CELEX: 51978PC0748
Language: en
Date: 1979-01-03
Title: Proposal for a Council Regulation introducing Community measures for the prevention of classical swine fever (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (78) 748
Vol. 1978/0275
 ---pagebreak--- Disclaimer
Conformément au règlement (CEE, Euratom) n° 354/83 du Conseil du 1er février 1983
concernant l'ouverture au public des archives historiques de la Communauté économique
européenne et de la Communauté européenne de l'énergie atomique (JO L 43 du 15.2.1983,
p. 1), tel que modifié par le règlement (CE, Euratom) n° 1700/2003 du 22 septembre 2003
(JO L 243 du 27.9.2003, p. 1), ce dossier est ouvert au public. Le cas échéant, les documents
classifiés présents dans ce dossier ont été déclassifiés conformément à l'article 5 dudit
règlement.
In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983
concerning the opening to the public of the historical archives of the European Economic
Community and the European Atomic Energy Community (OJ L 43, 15.2.1983, p. 1), as
amended by Regulation (EC, Euratom) No 1700/2003 of 22 September 2003 (OJ L 243,
27.9.2003, p. 1), this file is open to the public. Where necessary, classified documents in this
file have been declassified in conformity with Article 5 of the aforementioned regulation.
In Übereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom 1.
Februar 1983 über die Freigabe der historischen Archive der Europäischen
Wirtschaftsgemeinschaft und der Europäischen Atomgemeinschaft (ABI. L 43 vom 15.2.1983,
S. 1), geändert durch die Verordnung (EG, Euratom) Nr. 1700/2003 vom 22. September 2003
(ABI. L 243 vom 27.9.2003, S. 1), ist diese Datei der Öffentlichkeit zugänglich. Soweit
erforderlich, wurden die Verschlusssachen in dieser Datei in Übereinstimmung mit Artikel 5
der genannten Verordnung freigegeben.
 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                               COM(78)748 final
                                               Brussels - 3 January 1979
                           Proposal for a
                         Council Regulation
               introducing Community measures for the
                prevention of classicla swine fever
       ( submitted to the Council by the Commission )
   C0M(78 ) 748 final
 ---pagebreak---                         EXPLANATORY  MEMORANDUM
Classical swine fever is a serious contagious disease of pigs which in its
acute form has a high mortality rate and in its other forms results in
diminished profits owing to abortions , sterility and reduced growth rates .
The approach to the disease, particularly the action taken to deal with
outbreaks , varies considerably from one Member State to another , and this
is a barrier to intra-Community trade .
The purpose of this regulation is to give the Community an efficient harmonized
system of action for fighting classical swine fever in the Community . 1 ^: is
particularly necessary to eliminate sources of the disease by slaughtering
animals that are either infected or are potential transmitters of it and by
applying rigorous disinfection and control measures to holdings suspected of
being contaminated . It is indispensable, in order to eliminate all risk of
epizootics , that rapid, precise and harmonized diagnostic methods be used by
the responsible national laboratories .
This regulation is the basis of a Community operation for the- establishment
and maintenance of uniform health standards in respect of classical swine fever .
 ---pagebreak---                                 COUNCIL REGULATION
                     introducing Community measures fcv tiia
                      prevention 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 one of the Community 's tasks in the veterinary field is to improve the
  health of livestock , thereby increasing the profitability of stock farming ;
  Whereas , moreover , such action should help to remove those remaining barriers
  to trade between Member States in live animals and fresh meat which are caused
  by differences in their respective animal health situations ;
  Whereas an outbreak of classical swine fever can take on epizootic proportions , -
  causing mortality and disturbances on a scale which threatens the profitability
  of pig farming as a. whole ;        •
  Whereas provisions must be adopted as soon as there is suspicion of the disease
  so .that immediate and effective action can be taken as soon as it is confirmed;
. Whereas it is necessary to prevent any spread of the disease if an outbreak occurs
  by carefully monitoring movements of animals , the use of products liable to be
   contaminated and vaccination ;
   Whereas the methods of diagnosing the disease in all its forms under the auspices
   of the laboratories responsible and the preparation of vaccine must be harmonized ;
   Whereas common measures for the prevention of classical swine fever form a basis
   for maintaining a uniform standard of animal health and whereas to that end a
   procedure should be laid down to establish , close cooperation between the Member
   States and the Commission,
   HAS ADOPTED THIS REGULATION
 ---pagebreak---                                   Article 1
  This Regulation introduces Community measures for the prevention of classical
 swine fever .
                                  Article 2
 For the purposes of this Regulation the following definitions shall apply :
 a ) holding                           means any establishment ( agricultural or other ),
                                       situated in the territory of a Member State , in
                                       which animals of the porcine species are kept or
                                       bred ;
 b ) slaughter pig                     means a porcine animal which is intended to be
                                       brought immediately to a slaughterhouse for
                                       slaughter ;
 c ) fattening pig                     means a porcine anima I fattened and intended
                                        for slaughter at the end of the fattening period
                                       with a view to meat production ;
 d ) breeding pig  :                   means a male or female porcine animal intended
                                       or used for reproduction with a view to multi­
                                       plication of the species ;
 e > pig suspected of being infected with swine fever      : means any pig showing
                                       clinical signs or post-mortem lesions or
                                       reactions to laboratory tests      carried out
                                       according to Article 11, indicating the possible
                      - ^              presence of swine fever ;
 f > pig infected with swine fever s means any pig
           - v/                    ' - in which clinical symptoms or post-mortem
         '                          j     lesions of 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 ;
 >) official veterinarian s
9 Q'ftclal veterinarian               means the veterinarian designated by the
                                      competent central authority of the Member State;
h) -swH
     swillL r:                        means waste from kitchens , restaurants or
                                      Industries using meat .                             1
                                 Article 3
The suspicion or existence of swine fever must be notified immediately to the
competent authority *
 ---pagebreak---                               Article 4
Where a holding contains one or more pigs suspected of being infected with
swine fever , the official veterinarian shall immediately set in motion
official means of investigation aimed at confirming cr disuroviny the presence
of the said disease .
From the moment when suspicion is notified ithe competent authority shall
order that :
- the holding be placed under official surveillance ;
- all the pigs in the various categories on the holding shall be counted
   and a list       compiled of the pigs already dead or likely to be
   infected in each category ; this must also include pigs born durinq the
   period of suspicion ;
- all the pigs on the holding shall remain in isolation in their living
   quarters ;
- no pigs may enter or leave the holding ; the competent authority may ,
   if necessary , prohibit animals of other species from leaving the holding ;
- no pigmeat may leave the holding , except where accompanied by an authorizat
   from the competent authority ;
- no dead pigs may leave except where accompanied by an authorization from
   the competent authority ;
- no animal feed , utensils , materials or waste may leave the holding ,
   except where accompanied by an authorization from the competent authority ;
- the entry of persons to the holding shall be subject to authorization by
   the competent authority ;
- the entry of vehicles to the holding shall be subject to authorization by
   the competent authority ;
- appropriate means of disinfection must be used at the entrance and exits
   of buildings housing pigs and of the holding itself ;
- an epizootlological enquiry shall be carried out In accordance with
   Articles 7 and 8 .
 The measures provided for In paragraph 1 shall not be lifted until the
 suspicion of swine fever has been officially ruled out .
 ---pagebreak---                                    Article 5
 In cases where the presence of swine fever is officially confirmed , the             '*
competent authority shall prescribe , in addition to the measures listed in
Article 4 ( 1 ), the application of the following measures :
-• all pigs on the holding shall be slaughtered without delay under official
    control and in such a way that there is no risk of the swine fever virus
    spreading during transport and slaughter ;
» after slaughter of the pigs mentioned above , all carcases mu' t be destroyed undff
    official control in such a way that there is no risk of the swine f«?ver virus
    spreading ;
- meat of pigs slaughtered on the premises during the period between the probable
    introduction of disease to the holding and the taking of official measures    and
    stored on the holding, shall be destroyed under official control in such a way
    as to prevent the spread of the swine fever virus ;
- pigs having died on the premises shall also be destroyed under official control
    in such a way as to prevent the spread of the swine fever virus ;
 - all substances and waste likely to be contaminated , such as f eedingstuff s ,
    shall be subjected to a treatment ensuring the destruction of any swine fever
    virus present ; this treatment must be carried out in accordance with the .
    instructions of the official veterinarian;
 - after the pigs have been disposed of , the buildings used for housing the pigs ,
    the vehicles used for transporting them and all equipment likely to be
    contaminated shall be cleaned and disinfected in accordance with the prav! sio.u
    of Article 10;      ;
 • the reintroduction of pigs to the holding may not take place until at least
     15 days after completion of the cleaning and disinfection operations
     carried out in accordance with Article 10 ;
 ** an epizootiological enquiry shall be carried out in accordance with the
    provisions of Articles 7 and 8 *
 ---pagebreak---                               Article 6
In order that the fattening of pigs may be completed the Member States
may, by way of derogation from the first and second indents of Article 5,
postpone the slaughter of certain of the pigs on an infected holding , or ref re >
from destroying th^ir meat , provided that :
- the structure and size of the holding are such that each pig unit is
   housed , kept and fed completely separately ;
- the pigs whose slaughter is postponed are healthy and housed in
   buildings or blocks apart from that or those containing pigs infected
   with swine fever , with no direct or indirect contact with the latter ,
   including during the incubation period of the disease ;
- the pigs remain in their living quartern where they shall be isolated ; they
   may only be moved from the holding to a slaughterhouse under official
   supervision for the purpose of immediate slaughter ;
- the pigs whose slaughter is postponed are marked in an indelible manner ;
- slaughter of all the     pigs takes place within a period of not more than
   three months from the day when the disease was officially confirmed ;
- meat originating from these pigs      is     used in such a way that there
    is no risk of the swine fever virus spreading ;
-» the holding remains subject to the other measures laid down in Articles 4 at
    5 until the slaughter of all pigs in the herd and the completion of
    cleaning and disinfection operations in accordance with the provisions of
    Article 10;
 - the reintroduction of pigs to the holding does not take place until at
    least 15 days after completion of the cleaning and disinfection , carried
    out in accordance with the provisions of Article 10, of all the pigs'
     living quarters .
  If the disease is officially confirmed among pigs in a unit which is accorded
  a derogation pursuant to paragraph 1 > this unit at least shall be treated
  pursuant - to the first and second Indents of Article 5 .
 ---pagebreak---                                         - 6 -
                                      Article 7
The epizootiological enquiry shall deal with :
- the length of time during which swine fever may have existed on the holding
   before the disease was officially confirmed ;
- the possible origin of swine fever on the holding and the identification of
   other holdings on which there are pigs which may have become infected from
   the same source ;
- the movement of persons , vehicles , pigs , carcases , meat or material likely
   to have transported the virus from the holding .
                                      Article 8
1 . < a ) Where the official veterinarian finds , or considers on the basis of confirmed
          dat ^ that swine fever could have been introduced from another holding on to
          the holding referred to in Article 4 , or from the latter holding on to another
          holding , as a result of the movement of persons , pigs or vehicles or in any
          other way , those other holdings shall be placed under official surveillance .
          The official surveillance , the purpose of which shall be to detect
          immediately any suspicion of swine fever , count animals and monitor their
          movements and, where appropriate , implement some or all of the measures
          provided for in Article 4(1 ), shall be lifted if the suspicion of swine
          fever in respect of the holding referred to in Article 4 is officially
          ruled out .
    ( b) Where the official veterinarian finds , or considers on the basis of
          confirmed data , that swine fever could have been introduced on to the
          holding referred to in Article 5 from another holding as a result of
          the movement of persons , pigs or vehicles or in any other way , that
          other holding shall be subject to the provisions of Article 4 .
          Where the official veterinarian finds , or considers on the basis of
          confirmed data , that swine fever could have been introduced on to the
          holding referred to in Article 5 from another holding as a result of
          the movement of persons, pigs or vehicles or In any other way, that other
          holding shall be placed under official survei Itance .
 ---pagebreak---                                    - 7 -
    The official surveillance, the purpose of which shall be to detect immpdi ately
    any suspicion of swine fever, count animals and monitor their movements
    and, where appropriate, implement some or all of the measures provided
    for in Article 4(1 ), shall be maintained for at least 30 days following the
    date on which, according to estimates, the disease could have been introduced .
2 . When a holding has been subjected to the provisions of paragraph 1(a ) and the
    second subparagraph of paragraph 1 ( b ),- the competent authority may authorize the
    movement from the holding of pigs other than those which led to the imposition
    of the said measures , for transport directly to a slaughterhouse under official
    supervision for the purpose of immediate slaughter .
     Prior to granting such authorization, the official veterinarian must have carried
     out an examination of the pig herd and confirmed that none of the pigs is
     suspected of being infected with swine fever .
3 . The competent authority may, where it considers that conditions permit , limit
    the measures provided for in paragraph 1(a ) and the second subparagraph of
    paragraph Kb) to a part of the holding and the pigs contained therein,
    provided that the pigs in these units have been housed, kept and fed
    completely separately .
                                   Article 9
1 . Once the presence of swine fever is officially confirmed, the competent
    authority shall establish a protection zone with a minimum radius of 2 km
    around the infected holding .
2 . a ) The following measures shall apply to the protection zone :
        - the movement of pigs on public roads shall be prohibited;
        - the pigs may only be moved from the holding on which they are kept directly
          to a slaughterhouse under official supervision for the purpose of immediate
          slaughter . Such movement may be authorized by the competent authority only
          after the official veterinarian has carried out an examination of all pigs
          on the holding and confirmed that none of the pigs is suspected of being
           infected with swine fever;
        - itinerant boar service shall be prohibited;
                                                    ' ι
        - fairs , markets , shows or gatherings of pigs, including collection and
           distribution of pigs by dealers, shall be prohibited .
 ---pagebreak---  b ) The measures applied in the protection zone shall be maintained until
     at least 15 days after the elimination of all pigs on the holding where
     there were pigs infected with swine fever and the completion of the cleaning
     and disinfection operations on that holding in accordance with the provisions
     of Article 10 .
 Where the prohibitions provided for in paragraph 2(a ) are maintained beyond
 the 15 days prescribed because of the appearance of new cases of the disease
 and housing problems result , for the purposes of animal welfare the competent
authority may , following an application by the owner stating the nature and
 extent of the problem, authorize the removal of piglets for fattening from a
holding within the protection zone , provided that :
a ) the official veterinarian has verified the facts ;
b ) the pigs have been examined and declared sound and are transported directly
     to the holding of destination without coming into contact with other animals ,
     the means of transport used being cleaned and disinfected before and after
     use ;
c ) the holding of destination is located    either in the protection zone or
     within 20 Vm' of that zone and has adequate housing facilities ;
d) the holding of destination is , upon arrival of the pigs , placed under
     official surveillance so that any suspicion of swine fever can be detected
     immediately , animals can be counted and their movements monitored .
The official surveillance measures provided for in d) shall be maintained
for as long as those provided for in the protection zone in which the
holding from which the pigs originated is located are maintained in accordance
with paragraph 2(b ).
Where the prohibitions provided for in paragraph 2(a ) are maintained as a
result of the derogation provided for in Article 6, the movement of animals
other than directly to a slaughterhouse may be authorized subject to the
following conditions :
" fattening pigs may be moved out of the zone provided that the official
   veterinarian is satisfied that there has been no contact with infected pigs
   and has examined them to rule out any suspicion of the disease;
- breeding pigs may be moved out of the zone provided that they have been
   examined by the official veterinarian and found free from all symptoms of
   the disease and that they have been examined for swine fever in accordance
   with Article 11 and the results were negative .
 ---pagebreak---                                         - 9 -
                                     Article 10
The disinfectants to be used for the purposes of this Regulation and their
concentrations shall be officially approved by the competent authority of the
Member State concerned .
The cleaning and disinfection operations to be undertaken pursuant to this
Regulation shall be carried out under official supervision in accordance with
the instructions given by the official veterinarian .
                                    Article 11
1 . Samples shall be taken, and the laboratory tests designed to detect the presence
       of classical swine fever carried out , in accordance with Annex I.   The provision
       of Annex I may be extended or amended in accordance with the procedure laid down
        in Article 16 .
2 . A national laboratory shall be responsible for coordinating standards and method
       of diagnosis in each Member State in accordance with the provisions of Annex II .
3 . A Community laboratory shall liaise between the national laboratories referred t
        in paragraph 2 .
       The Council , acting on a proposal from the Commission, shall designate the
        Community laboratory and shall determine before    Its powers and the conditions
        of its operation .
                                 Article 12
1 . Without prejudice to Community provisions already existing on the subject ,
        Member States shall inform the Commission and the other Member States about the
        epizootiology and development of the disease in accordance with the provisions
        set out in Annex III .
2 . The provisions of Annex III may be extended or amended in accordance with the
        procedure laid down in Article 16 .
                                  Article 13
 1 . When pigs are moved frcsn ths holding on which they are kept , they must be
         provided with a mark enabling their holding of origin to be readily identified .
    ■ ■ The marking must be done Irs accordance with the Instructions of the competent
         authority .
 ---pagebreak---                                         10 -
2 . Persons engaged in the transport or sate of pigs must be in a position to supply
     the competent authority with information concerning the movements of pigs which
     they have transported or sold, and furnish proof of such movements . The samp
     obligation shall be incumbent on all persons keeping pigs in respect of the
     pigs entering or leaving their holding .
                                    Article 14
1 . Where swine fever is detected on a holding , the measures to control the
   . disease may be supplemented by the vaccination of pigs on holdings threatened
     with contamination in a territorial area demarcated by the competent authority .
2 . Treatment with specific immune-serum or sero vaccination shall be prohibited .
3 . Requirements relating to swine fever vaccine shall be adopted in accordance
     with the procedure laid down in Article 16 .
4 . Swine fever vaccines imported into a Member State from non-member countries
     must fulfil the same conditions as those produced in the Member States and
     must be authorized and controlled by the competent central authority in the
      importing Member State .
5 . Without prejudice to national provisions where they provide for preventive
      vaccination of pigs against swine fever , whether in all or part of the
      national territory , where all categories of pigs are vaccinated pursuant to
      paragraph 1 sows vaccinated during gestation may leave the vaccinated area only
      to be taken to a slaughterhouse for slaughter .
 6 . The pigs vaccinated shall be permanently marked in accordance with the
      instructions of the competent authority .
                                    Article 15
 t . The use of swill originating from means of international transport such as
      boats , land vehicles or aircraft shall.be prohibited for the feeding of pigs .
      Such swill must be collected and destroyed under official control .
 2 . Swill for the feeding of pigs must be heat-treated so as to ensure the .
       destruction of swine fever virus . Swill so treated may be used for feeding
       to fattening pigs only .                    .
 ---pagebreak---                                     - 11
3 . The collection, transport and treatment of swill intended for feeding to
    pigs must be subject to official authorization .     Swill must be transported
    in vehicles or containers designed in such a way th^t ^t cannot leak or fall
    out of the vehicle during transport .
    The vehicles or containers used for the transport of swill must be cleaned
    and disinfected each time after use according to the instructions of the
    competent authority .
A. The authorization for the treatment of swill referred to in paragraph 3
    shall be granted subject to the following conditions :
    - the holding must have facilities which ensure that there is complete
       separation between untreated and treated swill ;
    - the premises for storage of untreated swill and the premises where
       treatment takes place must be easy to clean and disinfect .
5 . The swill collected in accordance with paragraph 3 may be used only on the
    holding where it has been treated .
    Member States may authorize the treatment of swill in special establishments
    equipped for the purpose , on which there are no animals and which are under
    official control . In this case ,. by way of derogation from paragraph 2 , the swil
    may , after treatment , be used for the feeding of all categories of pigs ,
    provided that its distribution and use are controlled so as to avoid all risks
    of the spread of swine fever virus .
6 . The authorization referred to in paragraph 3 shall not be required in the case
    of holdings using their own swill for feeding to their own pigs , provided that
    such swill is heat-treated in a manner such as to ensure the destruction of
    swine fever virus .
                                   Article 16
1 . Where the procedure laid down 1n this Article is to be followed, the matter shal
    without delay be referred by the Chairman , either on his own initiative or at
     the request of a Member State, to the Standing Veterinary Committee
     ( hereinafter referred to as 'the Committee 1 ) set up by the Council Decision of
     15 October 1968 .
 ---pagebreak--- 2 . Within the Committee the votes of the Member States shall be weighted as
    laid down in Article 148 ( 2 ) of the Treaty . The Chairman shal l not vote .
3 . The representative of the Commission shall submit a draft of the measures
    to be adopted . The Committee shall deliver its opinion on these measures
    within a time limit set by the Chairman having regard to the urgency of the
    questions under examination .   Opinions shall be delivered by a majority of
    41 votes .
4 . The Commission shall adopt the measures and shall implement th»»m immediately /
    where they are in accordance with the opinion of the Committee .    Where the
    measures envisaged are not in accordance with the opinion of the Committee ,
    or if no opinion is delivered, the Commission shall without delay submit
    to the Council a proposal on the measures to be taken .    The Council shall
    adopt the measures by a qualified majority .
    If the Council has not adopted any measures within three months of the date
    on which the matter is referred to it , the Commission shall adopt the proposed
    measures and shall implement them immediately .
                                   Article 17
Article 16 shall apply until 21 June 1981 .
                                   Article 18
This Regulation shall enter into force onl July 1980 .
This Regulation shall be binding in Its entirety and directly applicable in all
Member States .
 Done at Brussels,                                          For the Council
                                                            The President
 ---pagebreak---                                   ANNEX   I
DIAGNOSTIC PROCEDURES FOR THE CONFIRMATION OF SWINE FEVER
The following guidelines , standards and minimum criteria are laid down for
the diagnostic procedures . The designated National Swine Fever Laboratories
shall , define the materials and methods for use in the diagnosis of swine fever .
A. Collection of materials for diagnosis
    1.      For virus isolation and antigen detection , tonsil tissue is considered
            essential . Samples of kidney, spleen and ileum , together with maxillary
            and mesenteric lymph nodes should also be collected . Each sample of the
            tissue should be placed in a separate 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 . a ) Blood samples for virus isolation should be collected, preferably from
            pigs showing signs of fever or other signs of disease . Sterile non
            cytotoxic tubes should be used for this purpose , and the samples should be
            kept cool , preferably at refrigerator temperature and then subjected to
            laboratory testing without delay .
        b ) Blood samples may be collected for virus isolation from leucocytes of
            suspected pigs . Blood is prevented from clotting preferably by the
                             1)
            addition of EDTA . The samples should be kept cool at refrigerator
            temperature and submitted to laboratory testing within two days .
    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       recovered from suspect infection and from sows
             known to have been in contact with infected or suspect cases . In such
             suspect holdings 3lt respect or in contact animals up to 20 and 25% of any
             additional number should be sampled . The samples should be collected and
             handled as described in paragraph 2<a >.
 -■V Ethylene .Diamine TeifaacetJc Acid, Sodlum salt . >• >
 ---pagebreak---         In order to ensure a high probability of detection of antibody induced
       by swine fever virus, samples should be collected from each unit of the
       holding at this level .
        Sero diagnosis should not be attempted where vaccination has been
        officially carried out .
The laboratory diagnosis of swine fever
The principle basis for the laboratory diagnosis of swine fever shall be the
demonstration of viral antigen in organ tissues as described in sub-paragraph 1 .
In the case of negative or inconclusive results , the tests shall be repeated
on the same samples . Additional samples should be collected from the same
source .
Virus isolation is required in cases of inconclusive or negative results from
material derived from animals giving rise to suspicion of swine fever or-with
material from holdings which have had contact with cases of swine 'fever . Where
in such circumstances the demonstration of viral antigen or virus isolation
has not been successful , tests for the detection of neutralizing 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 .
Materials, methods and diagnostic criteria shall be prescribed by the National
 Swine Fever Laboratory in each Member State .
 1 . Demonstration of viral antigen
     For the demonstration of viral antigen in organ tissues , the direct
     immunofluorescence technique shall be applied to thin cryostat sections
     ( up to 5 microns ) of tonsils and tissues of other organs as specified in
     paragraph A 1     For the application of the direct immunofluorescence
     the following requirements shall be adopted :
     a ) Hyperimmune serum shall be prepared from pigs free from infections or
          antibody which could affect the specificity or quality of the reaction.'""'
     b ) Fluorescein conjugated immunoglobulin prepared from swine fever
          hyperimmune pig serum as specified under a ) shall have a minimum working
          titre of 1 : 20 as determined in swine fever infected cell cultures and
          confirmed by check tests on tissue sections . The working dilution of the
          conjugate shall combine a maximum of brilliance with a minimum of    v   *
          background staining .
 ---pagebreak---     c ) Any sample showing specific cytoplasmic fluorescence shall be considered
        positive for swine fever . In case of doubt , the results should be
        confirraed by virus isolation in cell cultures .
    d ) When fluorescence has been detected which is suspected to be due to
        vaccinal virus , the holding shall be regarded as a suspect holding until
        such a time as the Competent Authority is satisfied that no swine fever
        exists on the holding .
2 . Vi rus isolation and identification in cell cultures
    a ) Virus isolation from tissue samples is performed on susceptible /"PK 157
        cell cultures or equally susceptible cell lines .   Cell cultures grown on
        coverslips are exposed to a suitably prepared 10% suspension of tissue
        from the suspected animal ; starting with a 10% suspension , the cultures
        shall be stained and examined for specific cytoplasmic fluorescence at
         intervals from 24 to 72 hours from the time of inoculation .
    b ) Virus isolation from blood samples , collected and handles as indicated
         in paragraph A 2 b ) is performed by the inoculation of cell cultures
        according to the procedures described in paragraphs A 2 a ) or A 2 b )
         respectively .  These cultures should be exposed to buffy coat suspension
         reconstituted to the original blood volume .  In the case of serum sample
         the cell cultures should be exposed to not more than a 20% dilution of
        the serum to be tested .
Detection of antibody induced by swine fever virus in blood samples
The detection of neutralising 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 collected according to the
 specifications in Paragraph A 2 a and subjected to an approved test .
  The following tests based on the direct immunofluorescence technique are
  approved for use and must be carried out with the inclusion of appropriate
  positive and negative sert«» controls .
 ---pagebreak---                                - 4 -
1 . The Plaque Reduction Test ( PRT )
    This test is based on the microplaque counting method . Three-fold
    dilutions of serum commencing at 1 : 20 are tested against an equal volume
    of virus suspension containing 300 to 1,000 plaque forming units ( PFU ) of
    a virulent strain of swine fever virus using at least 2 monolayer cultures
    per dilution .
    The results are expressed as the plaque reduction titre , which is the
    reciprocal of the serum dilution which reduces the number of fluorescent
    foci by 90% as compared with the 1 : 20 diluted negative control serum .
    The titres are determined graphically .
2 . The Neutralisation Index Test ( NI Test )
    The test is based on the microplaque counting method .    A stock of virus
    is titrated in cell cultures in the presence of an equal volume of a
    1 : 20 dilution of serum .. At least two monolayer cultures are required
    for each log^g dilution of virus suspension .
    The degree of neutralising activity is expressed as the difference between
    the infectious titre in the presence of a 1 : 20 dilution of known
    negative serum and the titre of the same virus suspension in the presence
    of the suspect serum .
    This difference is the Neutralisation Index and is expressed
    logarithmically .
3 . The virus neutralization and immunofluorescence test ( NIFT )
    This test is based on the determination of the fifty percent end point .
    Cultures are inoculated with constant amounts of virus after incubation
    with serum and the results are based on the absence of any specific
     cytoplasmic fluorescence .
    The sera are diluted 1:5 for screening purposes .      Two fold dilutions
    of serum starting at 1 : 5 are prepared when a full titration is necessary .
     Each dilution is mixed with an equal volume of virus suspension     .
     containing 100 to 200 infectious doses ( TCIDgg). At least two cultures
     are used at each dilution level . The NIFT results are expressed as the
     reciprocal of the dilution at which half the inoculated celt cultures fall
     to show any specific fluorescence .  Arv end-point between two dilution
     levels is interpolated .
 ---pagebreak--- Evaluation of the results of Laboratory testing
1 . The demonstration of viral antigen in organ tissues or virus isolation from
      tissue samples following the techniques defined in paragraphs B 1 and B 2
      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 according
      to paragraph Bid ).
2 . Following the detection of antibody reacting with swine fever virus , the
      herd of origin shall be regarded as suspect .
      a ) In order to rule out the suspicion of swine fever raised by the detection
            of antibody, the test described in Section E below shall be used to
            distinguish between swine fever reacting antibody that may have been
            induced by BVD virus and such antibody due to swine fever 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 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 ) Plaque Reduction Test ( PRT )
              A titre of ^ 50 in any pig together with clinical or epi zootiological
              evidence giving rise to suspicion of disease shall constitute a positive
              diganosis .
              A titre of ^ 50 in any pig without clinical or epizootiological evidence
             gives rise to suspicion of disease and should be followed by differential
              diagnostic procedures .
       ( b ) Neutralization Index ( NI )
              A titre of 3^1.0 in any pig together with clinical or epizootiological
              evidence giving rise to suspicion of disease shall constitute a positive
              diagnosis .
              A titre of ^- 1.0 in any pig without clinical or epizootiological evidence
              gives rise to suspicion of disease and should be followed by differential
              diagnostic procedures .                ,
       ( e ) Virus Neutrali zat ion    nd immunof luorescence test ( NIFT )
              A titre of ^5      any -sig together with clinical or epizootiological
              evidence giving rise to suspicion of disease shall constitute a positive
              diagnosis .
'■ v           A titre of ^ 5 in any pig without clinical or epi zootiological evidence
-           . gives rise to suspicion of disease end should be followed by differential
               diagnostic procedures .
 ---pagebreak--- E Differential diagnosis between swine fever ( SF) and bovine virus diarrhoea ( BVO )
  1 . Tests for the differential diagnosis of swine fever ( SF ) and bovine virus
      diarrhoea ( BVO ) are based on parallel end-point titrations of the sera with
      both SF and BVO virus strains using fully comparable methods . The SF and
      BVO virus strains for use should be approved by the National Swine Fever
      Laboratory .
      To rule out the suspicion of swine fever raised by the detection of antibody
      blood samples should be examined by comparative end-point titrations for
      neutralising antibody against SF-virus and BVD-virus .
  2 . The results of the comparative serological tests between swine fever and
      bovine virus diarrhoea shall be interpreted as follows :
      a ) If the comparative tests show :
          - that more than one pig has antibody to SF with no antibody to BVD / or
          - that the titres against SF-virus are equal to or higher than the titres
              against BVO in a large proportion of the pigs , swine fever shall be
              confirmed .
      b ) If the comparative tests show some of the titres to SF-virus to be equal
           to or higher than the titres to BVD-virus     in a proportion of the pigr
           there shall be suspicion of swine fever and differentiation shall proceed
           as follows :
           - those pigs which show neutralizing titres against SF-virus which are
              higher than or equal to the titres against BVD-virus shall be slaughtered
              and their foetuses together with any tissues estimated to be of value
              shall be subjected to examination for swine fever antigen or virus .
           - if swine fever antigen or virus is detected, swine fever shall be
              confirmed .
           - if the examination defined in the second indent above fails to reveal
              the presence of swine fever 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
                                                                              L
              significantly ( four-fold or greater ) higher titres against BVD-virus
              than SF-virus , suspicion shall be ruled out .
           ~ if one or more animals show a titre against SF virus that is equal to or
              higher than its titre to BVD-virus , swine fever shall be confirmed .
       c ) If the BVD titres are such as not to exclude the possibility of swine
            fever , the holding shall be considered as suspect and be retested after
            at least 30 days .
 ---pagebreak---                              ANNEX   II
The national swine fever laboratories are as follows :
Denmark                National Virus Research Institute , Lindholm
Italy                  Istituto zooprofilattico sperimentale dell' Umbria e delle
                       Marche - Perugia
Great Britain          Central Veterinary Laboratory
                       Weybridge - Surrey - England
Northern Ireland       Veterinary research laboratory
                       Stormont - Belfast
Belgium                Institut national de recherches vétérinaires
                       Groeselenberg 99    Bruxelles B 1180
France                 Laboratoire central de Recherches vétérinaires
                       d' Alfort , Rue Pierre Curie 22 , 94700 Maisons Alfort
Luxembourg             Laboratoire bactériologique de médecine vétérinaire
                       de l' Etat ; Avenue Gaston Oiderich 54 , Luxemburg
Ireland                Veterinary research laboratory
                       Abbotstown - Castleknock     - Co . Dublin
Germany                Bundesforschungsanstalt    "für Viruskrankheiten "" der Tiere,
                       Tübingen
Netherlands            Central veterinary Institute - Lelystad
The national swine fever laboratory in each Member State shall be responsible
for coordinating the standards and diagnostic methods laid down in each swine
fever diagnostic laboratory within the Member State, by :
( a ) providing diagnostic reagents to individual laboratories where required ;
< b ) controlling the quality of all diagnostic reagents used in that Member State;
                                                                  I .
( c ) arranging comparative tests periodically ;
( d ) holding isolates of swine fever virus from cases confirmed in that Member State .
 ---pagebreak---                                  ANNEX III
                        Epizootiologic information
1 . Within 24 hours of notification of an outbreak of swine fever , the Member
     State concerned must forward the following information to the Commission and
     the other Member States :
     - the date on which swine fever was suspected;
     - the date on which swine fever was confirmed and methods used for confirmation ;
     - the location of the infected holding and its distance from the nearest pig
        farms ;
     - the number of pigs of each category on the holding ;
     - for each category , the number of pigs in which swine fever has been confirmed
        and the morbidity of the disease .
2 . The information specified in paragraph 1 shall be followed as soon as possible
     by a report stating the following :
      - the date on which the pigs on the holding were slaughtered and destroyed ;
      - where the derogation provided for in Article 6 has been applied , the number
        of pigs slaughtered and destroyed and the number of pigs which are to be
        slaughtered at a later date and the time limit laid down for their slaughter ;
      - any information relating to the possible origin of the disease , or the origin
        of the disease if this has been ascertained .
 3 . The Member State concerned shall forward the information specified in
      paragraph 1 to the Commission and the other Member States in respect of each
      subsequent outbreak of swine fever on other holdings , until the number  of
      infected holdings and the dispersion of the disease show the epizootic to be
      extensive .