Council Directive 2002/60/EC
of 27 June 2002
laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever
(Text with EEA relevance)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease(1), and in particular Article 15 and Article 24(1) thereof,
Having regard to the proposal from the Commission,
Whereas:
(1) The general measures laid down in Directive 92/119/EEC are aimed at preventing the further spread of certain animal diseases of major economic importance and in particular at controlling the movement of animals and products liable to spread the infection.
(2) The International Office of Epizootics (OIE) is the technical reference body for animal health recognised by the World Trade Organisation. It has drawn up a list of epidemic animal diseases of major economic importance (List A).
(3) It is necessary and appropriate that Directive 92/119/EEC should apply to all the epidemic diseases on List A, with the exception of those for which specific provision has already been made at Community level.
(4) Teschen disease is no longer included in List A. It is therefore appropriate to delete that disease from the list set out in Annex I to Directive 92/119/EEC.
(5) African swine fever is a disease of major economic importance, included in List A, which occurs in certain limited areas of the Community. It is therefore appropriate to establish Community measures for the control of that disease.
(6) African swine fever should be included in the list set out in Annex I to Directive 92/119/EEC and specific provisions for its control should be laid down in accordance with Article 15 of that Directive.
(7) Measures should be adopted to control the movement of pigs and their products from areas subject to restrictions arising from an outbreak of African swine fever. Such measures should be similar to those established at Community level for the control of other pig diseases such as swine vesicular disease and classical swine fever.
(8) In particular, Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever(2) should be used as a model for the establishment of specific measures for the control of African swine fever. However, adjustments should be made particularly because of the differences between the two diseases, the current lack of vaccines and especially the incubation period for African swine fever and the possibility that this disease is transmitted by vectors.
(9) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(3),
HAS ADOPTED THIS DIRECTIVE:
Article 1
Subject-matter
This Directive lays down the minimum Community measures for the control of African swine fever.
It removes Teschen disease from the group of diseases to which the general control measures laid down in Directive 92/119/EEC apply.
Article 2
Definitions
For the purposes of this Directive:
(a) "pig" shall mean any animal of the Suidae family, including feral pigs;
(b) "feral pig" shall mean a pig which is not kept or bred on a holding;
(c) "holding" shall mean any agricultural or other premises located in the territory of a Member State where pigs are being bred or kept on a permanent or temporary basis. This definition does not include slaughterhouses, means of transport and fenced areas where feral pigs are kept and may be hunted; these fenced areas must be of a size and structure that makes the measures laid down in Article 5(1) not applicable;
(d) "diagnostic manual" shall mean the diagnostic manual referred to in Article 18(3);
(e) "pig suspected of being infected with African swine fever virus" shall mean any pig or pig carcase exhibiting clinical symptoms or showing post mortem lesions or reactions to laboratory tests carried out in accordance with the diagnostic manual which indicate the possible presence of African swine fever;
(f) "case of African swine fever" or "pig infected with African swine fever" shall mean any pig or pig carcase:
- in which clinical symptoms or post mortem lesions of African swine fever have been officially confirmed, or
- in which the presence of the disease has been officially confirmed as the result of a laboratory examination carried out in accordance with the diagnostic manual;
(g) "outbreak of African swine fever" shall mean the holding where one or more cases of African swine fever has or have been detected;
(h) "primary outbreak" shall mean the outbreak within the meaning of Article 2(d) of Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community(4);
(i) "infected area" shall mean the area of a Member State where, following the confirmation of one or more cases of African swine fever in feral pigs, disease eradication measures are in place in accordance with Article 15 or 16;
(j) "primary case of African swine fever in feral pigs" shall mean any case of African swine fever which is detected in feral pigs in an area in which no measures are in place in accordance with Article 15 or 16;
(k) "contact holding" shall mean a holding where African swine fever may have been introduced, whether as a result of the location, movement of persons, pigs or vehicles or in any other way;
(l) "owner" shall mean 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;
(m) "competent authority" shall mean the competent authority within the meaning of Article 2(6) of Directive 90/425/EEC(5);
(n) "official veterinarian" shall mean the veterinarian designated by the competent authority of the Member State;
(o) "processing" shall mean one of the treatments for high risk material laid down in Article 3 of Directive 90/667/EEC(6), applied in such a way as to avoid the risk of spread of the African swine fever virus;
(p) "killing" shall mean the killing of pigs within the meaning of Article 2(6) of Directive 93/119/EEC(7);
(q) "slaughter" shall mean the slaughter of pigs within the meaning of Article 2(7) of Directive 93/119/EEC;
(r) "vector" shall mean a tick of the species Ornithodorus erraticus.
Article 3
African swine fever notification
1. Member States shall ensure that the presence or the suspected presence of African swine fever is compulsorily and immediately notifiable to the competent authority.
2. Without prejudice to existing Community provisions on notification of outbreaks of animal diseases, the Member State in whose territory African swine fever is confirmed shall:
(a) give notification of the disease and provide information to the Commission and the other Member States in accordance with Annex I on:
- the outbreaks of African swine fever which are confirmed in holdings,
- the cases of African swine fever which are confirmed in a slaughterhouse or in means of transport,
- the primary cases of African swine fever which are confirmed in feral pigs,
- the results of the epidemiological inquiry carried out in accordance with Article 8;
(b) provide information to the Commission and the other Member States on the further cases confirmed in feral pigs in an African swine fever infected area in accordance with Article 16(3)(a) and (4).
Article 4
Measures in cases where the presence of African swine fever on a holding is suspected
1. Where a holding contains one or more pigs suspected of being infected with African swine fever virus, Member States shall ensure that the competent authority immediately sets in motion official means of investigation to confirm or rule out the presence of the said disease in accordance with the procedures laid down in the diagnostic manual.
When the holding is visited by an official veterinarian, a check of the register and of the pig identification marks referred to in Articles 4 and 5 of Council Directive 92/102/EEC of 27 November 1992 on the identification and registration of animals(8) shall also be carried out.
2. When the competent authority considers that the presence of African swine fever in a holding cannot be ruled out, it shall immediately have the holding placed under official surveillance and shall in particular order that:
(a) all the pigs in the various categories on the holding are to be counted and a list compiled of the number of pigs already sick, dead or likely to be infected in each category; the list shall be updated to take account of pig births and deaths during the period of suspicion; the information on the list shall be produced upon request and may be checked at each visit;
(b) all the pigs on the holding shall be restricted to their living quarters or confined in some other place where they can be isolated;
(c) no pigs may enter or leave the holding. The competent authority may, if necessary, extend the ban on leaving the holding to cover other species of animals and require the application of appropriate measures to destroy rodents or insects;
(d) no pig carcases may leave the holding without an authorisation issued by the competent authority;
(e) no meat, pig products, semen, ova or embryos of pigs, animal feed, utensils, materials or waste likely to transmit African swine fever may leave the holding without an authorisation issued by the competent authority; meat, pig products, semen, ova or embryos shall not be moved from the holding for intra-Community trade;
(f) the movement of persons to or from the holding shall be subject to written authorisation by the competent authority;
(g) the movement of vehicles to or from the holding shall be subject to written authorisation by the competent authority;
(h) appropriate means of disinfection shall be used at the entrances and exits of buildings housing pigs and of the holding itself; any person entering or leaving pig holdings shall comply with appropriate hygiene measures necessary to reduce the risk of African swine fever virus spreading. Furthermore, all means of transport shall be carefully disinfected before leaving the holding;
(i) an epidemiological inquiry shall be carried out in accordance with Article 8.
3. Where required by the epidemiological situation, the competent authority:
(a) may apply the measures provided for in Article 5(1) in the holding referred to in paragraph 2 of this Article; however, the competent authority may, where it considers that conditions permit, limit the application of these measures only to the pigs suspected of being infected or contaminated with African swine fever virus and the part of the holding where they were kept, provided that those pigs have been housed, kept and fed completely separately from the other pigs in the holding. In any case, a sufficient number of samples shall be taken from the pigs when they are killed in order that the presence of African swine fever virus can be confirmed or ruled out, in accordance with the diagnostic manual;
(b) may establish a temporary control zone around the holding referred to in paragraph 2; some or all the measures referred to in paragraphs 1 or 2 shall be applied in the pig holdings within this zone.
4. Once adopted, the measures provided for in paragraph 2 shall not be lifted until the presence of African swine fever has been officially ruled out.
Article 5
Measures in cases where the presence of African swine fever on a holding is confirmed
1. In cases where the presence of African swine fever is officially confirmed in a holding, Member States shall ensure that, in addition to the measures referred to in Article 4(2), the competent authority prescribes that:
(a) all pigs on the holding are to be killed without delay under official supervision and in such a way as to avoid the risk of African swine fever virus spreading during transport or killing;
(b) a sufficient number of samples are to be taken, in accordance with the diagnostic manual, from the pigs when they are killed, in order that the manner of introduction of African swine fever virus into the holding and the length of time during which it may have existed on the holding before the disease was notified may be established;
(c) the carcases of pigs which have died or have been killed are to be processed under official supervision;
(d) meat of pigs slaughtered during the period between the probable introduction of the disease into the holding and the taking of official measures is wherever possible to be traced and processed under official supervision;
(e) semen, ova or embryos of pigs collected from the holding during the period between the probable introduction of disease into the holding and the taking of official measures are to be traced and destroyed under official supervision in such a way as to avoid the risk of African swine fever virus spreading;
(f) all substances and waste likely to be contaminated, such as feedingstuffs, are to be processed; all materials for single use which may be contaminated and in particular those used for the killing operations are to be destroyed; these actions are to be carried out in accordance with the instructions of the official veterinarian;
(g) after the pigs have been eliminated, the buildings used for housing the pigs, the vehicles used for transporting them or their carcases and the equipment, bedding, manure and slurry likely to be contaminated are to be cleaned, if necessary disinsectised, disinfected and treated in accordance with Article 12;
(h) in the case of a primary outbreak of disease, the African swine fever virus isolate is to be subject to the laboratory procedure laid down in the diagnostic manual to identify the genetic type;
(i) an epidemiological inquiry is to be carried out in accordance with Article 8.
2. In cases where an outbreak has been confirmed in a laboratory, a zoo, a wild life park or a fenced area where pigs are kept for scientific purposes or purposes related to conservation of species or conservation of rare breeds, the Member State concerned may decide to derogate from paragraphs 1(a) and 1(e), provided that basic Community interests are not adversely affected.
Such a decision shall immediately be notified to the Commission.
The Commission shall in all cases immediately review the situation with the Member State concerned and in the Standing Veterinary Committee at the earliest possible opportunity. If necessary, measures to prevent the disease spreading shall be adopted in accordance with the procedure referred to in Article 24(2).
Article 6
Measures in cases where the presence of African swine fever is confirmed in holdings consisting of various production units
1. Where the presence of African swine fever is confirmed in holdings which consist of two or more separate production units and in order that the fattening of pigs may be completed, the competent authority may decide to derogate from the provisions of Article 5(1)(a) as regards healthy pig production units on a holding which is infected provided that the official veterinarian confirms that the structure, size and distance apart of these production units and the operations carried out there are such that the production units provide completely separate facilities for housing, keeping and feeding, so that the virus cannot spread from one production unit to another.
2. If use is made of the derogation referred to in paragraph 1, Member States shall draw up detailed rules for applying it in the light of the animal health guarantees which can be secured.
3. Member States which make use of this derogation shall immediately notify the Commission thereof. The Commission shall in all cases immediately review the situation with the Member State concerned and in the Standing Veterinary Committee at the earliest possible opportunity. If necessary, measures to prevent the disease spreading shall be adopted in accordance with the procedure laid down in Article 24(2).
Article 7
Measures in contact holdings
1. Holdings shall be recognised as contact holdings where the official veterinarian finds, or considers on the basis of the epidemiological inquiry carried out in accordance with Article 8, that African swine fever may have been introduced, either from other holdings to the holding referred to in Article 4 or 5, or from the latter holding to other holdings.
Article 4 shall be applied in such holdings until the presence of African swine fever has been officially ruled out.
2. The competent authority shall apply the measures provided for in Article 5(1) in the contact holdings referred to in paragraph 1 of this Article if the epidemiological situation so requires.
A sufficient number of samples shall be taken from the pigs, in accordance with the diagnostic manual, when they are killed in order that the presence of African swine fever virus in these holdings can be confirmed or ruled out.
Article 8
Epidemiological inquiry
Member States shall ensure that the epidemiological inquiry in relation to suspected cases or outbreaks of African swine fever is carried out on the basis of questionnaires, prepared within the framework of the contingency plans referred to in Article 21.
Such an inquiry shall deal at least with:
(a) the length of time during which African swine fever virus may have existed on the holding before the disease was notified or suspected;
(b) the possible origin of African swine fever on the holding and the identification of other holdings in which pigs may have become infected or contaminated from the same source;
(c) the movement of persons, vehicles, pigs, carcases, semen, meat or any material which could have carried the virus to or from the holdings in question;
(d) the possibility that vectors or feral pigs cause the disease to spread.
If the results of this inquiry suggest that African swine fever may have spread from or to holdings located in other Member States, the Commission and the Member States concerned shall be immediately informed.
Article 9
Establishment of protection and surveillance zones
1. Immediately after the diagnosis of African 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.
The measures referred to in Articles 10 and 11 shall be applied in the respective zones.
2. When establishing zones, the competent authority must take account of:
(a) the results of the epidemiological inquiry carried out in accordance with Article 8;
(b) the geographical situation, particularly natural or artificial boundaries;
(c) the location and proximity of holdings;
(d) patterns of movements and trade in pigs and the availability of slaughterhouses and facilities for processing carcases;
(e) the facilities and personnel available to control any movement of pigs within the zones, in particular if the pigs to be killed have to be moved away from their holding of origin.
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 competent authority shall take all necessary measures, including the use of prominent signs and warning notices and the 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 in accordance with Articles 10 and 11, and shall take such measures as it considers appropriate to ensure the adequate enforcement of these measures.
Article 10
Measures in the established protection zone
1. Member States shall ensure that the following measures are applied in the protection zone:
(a) a census of all the holdings shall be carried out 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 in order to conduct a clinical examination of the pigs and to check the register and the pig identification marks referred to in Articles 4 and 5 of Directive 92/102/EEC;
(b) the movement and transport of pigs on public or private roads, excluding when necessary the service roads of holdings, shall be prohibited unless approved by the competent authority when allowing the movements referred to in point (f). This prohibition need not be applied to the transit of pigs by road or rail without unloading or stopping. Furthermore, in accordance with the procedure referred to in Article 24(2), a derogation may be granted for slaughter pigs coming from outside the protection zone and on their way to a slaughterhouse situated in the said zone for immediate slaughter;
(c) trucks and other vehicles and equipment, which are used to transport pigs or other livestock or material which may be contaminated (such as carcases, feedingstuff, manure, slurry and so forth) shall be cleaned, disinfected, if necessary disinsectised and treated as soon as possible after contamination, in accordance with Article 12. No truck or vehicle which has been used for the transport of pigs may leave the zone without being cleaned and disinfected and then inspected and re-authorised for transport by the competent authority;
(d) no other domestic animal may enter or leave a holding without the authorisation of the competent authority;
(e) all dead or diseased pigs on a holding shall be immediately notified to the competent authority, which shall carry out appropriate investigations in accordance with the procedures laid down in the diagnostic manual;
(f) pigs may not be removed from the holding in which they are kept for at least 40 days after the completion of the preliminary cleansing and disinfection, and, if necessary, disinsectisation of the infected holdings. After 40 days, subject to the conditions referred to in paragraph 3, the competent authority may authorise the removal of pigs from the said holding to be directly transported to:
- a slaughterhouse designated by the competent authority, preferably within the protection or surveillance zone for the purpose of immediate slaughter,
- a processing plant or a suitable place where the pigs are immediately killed and their carcases are processed under official supervision,
- in exceptional circumstances, to other premises located within the protection zone. Member States making use of this provision shall immediately inform the Commission thereof in the Standing Veterinary Committee;
(g) semen, ova or embryos of pigs shall not leave the holdings situated within the protection zone;
(h) any person entering or leaving pig holdings shall comply with appropriate hygiene measures as necessary to reduce the risk of African swine fever virus spreading.
2. Where the prohibitions provided for in paragraph 1 are maintained beyond 40 days because of further outbreaks of the disease and as a result animal welfare or other problems arise in keeping the pigs, subject to the conditions referred to in paragraph 3, the competent authority may, following a reasoned application by the owner, authorise the removal of pigs from a holding within the protection zone, to be directly transported to:
(a) a slaughterhouse designated by the competent authority, preferably within the protection or surveillance zone for the purpose of immediate slaughter;
(b) a processing plant or a suitable place where the pigs are immediately killed and their carcases are processed under official supervision;
(c) in exceptional circumstances, to other premises located within the protection zone. Member States making use of this provision shall immediately inform the Commission thereof in the Standing Veterinary Committee.
3. Where reference is made to this paragraph, the competent authority may authorise the removal of pigs from the holding concerned, on condition that:
(a) an official veterinarian has carried out a clinical examination of the pigs in the holding and in particular of those to be moved, including the taking of the body temperature in accordance with the procedures laid down in the diagnostic manual and a check of the register and the pig identification marks referred to in Articles 4 and 5 of Directive 92/102/EEC;
(b) the checks and examinations referred to in point (a) have shown no evidence of African swine fever and compliance with Directive 92/102/EEC;
(c) the pigs are transported in vehicles sealed by the competent authority;
(d) the vehicle and equipment which have been involved in the transport of the pigs are immediately cleaned and disinfected after the transport in accordance with the provisions referred to in Article 12;
(e) if the pigs are to be slaughtered or killed, a sufficient number of samples is then taken from the pigs in accordance with the diagnostic manual in order that the presence of African swine fever virus in these holdings can be confirmed or ruled out;
(f) if the pigs are to be transported to a slaughterhouse:
- the competent authority responsible for the slaughterhouse has been informed of the intention to send the pigs and notifies the dispatching competent authority of their arrival,
- on arrival at the slaughterhouse, these pigs are kept and slaughtered separately from other pigs,
- during ante and post mortem inspection carried out at the designated slaughterhouse, the competent authority takes into account any signs of the presence of African swine fever,
- the fresh meat from these pigs is either processed or marked with the special mark referred to in Article 5a of Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community trade in fresh meat(9), and is processed separately in accordance with the rules laid down in Article 4(1)(a)(i) of Council Directive 80/215/EEC of 22 January 1980 on animal health problems affecting intra-Community trade in meat products(10). This must be done at an establishment designated by the competent authority. The meat must be sent to the said establishment on condition that the consignment is sealed before departure and remains sealed throughout the transport.
4. The measures in the protection zone shall continue to be applied at least until:
(a) cleansing, disinfection and, if necessary, disinsectisation in the infected holdings have been carried out;
(b) pigs on all holdings have undergone clinical and laboratory examinations carried out in accordance with the diagnostic manual in order to detect the possible presence of African swine fever virus.
The examinations referred to in point (b) shall not take place until 45 days have elapsed since the completion of preliminary cleansing, disinfection and, if necessary, disinsectisation measures on the infected holdings.
5. However, by way of derogation from paragraphs 1(f), and from paragraphs 2 and 4, the 40- and 45-day periods stipulated therein may be reduced to 30 days if, in accordance with the diagnostic manual, the Member States have applied an intensive sampling and testing programme making it possible to rule out the presence of African swine fever on the holding in question.
Article 11
Measures in the established surveillance zone
1. Member States shall ensure that the following measures are 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 when necessary the service roads of holdings, shall be prohibited, unless approved by the competent authority. This prohibition need not be applied to the transit of pigs by road or rail, without unloading or stopping, or to slaughter pigs coming from outside the surveillance zone and on their way to a slaughterhouse situated in the said zone for immediate slaughter;
(c) trucks and other vehicles and equipment which are used to transport pigs or other livestock or material which may be contaminated (such as carcases, feedingstuff, manure, slurry and so forth) shall be cleaned, disinfected, if necessary disinsectised and treated as soon as possible after contamination, in accordance with Article 12. No truck or vehicle which has been used in the transport of pigs may leave the zone without having been cleaned and disinfected;
(d) no other domestic animal may enter or leave a holding during the first seven days after establishment of the zone without the authorisation of the competent authority;
(e) all dead or diseased pigs on a holding shall be immediately notified to the competent authority, which shall carry out appropriate investigations in accordance with the procedures laid down in the diagnostic manual;
(f) pigs may not be removed from the holding in which they are kept for at least 30 days after the completion of the preliminary cleansing, disinfection and, if necessary, disinsectisation of the infected holdings. After 30 days, subject to the conditions set out in Article 10(3), the competent authority may authorise the removal of the pigs from the said holding to be directly transported to:
- a slaughterhouse designated by the competent authority, preferably within the protection or surveillance zone, for the purpose of immediate slaughter,
- a processing plant or a suitable place where the pigs are immediately killed and their carcases are processed under official supervision, or
- in exceptional circumstances, other premises located within the protection or surveillance zone. Member States making use of this provision shall immediately inform the Commission thereof in the Standing Veterinary Committee.
However, if the pigs are to be transported to a slaughterhouse, at the request of a Member State, accompanied by appropriate justification, and in accordance with the procedure referred to in Article 24(2), derogations from Article 10(3)(e) and (f), fourth indent, may be authorised, in particular with respect to the marking of the meat from these pigs and its subsequent use, and the destination of the treated products;
(g) semen, ova or embryos of pigs shall not leave the holdings situated within the surveillance zone;
(h) any person entering or leaving pig holdings shall comply with appropriate hygienic measures as necessary to reduce the risk of African swine fever virus spreading.
2. Where the prohibitions provided for in paragraph 1 are maintained beyond 40 days because of further outbreaks of the disease, and where as a result animal welfare or other problems arise in keeping the pigs, subject to the conditions referred to in Article 10(3), the competent authority may, following a reasoned application by the owner, authorise the removal of pigs from a holding within the surveillance zone to be directly transported to:
(a) a slaughterhouse designated by the competent authority, preferably within the protection or surveillance zone, for the purpose of immediate slaughter;
(b) a processing plant or a suitable place where the pigs are immediately killed and their carcases are processed under official supervision, or
(c) in exceptional circumstances, other premises located within the protection or surveillance zone. Member States making use of this provision shall immediately inform the Commission thereof in the Standing Veterinary Committee.
3. The measures in the surveillance zone shall continue to be applied at least until:
(a) cleansing, disinfection and, if necessary, disinsectisation in the infected holdings have been carried out;
(b) pigs on all holdings have undergone clinical and, where necessary, laboratory examinations as laid down in the diagnostic manual in order to detect the eventual presence of African swine fever virus.
The examinations referred to in point (b) shall not take place until 40 days have elapsed since the completion of preliminary cleansing, disinfection and, if necessary, disinsectisation measures on the infected holdings.
4. However, by way of derogation from paragraph 1(f), and from paragraphs 2 and 3, the 30-day periods stipulated in paragraph 1(f) and the 40-day periods stipulated in paragraphs 2 and 3 may be reduced respectively to 21, 30 and 20 days if, in accordance with the diagnostic manual, the Member States have applied an intensive sampling and testing programme making it possible to rule out the presence of African swine fever on the holding in question.
Article 12
Cleansing, disinfection and treatment with insecticides
Member States shall ensure that:
(a) the disinfectants and insecticides to be used and their concentrations are officially approved by the competent authority;
(b) the cleansing, disinfection and, if necessary, insecticide operations are carried out under official supervision in accordance with:
- the instructions given by the official veterinarian; and
- the principles and procedures laid down in Annex II.
Article 13
Repopulation of pig holdings following disease outbreaks
1. The reintroduction of pigs to holdings referred to in Article 5 shall not take place until at least 40 days after completion of the cleansing, disinfection and, if necessary, disinsectisation operations in the holding in question in accordance with paragraphs 2 to 5 of this Article.
2. The reintroduction of pigs shall take account of the type of farming practised on the holding concerned, and shall conform to one of the procedures set out in paragraphs 3 and 4.
3. In the case of holdings where the occurrence of disease has not been linked to vectors, the following procedure shall apply:
(a) as regards open-air holdings, the reintroduction of pigs shall start with the introduction of sentinel pigs which have been checked and found negative for the presence of antibodies against African swine fever virus or which come from holdings not subjected to any restrictions related to African swine fever. The sentinel pigs shall be placed, in accordance with the requirements of the competent authority, throughout the infected holding and shall be sampled 45 days later, and shall be tested for the presence of antibodies, in accordance with the diagnostic manual. No pig may leave the holding before the negative results of the serological tests are available; if none of the pigs has developed antibodies against African swine fever virus, full repopulation may then take place;
(b) as regards all other forms of rearing, the reintroduction of pigs shall either take place in accordance with the measures provided for in point (a) or shall be based on total repopulation, provided that:
- all the pigs arrive within a period of 20 days and come from holdings not subjected to any restrictions related to African swine fever,
- pigs in the repopulated herd shall be subjected to a serological examination in accordance with the diagnostic manual. Sampling for that examination shall be carried out at the earliest 45 days after the arrival of the last pigs,
- no pig may leave the holding before the negative results of the serological examination are available.
4. In the case of holdings where the occurrence of disease has been linked to vectors, restocking shall not take place for at least six years unless:
(a) specific operations to eliminate the vector from the premises and places where the pigs are to be kept or can come into contact with the vector have been successfully carried out under official supervision, or
(b) it has been possible to show that the persistence of the vector no longer represents a significant risk of African swine fever being transmitted.
Thereafter, the measures laid down in paragraph 3(a) shall apply.
In addition to those measures, however, no pig may leave the holding in question after full repopulation until further serological examinations for African swine fever have been carried out with negative results on samples collected from the pigs in the holding at the earliest 60 days after full repopulation, in accordance with the diagnostic manual.
5. Where the occurrence of disease has not been linked to vectors, and if more than six months have elapsed since the completion of the cleansing and disinfection operations in the holding, the competent authority may authorise derogation from paragraph 3, taking into account the epidemiological situation.
6. The reintroduction of domestic animals of species other than pigs to the holdings described in Article 5 shall be subject to authorisation by the competent authority, which shall take account of the risk of spreading the infection or of the persistence of vectors presented by such reintroduction.
Article 14
Measures in cases where African swine fever is suspected or confirmed in a slaughterhouse or means of transport
1. Where there is a suspicion of African swine fever in a slaughterhouse or means of transport, Member States shall ensure that the competent authority immediately sets in motion official means of investigation to confirm or to rule out the presence of the disease in accordance with the procedures laid down in the diagnostic manual.
2. Should a case of African swine fever be detected in a slaughterhouse or means of transport, the competent authority shall ensure that:
(a) all susceptible animals in the slaughterhouse or in the means of transport are killed without delay;
(b) the carcases, offal and animal waste of possibly infected and contaminated animals are processed under official supervision;
(c) cleansing, disinfection and, if necessary, disinsectisation of buildings and equipment, including vehicles, takes place under the supervision of the official veterinarian in accordance with Article 12;
(d) an epidemiological inquiry is carried out as provided in Article 8 mutatis mutandis;
(e) the African swine fever virus isolate is subject to the laboratory procedure laid down in the diagnostic manual, to identify the genetic type of virus;
(f) the measures referred to in Article 7 are applied in the holding where the infected pigs or carcases came from and in the other contact holdings. Unless otherwise indicated by the epidemiological inquiry, the measures laid down in Article 5(1) shall be applied in the holding of origin of the infected pigs or carcases;
(g) no animals are reintroduced for slaughter or transport until at least 24 hours after completion of the cleansing, disinfection and, if necessary, disinsectisation operations conducted in accordance with Article 12.
Article 15
Measures in cases where African swine fever is suspected or confirmed in feral pigs
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 or rule out the presence of the disease, by giving information to the owners 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 a primary case of African swine fever in feral pigs has taken place, in order to reduce the spread of disease, the competent authority of a Member State shall immediately:
(a) establish an expert group including veterinarians, hunters, wild life biologists and epidemiologists. The expert group shall assist the competent authority in:
- studying the epidemiological situation and defining an infected area in accordance with Article 16(3)(b),
- establishing appropriate measures to be applied in the infected area in addition to the ones referred to in points (b) and (c); these measures may include suspension of hunting and a ban on feeding feral pigs,
- drawing up the eradication plan to be submitted to the Commission in accordance with Article 16,
- carrying out checks to verify the effectiveness of the measures adopted to eradicate African swine fever from the infected area;
(b) place under official surveillance pig holdings in the defined infected area, and shall in particular order that:
- an official census be carried out of all categories of pigs on all holdings; the census shall be kept up to date by the owner. The information in the census shall 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,
- all pigs on the holding be kept in their living quarters or some other place where they can be isolated from feral pigs. Feral pigs must not have access to any material which may subsequently come in contact with the pigs on the holding,
- no pigs enter or leave the holding, except where authorised by the competent authority having regard to the epidemiological situation,
- appropriate means of disinfection and if necessary disinsectisation be used at the entrance and exits of buildings housing pigs and of the holding itself,
- appropriate hygiene measures be applied by all persons coming into contact with feral pigs, to reduce the risk of African swine fever virus spreading,
- all dead or diseased pigs with African swine fever symptoms on a holding be tested for the presence of African swine fever,
- no part of any feral pig, whether shot or found dead, nor any material or equipment which could be contaminated with African swine fever virus, shall be brought into a pig holding,
- pigs, their semen, embryos or ova shall not be moved from the infected area for intra-Community trade;
(c) arrange that all feral pigs shot or found dead in the defined infected area are inspected by an official veterinarian and examined for African swine fever in accordance with the diagnostic manual. Carcases of all animals found positive shall be processed under official supervision. Where such testing proves negative as regards African swine fever, Member States shall apply the measures laid down in Article 11(2) of Council Directive 92/45/EEC of 16 June 1992 on public health and animal health problems relating to the killing of wild game and the placing on the market of wild-game meat(11). Parts not intended for human consumption shall be processed under official supervision;
(d) ensure that the African swine fever virus isolate is subject to the laboratory procedure indicated in the diagnostic manual, to identify the genetic type of virus.
3. If a case of African swine fever has occurred in feral pigs in an area of a Member State close to the territory of another Member State, the Member States concerned shall collaborate in the establishment of disease control measures.
Article 16
Plans for the eradication of African swine fever from a feral pig population
1. Without prejudice to the measures laid down in Article 15, Member States shall submit to the Commission within 90 days of the confirmation of a primary case of African swine fever in feral pigs a written plan of the measures taken to eradicate the disease in the area defined as infected, and of 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. The plan, if necessary with amendments, shall be approved in accordance with the procedure referred to in Article 24(2).
The plan may subsequently be amended or supplemented to take account of developments in the situation.
If these amendments concern the re-definition of the infected area, Member States shall ensure that the Commission and the other Member States are informed of these amendments without delay.
If the amendments concern other provisions of the plan, Member States shall submit the amended plan to the Commission for examination and eventual approval in accordance with the procedure referred to in Article 24(2).
2. After the measures provided for in the plan mentioned in paragraph 1 have been approved, they shall replace the initial measures laid down in Article 15, on a date which shall be decided upon when approval is given.
3. The plan mentioned in paragraph 1 shall contain information on:
(a) the results of the epidemiological investigations and controls carried out in accordance with Article 15 and the geographical distribution of the disease;
(b) the definition of the infected area within the territory of the Member State concerned. When defining the infected area, the competent authority shall take into account:
- the results of the epidemiological investigations carried out and the geographical distribution of the disease,
- the feral pig population in the area,
- the existence of major natural or artificial obstacles to movements of feral pigs;
(c) the organisation of close cooperation between biologists, hunters, hunting organisations, the wildlife services and veterinary authorities (animal health and public health);
(d) the information campaign to be enforced to increase hunters' awareness of the measures they have to adopt in the framework of the eradication plan;
(e) specific efforts made to determine the extent of the infection in the feral pig population, by investigating feral pigs shot by hunters or found dead, and by laboratory testing, including age-stratified epidemiological investigations;
(f) the requirements to be complied with by hunters in order to avoid any spread of the disease;
(g) the method of removal of feral pigs found dead or shot, which shall be based on:
- processing under official supervision, or
- inspection by an official veterinarian and laboratory tests as provided for in the diagnostic manual. Carcases of all animals found positive shall be processed under official supervision. Where such testing proves negative as regards African swine fever, Member States shall apply the measures laid down in Article 11(2) of Directive 92/45/EEC. Parts not intended for human consumption shall be processed under official supervision;
(h) the epidemiological inquiry which is carried out on each feral pig, whether shot or found dead. This inquiry 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;
(i) surveillance programmes and prevention measures applicable to the holdings situated in the defined infected area, and, if necessary, in its surroundings, including the transport and movement of animals within, from and to the area; these measures shall at least include the ban on moving pigs, their semen, embryos or ova from the infected area for intra-Community trade and may include a temporary ban on pig production and on the establishment of new holdings;
(j) other criteria to be applied for lifting the measures taken;
(k) the authority with responsibility for supervising and coordinating the departments responsible for implementing the plan;
(l) the information system established in order that the expert group appointed in accordance with Article 15(2)(a) can review on a regular basis the results of the eradication plan;
(m) the disease monitoring measures which shall be enforced at the earliest 12 months after diagnosis of the last case of African swine fever in feral pigs in the defined infected area; these monitoring measures shall stay in place for at least 12 additional months and shall at least include the provisions already enforced in accordance with points (e), (g) and (h).
4. A report concerning the epidemiological situation in the defined area and the results of the eradication plan shall be transmitted to the Commission and to the other Member States in the Committee referred to in Article 23 every six months.
More detailed rules relating to the information to be provided by the Member States on this matter may be adopted in accordance with the procedure referred to in Article 23(2).
Article 17
Measures to prevent the spread of African swine fever virus by means of vectors
1. Should the presence of vectors be possible or suspected on a holding where African swine fever has been confirmed, the competent authority shall ensure that:
(a) the infected building and its surroundings are checked for the presence of vectors, by means of physical inspection and, if necessary, the trapping of specimens in accordance with Annex III;
(b) where the presence of vectors is confirmed:
- appropriate laboratory tests are carried out to confirm or rule out the presence of African swine fever virus in the vectors,
- further appropriate monitoring, checking and control measures are established in the holding and in the area around the holding;
(c) where the presence of vectors is confirmed but its control is impracticable, pigs and if necessary other domestic animals are not kept on the holding for at least six years.
2. Information on the implementation of paragraph 1 shall be provided by the Member State concerned to the Commission and to the other Member States in the framework of the Standing Veterinary Committee.
3. Further measures for the monitoring and control of vectors and for the prevention of African swine fever may be adopted in accordance with the procedure referred to in Article 24(2).
Article 18
Diagnostic procedures and bio-safety requirements
1. Member States shall ensure that:
(a) diagnostic procedures, sampling and laboratory testing to detect the presence of African swine fever are carried out in accordance with the diagnostic manual;
(b) a national laboratory is responsible for coordinating standards and methods of diagnosis in each Member State in accordance with Annex IV.
2. The national laboratories referred to in Annex IV shall liaise with the Community reference laboratory as indicated in Annex V. Without prejudice to the provisions of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field(12), and in particular Article 28 thereof, the powers and duties of the laboratory shall be those described in that Annex.
3. In order to ensure uniform procedures to diagnose African swine fever and an appropriate differential diagnosis with classical swine fever, within six months of the date when this Directive enters into force and in accordance with the procedure referred to in Article 23(2), an African swine fever diagnostic manual shall be adopted to establish at least:
(a) minimum quality standards to be observed by African swine fever diagnostic laboratories and for the transport of samples;
(b) criteria and procedures to be followed when clinical or post mortem examinations are carried out to confirm or exclude the presence of African swine fever;
(c) criteria and procedures to be followed for the collection of samples from live pigs or their carcases, to confirm or exclude African swine fever by laboratory examinations, including sampling methods for serological or virological screenings carried out in the framework of the application of the measures provided for in this Directive;
(d) laboratory tests to be used for the diagnosis of African swine fever, including criteria for evaluating the results of the laboratory tests;
(e) laboratory techniques for the genetic typing of the African swine fever virus isolate.
4. In order that appropriate bio-safety conditions are guaranteed to protect animal health, the African swine fever virus, its genome and antigens and vaccines for research, diagnosis or manufacture shall be manipulated or used only in places, establishments or laboratories approved by the competent authority.
The list of approved places, establishments or laboratories shall be transmitted to the Commission not later than 1 January 2004 and shall be kept updated thereafter.
5. Annexes IV and V and the diagnostic manual may be supplemented or amended in accordance with the procedure referred to in Article 23(2).
Article 19
Use, manufacture and sale of African swine fever vaccines
Member States shall ensure that:
(a) the use of African swine fever vaccines is prohibited;
(b) the manipulation, manufacture, storage, supply, distribution or sale of African swine fever vaccines in the territory of the Community is carried out under official control.
However, to take account of developments in scientific and technical research into the production of such a vaccine, the Commission shall submit to the Council a report accompanied if necessary by appropriate proposals to update this Directive.
Article 20
Community controls
Experts from the Commission may make on-the-spot checks in cooperation with the competent authorities of the Member States, in so far as this is necessary to ensure uniform application of this Directive. The Member State in whose territory checks are made shall provide the experts with all the assistance necessary for carrying out their duties. The Commission shall inform the competent authority of the results of the checks made.
The rules of application of this Article and in particular those governing the procedure for cooperation with the national authorities shall be adopted in accordance with the procedure referred to in Article 23(2).
Article 21
Contingency plans
1. Each Member State shall draw up a contingency plan specifying the national measures to be implemented in the event of an outbreak of African swine fever, taking into account local factors, such as, in particular, the density of pigs, which are likely to influence the spread of African swine fever.
This plan shall allow access to facilities, equipment, personnel and all other appropriate materials necessary for the rapid and efficient eradication of the outbreak.
2. The criteria and requirements to be applied for drawing up the contingency plan shall be those set out in Annex VI.
In accordance with the procedure referred to in Article 23(2), those criteria and requirements may be amended or supplemented to take into account the specific nature of African swine fever and the progress made in the development of disease control measures.
3. 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 plans, if necessary amended, shall be approved in accordance with the procedure referred to in Article 23(2).
The plans may be subsequently amended or supplemented, in accordance with the procedure referred to in Article 23(2), to take into account developments in the situation. In any event, every five years each Member State shall update the plan and submit it to the Commission for approval in accordance with the procedure referred to in Article 23(2).
Article 22
Disease control centres and expert groups
1. Member States shall ensure that a fully functional national disease control centre can be immediately set up in the event of any outbreaks of African swine fever.
2. 2. The national disease control centre shall direct and monitor the operations of the local disease control centres referred to in paragraph 3. It shall be responsible, inter alia, for:
(a) defining the necessary control measures;
(b) ensuring the prompt and efficient implementation of the abovementioned measures by the local disease control centres;
(c) allocating staff and other resources to local disease control centres;
(d) providing information to the Commission, to other Member States, the national veterinary organisations, national authorities and the agricultural and trading bodies;
(e) liasing with diagnostic laboratories;
(f) liasing with the press and other media;
(g) liasing with the police authorities to ensure that specific legal measures are taken.
3. Member States shall ensure that fully functional local disease control centres can be immediately set up in the event of any outbreaks of African swine fever.
4. Certain functions of the national disease control centre may, however, be delegated to the local disease control centre operating at an administrative level as provided for in Article 2(2)(p) of Directive 64/432/EEC(13) or at another level, provided the objectives of the national disease control centre are not thereby compromised.
5. Member States shall create a permanently operational expert group to maintain the expertise needed to assist the competent authority in ensuring disease preparedness.
In the event of an outbreak the expert group shall assist the competent authority at least in:
(a) the epidemiological enquiry;
(b) sampling, testing and interpretation of results of laboratory tests;
(c) establishment of disease control measures.
6. Member States shall ensure that the national and local disease control centres and the expert group have staff, facilities and equipment including communication systems as necessary, and a clear and effective chain of command and management to ensure the prompt implementation of the disease control measures laid down in this Directive.
Details regarding staff, facilities, equipment, chain of command and management of the national and local disease control centres and of the expert group shall be laid down in the contingency plans referred to in Article 21.
7. Further criteria and requirements concerning the function and duties of the national disease control centres, local disease control centres and expert groups may be laid down in accordance with the procedure provided for in Article 23(2).
Article 23
Normal regulatory procedure
1. The Commission shall be assisted by a Committee.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.
The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months.
3. The Committee shall adopt its rules of procedure.
Article 24
Accelerated regulatory procedure
1. The Commission shall be assisted by a Committee.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.
The period provided for in Article 5(6) of Decision 1999/468/EC shall be 15 days.
3. The Committee shall adopt its rules of procedure.
Article 25
Amendment of Annex I to Directive 92/119/EEC
In Annex I to Directive 92/119/EC the words "Teschen disease" shall be replaced by the words "African swine fever".
Article 26
Implementing measures
1. Annexes I to VI to this Directive shall be amended in accordance with the procedure laid down in Article 23(2).
2. Any detailed rules necessary for the implementation of this Directive may be adopted in accordance with the procedure laid down in Article 23(2) or when the epidemiological situation so requires, in accordance with the procedure laid down in Article 24(2).
Article 27
Transitional provisions
Pending the application of this Directive, transitional provisions on the control of African swine fever may be adopted in accordance with the procedure referred to in Article 23(2).
Article 28
Transposition into national law
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2003. They shall forthwith inform the Commission thereof.
They shall apply those provisions from 1 July 2003.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making a reference shall be laid down by Member States.
Article 29
Entry into force
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.
Article 30
Addressees
This Directive is addressed to the Member States.
Done at Luxembourg, 27 June 2002.