yes
             disinfection
          5. Specified disinfection procedures                    Yes               Yes               Yes
          6. The workplace is to be maintained at an air           No               Recommended       Yes
             pressure negative to atmosphere
          7. Efficient vector control (e.g. rodents and            Recom-           Yes               Yes
             insects)                                              mended
          8. Collection and treatment of effluents                 No               Recommended       Yes
          9. Surfaces impervious to water                         Yes, for          Yes, for          Yes, for bench,
                                                                   bench            bench and         floor        and
                                                                                    floor             ceilings
         10. Surfaces resistant to acids, alkalis, solvents,       Recom-           Yes               Yes
             disinfectants                                         mended
         11. Safe storage of a biological agent                    Recom-           Yes               Yes, secure
                                                                   mended                             storage
 ---pagebreak--- N o C 150/14                             Official Journal of the European Communities                                   8. 6. 88
                                                            ANNEX     IV
           The additional measures required at each of the three physical containment levels for laboratories and
                                            animal rooms, as referred to in Article 14 (6)
                                                                                     Containment levels
                                Specific measures
                                                                           1                 2                3
            1. An observation window, or alternative, is to be      Recom-            Recom-            Yes
               present, so that occupants can be seen               mended            mended
           2. A laboratory is to contain own equipment              No                Recom-            Yes
                                                                                      mended
           3. A microbiological safety cabinet is to be used        Recom-            Yes               Yes, with glove
                                                                    mended                              ports
           4. Infected material including any animal is to be       Recom-            Yes               Yes
               handled in a safety cabinet or isolator              mended
           5. Autoclave or incinerator for animals                  Recom-            Yes               Yes
                                                                    mended