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Royal Decree 650/1994, 15 April, Which Establishes General Measures To Combat Certain Animal Diseases And Specific Measures Against Swine Vesicular Disease.

Original Language Title: Real Decreto 650/1994, de 15 de abril, por el que se establece medidas generales de lucha contra determinadas enfermedades de los animales y medidas específicas contra la enfermedad vesicular porcina.

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TEXT

The rational development of the agricultural sector and the protection of animal health go through the establishment of control measures in the event of outbreaks of diseases, as these can be acquired quickly. epizootic proportions.

The control measures to be applied will prevent the spread of diseases by controlling the movements of animals and products, in the principle that such measures must be common in the territory of the Member States. to be able to maintain a uniform animal health level.

Council Directive 92/119/EEC of 17 December lays down general Community measures for the control of certain animal diseases and specific measures in respect of swine vesicular disease, it is necessary to incorporate the measures set out in it into the domestic legal order by this Royal Decree.

This Royal Decree is dictated, once the sector has been consulted, by virtue of the exclusive competence attributed to the State in the field of bases and general coordination of health by Article 149.1.16 of the Constitution.

Under its virtue, on the proposal of the Minister of Agriculture, Fisheries and Food, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 15 April 1994,

DISPONGO:

Article 1.

This Royal Decree lays down the general Community measures for the fight to be applied in the event of the occurrence of one of the diseases listed in Annex I.

Article 2.

For the purpose of this Royal Decree, the following definitions shall apply:

1. Holding: any establishment (agricultural or other) situated in Spanish territory where animals are kept or reared.

2. Animal: any domestic animal belonging to a species which may be directly affected by any of the above mentioned diseases or any wild vertebrate animal which may participate in the epidemiology of the disease, acting as carrier or reservoir of infection.

3. Vector: any vertebrate or invertebrate animal which, by mechanical or biological means, can transmit and propagate the pathogenic agent concerned.

4. Owner or keeper: any natural or legal person who owns or is in charge of the animals, with or without remuneration.

5. Incubation period: the length of time between exposure to the pathogen and the occurrence of clinical symptoms. The duration of this period shall be as set out in Annex I for each disease.

6. Confirmation of infection: the declaration by the competent authority of the presence of one of the diseases listed in Annex I, based on laboratory data. However, in the event of an epidemic, the competent authority may confirm the presence of the disease on the basis of clinical and/or epidemiological data.

7. Competent authority: the competent bodies of the Autonomous Communities.

8. Official veterinarian: the veterinarian designated by the competent authority.

Article 3.

The suspicion of the occurrence of one of the diseases listed in Annex I shall be notified to the competent authority immediately and immediately.

Article 4.

1. Where there are animals suspected of being infected or contaminated by one of the diseases listed in Annex I on a holding, the official veterinarian shall immediately apply the official investigation measures to the check or rule out the presence of the disease in question. In particular, it shall carry out or cause the taking of samples suitable for laboratory examinations and the diagnosis of the disease, as well as for subsequent dispatch to the laboratory referred to in Article 17 of this Royal Decree- to confirm, where appropriate, the diagnosis of the disease and to check the type of virus, subtype and variant. To this end, suspected animals may be transported to the laboratory under the control of the competent authority, which shall take appropriate measures to prevent the spread of the disease.

2. Immediately upon notification of suspected presence of the disease, the competent authority shall place the holding under official surveillance and shall in particular order:

(a) The compilation of a census of all categories of animals belonging to the susceptible species and the accounting of the number of animals in each category killed, infected or exposed to infection or contamination. The census will be kept up to date to record in it the animals born and killed for as long as the suspicion is prolonged. The information contained in the census shall be updated, when so requested and in each inspection, its veracity shall be verified.

(b) that all animals in the holding belonging to the susceptible species are kept in their habitacles or somewhere else where they can be isolated, taking into account, where appropriate, the possible presence of vectors.

c) That no animal belonging to the susceptible species should be removed from the holding.

(d) Subject to the authorisation of the competent authority, which shall determine the conditions necessary for this purpose in order to avoid any risk of the spread of the disease:

1. All movement of persons, animals of other species not susceptible to the disease in question and vehicles whose destination or origin is the holding.

2. All movement of meat or carcasses of animals, feed, material, waste, litter, litter, manure or any other element capable of transmitting the disease concerned.

(e) The application of appropriate disinfection measures at the entrances and exits of the holding and of the buildings, premises or places where the animals of the susceptible species are located.

(f) An epidemiological investigation is carried out in accordance with the provisions of Article 8.

3. Pending the entry into force of the official measures referred to in paragraph 2, the owner or keeper of an animal suspected to be affected by the disease shall take the necessary measures to ensure compliance with the requirements. provisions referred to in paragraph 2, excluding paragraph (f).

4. The competent authority may extend the measures provided for in paragraph 2 to other holdings where its location, configuration or contacts with the suspected existence of the disease, make it possible to suspect a possible pollution.

5. The measures referred to in paragraphs 1 and 2 shall cease to apply when the official veterinarian disregards the suspected presence of the disease.

Article 5.

1. As soon as the declaration of one of the diseases referred to in Annex I is officially confirmed, the competent authority shall, in addition to the provisions referred to in Article 4 (2), order the following measures:

(a) The "on site" slaughter and without delay of all animals of the susceptible species on the holding. Dead or slaughtered animals shall be either burned or buried in situ, if possible, or destroyed by dismemberment. These operations shall be carried out in such a way as to limit the risk of the spread of the disease to the maximum.

(b) The destruction or appropriate treatment of all materials or wastes, such as feed, litter, manure and purine, possibly contaminated. This treatment shall be carried out in accordance with the instructions of the official veterinarian and shall ensure the total destruction of the pathogen or the vector of the pathogen.

(c) After the operations referred to in paragraphs (a) and (b) above, the cleaning and disinfection, in accordance with the provisions of Article 16, of the buildings in which the animals of the susceptible species and their animals are housed the surroundings, the transport vehicles and any material that may be contaminated.

(d) The conduct of an epidemiological investigation in accordance with the provisions of Article 8.

2. Where the burial is used, it shall be carried out in sufficient depth so that the carnivorous animals cannot unearth the bodies or wastes referred to in paragraphs (a) and (b) of paragraph 1, and on suitable grounds to avoid contamination of water layers or any damage to the environment.

3. The competent authority may apply the measures provided for in paragraph 1 to other neighbouring holdings as soon as their location, configuration or contacts with the holding in which the presence of the disease has been confirmed allow for suspicion of possible contamination.

4. The repopulation of the holding shall be authorised by the competent authority after the official veterinarian has inspected and considered satisfactory the cleaning and disinfection operations carried out in accordance with Article 16.

Article 6.

In case of infection or suspicion in wild animals, the competent authority shall take appropriate measures to prevent the spread of the disease, and shall inform the Ministry of Agriculture, Fisheries and Food for its notification to the Commission of the European Community, through the appropriate channel.

Article 7.

1. In the case of holdings with two or more separate units of production, the competent authority may exempt from compliance with the requirements of Article 5 (1) (a) of the first subparagraph of Article 5 (1). the infected holding provided that the official veterinarian has established that the structure and size of those units and the operations carried out therein are such that the units are completely separate in respect of stables; maintenance, personnel, material and food, avoiding the spread of the pathogenic agent other.

2. Where the use of paragraph 1 is made, the rules laid down in Commission Decision 88 /397/EEC shall apply 'mutadis mutandi'. Those rules may be amended as regards a specific disease, where appropriate, by the Commission of the European Community.

Article 8.

1. The epidemiological investigation will focus on the following aspects:

a) The period of time during which the disease may have existed on the holding prior to its notification or suspicion.

(b) The possible origin of the disease on the holding and identification of other holdings where there are animals of susceptible species which may have carried the pathogen inside or outside the holdings.

(c) The movement of persons, animals, bodies, vehicles, materials and substances that may have carried the pathogen inside or outside the holdings concerned.

d) Where appropriate, the presence and distribution of the disease vectors.

2. In order to coordinate measures to ensure the eradication of the disease as soon as possible and to carry out the epidemiological investigation, a national crisis centre shall be established in accordance with the rules which, where appropriate, are adopted by the Council of the European Community.

Article 9.

1. Where the official veterinarian finds or considers, on the basis of confirmed data, that the disease has been transmitted from other holdings to that referred to in Article 4 or from the latter to other holdings, as a result of the movement of persons, animals or vehicles or in any other form such other holdings shall be placed under official surveillance in accordance with Article 4. Surveillance shall not be withdrawn until the absence of the disease has been officially declared on the holding.

2. Where the official veterinarian finds or considers, on the basis of confirmed data, that the disease has been transmitted from other holdings to that referred to in Article 5 or from the latter to other holdings as a result of the movement of persons, animals or vehicles or in any other form, such other holdings shall be placed under official surveillance in accordance with Article 4; such surveillance shall not be withdrawn until the presence has been officially denied of the disease on the holding.

3. Where a holding has been subject to the provisions of paragraph 2, the competent authority shall maintain in it the application of the provisions of Article 4 during at least one space of time equivalent to the maximum incubation period. each disease, from the likely date of introduction of the calculated infection by means of epizootic research carried out in accordance with Article 8.

4. Where it considers that the circumstances permit, the competent authority may provide that the measures provided for in paragraphs 1 and 2 shall be limited to part of the holding and to the animals in the holding provided that the holding complies with the conditions laid down in the the conditions set out in Article 7, or only to animals of susceptible species.

Article 10.

1. Where the diagnosis of the disease in question is officially confirmed, the competent authority shall define, around the infected holding, a protection zone of a minimum radius of 3 kilometres, which is recorded in a zone of monitoring of a minimum radius of 10 kilometres. For the delimitation of these zones, account shall be taken of the geographical, administrative, ecological and epizootic factors related to the disease concerned, as well as the control structures.

2. Where the protection or surveillance zone is extended to France, Portugal or Andorra, the competent bodies of the Autonomous Communities shall notify the Ministry of Agriculture, Fisheries and Food of this fact for the purposes of it can be established with the States that may be affected, the timely collaboration in the delimitation of the zones.

3. The delimitation of the zones and the duration of the restriction measures may be amended, where appropriate, by the Commission of the European Community, on its own initiative.

These amendments may also be carried out at the request of the competent authority, which shall forward it to the Ministry of Agriculture, Fisheries and Food for communication to the Commission of the European Communities, through the appropriate channel, considering: the geographical situation and the ecological factors; the meteorological conditions; the presence, distribution and type of the vectors; the results of the epizootic studies carried out on the basis of Article 8; the results of the laboratory test; the measures of struggle that have been applied.

Article 11.

1. The competent authority shall apply the following measures in the protection zone:

(a) Localization of all farms in the area with animals of susceptible species.

(b) Regular visits to holdings with animals of susceptible species, with clinical examinations of those species and, where appropriate, sampling for laboratory examination; a record of the visits and observations shall be carried out. The frequency of such visits shall be proportional to the seriousness of the epizootic on the holdings with the greatest risks.

c) The prohibition of the movement and transport of animals of susceptible species by public or private communication routes, except in the case of roads leading to holdings; however, the authority competent may not apply such prohibition to the transit of animals by road or rail without unloading or stopping.

(d) Prohibition that animals belonging to susceptible species are removed from the holding in which they are, unless they are to be transported directly and under official supervision for slaughter immediately, to a slaughterhouse situated in that area, or if that area does not have a slaughterhouse with veterinary control, to a slaughterhouse in the surveillance zone designated by the competent authority. Transport shall be authorised by the competent authority where the official veterinarian has carried out an examination of all the animals of the susceptible species on the holding and confirmed that none of them is suspected of being infected. The competent authority on which the slaughterhouse is dependent shall be informed of the intention to send the animals.

2. The measures applied in the protection zone shall be maintained for a period of at least equal to the maximum incubation period corresponding to the disease concerned, from the moment the elimination of all the diseases concerned has been completed. animals from the infected holding, in accordance with Article 5, and the cleaning and disinfection operations provided for in Article 16. However, where the disease is transmitted by an insect vector, the competent authority may fix the period of application of the measures and determine the provisions concerning the possible introduction of the control animals. The competent authority shall notify the measures taken to the Ministry of Agriculture, Fisheries and Food for communication to the Commission of the European Community and to the other Member States through the appropriate channel.

At the end of the period referred to in the preceding paragraph, the rules applied in the surveillance zone shall also apply in the protection zone.

Article 12.

1. The competent authority shall apply the following measures in the surveillance zone:

(a) Identification of all holdings with animals of susceptible species.

(b) Prohibition of the movement of animals of susceptible species by public means of communication, except in the case of driving them to pasture or buildings reserved for them. However, the competent authority may not apply that prohibition to the transit of animals by road or rail without unloading or stopping.

(c) The authorisation of the competent authority to transport animals of susceptible species within the surveillance zone shall be specified.

(d) Animals of susceptible species may not be removed from the surveillance zone for at least the incubation period after the last recorded case. After this period of time, they may leave that area to be transported directly and under official supervision to a slaughterhouse, designated by the competent authority, for immediate slaughter. The competent authority may authorise transport only where the official veterinarian has examined all the animals of the susceptible species on the holding and has confirmed that none of them is suspected of being infected. The competent authority responsible for the slaughterhouse shall be informed of the intention to send the animals.

2. The measures applied in the surveillance zone shall be maintained for at least a period of time equal to the maximum incubation period after all the animals referred to in Article 5 have been removed from the holding and that have carried out the cleaning and disinfection operations on that holding in accordance with Article 16. However, where the disease is transmitted by an insect vector, the competent authority may fix the period of application of the measures and determine the provisions concerning the possible introduction of the control animals. The competent authority shall communicate to the Ministry of Agriculture, Fisheries and Food the measures taken to ensure that that report immediately to the Commission of the European Community and to the Member States, through the appropriate channel.

Article 13.

Where the prohibitions provided for in Article 11 (1) (d) and in Article 12 (1) (d) are maintained for more than 30 days, due to the occurrence of new cases of the disease, disease, and problems of accommodation of animals are created, the competent authority may, at the justified request of the owner, authorise the departure of the animals from a holding located in the protection zone or in the surveillance zone, as appropriate, provided that:

a) The official veterinarian has checked the reality of the facts.

(b) All animals present on the holding have been inspected.

c) A clinical examination has been submitted, with a negative result, the animals to be transported.

(d) Each animal has been provided with an eartag or has been identified by any other authorised means.

e) The holding of destination is located in the protection zone or in the surveillance zone.

All necessary precautions must be taken, in particular by cleaning and disinfecting trucks after transport, to avoid the risk of spreading the pathogen during transport.

Article 14.

1. The competent authority shall take the necessary measures to inform, at least the inhabitants of the protection and surveillance zone, of the restrictions in force and shall take all the measures necessary for the proper implementation of the those measures.

2. Where, in a given region, the epizootic in question is of exceptional gravity, all additional measures to be taken by the competent authority shall be adopted in accordance with the procedure laid down in Community legislation.

Article 15.

Notwithstanding the provisions of the general provisions laid down in this Royal Decree, the specific provisions relating to the control and eradication measures peculiar to each of the diseases shall be: for swine vesicular disease, as set out in Annex II; for each of the other diseases referred to in Annex I, those laid down by the Council of the European Community, acting by a qualified majority on a proposal of the Commission of the European Community.

Article 16.

1. The competent authority shall take appropriate measures to ensure that:

(a) Disinfectants or insecticides to be used, as well as, where appropriate, their concentration, are officially authorised.

(b) Cleaning, disinfection and disintering operations are carried out under official supervision: in accordance with the instructions of the official veterinarian and in such a way as to eliminate any risk of spread or survival of the pathogen.

(c) Once the operations referred to in subparagraph (b) have been completed, the official veterinarian shall verify that the measures have been applied correctly and that the time taken to ensure complete elimination of the measures has elapsed. the disease in question before the animals of the susceptible species are introduced, a period which may in no case be less than 21 days.

2. The procedures for cleaning and disinfection of an infected holding shall be, for swine vesicular disease, those listed in Annex II; for the other diseases, they shall be determined in accordance with the provisions of the Article 15 of this Royal Decree, in the framework of the elaboration of the specific measures specific to each of the diseases referred to in Annex I.

Article 17.

1. The Laboratory of High Biological Safety (INIA) E-28130 Madrid is designated as a national laboratory to detect at any time and, in particular, the first manifestations of the disease in question, the type, subtype and variant of the virus and confirm the results obtained by the diagnostic laboratories authorised by the competent authority. This laboratory shall also be responsible for monitoring the reagents used by these diagnostic laboratories.

2. The designated national laboratory shall be responsible for coordinating the standards and diagnostic methods established in each diagnostic laboratory approved by the competent authority of the disease concerned, as well as the use of reagents. To this end:

a) You will be able to provide diagnostic diagnostic laboratories for diagnosis.

b) Control the quality of all diagnostic reagents used.

c) You will periodically organize comparative tests.

d) Keep isolated disease viruses in question collected from confirmed cases.

e) Will confirm the positive results obtained in the diagnostic laboratories.

Article 18.

1. The Community reference laboratory for swine vesicular disease is as follows:

AFRC Institute for Animal Health.

Pirbright Laboratory.

Ash Road.

Pirbright.

Woking.

Surrey.

GU24ONF

United Kingdom.

2. Without prejudice to the provisions of Decision 90 /424/EEC, and in particular Article 28 thereof, the powers and functions of the laboratory referred to in the preceding paragraph shall be as set out in Annex III.

Article 19.

1. Vaccination against the diseases referred to in Annex I may only be carried out where such vaccination constitutes a supplement to the control measures taken at the time of the occurrence of the disease concerned.

In this case, the competent authority shall send to the Ministry of Agriculture, Fisheries and Food the information necessary for its transfer to the Commission of the European Community, for the purposes of the procedure provided for, be able to take the decision to carry out the vaccination in addition to the control measures taken by the competent authority.

Such a decision shall be based, in particular, on the basis of Community legislation, on the following criteria: concentration of animals of the species involved in the affected area; characteristics and composition of each vaccine used; forms of control of the distribution, storage and use of vaccines; species and age of animals which may or must be vaccinated; areas where vaccination may or should be carried out; duration of the marketing year vaccination.

2. In the case provided for in paragraph 1:

(a) The vaccination or revaccination of animals of susceptible species found on holdings referred to in Article 4 shall be prohibited.

b) The injection of hyperimmune serum will be prohibited.

3. In cases where vaccination is carried out by the competent authority, the following measures shall apply:

(a) All vaccinated animals shall be identified with a clear and legible mark by means of an approved method in accordance with the procedure laid down in Community legislation.

(b) All vaccinated animals shall remain in the vaccination zone unless they are sent for immediate slaughter to a slaughterhouse designated by the competent authority. In this case, the shipment shall only be authorised where the official veterinarian has examined all the animals of the susceptible species on the holding and confirmed that none of them is suspected of being infected.

4. In accordance with the procedure laid down in Community legislation, animals of susceptible species may be authorised to leave the vaccination zone after completion of the vaccination operations and after a period of time to be determined. following the same procedure.

5. The Ministry of Agriculture, Fisheries and Food, in accordance with the data submitted by the competent authority, shall inform the Commission of the European Community, through the appropriate course, of the progress made in the implementation of the vaccination measures.

6. By way of derogation from paragraph 1, the competent authority may decide on emergency vaccination, after consulting the Ministry of Agriculture, Fisheries and Food on whether it affects the fundamental interests of the European Union. If such a Ministry is to be regarded as such fundamental interests of the European Union. If it is considered that such interest would be adversely affected by vaccination, the Ministry may not be able to carry out the vaccination. In the case of emergency vaccination, it shall be communicated by the Ministry of Agriculture, Fisheries and Food to the Commission of the European Community through the appropriate course. This decision shall take into account in particular the degree of concentration of animals in certain regions, the need to protect particular breeds and the geographical area in which vaccination is practised, and shall be examined immediately by the Commission. competent Community authority which may, where appropriate, decide to maintain, amend, extend or abolish such measures.

Article 20.

1. The Ministry of Agriculture, Fisheries and Food shall prepare an emergency plan in coordination with the Autonomous Communities specifying the national measures to be applied to all the diseases referred to in Annex I to this Regulation. the case of outbreaks of one of these diseases.

This plan should allow staff access to facilities, equipment and any other appropriate material needed for the rapid and effective eradication of the outbreak.

2. The general criteria to be applied for the drawing up of the emergency plans are set out in paragraphs 1 to 5 and 10 of Annex IV, referring paragraphs 6 to 9 to the criteria to be adopted in the light of the disease treat. However, the Ministry of Agriculture, Fisheries and Food may limit itself to applying the criteria for the production laid down in paragraphs 6 to 9 where the criteria set out in paragraphs 1 to 5 and 10 have already been adopted by the Ministry of Agriculture, Fisheries and Food. the occasion of the submission of plans for the implementation of measures to combat another disease.

3. Once the emergency plan has been drawn up, as indicated above, it shall be submitted, through the appropriate course and in accordance with the procedure laid down in Community legislation, for approval to the Commission of the European Community, which may make amendments or supplement it taking into account the development of the situation.

4. The implementation of the emergency plans, once approved, corresponds to the competent authorities.

Article 21.

In the event that veterinary experts from the European Community Commission, in so far as it is necessary to ensure the uniform application of this Royal Decree, carry out on-the-spot checks on the ground, the competent authority and the Ministry of Agriculture, Fisheries and Food, in the field of their competence, shall be provided with assistance for the performance of their tasks, for which the representatives of the said Department may accompany such experts.

Article 22.

The conditions for the financial participation of the European Community in the actions related to the implementation of this Royal Decree are defined in Decision 90 /424/EEC.

Single additional disposition.

This Royal Decree is dictated by article 149.1.16.a of the Constitution on the exclusive competence of the State in the field of bases and general coordination of health.

First disposition first.

The Minister of Agriculture, Fisheries and Food is empowered to dictate the provisions necessary for the implementation and development of this Royal Decree in the field of its powers.

Final disposition second.

This provision shall enter into force on the day following that of its publication in the Official Gazette of the State.

Given in Madrid to April 15, 1994.

JOHN CARLOS R.

The Minister of Agriculture, Fisheries and Food,

VICENTE ALBERO CHAIR

ANNEX I

List of notifiable diseases

Maximum diseases

Rift Valley Fever

Incubation

Bovine Peste

21 days

Peste of small ruminants

21 days

Swine vesicular disease

28 days

language

40 days

epizootic haemorrhagic disease

40 days

Shepox and goat pox

21 days

21 days

21 days

Tessic_table_to_izq"> Teschen Disease

40 days

nodular Dermatosis

28

30 days

ANNEX II

Specific measures for the control and eradication of certain diseases

In addition to the general provisions set out in this Royal Decree, the following specific provisions shall apply with regard to swine vesicular disease.

1. Description of the disease.

Swine disease impossible to distinguish clinically from foot-and-mouth disease. It causes vesicles in the muzzle, lips, tongue and the threads of the hooves. The disease is of very variable severity can infect a pig pig without manifesting clinical lesions. The virus can survive for long periods outside the body and even in fresh meat, it is extremely resistant to normal disinfectants and has the property of being persistent; it is stable in a pH zone between 2.5 and 12, which requires very deep cleaning and disinfection.

2. Incubation period.

For the purposes of this Royal Decree the maximum incubation period shall be considered to be twenty-eight days.

3. Diagnostic confirmation procedures, differences in swine vesicular disease.

The methods of collection of diagnostic materials, laboratory diagnostic tests, antibody detection and evaluation of the results of laboratory tests will be determined by the Commission of the European Union. European Community, through the Standing Veterinary Committee.

4. Confirmation of the presence of swine vesicular disease.

By way of derogation from Article 2 (6) of this Royal Decree, the presence of swine vesicular disease shall be confirmed:

(a) In holdings where the swine vesicular disease virus is isolated, either in pigs or in the environment.

(b) On holdings hosting pigs seropositive to swine vesicular disease, provided that such pigs or other pigs present on the holding show characteristic lesions of the vesicular disease swine.

(c) On holdings hosting pigs that have clinical symptoms or are seropositive, provided that there is a direct epidemiological link to a confirmed outbreak.

d) In other piaras in which seropositive pigs have been detected. In that case, the competent authority shall carry out additional examinations, in particular a new sampling test with an interval of at least 28 days between the samples taken, before confirming the presence of the disease. The provisions of Article 4 shall continue to apply until such additional examinations have been completed. If subsequent examinations do not reveal symptoms of the disease and if the seropositivity of the pigs persists, the competent authority shall order that the pigs subjected to the tests be slaughtered and destroyed under their control or slaughtered under their control. control in a designated slaughterhouse.

The competent authority shall require that the pigs in question, from the time they arrive at the slaughterhouse, be kept and slaughtered apart from the other pigs and that their meat is exclusively reserved for the domestic market.

5. Protection zone.

1) The dimensions of the protection zone shall be as defined in Article 10 of this Royal Decree.

2. By way of derogation from Article 11, in the case of swine vesicular disease, the measures provided for in that Article shall be replaced by the following:

(a) All holdings that host animals of susceptible species within the area shall be identified.

(b) A regular visit shall be made to holdings which host animals of susceptible species and to examine clinically such animals, including, where appropriate, sampling for the purpose of laboratory examination, It is understood that a record of the visits and observations made shall be carried out; the frequency of such visits shall be proportional to the seriousness of the epizootic on the holdings with the greatest risks.

c) It shall prohibit the movement and transport of animals of susceptible species on public or private roads, excluding roads leading to holdings. However, the competent authority may authorise the transit of animals by road or ferrotaril without unloading or stopping.

(d) However, the Commission may, through the Standing Veterinary Committee, grant a derogation in the case of slaughter pigs coming from outside the protection zone and directed to a slaughterhouse located in that Member State. zone.

(e) Trucks and other vehicles and equipment used within the protection zone for the transport of pigs or other animals or materials which may be contaminated, in particular, feed, manure or slurry may not be leave: a holding situated within the protection zone, the protection zone, or a slaughterhouse, without having been cleaned and disinfected in accordance with the procedures laid down by the competent authority. Those procedures shall determine, in particular, that no truck or vehicle which has been used for the transport of pigs may leave the area without being inspected by the competent authority.

(f) The pigs may not leave the holding which is in the course of the twenty-one day following the end of the preliminary cleaning and disinfection operations of the infected holding, established in the Article 16, 21 days after the authorisation of the pigs to leave the holding may be granted for the purpose of driving:

1. º directly to a slaughterhouse designated by the competent authority, preferably within the protection or surveillance zone, provided that all the pigs present on the holding have been inspected; the pigs which are to be transported for slaughter have undergone a clinical examination; each pig has been fitted with an eartag or has been identified with any other authorised means; the transport shall be carried out in vehicles sealed by the competent authority.

The competent authority responsible for the slaughterhouse shall be informed of the intention to send pigs to the slaughterhouse.

On arrival at the slaughterhouse, the pigs shall be housed and slaughtered apart from other pigs. Vehicles and equipment which have been used for the transport of pigs before leaving the slaughterhouse shall be cleaned and disinfected.

During the "ante" and "post-mortem" inspections carried out at the designated slaughterhouse, the competent authority shall take into account any symptoms associated with the presence of the swine vesicular disease virus.

In the case of pigs slaughtered in accordance with these provisions, statistically representative blood muestas shall be taken. In the case of positive results confirming the existence of swine vesicular disease, the measures provided for in paragraph 7.3 shall apply.

2. º In exceptional circumstances, directly to other premises located within the protection zone provided that all the pigs present on the holding have been inspected; the pigs to be transported have have been subjected to a clinical examination with a negative result; each pig has been fitted with an eartag or has been identified with any other authorised means.

g) Fresh meat obtained from pigs referred to in paragraph 1 (f) shall be marked in accordance with Chapter XI, paragraph 50, of Annex I to Royal Decree 147/1993 of 29 January establishing the sanitary conditions for the production and placing on the market of fresh meat, with two perpendicular traces in the form of an oblique cross which crosses the seal and whose intersection is situated in the centre, so as to allow the indication to be read placed inside.

The meat will subsequently undergo heat treatment in an airtight container whose FC value is equal to or greater than 3.00, as provided in Royal Decree 1066/1990 of 27 July laying down the requirements of animal health to be collected by meat products intended for intra-Community trade or imported from third countries. These operations shall be carried out in establishments designated by the competent authority.

The meats shall be dispatched to such establishment provided that the consignment is sealed prior to departure and remains sealed during transport.

However, the Commission of the European Community, at the request of the Ministry of Agriculture, Fisheries and Food, in accordance with the data submitted by the competent authority, together with appropriate justifications, may approve specific solutions, in particular as regards the marking of the meat and its subsequent use, as well as the destination of the products resulting from the treatment.

3) The application of the measures in the protection zone shall be maintained at least until:

(a) All the measures provided for in Article 16 of this Royal Decree have been carried out.

(b) All holdings in the area have been the subject of a clinical examination of the pigs to enable it to be established that they do not have any disease symptoms suggesting the presence of swine vesicular disease; and serological examination of a statistical sample of pigs which has not revealed the presence of antibodies against the swine vesicular disease virus. The serological screening programme shall take into account the transmission of swine vesicular disease and the manner in which pigs are housed. The programme shall be determined by the Commission of the European Community.

The examination and sampling referred to in paragraph (b) may not be carried out before the end of the twenty-eight day following the conclusion of preliminary operations for the cleaning and disinfection of the holding. infected.

4. At the end of the period referred to in paragraph 3, the rules applying to the surveillance zone shall also apply to the protection zone.

6. Surveillance zone.

1) The dimension of the surveillance zone shall be as defined in Article 10.

2. In the case of swine vesicular disease, the measures provided for in Article 12 shall be replaced by the following:

(a) Identification of all holdings that host animals of susceptible species.

(b) Any movement of pigs, except direct driving to the slaughterhouse, shall be authorised from a holding in the surveillance zone provided that no pig has been introduced into the area in the first 21 days. holding: the owner or the person in charge of the pigs shall keep a record of all movements of the pigs.

(c) The competent authority may authorise the transport of pigs from the surveillance zone, provided that:

All pigs present on the holding have been inspected within forty-eight hours preceding transport.

A clinical examination has been performed with a negative result within forty-eight hours preceding transport.

A serological examination of a statistical sample of the pigs to be carried without having revealed the presence of antibodies against the disease has been carried out within 14 days before transport. However, in the case of slaughter pigs, the serological examination may be carried out on samples of blood taken at the slaughterhouse of destination designated by the competent authority in its territory. In the case of positive results confirming the presence of swine vesicular disease, the measures provided for in paragraph 7.3 shall apply.

Each pig has been provided individually with an eartag or has been identified by any other type approved.

The trucks and other vehicles and equipment used to transport the pigs are cleaned and disinfected after each transport.

(d) lorries, as well as other vehicles and equipment used to transport pigs or other animals or materials which are contaminated or used within the surveillance zone, shall not be allowed to leave the that area without having been cleaned and disinfected in accordance with the procedures laid down by the competent authority.

3) The dimension of the surveillance zone may be amended in accordance with the provisions laid down in Article 10 (3

.

The measures of the surveillance zone shall apply at least until: all the measures provided for in Article 16 have been carried out and all the measures required in the protection zone have been carried out.

7. Common measures of a general nature.

In addition to the above measures, the following common provisions should be applied:

1) Where the presence of swine vesicular disease is confirmed, the competent authority shall order that, as far as possible, in addition to the measures provided for in Article 4 (2) and Article 5 of the Royal Treaty, Decree, the meat of pigs slaughtered in the course of the period between the probable introduction of the disease on the holding and the implementation of the official measures are located and destroyed under official control in such a way that it is eliminated. the whole spread of swine vesicular disease virus.

2) Where the official veterinarian has reason to suspect that the pigs on a holding have been contaminated as a result of movement of persons, animals or vehicles or in any other form, the pigs of the holding shall remain subject to the movement restrictions referred to in Article 9 of this Royal Decree, at least until the holding has been subject to:

(a) A clinical examination of the pigs with a negative result.

(b) A serological examination of a representative sample of pigs which has not revealed the presence of antibodies against the swine vesicular disease virus in accordance with paragraph 3 (3) (b).

The examination referred to in paragraphs (a) and (b) may not be carried out until twenty-eight days have elapsed from the possible contact between the contaminated premises and the movements of persons, animals, vehicles or vehicles. other agents.

3) Where the presence of swine vesicular disease is confirmed in a slaughterhouse, the competent authority shall ensure that:

(a) All pigs present in the slaughterhouse are slaughtered without delay.

(b) The carcases and offal of infected and contaminated pigs shall be destroyed, under official control, in such a way as to avoid the risk of spreading swine vesicular disease virus.

(c) The cleaning and disinfection of buildings and equipment, including vehicles, shall be carried out under the control of the official veterinarian in accordance with the instructions laid down by the competent authority.

(d) An epidemiological survey is carried out in accordance with Article 8 of this Royal Decree.

e) No pigs are reintroduced for slaughter before 24 hours at least after the completion of the cleaning and disinfection operations in accordance with paragraph (c).

8. Cleaning and disinfection of infected holdings.

In addition to the provisions set out in Article 16 of this Royal Decree, the following measures shall apply:

1) Preliminary cleansing and disinfection procedure.

(a) As soon as the carcases of pigs for destruction have been collected, they shall be sprayed with a disinfectant approved in accordance with Article 16 at the concentration required for swine vesicular disease, parts of the premises which have housed the pigs and any other part of the premises contaminated during the slaughter. The disinfectant used shall remain on the surface for at least 24 hours.

(b) All tissues and all blood spilled, if appropriate, during slaughter shall be collected and carefully destroyed together with the carcases (the slaughter shall always be carried out on a watertight surface).

2) Intermediate cleaning and disinfection procedures.

(a) All manure, litter and contaminated food must be removed from buildings, piled up and sprayed with an authorised disinfectant. The slurry must be treated according to an appropriate method to kill the virus.

b) All mobile accessories must be removed from the premises and cleaned and disinfected separately.

c) Fat and other stains must be removed from all surfaces by applying a degreaser and then washing with water under pressure.

d) The disinfectant should then be applied again by spraying all the surfaces.

e) Watertight rooms must be disinfected by fumigating.

(f) Repairs to the soil, walls and other damaged parts shall be authorised after inspection of an official veterinarian and immediately carried out.

g) Once the repairs are completed they must be inspected to verify if they have been performed successfully.

(h) All parts of premises that are completely free of combustible materials may be subjected to heat treatment with the aid of a lanzas.

i) All surfaces must be sprayed with an alkaline disinfectant whose Ph is greater than 12.5 or with any other authorized disinfectant. The disinfectant must be removed with water forty-eight hours later.

3) Final cleaning and disinfection procedure.

Treatment with flamethrowers or with alkaline disinfectant [paragraph 2 (h or i)] must be repeated fourteen days later.

9. Repopulation of the infected holdings.

In addition to the measures provided for in Article 5 (4) of this Royal Decree, the following provisions shall apply:

1) Repopulation must not begin before four weeks elapse from the first complete disinfection of the premises, i.e. from stage 3 of the cleaning and disinfection procedures.

2. The reintroduction of pigs shall take into account the type of farming practised on the holding concerned and shall be appropriate to the following provisions:

(a) In the case of open-air holdings, restocking shall commence by the introduction of a limited number of tell-tale piglets which have reacted negatively to a control of the presence of antibodies against the virus of swine vesicular disease. The control piglets shall be distributed throughout the infected holding, in accordance with the requirements of the competent authority, and shall be subject to a clinical examination twenty-eight days after they have been introduced into the holding and a serological examination by sampling.

If none of the piglets shows any clinical manifestation of the swine vesicular disease or produces antibodies against the disease virus, the complete repopulation may be carried out.

(b) For all other forms of breeding, the reintroduction of the pigs shall be carried out either in accordance with the measures laid down in subparagraph (a) or by a total restocking, provided that all pigs arrive within a period of eight days from holdings situated outside the restriction zones on account of swine vesicular disease and shall be seronegative; no pig may leave the holding for a period of 60 days after the arrival of the last pigs; the repopulated piara is the subject of a clinical and serological examination in accordance with the provisions laid down by the competent authority. Such examination shall not take place before the end of the period of twenty-eight days.

ANNEX III

Community reference laboratories for the diseases in question

The competencies and functions of the Community reference laboratories for the diseases in question are as follows:

1. To coordinate, after consultation with the Commission, the methods of diagnosis of the disease in question in the Member States, in particular by:

(a) The specification, possession and delivery of virus strains of the diseases concerned to be subjected to serological testing and preparation of the antiserum.

(b) The delivery of the reference sera and other reference reagents to the national reference laboratories in order to harmonise the tests and reagents used in each Member State.

c) The creation and conservation of a collection of strains and isolated matter of the virus of the diseases concerned.

d) The periodic community comparative testing of diagnostic procedures.

e) The collection and selection of data and all types of information on the diagnostic methods used and the results of the tests carried out in the Community.

f) The characterization of the disease virus isolated from the disease in question by means of the most advanced methods to achieve a better understanding of the epizootiology of the disease.

g) The monitoring of the development of the situation, all over the world, of the control, epizootiology and prevention of the disease in question.

h) The carrying out of technical tests on the virus of the disease in question and other viruses related to it in order to make a rapid differential diagnosis.

i) The thorough knowledge of the preparation and use of the immunological veterinary medicine products used for the eradication and control of the disease concerned.

2. To contribute actively to the identification of the disease outbreaks in the Member States, by studying the isolated matter of the virus sent to confirm the diagnosis, to carry out its characterization and to carry out studies. epizootiological.

3. To facilitate the training or retraining of experts in laboratory diagnostics to harmonise diagnostic techniques throughout the Community.

ANNEX IV

Minimum criteria applicable to emergency plans

The intervention plans must set, at least:

1. The creation, at national level, of a crisis centre aimed at coordinating all emergency measures.

2. A list of local emergency centres equipped with the appropriate equipment to coordinate control measures at local level.

3. Detailed information on the staff responsible for emergency measures, their qualifications and responsibilities.

4. The possibility, for any local emergency centre, to establish contact with persons or organisations directly or indirectly affected by an infestation.

5. The availability of equipment and materials needed to properly carry out emergency measures.

6. The precise instructions concerning the actions to be taken when suspected and confirmed cases of infection or contamination, including the means of destruction of the dead bodies.

7. Training programmes to update and develop knowledge on procedures on the ground and administrative procedures.

8. For diagnostic laboratories, a "post-mortem" examination service, the necessary capacity for serological tests, histological examinations, etc., and the updating of rapid diagnostic techniques (for these purposes, it is appropriate to establish provisions for the rapid transport of samples.

9. Details concerning the quantity of vaccines against the disease in question which are deemed necessary in the event of the use of emergency vaccination.

10. Regulatory provisions for the implementation of the intervention plans.