Council Directive 91/685/EEC of 11 December 1991 amending Directive 80/217/EEC introducing Community measures for the control of classical swine-fever
Date: 1991-12-11
Institutions: Council of the European Union
Subjects: animal plague, health control, swine













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31991L0685

Council Directive 91/685/EEC of 11 December 1991 amending Directive 80/217/EEC introducing Community measures for the control of classical swine-fever  


Official Journal L 377 , 31/12/1991 P. 0001 - 0014 Finnish special edition: Chapter 3 Volume 40 P. 0027  Swedish special edition: Chapter 3 Volume 40 P. 0027  





COUNCIL DIRECTIVE  of 11 December 1991 amending Directive 80/217/EEC introducing Community measures for the control of  classical swine-fever (91/685/EEC)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 (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Directive 80/217/EEC (4), as last amended by Directive 87/486/EEC (5), introduced Community  measures for the control of classical swine-fever; Whereas, during the period covered by Directive 80/217/EEC, this disease has, owing 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 evolution of the disease, the availability of improved diagnostic methods  and 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 relate to the 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, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 80/217/EEC is hereby amended as follows:  1. Article 2 shall be replaced by the following: 'Article 2  For the purposes of this Directive the following definitions shall apply: (a) 'pig`: any animal of the Suidae family; (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`: a holding within the meaning of Article 2 (4) of Directive 90/425/EEC (*), as last  amended by Directive 91/174/EEC (**); (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; (j) 'competent authority`: the competent authority within the meaning of Article 2 (6) of Directive  90/425/EEC; (k) 'official veterinarian`: the veterinarian appointed by the competent authority; (l) 'rendering`: the processing of high-risk material in accordance with Directive 90/667/EEC (1) (m) 'swill`: waste from kitchens, restaurants or, as the case may be, from industries using meat.` (*) OJ N° L 224, 18. 8. 1990, p. 29. (**) OJ N° L 85, 5. 4. 1991, p. 37. (1) OJ N° L 363, 27. 12. 1990, p. 51.  2. in Article 5: (a) the following shall be added to the seventh ident of paragraph 1: 'The reintroduction of pigs shall take account of the type of farming practised on the holding  concerned and must conform to one of the following procedures: 1. as regards open-air pig holdings: 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, 21 and 42 days after having been placed 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 re-population may take  place; 2. for all other forms of rearing, the reintroduction of pigs shall take place either in accordance  with the measures provided for in paragraph 1 or with the following provisions: - the reintroduction of piglets shall be based on total repopulation, provided that: - all the pigs arrive within a period of eight days and come from holdings situated outside the  restriction zone, - no pig may leave the holding for a period of 60 days after the arrival of the last pigs, - the repopulated herd is subjected to a serological examination in accordance with Annexes I and  IV. That examination may be carried out at the earliest 30 days after the arrival of the last  pigs.`; (b) paragraph 2 shall be replaced by the following text: '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 shall be inserted: 'Article 6a 1.  Immediately after the competent authority of a Member State 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 to hunters, and by  investigations 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 be carried out 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. However, as regards open-air pig holdings, the first census carried out may be done on the basis of  an estimate; (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 enter or leave the holding save where authorized by the competent authority having  regard to the epidemiological situation; (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 with classical swine-fever symptoms on a holding be tested for the  presence of classical swine-fever; (f) no part of any feral pig (whether shot or found dead) shall be brought into a holding. 3.  Without prejudice to the measures laid down in paragraph 2, Member States shall submit to the  Commission at the earliest opportunity a written plan of the measures taken to eradicate the  disease in an area defined as infected and the measures applied on the holdings in that area. 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 siutation. 4.  After the measures provided for in the plan mentioned in paragraph 3 have been approved, they  shall replace the initial measures referred to in paragraph 2, on a date which shall be decided  upon when approval is given. 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 existence of major natural or man-made obstacles to 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 testing; (d) the organization of close cooperation between biologists, hunters, hunting organizations, the  wildlife services and veterinary services (animal health and public health); (e) the reduction of the feral pig population and the issuing of hunting permits; the requirements  to be complied with by hunters in order to avoid any spread of the disease; the period adopted for  reduction of the feral pig population shall consist of an initial eradication period to be followed  by a surveillance period; (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 epizootiological 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 on which 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-prevention 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 is inserted: 'Article 7a In order to provide full coordination of all measures necessary to ensure eradication of clasiscal  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 the Community crisis unit shall be adopted  by the Council acting on a proposal from the Commission.`;  5. the second subparagraph of Article 8 (2) shall be replaced by the following: 'Where an authorization has been 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 that the meat of the said pigs complies with  the conditions laid down in Article 9 (4) (g).`;  6. Article 9 shall be 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 authority shall establish a protection zone with a radius of at least  three kilometres around the outbreak site, which shall itself be included in a surveillance zone of  a radius of at least 10 kilometres. 2.  When establishing zones, the competent authority must 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 breeding and slaughter pigs and the availability of slaughterhouses; (f) the facilities for checking and the nature of the checks employed, whether or not slaughter is  carried out on the infected premises. 3.  If a zone includes parts of the territory of several Member States, the competent authorities  of the Member States concerned shall collaborate to establish the zone. 4.  The following measures shall be applied in the protection zone: (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 not more than  seven days; (b) the movement and transport of pigs on public or private roads shall be prohibited. This  prohibition shall not apply to the transit of pigs by road or rail without unloading or stopping.  However, in accordance with the procedure may be granted for slaughter pigs coming from outside the  protection zone and on their way to a slaughterhouse situated in the said zone; (c) trucks and other vehicles and equipment, which are used to transport pigs or other livestock or  material which may be contaminated (e.g. 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. Those procedures shall provide in particular that no truck or vehicle which  has been used in the transport of pigs may leave the zone without being inspected by the competent  authority; (d) no other species of animal may enter or leave a holding without the authorization of the  competent authority; (e) all dead or diseased pigs on a holding shall be notified to the competent authority, which  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 for 21 days after the completion  of the preliminary cleaning and disinfection of the infected holdings as provided for 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, provided that: - 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 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 the 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 any signs relating to the presence of the classical swine-fever  virus, (ii) under exceptional circumstances, directly to other premises located within the protection zone  provided that: - an inspection of all the pigs on the holdings 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; (g) fresh meat from the pigs referred to in paragraph 4 (f) shall be marked in accordance with the  Annex to 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 the rules laid  down in 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 must be done at an establishment  designated by the competent authority. The meat shall be sent to the said establishment on condition that the consignment is sealed before  departure and remains sealed throughout the transport. However, at the request of a Member State, accompanied by appropriate justification and in  accordance with the procedure laid down in Article 16, specific solutions may be adopted, in  particular with respect to the marking of meat and its subsequent use, and the destination of the  processed products.  (*) OJ N° L 302, 31. 12. 1972, p. 24. Directive last amended by Directive 89/662/EEC (OJ N° L 395,  30. 12. 1989, p. 13). (**) OJ N° L 47, 21. 2. 1980, p. 4. Directive last amended by Directive 89/662/EEC. 5.  The measures in the protection zone shall continue to be applied 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 which has revealed that they have no signs of disease suggesting  classical swine-fever, and (ii) a serological examination in accordance with Annexes I and IV without the detection of  antibodies to the 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 or private roads, excluding the service roads of  holdings, shall be prohibited, unless approved by the competent authority. This prohibition shall  not apply to the transit of pigs by road or rail, without unloading or stopping; (c) trucks and other vehicles and equipment which are used to transport pigs or other livestock or  material which may be contaminated (e.g. 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 procedures laid down by the competent authority; (d) no other species of animal may enter or leave a holding during the first seven days after  establishment of the zone without the authorization of the competent authority; (e) all dead or diseased pigs on a holding shall be reported to the competent authority, which  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 for seven days after the  completion of the preliminary cleaning and disinfection of the infected holding provided for in  Article 10; after seven 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, provided that: - 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 any signs relating to the presence of the classical swine-fever  virus; (ii) under exceptional circumstances, directly to other prenises located within the protection  zone, provided that: - 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 used for the transport of these pigs must be cleaned and  disinfected after each transport operation; (g) fresh meat derived from the pigs referred to in paragraph 6 (f) shall be marked as described in  the Annex to Directive 72/461/EEC and subsequently treated in accordance with the 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 on condition that the consignment is sealed before  departure and remains sealed throughout the transport. However, at the request of a Member State, accompanied by appropriate justification and in  accordance with the procedure laid down in Article 16, specific solutions may be adopted, in  particular with respect to the marking of meat and its subsequent use, and the destination of the  processed products. 7. The measures in the surveillance zone shall continue to be applied at least until: (a) all measures laid down in Article 10 have been carried out; (b) the pigs on all holdings have undergone a clinical examination and have been found to have no  signs of disease suggesting classical swine-fever; (c) a serological examination has been carried out by representative sampling of the holdings, to  be determined in accordance with the procedure laid down in Article 16 and such sampling has failed  to reveal any antibodies to the classical swine-fever virus. The examinations referred to in (b) and (c) may not take place before 15 days have elapsed after  completion of preliminary cleaning and disinfection measures on the infected holding. 8. By derogation from paragraphs 4 (f) and 6 (f), the competent authority may authorize that pigs  be moved from the holding to be transported to a rendering plant for rendering or to a place where  the pigs are slaughtered in order to be burned or buried. These animals shall be tested at random  for the presence of the classical swine-fever virus. The criteria laid down in Annex IV with regard  to the collection of blood samples shall be taken into account during such random testing. All necessary precautions shall be taken to avoid the risk of spreading the virus during such  transport, in particular by cleaning and disinfecting the truck after the transport. 9. Where the prohibitions provided for in paragraphs 4 (f) and 6 (f) are maintained beyond 30 days  because of an outbreak of further cases of the disease and as a result problems arise in keeping  the pigs, the competent authority may, following a reasoned application by the owner, authorize  removal of pigs from a holding within the protection or surveillance zone, as the case may be,  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 carried 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. Es All necessary precautions shall be taken to avoid the risk of spreading the virus during such  transport, in particular by cleaning and disinfecting the truck after the transport. 10. The competent authority shall take all necessary measures, including the use of prominent signs  and warning notices and use of media resources, such as the press and television, to ensure that  all persons in the protection and surveillance zones are fully aware of the restrictions in force,  and shall take such measures as they consider appropriate to ensure the adequate enforcement of  these measures.`;  7. Article 10 shall be 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 an infected holding as laid down in Annex V.`;  8. the following Article shall be inserted: 'Article 10a Should classical swine-fever be confirmed in a slaughterhouse, the competent authority shall ensure  that: (a) all pigs in the slaughterhouse are slaughtered without delay; (b) the carcases and offal 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; (d) an epidemiological enquiry is carried out in accordance with Article 7; (e) no pigs are reintroduced for slaughter until at least 24 hours after completion of the cleaning  and disinfection operations carried out in accordance with (c).`;  9. Article 14 shall be 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 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 in the territory  of the Community are carried out under official control. 2. Notwithstanding paragraph 1 concerning the use of classical swine-fever vaccine, it may be  decided, when classical swine-fever has been confirmed and threatens to spread, that emergency  vaccination may be introduced. In this case, the Member State concerned shall submit to the  Commission an emergency vaccination plan which shall include information on: (a) the disease situation which has resulted in the request for emergency vaccination; (b) the extent of geographical area in which emergency vaccination is to be carried out; (c) categories of pigs and the approximate number of pigs to be vaccinated; (d) the vaccine to be used; (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 procedure laid down in Article 16, the emergency vaccination plan  may be approved or amendments and additions may be requested before approval is given, especially  where marking is concerned. 3. Any Member State which carries out 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 that  area; - all fresh pig meat produced from pigs vaccinated during the emergency vaccination bears the stamp  provided for in Article 5a of Directive 72/461/EEC and is stored and transported separately from  meat not bearing the said stamp. 4. Paragraph 3 shall apply during the emergency vaccination period and for a minimum of six months  following completion of the vaccination operations in the affected area. In accordance with the procedure laid down in Article 16 and before the end of the said six-month  period, measures shall be taken to ban: (a) sero-positive pigs from leaving the holding where they are kept, except for immediate  slaughter; (b) piglets of sero-positive sows from leaving their holding of origin unless being transported  to: - a slaughterhouse for immediate slaughter, - a holding designated by the competent authority, from which they are to be sent directly to the  slaughterhouse, - a holding after obtaining a negative result from a serological test for antibodies against the  classical swine-fever virus. 5. If necessary, the Commission shall adopt rules relating to the production, packaging,  distribution and state of the stocks of classical swine-fever vaccines in the Community.`; 10. Article 14a shall be replaced by the following: 'Article 14a Veterinary experts from the Commission may, in collaboration with the autorities of the Member  State concerned and, 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 such  checks. A Member State in whose territory a check is being carried out shall give all 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. The following Article shall be inserted: 'Article 14b 1. Each Member State shall draw up a contingency plan specifying the national measures to be  implemented in the event of an outbreak of classical swine-fever. This plan should allow access to facilities, equipment, personnel and all other appropriate  materials necessary for the rapid and efficient eradication of the outbreak. It must give a precise  indication of the vaccine requirements which each Member State concerned considers it needs in the  event of emergency vaccination. 2. The criteria to be applied mutatis mutandis for drawing up the contingency plan shall be those  laid down in Commission Decision 91/42/EEC of 8 January 1991 laying down the criteria to be applied  when drawing up contingency plans for the control of foot and mouth disease in application of  Article 5 of Council Decision 90/423/EEC (*). The Commission may, in accordance with Article 16, amend or supplement those criteria taking into  account the specific nature of classical swine-fever. 3. Plans drawn up in accordance with the criteria provided for in paragraph 2 shall be submitted to  the Commission not later than 1 January 1993. 4. The Commission shall examine the plans in order to determine whether they permit the desired  objective to be attained and shall suggest to the Member State concerned any amendments required,  in particular to ensure that they are compatible with those of the other Member States. The Commission shall approve the plans, if necessary amended, in accordance with the procedure laid  down in Article 16. The plans may subsequently be amended or supplemented, in accordance with the same procedure, to  take into account developments in the situation. (*) OJ N° L 23, 29. 1. 1991, p. 29.` 12. Annex I shall be replaced by the following: 'ANNEX I DIAGNOSTIC PROCEDURES FOR THE CONFIRMATION OF DIFFERENTIAL DIAGNOSIS OF CLASSICAL SWINE-FEVER Notwithstanding the period required for antibodies to develop, 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,  partoid, 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 prohability of detection of antibody, samples  should be collected from each unit of the holding at this level. 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, tests for the detection of antibody shall be applied to blood  samples from animals which are no longer suspect and from those suspected of having 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 pestvirus-specific polyclonal antiserum to CSF  virus, labelled with a fluorochrome, enzyme or biotin, according to the following cirteria: (a) hyperimmune serum shall be prepared from pigs which are free from infections or the serum of  which is free from any antibody which could affect the specifity or quality of the reactions; (b) labelled immunglobulin 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). 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 inoculates, such cell 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 the 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 distinguish the CSF virus from the bovine virus diarrhoea (BVD) or border disease  (BD) viruses. (b) Only monoclonals which have been officially recommended by the Community Referernce Laboratory  for Classical Swine-Fever should be used. (c) The monoclonals should be grouped into four panels according to the following criteria: >TABLE> Each panel may be represented by either a single monoclonal or a mixture of the  competent monoclonal antibodies, provided that the spectrum of reactivity corresponds to that given  above. (d) The interpretation of the reaction patterns is summarized as follows: >TABLE>C. DETECTION OF ANTIBODIES TO CLASSICAL SWINE-FEVER VIRUS The detection of CSF virus antibodies 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 purpose 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 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 Community 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 Community Reference Laboratory for Classical Swine-Fever. 1. The virus-neutralization test This test is based on the determination of the neutralizing 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-linked antibody (NPL) assays must 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 log10) infectious doses (TCID 50). At least two  cultures are used for each dilution. 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. A point between two dilution levels is estimated. 2. The enzyme-linked immunosorbent assay (Elisa) Competitive, blocking and indirect techniques may be used on any suitable support. It is recommanded 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. Antigen 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. 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 assay should use an anti-porcine immunoglobulin reagent which detects both lgG and  lgM. The sensitivity of the Elisa should be high enough to score positive any serum reacting in the  neutralization test and also reference positive sera as issued by the Community Reference  Laboratory for CSF.The Elisa procedure may be used only with serum or plasma samples derived from individual pigs. If the Elisa procedure used is not CSF-specific, 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 that 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. (a) In order to rule out the suspicion of CSF raised by the detection of antibody, the test  described in Section E shall be used to distinguish between CSF-reactive antibody which 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  7 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  7  1/10 in any pig without clinical or epizootiological 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 Elisa result. E. SEROLOGICAL PROCEDURES FOR THE DIFFERENTIAL DIAGNOSIS BETWEEN CLASSICAL SWINE-FEVER AND OTHER  PESTIVIRUSES 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 section C). 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 refrence strains of CSF and other  pestiviruses shall be interpreted as follows: (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 pestiviruses in more than one of the pigs, there shall be suspicion of CSF and  differentiation shall proceed as follows: - those pigs which show 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  foetuses, shall be subjected to examination for CSF antigen or virus, following the procedure  defined in B (1), (2) or (3), - if CSF virus antigen or virus is detected, CSF shall be confirmed, - if the examination defined in the second indent 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 shall be ruled out, - if one or more animals show a titre against CSF virus which is equal to, or higher than, its  titre to BVD/BD virus, the result shall be 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. F. THE DIFFERENTIAL DIAGNOSIS OF AFRICAL 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 heamorrhagic syndrome of pigs. 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 antobodies in organs and tissue fluids. In the case of inconclusive or negative results of at least two tests on samples from animals  giving rise to suspicion of ASF or with material from holdings which had contracts 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 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 confirm ASF diagnosis. (b) Pig inoculation A pool is made with aliquote for each 10 % tissue suspension and 2 ml 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 rectal temperature and onset of clinical signs for 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. G. DETECTION OF ANTIBODIES INDUCED BY ASF-VIRIS IN BLOOD SAMPLES AND TISSUE FLUIDS The detection of antibodies 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 (IIF) test; (b) Elisa`.; 12. The following Annexes shall be added after Annex III: '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. Sampling of groups - If 20 or fewer than 20 pigs in a group: - two pigs. Where the group consists of a sow with piglet, only the sow shall be sampled, - if more than 20: - two pigs + 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 >TABLE>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 for 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 seven days the premises should be treated with a degreasing agent, rinsed with cold  water, sprayed with disinfectant and rinsed again with 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.` Article 2 Member States shall bring into force the laws, regulations and administrative  provisions necessary to comply with this Directive not later than 1 July 1992. They shall fortwith  inform the Commission thereof. When the above measures are adopted by the Member States, they 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, 11 December 1991. For the CouncilThe PresidentP. BUKMAN    (1)OJ N° C 226, 31. 8. 1991, p. 6.  (2)OJ N° C 326, 16. 12. 1991.  (3)Opinion delivered on 28 November 1991 (not yet published in the Official Journal).  (4)OJ N° L 47, 21. 2. 1980, p. 11.  (5)OJ N° L 280, 3. 10. 1987, p. 21.