CELEX: 51991PC0270(03)
Language: en
Date: 1991-07-19
Title: PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING DIRECTIVES 64/432/EEC, 72/461/EEC AND 80/215/EEC AS REGARDS CERTAIN MEASURES RELATING TO CLASSICAL SWINE FEVER

COMMISSION OF THE EUROPEAN COMMUNITIES
                                       C0M(91) 270 final
                                       Brussels, 19 July 1991
                REPORT FROM THE COMMISSION TO THE COUNCIL
          ON THE CLASSICAL SWINE FEVER SITUATION IN ACCORDANCE
         WITH ARTICLE 4b(2) OF COUNCIL DIRECTIVE 64/432/EEC OF
            26 JUNE 1964 ON ANIMAL HEALTH PROBLEMS AFFECTING
            INTRA-COMMUNITY TRADE IN BOVINE ANIMALS AND SWINE
                               Proposal for a
                             COUNCIL DIRECTIVE
     amending Directive 80/217/EEC introducing Community measures
                 for the control of classical swine fever
                               Proposal for a
                              COUNCIL DECISION
       amending Directive 80/1095/EEC and Decision 80/1096/EEC as
       regards certain measures relating to classical swine fever
                               Proposal for a
                             COUNCIL DIRECTIVE
      amending Directives 64/432/EEC, 72/461/EEC and 80/215/EEC as
       regards certain measures relating to classical swine fever
                               Proposal for a
                             COUNCIL DIRECTIVE
   amending Directive 72/462/EEC on health and veterinary inspection
    problems upon importation of bovine animals and swine and fresh
                meat or meat products from third countries
                       (presented by the Commission)
 ---pagebreak---                                     -2 -
                           EXPLANATORY MEMORANDUM
The Council by Decision 80/1096/EEC In 1980 introduced Community
financial measures for the eradication of classical swine fever. The
measures were linked with actions to be taken under an accelerated
eradication plan which had the objective to render and keep the territory
of the Community free of classical swine fever without the necessity of
recourse to systematic vaccination. This action was planned to run for a
period of 5 years. Member States, which were not officially swine fever
free, were to prepare and present eradication plans which, subject to
certain conditions, could be implemented on a regional basis. Community
financial contributions were made available for compensation to owners
for the slaughter and destruction of animals, emergency vaccination,
systematic vaccination for up to 2 years and for serological tests.
The 5 years period   initially allowed for disease eradication was later
extended to 6 years  and in 1987 supplementary measures were added for a
period of 4 years    extending the total period for implementation of
eradication plans to  10 years.
At the time that these eradication plans were coming into operation, an
epidemic of classical swine fever occurred in Belgium. The disease
subsequently appeared in the Netherlands and certain areas of Germany.
The highest annual number of outbreaks recorded within the Community
during the implementation of the accelerated eradication plans was in
1984, when a total of 1272 outbreaks occurred. Since then the situation
has gradually improved except for a period in 1990, when an epidemic was
experienced in Belgium. By and large the strategy - the non-vaccination
and stamping-out policy - has been successful as 8 of 12 Member States
now fulfill the requirements for recognition as officially swine fever
free Member States and 4 Member States have large areas which at the
level of regions comply with the conditions for recognition. The ultimate
goal of eliminating classical swine fever virus from the Community is in
sight although the rather recently reported occurrence of the disease in
the European wild boar in two areas (Hessen, Germany and Tuscany, Italy)
may have postponed the date.
Experience gained during the implementation of the eradication plans and
the completion of the single market justify the modifications of existing
working procedures and amendments to existing legislation concerning
disease eradication and trade in live pigs, fresh pigmeat and pigmeat
products.
 ---pagebreak---                                   - 3 -
The attached report describes the disease situation, rules for trade and
measures applied to classical swine fever eradication since 1980, while
proposals for amending legislation are presented in respect of Council
Decision 80/1096/EEC and Council Directive 80/217/EEC, 80/1095/EEC,
64/432/EEC, 72/461/EEC, 80/215/EEC and 72/462/EEC.
Finally it is the intention by Commission Decision to add classical swine
fever to the list of diseases in Article 3(1) of Council Decision
90/424/EEC on expenditure in the veterinary field.
 ---pagebreak---                                       - 4 -
              Report from the Commission to the Council on the
                classical swine fever situation in accordance
             with Article 4b(2) of Council Directive 64/432/EEC
                  of 26 June 1964 on animal health problems
                  affecting intra-Community trade in bovine
                                animals and swine
 INTRODUCTION
The occurrence of animal diseases has, since the earliest days of the
Community, been an obstacle to the creation of a common market based on
freedom of    trade   in  livestock, meat and products of     animal origin.
Disparities between health standards in the Member States, between the
methods used to control animal diseases and between the prophylactic
measures applied on the farm have restricted the marketing of such goods.
 It is indeed unreasonable to jeopardize the high standards of health
achieved by a Member State by obliging         it to admit to   its territory
 livestock or products which, if not reliably guaranteed as safe, are
 liable to reintroduce diseases which have been eradicated at considerable
technical and financial cost.
Classical   swine   fever   is regarded   as one of    the economically   most
important diseases affecting the pig industry. It often produces a high
mortality and causes further setbacks in pig farming due to abortions,
retarded growth, etc. The        importance of   the disease was   taken  into
account at the time of the first enlargement of the Community when,
because of    exceptional    circumstances  in the acceding Member States,
authorization was given for them to maintain their national           laws on
imports, namely the ban on        imports from countries with outbreaks of
classical swine fever and a policy of vaccination.
 ---pagebreak---                                     - 5 -
In order to dismantle these barriers to trade, the Community decided in
1980 to eradicate classical swine fever from the whole of its territory
by  applying    a   common  policy  of  slaughter   and   gradual  abolition   of
systematic   vaccination    for  the purposes of    prevention.    This kind of
common strategy was the only way of ensuring the liberalization of trade
and  the establishment of a true       internal  market    that might   otherwise
serve as a network for the propagation of this epidemic disease.
I.  DISEASE ERADICATION
1.  Eradication plans in Member States
    Plans for the eradication of classical swine fever were launched in
    the early 1980's to stamp out the disease from those Member States
    where it still existed.      Likewise, plans were introduced for Greece,
    Portugal and Spain at the time they joined the Community.
    The   final   goal  of each plan was that     the Member    State concerned
    should obtain a status as "officially swine fever free" based on the
    following health requirements :
    -   no swine fever to be detected during the previous 12 months,
    -   vaccination against swine fever had not been authorized            for at
        least 12 months,
    -   holdings not to contain pigs vaccinated against swine fever during
        the last 12 months.
    Community     financial  measures  to   support   the   eradication   of  the
    disease, Council Decision 80/1096/EEC, include provisions for payment
    of :
    -   compensation for slaughtered and destroyed animals,
    -   vaccination (emergency vaccinations and prophylactic vaccinations
        for a limited period only as part of an eradication plan),
        laboratory tests for detecting the disease.
 ---pagebreak---                                  - 6 -
   The measures applied by individual Member States to eradicate
   classical swine fever were in accordance with the provisions laid
   down     in    Directive 80/217/EEC,     Directive    80/1095/EEC   and
   Decision 80/1096/EEC, but the application of the measures have varied
    in respect of
   -   the period allowed for prophylactic vaccination,
   -   the priority given to the eradication of classical swine fever on
       a regional level.
   Table 1 provides information on the operation of national eradication
   plans.
2. Vaccination
    In the past there have been two main strategies for the control of
   classical swine fever.
   The first was based on a systematic and comprehensive vaccination
   programme    which   might   be    continued    indefinitely; different
   vaccination programmes were available and if properly implemented
   vaccination would normally prevent acute and subacute disease
   outbreaks. Pig owners knew that they could live with the disease and
   stay in business. The disease was controlled, but not the infection
   causing it.
   The second strategy was a policy based on the eradication of disease
   and elimination of the infection without recourse to vaccination.
   This strategy calls for the slaughter of all infected pigs and the
   tracing of their contacts. An important tool in tracing contacts is
   the serological examination of blood samples for antibodies to
   classical swine fever virus.
   Systematic vaccination is Justified where the disease is endemic as
   vaccination reduces immediate losses. Such situations occurred in
   Member States during the 1960s (there were more than 6 000 outbreaks
   in 1961) and in the 1970s (more than 5 000 outbreaks in 1972).
 ---pagebreak---                                                 - 7 -
              Table 1 Implementation of plans for eradication of classical swine fever
         Member        Eradication        Vaccination          Status        No. of regions
         State        plan started          stopped           obtained        recognised
                                                            as O.S.F.(2)       as O.S.F.
  Belgium               1/1/1982            1/4/1988                            8/9(3)
  Denmark                                                       1981
  Germany               1/1/1982            1/1/1989                           26/30(4)
  Greece                1/8/1983            1/1/1988            1990
  Spain                                     1/7/1988            1989
  France                1/6/1982           30/4/1983                            94/96(5)
  Ireland                                                       1981
  Italy                 1/3/1983           1/1/1990(1)                           0/95(6)
  Luxembourg                                                    1981
  The Netherlands       1/3/1982           15/7/1986            1989
  Portugal              1/7/1987            1/7/1989            1991
  United Kingdom                                                1981
(1)  Except in Sardinia
(2)  O.S.F. - Officially swine fever free
(3)  Number of O.S.F. recognised regions/total number of regions
(4)  Regions in the territory of Germany which have participated                        in the
     eradication programme since 1982. The regions included in the programme by
    Commission Decision 90/483/EEC are recognised as swine fever free regions
     by Council Decision 90/678/EEC.
(5) All regions (94) on the mainland are O.S.F.
(6) A total of 87 regions are recognised as swine fever free.
 ---pagebreak---                                  - 8 -
    If however, classical swine fever outbreaks are sporadic or rare,
    vaccination is an unnecessary extra cost.
    The simultaneous use of both strategies creates major problems for
    the movement of animals (trade), and the tracing of contact animals
    moved to and from diseased herds (epidemiological investigations).
    A Commission funded study of the epidemiology and economics of swine
    fever eradication within the Community carried out during the mid-
    1970s< 1 ), concluded in favour of adopting a non-vaccination policy.
    The decision to cease vaccination was taken in 1985.
    A number of third countries such as Australia, Canada, the
    Scandinavian countries, New Zealand and the USA have successfully
    applied a non-vaccination policy for a number of years. Once
    vaccination was prohibited, it was never thereafter utilised. The ban
    on the use of vaccine in these countries was linked to a ban on the
    importation of pigs, fresh pigmeat and untreated products from
    vaccinating countries. With the establishment of the single market
    it is important to continue with a non-vaccination policy in the
    light of intra-Community trade as well as of trade with third
    countries.
3.  Disease situation
    Outbreaks of classical swine fever during the 1980s have been
    recorded in 10 out of 12 Member States, Annex 1. The recorded
    outbreaks from 1980-1989 totalled 3 745, compared to 13 553 outbreaks
    recorded from 1970-1979. Two Member States, Belgium and Germany,
    have during the 1980s experienced outbreaks every year, while two
    Member States, Denmark and Ireland, did not have any outbreaks.
(1) Studies on the epidemiology and economics of swine fever eradication,
    Commission of the European Communities, 1977.
 ---pagebreak---                                     - 9 -
   The relative     large number of outbreaks recorded         in Germany during
   1989 and 1990 is to a great extent due to the occurrence of classical
   swine   fever   in wild    boar;   each  wild   boar, shot     or   found   dead,
   infected    by   classical   swine   fever   is   recorded   as   an    outbreak.
   Information on the number of outbreaks recorded in domestic pigs and
   in the wild boar during 1990 is given in Annex 2.
   An  analysis    of  outbreaks   to determine     the   sources of      infections
   during 1990 has revealed that the major sources were :               fomites and
   contacts with neighbouring herds, Annex 3.
   The main    diagnostic method      used  to diagnose     outbreaks     in Member
   States    is   the   demonstration    of   viral    antigen    by    the   direct
   immunofluosescence technique, Annex 4.
4. Financial consequences
   Community financial aid is made available to the Member States from
   the day when the eradication plans are           implemented.     In accordance
   with the provisions of Council Decision 80/1096/EEC the aid has been
   aval table to cover :
   -  up to 50% of the cost of slaughter and destruction as paid by the
      Member    States    in  compensation    to   the   owners   of    slaughtered
      animals,
   -  up    to  0.125    ECU   per  animal    for   emergency    or   prophylactic
      vaccination, provided that it is part of a plan,
   -  up to one ECU per sample examined          in a laboratory     in connection
      with detection tests.
   The Community financial aid provided since the commencement of the
   eradication programmes is listed below :
 ---pagebreak---                                    - 10 -
Î   Year of control    !        Payments made of Community             I
!       measures        !     financial aid (reimbursements)           !
i        1982          !        4.6MECU             6.07%              I
|        1983           i      14.4MECU            19.12%               !
I        1984          |       26.4MECU            34.95%              !
!        1985           !      13.7MECU            18.16%              i
I        1986          ',       6.5MECU             8.61%              !
!        1987           !       4.1MECU             5.40%
I        1988          !        1.9MECU             2.62%              !
!        1989           !       3.8MECU             5.05%               !
!        1990*          i                                               !
!  Total                !      75.4MECU           100.00%
i                      i                                               i
I                      I                                            ___!
*  Applications for reimbursements not received May 1991
5.  Experience gained - measures for the future
    Outbreaks of classical swine fever caused by highly virulent strains
    of the virus are normally readily recognised as they produce a
    disease which    is characterised by rise        in body temperature,
    depression, loss of appetite, purulent conjunctivitis, stilted gait,
    incoordination, diarrhoea and a high mortality. During the 1980s a
    number of outbreaks have been caused by strains of low virulence,
    which produce weak or indistinct signs of disease. This type of
    virus strain spreads rather slowly through a herd and the infection
    may be present in a population for some time (weeks) before it is
    detected. Virological    and serological    testing methods are of
    paramount importance for the confirmation of such infections.
    The use of rapid serological testing methods (EL ISA-test), however,
    have been faced with problems in herds which recently have changed
    from having a vaccination status to a non-vaccination status as
    detected antibodies can be caused by a field virus or a vaccine
    antigen. Verification of the result requires additional laboratory
    tests, unless misinterpretation can be ruled out by individual pig
    identification and vaccination records.
 ---pagebreak---                                  - 11 -
The repeated epidemics in some Member States can             be related to the
dense population of pigs in the affected areas and it seems likely
that the introduction of virus strain of low virulence              into densely
populated areas will create major eradication problems;             particularly
if large numbers of animals are being moved between herds.
The occurrence of classical        swine   fever    in European wild      boar  as
recently  reported    from   the areas of Hessen, Germany          and   Tuscany,
Italy has added new dimensions to the disease situation; and this
represents a    permanent source of       infection that will remain within
the borders of the Community        for some time.      The   importance of the
infected  wild   boar   as a source of        infection of    domestic    pigs  is
difficult to assess, but it is evident that special attention must be
given to this matter in the future.
Measures for thg future
On balance, the Commission       is of the opinion that         the eradication
programmes have been well designed and by and large well             implemented.
At  this moment    in time, however,        it appears    appropriate     to draw
attention   to certain     topics which      in the    future   deserve    special
attention due to the nature of the disease and the completion of the
single market.
1. The   non-vaccination       policy     should     continue.    If    emergency
   vaccination    is carried    out    live   animals   should   remain     in the
   vaccinal   zone.   Meat, subject     to appropriate heat-treatment, can
   leave the zone.
 ---pagebreak---                               - 12 -
  2. Measures for the control of classical swine fever in the European
     wild boar should be established.
  3. The diagnostic methods for the confirmation of classical swine
     fever have been improved in recent years. These improved methods
     should be available and used in all Member States.
  4. All Member States should have contingency plans to ensure rapid
     implementation of adopted legislation on control and eradication
     measures.
  5. The adoption of Council Decision 90/424/EEC of 26 June 1990 on
     expenditure   in the veterinary field provides for Community
     financial aid, in the event of the occurrence of classical swine
     fever, within the framework of this decision; thus classical
     swine fever will be treated from a financial point of view like a
     number of the other economically important diseases listed in
     Article 3 of the said Decision.
I Conditions for trade
  The status "officially swine fever free" and "swine fever free".
  With the aim of dismantling trade barriers prior to the total
  eradication of classical swine fever from the Community, since 1980
  it has been possible for geographical regions to obtain status as
  "officially swine fever free" or as "swine fever free". The
  conditions for obtaining the officially swine fever free status
  include :
  - no detection of swine fever for at least 12 months,
  - no vaccination against swine fever had been authorized for at
     least 12 months,
  - holdings do not contain pigs which have been vaccinated against
     swine fever within the last 12 months
  while the condition for obtaining a "swine fever free status" is no
  detection of swine fever for at least 12 months.
 ---pagebreak---                                        - 13 -
 In principle a Member State can at any time within its territory have
three different types of regions e.g. "officially swine fever free",
"swine fever free" and no status regions.                Where an outbreak occurs
 in an "officially swine fever free" or "swine fever free" region the
status shall     immediately be suspended by the Member State concerned
 in  accordance      with    the     provisions     of    Directive 64/432/EEC     or
72/461/EEC.     Depending on the evolution of the disease the status may
be reinstated or withdrawn.
 In general live animals, fresh pigmeat and pigmeat products can move
freely   between    regions/Member       States having      the same status.      The
system set up for trade has by and large worked satisfactorily, but
 it has been criticized on a number of occasions for not providing
sufficient     protection     to Member      States, which      have  obtained    the
officially swine fever free status for a                 large number of regions,
but not the whole territory.
When   applying     the   regional      approach    to   disease   eradication    and
control    it   is appropriate        to   impose    the   measures  on   the   areas
directly affected.       The present system does not follow this approach
 in full as the status of regions is fixed prior to outbreaks;                 thus a
pig holding situated        100km away from an outbreak may            lose trading
opportunities, while this may not be the case for a holding situated
in a neighbouring region only 15km away from an infected holding.
Measures for the future
The principle of régionalisation should apply in respect of classical
swine fever as it applies for foot-and-mouth disease.                  In the event
of an outbreak a protection and surveillance zone should immediately
be established around the outbreak.              This will ensure an       immediate
ban on   the movement      of     live pigs and      fresh meat out of       an area
                                2
covering    at   least   300km .      Should   an   epidemic    develop  additional
protection     measures    can     be    introduced     in   accordance   with    the
provisions of Council Directive 90/425/EEC concerning the veterinary
and   zootechnical      checks     applicable     to   intra-Community     trade   in
certain   live animals and products with a view to the completion of
the internal market.
 ---pagebreak---                                 - 14 -
III RELATIONSHIP BETWEEN DISEASE ERADICATION AND CONDITIONS FOR TRADE
    The strategy to eradicate classical swine fever has been reasonably
    successful as 8 out of 12 Member States now fulfil the conditions for
    being recognized as officially swine fever free Member States and 4
    Member States have large areas which at a regional level comply with
    the conditions for recognition as officially swine fever free.
    Certain Member States have encountered difficulties during periods
    following the cessation of vaccination.
    The elimination of classical swine fever from the Community before
    1993 is not likely. But free movement of pigs and their products
    without spread of disease can be established provided restrictions
    are placed on holdings and areas directly affected by the disease.
    The following proposals, annexed to this report :
    a) Draft Proposal    for a Council     Directive amending Directive
       80/217/EEC introducing Community    measures for the control of
       classical swine fever
    b) Draft   Proposal   for a Council     Decision  amending  Directive
       80/1095/EEC and Decision 80/1096/EEC as regards certain measures
       relating to classical swine fever
    c) Draft Proposal    for a Council Directive amending Directives
       64/432/EEC, 72/461/EEC and 80/215/EEC as regards certain measures
       relating to classical swine fever
    d) Draft Proposal    for a Council Directive amending Directive
       72/462/EEC on health and veterinary problems upon importation of
       bovine animals and swine and fresh meat or meat products from
       third countries
    have been drawn up for this purpose.
 ---pagebreak---                                               - 15 -
                                                         ANNEX
               Number of outbreaks of Classical Swine Fever In Member States 1980-1990
    Country        1980    1981    1982    1983    1984    1985    1986    1987    1988  1989 1990
Belgium               7      37     102      26       9      67      80      83        2    8  113
Denmark               0       0       0       0       0        0      0       0        0    0    0
France               19       6       8      13      17        2     20       5      15     0    4
Germany              18       4      19     535    1041     351      46      41        3   64  118
Greece                       20       4       2       3        1      0       0        0    0    0
Spain                40      84      24       7       1        1      0       0        0    0    0
Ireland               0       0       0       0       0        0      0       0        0    0    0
Italy                 0       5      34      48      13      25      28      13      12    11   15
Luxembourg            0       8       1       1       0        0      0       1       0     0    0
Netherlands           0      11      65     161     176      36       1       1       0     0    2
Portugal                    171      43      16       9        3      0       0       0     0   .0
United Kingdom        0       0       0       0       0        0     10       1       0     0    0
Total                84     346     300     809    1271     486     185     145      32    83  252
 ---pagebreak--- ANNEX 2
        o
         i
 ---pagebreak---                                                          Annex 3
                       C-S-F-EUR12
                    ORIGINS OF DISEASE!
                          1990
                                              87
                                                                 01.UNK-cont.
                                                                 02UNK_ FIN
                                                                 03.WASTE FOOD
                                                                 04. MARKET
                 48                                              05.Neighb. C.
                                                                 06. Purchase
 38
                                                                 08.Transport
                                                                 09.Human spr
                                                                 lO.Fomite spr
     20                                   23
                                                                 13. Latent
                             12                                  88. Other
'01 '02 '03 '04 '05         '06      '08 '09 '10 '13 '88
 ---pagebreak---                                         - 18 -
                                                             ANNEX 4
                 The use of diagnostic methods for confirmation of
                           Classical Swine Fever, 1988 - 1990
   Codes for notification (82/894/EEC Disease notification)
   DIAGNOSTIC METHODS
   Direct immunofluorescence                                         0:1
   Virus isolation                                                   0:2
   Plaque reduction                                                  0:3
   Neutralization test (Ni)                                          0:4
   Virus neutralization and Immunofluorescence test (NIFT)           0:5
   CI in i caI d i agnosis on I y                                    0:6
             TIME-INTERVAL UNDER REPORT: FROM 1/1-1988 TO 31/12-1990
                                    DISEASE:   10 CSF
                1                                                          I    1
                  Country                      01     02   03    04    05    06
                  Germany                     138     12               21     9
                  France                       16                        1
                   Italy                       28      8                      2
                  Netherlands                          1
                  Be 1g i urn                  82     37                      2
                  Luxembourg
                  United Kingdom
                   Ireland
                  Denmark
                  Greece
                  Spain
                  Portugal
                  TOTALS                     264      58               22    13
*)
 ---pagebreak---                                   - 19 -
                               Proposal for a
                             COUNCIL DIRECTIVE
                 amending Directive 80/217/EEC introducing
       Community measures for the control of classical swine fever
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
and in particular Article 43 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament,
Having regard to the opinion of the Economic and Social Committee,
Whereas Council Directive 80/217/EEC^ 1 ), as last amended by Directive
87/486/EEC^ 2 ^,  introduced Community measures for the control of
classical swine fever;
Whereas during the period covered by Directive     80/217/EEC the disease
has, thanks to the measures adopted to combat it,  been eradicated in most
Member States; whereas, however, certain serious    difficulties have been
experienced in eradicating the disease in areas    with a high density of
pigs and in areas containing wild boar;
Whereas, in view of the disease evolution, the availability of improved
diagnostic methods and of the completion of the internal market for
1 January 1993, it is necessary to amend the control measures already
taken at Community level to control classical swine fever;
Whereas these amendments are related to cleaning and disinfection of
infected farms, disease in wild boar, the use of crisis units, movement
controls in protection and surveillance zones, emergency vaccination and
diagnostic procedures,
(1) OJ No L 47, 21.02.1980, p. 11.
(2) OJ No L 280, 03.10.1987, p. 21.
 ---pagebreak---                                    - 20 -
HAS ADOPTED THIS DIRECTIVE:
                                 Article 1
Directive 80/217/EEC is hereby amended as follows:
1.  Article 2 is replaced by the following:
                                 "Article 2
    For the purposes of this Directive the following definitions shall
    apply:
    (a) "pig": any animal of the family suidae;
    (b) "breeding pig": a pig intended or used for reproduction with a
        view to multiplication of the species;
    (c) "fattening pig": a pig fattened and intended for slaughter at the
        end of the fattening period with a view to meat production;
    (d) "slaughter pig": a pig which is intended for slaughter without
        undue delay in a slaughterhouse;
    (e) "feral pig": a pig which is not kept or bred in a holding;
    (f) "holding": any establishment (agricultural or other) situated in
        the territory of a Member State, in which pigs are kept or bred;
    (g) "pig suspected of being infected with classical swine fever": any
        pig exhibiting clinical symptoms or showing post-mortem lesions
        or reactions to laboratory tests carried out according to
        Article 11, indicating the possible presence of classical swine
        fever ;
    (h) "pig infected with classical swine fever": any pig
             in which clinical symptoms or post-mortem         lesions of
             classical swine fever have been officially confirmed, or
             in which the presence of this disease has been officially
             confirmed as the result of a laboratory examination carried
             out in accordance with Article 11;
    (i) "owner or keeper": any person or persons, either natural or
         legal, having ownership of the pigs, or charged with keeping the
        said animals, whether or not for financial reward;
 ---pagebreak---                                   - 21 -
   (k) "competent authority": veterinary authority appointed for the
       purpose by the national administration for the Member State
       concerned,    being   directly    responsible   to   the    national
       administration within the scope of this Directive, and reporting
       through the national administration;
   (I) "official veterinarian": the veterinarian        appointed   by  the
       competent authority of the Member State;
   (m) "rendering": the processing of high-risk material in accordance
       with    the provisions as      laid down     in Council    Directive
       90/667/EEC*;
   (n) "swill": wast from kitchens, restaurants or, as the case may be,
       from industries using meat.
       *0J No L 363, 27.12.1990, p. 51."
2. In Article 5
   (a) the following is added to the seventh indent of paragraph 1:
       "The reintroduction of pigs shall start with the introduction of
       sentinel piglets, which have been checked and found negative for
       the presence of antibodies against classical swine fever virus.
       The sentinel piglets shall be placed in accordance with the
       requirements of the competent authority throughout the infected
       holding and be rechecked after 21 and 42 days after placing on
       the holding for the presence of antibodies.
       If none of the piglets has developed antibodies against classical
       swine fever virus and as soon as the results of the second test
       are available, with a negative result, full repopulation may take
       pI ace."
   (b) paragraph 2 is replaced by the following:
       "2. The competent authority may apply the measures provided for
            in paragraph 1 to other holdings where pigs may have become
            infected as a result of their location and direct or indirect
            contact with the infected holding."
3. The following Article 6a is inserted:
 ---pagebreak---                              - 22 -
                          "ARTICLE 6a
1. Immediately after the competent authority has information that
   feral pigs are suspected of being infected, it shall take all
   appropriate measures to confirm the presence of the disease, by
   giving information to the owners or keepers of pigs and the
   hunters, and by investigation of all feral pigs, shot or found
   dead, including laboratory testing.
2. As soon as confirmation of infection in feral pigs has taken
   place, the competent     authority of a Member State shall
   immediately place under official surveillance holdings in the
   defined infected area and shall in particular order that:
   (a) an official census shall be made of all categories of pigs on
       all holdings; the census must be kept up to date by the owner
       or keeper; the information in the census must be produced on
       request and may be checked at each inspection;
   (b) all pigs on the holding be kept in their living quarters or
       some other place where they can be isolated from feral pigs.
       The feral pigs must not have access to any material which may
       subsequently come in contact with the pigs on the holding;
   (c) no pigs shall enter or leave the holdings;
   (d) appropriate means of disinfection be used at the entrances
       and exits of buildings housing pigs and of the holding
        itself;
   (e) all dead or diseased pigs on a holding s:.all be tested for
       the presence of classical swine fever;
   (f) no part of any feral pig (shot or found dead) shall enter a
       ho Id i ng;
   (g) persons engaged in hunting feral pigs shall not enter a pig
       ho Id i ng.
3. Without prejudice to the measures laid down in paragraph 2 Member
   States shall present as soon as possible a written plan to the
   Commission about the measures taken to eradicate the disease in a
   defined infected area and the measures applied to the holdings
   situated in the said area.
 ---pagebreak---                               - 23 -
   The Commission shall examine the plan in order to determine
   whether it permits the desired objective to be attained and shall
   approve the plan, if necessary with amendments, in accordance
   with the procedure laid down in Article 16.
   The plan may subsequently be amended or supplemented,           in
   accordance with the same procedure, to take account            of
   developments in the situation.
4. After approval has been given for the measures provided for in
   the plan, those measures shall replace the initial measures
   referred to in paragraph 2, on a date which shall be decided upon
   in the course of giving approval.
5. The plan mentioned in paragraph 3 shall contain information on:
   (a) a defined infected area within the territory of the Member
       State referred to in paragraph 2. When defining the infected
       area the competent authority shall take into account:
       (i)    the geographical distribution of the disease,
       (ii) the feral pig population in the area,
       (iii) the availability of natural and man-made borders of
              importance for movements of feral pigs.
   (b) the approximate number of groups of feral pigs and their size
        in the defined area;
   (c) specific efforts made to determine the extent of the
        infection in the feral pig population, by investigation of
       feral pigs shot by hunters or found dead, and by laboratory
       test ing;
   (d) the organization of close cooperation between biologists,
       hunters, hunting organizations, the wild life services and
       veterinary services (animal health and public health);
   (e) the reduction of the feral pig population, and the licensing
       of hunting; the period decided to be used for reduction of
       the feral pig population shall consist of an Initial
       eradication period to be followed by a surveillance period;
 ---pagebreak---                                   - 24 -
       (f) the method of removal of feral pigs, found dead or shot. In
            the first phase (eradication period) the removal shall be
            based on destruction under supervision of the competent
            authority. In the second phase (surveillance period) the
            removal shall be in accordance with the requirements laid
            down by the competent authority;
       (g) the epizootiolog lea I enquiry which is carried out on each
            feral pig (shot or found dead). This enquiry must include the
            completion of a questionnaire which supplies information
            about :
            - the geographical area where the animal was found dead or
              shot,
            - the date when the animal was found (dead or shot),
            - the person who found or shot the animal,
            - the age and sex of the pig,
            - if shot: symptoms before shooting,
            - if found dead: the state of the carcase,
            - laboratory findings;
       (h) disease preventive measures applicable to the holdings
            situated   in the defined     infected area, including the
            transport and movement of animals within, from and to the
            area*,
       (i) the criteria to be applied for lifting the measures taken to
            eradicate the disease in the defined area and the measures
            applied to holdings in the area."
4. The following Article 7a is inserted:
                               "Article 7a
   In order to provide full coordination of all measures necessary to
   ensure eradication of classical swine fever as quickly as possible
   and for the purpose of carrying out the epizootiological enquiry, a
   crisis unit shall be established.
   The general rules concerning national crisis units and Community
   crisis unit are laid down by EEC Council Regulation ../.../EEC*.
   *0J No L
 ---pagebreak---                                   - 25 -
5. In Article 8 the second sentence of paragraph 2 is replaced by the
   fol lowing:
        "in the event an authorization Is given to remove pigs for
        slaughter the competent authority concerned shall ensure that the
        conditions for removal and slaughtering of pigs fulfil the
        requirements laid down in Article 9(4)(f)(i) and the meat derived
        from the said pigs shall comply with the conditions laid down in
        Article 9(4)(g). M
6. Article 9 is replaced by the following:
                                "Article 9
   1.   Immediately after the diagnosis of classical swine fever has been
        officially confirmed in pigs on a holding, the competent
        authorities shall establish a protection zone with a radius of at
        least 3 kilometres around the outbreak site, which is itself
        included in a surveillance zone of a radius of at least 10
        kiIometres.
   2.   The competent authority must during the establishment of zones
        take account of:
        (a) the results of the epidemiological studies carried out in
            accordance with Article 7;
        (b) the available serological evidence;
        (c) the geographical situation particularly natural boundaries;
        (d) the location and proximity of holdings;
        (e) patterns of trade in growing and slaughter pigs and the
            availability of slaughterhouses;
        (f) the facilities for control and the nature of the control
            measures employed, particularly whether or not slaughter is
            carried out on the infected premises.
   3.   In the case that a zone or zones include parts of the territory
        of several Member States, the competent authorities of the Member
        States concerned shall collaborate to establish the zones.
   4.   The following measures shall be applied in the protection zone:
 ---pagebreak---                              - 26 -
   (a) a census of all the holdings shall be made as soon as
       possible; after the establishment of the protection zone
       these holdings shall be visited by an official veterinarian
       within at least 7 days;
   (b) the movement and transport of pigs on public or private
       roads, excluding the service roads of holdings, shall be
       prohibited. This prohibition shall not apply to the transit
       of pigs by motorway or rail without unloading or stopping-,
   (c) trucks and other vehicles   and equipment, which are involved
       in the transport of pigs,  or other livestock and in material
       which may be contaminated  (eg. feedingstuff, manure, slurry,
       etc.) and which are used   within the protection zone, shall
       not leave:
       (i)   a holding situated within the protection zone,
       (ii) the protection zone,
       (iii) a slaughterhouse,
       without having been cleaned and disinfected in accordance
       with the procedures laid down by the competent authority. The
       procedures shall include that no truck or vehicle, which has
       been involved in the transport of pigs, can leave the zone
       without being inspected by the competent authority;
   (d) no other species of animals may enter or leave a holding
       without the authorization of the competent authority;
   (e) all dead or sick pigs on a holding shall be reported to the
       competent authority, who shall carry out any investigations
       necessary to establish the presence of classical swine fever;
   (f) pigs may not be removed from a holding in which they are kept
       until 21 days after the completion of preliminary cleaning
       and disinfecting measures as laid down in Article 10; after
       21 days authorization may be given to remove pigs from the
       said holding:
       (i)   directly to a slaughterhouse, designated by the
             competent authority, preferably within the protection
             or surveillance zone, under the following conditions:
5)
 ---pagebreak---                              - 27 -
          - an inspection of all the pigs on the holding has been
             carried out;
          - a clinical examination of the pigs to be moved for
             slaughter,      including   the  taking   of   the  body
             temperature of a proportion thereof, has been carried
             out;
          - each pig has been marked by ear marking;
          - the pigs are transported in vehicles which are
             sealed by the competent authority.
          The      competent     authority   responsible     for  the
          slaughterhouse shall be informed of the intention to
          send pigs to it.
          On arrival at the slaughterhouse these pigs shall        be
          kept and slaughtered separately from other pigs.        The
          vehicle and equipment which have been involved in       the
          transport of pigs shall immediately be cleaned          and
          disinfected.
          During ante and post mortem inspection carried out at
          the designated slaughterhouse, the competent authority
          shall take into account the possible signs relating to
          the presence of the classical swine fever virus
           infection.
    (ii)  under exceptional circumstances directly to other
          premises located within the protection zone under the
          following conditions:
          - an inspection of all the pigs on the holding has been
             carrled out;
          - a clinical examination of the pigs to be moved,
             including the taking of the body temperature of a
             proportion thereof, has been carried out;
          - each pig has been marked by ear marking.
(g) Fresh meat derived from pigs, referred to in paragraph 4(f)
    shall be given the mark as described in the Annex of Council
    Directive 72/461/EEC of 12 December 1972, on health problems
    affecting     intra-Community     trade  in fresh     meat*,  and
    subsequently treated in accordance with rules laid down in
 ---pagebreak---                               - 28 -
       Article 4(1) of Council Directive 80/215/EEC of 22 January
       1980 on animal health problems affecting intra-Community
       trade in meat products**. This shall be done at an
       establishment designated by the competent authority.
       The meat shall be sent to the said establishment under the
       condition that the consignment is sealed during transport.
5. The measures in the protection zone shall be maintained at least
   until
   (a) all measures laid down in Article 10 have been carried out,
   (b) pigs on all holdings have undergone
       (i)    a clinical examination and have been found to have no
              signs of illness suggesting classical swine fever, and
       (ii)   a serological examination in accordance with the
              provisions of Annex I and IV without the detection of
              antibodies to classical swine fever virus.
   The examination referred to in (i) and (ii) shall not take place
   before 30 days have elapsed after the completion of preliminary
   cleaning and disinfection measures on the infected holding.
6. The following measures shall be applied in the surveillance zone:
   (a) a census shall be taken of all pig holdings;
   (b) the movement  and transport of pigs on public roads, excluding
       the service   roads of holdings shall be prohibited, unless
        licensed by  the competent authority. This prohibition shall
       not apply to  the transit of pigs by motorway or rail, without
       unloading or  stopping;
   (c) trucks and other vehicles and equipment, which are involved
       in the transport of pigs, or other livestock and in material
       which may be contaminated (eg. feedingstuff, manure, slurry,
       etc.) and which are used within the surveillance zone shall
       not leave the zone without having been cleaned or disinfected
       in accordance with the requirements of the competent
       authority;
 ---pagebreak---                              - 29 -
(d) no other species of animals may enter or leave a holding
    during the first 7 days after the establishment of the zone
    without the authorization of the competent authority;
(e) all dead pigs on a holding shall be reported to the competent
    authorities who shall carry out any investigations necessary
    to establish the presence of classical swine fever-,
(f) pigs may not be removed from a holding on which they are kept
    until 7 days after the completion of preliminary cleaning and
    disinfection measures as laid down in Article 10; after 7
    days authorization may be given to remove pigs from the said
    ho Id i ng:
    (i)     directly to a slaughterhouse, designated by the
            competent authority, preferably within the protection
            or surveillance zone, under the following conditions:
            - an inspection of all the pigs on the holding has been
              carried out;
            - a clinical examination of the pigs to be moved for
              slaughter,     including   the taking     of the body
              temperature of a proportion thereof, has been carried
              out;
            - each pig has been marked by ear marking;
            - the pigs are transported in vehicles which are sealed
              by the competent authority.
            The    competent     authority    responsible  for   the
            slaughterhouse shall be informed of the intention to
            send pigs to it.
            On arrival at the slaughterhouse these pigs shall be
            kept and slaughtered separately from other pigs.
            During ante and post mortem inspection carried out at
            the designated slaughterhouse, the competent authority
            shall take into account the possible signs relating to
            the presence of the classical swine fever infection.
    (ii)    under exceptional circumstances directly to another
            premises    located within     the protection zone or
            surveillance zone under the following conditions:
 ---pagebreak---                               - 30 -
              - an inspection of all the pigs on the holding has been
                 carried out;
              - a clinical examination of the pigs to be moved,
                 including the taking of the body temperature of a
                 proportion thereof, has been carried out;
              - each pig has been marked by ear marking.
              Trucks and other vehicles and equipment, which are
               involved in the transport of these pigs, shall be
              cleaned and disinfected after each transport.
   (g) Fresh meat derived from pigs, referred to in paragraph 6(f)
        shall be given the mark as described in the Annex of
        Directive 72/461/EEC, and subsequently treated in accordance
        with rules laid down in Article 4(1) of Directive 80/215/EEC.
        This shall be done at an establishment designated by the
        competent authority.
        The meat shall be sent to the said establishment under the
        condition that the consignment is sealed during transport.
7. The measures     in the surveillance zone shall be maintained at
    least untiI
   (a) all measures laid down in Article 10 have been carried out,
   (b) pigs on all holdings have undergone
        (i)   a clinical examination and have been found to have no
              signs of illness suggesting classical swine fever, and
        (ii)  a serological examination in accordance with the
              provisions of Annex I and IV without the detection of
              antibodies to classical swine fever virus infection.
   The examination referred to In (i) and (ii) shall not take place
   before 15 days have elapsed after the completion of preliminary
   cleaning and disinfection measures on the infected holding.
8. By derogation from the provisions in paragraph 4(f) and  6(f), the
   competent authority may authorize that pigs are moved     out from
   the holding to be transported to a rendering plant for   rendering
   or to a place where the pigs are killed in order to be   burned or
 ---pagebreak---                               - 31 -
    buried. These animals shall be tested at random for the presence
    of the classical swine fever virus and the criteria for
    collecting blood samples given in Annex IV shall be taken into
    account during the random testing.
    All necessary precautions shall be taken to avoid the risk of
    spread of the virus by this transport, such as cleaning and
    disinfecting of the truck after the transport.
9.  Where the prohibitions provided for in paragraph 4(f) and 6(f)
    are maintained beyond 30 days because of the occurrence of
    further cases of disease and as a result problems arise in
    keeping the pigs, the competent authority may, following an
    application by the owner explaining the grounds for such
    application, authorize removal of pigs from a holding within the
    protection zone, respectively the surveillance zone, provided
    that
    (a) the official veterinarian has verified the facts;
    (b) an inspection of all pigs on the holding has been carried
         out ;
    (c) a clinical examination of the pigs to be moved, including the
         taking of the body temperature of a proportion thereof, has
         been carr ied out;
    (d) each pig has been marked by ear marking;
    (e) the holding of destination is located in the protection zone
         or within the surveillance zone.
    All necessary precautions shall be taken to avoid the risk of
    spread of the virus by this transport, such as cleaning and
    disinfecting the truck after the transport.
10. The competent authority shall take all necessary measures,
    including the use of prominent signposts and warning notices and
    use of media resources such as the press and television to ensure
 ---pagebreak---                                  - 32 -
       that all persons in the protection and surveillance zones are
       fully aware of the restrictions in force, and shall take such
       measures as may be considered appropriate to ensure the adequate
       enforcement of these measures.
        *0J No L 302, 31.12.1972, p. 24.
       **0J No L 47, 21.2.1980, p. 4."
7. Article 10 is replaced by the following:
                               "Article 10
   Member States shall ensure that
   (a) the disinfectants to be used and their concentrations          are
       officially approved by the competent authority-,
   (b) the cleaning and disinfection operations are carried out under
       official supervision in accordance with
       (i)   the instructions given by the official veterinarian, and
       (ii)  the procedure for cleaning and disinfecting of an infected
             holding as laid down in Annex V."
8. The following Article 10a is inserted:
                              "Article 10a
   In the event classical swine fever is confirmed in a slaughterhouse
   the competent authority shall ensure that:
   (a) all pigs in the slaughterhouse are slaughtered without delay;
   (b) the carcases and offals of infected and contaminated pigs are
       destroyed under official supervision in such a way as to avoid
       the risk of classical swine fever virus spreading-,
   (c) cleaning and disinfection of buildings and equipment including
       vehicles take place under the supervision of the official
       veterinarian in accordance with instructions laid down by the
       competent authority;
 ---pagebreak---                                  - 33 -
   (d) an epidemiological enquiry is carried out in accordance with the
       provisions of Article 7;
   (e) the re introduction of pigs for slaughter does not take place
       until at least 24 hours after completion of the cleaning and
       disinfection operations carried out in accordance with (c)."
9. Article 14 is replaced by the following:
                               "Article 14
   1.  Member States shall ensure that:
       (a) the use of classical swine fever vaccines is prohibited;
       (b) the manipulation of classical swine fever virus for research,
           diagnosis and/or manufacture of vaccines shall be carried out
           only in approved establishments and laboratories;
       (c) the storage, supply, distribution and sale of classical swine
           fever vaccines on the territory of the Community are carried
           out under official control.
   2.  Notwithstanding the provisions of paragraph 1 concerning the use
       of classical swine fever vaccine, it may be decided, when
       classical swine fever has been confirmed and is tending to spread
       alarmingly, that emergency vaccination may be introduced. In this
       case the Member State concerned sha11 submit to the Commission an
       emergency vaccination plan which shall include information on-.
       (a) the disease situation which has resulted    in the demand for
           the emergency vaccination,
       (b) the extent of the geographical      area  in which   emergency
           vaccination is to be carried out,
       (c) categories of pigs and approximate     number  of pigs  to be
           vaccinated,
       (d) the vaccine to be used,
 ---pagebreak---                                   - 34 -
        (e) the duration of the vaccination campaign,
        (f) the identification    and  registration   of  the    vaccinated
            animals,
        (g) measures for the movement of pigs and their products,
        (h) other matters appropriate to the emergency situation.
        The   Commission   shall   immediately   examine   the    plan   in
        collaboration with the Member State concerned. In accordance with
        the procedures laid down in Article 16 the emergency vaccination
        plan may be approved or amendments and additions may be requested
        before approval is given.
    3.  In the event of emergency vaccination a Member         State  which
        practices emergency vaccination shall ensure that:
            no live pigs leave the vaccination area except for immediate
            slaughter in a slaughterhouse designated by the competent
            authority and situated within the vaccination area or close
            to this area-,
            all fresh pig meat produced from pigs vaccinated during the
            emergency vaccination shall bear the stamp provided for in
            Article 5a of Directive 72/461/EEC and be stored and
            transported separately from meat not having the said stamp.
    4.  The provisions of paragraph 3 shall apply during the emergency
        vaccination period and for a minimum of 12 months following
        completion of the vaccination operations in the affected area.
    5.  If necessary, the Commission shall adopt rules relating to the
        production, packaging, distribution and state of the stocks of
        anti classical swine fever vaccines in the Community."
10. Article 14a is replaced by the following:
 ---pagebreak---                                   - 35 -
                               "Article 14a
    Veterinary experts from the Commission may, in collaboration with the
    authorities of the Member State concerned, in so far as is necessary
    to ensure uniform application of this Directive, make on-the-spot
    checks; the Commission shall inform the Member States of the results
    of the investigation.
    A Member State in whose territory a check is being carried out shall
    give all the necessary assistance to the experts in carrying out
    their duties.
    The general provisions for implementing this Article shall be
    determined in accordance with the procedure laid down in Article 16."
11. Annex I is replaced by the following:
 ---pagebreak---                                   - 36 -
                                 "ANNEX \
                DIAGNOSTIC PROCEDURES FOR THE CONFIRMATION
            OF DIFFERENTIAL DIAGNOSIS OF CLASSICAL SWINE FEVER
The following guidelines, standards and minimum criteria are laid down
for the diagnostic procedures of Classical Swine Fever (CSF).
A.  COLLECTION OF MATERIALS FOR DIAGNOSIS
    1.  For virus isolation and antigen detection, tonsil and spleen
        tissues are considered essential. Preferably at least two other
        lymphatic    tissues   should   be   collected,    such   as   the
        retropharyngeal, parotid, mandibular or mesenteric lymph nodes
        together with ileum or kidney. Each sample of the tissue should
        be placed in a separate sealed plastic bag and labelled. The
        samples should be transported and stored            in  leak-proof
        containers. They should not be frozen but kept cool at
        refrigerator temperature and tested without delay.
    2.  Blood samples for virus isolation from leucocytes should be
        collected from pigs showing signs of fever or other signs of
        disease. EDTA or heparin should be used as anticoagulants. The
        samples must be kept cool at refrigerator temperature and
        submitted to laboratory testing without delay.
    3.  Blood samples for the detection of antibody as an aid to
        diagnosis of clinical outbreaks and for the purposes of
        surveillance, should be taken from animals which have recovered
        from suspect infection and from pigs known to have been in
        contact with infected or suspect cases. In such suspect holdings
        all of the first 20 suspect or in-contact animals, and 25% of any
        additional animals, should be sampled. In order to ensure a high
        probability of detection of antibody, samples should be collected
        from each unit of the holding at this level.
 ---pagebreak---                                   - 37 -
B. THE LABORATORY DIAGNOSIS OF CLASSICAL SWINE FEVER
   The principal basis for the laboratory diagnosis of CSF shall be the
   demonstration of viral antigen, virus or antibodies in organs or
   tissue fluids.
   In the case of inconclusive results, the tests shall be repeated on
   the same samples. Additional samples should be collected from the
   same source if clinical suspicion continues.
   Serological tests for the detection of antibodies may be used as an
   adjunct to diagnosis in cases of suspect CSF. If the demonstration
   of viral antigen or virus isolation has not been successful on
   material derived from animals giving rise to suspicion of CSF or with
   material from holdings which have had contact with cases of CSF, then
   tests for the detection of antibody shall be applied to blood samples
   of animals which have recovered from the suspect disease and from
   those known to have been in contact with the disease.
   1.  Demonstration of viral antigen
       For the demonstration of viral antigen in organ tissues, a direct
        immune labelling system should be used on thin cryostat sections
       (up to five microns) of tonsils and tissues of other organs as
       specified in A (1). The diagnostic reagent must be a pestivirus-
       specific polyclonal antiserum to CSF virus, labelled with a
       fluorochrome, an enzyme, or biotin, according to the following
       criter ia:
       (a) hyperimmune serum shall be prepared from pigs free from
             infections or antibody which could affect the specificity or
            quality of the reaction;
       (b) labelled immunoglobulin prepared from CSF hyperimmune pig
            serum as specified under (a) shall have a minimum working
            titre of 1/20 as determined in CSF virus infected cell
            cultures and confirmed by check tests on tissue sections.
            The working dilution of the conjugate shall combine a maximum
            of signal with a minimum of background staining;
       Any sample showing specific cytoplasmic reaction shall be
       considered positive for pestivirus. In such cases further tests
       must be carried out as described in B(3).
 ---pagebreak---                              - 38 -
2. Virus isolation and identification in cell cultures
   (a) Virus    isolation from tissue samples        is performed on
       susceptible cell     cultures of PK15 or other            equally
       susceptible cell lines. Organ suspension from a suspected
       animal should be inoculated at a dilution of 1/10.
   (b) Virus isolation from blood samples, collected and handled as
        indicated in paragraph A(2), is performed by the inoculation
       of cell cultures with buffy coat suspension reconstituted to
       the original blood volume.
   (c) For detection of viral antigen in the cytoplasm of Inoculated
       monolayers, ceil cultures shall be treated with labelled
       polyclonal antiserum. The staining should be applied at
        intervals from 24 to 72 hours from the time of inoculation.
   (d) Positive    cultures  should   be subject       to   differential
       diagnostic tests as specified in B(3). Negative results
       after the first cell culture passage may require second or
       even more passages in order to isolate virus.
3. Monoclonal antibody typing of pestivirus isolates
   (a) Duplicates of tissue cryostat sections or cell cultures which
       give positive reactions with polyclonal            antiserum as
       described in B(1) and (2) shall be further examined by
        labelled monoclonal antibodies to differentiate between CSF
       virus and bovine virus diarrhoea (BVD)/border disease (BD)
       viruses.
   (b) Only monoclonal s which have been officially recommended by
       the EC Reference Laboratory for Classical Swine Fever,
       following extensive characterization, should be used.
   (c) The monoclonal s should be grouped into four panels according
       to the following criteria:
              Panel number               Reactivity
                1                   All  pest iviruses
                2                   All  CSF viruses
                3                   CSF  vaccine strains
                4                   AI I BVD/BD viruses
 ---pagebreak---                                   - 39 -
            Each panel may be represented either by a single monoclonal
            or by a mixture of the component monoclonal antibodies,
            provided that the spectrum of reactivity corresponds to that
            given above.
        (d) The interpretation of the reaction patterns is summarised as
            fol lows:
                Panel
              12 3 4        Interpretation
              +  +          CSF confirmed
              +  + + -      CSF vaccine strain
              +       +     BVD/BD virus
              +          )
              +  + - +   )  Virus unclassified,
              +  + + +   )  further tests
                         )  required
C. DETECTION OF ANTIBODY TO CLASSICAL SWINE FEVER VIRUS
   The detection of CSF virus antibody in blood samples is carried out
   to assist in the diagnosis of swine fever in holdings containing pigs
   showing clinical signs of the disease or in pigs believed to have had
   contact with infected pigs. It may also be carried out for the
   purposes of surveillance or for surveys in herds of unknown status.
   For these purposes, blood samples should be subjected to an approved
   test.
   The following tests are approved for use and must be carried out with
   the inclusion of appropriate positive and negative serum controls.
   The virus strains to be used for serological tests should be agreed
   at a meeting of the National Swine Fever Laboratories (NSFL), and
   issued as required by the EC Reference Laboratory for Classical Swine
   Fever to the NSFL, upon request.
   All test procedures used must be shown to give satisfactory results
   with CSF reference sera supplied by the EC Reference Laboratory for
   Classical Swine Fever.
 ---pagebreak---                              - 40 -
1. The virus neutralization test
   This test is based on the determination of the 50% endpoint.
   Cultures are inoculated with mixtures of diluted serum and a
   constant amount of virus after a specified incubation period at
   37*C. The results are based on the absence of any viral
   replication detectable by an immune labelling system. Either
   neutralization-immunofluorescence   (NIF) or    the neutralizing
   peroxidase-1 inked antibody (NPLA) assays may be used. Detailed
   protocols will be supplied by the EC Reference Laboratory for CSF
   as required.
   For screening purposes the sera are initially diluted 1/10. When
   a full titration is necessary two-fold dilutions of serum
   starting at 1/10 are prepared. Each dilution is mixed with an
   equal volume of virus suspension containing 100 (+/- 0.5 log 10 )
   infectious doses (TCID 50). At least two cultures are used at
   each dilution level. After an appropriate incubation period the
   cell cultures are fixed and viral antigen is detected by an
   immune labelling system. The results are expressed as the
   reciprocal of the initial serum dilution at which half the
   inoculated cell cultures fail to show any specific labelling. An
   end-point between two dilution levels is estimated.
2. The enzyme-1inked immunosorbent assay (ELISA)
   Competitive, blocking and indirect techniques may be used on any
   suitable support.
   It is recommended that the tests used should minimize cross-
   reactions with BVDV and other pestiviruses. However, the test
   system must ensure identification of all CSF infections, and at
   all stages of the immune response to infection.
   Ant i gen :
   The antigen should be derived from or correspond to viral
   proteins of one of the recommended CSF virus strains. Cells used
   to prepare antigen should be free of any other pestivirus
   infection.
 ---pagebreak---                                  - 41 -
       Antisera:
       Polyclonal antisera for competitive or blocking assays should be
       raised in pigs or rabbits by infection with one of the
       recommended CSF virus strains or with the lapinized C strain.
       Monoclonal antibodies should be directed against or correspond to
       an immunodominant viral protein of CSF virus. Indirect assays
       should use an anti-porcine immunoglobulin reagent that detects
       both IgG and IgM.
       The sensitivity of the EL I SA should be high enough to score
       positive any serum recating In the neutralization test, and also
       reference positive sera as issued by the EC Reference Laboratory
       for CSF.
       The EL I SA may only be used with serum or plasma samples derived
       from individual pigs.
       If the EL I SA procedure used is not CSF specific, then positive
       samples should be further examined by differential tests as
       specified in section E.
D. EVALUATION OF THE RESULTS OF LABORATORY TESTING
   1.  The demonstration of CSF virus antigen in organ tissues or cell
       cultures after virus isolation from tissue samples following the
       techniques defined in B (1), (2) and (3) shall form the basis of
       confirmation of the presence of the disease except in the case of
       a reaction demonstrated to be due to vaccinal virus specified
       according    to B (3). The demonstration of BVD/BD antigen
       according to B (3) shall rule out suspicion of CSF provided there
       are no other grounds for such suspicion. Following unusual or
       unexpected results of monoclonal typing according to B (3)
       pestivirus isolates shall be considered unclassified and the herd
       of origin regarded as suspect pending further testing. This may
       include submission of the virus to a reference laboratory for
       characterization, and serological investigations on the herd of
       origin.
   2.  Following the detection of antibody reactive with CSF virus, the
       herd of origin shall be regarded as suspect.
 ---pagebreak---                                   - 42 -
       (a) In order to rule out the suspicion of CSF raised by the
            detection of antibody, the test described in Section E below
            shall be used to distinguish between CSF-reactive antibody
            that may have been induced by other pestiviruses and such
            antibody due to CSF virus itself. All original samples shall
            be retested by the differential test.
       (b) If suspicion cannot be ruled out on the first differential
            test, a further test shall be carried out at least 30 days
             later to follow up the possible spread of infection. All of
            the first 20 animals on the suspect holding shall be sampled
            and 25% of any additional animals.
   3.  Interpretation of serological results
       A virus neutralization titre of >. 1/10 in any pig together with
       clinical or epizootiological evidence giving rise to suspicion of
       disease shall constitute a positive diagnosis. A titre of >. 1/10
       in any pig without clinical or epizootiologiaI evidence gives
       rise to suspicion of disease and should be followed by
       differential diagnostic procedures.
       The same criteria should be applied for any pig giving a positive
       EL I SA result.
E. SEROLOGICAL    PROCEDURES FOR THE DIFFERENTIAL      DIAGNOSIS  BETWEEN
   CLASSICAL SWINE FEVER AND OTHER PEST IVI RUSES
   1.  Tests for the differential diagnosis of CSF and other pestivirus
       infections are based on parallel testing of the sera with both
       CSF and BVD/BD virus strains using fully comparable methods.
       The CSF and BVD/BD virus strains for use should have been
       officially approved (see C above). To rule out the suspicion of
       CSF raised by the detection of antibody, blood samples should be
       examined by comparative end-point titrations for neutralizing
       antibody against CSF virus and BVD/BD virus.
       In blocking ELISA, a comparison of percentage blocking with CSF
       and BVD/BD antigens may be used.
   2.  The results of the comparative serological tests using reference
       strains of CSF and other pestiviruses shall be interpreted as
       foI Iows:
 ---pagebreak---                                - 43 -
     (a) if the comparative tests show that more than one pig has
         antibody to CSF virus with no antibody to other pestiviruses
         the test result is considered positive for CSF.
     (b) if the comparative tests show that the titres to CSF virus
         are equal to or higher than the titres to other pest(viruses
         in more than one of the pigs there shall be suspicion of CSF
         and differentiation shall proceed as follows:
         - those pigs which shown neutralizing titres against CSF
           virus which are higher than or equal to the titres against
           other pestiviruses shall be slaughtered. Their tissues
           and, if pregnant, their fetuses, shall be subjected to
           examination for CSF antigen or virus, following the
           procedure defined in B (1, 2 or 3 ) .
         - if CSF viral   antigen or virus   is detected, CSF shall be
           conf irmed,
         - if the examination defined in the second indent above fails
           to reveal the presence of CSF antigen or virus, the holding
           shall be considered as suspect until'a further set of blood
           samples collected at least 30 days later has been subjected
           to further comparative tests.
         - if these subsequent comparative tests show all animals to
           have significantly (four-fold or greater) higher titres
           against BVD/BD virus than against CSF virus, suspicion
           shalI be ruled out,
         - if one or more animals show a titre against CSF virus that
           is equal to or higher than its titre to BVD/BD virus, then
           the result is considered positive for CSF.
     (c) if the BVD/BD titres are such as not to exclude the
         possibility of CSF, the holding shall be considered as
         suspect and be retested after at least 30 days.
THE DIFFERENTIAL DIAGNOSIS OF AFRICAN SWINE FEVER (ASF)
ASF cannot be differentiated from Classical Swine Fever by either
clinical or post-mortem examinations and both of these diseases
should be considered in the differential diagnosis of any acute
febrile haemorrhagic syndrome of pigs.
 ---pagebreak---                                - 44 -
Laboratory tests are essential to distinguish between the two
diseases. A positive diagnosis in an ASF-free country should be
based on the isolation and identification of ASF virus.
The principal basis for the laboratory diagnosis of ASF shall be the
demonstration of virus, viral antigen or antibodies in organs and
tissue fluids.
In case of inconclusive or negative results of at least 2 tests on
samples from animals giving rise to suspicion of ASF or with material
from holdings which had contacts with cases of ASF, additional
material should be collected in the same holding and from animals
which have been in contact with the disease.
1.  Demonstration of viral antigen.
    For     the   demonstration   of   viral    antigen   the   direct
     immunofluorescence technique or other suitable techniques shall
    be applied to thin cryostat sections of organ tissues or smears,
    or on sediments from leucocyte cultures. The procedures used are
    similar to those described for CSF, except that ASF-specific
    reagents are used.
2.  Virus isolation and identification
    (a) Haemadsorption (HAD) test
         The HAD test is carried out by inoculating either prepared
         10% tissue suspensions or blood collected in the field from
         suspect pigs into primary pig leucocyte cultures or by
         preparing leucocyte cultures from the blood of febrile pigs
         inoculated at the laboratory or collected in the field.
         Haemadsorption consists of the attachment of large numbers of
         pig erythrocytes to the surface of infected cells and is
         diagnostic for ASF.
    (b) Pig inoculation
         A pool is made with aliquots of each 10% tissue suspension
         and 2ml inoculated intramuscularly into each of four pigs:
         two of these should be vaccinated against CSF and two
         unvaccinated. Pigs should be examined daily for increase of
 ---pagebreak---                                     - 45 -
             rectal temperature and onset of clinical signs for up to 21
             days. If fever develops blood samples should be collected
             for preparation of leucocyte cultures for the HAD test
             (autorosette   and   inoculation of primary    pig   leucocyte
             cultures). If no clinical signs develop blood should be
             taken   for  detection of antibodies after       the  21 day
             observation period.
    DETECTION OF ANTIBODY     INDUCED  BY  ASF-VIRUS IN BLOOD  SAMPLES  AND
    TISSUE FLUIDS
    The detection of antibody in samples of serum or tissue fluid is
    carried out to assist in the diagnosis of ASF in holdings containing
    pigs showing clinical signs suspicious of disease or in pigs believed
    to have had contact with ASF infected pigs. It may also be carried
    out for the purpose of surveillance or for surveys in herds of
    unknown status.
    For these purposes samples should be subjected to an approved test.
    The following are approved for use and must be carried out with the
    inclusion of appropriate positive and negative serum controls.
    (a) Indirect immunofluorescence ( M F ) test
    (b) EL ISA"
12. The following annexes are added after Annex III
 ---pagebreak---                                    - 46 -
                                 "ANNEX IV
           SEROLOGICAL SCREENING OF PIGS IN THE PROTECTION ZONE
        AND SURVEILLANCE ZONE FOR DETECTION OF ANTIBODIES AGAINST
                        CLASSICAL SWiNE FEVER VIRUS
The programme for serological screening shall take into account the
transmission of classical swine fever and the way pigs are kept, e.g. a
reference to whether pigs are kept in groups or not.
1•  Serological screening of pigs kept in a group
        A group is two or more pigs kept in direct contact.
        Samp Iing of groups
             if 20 or less than
            20 pigs in a group -     2 pigs. In the event the groups
                                     consists of a sow with piglet, only
                                     the sow shall be sampled;
             if more than 20         2 pigs -i- 5% of the remainder.
        All groups shall be sampled.
2.  Serological screening of pigs kept individually: this Includes pigs
    kept in close proximity to each other but having no direct contact,
    e.g. tethered sows
        Sampling procedure
        No of pigs                pigs to be tested
        less than 20              al I
        20 - 100                  20 + 20% of the remainder
        more than 100             20 + 10% of the remainder
                                  (at least 36)
 ---pagebreak---                                     - 47 -
                                   ANNEX V
                  PROCEDURE FOR CLEANING AND DISINFECTING
                             AN INFECTED HOLDING
I. Preliminary cleaning and disinfection
    a)  As soon as the carcases of the pigs have been removed for
        disposal, those parts of the premises in which the pigs were
         housed and any parts of other buildings, yards etc contaminated
        during slaughter or post-mortem examination should be sprayed
        with disinfectants approved for use in accordance with Article
         10.
    b)  Any tissue or blood which may have been spilled during slaughter
        or post-mortem or gross contamination of buildings, yards,
        utensils etc should be carefully collected and disposed of with
        the carcases.
    c)  The used   disinfectant  shall  remain on the surface   at least 24
        hours.
II. Final cleaning and disinfection
    a)  Grease and dirt should be removed from all surfaces by the
        application of a degreasing agent and washed with cold water.
    b)  After washing with cold water as described   in a) further spraying
        with disinfectant should be applied.
    c)  After 7 days the premises should be treated with a degreasing
        agent, rinsed with cold water, sprayed with disinfectant and
        rinsed again in cold water.
    d)  Manure and used bedding should be stacked to heat, sprayed with
        disinfectant and left for 42 days. Slurry should normally be
        stored for 42 days after the last addition of infective material.
        This period may be extended if the slurry has been heavily
        contaminated."
 ---pagebreak---                                   - 48 -
                                Article 2
Member   States shall bring    into force the    laws, regulations and
administrative provisions necessary to comply with this Directive not
later than 31 December 1991. They shall forthwith inform the Commission
thereof.
When Member States adopt these provisions, these shall contain a
reference to this Directive or shall be accompanied by such reference at
the time of their official       publication. The procedure    for such
reference shall be adopted by Member States.
                                Art icle 3
This Directive is addressed to the Member States
Done at Brussels,                                      For the Council
                                                       The President
 ---pagebreak---                                      - 49 -
                                Proposal for a
                               COUNCIL DECISION
           amending Directive 80/1095/EEC and Decision 80/1096/EEC
       as regards certain measures relating to classical swine fever
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
and in particular Article 43 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament,
Having regard to the opinion of the Economic and Social Committee,
Whereas Council Directive 80/1095/EEC^ 1 ), as last amended by Directive
87/487/EEC^2^, lays down conditions designed to render and keep the
territory of the Community free from classical swine fever;
Whereas Council Decision 80/1096/EEC^3^, as last       amended by Decision
87/488/EEC^4^,     introduced   Community   financial   measures   for the
eradication of classical swine fever;
Whereas the measures applied to eradicate classical swine fever have
gradually improved the health status of the pig population on the
territory of the Community; whereas it has been possible due to this
improved status to recognize areas (regions or Member States) as
officially swine fever-free or swine fever-free;
Whereas one of the given objectives to keep the territory of the
Community free from classical swine fever has been reached in large
areas; whereas it is necessary to take this situation into account and
consequently amend Directive 80/1095/EEC and Decision 80/1096/EEC,
HAS ADOPTED THIS DECISION:
(1) OJ  No  L 325, 01.12.1980, p.  1.
(2) OJ  No  L 280, 03.10.1987, p. 24.
(3) 0J  No  L 325, 01.12.1980, p. 5.
(4) 0J  No  L 280, 03.10.1987, p. 26.
 ---pagebreak---                                   - 50 -
                                Article 1
In Article 12(2) of Directive     80/1095/EEC the date  1  July  1993 is
replaced by 1 January 1992.
                                Article 2
The following sentence is added to Article 2(1) of Decision 80/1096/EEC:
"Nevertheless, the participation of the Community is limited to measures
carried out before 1 January 1992".
                                Art icle 3
This Decision is addressed to the Member States
Done at Brussels,                                      For the Counci
                                                       The President
 ---pagebreak---                                   - 51 -
                              Proposal for a
                            COUNCIL DIRECTIVE
        amending Directives 64/432/EEC, 72/461/EEC and 80/215/EEC
           as regards certain measures relating to swine fever
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
and in particular Article 43 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament,
Having regard to the opinion of the Economic and Social Committee,
Whereas Council Directive 64/432/EEC of 26 June 1964 on animal health
problems affecting intra-Community trade in bovine animals and swine*1*,
as last amended by Decision 91/13/EEC*2*, defines in particular the
conditions which must be satisfied as regards classical swine fever by
live pigs intended for intra-Community trade;
Whereas Council Directive 72/461/EEC of 12 December 1972 on health
problems affecting intra-Community trade in fresh meat*3*, as last
amended by Directive 89/662/EEC*4*, defines the conditions which must be
satisfied as regards classical swine fever by fresh pig meat intended for
intra-Community trade;
Whereas Council Directive 80/215/EEC of 22 January 1980 on animal health
problems affecting intra-Community trade in meat products*5*, as last
amended by Directive 89/662/EEC, defines in particular the conditions
which must be satisfied as regards classical swine fever for meat
products intended for intra-Community trade;
Whereas the measures applied to eradicate classical swine fever have
gradually improved the health status of the pig population on the
territory of the Community;
(1) OJ No  121, 29.07.1964, p. 1977/64
(2) OJ No L 8, 11.01.1991, p. 26.
(3) OJ No L 302, 31.12.1972, p. 24.
(4) OJ No L 395, 30.12.1989, p. 13.
(5) 0J No L 47, 21.2.1980, p. 4.
 ---pagebreak---                                  - 52 -
Whereas one of the given objectives to keep the territory of the
Community free from classical swine fever has been reached in large
areas; whereas it is necessary to take this situation into account and
consequently amend Directives 64/432/EEC, 72/461/EEC and 80/215/EEC;
Whereas in this context it is appropriate not to extend the type of
guarantees laid down in Article 4b of Directive 64/432/EEC and of
Article 13b of Directive 72/461/EEC and to discontinue the measures laid
down in Article 10 of Directive 80/215/EEC,
HAS ADOPTED THIS DIRECTIVE:
                                Article 1
Directive 64/432/EEC is hereby amended as follows :
1.   In Art icle 2 :
    (a) the words "swine fever" in the second    line of (i) of point (ii)
         are deleted,
    (b) the definitions in (p), (q) and (r) are deleted.
2.  In Artide    3:
    (a) the words "swine fever"   in the  introducing phrase of paragraph
         2(b) are deleted,
    (b) the words "swine fever or" in paragraph 2(b)(i) are deleted,
    (c) paragraph 2(b)(ii) is deleted,
    (d) the words "swine fever" in paragraph 2(c)(ii) are deleted.
 ---pagebreak---                                      - 53 -
    e)   the first sentence of paragraph 4 is replaced by the following :
         "Swine  for  breeding   and   production must moreover  come  from
         brucellosis free stock"
3.  Article 4b is replaced by the following:
                                  "Article 4b
     In addition to the measures provided for in this Directive concerning
     classical swine fever each Member State shall ensure that pigs sent
     from its territory to that of another Member State shall not come
     from a holding or an area which is subject to restrictions for
    classical swine fever in conformity with the provisions of Council
    Directive 80/217/EEC of 22 January 1980 introducing Community
    measures for the control of classical swine fever*.
    *0J No L 47, 21.2.1980, p. 11."
4.   In Annex F, Form III, V, the point (c) is deleted.    The points "(d),
     (e) (f) and (g)" becomes "(c), (d), (e) and (f)".
                                   Article 2
Directive 72/461/EEC is hereby amended as follows:
In Article 3 the following point (e) is added after point (d):
"(e)     The meat shall not be the subject of animal health restrictive
         measures pursuant     to the provisions of Council       Directive
         80/217/EEC of 22 January 1980 introducing Community measures for
         the control of classical swine fever*.
         *0J No L 47, 21.2.1980, p. 11."
                                   Art icle 3
Article 10 of Directive 80/215/EEC is hereby deleted.
 ---pagebreak---                                   - 54 -
                                Art icle 4
Member   States shall bring    into force the     laws, regulations and
administrative provisions necessary to comply with this Directive not
later than 1 January 1992. They shall forthwith inform the Commission
thereof.
When Member States adopt these provisions, these shall contain a
reference to this Directive or shall be accompanied by such reference at
the time of their official       publication. The procedure     for such
reference shall be adopted by Member States.
                                Art icle 5
This Directive is addressed to the Member States
Done at Brussels,                                       For the Council
                                                        The President
 ---pagebreak---                                     - 55 -
                               Proposal for a
                             COUNCIL DIRECTIVE
    amending Directive 72/462/EEC on health and veterinary inspection
        problems upon importation of bovine animals and swine and
             fresh meat or meat products from third countries
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
and in particular Article 43 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament,
Having regard to the opinion of the Economic and Social Committee,
Whereas Council Directive 72/462/EEC*1*, as last amended by Directive
91/69/EEC*2*, defines    in particular     the conditions which must be
satisfied as regards classical swine fever upon importation of live pigs,
fresh pig meat and meat products from third countries;
Whereas in view of the improved health situation within the Community in
respect of classical swine fever and the discontinuation of systematic
vaccination against the said disease, it is necessary to amend the
conditions laid down for importation of live pigs, fresh pig meat and
meat products,
HAS ADOPTED THIS DIRECTIVE:
                                  Article 1
Directive 72/462/EEC is hereby amended as follows:
1.  The following paragraphs 4, 5 and 6 are added to Article 6:
    "4. In respect of classical swine fever      pigs must come  from the
        territory of a third country which:
(1) OJ No L 302, 31.12.1972, p. 28.
(2) OJ No L 46, 19.02.1991, p. 37.
 ---pagebreak---                                   - 56 -
           has been    free from classical swine  fever  for at   least  12
           months,
           has not permitted vaccination for the preceding 12 months
           does not allow on its territory pigs which have been
           vaccinated less than 12 months previously.
       By way of derogation from paragraph 4 it may be decided, in
       accordance with the procedure laid down in Article 29, to
       authorize the importation of pigs coming from a part of the
       territory of a third country provided that vaccination against
       classical    swine fever   is prohibited throughout     the entire
       territory of that country and the part of the territory of the
       third country fuifiIs the conditions laid down in paragraph 4.
       By way of derogation from paragraph 4, in the event classical
       swine fever occurs      in a third country which fulfils the
       conditions of paragraph 4, it may be decided, in accordance with
       the procedure laid down in Article 29, that the period of
       12 months referred to in the first Indent of paragraph 4 may be
       reduced to 6 months if:
       (a) an outbreak or a number of epizootiologically interrelated
           outbreaks occur within a geographically limited area, and
       (b) the outbreak or outbreaks have been stamped out, within a
           period of 3 months and without recourse to vaccination."
2. The following subparagraph (c) is added to Article 14(2):
       "(c)   in which no classical swine fever has been detected for at
              least    the preceding   12 months,    vaccination    against
              classical swine fever has not been authorized for at least
              the preceding 12 months and in which no pigs have been
              vaccinated against classical swine fever in the preceding
              12 months."
   The following sentence is added to Article 15:
   "In accordance with the the procedure laid down in Article 29, it may
   be decided to derogate from the provisions laid down in Article
   14(2)(c)."
 ---pagebreak---                                   - 57 -
                                Art icle 2
Member   States shall bring    into force the      laws, regulations and
administrative provisions necessary to comply with this Directive not
later than 1 January 1992. They shall forthwith inform the Commission
thereof.
When Member States adopt these provisions, these shall contain a
reference to this Directive or shall be accompanied by such reference at
the time of their official       publication. The procedure      for such
reference shall be adopted by Member States.
                                Article 3
This Directive is addressed to the Member States
Done at Brussels,                                For the Council
                                                 The President
 ---pagebreak---  ---pagebreak---                                                                      ISSN 0254-1475
                                                              COM(91) 270 final
                                                      DOCUMENTS
EN                                                                              03
                                 Catalogue number : CB-CO-91-313-EN-C
                                                             ISBN 92-77-74297-6
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