Proposal for a COUNCIL DIRECTIVE 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

(presented by the Commission)

EXPLANATORY MEMORANDUM

African swine fever, hereinafter ASF, is a viral infection of domestic and feral pigs (wild boar) that causes a serious disease, which may be transmitted by vectors (ticks of the genus Ornithodorus).

No vaccines are available to control ASF. Due to the very high mortality rate associated with this disease and its potentially devastating effect for the pig sector, ASF is categorised by the Office International of Epizooties (OIE) in the list A, which includes the most important infectious animal diseases.

ASF originates from Africa, where the virus is endemic in a larg part of the continent in the local wild pig (warthog) and in the local vector (the tick Ornithodorus moubata).

The sporadic occurrence of ASF in certain limited areas of the Community impairs both internal and international trade, through restrictions on movement of pigs and pig products. Indeed, ASF is still found in the internal part of the island of Sardinia in Italy, where ASF virus circulates in the local free-ranging pig population living in contact with the wild boar.

ASF has also been present for some decades in the Iberian Peninsula. However, in the mid '90s it was succesfully eradicated from the domestic and the wild pig population in Spain and Portugal, with the financial support of the Community. Nevertheless, in November 1999 an outbreak of disease in domestic pigs was reported in Alentejo in Portugal, probably due to the persistence of ASF virus in the local vector (the tick Ornithodorus erraticus, which conversely is not present in Sardinia, where only pig-to-pig circulation of virus takes place).

The biological cycle linking ASF virus, Ornithodorus erraticus and the pig is complex and unusual. In addition, the level of virus infection in this vector naturally lapses with time, provided that contacts between pigs and infected ticks are prevented. As a result, the risk of further outbreaks of ASF occurring in the European Union, due to virus persistence in ticks, is low, and it is expected to decrease and eventually vanish in the next few years.

However, ASF is the only disease included in the list A of the OIE for which no harmonized control measures are laid down at Community level. Therefore, there is a need to lay down Community legislation in this regard, in order to ensure a better disease control and possibly its eradication from the whole territory of the European Union. Community legislation must also be aimed at guaranteeing a rapid disease control in case of introduction of the disease agent in the ASF-free areas of the European Union.

At the same time the opportunity is taken to make an overdue amendment to Community legislation concerning another pig disease (Teschen disease). Council Directive 92/119/EEC introduces general measures for the control of certain animal diseases and specific measures relating to swine vesicular disease. This Directive at present applies to Teschen disease, a slowly spreading disease of pigs of very limited importance, with a low mortality rate, for which reasons it was deleted some years ago from the list A of the OIE.

It is, therefore, appropriate to amend Directive 92/119/EEC to exclude Teschen disease from the group of diseases to which Directive 92/119/EEC is applicable, as this Directive should only refer to epizootic diseases included in the list A of the OIE.

The Commission proposal attached hereby is aimed at:

1. amending Council Directive 92/119/EEC to include ASF amongst the animal diseases covered by in this Directive and, at the same time, to exclude Teschen disease from this group of diseases;

2. adopting more specific provisions for the control of ASF.

The measures necessary to control ASF in domestic and wild pigs are very similar to the ones necessary to control other pig diseases included in the list A of the OIE, such as swine vesicular disease and classical swine fever. Indeed, there are several analogies that exist between African and classical swine fever. Therefore, the measures laid down in this proposal take into account the new Directive on the control of classical swine fever, which has been recently adopted by the Council after an in-depth debate.

The measures introduced by means of this proposal reflect:

(a) the general provisions laid down in Directive 92/119/EEC;

(b) the provisions established in the newly adopted Council Directive 2001/89/EC on the control of classical swine fever;

(c) the differences existing between African and classical swine fever and in particular:

- the incubation period, to which some disease control measures are related, such as the standstill in infected or suspected holdings;

- the possibility of ASF virus replication and persistence in a tick vector;

- the lack of any vaccine to control ASF.

Provisions are also included in this text in order that a single Diagnostic Manual, which will cover both African swine fever and classical swine fever, is established at Community level.

By means of this proposal, the Centro de Investigación en Sanidad Animal of Valdeolmos (Spain) will be appointed as Community Reference Laboratory for African swine fever, taking into account its internationally recognised role as a leader in the research and diagnosis on this disease.

Proposal for a COUNCIL DIRECTIVE 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 Articles 15 and 24 (1) thereof,

[1] OJ L 62,15.3.1993, p. 69. Directive as amended by the 1994 Act of Accession.

Having regard to the proposal from the Commission [2],

[2] OJ...

Whereas:

(1) The general measures laid down in Directive 92/119/EEC have the aim of preventing the further spread of certain animal diseases of major economic importance and in particular of 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 recognized by the World Trade Organization. It has drawn up a list of epidemic animal diseases of major economical 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 appropriate, therefore, 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 [3] should be used as a model for the establishment of specific measures for the control of African swine fever. However, adjustments should be made because of the differences between the two diseases and, in particular, account should be taken of the incubation period for African swine fever and the possibility that this disease is transmitted by vectors.

[3] OJ L 316, 1.12.2001, p. 5.

(9) A procedure for close cooperation between the Member States and the Commission should be introduced,

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, the following definitions shall apply:

(a) "pig" means any animal of the Suidae family, including feral pigs;

(b) "feral pig" means a pig which is not kept or bred on a holding;

(c) "holding" means 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" means the diagnostic manual referred to in Article 18(3);

(e) "pig suspected of being infected with African swine fever virus" means any pig or pig carcass 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" means any pig or pig carcass:

- 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" means the holding where one or more cases of African swine fever has or have been detected;

(h) "primary outbreak" means the outbreak within the meaning of Article 2(d) of Council Directive 82/894/EEC [4];

[4] OJ L 378, 31.12.1982, p. 58. Directive as last amended by Commission Decision 2000/556/EC (OJ L 235, 19.9.2000, p. 27).

(i) "infected area" means 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" means 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 Articles 15 or 16;

(k) "contact holding" means 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" means 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" means the competent authority within the meaning of Article 2(6) of Council Directive 90/425/EEC [5];

[5] OJ L 224, 18.8.1990, p. 29. Directive as last amended by Directive 92/118/EEC (OJ L 62, 15.3.1993, p. 49).

(n) "official veterinarian" means the veterinarian designated by the competent authority of the Member State;

(o) "processing" means one of the treatments for high risk material laid down in Article 3 of Council Directive 90/667/EEC [6], applied in such a way as to avoid the risk of spread of african swine fever virus;

[6] OJ L 363, 27.12.1990, p. 51. Directive as last amended by the Act of Accession of Austria, Finland and Sweden.

(p) "killing" means the killing of pigs within the meaning of Article 2(6) of Council Directive 93/119/EEC [7];

[7] OJ L 340, 31.12.1993, p. 21.

(q) "slaughter" means the slaughter of pigs within the meaning of Article 2(7) of Directive 93/119/EEC;

(r) "vector" means 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 are 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 a African swine fever infected area in accordance with the provisions laid down in 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 [8] shall also be carried out.

[8] OJ L 355, 5.12.1992, p. 32. Directive as amended by the 1994 Act of Accession.

2. When the competent authority considers that the presence of African swine fever in a holding cannot be ruled out, it shall 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 be 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 carcasses may leave the holding without an authorization 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 authorization 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 authorization by the competent authority;

(g) the movement of vehicles to or from the holding shall be subject to written authorization 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 fulfil appropriate hygienic measures necessary to reduce the risk of spread of African swine fever virus. 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 of Article 5(1) in the holding referred to in paragraph 2; 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 these 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 spread of African swine fever virus 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 carcasses 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 disease to 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 spread of African swine fever virus;

(f) all substances and waste likely to be contaminated, such as feedingstuffs, are to be subjected to a treatment ensuring the destruction of African swine fever virus; 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 carcasses and the equipment, bedding, manure and slurry likely to be contaminated are to be cleaned and disinfected or 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 the provisions laid down in paragraphs 1(a) and 1(e), provided that basic Community interests are not endangered.

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 spreading of the disease 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 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, the 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 spreading of the disease shall be adopted in accordance with the procedure laid down in Article 24(2).

Article 7 Measures in contact holdings

1. Holdings shall be recognized 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 Article 5, or from the latter holding to other holdings.

The provisions of 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 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 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, carcasses, semen, vectors, meat or any material which could have carried the virus to or from the holdings in question.

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 ten 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 carcasses;

(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 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 for a clinical examination of the pigs and for a check of the register and of 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 carcasses, feedingstuff, manure, slurry and so forth) shall be cleaned, disinfected and treated as soon as possible after contamination, in accordance with the provisions and procedures laid down in Article 12. No truck or vehicle which has been used in connection with the transport of pigs may leave the zone without being cleaned and disinfected and then inspected and authorized by the competent authority;

(d) no other domestic 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 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 of the infected holdings. After 40 days, subject to the conditions set out in paragraph 3, the competent authority may authorize 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 carcasses are processed under official supervision;

- under exceptional circumstances, to other premises located within the protection zone. Member States availing themselves 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 observe appropriate hygienic measures as necessary to reduce the risk of spread of African swine fever virus.

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 set out in paragraph 3, the competent authority may, following a reasoned application by the owner, authorize 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 carcasses are processed under official supervision;

(c) under exceptional circumstances, to other premises located within the protection zone. Member States availing themselves 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 authorize 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 have shown no evidence of African swine fever and compliance with the provisions of 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 relating to 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 [9], and is subsequently treated in accordance with the rules laid down in Article 4 (1) (a) (i) of Council Directive 80/215/EEC [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.

[9] OJ L 302, 31.12.1972, p. 24. Directive as last amended by the 1994 Act of Accession.

[10] OJ L 47, 21.2.1980, p. 4. Directive as last amended by the 1994 Act of Accession.

4. The measures in the protection zone shall continue to be applied at least until:

(a) cleansing and disinfection 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 and disinfection measures on the infected holdings.

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 carcasses, feedingstuff, manure, slurry and so forth) shall be cleaned, disinfected and treated as soon as possible after contamination, in accordance with the provisions and procedures laid down in 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 authorization 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 and disinfection of the infected holdings. After 30 days, subject to the conditions set out in Article 10(3), the competent authority may authorize 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 carcasses are processed under official supervision;

- under exceptional circumstances, other premises located within the protection or surveillance zone. Member States availing themselves 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 the provisions laid down in Article 10(3)(e) and (f), fourth indent, may be authorized, 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 observe appropriate hygienic measures as necessary to reduce the risk of spread of African swine fever virus.

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 set out in Article 10(3), the competent authority may, following a reasoned application by the owner, authorize 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 carcasses are processed under official supervision;

(c) under exceptional circumstances, other premises located within the protection or surveillance zone. Member States availing themselves 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 and disinfection 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 and disinfection measures on the infected holdings.

Article 12 Cleansing and disinfection

Member States shall ensure that:

(a) the disinfectants to be used and their concentrations are officially approved by the competent authority;

(b) the cleansing and disinfection operations are carried out under official supervision in accordance with:

- the instructions given by the official veterinarian; and

- the principles and procedures for cleansing, disinfecting and treatment laid down in Annex II.

Article 13 Re-population 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 and disinfection operations in accordance with Article 12.

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 re-population 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 twenty 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 6 years, unless specific operations to eliminate the vector from the premises and places where the pigs are to be kept or can come in contact with the vector have been successfully carried out under official supervision. 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 re-population 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, if more than 6 months have elapsed since the completion of the cleansing and disinfection operations in the holding, the competent authority may authorize derogation from the provisions laid down in paragraph 3, taking into account the epidemiological situation.

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 carcasses, offal and animal waste of possibly infected and contaminated animals are processed under official supervision;

(c) cleansing and disinfection 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 carcasses 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 carcasses;

(g) no animals are reintroduced for slaughter or transport until at least 24 hours after completion of the cleansing and disinfection 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 the provisions laid down in 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 audits 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. The 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 authorized by the competent authority having regard to the epidemiological situation;

- appropriate means of disinfection be used at the entrance and exits of buildings housing pigs and of the holding itself;

- appropriate hygienic measures be applied by all persons coming in contact with feral pigs, to reduce the risk of spread of African swine fever virus;

- 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. Carcasses 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 [11]. Parts not intended for human consumption shall be processed under official supervision;

[11] OJ L 268, 14.9.1992, p. 35. Directive as last amended by Directive 97/79/EC (OJ L 24, 30.1.1998, p. 31).

(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 from 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 organization of close cooperation between biologists, hunters, hunting organizations, the wildlife services and veterinary services (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. Carcasses 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 carcass;

- 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;

(j) other criteria to be applied for lifting the measures taken;

(k) the authority with responsibility for supervising and co-ordinating 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 that shall be enforced after a period of at least twelve months has elapsed from the last confirmed case of African swine fever in feral pigs in the defined infected area; these monitoring measures shall stay in place for at least twelve months and shall at least include the measures 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 every six months.

More detailed rules relating to the information that is 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;

(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 and control measures are established in the area around the holding;

(c) where the presence of vectors is confirmed but its control is impracticable, pigs are not kept on the holding for at least 6 years.

2. Information on the implementation of the provisions laid down in 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 the provisions of Annex III.

2. The national laboratories shall liaise with the Community reference laboratory as indicated in Annex IV. Without prejudice to the provisions of Council Decision 90/424/EEC [12], and in particular Article 28 thereof, the powers and duties of the laboratory shall be those described in that Annex.

[12] OJ L 224, 18.8.1990, p. 19. Decision as last amended by Decision 2001/572/EC (OJ L 203, 28.7.2001, p. 16).

3. In order to ensure uniform procedures to diagnose African swine fever and an appropriate differential diagnosis with classical swine fever, within six months from the date when this Directive enters into force and in accordance with the procedure referred to in Article 23(2), the classical swine fever diagnostic manual adopted in accordance with Article 17(3) of Directive 2001/89/EC shall be amended to include at least:

(a) minimum quality standards to be observed by the 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 carcasses, 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 within six months of the date laid down in the second subparagraph of Article 27 and shall be kept updated thereafter.

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.

Article 20 Community controls

Experts from the Commission may, in co-operation with the competent authorities of the Member State concerned, and in so far as it is necessary to ensure the uniform application of this Directive, make on-the spot checks in accordance with the procedures laid down in Commission Decision 98/139/EC [13].

[13] OJ L 38, 12.2.1998, p. 10.

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.

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 mutatis mutandis for drawing up the contingency plan shall be those set out in Annex VII to Directive 2001/89/EC.

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).

Whenever necessary, the plans shall subsequently be amended or supplemented, in accordance with the procedure referred to in Article 23(2), to take into account developments in the situation. In any case, 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

In order to ensure full coordination of the measures necessary for the swift eradication of African swine fever, the provisions laid down in Article 23 of Directive 2001/89/EC shall apply mutatis mutandis.

Article 23 Normal regulatory procedure

1. The Commission shall be assisted by the Standing Veterinary Committee established by Decision 68/361/EEC [14].

[14] OJ L 255, 18.10.1968, p. 23.

2. Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC [15] shall apply, in compliance with Article 7 thereof.

[15] OJ L 184, 17.7.1999, p. 23.

The period referred to in Article 5(6) of Decision 1999/468/EC shall be three months.

Article 24 Accelerated regulatory procedure

1. The Commission shall be assisted by the Standing Veterinary Committee established by Decision 68/361/EEC.

2. Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 thereof.

The period referred to in Article 5(6) of Decision 1999/468/EC shall be 15 days.

Article 25 Amendment ofo Annex I to Directive 92/119/EEC

In Annex I of Directive 92/119/EC the words "Teschen disease" are replaced by the words "African swine fever".

Article 26 Amendments to the annexes and adoption of further detailed rules

1. The Annexes to this Directive may be amended as necessary in accordance with the procedure referred to in Article 23 (2).

2. Any further detailed rules necessary for the implementation of this Directive shall be adopted in accordance with the procedure referred to in Article 23 (2).

Article 27 Transposition into national law

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2002 at the latest. They shall forthwith inform the Commission thereof.

They shall apply those provisions from 1 January 2003. When Member States adopt the provisions referred to in the first paragraph, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 28 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 29 Entry into force

This Directive shall enter into force on the twentieth 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 Brussels,

For the Council

The President

ANNEX I

Notification of disease and further epidemiological information to be provided by the Member State where African swine fever has been confirmed

1. Within 24 hours of the confirmation of any primary outbreak, primary case in feral pigs or case in a slaughterhouse or means of transport, the Member State concerned must notify by means of the Animal Disease Notification System established in accordance with Article 5 of Council Directive 82/894/EEC:

(a) the date of dispatch;

(b) the time of dispatch;

(c) the name of Member State;

(d) the name of disease;

(e) the number of the outbreak or case;

(f) the date on which African swine fever was suspected,

(g) the date of confirmation;

(h) the methods used for confirmation;

(i) whether the disease has been confirmed in feral pigs or in pigs in a holding, slaughterhouse or means of transport;

(j) the geographical location where the outbreak or the case of African swine fever has been confirmed;

(k) the disease control measures applied.

2. In the case of primary outbreaks or cases in slaughterhouses or means of transport, the Member State concerned must forward the following information in addition to the data referred to in point 1:

(a) the number of susceptible pigs in the outbreak, slaughterhouse or means of transport;

(b) the number of dead pigs of each category in the holding, slaughterhouse or means of transport;

(c) for each category, the morbidity of the disease and the number of pigs in which African swine fever has been confirmed;

(d) the number of pigs killed in the outbreak, or in the slaughterhouse or means of transport;

(e) the number of carcasses processed;

(f) in the case of an outbreak, its distance from the nearest pig holding;

(g) if African swine fever was confirmed in a slaughterhouse or means of transport, the location of the holding or holdings of origin of the infected pigs or carcasses.

3. In the case of secondary outbreaks, the information referred to in points 1 and 2 must be forwarded within the time-limits laid down in Article 4 of Directive 82/894/EEC.

4. The Member State concerned shall ensure that the information to be provided in accordance with points 1, 2 and 3, in relation to any outbreak or case of African swine fever in a holding, slaughterhouse or means of transport is followed as soon as possible by a written report to the Commission and the other Member States including at least:

(a) the date on which the pigs in the holding, slaughterhouse or means of transport were killed and their carcasses processed;

(b) the results of the tests carried out on samples taken when pigs were killed;

(c) where the derogation provided for in Article 6(1) has been applied, the number of pigs killed and processed, and the number of pigs which are to be slaughtered at a later date together with the time limit laid down for their slaughter;

(d) any information relating to the possible origin of the disease or, if ascertained, its actual origin ;

(e) information on the control system established to ensure that the measures laid down in Article 10 and 11 for the control of animal movements are effectively implemented;

(f) in the case of a primary outbreak or of a case of African swine fever in a slaughterhouse or means of transport, the genetic type of virus responsible for the outbreak or for the case;

(g) where pigs have been killed in contact holdings or in holdings containing pigs suspected of being infected with African swine fever virus, information on:

- the date of killing and the number of pigs of each category killed in each holding;

- the epidemiological link between the outbreak or case of African swine fever and each contact holding or the other reasons that have induced the suspicion that African swine fever is present in each suspected holding;

- the results of the laboratory tests carried out on the samples taken from the pigs in the holdings and when such pigs were killed;

where pigs in contact holdings have not been killed, information must be provided concerning the reasons for this decision.

ANNEX II

Principles and procedures for cleansing and disinfection

1. General principles and procedures:

(a) the cleansing and disinfection operations and where necessary the measures to destroy rodents and insects must be carried out under official supervision and in accordance with the instructions given by the official veterinarian;

(b) the disinfectants to be used and their concentrations must be officially approved by the competent authority to ensure destruction of African swine fever virus;

(c) the efficacity of disinfectants must be checked before use, as the efficacity of certain disinfectants is diminished by prolonged storage;

(d) the choice of disinfectants and of procedures for disinfection must be made taking into account the nature of the premises, vehicles and objects which are to be treated;

(e) the conditions under which degreasing agents and disinfectants are used must ensure that their efficacy is not impaired. In particular technical parameters indicated by the manufacturer, such as pressure, minimum temperature and required contact time must be observed;

(f) irrespective of the disinfectant used, the following general rules apply:

- thorough soaking of bedding and litter as well as faecal matter with the disinfectant,

- washing and cleansing by careful brushing and scrubbing of the ground, floors, ramps and walls after the removal or dismantling, where possible, of equipment or installations otherwise impairing the effective cleansing and disinfection procedures,

- then, further application of disinfectant for a minimum contact time as stipulated in the manufacturer's recommendations.

(g) where washing is carried out with liquids applied under pressure re-contamination of the previously cleansed parts must be avoided;

(h) washing, disinfecting or destroying of equipment, installations, articles or compartments likely to be contaminated must be included;

(i) following the disinfection procedures re-contamination must be avoided;

(j) cleansing and disinfection required in the framework of this Directive must be documented in the holding or vehicle register and where official approval is required be certified by the supervising official veterinarian.

2. Special provisions on the cleansing and disinfection of infected holdings:

(a) preliminary cleansing and disinfection:

- during the killing of the animals all necessary measures must be taken to avoid or minimize the dispersion of African swine fever virus. Those measures include inter alia the installation of temporary disinfection equipment, supply of protective clothing, showers, decontamination of used equipment, instruments and facilities and the interruption of power supply to the ventilation,

- carcasses of killed animals must be sprayed with disinfectant;

- if the carcasses have to be removed from the holding for processing, covered and leak proof containers must be used,

- as soon as the carcasses of the pigs have been removed for processing, those parts of the holding in which the animals were housed and any parts of other buildings, yards etc. contaminated during killing, or post-mortem examination must be sprayed with disinfectants approved in accordance with Article 12,

- any tissue or blood spilled during slaughter or post-mortem or gross contamination of buildings, yards, utensils etc. must be carefully collected and processed with the carcasses,

- the disinfectant must remain on the surface for at least 24 hours;

(b) final cleansing and disinfection:

- manure and used beddings must be removed and treated as provided in point 3(a);

- grease and dirt must be removed from all surfaces by the application of a degreasing agent and the surfaces washed with water,

- after washing with cold water, further spraying with disinfectant must be applied,

- after seven days the premises must be treated with a degreasing agent, rinsed with water, sprayed with disinfectant and rinsed again with water.

3. Disinfection of contaminated bedding, manure and slurry:

(a) manure and used bedding must be stacked to heat, sprayed with disinfectant and left for at least 42 days or destroyed by burning or burying;

(b) slurry must be stored for at least 60 days after the last addition of infective material, unless the competent authorities authorize a reduced storage period for slurry which has been effectively treated in accordance with the instructions given by the official veterinarian so as to ensure the destruction of the virus.

4. However, by way of derogation from points 1 and 2, in the case of open-air holdings the competent authority may establish specific procedures for cleansing and disinfection, taking into account the type of holding and the climatic conditions.

ANNEX III

National African swine fever laboratories and their responsibilities

1. The national African swine fever laboratories are as follows:

Belgium

Centre d'Etude et de Recherche Vétérinaires et Agrochimiques, 1180 Bruxelles

Denmark

Statens veterinære Institut for Virusforsknig, Lindholm, 4771 Kalvehave

Germany

Bundesforschungsanstalt für Viruskrankheiten der Tiere, Tubingen

Greece

Veterinary Institute of Infectious and parasitic diseases, 15310 Ag. Paraskevi

Spain

Centro de Investigación en Sanidad Animal, 28130 Valdeolmos (Madrid)

France

AFSSA-Ploufragan, Zoopole des Cotes d'Armor, 22440 Ploufragan

Ireland

Veterinary Research Laboratory, Abbotstown, Castleknock, Dublin 15

Italy

Istituto Zooprofilattico Sperimentale dell'Umbria e delle Marche, 06100 Perugia

Luxembourg

Laboratoire de Medicine Veterinare de l'Etat, 1020 Luxembourg

The Netherlands

Instituut voor Veehouderij en Diergezondheid (ID-Lelystad), 8200 AB Lelystad

Austria

Bundensanstalt für Veterinärmedizinische Untersuchungen in Mödling, Rober Koch-Gasse 17, 2340 Mödling

Portugal

Laboratório Nacional de Investigação Veterinária, 1500 Lisboa

Finland

Eläinlääkintä- ja elintarviketutkimuslaitos, 00231 Helsinki

Sweden

Statens veterinrmedicinska anstalt, 75189 Uppsala

United Kingdom

Institute for Animal Health, Pirbright, Woking, Surrey GU24 ONF

2. The national African swine fever laboratories are responsible for ensuring that in each Member State the laboratory testing to detect the presence of African swine fever and the identification of the genetic type of virus isolates are carried out in accordance with the diagnostic manual. To this end they may make special agreements with the Community Reference Laboratory or with other national laboratories.

3. The national African swine fever laboratory in each Member State are responsible for coordinating the standards and diagnostic methods in each African swine fever diagnostic laboratory within that State. To this end:

(a) they may provide diagnostic reagents to individual laboratories;

(b) they shall control the quality of all diagnostic reagents used in that Member State;

(c) they shall arrange comparative tests periodically;

(d) they shall hold isolates of African swine fever virus from cases and outbreaks confirmed in that Member State.

ANNEX IV

Community Reference Laboratory for African swine fever

1. The Community Reference Laboratory for African swine fever is: Centro de Investigación en Sanidad Animal, 28130 Valdeolmos, Madrid, Spain

2. The functions and duties of the Community Reference Laboratory for African swine fever are:

(a) To coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing African swine fever, specifically by:

- storing and supplying cell cultures for use in diagnosis;

- typing, storing and supplying strains of African swine fever virus for serological tests and the preparation of anti-sera;

- supplying standardized sera, conjugate sera and other reference reagents to the national laboratories in order to standardize the tests and reagents employed in the Member States;

- building up and holding an African swine fever virus collection;

- organizing periodic comparative tests of diagnostic procedures at Community level;

- collecting and collating data and information on the methods of diagnosis used and the results of tests carried out;

- characterizing isolates of the virus by the most up-to-date methods available to allow greater understanding of the epizootiology of African swine fever;

- keeping abreast of developments in African swine fever surveillance, epizootiology and prevention throughout the world;

- retaining expertise on the virus causing African swine fever and other pertinent viruses to enable rapid differential diagnosis;

(b) to make the necessary arrangements for training or re-training experts in laboratory diagnosis with a view to harmonizing diagnostic techniques;

(c) to have trained personnel available for emergency situations occurring within the Community;

(d) to perform research activities and whenever possible coordinate research activities directed towards an improved control of African swine fever.

3. The Community Reference Laboratories for classical swine fever and African swine fever shall organize their activites in such a way so as to ensure a proper co-ordination of the comparative tests organized at Community level for the diagnosis of these two diseases.