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 (presented by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (88) 165
Vol. 1988/0049
 ---pagebreak--- Disclaimer
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In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983 concerning
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                           COM(88 ) 165 final - SYN 129
                                           Brussels , 5 April 1988
                          Proposai for a
                        COUNCIL DIRECTIVE
     ON THE PROTECTION OF WORKERS FROM THE RISKS RELATED
           TO EXPOSURE TO BIOLOGICAL AGENTS AT WORK
                 ( presented by the Commission )
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 ---pagebreak---                          PROPOSAL FOR A COUNCIL DIRECTIVE
                ON THE PROTECTION OF WORKERS FORM THE RISKS RELATED
                     TO EXPOSURE TO BIOLOGICAL AGENTS AT WORK
                               EXPLANATORY MEMORANDUM
1 • IntreductioD
      The Communi cati on of the Commission of the European Communities on its
      programme    concerning   safety ,    hygiene and health at work ( 1 ) stated
      that   it   intended to make a proposal for a      Directive  on   biological
      agents    which affect health ,     such as pathogenic  microorganisms ,  and
      genetic engineering techniques which may present a risk to health .
      A  strategy for controlling dangerous agents was adopted under Council
      Directive 80/ 1107 / EEC covering all chemical ,    physical and   biological
      agents at the workplace .    Several Council Directives have been adopted
      on chemical agents and one on a physical agent ( noise ). The Commission
      has not yet proposed specific measures for biological agents .
      It has , however , been proved that many biological agents are harmful to
      health ,   and hence that exposure to these agents increases the risk of
      disease .   Workers can become exposed to these agents in a wide variety
      of activities , such as :
      - research and development 1 aboratori es ,
      - hospital isolation units ,
      - clinical , veterinary and diagnostic 1 aboratori es ,
      - certain branches of industry .
 ( 1 ) Com ( 520 ) final
                                        1
 ---pagebreak---     It is particularly important that workers in the above-mentioned areas
    of activity are exposed to biological agents as little as possible , if
    at   all ,   in   order  to  prevent them from   developing   infections     or
    diseases .
2 . 5ummary_of_reguIatioos_on_exEOsure_to_biological_ageQts_at_wgrk_in_the
    yarioys_Meiber_States
    Most   Member States recognize the need to protect workers against          the
    risks related to exposure to biological agents . This matter has become
    more important with the development of biotechnologies in which biolo¬
    gical agents that are dangerous for people can be used or produced .
    However ,    this   question is dealt with in a different way in      the   na¬
    tional     legislation   of each Member State .  In  some   cases ,   national
    legislation      does not provide for any specific measures .    The measures
    which     do exist are mostly of a general nature and provide some        legal
    protection      against  the effects of biological   agents .  Other    Member
    States already apply quite detailed legislation , but this often proves
    to   be inadequate in some areas ,     particularly as  regards     biotechno-
    logi es .
    The   proposal for a Directive referred to here aims to protect workers
    against the risks to their health and safety arising from exposure           to
    biological agents and thus to promote the progressive harmoni zati on of
    existing requirements in the Member States in this field .
    The main regulations currently in force in the Member States on           expo¬
    sure to biological agents at work are described below .
BELGIUM
    A safety survey must be carried out and safety instructions drawn up
    before a new process or activity is used at work which is likely to
    pose a threat to the health of workers due to the presence of biologi ¬
    cal agents .
                                     2
                                                                                 3
 ---pagebreak---     Employers     are   obliged   to take measures to eliminate or         reduce     the
    danger to workers if there is an obvious risk of exposure to               biologi ¬
    cal agents .
    Medical examinations are carried out and workers are given information
    on protective measures .
    Lastly ,   there    are   specific provisions for pregnant women ,         and    for
    workers under the age of 18 ,        as well as for vaccinating workers hand¬
    ling skin and hair of animal origin agai nst smallpox and tetanus .
FEDERAL REPUBLIC OF GERMANY
List    of   the   relevant legal provisions and directives in force              in   the
Federal Republic of Germany concerning biological agents :
Law on the prevention and control of communicable human diseases ( Bundes-
Seuchengesetz )     in    its  published version of 18 December         1979    ( Bundes-
gesetzbl att I p.      2262 , 1980 p. 151 ), most recently amended by the Law of
27 June 1985 ( BGB1 I p. 1254 ) chap . 3 , 8 , 9 , 19-29 .
Regulations on pathogens of 21 November 1917 ( published in              Rei chsgesetz-
bl att p. 1069 , BGB1 III p. 2126 - 1 - 1 ) chap . 1 , 2 .
Law   reforming the legislation on pharmaceuti cal s of 24 August 1976 ( BGBl
I p.    2445 ), amended by the Law of 24 February 1983 ( BGBl I p. 169 ) chap .
4 , 13-20 , 32 , 35 .
Law    on livestock epidemics ,      in its published version of 28         March     1980
( BGBl I p. 386 ) chap . 10 .
Order    concerning     the importation of live animal pathogens and vaccines
containing them ( Ti erseuchenerreger-Ei nfuhrverordnung ) of 7 December 1971
( BGBl I p.     1960 ,  most recently amended by the amending order of 19 July
1983 BGBl I p. 958 ).
Order     concerning    working    with    animal  pathogens    ( Ti erseuchenerreger-
Verordnung ) of 25 November 1985 ( BGBl I p. 2123 ).
Order     concerning     dangerous   substances    ( Gef ahrstoffverordnung )      of   26
August 1986 ( BGBl I p. 1470 ) chap . 14-36 .
                                        3
                                                                                           7
 ---pagebreak--- ! aw on works dortors , safety engineers and other experts on occupational
safety ( Arbeitssi cherhei tsgesetz ) of 12 December 1973 ( BGB1 I p. 1885 ).
Directives     on protection from hazards presented by nucleic acids      formed
by in vitro recombination ( fifth revision ),     Bundesanzei ger No 109 of    20
 June 1986 .
Accident prévention régulations :
   Ulorks doctors UBG 123
- Occupational preventive medicine UBG 100 ( and implementing orders )
   Health service UBG 103
- Biotechnology UBG 102
DENMARK
    There    are specific regulations for sewage work ,    including provisions
    for certain vaccinations ( polio and tetanus ), and for genetic enginee ¬
    ring ,   including those specifying containment levels for a prior      risk
    assessment , which also involves cl assif i cation of the biological agent
    concerned .
    Other    areas of work activity in which there is a risk of exposure       to
    biological    agents are covered by the general provisions of Danish law
    on the working environment and the protection of workers .      Under these
    provisions employers must ensure that the working environment is        safe
    and that it does not constitute a risk to health of workers .
    The    Danish  Ministry of Public Health is    publishing   guidelines    and
    recommendations     of   the risks of infection with   contagious   diseases
    such as hepatitis B and AIDS . Since these guidelines are mainly con¬
     cerned with the protection of public health , they outline general
     hygiene   measures    and  do not take the specific   conditions  of   some
    workers into consideration .
SPAIN
     In addition to provisions of a general nature on the health of workers
     ( general health law ) and on occupational diseases , regulations have
     been   adopted on medical examinations and the organization of medical
    services , as well as on industrial medical services .
                                     4
                                                                               J
 ---pagebreak---    Preventive measures are included in the general regulation on hygiene
   and safety at work and in the general law on social security .
   Several   specific provisions are contained in the general          regulations
   on   sanitary   measures for foodstuffs    ( codex alni i nentari us ) .  medico-
   therapeutic equipment , preventive medicine and hygiene in hospitals ,
   abattoirs and meat which is intended for export to other Member
   States . The legislation also includes an obligation to provide notifi ¬
   cation of some infectious diseases .
   Lastly , a law has been passed on toxic and dangerous waste .
FRANCE
   General regulations on hygiene and health apply .
   These   provide specifically for
   - all   types of pollutants which can be released in work areas            to  be
      collected at source ;
   - the   atmosphere   of    workrooms to be protected from all        sources   of
      infection ;
   - the cleaning of rooms in which organic substances are handled ;
   - the availability of showers for dirty or unhealthy work .
   In   addition ,  every   new product which comes onto the market must          be
   studied and appraised by the relevant authorities .
GREECE
   There is no specific legislation governing the exposure of workers             to
   biological substances .
   However , Chapter 5 of General Law No 1568/85 on the hygiene and safety
   of workers contains articles on the general principles for             preventing
   occupational    diseases ,   including those resulting from biological         a-
   gents .
   Special legislation is planned for tanneries , abattoirs and meat
   shops . In addition , commissions on infectious in hospitals are res¬
   ponsible for applying codes of practice .
                                    5
                                                                                    G
 ---pagebreak---    No data are available on the number of workers concerned and the type
   of biological substances to whi ch they are exposed .
IRELAND
   Linder public health legislation , the Director of Community Care ( Medi ¬
   cal Officer of Health ) can make enquiries about the spread in the
   community of biological agents that can involve a risk .             There is also
   some   factory legislation ( worker protection ) relating specifically to
   anthrax ( wool and hair , hides and skins ).
ITALV
   Occupational safety legislation in Italy does not include a comprehen¬
   sive   set of preventive or protective measures for workers exposed                 to
   risks from biological agents at work . Presidential Decree No 303 of 19
   March 1956 ,  entitled " General regulations governing occupational                hy ¬
   giene ",  provides    for   periodic preventive medical          examinations      for
   workers   exposed   to the risk of leptospirosis ( for those           working      in
   sewers ,  canals   and    marsh ! and ) ,  ankyl ostoai asi s ( for those     working
   underground and in brick furnaces ), carbuncles and glanders ( for those
   working   in  veterinary     hospitals ,     slaughterhouses ,     carcass     dumps ,
   tanning   factories ,   rendering       plants and for those involved         in   the
   collection   of   animal waste ),       tuberculosis and syphilis       ( for    those
   working in non-raechani zed glass blowing ).
   Under Laws No 292 of 5 March 1963 and No 149 of 20 March 1968 , as well
   as the Health Ninistry Decrees of 16 and 22 September 1975 , farmhands ,
   shepherds , livestock farmers , stablehands , jockeys , people involved in
   tending racecourse tracks , refuse collectors , platelayers , road-
   workers , building workers , asphalters , rag- and - bone men , refuse hand ¬
   lers , paper and board manuf acturers and railway , harbour and dock
   workers are all required to have an anti -tetanus vaccination . Lastly ,
   Law No 1033 of 14 December 1970 on financial measures to combat tuber ¬
   culosis prescribes vaccination for workers in hospitals , clinics and
   psychiatric hospitals ( and for their farailies ), medical students and
   soldiers with a negative cuti reacti on .
                                      6
 ---pagebreak--- LUXEMBOURG
   General provisions are contai ned in the basic Law of 23 August 1924 on
   the health and safety of workers in factories , industrial and comaier-
   cial enterprises ,     and of those employed in construction , development ,
   repair      or excavation work .  More specific decrees have been issued on
   the basis of his law .
   Moreover , the Law of 1 * April 1979 on dangerous , unhealthy or unplea ¬
   sant working premises provides for operating licences to be granted
   for such premises on a case - by - case basis .
NETHERLANDS
   The     Law   on  the working environment includes general    provisions  on
   occupational health care and the safety of workers .
   There are no specific national provisions on the protection of workers
   against biological agents ,      but preparatory work is being carried   out
   in this area .
PORTUGAL
   A Statutory Order on the production , import , marketing and use          of
   biological products intended for veterinary usage was published           in
   1987
   Provision      has been made for compulsory vaccinations    against  tetanus
   under certain circumstances .
   Lastly , there is compulsory notification in the case of some occupa¬
   tional diseases resulting from exposure to certain microbiological
   agents .
UNITED KINODON
   The Health and Safety at Work Act ( HSU ) provides a general framework
   for health and safety at work . The Dangerous Pathogens and Genetic
   Manipulation Regulations impose only notification requirements . At the
   moment , detailed guidance on the assessment and control of hazards
   from biological agents is produced by the Health and Safety Executive
    ( HSE ) in the form of notes and codes of practice drawn up under the
    aegis of advisory committees ( the Advisory Committee on Dangerous
   Pathogens and the Advisory Committee on Genetic Mani pul ation ) .
                                     7
                                                                            8
 ---pagebreak---     Tht requirements of the HSU) Act of 1974 apply to biological agents , in
    particular Sections 2 ( under which it is the duty of every employer to
    ensure , as far as is reasonably practicable , the health and safety of
    all his or her employees ) and 3 thereof ( which stipulates that em¬
    ployers and the self-employed must conduct their undertakings so as to
    ensure , as far as is reasonably practicable , that persons not in their
    employment ,    who may be affected thereby ,   are not exposed to risks to
    their health and safety ) .
    The Health and Safety ( Genetic Mani pul ati on ) Regulations of 1978 , made
    under the HSU Act , require that the HSE be notified of any intention
    to   carry out genetic manipulation as defined in the Regulations ,        and
    that   details of individual experiments be      provided . A   consultative
    document   will be issued by the Health and Safety Commission on        revi ¬
    sions   of   these   Regulations ,   which will include proposals   for       ie
    statutory    obligation    to notify the HSE of the “ use " of   genetically
    manipulated     organisms and the planned release of such organisms      into
    the environment .    Both these activities are at present broadly covered
    by voluntary notification schemes .
    There   is no specific requirement to provide notification of the        fer¬
    mentation    of   non-mani pul ated organisms on an industrial scale or      of
    their release into the environment . However , the Control of Pesticides
    Regulations     of 1986 ,  made under the Food and Environment    Protection
    Act of 1985 ,    provide for statutory powers to approve pesticides       ( in¬
    cluding mi croorganisms ) and make it an offence to sell ,     supply , store
    or use an unapproved pesticide . The use of non-i ndi genous plant pest
    organisms in a fermentation process requires a licence under the Plant
    Pests ( Great Britain ) Order of 1980 .
    The   HSE  must be notified of any intention to work with or       transport
    certain of the most dangerous pathogens under the Health and Safety
    ( Dangerous Pathogens ) Regulations of 1981 . These Regulations are also
    under review .
3 . Gener al_BrinçiEles_gf_the_Eroposal
    Experience to date in some Member States has shown that the risks
    arising from exposure to biological agents at work must be assessed
    before workers can be given adequate protection against them .
                                      8
                                                                               3
 ---pagebreak---     The    assessment should enable the nature and level of the following to
    be determi ned :
    - the intri nsi c danger of the agents ,
    - exposure or potential exposure of workers to these agents ,
 , - the probability/ risk of propagation in the community .
    Before    a    biological    agent is designated a    health   hazard ,   various
    factors Bust be considered ,        such as existing epidemiological data and
    the    guidelines    issued by the appropriate authorities on the         way    in
    which some agents should be controlled .
    The    Member    States   will   then have   to   classify   biological    agents
    according to their level of danger ,        using the definitions proposed in
    this Directive . The cl assi f i cati on will cover research and developeent
    1 aboratori es , animal and industrial processes .
    The proposal for a Directive includes a very clear distinction between
    a   conscious decision to work with biological agents ( voluntary            expo¬
    sure )   and incidental exposure to agents .       Different   provisions     have
    been nade for the two groups .
    Biological      agents   for   use in biotechnologies are     included    in   the
    proposal      for a Directive in such a way as to cover the        agents    which
    have    already been designated dangerous and are used for genetic mani ¬
    pulation ,     as well as those which can become dangerous as a result           of
    such nani pul at ion .
    The proposal for a Directive aims to provide guidelines for drawing up
    measures to protect workers against agents which are known to be
    dangerous and those which are suspected of being dangerous .
4 . Présent ation_of_the_pro£osal
    Article     1   covers measures of a general nature and states         that   " the
     purpose ( of this Directive ) is to protect workers against risks ,
     including the prevention of such risks , arising from exposure to
     biological agents at work ".
    Article 2 contains definitions of " biological agents ",          " Groups 1-4 of
     biological agents ", " mi croorgani sms " , " cell cultures ", " genetically
    modified biological agents ", " genetic mani pul ation ", " incidental expo¬
     sure   to    biological    agents " and a " conscious decision to     work   with
     biological agents ( voluntary exposure )".
                                        9
                                                                                   -7o
 ---pagebreak--- One of the key parts of the proposal is Article 3 , which 1 ays down the
scope of the Directive . The risk must be assessed for each activity
and may also be further assessed . This article also 1 ays down which
types of information must be used in the cl assi f i cat l on of     biological
agents .    Point    5   states that the proposal for a Directive      will   not
apply to some agents ,       and point 6 specifies which provisions will not
apply    to    activities    involving   incidental   exposure   to  biological
agents .
Articles     4   and    5 are of a general nature and    apply   to  incidental
exposure     and to activities which involve a conscious decision to work
with biological agents .
Article 4 lays down the measures for avoiding the exposure of workers
to biological agents or , where this is not reasonably practicable , for
reducing     the   exposure to as low a level as is necessary in order         to
adequately      protect    the health and safety of the    workers   concerned .
Other    measures      provide for the limitation of the number     of    workers
exposed , the design of work processes , collective and personal protec¬
tion ,   adequate and information training for workers ,        the use of bio¬
hazard signs and emergency procedures .
Article     5 deals with the obligation of employers to provide          informa¬
tion and adequate instruction to workers ,         e.g.  on serious    incidents
and accidents .
Articles     6-12 inclusive contain provisions applicable only to activi ¬
ties   which     involve    a conscious decision    to  work   with  biological
agents .
Article 6 1 ays down the measures to be taken for working clothes ,
personal protective equipment and the provision of areas where workers
can eat and drink . They must be provided with skin and eye antiseptics
and , if appropriate , showers and must not be charged for the cost of
these measures .
Under Article 7 ,       employers must keep a record of the workers involved
in   the activities involving Group 3 and/or Group 4 biological agents ,
as well as of accidents and incidents .
Doctors and workers will also have access to these records .
                                   10
                                                                               'H
 ---pagebreak--- Article 8 provides for the replacement ,         as far as possible , of a
hazardous agent by a less hazardous or non-hazardous one . In addition ,
importers and suppliers must ensure that the agents are not dangerous
and that they are suitably described , packed and transported .
Under Article 9 ,       employers must take available to the responsible
authorities information on the results of assessments , the number of
workers exposed , protective and preventive measures , etc .
Under   Article 10 ,    employers must give prior notification of     genetic
manipulation       or work with a genetically modified biological      agent ,
work   with    a Group 4 biological agent or the intention     to   introduce
substantial     changes to a procedure of which notification has      already
been provided . The content of this notification is also laid down .
Employers     must   inform    the responsible authority  forthwith   of   any
incident that may have resulted in the release of any biological agent
which could be a hazard to the health of workers .
Article    11   obliges employers to draw up written     instructions    which
include    the procedure to be used in the case of a      serious   incident .
Furthermore ,    workers    or   their representatives must be   informed   as
quickly as possible when a serious accident or incident occurs .
Article    12 lays down the requirements for the health surveillance        of
workers , which include , when appropriate , the use of effective vac¬
cines and the keeping of individual health records .
Article    13   covers specific measures for health care     facilities    and
diagnostic     laboratories .    Following  the  above-mentioned   assessment
appropriate measures will be taken as laid down in Annex 3 of the
proposal for a Directive .
Article 14 deals with the physical containment levels set out in Annex
3   which are to be observed for the manipulation of biological        agents
in laboratories ( other than diagnostic 1 aboratories ) , animal rooms and
i ndustri al processes .
Once the hazard has been assessed , once of three physical containment
levels with different requirements will be chosen .
Certain    measures listed in annex 3 shall be applied in an       industrial
process , only when appropriate .
                                  11
 ---pagebreak---         A       minimum          physical              containment level will be                                used        for         biological
        agents            in     respect of vhich it has net yet been possible to                                                            reach         a
        conclusive assessment .                            Moreover , when the volume of biological agents
        handled has reached a certain figure ,                                             the physical containment                               level
        will          be increased .                                              ,,v.
        Additional measures are listed in annex 4                                                for laboratories and animal
        rooms .
        Under Article 15 ,                        in the section of final provisions ,                                         the annexes
        this Directive » ay he ad apttd to technical progress .
        Under            Article            16 .     the       fie»;utr States must ensure that                                      workers            .r e
        consulted on the provisions contained in this Directive .
   ? Under * ; Arti cl eivi ?-*-■-...■Her be ; ^5vates.ii«ii5b(..keep statistics ! > of . recognized
        cases            of   serious              i.l tness * fdr deiath due to ' exposure                                    to        biological
        agents ;- and . publ ishup - to- dace information on occupational                                                                     diseases
        caused by bi ological agents ;                                             ■ ; ,              5 ,.•*                                        ...-r .
        Article             18 lays down the time scale and procedures for applying this
        Directive in the Member States .
        Article                ■ rstates ^ that - the r;Di recti Oe-is ^addressed' to . the v , " Member
        States.'                is.,*;': s                                     wo. 1                               -'i r r t ft :*;.,    1. tve '       • "•
        Annex 1 sets out the criteria to be used for designating a genetically
       modified biological                         agent " non-hazardous " .
              r !) ei                  *f rj/' -i    i.i£' f. " ;v;; »?■'{■<? ■ ra'-n, sv                t »■ i ;   i v. <
        Annex 2 shows the biohazard si gn provided for in Article ,4 ( g ).                                                                          ,',.i
        Annex 3 sets out the specific measures required at each of the                                                                             three
        physical containment levels referred to in Articles 13 and 14 .
    .■ if"':- ii ‘ .< -r; g, ■>.:■»,MJ,                                               i;S.    ? ^- viSS                          1 f.i', :';1 :■<< N.iS.,
    ; Annex A sets - out additional measures required at each of • the . three
        physical containment levels for 1 abor(atopi es and -animal rooms referred
        to i n Art . , 14 . 6 « •                                     .     -r--*                                                     < u* <..w,i v,;
5 • Consultâtion
      -Pursuant ,to Article . * 11 8A of . the .Treaty establishing the European
      . Economic Qomqiynityj, ^, the Council . shall cooperate with the European
        Parliament and consult the Economic and Social Committee .
                                                                               1?
 ---pagebreak---                                 PROPOSAL F OR A
                             ÇQUNÇlL-fîlBEQIiyE
                                       y
               on the protection of workers from the risks
            related   to exposure to biological agents at work
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having    regard to the Treaty establishing the European Economic Commu¬
nity ,  and in particular Article 118A thereof ,
Having    regard to the proposal from the      Commission  ( 1 ),  established
following consultation with the Advisory Committee on safety ,         hygiene
and health protection at work ,
In co-operation with the European Parliament ( 2 ),
Having regard to the opinion of the Economic and Social Committee ( 3 ),
Whereas Council     Directive  80 / 1107/ EEC of 27 November    1980  on    the
protection    of workers from the risks related to exposure to chemical ,
physical and biological agents at work ( 4 ), as amended by the Act of
 Accession of Spain and Portugal , provides for Directives for certain
 agents ;
Whereas , under the terms of the said Directive , such 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 ;
1    OJ No .
2    OJ No .
                                                      %
3    OJ No .
4    OJ No L 327 , 3.12.1980 , p. 8
                                     1
 ---pagebreak--- Whereas    more   precise knowledge of the risks involved in exposure    to
biological    agents   at  work can be obtained through  the   keeping   of
records ;
Whereas employers must keep abreast of new developments in      technology
with a view to improving the protection of workers' health and safety ;
Whereas    it   is necessary , in order to ensure the highest   degree   of
protection    reasonably practicable ,  that workers and their   represen¬
tatives    be informed about the risks which biological agents can     pose
for    their health ,  and the measures necessary to lessen or   eliminate
th use   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 protection of the
health and safety of workers exposed to biological agents ,
                                    2
 ---pagebreak--- HAS ADOPTED THIS DIRECTIVE :
                                  OBJECTIVE
                                  Article 1
1.    The purpose of this Directive           is to protect workers       against
      risks to their health and safety , and to prevent
      such risks    arising or likely to arise from exposure to          biologi ¬
      cal agents at work .
2.    This   Directive shall apply to all workers with the exception            of
      workers engaged in sea transport and in air transport .
      For the purposes of this Directive " workers engaged in sea trans¬
      port   and   in air transport "   means personnel on board .
                                 DEFINITIONS
                                  Arti cl e 2
For the purposes of this Directive :
( a)  " Biological   agents "  are micro-organisms including         those   which
      have   been genetically manipulated ,       cell cultures and     multicel ¬
      lular human endoparasi tes .
(b)   A " Groyp_l " biological agent       is one that is most unlikely to
      cause human disease . It does not produce infection and is unlike¬
      ly to spread in the community .
      This   definition    includes any    geneti cal ly - modifi ed   biological
      agent   which fulfils the criteria for good microbiological            prac¬
      tice as laid down in Annex 1 .
 ( c) A " GrouE_2"   biological agent is one that may cause 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 .
                                     3
 ---pagebreak--- ( rt ) A " Group_3 " biological agent is one that may cause 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 .
Ce )   A   " Grpup_4 "    biological agent is one that causes     severe    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)    "Microorganism"      is    any microscopic unicellular or subcellular
       biological entity capable of replication .
( g)   " Genetically modified biological agent " is an organism derived by
       the techniques of genetic mani pul ation .
( h)   " Genetic   mani pul ation "   is the formation of a new 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 .
(i )   " Cell   culture " is the in vitro growth of     cells   isolated    from
       multicellular organisms .
(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 agents but where the work       activity
       may    result in workers being exposed to      biological   agents ,   in¬
       cluding    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 pathological material with infectious disease .
( 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 i ndustri al processes employing biological agents .
                                        4
 ---pagebreak---                                    ASSESSMENT
                                   6Eîl£lfi_3
1.    This   Di recti ye   shall apply to work activities in which      workers
      are or are potentially      exposed to biological agents as a      result
      of their work activities .
2.    In   the    case   of any activity or sector of    activity    likely  to
      involve     a risk of exposure to biological agents the risk Bust be
      assessed .    Member States shall fix the conditions of this assess¬
      ment    and   of any further assessment ,    if  necessary ,   and  shall
      determine by whom it is to be conducted . The assessment shall be
      conducted so as to determine the nature and degree of the :
      - inherent hazard of a biological agent to health ;
      - risk    of workers' exposure or potential exposure ,       including   a
         determi nation of whether this involves either incidental        expo¬
         sure , or a conscious decision to work with biological agents ;
      - risk of transfer from the workplace to the coaaunity ;
      - risk of further spread within the comnunity .
      This    assessment shall not apply to genetically aodified biologi ¬
      cal   agents which have been notified in accordance with the provisions
      of Council Directive         /    / EEC Aon deliberate release into the environ¬
      ment of genetically-modified organisms 7 (D
3.    The   identification of a biological agent as being        hazardous    to
      health shall be based on all available information including :
       - a  disease from which a worker is found to be       suffering    which
         has a direct connection with his work activity and/or epidemio¬
         logy   which indicates that a biological agent has been a source
         of human infection and/or illness ;
       - guidelines issued by a responsible authority which indicate
         that a biological agent should be controlled in soae 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 activity .
1 ) 0Л
                                      5
                                                                                 U
 ---pagebreak--- Biological     agents shall be assessed on the basis of the              maximum
degree of hazard ,      unless there is evidence , in individual cases ,
that the degree of hazard is lower .
The   assessment of a geneti cal 1 y - modi fi ed biological agent         shall
be made , when appropriate , on the same basis .
This Directive shall apply without prejudice to the provisions
of Council Directive                on the contained use of genetically-
modified microorganisms .
Articles 4 to 17, with the exception of Article 9, first indent, shall not apply if the
assessment     referred     to i n paragraph 2 shows that        the    exposure
and/or    potential exposure is to a Group 1 biological agent or to
a biological agent which causes disease only in animals and/or in
plants and that there is no identifiable             health risk to workers .
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 .
 ---pagebreak---      GFNFRAL PROVISIONS APPLICABLE TO WORK ACTIVITIES WHICH INVOLVE
     BOTH INCIDENTAL. FXPOSIIRF TO BIOLOGICAL AGENTS AND A CONSCIOUS
                   DECISION TO WORK WITH BIOLOGICAL AGENTS
                                  Article 4
The   risk    of workers' exposure must be avoided .   Where   this   is  not
reasonably practicable , having regard to the work activity and the
risk assessment referred to in Article 3 , paragraph 2 , exposure shall
be   reduced    to   as low a level as is necessary in   order    to  protect
adequately the health and safety of the workers concerned ,        in  parti ¬
cular     by  the following measures which are to be applied when      appro-
pri ate :
(a)   the limitation of the number of      workers exposed or     potentially
      exposed ;
(b)   the    prevention of exposure or its adequate control by the appro-
      pri ate   design   of work processes and/or the use    of   engineering
      control measures ;
(c)   collective     protection measures including the use and maintenance
      of adequate equipment ;
(d)   personal protection measures , where exposure cannot reasonably be
      avoided by other means ;
(e)   hygiene    measures designed to prevent the accidental transfer       or
      release of a biological agent from the workplace ;
(f)   the    provision    of up-to- date information on  biological    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 2 ) and other warning signs ;
(h)    emergency    procedures designed to minimize   workers ' exposure   re¬
      sulting from a serious accident or incident .
                                     7
 ---pagebreak---                                    0rtiçl£_ïj
1 .   At   the    beginning   of   employment   and  at  regular     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 workers and/or
      any workers' representatives in the undertaking or        establishment
           receive    explanations on the potential risks to health       from
      exposure to biological agents , the hygiene requirements , and the
      emergency procedures designed to minimize workers' exposure re¬
      sulting from a serious accident or incident .
                            ADDITIONAL PROVISIONS
               APPLICABLE TO WORK ACTIVITIES WHICH INVOLVE
          A CONSCIOUS DECISION TO WORK WITH BIOLOGICAL AGENTS
                                   ÊCti£le_6
1.    Appropriate    measures    shall   be taken so far  as   is   reasonably
      practical    for the protection of the health and safety of workers
      by provi di ng that :
 (a)  areas   are   set   aside where workers can eat    and   drink   without
      risking contamination by biological agents .
 ( b) workers   are   provided    with appropriate protective     clothing   or
      other appropri ate special clothing ;
 (c)  separate    storage places are provided for working      or   protective
      clothing and for street clothes ;
 ( d) protective respiratory equipment is placed in a well-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 .
                                      8
 ---pagebreak--- 2.   Working   clothes    and personal   protective    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          disinfected ,
     cleaned or , if necessary , destroyed .
3.   Workers   who handle biological agents must be provided with           skin
     and eye antiseptics ,    suitable washing facilities and ,      if appro­
     priate , showers .
4.   Workers   may   not   be  charged for the    cost   of   measures   taken
     pursuant to paragraphs 1 , 2 and 3 .
                                 ftrticle 7
1.    Employers     shall keep a record of workers exposed or potential ¬
     ly exposed to Group 3 and/or Group 4 biological 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 for at least 10 years following the end           of   exposure ,    in
     accordance with national laws and practice .
3.   The doctor and/or the authority 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 records which
     relates to him personally .
5.    Workers and/or any workers' representatives in the undertaking or
      establishment    shall have access to anonymous collective informa¬
      tion in the records .
                                    9
                                                                                  г
 ---pagebreak---                                  ôEticig.e
1 . The   use of a Group 3 or 4 biological agent shall be avoided ,          as
    far as     is reasonably practi cabl e/ by its replacement by a less
    hazardous or non -hazardous agent .
2.  Suppliers or importers of a Group 3 or 4 biological agent for use
    at work shall ensure that they are adequately         described ,   packed
    and transported .
                                 ÊEÎi£le_2
    Employers     shall  on request make available     to   the   responsible
    authorities     appropri ate information on :
          the    results  of the assessment referred to in      Article 3(2 );
          the activities in which workers have been exposed or           poten¬
          tially exposed to biological agents ;
          the number of workers exposed ;
          the    name of the person responsible for safety and health at
          work ;
          the    protective   and   preventive  measures    taken    including
          working procedures and methods ,
          an   emergency plan for the protection of workers from          expo¬
          sure    to a Group 3 or 4 biological agent which might         result
          from a loss of physical containment .
                                  Ac£içle_10
 1. Without prejudice to Directive          /   / EEC on the deliberate
     release of genetically-modified organisms , employers shall give
     a prior notification to the responsible authority , at least
     60 days before :
    - an intention to carry out genetic manipulation work or to            work
       with a genetically-modified biological agent in Group 2 , 3 or 4;
    - an    intention to introduce substantial changes to        a    procedure
       which has already been notified ;
                                   10
 ---pagebreak--- - WOT'I' with a Group 4 biological agent ,    or if there is an inten¬
   tion to handle , store or transport such an agent .
In the case of genetic manipulation work ,      or work with a geneti ¬
cally     modified biological agent ,        prior 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 .
In the case of a Group 4 biological agent           prior notification
shall include :
- the result of the assessment referred to in Article 3(2 );
- the name of the biological agent ;
- the protection and preventive measures that are envisaged ;
- the     name   of the person responsible for safety and   health   at
   work .
Employers      shall    inform forthwith the responsible authority of
any accident or incident that may have resulted in the release of
any biological agent such that it could cause severe human infec¬
tion and/ or illness .
                              Article 11
  Employers      shall display written instructions at the workplace
which shall       include the procedure to be used in the case of
-    a serious accident or incident .
 - work with a Group 4 biological agent .
A    serious accident or incident shall be reported immediately      to
 and recorded by the person responsible for the work .
 Workers and/or any workers' representatives in the 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 .
 ---pagebreak---                                     ACÎ1Ê1Ê_12
1 . The    specific rules for the health surveillance of workers                shall
    be   established by           Member States in accordance with          national
    law and practice .
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 directly possible to implement            individual     and
    hygiene measures .
3.  Where relevant , the assessment referred to in paragraph 2 should identify those workers for
    whom    speci al    protective measures may be required .          When    appro¬
    priate ,    effective     vaccines should be made available           for   those
    workers     who    are not already immune to the biological            agent     to
    which they are exposed or are potentially exposed .
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 for health           surveillance      may
    decide that other workers similarly exposed shall undergo assess¬
    ments 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 have been
     made , an individual health record shall be kept for at least 10
     years following the end <yt exposure , in accordance with national
     laws and practice .
     The    doctor or authority responsible for health surveillance                 may
     propose protective measures to be taken in respect of any indivi ¬
     dual worker .
 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 .
                                      12
 ---pagebreak---                          SPECIAL MEASURES FOR
                      HEALTH CARE FACILITIES AND
                       DIAGNOSTIC LABORATORIES
                            Art i c Le 13
Specific      measures shall be taken for health care facilities ,     in
particular isolation and post-mortem units , and clinical , veteri ¬
nary and diagnostic 1 aboratori es .
For    the    purposes   of the assessment referred to i n
Article 3(2),     particular attention shall be paid to :
- uncertainties       about  the presence of biological agents in     the
   materials and specimens being investigated .
- the     hazard of biological agents known or suspected to be       pre¬
   sent in the materials or specimems .
- the risk posed by the nature of the work activity .
The specific measures listed in Annex 3 for the physical contain¬
ment of biological agents shall be applied , when appropriate .
            SPECIAL MEASURE5 FOR INDUSTRIAL PROCESSES ,
                    LABORATORIES AND ANIMAL ROOMS
                              Artiçle_14
 Specific measures shall be taken for industrial processes , animal
 rooms and 1 aboratori es ,    excluding clinical , veterinary and diag¬
 nostic    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        agents
 using    the    definitions in Article 2 ( c ),  ( d ) and (e)  relating
 respectively to a Group 2 , 3 , and 4 biological agent .
 Following the assessment referred to in Article 3(2),
 special measures shall be taken as laid down in Annex 3 after
 matching the physical containment level for biological agents
 with    the degree of risk .
 For this purpose work activities involving :
 ---pagebreak---            a group 2 biological agent may be carried out only in         working
          areas     corresponding to at least the physical containment level
         2.
       - a    group 3 biological agent may be carried out only in        working
          areas corresponding to at least the physical containment           level
          3.
       - a    group 4 biological agent may be carried out only in        working
          areas corresponding to the physical containment level 4 .
3.     When     the volume of the biological agents which are being handled
       in groups 2 and /or 3 , justifies it the physical containment level
       shall be increased ,      when appropriate , to at least the level 3 or
       at 4 respectively ,      in order to ensure that the health and safety
       risks are minimized .
4.     In    an    industrial process in which there    is  adequate    physical
       containment of biological agents by means of a closed system , the
       specific      measures   listed in points 1 and 2 of Annex 3 shall        be
       applied only when appropriate .
5.     In    the    case of a biological agent in respect of     which    a    con­
       clusive      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             and    animal
       rooms are listed in Annex 4 .
                                  FINAL PROVISIONS
                                     âCÎi£lfi_15
The Annexes       to this Directive may be adapted to technical progress         in
accordance        with   the  procedure set out in Article    10  of   Directive
80 / 1107 / EEC .
                                     Article 1 6
Member      States     shall ensure that workers and/or workers'     representa¬
tives     where they exist in an       undertaking or establishment    are     con¬
sulted      on the provisions referred to i n this Directive and that          they
can be involved in their application .
                                       14
                                                                                    a
 ---pagebreak---                                   ÔEtiilÊ.lZ
1.   Member States shall keep national statistics of recognized         cases
     of  serious illness or death due to exposure to biological agents
     at work .
2.   Member    States shall publish up to date and appropriate      informa¬
     tion on occupational diseases caused by biological agents .
                                  Article 18
1.   Member    States shall adopt the laws ,    regulations and administra¬
     tive 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 Commission the provisions
     of  national      law which they adopt in the field governed     by this
     Directive .
                                  Art ic le 1 9
This Directive is addressed to the Member States .
                                                   Done at Brussels ,
                                                    For the Council
                                                     The President
                                    15
 ---pagebreak---                                                                                      Annex 1
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 DMA is inserted in r -
                    DNA   constructions ;    provides the major portion of       the
                    genome of the r-DNA organism ; same as recipient .
Uector :    An     agent   of transmission ;    for example a DNA vector      is    a
            self-repl i cati ng     molecule   of  DNA that   transmits    genetic
            information       from one cell or organism to      another .  Plamids
             ( and   some viruses )   are used as " vectors " for DNA in     bacte-
            ri al   cloning .
The   genetically       modified mi cro-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 .
 ---pagebreak--- rhe following table sets out the criteria for good microbiological practice                     ( GhP )    as
referred to in Article 2 ( b ) for a genetically modified biological agent .
                               1
        Host Organism          !   rDNA Engineered Organism           !        Oector / Insert
                               1
                               1
   Non-pathogeni c ;           ! - Non-Pathogeni c ;                  ! - Well    character ! zed and
                               1                                            free from known harm-
                               I                                            full sequences ;
   No adventitious agents ;    ! - As safe in industrial setting      !   - Limited in size as much
                               1   as host organism , but with        !     as possi bl e to the DMA
                               I   limited survival   without adverse !     required to perform
                               1
                                     consequences for human health    !     the intended function ;
                               I                                            should not increase the
                               1
                                                                            stability of the cons ¬
                               I                                            truct ( unless that is a
                                1                                           requirement of the in ¬
                               1                                            tended function );
   Extended history of safe !                                             - Should be poorly
   industrial use ; OR          !                                           mobi 1 isabl e ;
   Built-in limitations         !                                         - Shoul d not transfer any
   permitting optimal growth !                                              resistance markers to
   in industrial   setting but !                                            mi cro-organi sms not
   limited survival   without   !                                            known to acquire them
   adverse consequences         !                                            naturally ( if such ac¬
   outside the industrial       !                                           quisition could compro¬
   setting                      !                                           mise use of drug to con ¬
                                ;                                           trol disease agents ).
                                 1                                      1
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 physiological processes .
For the      purpose of this table " non-pathogeni c " means an agent which does not         cause      human
disease
 ---pagebreak--- BIO-HAZARD SIGN AS REFERRED
     TO IN ARTICLE A.g .
 ---pagebreak---                                           ÔÜNÊ*_3
               THE SPECIFIC MEASURES REQUIRED AT EACH OF THE THREE PHYSICAL
              CONTAINMENT LEVELS AS REFERRED TO IN ARTICLES 13 , PARAGRAPH 3
                             AND 14 PARAGRAPHS 2 , 3 , 4 AND 5
                                                            Containment levels
              Spécifie measures
1 . The workplace is to be in an isolated         Recommended
part of a building and separated by an
anteroom with two doors
2 . Input air and extract air to the workplace                    Yes , on     Yes , on
are to be filtered using ( HEPA ) or likewise                     extract air  input and
                                                                               extract air
3 . Access is to be restricted to nominated       Recommended                  Yes , via an
workers only                                                                   airlock
4 . The workplace is   to be sealable to                          Recommended
permit disinfection
5 . Specified disinfection procedures
6 . The workplace is   to be maintained                           Recommended
at an air pressure negative to atmosphere
7 . Efficient vector control  e.g. rodents        Recommended
and insects
8 . Collection and treatment of effluents                         Recommended
9 . Surfaces impervious to water                   Yes , for      Yes , for    Yes , for
                                                   bench           bench and   bench , floor
                                                                  floor        and ceilings
 10 . Surfaces résistant to acids , alkalis ,      Recommended
 solvents , disinfectants
 11 . Safe storage of a biological agent           Recommended                 Yes , secure
                                                                               storage
                                                                                       3C
 ---pagebreak---                                            ANNEX 4
                 THE ADDITIONAL MEASURES REQUIRED AT EACH OF THE THREE PHYSICAL
                      CONTAINMENT LEUELS FOR LABORATORIES AND ANIMAL ROOMS
                           AS REFERRED TO IN ARTICLE 14 , PARAGRAPH 6
I
                                                            Contai notent levels
                Spécifie measures
                                                        2                 3            4
  1 . An observation window , or alternative ,     Recommended     Recommended   Y es
  is to be present , so that occupants can be
  ьеем
  2 . A 1 aboratory is to contain own equipment    No              Recommended   Yes
  3 . A microbiological safety cabinet is to       Recommended     Yes           Yes , wich
  be used                                                                        glove ports
  4 . Infected material including any animal       Recommended     Yes           Yes
  is to be handled in a safety cabinet or
  i sol ator
  5.  Autoclave or incinerator for animais         Recommended     Yes           Yes
                                                                                      33
 ---pagebreak---                          FINANCIAL SHEET
        relating to the proposal for a Council Directive
                   on the protection of workers
                from the risks related to exposure
                   to biological agents at work
1 . Budget item concerned
    B 6482 : Health protection , hygiene and safety at work
    A 2510 : Compulsory consultation
2 . Leqal basis
    a ) Article 118A of the EEC Treaty added by the Single
        European Act
    b ) Commission communication on its programme concerning
        safety , hygiene and health at work ( SEC(87 ) 1216 ) .
3 . Proposal for classification as compulsory or
    non-compulsorv expenditure
    Non compulsory
4 . Description and grounds for the action
    4.1 .   Description
    4.1.1 . Aims of the proposal for a Directive
            The aim of the proposal is to protection workers
            from risks to their health and safety which arise
            or could arise from exposure to biological agents
            at work , especially the prevention of such risks .
    4.1.2 . Features    of   the  proposal   for    a    Directive
            ( especially those with financial implications )
            Harmonization of national legislation in the field
            of the protection of workers from biological
            agents , by means of adequate monitoring , training
            and information of workers and the provision of
            physical protection measures .
 ---pagebreak---                                              2
       A . 2. Grounds
              The action is justified on the legal ground
              indicated          under         point      2.      The    financial
              implications are inherent in the application of
              the Directive .
5 . Nature of expenditure and method of calculation
       5.1 .  Natu re of additio nal activ it i es              to be undertaken
              after adoption of the Directive
              a ) monitoring the application of the Directive at
                  Member State level             ;
              b ) consultation of experts ;
              c ) operation of the Committee .
       5.2 .  Types of activities deriving                   from point   5.1 .   and
              their financial implications
              It involves :
              - study contracts to examine problems related to
                 the operation of the Directive in practice ,
              - costs for consultation meetings with experts ,
              - operating costs of committees .
       5.3 .  Calculation of expenditure
              In view of the nature of the activities , it is
              impossible to estimate the expenditure precisely .
              The amounts under point 6.1 are overall estimates .
6 . Financial impact of the action on appropriations
       6.1 .  Schedule of commitment and payment appropriations
                           B 6482            A 2510 *     B 6482       A 2510
                           CA ( ECU )        CA ( ECU )   PA ( ECU )   ΡΛ ( ECU )
              1989           80.000            30.000        80.000     30.000
              1990           80.000            60.000        80.000     60.000
              1991           90.000            60.000        90.000     60.000
              1992         ICO . 000           60.000      100.000      60.000
              1993         110.000             60.000     110.000       60.000
              Total        460 . C00         270.000      460.000      270.000
              Share of Cc .am unity f inancincj            fin %i   in the over
              cost of the action : 100 %
7 .    Comments
      None .
    A : oncerns toe t . i    ._5 id , t tic* credits foreseen can only be used within
    the limits of the v a'. istle budgetary provis.ons
                                                                             SS
 ---pagebreak---                                3
8 . Financial impact on staff appropriations
    8.1 .  Staff  needed  solely  for   the execution of the
           action
           From 1989 one full-time category A official , one
           half-time category B official and one full-time
           category C official .
           The necessary staff will be obtained through
           internal redeployment or in the framework of the
           annual budgetary procedure .
    8.2 .  Staff appropriations needed
           From 1989 an estimated 158.000 ECU per year will
           be required .
 ---pagebreak---             ASSE5ShfcHI_.0F_IMeACI_0H_C0MPETmytNESS_AND_EMPL0YMfcNT
                        ( Directive on biological agents )
I.    The proposed Council Directive is designed to protect workers from the
      risks related to exposure to biological agents at work .
II .  The main activities to which the Directive applies are :
      research and development laboratories
      hospital isolation departments
      clinical and veterinary diagnostic laboratories
      industries using biological agents [ medical industries - vaccines !
      the sewage industry
      breweri es .
      As regards the relative numbers of small and medium-sized undertakings
      involved in each of these activities , medium-sized undertakings are
      concentrated mainly in the brewing and medical industries ,       whereas
      there are very few small undertakings in these two branches .
III . From the cost angle , the most important articles concern :
      - the reduction of worker exposure ,
      - the   introduction   of specific measures appropriate to the  intrinsic
        risk of the organisms ,
      - medical surveillance .
      The Directive is structured in such a way that different measures are
      laid down for activities which may involve incidental exposure to
      biological agents ( the degree of risk is smaller and the measures are
      therefore    less stringent - in particular ,   they do  not require   the
      drawing    up or   keeping of registers ) and for activities involving   a
      conscious decision to work with biological agents ( the degree of    risk
      is higher and the measures laid down are therefore stricter ).
 ---pagebreak---        The heaviest direct costs have been identified as those relating to
       medical surveillance . However , these will vary from one Member State to
       another ,   since  some Member States already have such surveillance sys¬
       tems , while in others they have not been required until now .
IU .   It should be pointed out that other indirect costs may be incurred in
       the application of the Directive , since the individual Meaber States
       may lay down more stringent protective measures for workers than those
       provided for in the Directive . Clearly , the level of such costs cannot
       be estimated , since it depends on the political and legislative
       approach chosen by each Member State and the stage reached in existing
       legislation and scientific development in each country .
U.     The Directive avoids imposing admi ni strati ve , f i nanci al or legal cons¬
       traints likely to hamper the creation and development of small and
       medium-sized undertaki ngs . As has already been pointed out , only a very
       few small     and medium-sized undertakings are involved       in  activities
       connected with the handling of biological agents .
       However , large undertakings may        have an advantage over small and
       medium-sized undertaki ngs , since      the higher the number of workers
       subject    to  medical surveillance the lower the average cost      for  each
       assessment . In order to keep these costs to a minimum , the obligations
       relating to medical surveillance have been adapted so as to fit in as
       far as possible with existing systems .
UI .   The information given above is based on the conclusions of a study of
       the impact of the proposed Directive on small and medium-sized under¬
       takings carried out hy the National Institute of Occupational Health
       ( Denmark ). However , the conclusions , not sufficiently representative of
       well-founded in that some Member States , such as France , the United
       King lost and the Federal Republic of Germany , did not supply data .
U'll . The advantages anticipated from the improvement in working conditions
       will seem from a better awareness of the health problems related to
       work with biological agents and a consequent reduction in the health
       risks which such work might pose . These improvements will benefit not
       only society as a whole but also individual undertakings . In the latter
       case , undertakings will certainly benefit from the reduction in the
       number of days lost through sickness .
UIII.The Advisory Committee for Safety , Hygiene        and Health Protection at
       Work gave an opinion on 2 and 3 July 1987 on     the necessary content of a
       proposal for a Directive in this field . The     Committee members confined
       themselves to technical questions only , and     the proposed Directive has
        been adapted to take account of their opinion .