Measures to combat foot-and-mouth disease are contained in Royal Decree 2223/1993 of 17 December 1993 laying down measures for the control of foot-and-mouth disease and animal health in trade Intra-Community trade and imports of animals of the bovine, porcine, fresh meat or meat products from third countries.

The European Union has established new measures for the control of foot-and-mouth disease by Council Directive 2003 /85/EC of 29 September 2003 on Community measures to combat foot-and-mouth disease, for which it is repeal Directive 85 /511/EEC and Decisions 89 /531/EEC and 91 /665/EEC and amend Directive 92 /46/EEC.

This regulation takes into account the epizootic disease of foot-and-mouth disease that occurred in certain Member States in 2001, which showed that a focus can quickly take on epizootic proportions and cause disturbances throughout the Union. European; the 1998 report of the expert groups of the Member States on a review of the Community legislation on foot-and-mouth disease; the conclusions of the International Conference on the Prevention and Control of Fever Foot-and-mouth disease, held in Brussels in December 2001; the European Parliament Resolution of 17 December 2001. December 2002, on the epizootic of foot-and-mouth disease of 2001 in the European Union; the recommendations of the 1993 report of the 30th session of the European Commission for the Fight against Foot and Mouth Disease, of the Organization for Agriculture and Food, and the changes introduced in the Zoosanitary Code and in the International Office of Epizootics (OIE) standards manual for the diagnostic tests and vaccines of the OIE.

This royal decree is structured into five titles, dedicated to:

(a) Title I, to the general provisions.

(b) Title II, the fight against foci, divided into nine chapters, which regulate, respectively, the notification of the disease; the measures in case of suspicion; the measures in case of confirmation; the measures in cases (a) special conditions; holdings consisting of different epizootiological production units and contact holdings; screening and surveillance zones; regionalisation, movement control and identification; vaccination; and recovery from the consideration of infection-free and foot-and-mouth disease.

c) Title III, preventive measures, and regulates in seven chapters laboratories and establishments handling foot-and-mouth disease virus; diagnosis of the disease; alert plan and alert exercises in time. real; the centres of struggle and groups of experts; antigen and vaccine banks; foot-and-mouth disease in other species; and supplementary guarantees for intra-Community trade.

(d) Title IV, to trade with third countries.

e) Title V, finally, to the implementing measures, including the sanctioning regime and the procedure for the adoption of special epizootiological measures.

Of this regulation, it should be noted that preventive measures are envisaged to prevent the arrival of foot-and-mouth disease in the European Union and livestock, from neighbouring countries or through the introduction into the territory of the Union of live animals and products of animal origin, immediate action as soon as the presence of the disease is suspected, in order to, if confirmed, implement immediate and effective control measures, and a new policy of vaccination of (a) the urgency and application of the principles of regionalisation, in order to enable the implementation of measures (a) strict measures to combat the disease in a given part of the European Union, without jeopardising the general interests of the Union.

In accordance with the provisions of Law 8/2003 of April 24, of animal health, the powers for the execution of this royal decree correspond to the autonomous communities, except as regards the movement of animals with third countries, which corresponds to the bodies of the General Administration of the State responsible for external health, as well as to affect the animals attached to the Ministries of the Interior and Defence and to their public bodies, in which this provision will be applied by them.

By this royal decree, Directive 2003 /85/EC is incorporated into the internal legal order, the minimum measures for the control of foot-and-mouth disease are established and the Royal Decree 1679/1994 of 22 July 1994 is amended, establish the health conditions for the production and placing on the market of raw milk, heat-treated milk and milk products.

In the elaboration of this royal decree, the autonomous communities and representative entities of the sectors affected have been consulted.

This royal decree is dictated by the habilitation contained in the fifth final provision of Law 8/2003, of April 24, of animal health.

In its virtue, on the proposal of the Ministries of Agriculture, Fisheries and Food and of Health and Consumer Affairs, with the prior approval of the Minister of Public Administration, according to the State Council and prior deliberation of the Council of Ministers at its meeting on 12 November 2004,

DISPONGO:

TITLE I

General provisions

Article 1. Object.

This royal decree aims to establish the minimum control measures to be applied in case of the outbreak of foot-and-mouth disease, regardless of the type of virus, as well as certain preventive measures aimed at improving the awareness and preparedness of the competent authorities and livestock farmers in the face of foot-and-mouth disease.

Article 2. Definitions.

1. For the purposes of this royal decree, the definitions contained in Article 3 of Law 8/2003 of 24 April of animal health shall apply. The national veterinary health alert system committee shall be provided for in Article 27 of Law 8/2003 of 24 April of animal health.

2. In addition,

following definitions shall apply:

(a) Animal of a sensitive species: any animal, production, company or wild species, suborders "Ruminantia", "Suina" and "Tylopoda" of the order "Artiodactyla".

In the case of specific measures, in particular those adopted pursuant to Article 15 and Article 80.2, they may be considered to be susceptible to foot-and-mouth disease, on the basis of scientific data, other animals, such as those of the orders "Rodentia" or "Proboscidae".

(b) Exploitation: without prejudice to the concept referred to in Article 3 (12) of Law 8/2003 of 24 April of animal health, it shall also be understood as holding the establishment, whether agricultural or not, including circuses, located on the national territory, where animals of susceptible species are reared or kept permanently or temporarily.

For the purposes of Article 10.1, this definition does not include the personal home areas of such establishments unless animals of susceptible species are permanently or temporarily kept in them. including those referred to in Article 80.2, the slaughterhouses, the means of transport, the border inspection posts, or the fenced areas in which animals of susceptible species are maintained and may be hunted if such fenced areas have a the size of the measures referred to in Article 10 inapplicable.

c) Rebane: any group of animals kept on a holding as an epizootiological unit; if more than one herd is kept on a holding, each of these herds shall be a separate unit and shall have the same health consideration.

Exceptionally, the competent authority may consider a single animal herd, depending on the health circumstances involved.

(d) Owner: any natural or legal person who owns an animal of a sensitive species or is in charge of its maintenance, with or without remuneration.

(e) Authorisation: the written authorisation granted by the competent authorities, which must be available in the copies necessary for subsequent inspections in accordance with the relevant legislation.

f) Incubation period: the time period between infection and the occurrence of clinical signs of foot-and-mouth disease; in particular, for the purpose of this royal decree, 14 days in the case of bovine animals and swine, and 21 days in the case of ovine and caprine animals and any other animals of a susceptible species.

g) Animal suspected of being infected: the animal of a susceptible species showing clinical signs or lesions observed in the autopsy or reactions in laboratory tests of such a type that may reasonably be suspected of presence of foot-and-mouth disease.

h) Animal suspected of being contaminated: the animal of a susceptible species which, according to the epizootiological information collected, may have been exposed directly or indirectly to the foot-and-mouth disease virus.

(i) Case of foot-and-mouth disease or animal infected with foot-and-mouth disease: the animal or animal carcass of a susceptible species in which the presence of foot-and-mouth disease has been officially confirmed taking into account the definitions in the Annex I:

1. Good for clinical signs or lesions observed in the officially confirmed autopsy and corresponding to foot-and-mouth disease.

2. ° Good as a result of a laboratory test performed in accordance with Annex XIII.

(j) FMD (FMD): the holding in which animals of susceptible species are kept and which conforms to one or more of the criteria listed in Annex I.

(k) Primary focus: the focus referred to in Article 4 (1) (a) (1) of Royal Decree 2459/1996 of 2 December 1996 establishing the list of diseases of compulsory declaration animals and giving the rules for their notification.

(l) Matanza: the killing of animals as defined in Article 2.f) of Royal Decree 54/1995 of 20 January on the protection of animals at the time of slaughter or killing.

m) Sacrifice of urgency: the slaughter in cases of urgency as defined in Article 2.g of Royal Decree 54/1995 of 20 January on the protection of animals at the time of slaughter or killing of animals which, according to epizootiological data, clinical diagnoses or laboratory test results, they are not considered to be infected or contaminated with the foot-and-mouth disease virus, including slaughter for reasons of animal welfare.

n) Transformation: one of the treatments for Category 1 or Category 2 materials, depending on the species concerned, as laid down in Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002, laying down the health rules applicable to animal by-products not intended for human consumption, applied in such a way as to avoid the risk of the spread of foot-and-mouth disease virus.

n) Regionalisation: the delimitation of a restricted zone in which restrictions on trade or movements of certain animals or animal products are applied as referred to in Article 45, in order to avoid spread of foot-and-mouth disease to the free zone, in which no restriction is applied in accordance with this royal decree.

o) Region: the province.

p) Sub-region: the area specified in the Annex to Commission Decision 2000 /807/EC of 11 December 2000 establishing the codified form and the codes for the notification of the diseases of the intended animals in Council Directive 82/894/EEC, which repeals Decisions 84 /90/EEC and 90 /442/EEC.

q) Community antigen and vaccine bank: the appropriate establishment, designated in accordance with the relevant procedure, for the storage of reserves in the European Union, both of the concentrated inactivated antigens of the Foot-and-mouth disease virus for the production of the vaccine against this disease, as well as immunological veterinary medicinal products (vaccines) reconstituted from such antigens and authorised in accordance with the rules in force in this respect.

r) Emergency vaccination: vaccination in accordance with Article 50.1.

s) Protective vaccination: the emergency vaccination carried out on holdings in a given area to protect animals of susceptible species within that area from the air spread or by means of fomites of the foot-and-mouth disease virus, and where the animals are intended to be kept alive after vaccination.

t) Vaccination for suppression: the emergency vaccination carried out exclusively in conjunction with a policy of animal suppression in a holding or area where it is urgent to reduce the amount of virus circulating foot-and-mouth disease and the risk of the spread of the virus outside the perimeter of the holding or area, and where the animals are intended to be destroyed after vaccination.

(u) wild animal: an animal of a susceptible species living outside a holding as defined in subparagraph (b) or in one of the establishments referred to in Articles 15 and 16.

v) Primary case of foot-and-mouth disease in wild animals: any case of foot-and-mouth disease detected in a wild animal in an area where measures are not implemented in accordance with Article 80 (3) or (4).

TITLE II

Fight against foci

CHAPTER I

Notification

Article 3. Notification of the disease.

1. The presence or suspicion of foot-and-mouth disease shall be subject to mandatory and immediate notification to the competent authority.

2. The owner or any person who takes care of animals, accompanies them during transport or takes care of them shall be obliged to notify without delay to the competent authorities or to the official veterinarian the presence, suspected or confirmed, of fever. Foot-and-mouth disease, and shall keep animals infected, or suspected of being infected with foot-and-mouth disease, removed from other places where animals of susceptible species are at risk of being infected or contaminated with the foot-and-mouth disease virus.

3. Veterinarians, including officers, personnel responsible for official or private laboratories, both veterinary and other, and any person who has any professional relationship with animals of susceptible species or products derived from such animals, shall be obliged to notify without delay to the competent authorities any information on the presence, suspected or confirmed, of foot-and-mouth disease, which they come to know before the official intervention in the field of the disease. royal decree.

4. Without prejudice to the provisions of Royal Decree 2459/1996 of 2 December 1996 establishing the list of diseases of compulsory declaration animals and giving the rules for their notification, the competent authority in the territory of which the a outbreak of foot-and-mouth disease or a primary case of foot-and-mouth disease in wild animals shall be confirmed and shall provide information and written reports, in accordance with Annex II, to the Ministry of Agriculture, Fisheries and Food, to ensure that the latter notifies the European Commission of the disease and informs the European Commission, through the appropriate course, and the other Member States, in accordance with the provisions of that Annex II.

CHAPTER II

Measures in case of suspected outbreak of foot-and-mouth disease

Article 4. Measures in case of suspected outbreak of foot-and-mouth disease.

1. Where one or more animals suspected of being infected or contaminated are found on a holding, the measures referred to in paragraphs 2 and 3 shall apply.

2. The competent authority shall immediately implement, under its supervision, the official means of investigation to confirm or rule out the presence of foot-and-mouth disease and, in particular, to take the relevant samples for the examination of necessary laboratory in order to confirm a focus according to the focus definition in Annex I.

3. As soon as the suspected infection is notified, the competent authority shall place the holding referred to in paragraph 1 under official surveillance and shall ensure in particular that:

(a) The counting of all categories of animals present on the holding is carried out and, of each category of animals of susceptible species, the number of animals already dead and the number of animals suspected of being infected or contaminated.

(b) The count referred to in subparagraph (a) shall be updated to take into account animals of susceptible species born or killed during the period of suspicion, and that this information is submitted by the owner at the request of the the competent authority and controlled by that authority on each visit.

(c) All stocks of milk, milk products, meat, meat products, meat preparations, carcases, skins, wool, semen, embryos, ova, slurry and manure, as well as the feed and bed in the meat, shall be recorded. exploitation, and that these records are preserved.

(d) No animal of a susceptible species shall be removed from the holding unless it is a holding consisting of different epizootiological units as referred to in Article 18 and all animal species Sensitive areas of the holding are kept in their premises of stables or in other places where their isolation is permitted.

(e) Appropriate means of disinfection shall be used in the entrances and exits of buildings or sites which host animals of susceptible species, as well as those of the holding itself.

(f) An epizootiological survey is carried out in accordance with the provisions of Article 13.

g) In order to facilitate the epizootiological survey, the necessary samples shall be taken for the performance of laboratory tests in accordance with paragraph 2.1.1.1 of Annex III.

Article 5. Movements of entry and exit from a holding in case of suspected outbreak of foot-and-mouth disease.

1. The competent authorities shall ensure that, in addition to the measures referred to in Article 4, any movement of entry and exit from a holding is prohibited where the presence of an outbreak of foot-and-mouth disease is suspected. This prohibition shall apply in particular:

(a) The removal from the holding of meat or carcases, meat products, preparations of meat, milk or milk products, semen, ova or embryos of animals of susceptible species, as well as of feed, utensils, objects or other materials such as wool, fur, hair or animal waste, purines, manure or any element that may be transmitted by the foot-and-mouth disease virus.

(b) The movement of animals of species that are not susceptible to foot-and-mouth disease.

(c) The entry and exit of persons on the holding, in the form and conditions provided for in Article 17.1.e) of Law 8/2003, of 24 April.

d) At the entry and exit of vehicles from the holding.

2. By way of derogation from the prohibition laid down in paragraph 1 (a), in the event of difficulties in storing milk on the holding, the competent authorities may decide that the milk is destroyed on the holding or that the milk is authorised transport, under veterinary supervision and only in a means of transport properly conditioned to avoid any risk of spreading the foot-and-mouth disease virus, from the holding to the nearest possible place where it can be removed or be transformed in accordance with the provisions of Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules for animal by-products not intended for human consumption, or being treated in such a way as to ensure the destruction of the virus from that disease.

3. By way of derogation from the prohibitions laid down in paragraph 1 (b), (c) and (d), the competent authorities may authorise such movements of entry and exit from the holding by applying all the conditions necessary to prevent the spread of foot-and-mouth disease virus.

Article 6. Extension of the measures to other holdings.

1. The competent authority shall extend the measures referred to in Articles 4 and 5 to other holdings where contamination is suspected due to its implementation, construction and configuration or contacts with animals of the exploitation referred to in Article 4.

2. The competent authority shall apply at least the measures referred to in Article 4 and in Article 5.1 to the establishments or means of transport referred to in Article 16, where the presence of animals of susceptible species does not suspect an infection or contamination with the foot-and-mouth disease virus.

Article 7. Temporary control zone.

1. The competent authority may establish a temporary control area where the epizootiological situation so requires, especially in the case of high density of animals of susceptible species, intensive movement of animals or persons in contact with animals of susceptible species, of delays in notifications of suspected or insufficient consideration of the possible origin and forms of introduction of the foot-and-mouth disease virus.

2. For holdings located in the temporary control area where animals of susceptible species are kept, at least the measures referred to in Article 4 (2) and (3) (a), (b) and (d) and in Article 5.1 shall apply.

3. The measures applied in the temporary control zone may be supplemented by the temporary prohibition of movements of all animals in all or part of an autonomous community, decided by its competent authority. However, the prohibition of movements of animals of susceptible species to foot-and-mouth disease shall not last longer than 72 hours, unless justified by exceptional circumstances.

Article 8. Preventive eradication programme.

1. Where the epizootiological or other data type so advises, the competent authority may apply a preventive eradication programme, including the preventive slaughter of animals of susceptible species which may be contaminated and, if deemed necessary, from animals from epizootiologically related production units or from adjacent holdings.

2. In this case, sampling and testing of animals of susceptible species shall be carried out at least in accordance with the provisions of paragraph 2.1.1.1 of Annex III.

3. The competent authority shall, in good time, notify the Ministry of Agriculture, Fisheries and Food for the transfer thereof to the European Commission, through the appropriate course, of the measures referred to therein. Article.

Article 9. Maintenance of the measures.

The measures provided for in Articles 4 to 7 shall not be withdrawn by the competent authority until the suspicion of foot-and-mouth disease has been officially ruled out.

CHAPTER III

Measures in case of confirmation of an outbreak of foot-and-mouth disease

Article 10. Measures in case of confirmation of an outbreak of foot-and-mouth disease.

1. As soon as a outbreak of foot-and-mouth disease is confirmed, the competent authorities shall ensure that, in addition to the measures referred to in Articles 4 to 6, the following measures are applied on the holding without delay:

(a) All animals of susceptible species on the holding shall be slaughtered on the spot.

In exceptional circumstances, animals of susceptible species may be slaughtered at the nearest appropriate place for that purpose, under official supervision and in such a way as to avoid the risk of spreading the foot-and-mouth disease virus. during transport and slaughter.

The competent authority shall notify the Ministry of Agriculture, Fisheries and Food for its transfer to the European Commission, through the appropriate course, of the existence of such exceptional circumstances and measures taken.

(b) The official veterinarian shall ensure that, prior to the killing of animals of susceptible species, or during the slaughter, all samples are taken in sufficient numbers and in accordance with the provisions of paragraph 2.1.1.1 of Annex III. appropriate for the epizootiological survey referred to in Article 13.

The competent authority may decide that the provisions of Article 4.2 shall not apply in the event of the occurrence of a secondary focus which is epizootiologically related to a primary focus of which it has already been taken samples in accordance with that paragraph, provided that such samples are adequate and in sufficient numbers for the epizootiological survey referred to in Article 13.

(c) The carcasses of animals of susceptible species which have died on the holding and the carcasses of animals which have been slaughtered in accordance with paragraph (a) shall be treated without undue delay and official supervision so that there is no risk of spreading the foot-and-mouth disease virus.

Where, by particular circumstances, the bodies need to be buried or incinerated, either on the spot or elsewhere, such operations shall be carried out in accordance with the instructions prepared in advance in the field of contingency plans referred to in Article 71.

(d) All products and substances referred to in Article 4 (3) (c) shall be kept in isolation until contamination can be discarded, or they shall be treated in accordance with the instructions of the official veterinarian in such a way as to ensure the destruction of any foot-and-mouth disease virus or shall be processed.

2. After the killing and processing of animals of susceptible species have been carried out and the measures provided for in paragraph 1 (d) have been applied, the competent authorities shall ensure that:

(a) All buildings in which animals of susceptible species, as well as their surroundings, have been housed in vehicles which have been used for transport and other buildings are cleaned and disinfected in accordance with Article 11. and equipment that may be contaminated.

(b) In addition, in the case of justified suspicion of contamination of the human habitation area or of the administrative area of the holding by the foot-and-mouth disease virus, these areas shall also be disinfected in an appropriate manner.

(c) Repopulation with animals is carried out in accordance with Annex V.

Article 11. Cleaning and disinfection.

1. The competent authorities shall ensure that the cleaning and disinfection operations, as an integral part of the measures referred to in this royal decree, are properly documented and carried out under official supervision and in accordance with the instructions given by the official veterinarian, using the disinfectants, and their working concentrations, which are officially authorised and registered for placing on the market as biocidal products for veterinary hygiene in accordance with the Royal Decree 1054/2002 of 11 October 2002 regulating the evaluation process for the registration, authorisation and placing on the market of biocidal products to ensure the destruction of foot-and-mouth disease virus.

2. The competent authorities shall ensure that the cleaning and disinfection operations, which include the appropriate pest control, are carried out in such a way as to reduce as much as possible the adverse effect on the environment which they may have. such operations.

3. The competent authorities shall endeavour to ensure, both in the authorisation and in the use of biocidal products, that all the disinfectants used, in addition to being able to disinfect effectively, also have the minimum possible effect negative on the environment and public health according to the best available technology.

4. The competent authorities shall ensure that the cleaning and disinfection operations are carried out in accordance with Annex IV.

Article 12. Location and processing of products and substances that come from animals of an outbreak of foot-and-mouth disease or which have been in contact with those animals.

The competent authorities shall ensure that the products and substances referred to in Article 4 (3) (c) from animals of susceptible species collected on a holding where a outbreak of foot-and-mouth disease has been confirmed, as semen, ova and embryos from animals of susceptible species present on that holding, during the period between the probable introduction of the disease on the holding and the implementation of official measures, shall be they are located and transformed or, in the case of materials other than semen, of the ova and of the embryos, are treated under official supervision in such a way as to ensure the destruction of the foot-and-mouth disease virus and to avoid the risk of further spread.

Article 13. Epizootiological survey.

1. The competent authorities shall ensure that epizootiological surveys are carried out concerning outbreaks of foot-and-mouth disease, carried out by specially trained veterinarians and from questionnaires prepared within the contingency plans provided for in this Regulation. Article 71, in order for the surveys to be standardised, rapid and focused. Such surveys shall cover at least:

(a) The duration of the period during which foot-and-mouth disease may have been present on the holding prior to its suspicion or notification.

(b) The possible origin of the foot-and-mouth disease virus from the holding and the determination of other holdings in which animals suspected of being infected or contaminated from the same outbreak are found.

(c) The possible extent of infection or contamination of animals of susceptible species other than bovine animals or swine.

(d) The movements of animals, persons, vehicles and materials referred to in Article 4.3.c) which could have carried the foot-and-mouth disease virus to or from the holdings concerned.

2. The competent authorities shall regularly inform and update the Ministry of Agriculture, Fisheries and Food for their transfer to the National Committee of the Veterinary Health Alert System and, through the appropriate course, to the Ministry of Agriculture, Fisheries and Food. the European Commission and the other Member States on the epizootiology and spread of foot-and-mouth disease virus.

Article 14. Additional measures in case of confirmation of outbreaks of foot-and-mouth disease.

1. The competent authority may order that, on the holding where a outbreak of foot-and-mouth disease has been confirmed, in addition to animals of susceptible species, animals of species that are not susceptible to such disease are also slaughtered and processed. This means that any risk of the spread of foot-and-mouth disease virus is avoided.

However, this shall not apply to animals of species that are not susceptible to foot-and-mouth disease which can be isolated, cleaned and disinfected in an effective manner and provided that they can be identified individually, in the case of Equidae, in accordance with the rules in force in this respect, to permit the control of their movements.

2. The competent authority may apply the measures referred to in Article 10 (1) (a) to neighbouring holdings or related production units epizootiologically, in the event that the epizootiological information or other indications are to suspect possible contamination of these holdings. The competent authority shall communicate to the Ministry of Agriculture, Fisheries and Food for subsequent transfer, through the appropriate course, to the European Commission, the intention to use these provisions prior to their implementation, wherever possible. In this case, the measures relating to the sampling and clinical examination of animals shall be applied, at least in accordance with the provisions of paragraph 2.1.1.1 of Annex III

3. Following the confirmation of the first outbreak of foot-and-mouth disease, the competent authority shall take all the necessary measures for emergency vaccination in an area which has at least the size of the surveillance zone established in accordance with the Article 21.

4. The competent authorities may apply the measures referred to in Articles 7 and 8.

CHAPTER IV

Applicable measures in special cases

Article 15. Measures applicable in the event of an outbreak of foot-and-mouth disease in the vicinity or within certain specific establishments not intended for livestock farming where susceptible species are kept permanently or temporarily.

1. Where there is a danger of an outbreak of foot-and-mouth disease infecting animals of susceptible species in a laboratory, zoo, wildlife park or fenced area, or in bodies, institutes or centres approved in accordance with Article 14 of the Royal Decree 1881/1994 of 16 September 1994 laying down the animal health conditions governing intra-Community trade in and imports from third countries of non-subjected animals, semen, ova and embryos, with regard to these conditions, to the provisions contained in Section 1 of Annex A to the Royal Decree 1316/1992 of 30 October 1992 laying down the veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market; and where animals are kept for scientific purposes or for the conservation of species or genetic resources of breeding animals, the competent authority shall ensure that all necessary biosecurity measures are taken to protect such animals. animals of the infection.

Such measures may include restricting access to public institutions or imposing special conditions on such access.

2. Where an outbreak of foot-and-mouth disease is confirmed in one of the establishments referred to in paragraph 1, the competent authority concerned may, after consulting the national committee of the veterinary health alert system, take the decision of derogating from Article 10 (1) (a), provided that fundamental interests of the European Union are not jeopardised, and in particular the animal health status of other Member States, and that all measures are taken to to avoid the risk of spreading the foot-and-mouth disease virus.

3. The decision referred to in paragraph 2 shall be immediately notified to the European Commission by the appropriate channel. In the case of genetic resources for breeding animals, the notification shall include a reference to the list of establishments provided for in accordance with Article 76.2.f. by means of which the competent authority has previously identified such establishments as breeding centres for animals of susceptible species essential for the survival of a breed.

Article 16. Measures applicable in slaughterhouses, border inspection posts and means of transport.

1. Where a case of foot-and-mouth disease is confirmed in a slaughterhouse, at a border inspection post designated and approved in accordance with Royal Decree 1430/1992 of 27 November 1992 laying down the principles governing the organisation of veterinary checks and the identity of animals entering the Community from third countries, or in a means of transport, the competent authority shall ensure that the following measures are applied in relation to the appropriate establishments or means of transport:

(a) All animals of susceptible species found in those establishments or means of transport shall be slaughtered immediately.

(b) The carcasses of the animals referred to in paragraph (a) shall be processed under official supervision in such a way as to avoid the risk of spreading the foot-and-mouth disease virus.

(c) Other animal waste, including offal, of animals infected or suspected of being infected and contaminated, shall be processed under official supervision in such a way as to avoid the risk of spreading Foot-and-mouth disease virus.

(d) Disinfection of the manure and slurry shall be carried out and shall only be withdrawn for treatment in accordance with Section II (5) of Part A of Chapter III of Annex VIII to this Regulation. Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules for animal by-products not intended for human consumption.

e) the cleaning and disinfection of buildings and equipment, including vehicles or means of transport, shall be carried out under the supervision of the official veterinarian in accordance with the provisions of Article 11 and with the instructions established by the competent authority.

(f) An epizootiological survey shall be carried out in accordance with Article 13.

2. The competent authorities shall ensure that the measures referred to in Article 19 are applied in the contact holdings.

3. The competent authorities shall ensure that no animal is reintroduced for slaughter, inspection or transport in the establishments or means of transport referred to in paragraph 1 until at least 48 hours have passed since the end of the year. completion of the cleaning and disinfection operations referred to in paragraph 1 (e).

4. Where the epizootiological situation so requires, in particular where the contamination of animals of susceptible species in holdings adjacent to the establishments or means of transport referred to in paragraph 1 is suspected, the the competent authorities shall ensure that, by way of derogation from the second subparagraph of Article 2 (b), a focus is declared on the establishments or means of transport referred to in paragraph 1 and the measures referred to in the Articles 10 and 21.

Article 17. Examination of the measures.

The measures necessary to prevent the spread of foot-and-mouth disease virus, in particular in relation to regionalisation in accordance with Article 45 and with emergency vaccination under Article 52, shall be applicable. adopted by the European Commission after examining the situation of the special cases referred to in Article 15.

CHAPTER V

Holdings consisting of different epizootiological production units and contact holdings

Article 18. Holdings consisting of different epizootiological production units.

1. In the case of holdings consisting of two or more separate production units, the competent authority may, in exceptional cases and after assessment of the risk, derogate from the provisions of Article 10.1.a. with the production units of those holdings not affected by foot-and-mouth disease.

2. The derogations referred to in paragraph 1 may be laid down only after the official veterinarian has confirmed, on the occasion of the official investigation referred to in Article 4.2, that the following conditions for preventing the the spread of foot-and-mouth disease virus between the production units referred to in paragraph 1 was already in force for a time equivalent to at least two incubation periods before the date on which the focus of the disease was identified; Foot-and-mouth disease on the holding:

(a) That the structure, including administration, and the size of the establishments allow for the complete separation of the accommodation and maintenance of the different herds of animals of susceptible species, including a separate airspace.

b) That the operations carried out in the different production units and, in particular, the management of the stables and pasture, the feeding and the disposal of the manure are completely separated and are carried out by different staff.

c) That machinery, working animals of species that are not susceptible to foot-and-mouth disease, equipment, facilities, instruments and disinfection tools used in the production units are completely separated.

3. In relation to milk, a derogation from Article 10 (1) (d) may be granted to a dairy holding, provided that:

(a) Such holdings comply with the conditions set out in paragraph 2.

b) The milking of each unit is performed separately.

c) And, depending on the intended use, the milk is at least subject to one of the treatments described in Parts A or B of Annex IX.

4. Where a derogation is established in accordance with paragraph 1, the implementing rules for the application of this derogation shall be adopted in advance.

The Autonomous Communities must notify the Ministry of Agriculture, Fisheries and Food, through the appropriate channel, to the European Commission, the exception, and must provide details of the measures adopted.

Article 19. Contact holdings.

1. A holding shall be recognised as being in contact when the official veterinarian observes or considers, on the basis of confirmed data, that the foot-and-mouth disease virus has been introduced as a result of the movement of persons, animals, products of animal or vehicle origin, or in any other form, from other holdings to a holding referred to in Article 4.1 or Article 10.1, or from a holding referred to in Article 4.1 or in Article 10.1 to other holdings.

2. Contact holdings shall be subject to the measures provided for in Article 4.3 and Article 5, which shall be maintained until the suspected presence of the foot-and-mouth disease virus has been officially ruled out on these holdings. contact, in accordance with the definition in Annex I and the research requirements referred to in paragraph 2.1.1.1 of Annex III.

3. The competent authority shall prohibit the departure of any animal from the contact holdings for a period corresponding to the incubation period indicated for the species referred to in Article 2.h

However, the competent authority, by way of derogation from Article 4 (3) (d), may authorise the transport of animals of susceptible species, under official supervision, directly to the nearest designated slaughterhouse. for their emergency slaughter.

Prior to the granting of that derogation, the official veterinarian shall carry out at least the clinical examinations referred to in paragraph 1 of Annex III.

4. Where the competent authority considers that the epizootiological situation permits, it may restrict the recognition as a contact holding provided for in paragraph 1 to a single unit of epizootiological production identified from the holding. and the animals contained therein, provided that such an epizootiological production unit complies with the requirements of Article 18.

5. Where an epizootiological relationship between an outbreak of foot-and-mouth disease and an establishment or a means of transport referred to in Articles 15 and 16 cannot be excluded, the competent authorities shall ensure that they are applied to such diseases. establishments or means of transport the measures provided for in Article 4 (2) and (3) and Article 5. The competent authorities may decide to apply the measures provided for in Article 8.

Article 20. Coordination of measures.

The measures necessary to ensure the coordination of the measures implemented under Articles 18 and 19, to be adopted by the European Commission in the event of a review of the situation in relation to the holdings provided for in those Articles.

CHAPTER VI

Protection and surveillance zones

Article 21. Establishment of protection and surveillance zones.

1. Immediately after confirmation of a outbreak of foot-and-mouth disease, the competent authorities, without prejudice to the measures referred to in Article 7, shall at least take the measures set out in paragraphs 2, 3 and 4.

2. The competent authority shall establish around the outbreak of foot-and-mouth disease referred to in paragraph 1 a protection zone with a minimum radius of three km and a surveillance zone with a minimum radius of 10 km. The geographical delimitation of these areas shall take into account the administrative limits, natural obstacles, monitoring facilities and technical progress which make it possible to predict the likely dispersion of the foot-and-mouth disease virus through air or by air. any other means.

This delimitation will be reviewed, if necessary, based on those elements.

3. The competent authority shall ensure that the protection and surveillance zones are marked by providing sufficient size signals on the access roads to the areas.

4. In order to ensure full coordination of all measures necessary to eradicate foot-and-mouth disease as soon as possible, local and national disease control centres as referred to in Articles 73 and 75 shall be established.

In order to carry out the epizootiological survey provided for in Article 13, these centres shall be assisted by a group of experts as referred to in Article 77.

5. The competent authorities shall without delay locate the animals which have been dispatched outside the areas during the 21 days preceding the date on which the first infection was calculated on a holding situated in the area of protection, and shall inform the Ministry of Agriculture, Fisheries and Food, for subsequent shipment, to the affected community or autonomous communities and, through the appropriate course, to the other Member States and the European Commission, of the results of the location of these animals.

6. The competent authorities shall cooperate in the location of fresh meat, meat products, meat preparations, raw milk and raw milk products derived from animals of susceptible species from the protection zone and produced between the calculated date of introduction of the foot-and-mouth disease virus and the date of entry into force of the measures provided for in paragraph 2. These fresh meat, meat products, meat preparations, raw milk and milk products crude shall be treated in accordance with Articles 25, 26 and 27 respectively, or shall be retained until officially discarding possible contamination with the foot-and-mouth disease virus.

Article 22. Measures to be applied to holdings located in the protection zone.

1. The competent authorities shall ensure that the protection zone is applied without delay, at least the following measures:

(a) The registration of all holdings with animals of susceptible species and the counting of all animals present on these holdings shall be made as soon as possible and kept up to date.

(b) All holdings with animals of susceptible species shall be subject to periodic veterinary inspections carried out in such a way as to prevent the spread of foot-and-mouth disease virus which may be present in the holdings; the relevant documentation, in particular the records referred to in subparagraph (a), shall be inspected, as well as the measures that have been applied to prevent the introduction or exit of the foot-and-mouth disease virus; also carry out clinical inspections as defined in paragraph 1 of Annex III or be taken samples of animals of susceptible species in accordance with paragraph 2.1.1.1 of Annex III.

(c) Animals of susceptible species shall not be allowed to leave the holding in which they are maintained.

2. By way of derogation from paragraph (1) (c), animals of susceptible species may be transported directly under official supervision for emergency slaughter to a slaughterhouse situated within the same protection zone or, if that area it has no slaughterhouse, a slaughterhouse outside the designated area designated by the competent authority, in means of transport cleaned and disinfected under official supervision after each transport operation.

This movement shall be authorised only if the competent authority, on the basis of a clinical examination carried out in accordance with Annex III (1), by the official veterinarian in all animals of susceptible species present on the holding, and after assessing the epizootiological circumstances, understands that there is no reason to suspect the presence of infected or contaminated animals on the holding. The meat of these animals shall be subject to the measures laid down in Article 25.

Article 23. Movement and transport of animals and their products in the protection zone.

The following activities are prohibited in the protection zone:

a) Movement between holdings and transport of animals of susceptible species.

(b) Fairs, markets, exposures and other concentrations of animals, including collection and dispersion, of susceptible species.

c) Itinerant monta of animals of susceptible species.

d) Artificial insemination of animals of susceptible species and collection of eggs and embryos of these animals.

Article 24. Additional measures and exceptions.

1. The competent authority may extend the prohibitions of Article 23:

(a) The movement or transport of animals of non-susceptible species between holdings located in the area or from or to the protection zone.

b) The transit of animals of all species through the protection zone.

(c) To events with a concentration of persons who have the possibility of contact with animals of susceptible species, in accordance with the rules in force in this respect, where there is a risk of spreading the virus

foot-and-mouth disease.

(d) The artificial insemination of animals of species that are insensitive to foot-and-mouth disease and to the collection of eggs and embryos of such species.

e) The movement of means of transport for the transport of animals.

(f) Slaughter on the holding of animals of susceptible species for private consumption.

(g) The transport of the goods referred to in Article 33 to holdings holding animals of susceptible species.

2. Competent authorities may authorise:

(a) The transit of animals of all species through the protection zone when the main roads or railways are used.

(b) The transport of animals of susceptible species whose origin, certified by the official veterinarian, is in holdings located outside the protection zones and transported directly on the basis of specified routes to Slaughterhouses also specified for immediate slaughter, under the condition that the means of transport be cleaned and disinfected

under official supervision in the slaughterhouse after each delivery and that this decontamination is recorded in the documentation of the means of transport.

(c) The artificial insemination of animals present on a holding, carried out by their staff with semen collected from animals present on the holding or with semen stored in that holding or with semen from a collection centre of semen delivered on the outside of the perimeter of the holding.

(d) The movement and transport of equidae taking into account the conditions set out in Annex VI.

(e) The transport, under certain conditions, of the goods referred to in Article 33 to holdings holding animals of susceptible species.

Article 25. Measures in relation to fresh meat produced in the protection zone.

1. The placing on the market of fresh meat, minced meat and meat preparations derived from animals of susceptible species from the protection zone is prohibited.

2. The placing on the market of fresh meat, minced meat and meat preparations of susceptible species which have occurred in establishments situated in the protection zone shall be prohibited.

3. Fresh meat, minced meat and meat preparations provided for in paragraph 1 shall be marked in accordance with Royal Decree 1976/2004 of 1 October 2004 laying down the animal health rules applicable to production, processing, distribution and introduction of products of animal origin intended for human consumption, and subsequently transported in sealed containers to an establishment designated by the competent authorities to be processed into products meat treated in accordance with the provisions of Annex VII.A. 1.

4. However, the prohibition laid down in paragraph 1 shall not apply to fresh meat, minced meat and meat preparations which have been produced at a previous date, at least in 21 days, to the date on which the first date was calculated. infection on a holding situated in the protection zone and which, since its production, have been stored and transported separately from the meat of these types produced after that date. Such meat shall be easily distinguishable from meat which does not satisfy the conditions for dispatch outside the protection zone, by means of a clear mark established in accordance with the rules in force.

5. However, the prohibition laid down in paragraph 2 shall not apply to fresh meat, minced meat or meat preparations from establishments situated in the protection zone if the following conditions are met: conditions:

a) That the establishment operates under strict veterinary control.

(b) Only fresh meat, minced meat or meat preparations as described in paragraph 4, or fresh meat, minced meat or meat preparations derived from animals reared and slaughtered outside the Community, are processed into the establishment of the protection zone or of animals transported to the establishment and slaughtered in accordance with the provisions of Article 24.2.b).

c) That all these fresh meat, minced meat or meat preparations bear the veterinary inspection stamp referred to in Chapter XI of Annex I to Royal Decree 147/1993 of 29 January establishing the health conditions for the production and placing on the market of fresh meat, or, in the case of meat from other biungulates, the health stamp referred to in Chapter III of Annex I to Royal Decree 1543/1994 of 8 July 1994, establish the health and animal health requirements applicable to production and marketing of domestic rabbit meat and farmed game meat, or, in the case of minced meat and meat preparations, the veterinary inspection mark referred to in Chapter VI of Annex I to Royal Decree 1916/1997 of 19 December 1997 laying down the sanitary conditions applicable to the production and placing on the market of minced meat and meat preparations.

d) That throughout the processing process, all these fresh meat, minced meat or meat preparations are clearly identified, and transported and stored separately from fresh meat, minced meat or meat preparations which do not meet the conditions for their dispatch outside the protection zone in accordance with this royal decree.

6. The competent authority shall certify compliance with the conditions of paragraph 5 with regard to fresh meat, minced meat and meat preparations intended for domestic or intra-Community trade. The competent authority shall supervise the control of compliance carried out by the local veterinary authority and, in the case of intra-Community trade, shall communicate to the Ministry of Agriculture, Fisheries and Food for subsequent shipment to the Ministry of Agriculture, Fisheries and Food. through the relevant channel, to the other Member States and to the European Commission, the relationship of the establishments which it has approved for the purpose of such certification.

7. A derogation from paragraph 1 may be granted subject to the specific conditions adopted by the European Commission, in particular concerning the marking of the health inspection of meat produced from animal species. sensitive products from protection zones which have been maintained for more than 30 days.

Article 26. Measures in relation to meat products produced in the protection zone.

1. The placing on the market of meat products produced from meat derived from animals of susceptible species from the protection zone is prohibited.

2. However, the prohibition laid down in paragraph 1 shall not apply to meat products which either have undergone any of the treatments specified in Part A (1) of Annex VII or have been produced from the products listed in Annex VII. meat referred to in Article 25.4.

Article 27. Measures in relation to milk and milk products produced in the protection zone.

1. The placing on the market of milk derived from animals of susceptible species from the protection zone and from dairy products produced from that milk is prohibited.

2. The placing on the market of milk and milk products of animals of susceptible species which have occurred in an establishment situated in the protection zone is prohibited.

3. However, the prohibition laid down in paragraph 1 shall not apply to milk and milk products derived from animals of susceptible species originating in the protection zone which were produced at an earlier date, at least 21%. days, to the date on which the first infection was calculated on a holding situated in the protection zone and which, since its production, has been stored and transported separately from milk and milk products produced thereafter of that date.

4. However, the prohibition laid down in paragraph 1 shall not apply to milk derived from animals of susceptible species from the protection zone or from milk products produced from that milk which have suffered from any of the treatments specified in Parts A or B of Annex IX depending on the use of milk or milk products.

The treatment shall be carried out under the conditions laid down in paragraph 6 in establishments referred to in paragraph 5, if there is no establishment in the protection zone, in establishments located outside the area. protection under the conditions laid down in paragraph 8.

5. However, the prohibition laid down in paragraph 2 shall not apply to milk and milk products prepared in establishments situated in the protection zone under the conditions laid down in paragraph 6.

6. The establishments referred to in paragraphs 4 and 5 shall comply with the following conditions

(a) The establishment shall operate under permanent and strict official control.

(b) All milk used in the establishment shall comply with paragraphs 3 and 4, or raw milk shall be obtained from animals outside the protection zone.

(c) During the whole production process, milk shall be clearly identified and transported and stored separately from raw milk and raw milk products which are not to be issued outside the production area. protection.

(d) The transport of raw milk from holdings situated outside the protection zone to the establishment shall be carried out on vehicles cleaned and disinfected before the transport operation and which have not been any subsequent contact with holdings located in the protection zone where animals of susceptible species are present.

7. The competent authority shall certify compliance with the conditions of paragraph 6 with regard to milk intended for domestic or intra-Community trade. The competent authority shall supervise the monitoring of compliance carried out by the local veterinary authority and, in the case of intra-Community trade, shall communicate to the Ministry of Agriculture, Fisheries and Food for subsequent shipment to the Ministry of Agriculture, Fisheries and Food. through the relevant channel, to the other Member States and to the European Commission, the relationship of the establishments which it has approved for the purpose of this certification.

8. The transport of raw milk from holdings situated in the protection zone to establishments located outside the protection zone and the processing of such milk shall be subject to the following conditions:

(a) The processing shall be authorised by the competent authorities, in establishments situated outside the protection zone, of raw milk produced by animals of susceptible species within the area of protection.

(b) The authorisation shall indicate the route of transport allocated to the designated establishment and the instructions on it.

(c) Transport must be carried out on vehicles which have been cleaned and disinfected prior to the operation of transport, constructed and maintained in such a way that there are no leakage of milk during transport, and equipped to avoid spray dispersion during loading and unloading of the milk.

(d) Before leaving the holding in which milk was obtained from animals of susceptible species, the connection tubes, tyres, spare-wheel compartments and lower parts of the vehicle shall be cleaned and disinfected. After the last disinfection and before leaving the protection zone, the vehicle shall have no contact with holdings located in the protection zone where animals of susceptible species are present.

e) The means of transport shall be strictly assigned to a defined geographical or administrative area, shall be marked accordingly and may only be moved to another area once cleaned and disinfected under official supervision.

9. The procurement and transport of samples of raw milk from animals of susceptible species from holdings situated in the protection zone to laboratories other than approved veterinary diagnostic laboratories shall be prohibited. for the diagnosis of foot-and-mouth disease, as well as the processing of milk in such laboratories.

Article 28. Measures in relation to semen, ova and embryos obtained from animals of susceptible species found in the protection zone.

1. The placing on the market of semen, ova and embryos obtained from animals of susceptible species from the protection zone is prohibited.

2. However, the prohibition laid down in paragraph 1 shall not apply to semen, ova or frozen embryos obtained and stored at least 21 days before the date on which the first infection with the virus is estimated to have occurred. of foot-and-mouth disease on a holding located in the area.

3. The frozen semen obtained, in accordance with the rules in force, after the date of infection referred to in paragraph 2, shall be stored separately and shall not be released until:

(a) All measures relating to the outbreak of foot-and-mouth disease in accordance with Article 36 have been lifted.

(b) All animals lodged at the semen collection centre have undergone a clinical examination and the samples collected in accordance with paragraph 2.2 of Annex III have been subjected to a serological test to demonstrate the absence of infection in the semen collection centre concerned.

(c) The donor animal has, with a negative result, been subjected to a serological test for the detection of antibodies against the foot-and-mouth disease virus by a sample taken at the earliest 28 days after collection. of the semen.

Article 29. Transport and distribution of manure from animals of susceptible species produced in the protection zone.

1. The transport and distribution of manure from holdings and establishments or means of transport referred to in Article 16, situated in the protection zone where there are animals of species, are prohibited within the protection zone. sensitive.

2. By way of derogation from the prohibition in paragraph 1, the competent authorities may authorise the manure of animals of susceptible species to be evacuated from a holding situated in the protection zone to a plant designated for processing in accordance with Section II (5) of Part A of Chapter III of Annex VIII to Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down the health rules for the animal by-products not intended for human consumption, or for their intermediate storage.

3. By way of derogation from the prohibition in paragraph 1, the competent authorities may authorise the manure of animals of susceptible species to be evacuated from a holding situated in the protection zone which is not subject to the measures laid down in the Articles 4 or 10, to be distributed on land designated for that purpose, if the following conditions are met:

(a) That the entire volume of manure has occurred at least 21 days before the date on which the first infection was calculated on a holding located in the protected zone and the manure is distributed at a low level. distance from the soil and at a sufficient distance from the holdings in which animals of susceptible species are present and are incorporated into the soil immediately.

b) Or, as regards the manure of bovine animals or pigs, that these requirements are met:

1. No animals suspected of being infected with the foot-and-mouth disease virus have been ruled out by an official veterinarian in all animals of the holding to be infected with the foot-and-mouth disease virus.

2. º That the entire volume of manure has been produced, at least, four days before the examination.

3. ° The manure is incorporated into the soil of land, designated for that purpose, close to the holding of origin, and at a sufficient distance from other holdings in which animals of susceptible species within the area of protection.

4. The competent authorities shall ensure that any authorisation to evacuate manure from a holding in which animals of susceptible species are kept is subject to strict measures to prevent the spread of foot-and-mouth disease virus, and The following shall be taken into account for the cleaning and disinfection of the watertight vehicles after unloading and before leaving the holding.

Article 30. Measures in relation to fur from animals of susceptible species in the protection zone.

1. The placing on the market of hides and skins of animals of susceptible species from the protection zone is prohibited.

2. However, the prohibition laid down in paragraph 1 shall not apply to fur:

(a) That they have been produced at least 21 days before the calculated date of infection of the holding referred to in Article 10.1 and that they have been stored separately from the skins produced after that date.

(b) Õ comply with the requirements set out in Annex VII.A. 2.

Article 31. Measures in relation to sheep wool, hair of ruminants and pig bristles produced in the protection zone.

1. The placing on the market of sheep wool, ruminant hair and pig bristles from the protection zone is prohibited.

2. However, the prohibition laid down in paragraph 1 shall not apply to wool, hair or sows without processing:

(a) which have been produced at least 21 days before the calculated date of infection of the holding referred to in Article 10.1 and which have been stored separately from the wool, hair and bristles produced after that date.

(b) Õ comply with the requirements set out in Annex VII.A. 3.

Article 32. Measures in relation to other animal products produced in the protection zone.

1. The placing on the market of animal products derived from animals of susceptible species not mentioned in Articles 25 to 31 is prohibited.

2. However, the prohibition laid down in paragraph 1 shall not apply to the products referred to in which:

(a) Hayan was produced at least 21 days before the calculated date of infection on the holding referred to in Article 10.1 and stored and transported separately from the products produced after that date.

b) Hayan treated in accordance with Annex VII.A. 4.

(c) In the case of specific products, comply with the relevant requirements set out in paragraphs 5 to 9

Annex VII.A.

(d) are composite products, not subject to any subsequent treatment, containing products of animal origin which either have undergone a treatment to ensure the destruction of any foot-and-mouth disease virus; or have been obtained from animals not subject to restrictions in accordance with this royal decree.

e) O that are packaged products intended to be used for in vitro diagnosis or as laboratory reagents.

Article 33. Measures in relation to feed, fodder, hay and straw produced in the protection zone.

1. The placing on the market of feed, fodder, hay and straw from the protection zone is prohibited.

2. However, the prohibition laid down in paragraph 1 shall not apply to feed, fodder, hay and straw:

(a) which have been produced at least 21 days before the calculated date of infection of the holdings referred to in Article 10.1 and which have been stored and transported separately from feed, fodder, hay and straw produced after that date.

(b) They are intended for use within the protection zone, subject to authorisation by the competent authorities.

(c) which have been produced in establishments where there are no animals of susceptible species.

(d) Õ which have been produced in establishments where there are no animals of susceptible species and which obtain their raw material from the establishments referred to in subparagraph (c) or from establishments located outside the area of protection.

3. However, the prohibition laid down in paragraph 1 shall not apply to fodder and straw produced on holdings where animals of susceptible species comply with the requirements laid down in Annex VII.B. 1.

Article 34. Exception authorization and additional certification.

1. Any derogation from the prohibitions referred to in Articles 24 to 33 shall be authorised by a specific decision of the competent authority, which shall adopt it only after it has been satisfied that all the relevant requirements have been met. for a sufficient period of time before the products leave the protection zone, as well as the absence of risk of the spread of the foot-and-mouth disease virus.

2. Any derogation from the prohibitions referred to in Articles 25 to 33 shall require additional certification by the competent authority in the case of national or intra-Community trade.

3. The implementing rules to be adopted by the European Commission for the implementation of the measures referred to in paragraph 2 shall also apply.

Article 35. Additional measures applied in the protection zone.

1. In addition to the measures applicable in the protection zone in accordance with this royal decree, the competent authorities, in their territorial scope of action, after consulting the national committee of the veterinary health alert system, may adopt the additional measures deemed necessary and proportionate to stop the spread of the foot-and-mouth disease virus, taking into account the particular epidemiological, zootechnical, commercial and social conditions of the affected area.

2. In this case, the competent authority or authorities concerned shall inform the Ministry of Agriculture, Fisheries and Food of the additional measures for their subsequent transfer through the appropriate course of action. the European Commission and the other Member States.

Article 36. Lifting of measures in the protection zone.

1. The competent authorities shall ensure that the measures applied in the protection zone are maintained until the following conditions are met:

(a) That at least 15 days have passed since the killing and safe disposal of all animals of susceptible species from the holding referred to in Article 10.1 and the termination of the prior cleaning and disinfection of that holding, carried out in accordance with Article 11.

b) That an investigation has been carried out on all holdings with animals of susceptible species located within the protection zone.

2. Following the lifting of the specific measures in the protection zone, the measures applied in the surveillance zone referred to in Articles 37 to 42 shall continue to apply for a minimum of 15 days until such measures are lifted. in accordance with Article 44.

3. The research referred to in paragraph 1 (b) shall be carried out to corroborate the absence of infection and at least in accordance with the criteria set out in Annex III.1, and shall include the measures referred to in Annex III, paragraph 2.3, in accordance with the criteria set out in paragraphs 2.1.1 and 2.1.3 of Annex III.

Article 37. Measures to be applied to holdings located in the surveillance zone.

1. The competent authorities shall ensure that the measures referred to in Article 22.1 are applied in the surveillance zone.

2. By way of derogation from the prohibition laid down in Article 22.1.c), and where there are no sufficiently capacity slaughterhouses within the surveillance zone, the competent authorities may authorise them to leave holdings situated in the area of animal surveillance of susceptible species in order to transport them directly and under official supervision for emergency slaughter in a slaughterhouse located outside the surveillance zone, if the following conditions are met:

(a) That the records referred to in Article 22.1 have been the subject of official control and the epizootiological situation of the holding does not give rise to any suspicion of infection or contamination with the fever virus

foot-and-mouth disease.

(b) All animals of susceptible species found on the holding have been subjected, with a negative result, to an inspection by the official veterinarian.

(c) A representative number of animals, taking into account the statistical parameters of paragraph 2.2 of Annex III, has undergone a comprehensive clinical examination to rule out the presence or suspicion that they exist. clinically infected animals.

(d) The slaughterhouse has been designated by the competent authority and is located as close to the surveillance zone as possible.

e) That the meat obtained from such animals is subjected to the treatment specified in Article 39.

Article 38. Movement of animals of susceptible species within the surveillance zone.

1. The competent authorities shall ensure that no animals of a susceptible species leave a holding situated in the surveillance zone.

2. However, the prohibition laid down in paragraph 1 shall not apply to the movement of animals which is carried out with one of the following purposes:

(a) Take them, without them coming into contact with animals of susceptible species from different holdings, to pasture located in the surveillance zone after at least 15 days since the last one has been recorded; the outbreak of foot-and-mouth disease in the protection zone.

b) Transporting them directly and under official supervision to slaughter them to a slaughterhouse located within the same area.

c) Transporting them in accordance with article 37.2.

d) Or transport them in accordance with Article 24.2.a) and b).

3. The movement of animals referred to in paragraph 2 (a) shall be authorised by the competent authority only after an examination by an official veterinarian of all the animals of susceptible species present on the holding, which shall include: tests on samples taken in accordance with paragraph 2.2 of Annex III have ruled out the presence of animals suspected of being infected or contaminated.

4. The competent authority shall authorise the movements of animals referred to in paragraph 2 (b) only after the measures referred to in Article 37.2.a) and (b) have been completed, with satisfactory results.

5. The competent authorities shall, without delay, locate the animals that have been dispatched outside the surveillance zone during the 21 days prior to the date on which the first infection was calculated on a holding located in the area. surveillance, and shall inform the Ministry of Agriculture, Fisheries and Food, for subsequent transfer by the Ministry of Agriculture, Fisheries and Food to the competent authority or authorities concerned and, through the appropriate course, to the competent authorities of the other Member States and the European Commission of the results of the location of such animals.

Article 39. Measures to be applied to fresh meat of animals of susceptible species from the surveillance zone and to meat products produced from such meat.

1. The placing on the market of fresh meat, minced meat and meat preparations derived from animals of susceptible species from the surveillance zone and meat products produced from such meat shall be prohibited.

2. The placing on the market of fresh meat, minced meat, meat preparations and meat products, derived from animals of susceptible species and produced in establishments situated in the surveillance zone, is prohibited.

3. However, the prohibition laid down in paragraph 1 shall not apply to fresh meat, minced meat and meat preparations which have been produced on at least 21 days prior to the date on which the first meat was calculated to take place in the first infection on a holding situated in the protection zone concerned and which, since its production, have been stored and transported separately from the meat of these types produced after that date. Such meat shall be easily distinguishable from meat which does not satisfy the conditions for dispatch outside the protection zone, by means of a clear mark established in accordance with the rules in force.

4. However, the prohibition laid down in paragraph 1 shall not apply to fresh meat, minced meat and meat preparations which have been produced from animals transported to the slaughterhouse under conditions, at least as stringent as those laid down in the provided for in Article 37 (2) (a), (b), (c), (d) and (e), provided that the meat is subject to the measures provided for in paragraph 5.

5. However, the prohibition laid down in paragraph 2 shall not apply to fresh meat, minced meat and meat preparations, obtained from establishments situated in the surveillance zone, if the following conditions are met:

a) That the establishment operates under strict veterinary control.

(b) Only fresh meat, minced meat and meat preparations, as described in paragraph 4, and subject to the additional conditions laid down in Annex VIIIB, or obtained from animals, are processed in the establishment. reared and slaughtered outside the surveillance zone, or obtained from animals transported in accordance with the provisions of Article 24.2.b).

c) That all these fresh meat, minced meat and meat preparations bear the veterinary inspection seal in accordance with Chapter XI of Annex I to Royal Decree 147/1993 of 29 January laying down the conditions for the meat and meat preparations health of the production and marketing of fresh meat, or, in the case of meat from other biungulates, the health stamp referred to in Chapter III of Annex I to Royal Decree 1543/1994 of 8 July 1994, establish the health and animal health requirements applicable to production and marketing of domestic rabbit meat and farmed game meat, or, in the case of minced meat and meat preparations, the mark of veterinary inspection referred to in Chapter VI of Annex I to Royal Decree 1916/1997 of 19 December 1997 laying down the health conditions applicable to the production and placing on the market of minced meat and meat preparations.

d) That throughout the production process all these fresh meat, minced meat or meat preparations are clearly identified, and transported and stored separately from fresh meat, minced meat or meat preparations. meat that does not meet the conditions for dispatch outside the surveillance zone in accordance with this royal decree.

6. However, the prohibition laid down in paragraph 1 shall not apply to meat products produced from fresh meat obtained from animals of susceptible species from the surveillance zone bearing the seal of inspection. veterinary legislation established for the purpose of Royal Decree 1976/2004 of 1 October 2004 laying down the animal health rules applicable to the production, processing, distribution and introduction of products of animal origin intended for human consumption, and which have been transported under official supervision to an establishment designated for processing in accordance with Annex VII.A. 1.

7. However, the prohibition laid down in paragraph 2 shall not apply to meat products produced in establishments situated within the surveillance zone and which either comply with the provisions of paragraph 6 or come from meat which comply with the provisions of paragraph 5.

8. The competent authority shall certify compliance with the conditions laid down in paragraphs 5 and 7 with regard to fresh meat, minced meat and meat preparations intended for domestic or intra-Community trade. The competent authority shall supervise the control of compliance carried out by the local veterinary authority and, in the case of intra-Community trade, shall communicate to the Ministry of Agriculture, Fisheries and Food for subsequent shipment to the Ministry of Agriculture, Fisheries and Food. through the relevant channel, to the other Member States and to the European Commission, the relationship of the establishments which it has approved for the purpose of such certification.

9. Derogations from the prohibition laid down in paragraph 1 may be granted subject to the specific conditions adopted by the European Commission, in particular in relation to the marking of veterinary inspection of meat obtained from animals of susceptible species from a surveillance zone maintained for more than 30 days.

Article 40. Measures to be applied to milk and milk products from animals of susceptible species produced in the surveillance zone.

1. The placing on the market of milk derived from animals of susceptible species from the surveillance zone and from dairy products produced from that milk is prohibited.

2. The placing on the market of milk and milk products from animals of susceptible species which have occurred in the surveillance zone is prohibited.

3. However, the prohibition laid down in paragraph 1 shall not apply to milk and milk products derived from animals of susceptible species originating in the surveillance zone which have occurred at least 21 days before the date of entry into force of this Regulation. the date on which the first infection was calculated on a holding situated in the protection zone concerned and which, from its production, has been stored and transported separately from milk and milk products produced after that date.

4. However, the prohibition laid down in paragraph 1 shall not apply to milk derived from animals of susceptible species from the surveillance zone, or to milk products produced from that milk which have suffered from any of the following: the treatments specified in Parts A or B of Annex IX depending on the use of milk or milk products.

The treatment shall be carried out under the conditions laid down in paragraph 6 in establishments referred to in paragraph 5 or, if there is no establishment in the surveillance zone, in establishments designated by the competent authorities located outside the protection and surveillance zones.

5. However, the prohibition laid down in paragraph 2 shall not apply to milk and milk products prepared in establishments situated in the surveillance zone under the conditions of paragraph 6.

6. The establishments referred to in paragraphs 4 and 5 shall comply with the following conditions:

a) The establishment will operate under strict veterinary control.

(b) All milk used in the establishment shall comply with paragraph 4 or shall be obtained from animals from outside the surveillance and protection zones.

(c) During the whole production process, the milk shall be clearly identified and transported and stored separately from milk and milk products which are not to be issued outside the surveillance zone.

(d) Transport to the establishment of raw milk from holdings located outside the protection and surveillance zones shall be carried out on vehicles cleaned and disinfected before the transport operation and which have not been carried out. no subsequent contact with holdings in the protection and surveillance zones where animals of susceptible species are present.

7. The competent authority shall certify compliance with the conditions of paragraph 6 with regard to milk intended for domestic or intra-Community trade. The competent authority shall supervise the control of compliance carried out by the local veterinary authority and, in the case of intra-Community trade, shall communicate to the Ministry of Agriculture, Fisheries and Food for subsequent shipment to the Ministry of Agriculture, Fisheries and Food. through the relevant channel, to the other Member States and to the European Commission, the relationship of the establishments which it has approved for the purpose of such certification.

8. The transport of milk from holdings located in the surveillance zone to establishments located outside the surveillance and protection zones and the processing of that milk shall be subject to the following conditions:

(a) The processing shall be authorised by the competent authorities, in establishments situated outside the protection and surveillance zones, of the raw milk produced by animals of susceptible species within the surveillance zone.

(b) The authorisation shall indicate the route of transport allocated to the designated establishment and the instructions on it.

(c) Transport must be carried out on vehicles which have been cleaned and disinfected prior to the operation of transport, constructed and maintained in such a way that there are no leakage of milk during transport and equipped to avoid spray dispersion during loading and unloading of the milk.

(d) Before leaving the holding in which milk was obtained from animals of susceptible species, the connection tubes, tyres, spare-wheel compartments and lower parts of the vehicle shall be cleaned and disinfected. After the last disinfection, and before leaving the protection zone, the vehicle shall have no contact with holdings located in the protection zone where animals of susceptible species are present.

e) The means of transport shall be strictly assigned to a defined geographical or administrative area, shall be marked accordingly and may only be moved to another area once cleaned and disinfected under official supervision.

9. The procurement and transport of samples of raw milk from animals of susceptible species from holdings situated in the surveillance zone to laboratories other than veterinary diagnostic laboratories authorised for the diagnosis of Foot-and-mouth disease, as well as the processing of milk in such laboratories, shall be subject to official authorisation and to measures preventing any spread of a possible foot-and-mouth disease virus.

Article 41. Transport and distribution of manure from animals of susceptible species produced in the surveillance zone.

1. The transport and distribution of manure from holdings and other establishments such as those referred to in Article 16 situated in that area where animals of susceptible species are animals are prohibited within and outside the surveillance zone.

2. By way of derogation from the prohibition laid down in paragraph 1, in exceptional circumstances, the competent authorities may authorise the transport of manure, in means of transport cleaned and disinfected thoroughly before and after their disposal. use, for distribution in certain areas within the surveillance zone, at sufficient distance from holdings where animals of susceptible species are present, if one of the following conditions is met:

(a) An examination, carried out by an official veterinarian in all animals of susceptible species present on the holding, has ruled out the presence of animals suspected of being infected with the foot-and-mouth disease virus, the Manure is distributed within walking distance of the soil to prevent the formation of aerosols, and is immediately buried.

(b) An official veterinarian has, with a negative result, carried out a clinical inspection on all animals of susceptible species present on the holding and the manure is injected into the soil.

(c) or manure is subject to the provisions of Article 29 (2).

Article 42. Measures in relation to other animal products produced in the surveillance zone.

The competent authorities shall ensure that the placing on the market of products of animal origin, other than those referred to in Articles 39 to 41, is subject to the conditions laid down in Articles 28, 30, 31 and 32.

Article 43. Additional measures applied in the surveillance zone.

In addition to the measures provided for in Articles 37 to 42, the competent authorities, in their territorial scope of action, after consulting the National Committee of the Veterinary Health Alert System, may adopt the measures (a) additional measures which they consider necessary and proportionate to stop the spread of foot-and-mouth disease virus, taking into account the particular epidemiological, zootechnical, commercial and social conditions of the affected area. Where specific measures are deemed necessary to restrict the movement of equidae, such measures shall take into account those referred to in Annex VI.

Article 44. Lifting of measures in the surveillance zone.

1. The competent authorities shall ensure that the measures applied in the surveillance zone are maintained until the following conditions have been met:

(a) That at least 30 days have passed since the killing and safe disposal of all animals of susceptible species from the holding referred to in Article 10.1, and the termination of prior cleaning and/or disinfection of that holding, carried out in accordance with Article 11.

(b) The requirements referred to in Article 36 shall be met in the protection zone.

c) That an investigation has been performed with a negative result.

2. The investigation referred to in paragraph 1 (c) shall be carried out in order to demonstrate the absence of infection in the surveillance zone, in accordance with the criteria set out in Annex III (1), and shall include, in accordance with the criteria laid down in 2.1 of Annex III, the measures referred to in paragraph 2.4 of Annex III.

CHAPTER VII

Regionalization, movement control, and identification

Article 45. Regionalisation.

1. Without prejudice to the provisions of Royal Decree 1316/1992 of 30 October 1992 laying down the veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market, and in particular Article 10 thereof, if it appears that the foot-and-mouth disease virus is spreading in spite of the measures taken in accordance with this royal decree, and that the epizootic is of an important nature and, in any case, where the emergency vaccination is applied, the competent authority of the community autonomous, or the Ministry of Agriculture, Fisheries and Food when it affects more than one Autonomous Community, regionalise the territory in one or more restricted and free zones, and inform the National Committee of the Health Alert System veterinary.

2. The Ministry of Agriculture, Fisheries and Food shall, on the basis of the information communicated by the competent authorities, notify the European Commission immediately of the measures applied in the restricted zone for examination and approval if appropriate, subject to modification by the latter, where appropriate, of the measures.

3. Furthermore, and without prejudice to the obligation to regionalise as referred to in paragraph 1, regionalisation and measures to be applied in the restricted zone to be decided, where appropriate, by the European Commission, shall apply. This decision may extend its effects to France or Portugal, not infected at the time the measures are taken, or vice versa.

4. Prior to the delimitation of the restricted zone, a complete epizootiological assessment of the situation shall be carried out, in particular as regards the possible time and the likely location of the introduction, the possible spread and the likely time needed to eradicate the foot-and-mouth disease virus.

5. The restricted zone shall be demarcated, as far as possible, taking into account administrative boundaries or natural obstacles. Regionalization will have as a starting point administrative units more than provinces. The restricted zone may be reduced, taking into account the results of the epizootiological survey provided for in Article 13, to an area of size not less than a sub-region and, if necessary, to the adjacent sub-regions. In case of spread of foot-and-mouth disease virus, the restricted zone shall be extended with more regions or sub-regions.

Article 46. Measures applied in a restricted zone.

1. Where regionalisation is applied, the competent authorities shall ensure that at least the following measures are taken:

(a) Control, within the restricted zone, of the transport and movement of animals of susceptible species, animal products and goods, as well as of the movement of the means of transport as they are potential vectors of the Foot-and-mouth disease virus.

(b) Localisation and marking, in accordance with current rules, of fresh meat and raw milk and, as far as possible, of other products in stock which cannot be dispatched outside the restricted zone.

(c) Specific certification of animals of susceptible species and products derived from such animals, and marking of health inspection in accordance with the rules in force, of products for human consumption intended for dispatch outside the restricted zone and which fulfil the conditions for such an issue.

2. Where regionalisation is applied, the competent authorities shall ensure that at least the animals of susceptible species dispatched from the restricted zone to other autonomous communities or other Member States are located between the date of It is estimated that the foot-and-mouth disease virus was introduced and the date on which regionalisation is applied, and why such animals are isolated under official veterinary control until their possible infection or contamination is officially ruled out.

3. The competent authorities shall cooperate in the location of fresh meat and raw milk and raw milk products derived from animals of susceptible species produced in the restricted zone between the calculated date of introduction of the Foot-and-mouth disease virus and the date of application of the regionalisation. These fresh meat shall be treated in accordance with Part A. 1 of Annex VII, whereas raw milk and raw milk products shall be treated in accordance with Part A or B of Annex IX, according to their use, or shall be retained until officially discarding possible contamination with the foot-and-mouth disease virus.

4. The specific measures to be taken by the European Commission, in particular with regard to the marking of veterinary inspection of products derived from animals of susceptible species from the restricted zone, shall also apply. not intended for placing on the market outside the market.

Article 47. Identification of animals of susceptible species.

1. Without prejudice to the rules in force on the identification of animals of the bovine, ovine, caprine and porcine species, the competent authorities shall ensure that, in the event of an outbreak of foot-and-mouth disease in their territory, the animals of susceptible species cannot leave the holding in which they are maintained if they are not identified in such a way as to enable those competent authorities to quickly locate their movements and their holding of origin or any holding from which they proceed.

2. By way of derogation from the preceding paragraph, in the special cases provided for in Article 15.1 and in Article 16.1, the competent authority may, in certain circumstances and in accordance with the health situation, authorise other forms of the rapid location of movements of these animals and their holding of origin or of any holding from which they originate.

The rules for the identification of these animals or the location of their holding of origin shall be established by the competent authority and notified to the Ministry of Agriculture, Fisheries and Food for subsequent shipment. through the relevant channel, to the European Commission.

3. The amendments to the measures taken on the permanent and additional indelible marking of animals, with the particular aim of combating foot-and-mouth disease, in particular in the case of vaccination carried out on the basis of the Articles 52 and 53, to be adopted by the European Commission.

Article 48. Control of movements in case of outbreak of foot-and-mouth disease.

1. The competent authorities shall ensure that, in the event of an outbreak of foot-and-mouth disease in their territory, the following measures for the control of movements of animals of susceptible species in the restricted zone established in accordance with Article 45:

(a) The owners shall provide the competent authority, upon request, with appropriate information on the entry or exit of animals from their holding. This information shall include at least for all animals of susceptible species the data set out in Section 3.a of Chapter II of Royal Decree 1716/2000 of 13 October on sanitary standards for intra-Community trade. of bovine animals and swine.

(b) Persons involved in the transport or placing on the market of animals of susceptible species shall provide the competent authority, upon request, with appropriate information on the movements of animals of susceptible species. have been transported or marketed. This information shall include at least the data referred to in Article 14.3 and in Article 18 of Royal Decree 1716/2000 of 13 October on health rules for the intra-Community trade in bovine animals and swine.

2. The competent authorities may, after consulting the national veterinary health alert system committee, extend some or all of the measures referred to in paragraph 1 to one part or to the whole of the free zone.

CHAPTER VIII

Vaccination

Article 49. Use, manufacture, sale and control of foot-and-mouth disease vaccines.

1. The use of vaccines against foot-and-mouth disease and the administration of hyperimmune sera against foot-and-mouth disease is prohibited in Spain, except in cases regulated in this royal decree.

2. The production, storage, supply, distribution and sale of foot-and-mouth disease vaccines in Spain shall be carried out under official control.

Specifically, the production of vaccines will be carried out under the official control of the Spanish Agency for Medicines and Health Products, in coordination with the Ministry of Agriculture, Fisheries and Food.

3. The placing on the market of foot-and-mouth disease vaccines shall be carried out under the supervision of the competent authorities, in accordance with Royal Decree 109/1995 of 27 January 1995 on veterinary medicinal products and other rules applicable to the effect.

4. The use of foot-and-mouth disease vaccines for purposes other than the induction of active immunity in animals of susceptible species, such as laboratory research, scientific research or vaccine testing, shall be subject to prior authorisation. authorisation by the competent body to that effect, in accordance with the provisions of Royal Decree 109/1995 of 27 January 1995 on veterinary medicinal products and other rules applicable to that effect and subject to appropriate biosecurity conditions.

Article 50. Decision to apply emergency vaccination.

1. It may be decided to apply emergency vaccination in Spain if at least one of the following conditions is met:

(a) That outbreaks of foot-and-mouth disease have been confirmed in Spain and threaten to spread in the rest of the national territory.

b) That there is a risk to Spain due to the geographical situation or the meteorological conditions of outbreaks reported in another Member State.

(c) There is a risk to Spain due to contacts, relevant epizootiologically, between holdings located in Spain and holdings with animals of susceptible species in another Member State where there are outbreaks of foot-and-mouth disease.

d) That there is a risk to Spain due to the geographical situation or the meteorological conditions of a neighbouring third country, including Andorra, where there are outbreaks of foot-and-mouth disease.

2. When taking a decision on the application of emergency vaccination, the measures provided for in Article 15 and the criteria set out in Annex X should be considered.

3. The decision to apply emergency vaccination shall be taken by the European Commission, and the competent authorities shall ensure that they are implemented and complied with.

4. The decision referred to in paragraph 3 shall be requested by the Ministry of Agriculture, Fisheries and Food, at the initiative or upon request of one or more autonomous communities or the cities of Ceuta and Melilla, after consultation of the national committee. of the veterinary health alert system.

5. By way of derogation from paragraph 3, by order of the Ministry of Agriculture, Fisheries and Food, after consultation of the National Committee of the Veterinary Health Alert System, emergency vaccination may be established, which shall be carried out In accordance with this royal decree, after written notification to the European Commission of the conditions specified in Article 51, without prejudice to the subsequent examination of this decision in the instances of the European Union and the the measures that may be taken by the European Commission.

6. In addition, and by way of derogation from paragraph 4, emergency vaccination in Spain shall apply where the decision to implement it is taken by the European Commission, after consultation with the Ministry of Agriculture, Fisheries and Food, on the initiative of the European Commission, if outbreaks of foot-and-mouth disease have been confirmed in Spain and threaten to spread in the rest of the national territory, and if there is a risk to other Member States due to the geographical situation or the weather conditions in relation to outbreaks reported in Spain.

Article 51. Conditions for emergency vaccination.

1. The decision to apply emergency vaccination in accordance with Article 50 (3) and (4) shall specify the conditions under which such vaccination is to be carried out, including at least the following:

(a) The delimitation, in accordance with Article 45, of the geographical area in which emergency vaccination is to be carried out.

b) The species and age of the animals to be vaccinated.

c) The duration of the vaccination campaign.

d) A specific ban on movements of animals, vaccinated and unvaccinated, of susceptible species and their products.

(e) Special, additional and permanent identification and the special register of vaccinated animals, in accordance with Article 47.3.

f) Other aspects relevant to the emergency situation.

2. The conditions for emergency vaccination, as referred to in paragraph 1, shall ensure that such vaccination is carried out in accordance with Article 52, irrespective of whether the vaccinated animals are subsequently slaughtered or are still alive.

3. The Ministry of Agriculture, Fisheries and Food, in coordination with the Autonomous Communities, shall carry out a programme of information to the public on the safety of meat, milk and milk products from vaccinated animals. for human consumption.

Article 52. Protective vaccination.

1. The competent authorities, in the event that protective vaccination is applied in Spain, shall ensure that:

(a) The vaccination zone shall be regionalised in accordance with Article 45. Where appropriate, the Ministry of Agriculture, Fisheries and Food shall carry out the necessary actions for close cooperation with France, Portugal or Andorra.

(b) Vaccination shall be carried out without delay, in accordance with the rules and principles of hygiene and biosecurity, in order to prevent the possible spread of the foot-and-mouth disease virus.

(c) All measures applied in the vaccination zone shall be carried out without prejudice to the measures provided for in Chapter VII of this Title.

(d) Where the vaccination zone includes, in whole or in part, the protection or surveillance zone:

1. The measures applicable in the protection or surveillance zone in accordance with this royal decree are maintained in that part of the vaccination zone until such measures have been lifted in accordance with Article 36 or the Article 44.

2. Once the measures applied in the protection zone and in the surveillance zone have been lifted, the measures applicable in the vaccination zone as provided for in Articles 54 to 59 shall continue to apply, both inclusive.

2. The competent authorities shall also ensure that the vaccination zone is surrounded by a surveillance zone (surveillance zone as defined by the International Office of Epizootics) of at least 10 km of width from the perimeter of the the vaccination zone. In this area, which shall be maintained until recovery from the consideration of infection-free and foot-and-mouth disease in accordance with Article 62:

a) Vaccination shall be prohibited.

b) Surveillance will be intensified.

(c) The movements of animals of susceptible species shall be subject to control by the competent authorities.

Article 53. Suppression vaccination.

1. The Ministry of Agriculture, Fisheries and Food, if it decides, in accordance with the provisions of Article 50 and taking into account all the circumstances under which the vaccination is to be carried out, shall notify it by the means of the on the European Commission and shall communicate to it data on the measures to be taken, including at least the measures referred to in Article 21.

2. The competent authorities shall ensure that the removal vaccination is carried out as follows:

a) Only within a protection zone.

(b) Only on holdings, clearly identified, which are the subject of the measures provided for in Article 10.1, in particular in paragraph (a) thereof. However, for logistical reasons and by way of derogation from Article 10 (1) (a), the killing of all animals on those holdings may be delayed to the extent necessary to comply with the provisions of Royal Decree 54/1995 of 20 January 1995. on the protection of animals at the time of their slaughter or killing, and in Article 10.1.c) of this royal decree.

Article 54. Measures applicable in the vaccination zone during the period between the start of emergency vaccination and at least 30 days after completion (phase 1).

1. The competent authorities shall ensure that the measures referred to in paragraphs 2 to 6 are applied in the vaccination zone during the period between the start of the emergency vaccination and at least 30 days after the vaccination. termination.

2. Movement of live animals of susceptible species between holdings within the vaccination zone and their exit from the vaccination zone shall be prohibited.

However, the competent authorities may authorise their direct transport for the purposes of the prohibition, after clinical inspection of the live animals concerned and of the herds of origin or dispatch of such animals. immediate slaughter in a slaughterhouse specified by the competent authority and situated within the vaccination zone or, in exceptional cases, in the vicinity of that area.

3. Fresh meat produced from vaccinated animals slaughtered during the period referred to in paragraph 1:

(a) They shall bear the stamp laid down for the purpose in Royal Decree 1976/2004 of 1 October 2004 laying down the animal health rules applicable to the production, processing, distribution and introduction of products of animal origin intended for human consumption.

(b) They shall be stored and transported separately from meat which does not bear the stamp referred to in subparagraph (a) and shall subsequently be transported in sealed containers to an establishment designated by the authorities. competent to be treated in accordance with the provisions of Part A. 1 of Annex VII.

4. Milk and milk products produced from vaccinated animals may be placed on the market within and outside the vaccination zone, provided that the final use is either human consumption or non-human consumption, at least one of the treatments referred to in Parts A and B of Annex IX, respectively. The treatment shall be carried out, under the conditions laid down in paragraph 5, in establishments located in the vaccination zone or, if there is no establishment in that area, in establishments located outside the vaccination zone, the raw milk has been transported under the conditions laid down in paragraph 7.

5. The establishments referred to in paragraph 4 shall comply with the following conditions

(a) The establishment shall operate under permanent and strict official control.

(b) All milk used in the establishment shall comply with paragraph 4 or the raw milk shall be obtained from animals outside the vaccination zone.

(c) During the whole production process, milk shall be clearly identified and transported and stored separately from raw milk and raw milk products which are not to be issued outside the production area. vaccination.

(d) The transport of raw milk to the establishment from holdings outside the vaccination zone shall be carried out on vehicles cleaned and disinfected before the transport operation and which have not been any subsequent contact with holdings located in a restricted area where animals of susceptible species are present.

6. The competent authority shall certify compliance with the conditions of paragraph 5 with regard to milk intended for domestic or intra-Community trade. The competent authority shall supervise the control of compliance carried out by the local veterinary authority and, in the case of intra-Community trade, communicate to the Ministry of Agriculture, Fisheries and Food for subsequent shipment to the Ministry of Agriculture, Fisheries and Food. through the relevant channel, to the other Member States and to the European Commission, the relationship of the establishments which it has approved for the purpose of this certification.

7. The transport of raw milk from holdings situated in the vaccination zone to establishments situated outside that area, and the processing of such milk, shall be subject to the following conditions:

(a) The competent authorities shall authorise the processing in establishments situated outside the vaccination zone of raw milk produced by animals of susceptible species within the area of vaccination.

(b) The authorisation shall indicate the route of transport allocated to the designated establishment and the instructions on it.

(c) Transport must be carried out on vehicles which have been cleaned and disinfected prior to the operation of transport, constructed and maintained in such a way that there are no leakage of milk during transport and equipped to avoid spray dispersion during loading and unloading of the milk.

(d) Before leaving the holding in which milk was obtained from animals of susceptible species, the connection tubes, tyres, spare-wheel compartments and lower parts of the vehicle shall be cleaned and disinfected. After the last disinfection, and before leaving the vaccination zone, the vehicle shall have no contact with holdings in that area where animals of susceptible species are present.

e) The means of transport shall be strictly assigned to a defined geographical or administrative area, shall be marked accordingly and may only be moved to another area once cleaned and disinfected under official supervision.

8. The procurement and transport of samples of raw milk from animals of susceptible species from holdings situated in the vaccination zone to laboratories other than approved veterinary diagnostic laboratories shall be prohibited. for the diagnosis of foot-and-mouth disease, as well as the processing of milk in such laboratories.

9. The collection of semen for artificial insemination shall be suspended from donor animals of susceptible species kept in semen collection centres located within the vaccination zone.

However, the competent authorities may authorise the collection of semen at the semen collection centres of the vaccination zone for the production of frozen semen, if the following conditions are met: conditions:

(a) It is ensured that the semen collected during the period referred to in paragraph 1 is stored separately for at least 30 days.

b) That before the dispatch of the semen:

1. The donor males have been vaccinated and the conditions provided for in Article 28.3.b) and c) are met.

2. O that the donor males have been vaccinated after negative results in a test to detect the presence of antibodies against the foot-and-mouth disease virus prior to vaccination and, in addition:

That a negative result has been obtained in a screening test, either from the virus or the viral genome, or in an authorized antibody detection test against non-structural proteins, performed at the end of the quarantine of the semen with samples taken from all animals of susceptible species present at the time at the semen collection centre.

That the semen complies with the conditions of Article 4.3 of Royal Decree 2256/1994 of 25 November 1994 laying down the animal health requirements applicable to intra-Community trade and imports of semen of animals of the bovine species.

10. The collection of ova and embryos from donor animals shall be prohibited.

11. The placing on the market of products of animal origin other than semen for artificial insemination from donor animals of susceptible species kept in semen collection centres located within the vaccination zone; or different ova and embryos of donor animals shall be subject to the conditions laid down in Articles 30, 31, 32 and 41.

Article 55. Measures applicable in the vaccination zone during the period between the emergency vaccination and the completion of the investigation and the classification of holdings (phase 2).

1. The competent authorities shall ensure that the measures provided for in paragraphs 2 to 5 are applied in the vaccination zone for a period starting at least 30 days after the emergency vaccination has been carried out, and shall end with the termination of the measures provided for in Articles 56 and 57.

2. Movement of animals of susceptible species between holdings within the vaccination zone as well as their exit from the vaccination zone shall be prohibited.

3. By way of derogation from the prohibition laid down in paragraph 2, the competent authorities may authorise direct transport for the immediate slaughter of animals of susceptible species from holdings provided for in Article 57.5 to a slaughterhouse located within or outside the vaccination zone, if the following conditions are met:

(a) That during transport, and in the slaughterhouse, such animals do not come into contact with other animals of susceptible species.

(b) The animals are accompanied by an official document certifying that all animals of susceptible species present on the holding of origin or dispatch have been the subject of an investigation pursuant to Article 56.2.

c) That transport vehicles are cleaned and disinfected before loading and after delivery of the animals, and that the date and time of cleaning and disinfection are recorded in the documentation of the means of transport.

(d) that the animals have been subjected to a health inspection at the slaughterhouse within 24 hours before slaughter, and in particular to an examination for the presence of foot-and-mouth disease, without showing any signs of this disease.

4. Fresh meat, with the exception of offal, produced from vaccinated, large and small ruminants during the period provided for in paragraph 1 may be placed on the market within and outside the vaccination zone if the following conditions are met: conditions:

a) That the establishment operates under strict veterinary control.

(b) Only fresh meat, with the exception of offal, which has undergone the treatment described in Annex VIII (A) (1), (3) and (4), or fresh meat obtained, is processed into the establishment of animals reared and slaughtered outside the vaccination zone.

c) That all these fresh meat bear the veterinary inspection seal in accordance with Chapter XI of Annex I to Royal Decree 147/1993 of 29 January laying down the health conditions for production and the placing on the market of fresh meat or, in the case of meat from other biungulates, the health stamp referred to in Chapter III of Annex I to Royal Decree 1543/1994 of 8 July 1994 laying down health requirements and (a) the health police applying to the production and marketing of domestic and hunting rabbit meat farm, or, in the case of minced meat and meat preparations, the veterinary inspection mark referred to in Chapter VI of Annex I to Royal Decree 1916/1997 of 19 December 1997 laying down the health conditions applicable to the production and marketing of minced meat and meat preparations.

d) That during the whole production process, the fresh meat is clearly identified, and transported and stored separately from the meat with different health considerations according to this royal decree.

5. The competent authority shall certify compliance with the conditions of paragraph 4 with regard to fresh meat intended for domestic or intra-Community trade. The competent authority shall supervise the control of compliance carried out by the local veterinary authority and, in the case of intra-Community trade, communicate to the Ministry of Agriculture, Fisheries and Food for subsequent shipment to the Ministry of Agriculture, Fisheries and Food. through the relevant channel, to the other Member States and to the European Commission, the relationship of the establishments which it has approved for the purpose of such certification.

6. Fresh meat produced from vaccinated porcine animals which have been slaughtered during the period referred to in paragraph 1 shall bear the veterinary inspection stamp provided for in the animal health legislation applicable to the Production, processing, distribution and introduction of products of animal origin intended for human consumption shall be stored and transported separately from meat which does not bear such a stamp and shall be transported subsequently in containers sealed, to an establishment designated by the competent authorities to be treated in accordance with the provisions of Part A. 1 of Annex VII.

7. Milk and milk products produced from vaccinated animals may be placed on the market within or outside the vaccination zone, provided that the final use is human consumption or non-human consumption has been subject to the following conditions: at least one of the treatments referred to in Parts A and B of Annex IX respectively. Such treatment must have been applied in an establishment situated within or outside the vaccination zone in accordance with the provisions of Article 54 (4) to (8

.

8. For the collection of semen, ova and embryos of animals of susceptible species, the measures laid down in Article 54 (9) and (10) shall continue to apply.

9. The placing on the market of products of animal origin, other than those provided for in paragraphs 4, 6, 7 and 8, shall be subject to the conditions laid down in Articles 30, 31, 32 and 41.

Article 56. Clinical and serological research in the vaccination zone (phase 2-A).

1. The competent authorities shall ensure that the measures provided for in paragraphs 2 to 3 are applied in the vaccination zone for a period starting at least 30 days after the emergency vaccination has been carried out, and will end with the completion of a clinical and serological investigation.

2. An investigation shall be carried out to identify the herds of animals of susceptible species which have been in contact with the foot-and-mouth disease virus without showing manifest clinical signs of the disease.

This investigation shall include a clinical inspection of all animals of susceptible species of all herds found in the vaccination zone, as well as laboratory tests in accordance with the provisions of paragraph 1. 3.

3. The laboratory tests shall consist of tests which meet the criteria of the diagnostic tests referred to in Annex XIII and approved by the European Commission and shall comply with one of the following conditions:

(a) Tests for foot-and-mouth disease virus infection, consisting of the test for antibodies against non-structural proteins of the foot-and-mouth disease virus or in another authorised method, shall be in accordance with the criteria of the sampling of holdings as set out in point 2.2 of Annex III. If the competent authorities also use control animals, the repopulation conditions of infected holdings in Annex V shall be taken into account.

(b) Testing of antibodies against non-structural proteins of foot-and-mouth disease virus shall be carried out on samples taken from all vaccinated animals of susceptible species and their unvaccinated offspring in all animals. flocks from the vaccination zone.

Article 57. Classification of the herds of the vaccination zone (phase 2-B).

1. The competent authorities shall ensure that holdings in which animals of susceptible species are kept:

(a) Be classified according to the result of the investigation provided for in Article 56.2 and the criteria set out in Annex I.

(b) Apply the measures referred to in paragraphs 2 to 4.

2. Holdings where there is at least one animal suspected of being infected and where the presence of the foot-and-mouth disease virus has been confirmed, in accordance with the criteria laid down in Annex I, shall be subject to the measures laid down in this Annex. in Articles 10 and 21.

3. Holdings in which there is at least one animal of a susceptible species suspected of being infected by a previous contact with the foot-and-mouth disease virus, but in which new tests are carried out on all animals of susceptible species present on the holding, have confirmed the absence of circulating foot-and-mouth disease virus, shall be subject to at least the following measures:

(a) Animals of susceptible species present on the holding:

1. º They will be sacrificed and their dead bodies will be transformed.

2. Or they shall be classified and, likewise, those animals which have been tested positive in at least one of the approved tests referred to in Article 56.3 shall be slaughtered and their carcasses processed; and animals of susceptible species present on the holding shall be slaughtered under conditions authorised by the competent authorities.

(b) The holdings shall be cleaned and disinfected in accordance with Article 11.

(c) The repopulation of animals shall be carried out in accordance with Annex V.

4. The competent authorities shall ensure that the following measures are applied to products derived from animals of susceptible species and produced during the period referred to in Article 56.1:

(a) The fresh meat produced from the other animals of susceptible species present on the holding referred to in paragraph 3 (a) 2 (a) shall apply the provisions of paragraphs 4, for meat of ruminants, and 6, for pigmeat, both in Article 55.

(b) Milk and milk products produced from such animals shall be subjected, at least, to one of the treatments specified in Parts A or B of Annex IX, depending on the intended use, and in accordance with provided for in Article 54 (4) to (8

.

5. Animals of susceptible species of holdings where the presence of an earlier or current infection with the foot-and-mouth disease virus, as referred to in Article 56 (3), has been officially ruled out may be subject to the measures provided for in the Article 58.

Article 58. Measures applicable to animals in the vaccination zone following the conduct of the investigation and the classification of holdings until the consideration of infection-free and foot-and-mouth disease (phase 3) is recovered.

1. The competent authorities shall ensure that the measures referred to in this Article, and in paragraph 1 of the following Article, are applied in the vaccination zone after the measures referred to in Article 57 have been carried out, and until such time as recovered, in accordance with Article 60, the consideration of infection-free and foot-and-mouth disease.

2. The competent authorities shall ensure that the movement of animals of susceptible species between holdings located in the vaccination zone is subject to authorisation.

3. The removal of animals from susceptible species in the vaccination zone shall be prohibited. By way of derogation from this prohibition, direct transport to a slaughterhouse may be authorised for immediate slaughter of animals of susceptible species under the conditions laid down in Article 55.3.

4. By way of derogation from the prohibition laid down in paragraph 2, the competent authorities may authorise the transport of unvaccinated animals of susceptible species in accordance with the following provisions:

(a) That within 24 hours of loading, all animals of susceptible species present on the holding have undergone a clinical examination and have not shown clinical symptoms of foot-and-mouth disease.

(b) The animals have been retained on the holding of origin for at least 30 days, during which period during which no animal of a susceptible species has been introduced into the holding.

c) That the holding of origin is not situated in a protection or surveillance zone.

(d) that animals intended for transport have been subjected on an individual basis, with a negative result, to tests for the detection of antibodies against the foot-and-mouth disease virus at the end of the isolation period; that holding has been carried out a serological investigation in accordance with paragraph 2.2 of Annex III, irrespective of the species concerned.

e) That the animals have not been exposed to any source of infection during their transport from the holding of origin to the place of destination.

5. The non-vaccinated offspring of vaccinated mothers shall be prohibited from leaving the holding of origin unless they are transported:

(a) A holding within the vaccination zone with the same health consideration as the holding of origin.

b) To a slaughterhouse for immediate slaughter.

(c) A holding designated by the competent authority and from which it is to be sent directly to the slaughterhouse.

(d) OR to any holding, once a negative result has been obtained in a serological test for the detection of antibodies against the foot-and-mouth disease virus which has been carried out with a blood sample taken before the test. dispatch from the holding of origin.

Article 59. Measures applicable to products of animal origin in the vaccination zone after the conduct of the investigation and the classification of holdings until the consideration of infection-free and foot-and-mouth disease (phase 3) is recovered.

1. Fresh meat produced from animals of susceptible non-vaccinated species may be placed on the market within and outside the vaccination zone under the following conditions:

(a) that the measures provided for in Article 57.3 have been completed throughout the vaccination zone, or the animals are transported to the slaughterhouse under the conditions laid down in paragraph 3 or subparagraph (d) of paragraph 4 of this Article. Previous article.

b) That the establishment works under strict veterinary control.

(c) That only fresh meat produced from the animals referred to in paragraph (a) or from animals reared or slaughtered outside the vaccination zone or the fresh meat referred to in paragraph 1 is transformed into the establishment; in paragraph 3 of this Article.

(d) that all these fresh meat bear the veterinary inspection mark in accordance with Chapter XI of Annex I to Royal Decree 147/1993 of 29 January laying down the health conditions for production and the placing on the market of fresh meat or, in the case of meat from other biungulates, the health stamp referred to in Chapter III of Annex I to Royal Decree 1543/1994 of 8 July 1994 laying down health requirements and (a) the health police applying to the production and marketing of domestic and hunting rabbit meat farm, or, in the case of minced meat and meat preparations, the veterinary inspection mark referred to in Chapter VI of Annex I to Royal Decree 1916/1997 of 19 December 1997 laying down the health conditions applicable to the production and marketing of minced meat and meat preparations.

e) that throughout the production process, fresh meat is clearly identified and transported and stored separately from meat from animals of different animal health considerations, conformity with the provisions of this royal decree.

2. Fresh meat produced from animals of susceptible species or of non-vaccinated seropositive offspring of vaccinated mothers, slaughtered after the measures provided for in Article 57 have been carried out, and until such time as recovered, in accordance with Article 60, the consideration of infection-free and foot-and-mouth disease, shall bear the mark of veterinary inspection provided for in the Royal Decree 1976/2004 of 1 October 2004 laying down the rules animal health requirements for the production, processing, distribution and introduction of the products of origin animals intended for human consumption, and shall be stored and transported separately from meat not bearing the mark, and subsequently transported in sealed containers to an establishment designated by the competent authorities with for treatment in accordance with Part A. 1 of Annex VII.

3. By way of derogation from paragraph 2, fresh meat and trimmed offal produced from vaccinated, large and small ruminants or their non-vaccinated seropositive offspring may be placed on the market within and outside the area of vaccination if the following conditions are met:

a) That the establishment operates under strict veterinary control.

(b) Only fresh meat, except offal, which has undergone the treatment described in Annex VIII (A) (1), (3) and (4) or the fresh meat referred to therein, is processed into the establishment. paragraph 1 of this Article or obtained from animals reared or slaughtered outside the vaccination zone.

c) That all these fresh meat bear the veterinary inspection seal in accordance with Chapter XI of Annex I to Royal Decree 147/1993 of 29 January laying down the health conditions for production and the placing on the market of fresh meat or, in the case of meat from other biungulates, the health stamp referred to in Chapter III of Annex I to Royal Decree 1543/1994 of 8 July 1994 laying down health and safety requirements animal health requirements for the production and placing on the market of domestic and hunting rabbit meat farm, or, in the case of minced meat and meat preparations, the veterinary inspection mark referred to in Chapter VI of Annex I to Royal Decree 1916/1997 of 19 December 1997 laying down the health conditions applicable to the production and marketing of minced meat and meat preparations.

d) That throughout the production process, fresh meat is clearly identified and transported and stored separately from meat with different health considerations according to this royal decree.

4. By way of derogation from paragraph 2, fresh meat obtained from vaccinated porcine animals and their non-vaccinated seropositive offspring produced during the period from the beginning of the inspection until they have been carried out by the measures provided for in Article 57 in the whole vaccination zone, and until at least three months after the last outbreak observed in that area, may only be placed on the domestic market within and outside the area of vaccination. vaccination if the following conditions are met:

a) That the establishment operates under strict veterinary control.

(b) Only fresh meat obtained from animals coming from holdings complying with the conditions laid down in Article 57.5 or fresh meat obtained from animals reared and reared shall be processed into the establishment. slaughtered outside the vaccination zone.

c) That all these fresh meats bear a health mark, which will be decided by the European Commission.

d) That throughout the production process, fresh meat is clearly identified and transported and stored separately from meat with different health considerations according to this royal decree.

5. The Ministry of Agriculture, Fisheries and Food, at the request of the Autonomous Communities, may request the European Commission to decide on the extension of the marketing of the meat referred to in paragraph 4 produced in another State. Member, in all or part of Spain, to be applied, if adopted, under the conditions to be laid down by that Commission.

6. The rules for the issue, from the vaccination zone, of fresh meat from vaccinated pigs produced after the period referred to in paragraph 4 and until the consideration of the product has been recovered shall also apply. infection-free zone in accordance with Article 62 which may be adopted by the European Commission.

7. The competent authority shall certify compliance with the conditions of paragraph 1 of paragraph 3 and, where appropriate, in accordance with paragraph 5, with regard to fresh meat intended for domestic trade or intra-Community The competent authority shall supervise the control of compliance carried out by the local veterinary authority and, in the case of intra-Community trade, shall communicate to the Ministry of Agriculture, Fisheries and Food for subsequent shipment to the Ministry of Agriculture, Fisheries and Food. through the relevant channel, to the other Member States and to the European Commission, the relationship of the establishments which it has approved for the purpose of such certification.

8. By way of derogation from paragraph 3, a special veterinary inspection mark, which cannot be confused with that referred to in paragraph (c) of that paragraph and in the paragraph, shall apply, if decided by the European Commission. (c) in paragraph 4, for fresh meat of ruminants which have not undergone treatment in accordance with Part A of Annex VIII, and minced meat and meat preparations made from such meat, to be placed on the market in a specific region of Spain.

9. Milk and milk products produced from vaccinated animals may be placed on the market within and outside the vaccination zone as long as the final use is human consumption or non-human consumption has been subject to at least one of the treatments referred to in Parts A and B of Annex IX respectively. The treatment shall be carried out in an establishment situated in the vaccination zone or in accordance with the provisions of Article 54 (4) to (7

.

10. The collection and transport of samples of raw milk from animals of susceptible species from holdings situated in the surveillance zone to a laboratory other than the approved veterinary diagnostic laboratory for the diagnosis of foot-and-mouth disease, and the processing of milk in such laboratories, shall be subject to official authorisation and appropriate measures to prevent any possible spread of the foot-and-mouth disease virus.

11. The placing on the market of products of animal origin, other than those provided for in this Article, except as provided for in paragraph 7 for fresh meat intended for intra-Community trade, shall be subject to the conditions laid down in the Articles 30, 31, 32 and 42.

CHAPTER IX

Recovery from consideration of infection-free and foot-and-mouth disease

Article 60. Recovery from consideration of infection-free and foot-and-mouth disease.

The consideration of all or part of Spain as free of infection and foot-and-mouth disease shall be restored by the appropriate decision of the European Commission, taking into account the conditions laid down in Articles 61 and 62.

Article 61. Recovery of the consideration after the eradication of foot-and-mouth disease without emergency vaccination.

1. The previous consideration of infection-free and foot-and-mouth disease, in the whole of the national territory, or in part of it if regionalised in accordance with Article 45, shall be recovered after the treatment and eradication of one or more outbreaks of foot-and-mouth disease. Foot-and-mouth disease without vaccination under the following conditions:

(a) That all the measures provided for in Articles 36 and 44 have been completed.

b) That is given at least one of the following conditions:

1. The relevant recommendations of the chapter on foot-and-mouth disease of the Zoosanitary Code of the International Office of Epizootics, in its latest version, are complied with.

2. What has happened at least three months since the last recorded outbreak of foot-and-mouth disease and, through clinical and laboratory surveillance in accordance with Annex III, the absence of infection with the virus has been confirmed. foot-and-mouth disease in all or part of the national territory concerned.

2. Decisions to recover from the consideration of infection-free and foot-and-mouth disease shall be taken by the European Commission.

Article 62. Recovery of the consideration after the eradication of foot-and-mouth disease with vaccination.

1. The previous consideration of infection-free and foot-and-mouth disease, in the whole of the national territory, or in part of it if regionalised in accordance with Article 45, shall be recovered after the treatment and eradication of one or more outbreaks of foot-and-mouth disease. Foot-and-mouth disease with vaccination if the following conditions are met:

(a) That all the measures provided for in Articles 36, 44, 54, 55, 56 and 57 have been completed.

b) That is given at least one of the following conditions:

1. What recommendations are met

relevant to the FMD chapter of the Animal Health Code of the International Office of Epizootics, in its latest version.

2. No, at least three months have passed since the slaughter of the last vaccinated animal, and serological surveillance has been carried out in accordance with the guidelines laid down by the European Commission.

3. What has happened at least six months since the last outbreak of foot-and-mouth disease, or since the termination of emergency vaccination if it is later, and, in accordance with the guidelines laid down by the European Commission, has been demonstrated the absence of infection in vaccinated animals by a serological investigation for the detection of antibodies against non-structural proteins of the foot-and-mouth disease virus.

2. Decisions to recover from the consideration of infection-free and foot-and-mouth disease shall be taken by the European Commission.

Article 63. Modifications of measures for the recovery of the consideration of infection-free and foot-and-mouth disease.

1. By way of derogation from Article 61, it shall apply, if adopted by the European Commission, the decision to withdraw the restrictions applied in accordance with this royal decree, once the requirements of the Articles have been met. 36 and 44, and clinical and serological research has been completed and confirmed the absence of infection with the foot-and-mouth disease virus.

2. By way of derogation from Article 62, it shall apply, if adopted by the European Commission, the decision to withdraw the restrictions applied in accordance with this royal decree, once the clinical investigation has been carried out and Article 57 of the Directive, and the measures referred to in Article 57, have been completed and confirmed the absence of infection with the foot-and-mouth disease virus.

3. Without prejudice to paragraphs 1 and 2, the decision that no animal of a sensitive species shall leave the territory or region in which the outbreak of foot-and-mouth disease has been given shall apply, if adopted by the European Commission. to another Member State until the consideration of infection-free and foot-and-mouth disease is recovered in accordance with the conditions of the Animal Health Code of the International Office of Epizootics, except that such animals:

(a) Have not been vaccinated and are sent directly to a slaughterhouse for immediate slaughter.

(b) OR have been isolated for at least 30 days just prior to loading and have been subjected to a serological test for the detection of antibodies against structural proteins of the foot-and-mouth disease virus, with result negative, carried out on samples taken within 10 days prior to loading.

4. Also, without prejudice to paragraph 2, it shall apply, if adopted by the European Commission, to the decision that, until recovery from the consideration of infection-free and foot-and-mouth disease in accordance with the conditions laid down in the of the Animal Health Code of the International Office of Epizootics, the radius of the surveillance zone around the vaccination zone provided for in Article 52.2 is reduced after the successful implementation of the measures referred to in Article 52.2 Article 57.

Article 64. Certification of animals of susceptible species and products derived from such animals for trade.

The competent authorities shall ensure that the additional certification for trade in animals of susceptible species or products derived from such animals, required under this royal decree, is prolonged until the consideration as free of infection and foot-and-mouth disease of Spain, or of the part of the national territory concerned, has been recovered in accordance with Articles 61 and 62.

Article 65. Movement of vaccinated animals of susceptible species after recovery from the consideration of infection-free and foot-and-mouth disease.

1. The dispatch for the intra-Community movement of animals of susceptible species vaccinated against foot-and-mouth disease shall be prohibited.

2. By way of derogation from the prohibition laid down in paragraph 1, the specific measures to be taken by the European Commission in respect of vaccinated animals of susceptible species which are kept in zoos and entered into a programme shall apply. for the conservation of fauna, or to be kept in establishments for the resources of breeding animals entered by the competent authorities in a list of animal breeding centres essential for the survival of the breed, without prejudice to the relevant provisions of the Health Code of the International Bureau of Epizootic diseases.

TITLE III

Preventive measures

CHAPTER I

Laboratories and establishments handling foot-and-mouth disease virus

Article 66. Laboratories and establishments handling live foot-and-mouth disease viruses.

1. The competent authorities, including the Spanish Agency for Medicinal Products and Health Products, in coordination with the Ministry of Agriculture, Fisheries and Food, shall strictly monitor the laboratories and establishments in which they are For the purposes of investigation, diagnosis or manufacture of live foot-and-mouth disease viruses, their genome, antigens or vaccines obtained from such antigens, and shall ensure that the handling of live foot-and-mouth disease virus for the purpose of investigation and diagnosis is performed exclusively at the Central Laboratory of Animal Health in Algete, Madrid.

2. The handling of live foot-and-mouth disease virus for the purpose of the manufacture of inactivated antigens for the production of vaccines, or of vaccines, as well as the use of live foot-and-mouth disease, shall be prohibited in Spain, without prejudice to the provisions of the previous paragraph. corresponding investigation.

3. The Ministry of Agriculture, Fisheries and Food shall ensure that the laboratory referred to in paragraph 1 operates in accordance with at least the biosecurity standards set out in Annex XII.

Article 67. Controls of laboratories and establishments handling live foot-and-mouth disease viruses.

Representatives of the Ministry of Agriculture, Fisheries and Food will collaborate with the European Commission's veterinary experts on the random checks they carry out to assess whether the safety systems applied in the laboratory set out in Annex XI complies with the biosecurity standards set out in Annex XII.

Article 68. Amendment of the list of approved laboratories and establishments handling live foot-and-mouth disease virus.

1. The amendments to the list of establishments and laboratories in Parts A and B of Annex XI to be adopted by the European Commission on the basis of the random checks provided for in Article 67 shall apply.

2. Regular updates shall also be applied to the list provided for in Annex XI adopted by the European Commission on the basis of the written information submitted by Spain and the other Member States.

Article 69. National reference laboratory and official laboratories of the Autonomous Communities.

1. It is designated as a national reference laboratory for foot-and-mouth disease as provided for in Annex XV.A.

2. The autonomous communities may designate the official laboratories in accordance with Article 30 of Law 8/2003 of 24 April on animal health, establishing laboratories of a public nature or, where appropriate, recognising or designating those laboratories. private character, competent to carry out tests such as those of a serological type in their territory, which do not involve the handling of live foot-and-mouth disease virus; in this case, they shall ensure that the laboratory tests on the Foot-and-mouth disease is carried out exclusively in those laboratories authorised for that purpose. If they do not establish, recognise or designate such laboratories, they shall ensure that the laboratory tests are carried out exclusively in the national reference laboratory.

However, these laboratories will not detect viruses in samples taken from suspected cases of vesicular diseases. Such laboratories do not have to comply with the biosecurity standards provided for in paragraph 1 of Annex XII, but they should have established procedures to ensure the effective prevention of the spread of foot-and-mouth disease viruses. eventually present.

Samples that give dubious results in the tests carried out must be transmitted to the national reference laboratory for confirmatory testing.

3. Laboratory tests to confirm the presence of foot-and-mouth disease virus or virus of other vesicular diseases shall be carried out exclusively by the national reference laboratory. However, at the request of a competent authority, the Ministry of Agriculture, Fisheries and Food may authorise, in an express and prior manner, and in duly substantiated cases, that such tests be carried out in any other national laboratory of reference to another State of the European Union.

4. Without prejudice to the functions provided for in Article 29.2 of Law 8/2003 of 24 April of animal health, the national reference laboratory shall be responsible for the coordination of diagnostic patterns and methods in Spain and shall carry out powers and tasks set out in Annex XV.B.

5. The national reference laboratory shall be in close contact with the Community reference laboratory and in particular shall be responsible for sending the appropriate samples.

6. The first priority of the laboratory investigations foreseen in this royal decree will be to confirm or rule out the presence of foot-and-mouth disease and to exclude the presence of other vesicular diseases.

When an outbreak of foot-and-mouth disease has been confirmed and the virus serotype has been identified, this virus will be characterised antigenically in relation to the reference vaccine strains, if necessary with the help of the laboratory. Community reference.

samples of domestic animals showing signs of vesicular disease and which are negative for foot-and-mouth disease virus shall be sent to the Community reference laboratory in order to continue the investigation. where relevant, in respect of swine vesicular disease virus.

7. The national reference laboratory shall be equipped with appropriate material and personnel, both in number and training, to carry out the laboratory investigations required under this royal decree.

CHAPTER II

Diagnosis of foot-and-mouth disease

Article 70. Patterns and tests for the diagnosis of foot-and-mouth disease and for the differential diagnosis of other vesicular diseases.

The Ministry of Agriculture, Fisheries and Food and the competent authorities shall ensure that their respective laboratories use the tests and patterns for diagnosis specified in Annex XIII.

CHAPTER III

Real-time alert and alert exercises

Article 71. Alert Plan.

1. The Ministry of Agriculture, Fisheries and Food, in coordination with the Autonomous Communities, will draw up an alert plan, which will specify the national measures necessary to maintain a high level of awareness and preparedness for the Foot-and-mouth disease as well as environmental protection, to be applied in case of outbreak of foot-and-mouth disease.

2. The alert plan shall establish access to all facilities, equipment, personnel and any other appropriate material to the extent necessary for the rapid and effective eradication of an outbreak of foot-and-mouth disease, shall ensure coordination with France. and Portugal and promote cooperation with neighbouring third countries.

3. The alert plan shall establish the measures to be applied in the case of the most unfavourable scenario, as referred to in paragraph 12 of Annex XVI, and shall indicate:

(a) The vaccine requirements considered necessary in case of emergency vaccination.

(b) Regions with areas of high stocking density, taking into account the criteria set out in Annex X.

4. The alert plan will ensure that all necessary arrangements are made to avoid in the event of a focus any damage to the environment that can be avoided, and will at the same time guarantee the highest level of fight against the disease, and to minimize damage caused as a result of a focus, especially where the dead or slaughtered animal carcasses need to be buried or burned on site.

5. The criteria and requirements for drawing up the alert plan shall be as set out in Annex XVI. The amendments adopted by the European Commission shall also apply, taking into account the specific nature of foot-and-mouth disease and progress in measures to combat disease and environmental protection.

6. Once the plan has been drawn up, it shall be submitted by the Ministry of Agriculture, Fisheries and Food to the approval of the European Commission in order to determine whether they can achieve the objective referred to in paragraph 1, which may propose any necessary amendments, in particular to ensure compatibility with those of the other Member States.

7. In the event of major changes to the alert plan, they shall be immediately communicated to the European Commission. The revised alert plan may subsequently be approved by the European Commission to take account of developments in the situation.

8. The plan shall be updated every five years, in particular taking into account the real-time alert exercises referred to in Article 72, and shall be submitted, as provided for in paragraph 6, to the approval of the European Commission.

9. The implementation of the plan, once approved, corresponds to the competent authorities.

Article 72. Real-time alert exercises.

1. The Ministry of Agriculture, Fisheries and Food, in coordination with the competent authorities, shall carry out real-time alert exercises in accordance with the alert plan approved for Spain and Annex XVI.

2. Whenever possible and practical, such alert exercises shall be carried out in real time in close cooperation with the competent authorities of France and Portugal or neighbouring third countries.

3. The Ministry of Agriculture, Fisheries and Food, through the appropriate channel, shall inform the European Commission of the main results of the alert exercises in real time. This information will be submitted to the European Commission as part of the data provided for in Royal Decree 2459/1996 of 2 December establishing the list of diseases of compulsory declaration animals and giving the rules for their notification, and other rules applicable to the effect.

CHAPTER IV

Fight Centers and Expert Groups

Article 73. National Committee of the Veterinary Health Alert System.

1. In case of outbreak of foot-and-mouth disease, the national health alert system committee shall act as a national emergency committee for the disease, directly or through a working group agreed in its own body, in the latter case if affects only some or some autonomous communities.

However, in case of urgency and until the action of that, a national emergency committee, which is fully functional, may be established within the Ministry of Agriculture, Fisheries and Food, in which the less, a representative of the community or of the autonomous communities that so desire, in whose territory the focus has occurred.

2. Without prejudice to the powers of the autonomous communities and the functions of the national committee provided for in Article 28.2 of Law 8/2003 of 24 April of animal health, the main task of the National Committee for the Alert System Veterinary health shall be responsible for directing and monitoring the operation of local centres for the fight against the disease, as provided for in Article 75. However, the national committee may decide that certain tasks assigned to it in principle are subsequently entrusted to the local centre for the control of the active disease at the administrative level of the province or the higher administrative level, the tasks of the National Committee on the Veterinary Health Alert System are not jeopardised.

3. The national committee shall at least be responsible for:

a) Plan the necessary measures of struggle.

b) Ensure the rapid and effective implementation of these measures by local disease control centres.

c) Assign staff and other resources to local disease control centers.

d) Provide information to the European Commission, the competent authorities of other Member States and other authorities in Spain, including competent authorities and bodies on the environment, as well as veterinary, agricultural and commercial organisations and bodies.

e) Organize an emergency vaccination campaign and also determine vaccination zones.

f) Be in contact with diagnostic laboratories.

g) Be in contact with the competent authorities on the environment to coordinate measures relating to veterinary and environmental safety.

h) Be in contact with the media.

i) Be in touch with law enforcement to ensure the proper implementation of concrete legal measures.

Article 74. Technical requirements of the national committee.

1. The Ministry of Agriculture, Fisheries and Food and the competent authorities of the autonomous communities shall ensure, within the scope of their respective powers, that the National Committee on the Veterinary Health Alert System has all the necessary means, such as personnel, facilities and equipment, to manage an effective eradication campaign.

2. The means referred to in paragraph 1 shall include at least the following:

(a) A system for the identification of herds and the location of animals, preferably computerised.

(b) All appropriate means of communication such as telephones, faxes and, if possible, facilities for communication with the media.

(c) A communication system that enables the exchange of information with local disease control centres, laboratories and other relevant organisations, preferably computerised.

d) Maps and other sources of information that can be used to direct the fight measures.

e) A shared journal that will be taken to record in chronological order all events related to an outbreak of foot-and-mouth disease and to allow the different activities to be linked and coordinated.

(f) Lists of laboratories and national and international organisations that are interested in a outbreak of foot-and-mouth disease and with whom it is necessary to contact in case of a focus.

g) Lists of employees and other persons who can be called immediately to work in local centres for the fight against the disease or in the expert groups referred to in Article 77 in the event of a fever

foot-and-mouth disease.

(h) Lists of competent environmental protection authorities and bodies with whom it is necessary to contact in the event of an outbreak of foot-and-mouth disease.

i) Maps where the appropriate areas of the transformation sites are identified.

(j) Lists of processing and processing undertakings which are authorised to treat or transform carcasses of animals and animal waste to which the task could be entrusted in the event of a outbreak of foot-and-mouth disease, Its capacity, address and contact details.

k) List of measures to monitor and control the passage of disinfectants and the incorporation of body fluids and tissues into the environment as a result of the decomposition of corpses, especially in relation to water surface and underground.

Article 75. Establishment, competencies and functions of local disease control centres.

1. The competent authorities of the autonomous communities shall ensure that, in the event of a outbreak of foot-and-mouth disease, local centres of fully functional disease control are immediately established.

2. The alert plan shall include provisions on the probable location of local disease control centres, their organisation, staff, accommodation, facilities and equipment, management systems, communication lines and channels of communication. information.

3. The competent authorities of the autonomous communities shall ensure that the local disease control centres operate in close coordination and cooperation with the National Committee of the Veterinary Health Alert System, in particular by as regards the measures referred to in Article 73.3.b).

4. The competent authorities of the autonomous communities shall ensure that the local disease control centres have the necessary organisation to implement rapidly the measures provided for in this royal decree to be applied in case of outbreak of foot-and-mouth disease.

Article 76. Technical requirements of local disease control centres.

1. The competent authorities of the autonomous communities shall ensure that the local centres for combating the disease have the necessary staff, facilities and equipment, as well as a clear management structure and effective management. to ensure the rapid implementation of the measures relating to the epizootiological survey, the protection of the environment, the processing of carcasses from infected flocks, the official surveillance of the areas, the location, well-being, the need for emergency slaughter, cleaning and disinfection and other hygiene measures, emergency vaccination and all other regulatory decisions.

2. The local disease control centres shall have at least the following:

(a) A telephone line reserved for communication with the National Committee of the Veterinary Health Alert System, accessible telephone lines where farmers and other rural people can obtain recent and accurate information about the measures taken.

b) Field personnel equipped with the tools necessary for the communication and efficient management of all the necessary data.

(c) A file system, preferably computerised, connected to the National Committee of the Veterinary Health Alert System and to all databases, laboratories and other necessary bodies.

d) A shared journal that will be taken to record in chronological order all events related to an outbreak of foot-and-mouth disease and to allow the different activities to be linked and coordinated.

e) Updated lists of persons, including private veterinarians, and local organisations in each region to be contacted and to be able to participate in the case of an outbreak of foot-and-mouth disease.

(f) Updated lists of holdings to which the provisions of Articles 15 and 18 may apply in the case of a outbreak of foot-and-mouth disease.

g) Updated inventory of possible sites for the incineration or burial of animals slaughtered in accordance with this royal decree to be processed in accordance with national and European Union legislation on environmental protection.

h) An updated list of the competent environmental authorities in each region, as well as other environmental bodies to be contacted and to be involved in case of foot-and-mouth disease outbreak.

(i) Layers in which suitable disposal sites are indicated for the burial of dead bodies that do not present a risk to the environment, especially for surface water or groundwater.

j) List of treatment and disposal companies authorized to treat or remove animal carcasses and animal waste.

k) List of measures to monitor and control the passage of disinfectants and the incorporation of body fluids and tissues into the environment as a result of the decomposition of corpses, especially in relation to water surface and underground.

Article 77. Group of experts.

1. A group of experts on foot-and-mouth disease shall be established as a collegiate body under the Directorate-General of Livestock of the Ministry of Agriculture, Fisheries and Food.

2. That group of experts shall be composed of the following members:

(a) President: the Director General of Livestock, Ministry of Agriculture, Fisheries and Food.

b) Vice-President: The Deputy Director-General for Animal Health.

c) Vocals: a minimum of six, of which two will be epidemiologists; two, veterinary scientists, and two, virologists, appointed by the Director General of Livestock from among accredited experts in each area.

(d) Secretary: an official of the Directorate-General of Livestock of the Ministry of Agriculture, Fisheries and Food, designated by its holder.

3. Its tasks shall be to advise and assist the competent authorities in ensuring preparedness in the event of a outbreak of foot-and-mouth disease. To this end, it shall be permanently active in order to maintain the necessary knowledge.

4. In case of suspected outbreak of foot-and-mouth disease, the group of experts shall at least take the following measures:

a) Evaluate the clinical landscape and the epizootiological situation.

b) Orientate on the sampling and analysis necessary to diagnose foot-and-mouth disease, together with appropriate accompanying measures.

5. In case of outbreak of foot-and-mouth disease, the group of experts shall at least take the following measures:

(a) Carry out, at least with the index case and where necessary on site, an assessment of the clinical landscape and an analysis of the epizootiological survey to collect the data necessary to determine:

1. The origin of the infection.

2. The date of introduction of the infectious agent.

3. The possible spread of the disease.

b) Inform the head of the veterinary services of the community or autonomous communities and the national committee of the veterinary health alert system.

(c) Orientate on screening, sampling, testing methods, control and other necessary measures, as well as on the applicable strategy, and also on biosecurity measures in the holdings or establishments mentioned in the Article 16 and in relation to emergency vaccination.

d) Follow and direct the epizootiological survey.

e) Complement epizootiological data with geographic, meteorological, or other information that is necessary.

f) Analyze epizootiological information and periodically perform risk assessments.

g) To help ensure that the transformation of animal carcasses and animal waste is done with the minimum detrimental effect on the environment.

6. This body shall adjust its action to the legal system of the collegiate bodies provided for in Chapter II of Title II of Law 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Administrative Procedure. Common.

CHAPTER V

Antigen and vaccine banks

Article 78. National antigen and vaccine banks.

1. Under the alert plan, the Ministry of Agriculture, Fisheries and Food may establish or maintain national antigen and vaccine banks for the storage of reserves, with a view to emergency vaccination, antigens or vaccines. authorised in accordance with Royal Decree 109/1995 of 27 January 1995 on veterinary medicinal products and other rules applicable to that effect.

2. The Ministry of Agriculture, Fisheries and Food may also designate establishments for the packaging and storage of vaccines in the event of emergency vaccination.

3. The Ministry of Agriculture, Fisheries and Food, in coordination with the Spanish Agency for Medicines and Health Products, as well as with the autonomous communities, will ensure that the antigens and vaccines formulated in the National antigen and vaccine banks comply with the minimum standards established for the Community antigen and vaccine bank in relation to safety, sterility and the content of non-structural proteins.

4. If a national antigen and vaccine bank is maintained, the Ministry of Agriculture, Fisheries and Food shall inform the European Commission of the stocks of antigens and vaccines they have. This information will be submitted to the European Commission every 12 months as part of the data provided for in Royal Decree 2459/1996 of 2 December establishing the list of diseases of compulsory declaration animals and giving the rules for its notification, and other rules applicable to that effect. Information on the quantities and subtypes of authorised antigens or vaccines stored in the national antigen and vaccine bank shall be considered classified information and shall not be published in particular.

Article 79. Community antigen and vaccine bank.

The Ministry of Agriculture, Fisheries and Food shall have access to the Community antigen and vaccine bank, upon request to the European Commission.

CHAPTER VI

Foot-and-mouth disease in other species

Article 80. Additional measures for the prevention and control of foot-and-mouth disease.

1. Without prejudice to the provisions of Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down the health rules applicable to animal by-products not intended for human consumption, the competent authorities shall ensure that the prohibition of feed animals with kitchen waste, in accordance with national and European Union legislation, applicable to all animals regardless of their use or the place in which they live.

The development provisions for the measures to be implemented by the Member States, which are to be adopted by the European Commission, will also apply.

2. The development provisions for the control of foot-and-mouth disease in animals which may be considered to be susceptible to foot-and-mouth disease, on the basis of scientific data, other than those of susceptible species, shall also apply. referred to in the first paragraph of Article 2.2.a), such as those of the orders "Rodentia" or "Probosciae", which are adopted by the European Commission.

3. As soon as the competent authority has information that there are wild animals suspected of being infected with foot-and-mouth disease, it shall take appropriate measures to confirm or rule out the presence of the disease by means of investigations in all wild animals of susceptible species which have been killed or found dead, including laboratory tests. It shall inform the owners of animals of susceptible species and the hunters of such suspicion.

4. As soon as the competent authority has confirmation of a primary case of foot-and-mouth disease in wild animals, it shall immediately apply the measures referred to in Part A of Annex XVII, in order to reduce the spread of the disease, and shall draw up a plan for the eradication of foot-and-mouth disease in accordance with Part B of Annex XVII. It will inform the owners of animals of susceptible species and the hunters of the confirmed case.

CHAPTER VII

Complementary guarantees for intra-Community trade

Article 81. Additional guarantees.

1. The additional guarantees required for foot-and-mouth disease in the case of intra-Community trade are as follows:

(a) Where the animals come from a Member State free of foot-and-mouth disease for at least two years, which has not carried out vaccination for at least 12 months and which does not admit in its territory the presence of animals which have have been vaccinated less than 12 months ago, a guarantee that they have not been vaccinated against foot-and-mouth disease.

(b) Where the animals come from a Member State which, within the 12 months immediately preceding it, has carried out prophylactic vaccination or has exceptionally resorted to emergency vaccination on its territory, the Introduction of animals shall be subject to:

1. The guarantee that they have not been vaccinated against foot-and-mouth disease.

2. A guarantee that bovine animals have been tested "probang-test" (laryn-pharynge scraping) with a negative result.

3. A guarantee that bovine animals and swine have been tested negative for a serological test with a view to detecting the presence of aftosos antibodies.

4. A guarantee that bovine animals and swine have been isolated in the country of dispatch, either on a holding or at a quarantine station, for 14 days, under the observation of a veterinarian official. No animal found on the holding of origin or, where appropriate, at the quarantine station may have been vaccinated against foot-and-mouth disease for a period of 21 days prior to dispatch and during the same period shall not be possible. to enter into the holding or quarantine station no new animal to be part of the consignment.

If sampling for the test indicated in this paragraph is carried out on the farms themselves, the animals intended for dispatch must be isolated from the other animals of the holding so far. of boarding.

5. º To submit a quarantine for 21 days.

In this case, the above guarantees may be required for a period of 12 months after the termination of the emergency vaccination operations.

(c) Where animals come from a Member State not free of foot-and-mouth disease, for at least two years before, they shall be subject to:

1. The guarantees referred to in paragraph (b), except for quarantine on the holding of origin.

2. The eventual additional guarantees which, if any, could be adopted by the European Commission.

2. Where emergency vaccination is carried out exceptionally on the whole territory and which allows for the presence of vaccinated animals, the entry into Spanish territory of live bovine animals shall be subject to:

(a) A coming from a Member State that meets the same criteria successfully:

In the case of bovine animals for reproduction or in production and meat of more than four months of age and who have been vaccinated at least 15 days and not more than four months before boarding, against types A, O, C or other exotic types of the aftoso virus by means of a vaccine prepared by inactivated virus, authorised and controlled by the competent authority of the issuing country.

In this case the aforementioned guarantee may be required for a period of 12 months after the termination of the emergency vaccination operations, for this period the duration of the validity of the vaccination for the bovine animals. revaccinated in the Member States where they were the subject of an annual vaccination and where slaughter is systematically practised on the basis of foot-and-mouth disease.

(b) A coming from a Member State free of foot-and-mouth disease for at least two years before, in which vaccination is not practised and where the presence of vaccinated animals on its territory is not permitted, with the certificate of which have not been vaccinated against foot-and-mouth disease and without prejudice to any possible foot-and-mouth vaccination prior to their admission to the holding of destination. The above guarantees may be required for a period of 12 months after the termination of the emergency vaccination operations.

3. Following the general provisions of the Treaty, the introduction into Spanish territory of breeding or rental animals of the porcine species may also be made subject to the investigation of antibodies against the swine vesicular disease, performed 30 days prior to boarding, of a negative result.

In the event that the tests are carried out on the holding, the animals destined to be dispatched from the other animals until their dispatch must be separated.

4. Where a Member State is authorised to carry out emergency vaccination on a part of its territory, the status of the rest of the territory shall not be affected, provided that the measures for immobilisation of the vaccinated animals are applied effective form over a period of 12 months counted from the completion of the vaccination operations.

TITLE IV

Exchanges with third countries

Article 82. Importation of animals.

1. Only imports of animals susceptible to foot-and-mouth disease from third countries shall be authorised:

a) Indemnes to the following diseases:

1. º 12 months in the case of rinderpest, contagious bovine perineumonia, bluetongue, African swine fever and porcine enzootic encephalomyelitis (Teschen disease).

2. º For six months if it is contagious vesicular stomatitis.

(b) In the last 12 months, vaccination of animals against diseases referred to in paragraph (a) .1. has not been carried out.

2. The introduction into national territory of animals of species susceptible to foot-and-mouth disease from the territory of a third country shall only be authorised where the documents are accompanied and meet the following conditions:

(a) Where the animals come from a third country which has been free from foot-and-mouth disease for at least two years, where vaccination has not been carried out for at least 12 months or allowed entry into its territory of animals vaccinated during the preceding 12 months, the certification that they have not been vaccinated against foot-and-mouth disease.

(b) Where the animals come from a third country which has been free from foot-and-mouth disease for at least two years, in which vaccination is carried out and the entry into its territory of vaccinated animals is permitted, certification Justification for:

1. The animals have not been vaccinated against foot-and-mouth disease.

2. º That cattle have returned negative results in a test for the detection of the foot-and-mouth disease virus carried out by the laryngopharynx scraping method (test of "Probang").

3. The animals have been tested negative in a serological test for the detection of antibodies against foot-and-mouth disease.

4. ° The animals have been isolated in a quarantine center of the exporting country for 14 days, subject to the control of an official veterinarian, requiring that no animal located in the quarantine center has been vaccinated. in the case of foot-and-mouth disease in the course of the 21 days prior to export and that no animal which is not part of the consignment has been introduced into the quarantine centre during the same period.

5. º That the animals have been in quarantine for a period of 21 days.

(c) Where animals come from a third country which has not been free from foot-and-mouth disease for at least two years:

1. º The warranties mentioned in paragraph (b) of this section.

2. º The additional guarantees to be established in your case by the European Commission.

For the purposes of this paragraph, it may continue to be considered that a third country has been free from foot-and-mouth disease for at least two years even if a limited number of outbreaks of the disease have been recorded in a limited part of the country. their territory, provided that such outbreaks have been eliminated within a period of less than three months.

Article 83. Importation of fresh meat.

1. Without prejudice to the provisions of paragraph 1 of the previous Article, the importation of fresh meat from third countries in which foot-and-mouth disease (strains A, O, C) is endemic is not practised in the case of systematic slaughter. the occurrence of an outbreak of foot-and-mouth disease or vaccination against such disease shall be permitted only if the following requirements are met:

(a) That the third country or a region of the third country has been authorised to import by the European Commission.

(b) The meat has matured, its pH is controlled, boned and the main lymph nodes have been removed.

2. The importation of offal for human consumption from third countries may be restricted, subject to prior scientific advice. For offal intended for the pharmaceutical industry and for the feeding of pet animals, the special conditions to be established by the European Commission shall be met.

3. The importation of fresh meat from third countries where vaccination against the SAT or ASIA 1 strains of foot-and-mouth disease is practised shall be authorised only if the following requirements are met:

(a) That the third country has regions in which vaccination is not permitted or outbreaks of foot-and-mouth disease have appeared in the course of 12 months. These regions will be approved by the European Commission.

(b) That the meat has matured, boned and the main lymph nodes have been removed and that its importation has not occurred until three weeks of slaughter.

(c) The importation of offal from such third countries shall not be permitted.

4. The importation of fresh meat from third countries where vaccination is not practised on a regular basis and the absence of foot-and-mouth disease has been determined shall be permitted in accordance with the rules applicable to trade

intra-Community

5. Fresh meat from third countries where vaccination is practised may be imported and have been free of foot-and-mouth disease for 12 months, provided that the importation is authorised by the European Commission.

TITLE V

Application measures

Article 84. Sanctioning regime.

In the event of non-compliance with the provisions of this royal decree, the regime of infringements and penalties laid down in Law 8/2003 of 24 April of animal health shall apply, without prejudice to any possible liability. civil, criminal or other order that may be present.

Article 85. Procedure for the adoption of special epizootiological measures.

When, when implementing the measures referred to in that royal decree, a competent authority, after consulting the national committee of the veterinary health alert system, considers that a measure does not comply with the epizootiological, or when it appears that the foot-and-mouth disease virus is spreading despite the measures taken in accordance with this royal decree, the said ministry may decide to request the European Commission, through the appropriate channel, the adoption of a decision in a special way to authorise Spain to implement alternative measures with an equivalent epizootiological effect for a limited period in accordance with the epizootiological situation.

Additional disposition first. Compulsory slaughter allowance.

In accordance with Article 21 of Law 8/2003 of 24 April of animal health, the compulsory slaughter of animals to be carried out in the infectious disease shall entitle the holder to the corresponding compensation. for compulsory slaughter, in accordance with the scales provided for in the rules in force.

Only those owners of livestock who have complied with the current animal health regulations shall be entitled to compensation.

Additional provision second. Precautionary and urgent measures.

1. The Ministers for Agriculture, Fisheries and Food and for Health and Consumer Affairs are empowered to establish, in the field of their respective powers, and in order to prevent the introduction or dissemination in the national territory of foot-and-mouth disease, or in order to prevent their spread in the event of suspected or confirmed cases or serious health risks, the precautionary measures to be taken in accordance with Article 8 of Law 8/2003 of 24 April.

2. The Minister for Agriculture, Fisheries and Food is also empowered to establish, within the scope of his powers, urgent measures to effectively prevent the transmission and spread to the rest of the national territory of fever. Foot-and-mouth disease, in exceptional situations where there is a serious danger of such an extension after the disease has been declared by the competent authority, in accordance with Article 26 of Law 8/2003 of 24 April.

First transient disposition. Modified alert plan.

The Ministry of Agriculture, Fisheries and Food shall forward to the European Commission, for approval, and within the time limit laid down in European Union legislation, the alert plan modified to take account of the provisions of the Article 71. The European Commission will examine this plan taking into account the objectives of this royal decree and will suggest any changes it deems necessary, in particular to ensure the compatibility of this plan with those of the other Member States. members.

Second transient disposition. Sampling.

Notwithstanding the provisions of the single derogation provision, pending the adoption of national or European Union legislation, the rules for the collection of samples and their submission to the laboratory for the diagnosis of foot-and-mouth disease shall be as laid down in Annex C to Royal Decree 2223/1993 of 17 December 1993 laying down measures for the control of foot-and-mouth disease and animal health in intra-Community trade in and imports of animals of the species of bovine animals, pigs, fresh meat or meat products from third parties countries, as long as they do not object to the provisions of this royal decree.

Single repeal provision. Regulatory repeal.

As many provisions of equal or lower rank are repealed, they are opposed to what was established in this royal decree, and specifically:

(a) Royal Decree 2223/1993 of 17 December 1993 laying down measures for the control of foot-and-mouth disease and animal health in intra-Community trade in and imports of animals of the species of bovine, porcine, fresh meat or meat products from third countries.

(b) Chapter I (5) of Annex A to Royal Decree 1679/1994 of 22 July 1994 laying down the health conditions for the production and placing on the market of raw milk, heat-treated milk and dairy products.

Final disposition first. Competence title.

This royal decree is of a state basic regulation and is dictated by the provisions of Article 149.1.16.a of the Constitution, which attributes to the State exclusive competence in the field of bases and general coordination. of the health. Except as provided for in Article 16, as regards the border inspection posts, Title IV and the relevant sanctioning system, which is issued under the provisions of Article 149.1.16.a, first indent, of the Constitution, which gives the State exclusive competence in the field of external health.

Final disposition second. Development, application, and modification faculty.

1. The Ministers for Agriculture, Fisheries and Food and for Health and Consumer Affairs are empowered to lay down, in the field of their respective powers, the provisions necessary for the implementation of the provisions of this royal decree. Specifically, the Minister of Agriculture, Fisheries and Food is empowered to establish, by ministerial order, after consultation with the Autonomous Communities, the rules for the collection of samples and their dispatch to the laboratory for diagnosis of foot-and-mouth disease.

2. The Ministers for Agriculture, Fisheries and Food and for Health and Consumer Affairs are empowered to amend, in the field of their respective powers, the content of the Annexes for their adaptation to European Union legislation.

3. The Ministers for Agriculture, Fisheries and Food and for Health and Consumer Affairs are also empowered to make, in the field of their respective powers, the provisions necessary for the implementation in Spain of decisions or acts adopted by the European Commission, as referred to in Article 17, Article 20, Article 25.7, Article 34.3, Article 39.9, Article 45.3, Article 46.4, Article 47.3, Article 50 (3), (5) and (6), paragraphs 4, 5, 6 and Article 59, Article 60, Article 61 (2), Article 63 (2), Article 63 (2), Article 61 (2) and Article 61 (2) of the Treaty. Article 68, paragraphs 5 and 7 of Article 71, paragraphs 1 and 2 of Article 80, Article 85, paragraph 2.1.1 of Annex V and paragraph 3.1 of Annex X.

Final disposition third. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, on November 12, 2004.

JOHN CARLOS R.

The First Vice President of the Government and Minister of the Presidency,

MARIA TERESA FERNANDEZ DE LA VEGA SANZ

ANNEX I

Focus Definition

A focus shall be declared in case a holding meets at least one of the following criteria:

1. That the foot-and-mouth disease virus of an animal, a product derived from that animal or its environment has been isolated.

2. Observed in an animal of a susceptible species clinical signs corresponding to foot-and-mouth disease, and it has been detected and identified in samples taken from the animal or from animals of the same epizootiological group the viral antigen or acid ribonucleic (RNA) specific virus of one or more serotypes of the virus of said disease.

3. That an animal of a susceptible species is found to be clinical signs corresponding to foot-and-mouth disease, and the animal or members of the same group give positive reaction to the antibody tests against structural or non-structural proteins. (e) structural measures of the disease virus, provided that prior vaccination, the presence of residual maternal antibodies or an inspecific reaction can be discarded as a possible cause of seropositivity.

4. That it has been detected and identified in samples taken from animals of susceptible species the viral antigen or the specific viral RNA of one or more serotypes of the foot-and-mouth disease virus, and the animals give positive reaction in the test of antibodies to the structural or non-structural proteins of the virus of that disease, provided that, in the case of antibodies to structural proteins, a vaccination may be discarded as a possible cause of the seropositivity. prior to the presence of residual maternal antibodies or an inspecific reaction.

5. That an epizootiological relationship has been established with a confirmed outbreak of foot-and-mouth disease and at least one of the following conditions is met:

(a) that one or more animals give a positive reaction to the antibody tests against the structural or non-structural proteins of the foot-and-mouth disease virus, provided that it can be discarded as a possible cause of the disease; A prior vaccination, the presence of residual maternal antibodies or an inspecific reaction.

(b) That has been detected and identified in samples taken from one or more animals of susceptible species of the viral antigen or specific viral RNA of one or more serotypes of the foot-and-mouth disease virus.

c) That the active infection with the foot-and-mouth disease virus has been shown to be seroologically active in one or more animals of susceptible species by means of seroconversion from negative to positive for antibody tests against structural or non-structural proteins of the foot-and-mouth disease virus, provided that prior vaccination, the presence of residual maternal antibodies or an inspecific reaction can be discarded as a possible cause of the seropositivity.

When a previously seronegative situation cannot reasonably be expected, this detection of seroconversion should be performed with duplicate samples taken from the same animals on two or more occasions, with an interval of at least five days, in case of structural proteins, and 21 days, in case of non-structural proteins.

(d) That clinical signs corresponding to foot-and-mouth disease are observed in an animal of a susceptible species.

ANNEX II

Notification of the disease and other epizootiological information to be provided by the competent authority in case of confirmation of foot-and-mouth disease

1. Within 24 hours of the confirmation of each primary focus or case in the establishments or means of transport referred to in Article 16, the competent authority shall notify the following by means of the notification system animal diseases established in accordance with Article 3, in conjunction with Article 4 (1) (a) of Royal Decree 2459/1996 of 2 December 1996 establishing the list of diseases of compulsory declaration animals and giving the rules for notification:

a) Date of issue.

b) Issue time.

c) Autonomous Community/country of origin.

d) Name of the disease and type of virus, where applicable.

e) The serial number of the focus.

f) The focus type.

g) The focus number of the focus related to this focus.

h) Province and geographical location of the holding.

i) Other or other provinces affected by restrictions.

j) Confirmation date and method used for confirmation.

k) Date of suspicion.

l) Calculated date of first infection.

m) Origin of the disease, to the extent that it can be noted.

n) Measures taken to combat the disease.

2. In the case of primary outbreaks or cases in the establishments or means of transport referred to in Article 16, in addition to the data referred to in paragraph 1, the competent authority shall also communicate the following information:

(a) Number of animals of all susceptible species present in the focus, or in the establishments and means of transport referred to in Article 16.

(b) Number of dead animals of susceptible species, broken down by species and types (breeding, fattening, slaughter, etc.), on the holding, slaughterhouse or means of transport.

(c) Morbidity of the disease and the number of animals of susceptible species in which foot-and-mouth disease has been confirmed, broken down by type (breeding, fattening, slaughter, etc.).

(d) Number of animals of susceptible species slaughtered in the focus, slaughterhouse or means of transport.

e) Number of bodies transformed and removed.

f) Distance from the focus to the nearest exploitation in which animals of susceptible species are present.

g) If the presence of foot-and-mouth disease has been confirmed in a slaughterhouse or in a means of transport, site of the holding or holdings of origin of the infected animals or carcases.

3. In the case of secondary outbreaks, the information referred to in paragraphs 1 and 2 shall be communicated within the time limit laid down in Article 3, establishing the list of diseases of compulsory declaration animals and giving the for its notification in accordance with Article 3, in conjunction with Article 4.1.b) of Royal Decree 2459/1996 of 2 December 1996.

4. The competent authority shall ensure that the information to be provided in connection with an outbreak or case of foot-and-mouth disease on a holding, slaughterhouse or means of transport pursuant to paragraphs 1, 2 and 3 shall be followed as soon as possible by a the written report, which shall be forwarded to the Ministry of Agriculture, Fisheries and Food for subsequent transfer by the Ministry of Agriculture, Fisheries and Food to the European Commission and to the other Member States, containing at least the following: items:

(a) The date on which the animals of susceptible species of the holding, slaughterhouse or means of transport have been slaughtered and the date on which their carcases have been processed.

(b) The results of the tests carried out on samples taken at the time of the slaughter of animals of susceptible species.

(c) Where the derogation provided for in Article 18 has been applied, the number of animals of susceptible species which have been slaughtered and processed, as well as, where appropriate, the number of species animals (a) sensitive to the need to be slaughtered at a later date and the time limit for such slaughter.

d) Any data concerning the possible origin of the disease or the origin of the disease when it has been determined.

e) In the case of a primary or primary case of foot-and-mouth disease in a slaughterhouse or means of transport, the genetic type of the virus responsible for the focus or case.

(f) Where animals have been slaughtered from susceptible species of contact holdings or from holdings with animals of susceptible species suspected of being infected with the foot-and-mouth disease virus, on:

1. The date of slaughter and the number of animals of susceptible species of each category slaughtered on each holding and, in the case of animals of susceptible species in contact holdings which have not been slaughtered, information on the reasons for this decision.

2. The epizootiological relationship between the outbreak or case of foot-and-mouth disease and each of the contact holdings and the reasons for suspecting the presence of foot-and-mouth disease on each suspicious holding.

3. The results of laboratory tests carried out on samples taken from animals of susceptible species on holdings and at the time of slaughter.

5. Where the system of notification of animal diseases does not work, another means of communication shall be used.

ANNEX III

Research

1. Clinical examination.

1.1 Holdings shall be the subject of clinical examinations of all animals of susceptible species for signs or symptoms of foot-and-mouth disease.

1.2 Special emphasis should be placed on animals that have been exposed to the foot-and-mouth disease virus with high probability, particularly by transport from risk holdings or by close contact with persons or equipment. which would have been in close contact with holdings at risk.

1.3 The clinical examination shall take into account the transmission of foot-and-mouth disease, including the incubation period referred to in Article 2.2.f), and how animals of susceptible species are maintained.

1.4 Relevant records kept on the holding will be thoroughly examined, paying particular attention to the data required for veterinary purposes by the European Union, as well as to the data, if available, on morbidity, mortality and abortions, clinical observations, changes in productivity and feed intake, purchase or sale of animals and visits of people who may be contaminated, and other data of importance as a background.

2. Sampling methods.

2.1 General provisions.

2.1.1 Serological sampling shall be carried out:

2.1.1.1 In accordance with the recommendations of the epizootiological team set up within the expert group referred to in Article 77.

2.1.1.2 And to allow for location and demonstration, also taking into account the definition of Annex I, absence of previous infection.

2.1.2 Where sampling is to be carried out in the context of disease surveillance after a focus, it shall not be initiated until at least 21 days have passed since the disposal of the susceptible animals from the holding or infected holdings and the carrying out of prior cleaning and disinfection operations, unless otherwise indicated in this Annex.

2.1.3 The sampling of animals of susceptible species shall be carried out in accordance with the provisions of this Annex in each case where sheep or goats or other susceptible animals which do not show clinical signs are related to the outbreak. clear, especially if such animals have been isolated from cattle and pigs.

2.2 Sampling of holdings.-On holdings where the presence of foot-and-mouth disease is suspected without clinical signs, sheep and goats and, when recommended by the epizootiological team, other susceptible species shall be examined following a sampling protocol to detect a prevalence of five per cent with a minimum confidence level of 95 per cent.

2.3 Sampling in protection zones. -To achieve the lifting, in accordance with Article 36, of the measures referred to in Articles 21 to 35, all holdings within the perimeter of the protection zone with sheep and goats which have not been in direct and close contact with bovine animals for a period of at least 21 days before sampling shall be examined in accordance with a sampling protocol to enable the detection of a prevalence of the disease Five percent with a minimum confidence level of 95 percent.

However, where the epizootiological circumstances permit and, in particular, in application of the measures provided for in Article 36.1.b), the competent authorities may decide that the samples shall be taken when they have at least 14 days after the removal of the susceptible animals from the holding or infected holdings and the carrying out of the prior cleaning and disinfection operations, provided that the sampling is carried out in accordance with the requirements laid down with paragraph 2.3, and statistical parameters shall be used to detect a prevalence of the two percent disease in the herd, with a minimum confidence level of 95 percent.

2.4 Sampling in surveillance zones. -To achieve the lifting, in accordance with Article 44, of the measures referred to in Articles 37 to 43, the holdings within the perimeter of the surveillance zone shall be examined in the presence of foot-and-mouth disease is suspected in the absence of clinical signs, particularly if there are sheep and goats. For the purposes of this investigation, the multi-phase sampling model shall be sufficient, provided that samples are taken:

2.4.1 Of holdings located in all administrative units within the perimeter of the area where sheep and goats have not been in direct and close contact with bovine animals for a period a minimum of 30 days before sampling is taken.

2.4.2 Of as many farms as previously mentioned as needed to detect, with a confidence level of at least 95 per cent, at least one infected holding if the calculated prevalence of the disease is two percent with a homogeneous distribution throughout the area.

2.4.3 And as many sheep and goats per farm as is necessary to detect, with a level of confidence of at least 95 percent, a prevalence of five percent of the disease within the herd, and all sheep and goats if there are less than 15 sheep and goats on the holding.

2.5 Sampling for tracking.

2.5.1 For the monitoring of areas outside those established in accordance with the provisions of Article 21 and in particular to demonstrate the absence of infection in the population of sheep and goats which is not in close and direct contact with bovine animals or unvaccinated pigs, a sampling protocol recommended by the International Office of Epizootics for monitoring purposes, or a monitoring protocol as referred to in paragraph 1, shall apply. 2.4, with the difference compared to that referred to in paragraph 2.4.2, that the prevalence calculated in the herd will be set at one percent.

3. The number of samples calculated in accordance with the requirements of paragraphs 2.2, 2.3 and 2.4.3 shall be increased to take into account the established diagnostic sensitivity of the test used.

ANNEX IV

Cleaning and disinfection principles and procedures

1. General principles and methods.

1.1 The cleaning and disinfection operations referred to in Article 11 must be carried out under official supervision and in accordance with the instructions of the official veterinarian.

1.2 The disinfectants used and their concentrations should be officially recognised in accordance with Royal Decree 1054/2002 of 11 October 2002, which regulates the evaluation process for registration, authorisation and the placing on the market of biocidal products to ensure the destruction of foot-and-mouth disease virus.

1.3 The activity of disinfectants should not be affected by prolonged storage.

1.4 The selection of disinfectants and disinfection methods must be made taking into account the nature of the premises, vehicles and objects to be treated.

1.5 The conditions for the use of degreases and disinfectants must ensure that their effectiveness is not affected. In particular, the technical parameters indicated by the manufacturer should be respected as pressure, minimum temperature and necessary contact time. The activity of the disinfectant should not be compromised by interaction with other substances, such as degreasing products.

1.6 Regardless of the disinfectant used, the following general rules apply:

1.6.1 Bed and fecal materials must be fully soaked with the disinfectant.

1.6.2 The washing and cleaning of all surfaces that may be contaminated and, in particular, of the earth, floors, ramps and walls must be done by brushing and scrubbing carefully after removing or disassembling, when possible, equipment or facilities that could make it more difficult for cleaning and disinfection processes to be effective.

1.6.3 After the minimum contact time indicated in the manufacturer's recommendations, the disinfectant must be applied again.

1.6.4 Water used in cleaning operations shall be disposed of in such a way as to avoid any risk of spreading the foot-and-mouth disease virus and in accordance with the instructions of the official veterinarian.

1.7 When washing with liquids under pressure and after disinfection, the recontamination of the parts cleaned or disinfected in advance should be avoided.

1.8 The washing, disinfection or destruction of equipment, installations, articles or compartments that may be contaminated should be included.

1.9 The cleaning and disinfection operations required in the field of this royal decree should be documented in the register of the holding or, in the case of vehicles, in the documentation of these, and, where necessary, the official approval, be certified by the supervising official veterinarian.

2. Special provisions on cleaning and disinfection of infected holdings.

2.1 Prior cleaning and disinfection.

2.1.1 During the slaughter of animals, all necessary measures shall be taken to prevent or minimise the spread of foot-and-mouth disease virus. Such measures shall include the installation of provisional disinfection equipment, the provision of protective clothing, showers, the decontamination of equipment, instruments and installations used and the interruption of the current electrical for ventilation.

2.1.2 The carcasses of the slaughtered animals shall be sprayed with disinfectant and removed from the holding in covered watertight containers for treatment and disposal.

2.1.3 As soon as the carcasses of animals of susceptible species are removed for processing and disposal, the parts of the holding in which the animals were lodged, as well as parts of other buildings, corrals, etc., contaminated during slaughter, slaughter or autopsy, shall be sprayed with disinfectants authorised for that purpose.

2.1.4 Any tissue or blood that has been shed during the slaughter or autopsy and any visible contamination of buildings, pens, utensils, etc., must be carefully collected and removed along with the channels.

2.1.5 The disinfectant used shall remain on the surface treated for at least 24 hours.

2.2 Final cleaning and disinfection.

2.2.1 Fat and dirt should be removed from all surfaces by application of a degreasing product, and then washed with cold water.

2.2.2 After washing with cold water, the surfaces will be sprayed with disinfectant again.

2.2.3 After seven days, the premises must be treated again by a degreasing product, rinsed with cold water, sprayed with disinfectant and rinsed again with cold water.

3. Disinfection of contaminated bed, manure and slurry.

3.1 The solid phase of the manure and the bed used will be piled up to heat, if possible by adding 100 kg of live lime granulated by a m3 of manure, to a minimum temperature in the whole heap of 70 oC, will be sprayed with Disinfectant and shall be left for at least 42 days, during which time the heap shall not be covered or repiled, in order to ensure the heat treatment of all its layers.

3.2 The liquid phase of manure and slurry shall be stored for at least 42 days after the last addition of infectious material. This period may be extended if the slurry has suffered significant contamination or when the weather conditions are adverse. This period may be reduced when disinfectant has been added to modify the pH of the whole substance sufficiently to destroy the foot-and-mouth disease virus.

4. Special cases.

4.1 Where, for technical or safety reasons, the cleaning and disinfection methods cannot be completed in accordance with this royal decree, buildings or establishments must be cleaned and disinfected as best as possible for the purposes of prevent the spread of foot-and-mouth disease virus and shall continue to be free from animals of susceptible species for at least one year.

4.2 By way of derogation from paragraphs 2.1 and 2.2, in the case of open-air holdings, the competent authority may define specific cleaning and disinfection methods, taking into account the type of installation and climatic conditions.

4.3 By way of derogation from paragraph 3, the competent authority may define specific manure disinfection methods based on scientific data that this method ensures the effective destruction of the manure virus. foot-and-mouth disease.

ANNEX V

Repopulation of the farms

1. General principles.

1.1 Repopulation shall not commence until 21 days have passed since the end of the final disinfection of the holding.

1.2 Animals may be introduced for restocking only under the following conditions:

1.2.1 Animals must not come from areas which are subject to animal health restrictions in relation to foot-and-mouth disease.

1.2.2 The competent authorities shall ensure that any residual virus of foot-and-mouth disease may be detected in animals intended for restocking, or from clinical signs, in the case of animals. of the bovine or porcine species, either by laboratory research, in the case of other species susceptible to foot-and-mouth disease, carried out at the end of the observation period referred to in point 1.3.

1.2.3 To ensure adequate immune reaction, as provided for in paragraph 1.2.2, in animals intended for restocking, the animals shall:

1.2.3.1 Good originating and proceeding from a holding situated in an area whose area corresponds to at least a circle of 10 km of radius whose centre is such a holding, where there has been no outbreak of fever Foot-and-mouth disease in the last 30 days at least.

1.2.3.2 Well, having been subjected to a test whose results have been negative, such as that described in Annex XIII, for detecting antibodies against the foot-and-mouth disease virus, carried out from samples taken before of the introduction into the holding.

1.3 Regardless of the type of animal husbandry practised on the holding, the reintroduction must comply with the following rules:

1.3.1 Animals shall be introduced into all units and buildings of the holding concerned.

1.3.2 In the case of a holding consisting of more than one unit or building, it shall not be necessary for the reintroduction to take place at the same time in all units or buildings. However, no animal of a species susceptible to foot-and-mouth disease may leave the holding before all animals reintroduced in all the units and buildings have complied with the entire repopulation process.

1.3.3 Animals shall be subject to a clinical inspection every three days for the first 14 days following the introduction.

1.3.4 During the period from 15 to 28 after reintroduction, the animals will be subject to a clinical inspection every week.

1.3.5 When at least 28 days have passed after the last reintroduction, a clinical examination shall be carried out on all animals and samples shall be taken to test for the presence of antibodies against the foot-and-mouth disease virus, in accordance with the requirements of paragraph 2.2 of Annex III.

1.4 The repopulation process shall be considered to be complete when the measures set out in paragraph 1.3.5 have ended with negative results.

2. Extent of the measures and exceptions.

2.1 Competent authorities may impose:

2.1.1 Use of control animals, especially in farms where cleaning and disinfection are difficult, such as outdoor holdings. The provisions on the use of control animals to be established by the European Commission shall also apply.

2.1.2 Additional security and control measures in relation to repopulation.

2.2 The competent authorities may derogate from the measures provided for in paragraphs 1.3.2 to 1.3.4 of this Annex when the repopulation is carried out after three months from the last focus in a zone of 10 km of radius whose centre is the holding subject to the repopulation activity.

3. Repopulation in connection with emergency vaccination.

3.1 Repopulation in a vaccination zone established under Article 52 shall be carried out either in accordance with paragraphs 1 and 2 of this Annex in accordance with Article 58 (2) or (4) (a), (c) and (d).

3.2 The competent authorities may authorise the restocking of holdings located outside the vaccination zone with vaccinated animals after the measures laid down in Article 62 have been completed and under the Following conditions:

3.2.1 Where the proportion of vaccinated animals used for restocking exceeds 75%, the vaccinated animals shall be subject, within a period of not less than 28 days from the last introduction of the animals of susceptible species, a test for the detection of antibodies against non-structural proteins, performed at random; the statistical parameters referred to in paragraph 2.2 of Annex III shall be used in the sampling; the unvaccinated animals shall be subject to the provisions of paragraph 1.

3.2.2 Where the proportion of vaccinated animals does not exceed 75%, unvaccinated animals shall be considered as a witness, and the provisions of paragraph 1 shall apply.

ANNEX VI

Restrictions on the movement of equidae

1. Minimum measures.-Where at least one outbreak of foot-and-mouth disease has been confirmed in accordance with Article 10, the competent authorities shall ensure that equidae are not dispatched to other Member States unless they are accompanied by the identification document referred to in Article 6.2 of Royal Decree 1133/2002 of 31 October 2002 regulating, in the field of equine breeds, the legal status of breeding books, breeders ' associations and the zootechnical characteristics of the different breeds, by the animal health certificate referred to in Annex C of the Royal Decree 1347/1992 of 6 November 1992 amending the rules for the control of African horse sickness and laying down animal health conditions governing intra-Community movements in equidae and imports of such animals from third countries.

2. Recommended additional measures.

2.1 Measures during the block.-In case the competent authorities apply a complete block as provided for in Article 7.3, it may be authorised for equidae requiring veterinary treatment. special in premises without animals of susceptible species, the transport of these equidae from holdings subject to the restrictions laid down in Articles 4 and 10, if the following conditions are met:

2.1.1 You must justify the urgency of the on-call veterinarian 24 hours a day seven days a week.

2.1.2 The target clinic agreement must be submitted.

2.1.3 The transport must be authorized by the competent authorities, which must be available 24 hours a day seven days a week.

2.1.4 Equidae must be accompanied during transport by an identification document in accordance with Article 6.2 of Royal Decree 1133/2002 of 31 October 2002, which is regulated in the field of equine breeds, the legal status of the breeding books, the breeders ' associations and the zootechnical characteristics of the different breeds.

2.1.5 Officers on duty must be informed of the route before departure.

2.1.6 Equidae should be brushed and treated with an authorised disinfectant or veterinary medicinal product that is effective.

2.1.7 Equidae must travel in a special transport medium for equidae, identified as such and cleaned and disinfected before and after this use.

2.2 Controls of equidae in relation to protection and surveillance zones.

2.2.1 The movement of equidae outside the protection and surveillance zones is not subject to other conditions other than those arising from Royal Decree 1347/1992 of 6 November, amending the rules for the fight against against African horse sickness and animal health conditions governing intra-Community movements of equidae and imports of such animals from third countries are laid down.

2.2.2 The movement of equidae within the protection and surveillance zones established in accordance with Article 21 is subject to the following conditions:

2.2.2.1 The use of equidae in holdings located in the protection and surveillance zone where there are no animals of susceptible species may be authorised in the protection zone provided that measures are applied appropriate cleaning and disinfection, and may not be subject to restrictions on establishments located in the surveillance zone.

2.2.2.2 Equidae may be transported without restriction, in special means of transport for equidae, to a holding which does not have animals of susceptible species.

2.2.2.3 In exceptional cases, the competent authorities may authorise the transport of equidae on registered or special means of transport for equidae from a holding which does not have animals of susceptible species until another holding with animals of susceptible species located in the protection zone, provided that the means of transport are cleaned and disinfected before the animals are loaded and before leaving the holding of destination.

2.2.2.4 The movement of equidae may be permitted on public roads, in grassland situated on holdings which do not maintain animals of susceptible species and in exercise facilities.

2.2.3 No restrictions shall be imposed on the collection of semen, ova and embryos of equidae from donor animals on holdings which do not keep animals of susceptible species in the protection and surveillance zone, or transport of semen, ova and embryos from equidae to receiving equidae on holdings which do not maintain animals of susceptible species.

2.2.4 The following conditions shall apply to visits by owners of equidae, veterinarians, inseminators and herders of holdings which have animals of susceptible species in the surveillance zones but which do not are subject to the restrictions referred to in Articles 4 and 10:

2.2.4.1 Equidae should be kept apart from animals of susceptible species and access to animals of susceptible species of the persons mentioned above should be effectively avoided.

2.2.4.2 All visitors must register.

2.2.4.3 The means of transport and the boots of the visitors must be cleaned and disinfected.

ANNEX VII

Treatment of products to ensure the destruction of the foot-and-mouth disease virus

Part A. Products of animal origin

1. Meat products which have undergone at least one of the treatments provided for in the first column of the table provided for in paragraph 1 of Annex III to Royal Decree 1976/2004 of 1 October 2004 laying down the rules animal health requirements for the production, processing, distribution and introduction of products of animal origin intended for human consumption.

2. Hides and skins which satisfy the requirements of Article 20 and Part A. 2.c. or (d) of Chapter VI of Annex VIII to Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules for animal by-products not intended for human consumption.

3. Sheep wool, hair of ruminants and pig bristles which satisfy the requirements of Article 20 and Part A. 1 of Chapter VI of Annex VIII to Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules for animal by-products not intended for human consumption.

4. Products derived from animals of susceptible species which have undergone:

a) A heat treatment in a hermetically closed container, with a value of F equal to or greater than 3,00.

(b) A heat treatment whereby the core temperature has been maintained at least 70 ° C for a minimum of 60 minutes.

5. Blood and blood products from animals of susceptible species which are used for technical purposes, including pharmaceutical products, in vitro diagnosis and laboratory reagents, which have undergone at least one of the treatments referred to in point B. 3.e) (ii) of Chapter IV of Annex VIII to Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules for animal by-products not intended for human consumption.

6. Lard and rendered fats which have undergone the heat treatment referred to in Chapter IV of Chapter IV of Annex VII to Regulation (EC) No IV. 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules for animal by-products not intended for human consumption.

7. Pet food and chewable accessories for dogs which comply with the requirements laid down in paragraphs B. 2, B. 3 or B. 4 of Chapter II of Annex VIII to Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down the health rules for animal by-products not intended for human consumption.

8. Game trophies of ungulates meeting the requirements of paragraphs A. 1, A. 3 or A. 4 of Chapter VII of Annex VIII to Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002.

9. Animal casings which, in accordance with Chapter 2 of Annex I to Royal Decree 2551/1994 of 29 December 1994 laying down animal and health conditions governing trade in and imports of non-originating products subject, in respect of these conditions, to the specific rules laid down in Chapter I of Annex A to Royal Decree 49/1993 of 15 January 1993 on veterinary checks applicable in intra-Community trade in products of animal origin, and, as regards pathogens, in Royal Decree 1316/1992 of 30 October 1992, laying down veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market, having been cleaned and scraped and, after scraped, salted with sodium chloride for 30 days or bleached or dried, and protected from recontamination after treatment.

Part B. Products that are not of animal origin

1. The straw and fodder that:

a) Or they have been submitted:

1. The action of steam in a closed enclosure for at least 10 minutes at a minimum temperature of 80 ° C.

2. ° O to the action of formol vapours (gaseous formaldehyde) produced in a closed enclosure for at least eight hours and at a temperature of at least 19 ° C, using commercial solutions with a concentration of 35-40 per percent.

(b) Or have been stored, packed or in bales, indoors at facilities located at least two km from the nearest foot-and-mouth disease outbreak and are not removed from the establishment before a minimum of three months has passed. from the termination of the cleaning and disinfection measures referred to in Article 11, and in any case not before the end of the restrictions in the protection zone.

ANNEX VIII

Conditions applicable to the production of fresh meat

Part A. Treatment of fresh meats

1. Boneless fresh meat-Carnes described in Article 2 (a) of Royal Decree 147/1993 of 29 January 1993 laying down health conditions for the production and marketing of fresh meat, together with the diaphragms but excluding of the offal, from which the bones and the main accessible lymph nodes have been separated.

2. Offal conditioned.

a) Heart of which the lymph nodes, connective tissue, and attached fat have been completely separated.

b) Liver from which the lymph nodes, connective tissue, and attached fat have been completely separated.

(c) Whole masseter muscles, cut in accordance with paragraph 41.a) of Chapter VIII of Annex I to Royal Decree 147/1993 of 29 January laying down health conditions for the production and marketing of Fresh meat, whose lymph nodes, connective tissue and attached fat have been completely removed.

d) Language with the epithelium but without bones, cartilage or tonsils.

e) Pulmons from which the trachea, major bronchi, and mediastinal and bronchial lymph nodes have been separated.

f) Other bone-free offal or cartilage from which the lymph nodes, connective tissue, attached fat, and mucous membranes have been completely separated.

3. Maturation.

a) Maturation of the channels at a temperature above + 2 ° C for at least 24 hours.

b) Registered value of pH less than 6.0 in the middle of the long dorsal muscle.

4. Effective measures should be implemented to avoid cross-contamination.

Part B. Additional measures applicable to the production of fresh meat of animals of susceptible species from the surveillance zone

1. The production of fresh meat, excluding heads, viscera and offal intended for placing on the market outside the protection and surveillance zone, shall at least comply with one of the following additional conditions:

a) For ruminants:

1. The animals have been subjected to the controls provided for in Article 24.2.

2. º That the meat has undergone the treatment provided for in paragraphs 1, 3 and 4 of Part A.

b) For all animals of susceptible species:

1. º That the animals have remained on the holding for at least 21 days and have been identified to allow the location of the holding of origin.

2. ° The animals have undergone the controls provided for in Article 24.2.

3. º That the meat has been clearly identified or held under official control for at least seven days and has not been released until all suspected infection with the foot-and-mouth disease virus has been officially excluded. source exploitation at the end of the retention period.

c) For all animals of susceptible species:

1. The animals have completed a 21-day period of blockade on the holding of origin during which no animal of a species susceptible to foot-and-mouth disease has been introduced into the holding.

2. ° The animals have been subjected to the controls provided for in Article 24.2 within 24 hours of loading.

3. The samples taken in accordance with the statistical requirements referred to in Annex III (2.2) within 48 hours of the load have been subjected, with negative result, to a test for the detection of the presence of antibodies against the foot-and-mouth disease virus.

4. º that the meat has been held under official control for 24 hours and has not been released before a new inspection of the animals carried out on the holding of origin has excluded by a clinical inspection the presence of infected animals or suspected of being infected.

2. The conditioned offal must bear the veterinary inspection mark provided for in the Royal Decree 1976/2004 of 1 October 2004 laying down the animal health rules applicable to the production, processing, distribution and the introduction of products of animal origin intended for human consumption and subject to one of the treatments referred to in paragraph 1 of Part A of Annex VII to this royal decree.

3. The other products shall be subject to the treatments referred to in Article 32.

ANNEX IX

Milk treatment to ensure the destruction of the foot-and-mouth disease virus

Part A. Milk and milk products intended for human consumption

It is accepted that the following treatments provide sufficient assurance regarding the destruction of the foot-and-mouth disease virus in milk and milk products for human consumption. The necessary precautions should be taken to avoid contact, after treatment, of milk or milk products with any possible source of foot-and-mouth disease virus.

1. Milk intended for human consumption shall at least be subject to one of the following treatments:

1.1 Sterilization to a minimum level of F03.

1.2 UHT Treatment ⁽¹⁾.

1.3 HTST Treatment ⁽²⁾, applied twice to milk with a pH equal to or greater than 7.0.

1.4 HTST treatment of milk with a pH below 7.0.

1.5 HTST treatment combined with other physical therapy such as:

1.5.1 Well a pH decrease below 6 for at least one hour.

1.5.2 Well, an additional heating to 72 ° C or more, combined with desiccation.

2. Milk products must undergo at least one of the treatments referred to above or be produced from treated milk in accordance with the provisions of paragraph 1.

Part B. Milk and milk products not intended for human consumption and milk and milk products for animal consumption

It is accepted that the following treatments provide sufficient assurance regarding the destruction of the foot-and-mouth disease virus in milk and milk products not intended for human consumption or intended for animal consumption. The necessary precautions should be taken to avoid contact, after treatment, of milk or milk products with any possible source of foot-and-mouth disease virus.

1. Milk not intended for human consumption and milk intended for animal consumption shall at least be subject to one of the following treatments:

1.1 Sterilization to a minimum level of F03.

1.2 UHT Treatment ⁽³⁾ combined with other physical treatment as referred to in section 1.4.1 or 1.4.2.

1.3 HTST Treatment ⁽⁴⁾ applied twice.

1.4 HTST treatment combined with other physical therapy such as:

1.4.1 Well a pH decrease below 6 for at least one hour.

1.4.2 Well, an additional heating to 72 ° C or more, combined with desiccation.

2. Milk products shall be subject to one of the above treatments or produced from milk treated in accordance with paragraph 1.

3. Whey to be given to animals of susceptible species and produced from treated milk as described in paragraph 1 shall be collected when at least 16 hours have passed since the coagulation of the milk and its pH is recorded. it must be less than 6,0 prior to its transport to pig holdings.

(1) UHT = ultra-high temperature treatment at 132 ° C for at least one second.

(2) HTST = short pasteurisation at high temperature: pasteurisation at 72 ° C for at least 15 seconds, or with equivalent pasteurisation effect as a negative reaction in the phosphatase test.

(3) UHT = ultra-high temperature treatment at 132 ° C for at least one second.

(4) HTST = short pasteurisation at high temperature: pasteurisation at 72 ° C for at least 15 seconds, or with equivalent pasteurisation effect as a negative reaction in the phosphatase test.

ANNEX X

Criteria for the decision to apply protective vaccination and guidelines for emergency vaccination programs

1. Criteria for the decision to apply protective vaccination (in accordance with the report of the Scientific Committee on Animal Health, 1999).

predominantly species clinically affected.

Limited.

Criteria	Decision
	Vaccination	Non-vaccination
Sensitive animal population density.	High.	Low.
Predominantly Pigs.	Predominantly ruminants
Output from the zonade protection of possibly infected animals or their products.	Tests.	No evidence
Probability of airborne virus air propagation from the farms infected.	High.	Low or null.
vaccine.	Available.	Available
of the foci (location)		Known.
Fast ascent.		Unpronounced or slight ascent
Extends.		Limited.
Public Reaction to the total eradication policy.	Strong.		Yes.
Yes.	Yes.	Yes.	Yes.	Yes.	Yes.	Yes. Table_table_izq"> No.

2. Additional criteria for the decision to apply emergency vaccination.

Criteria	Decision
	Vaccination	Non-vaccination
of regionalization by third countries.	Known.	Unknown.
economic strategies that come into play.	It is foreseeable that a control strategy without emergency vaccination will lead to significantly higher economic losses in the agricultural sectors. and non-agricultural.	It is foreseeable that a control strategy with emergency vaccination will lead to economic losses based on high in the agricultural and non-agricultural sectors.
is foreseeable that the standard of 24/48 hours cannot be applied from effective way for two consecutive days.	Yes.	No.
Important social and social impacts psychological of the total eradication policy.	Yes	No.
Existence intensive production of livestock in an area other than a high livestock load.	Yes.	No.

* The standard of 24/48 hours means that:

(a) Within 24 hours of the confirmation of the disease it is not possible to remove infected flocks from the holdings referred to in Article 10.

b) That the preventive slaughter of animals that may be infected or contaminated cannot be safely performed within 48 hours.

3. Definition of areas with high livestock load.

3.1 When taking decisions on the measures to be taken to implement this royal decree, and in particular the measures referred to in Article 52.2, in addition to a comprehensive epizootiological assessment, take into account the definitions of high stocking density (ZECG) areas as set out in point 3.2 or, where appropriate, the definition set out in Article 2 (t) of Royal Decree 1071/2002 of 18 October 2002 establishing the minimum measures to combat classical swine fever, and the strictest definition shall be used.

The amendments to the definition that are decided by the European Commission, on the basis of new scientific data, will also apply.

3.2 Animals of susceptible species:

In the case of animals of susceptible species, ZECG shall mean a geographical area, of a radius of 10 km around a holding where animals of susceptible species suspected of being infected with the virus are infected. foot-and-mouth disease, or with confirmed infection of this virus, with a density of animals of susceptible species exceeding 1,000 head per km2.

This holding must be found either in a sub-region as defined in Article 2.2.p), the density of animals of susceptible species is greater than 450 head per km2, or less than 20 km from a sub-region of this sub-region. type.

ANNEX XI

National laboratory authorised to handle live foot-and-mouth disease virus

Central Laboratory for Animal Health in Algete, Madrid.

ANNEX XII

Biosafety standards for laboratories and establishments handling live foot-and-mouth disease viruses

1. Laboratories and establishments handling live foot-and-mouth disease viruses shall at least comply with the minimum requirements laid down in the minimum standards for laboratories working with the foot-and-mouth disease virus in vitro and in vivo, drawn up by the European Commission for the Fight against Foot and Mouth Disease at its 26.th session in Rome in April 1985, as amended in 1993.

2. Laboratories and establishments handling live foot-and-mouth disease viruses shall be subject to at least two inspections within five years, one of which shall be carried out without prior notice.

3. The inspection team will have at least one expert from the European Commission, an expert on foot-and-mouth disease and an independent expert on biosafety issues in laboratories working with dangerous micro-organisms.

4. The inspection team shall submit a report to the European Commission and to the Member States in accordance with the relevant rules.

ANNEX XIII

Patterns and tests for the diagnosis of foot-and-mouth disease and for the differential diagnosis of other vesicular viral diseases

For the purposes of this Annex, "test" means a laboratory diagnostic method, and by "pattern", a reference reagent that has become internationally accepted pattern after a comparative test performed in several different laboratories.

Part A. Diagnostic Tests

1. Recommended methods.-The diagnostic tests that the Manual of Standards for Diagnostic Tests and Vaccines of the International Office of Epizootics (OIE), hereinafter referred to as "the OIE Manual", describes as the prescribed tests for international trade shall constitute the reference tests for the diagnosis of vesicular diseases. Laboratories shall adopt patterns and tests that are at least as stringent as those defined in the OIE Manual.

The methods of testing more stringent than those defined in the OIE Manual to be adopted by the European Commission shall also apply.

2. Methods of substitution.-The use of tests as defined in the OIE Manual as replacement tests ("alternative tests"), or other tests not included in the OIE Manual, is authorised provided that the results of the test have been demonstrated The test complies with at least the sensitivity and specificity parameters set out in the OIE Manual, or in the annexes to the European Union legislation if these are more stringent.

Laboratories which obtain results for the purposes of domestic, intra-Community or international trade shall obtain and maintain the records necessary to demonstrate that their test methods comply with the relevant standards of the OIE or the European Union.

3. Quality standards and control.-The laboratories will participate in periodic standardization and external quality assurance exercises organized by the Community Reference Laboratory.

In the context of such exercises, the Community reference laboratory may take into account the results achieved by a laboratory which, within a reasonable time, has participated in a quality assurance exercise. organised by one of the international organisations in charge of the external quality assurance of the diagnosis of vesicular viral diseases, such as the OIE, the Food and Agriculture Organization of the United Nations (FAO) or the International Atomic Energy Agency.

The laboratories will apply internal quality assurance programs. The specification of such programmes to be established by the European Commission shall apply. In the absence of the adoption of development provisions, the specifications set out in the OIE guidelines on the evaluation of the quality of laboratories (OIE Commission of Patrons, September 1995) shall apply.

As part of the quality assurance, the laboratories shall demonstrate that the tests used systematically comply with the rules of sensitivity and specificity defined in the OIE Manual, or in Annex XIV of this Royal decree if these are stricter.

4. Procedures for the adoption and review of tests and patterns for the diagnosis of vesicular viral diseases. -Testing and patterns for the diagnosis of vesicular viral diseases to be adopted by the Commission shall apply. European.

The European Commission may take into account the scientific opinion drawn up at the meetings of the national laboratories to be organised by the Community reference laboratory.

5. Procedure for monitoring compliance.-Data from the standardisation and external quality assurance exercises organised by the Community reference laboratory shall be evaluated at the annual meetings of the laboratories. national and shall communicate to the European Commission for review of the list of national reference laboratories.

The European Commission will ask laboratories whose tests do not comply with the established rules of sensitivity and specificity to modify their methods within an appropriate time frame to ensure compliance with such standards. In the event that the required level of adequacy cannot be demonstrated within the required time limit, the results of all tests carried out after the deadline shall no longer be recognised in the European Union.

6. Selection and transport of samples.-An aliquot part of the field material should be sent to the national reference laboratory. However, where such samples are not available, or are not provided for transport, material from passes in animals, obtained with the same host species, or material from limited-country crops may be used. cell.

Treatment that has experienced material from animal passes or cell cultures should be specified.

Samples for the diagnosis of vesicular viral diseases may be transported to 4 oC if the transport time to the target laboratory is expected to be less than 24 hours.

For samples of the esophagus or pharynx (obtained by esophageal probe), transport in solid carbon dioxide or liquid nitrogen is recommended, especially if delays at airports cannot be excluded.

Special precautions need to be taken to safely condition material from suspected cases of foot-and-mouth disease at both national and international levels. These precautions should be aimed primarily at preventing the break or leakage of packaging and the risk of contamination, but it is also important to ensure that the samples arrive in a satisfactory state. It is preferable to use frozen containers instead of ice to avoid the possibility of water leakage from the container.

Before issuing the samples, it is necessary to reach an agreement with the receiving laboratory on the delivery of a preliminary acknowledgement of receipt and the conformity of the reception.

Compliance with the import and export rules of the Member States concerned should be ensured.

Part B. Patterns

The protocols specified in the OIE Manual for diagnostic tests and vaccines indicate virus isolation reference methods, antigen detection and antibody detection in relation to the vesicular diseases.

1. Foot-and-mouth disease.

1.1 antigen detection.-The patterns for the detection of foot-and-mouth disease virus antigens to be established by the European Commission shall apply, after consultation with the Community reference laboratory.

In the global reference laboratory (MRL) of the OIE/FAO for foot-and-mouth disease, standard inactivated antigens of all seven serotypes can be obtained.

The national reference laboratory must ensure that its antigen detection system is valid with these minimum standards. If necessary, you may ask the Community Reference Laboratory for advice on the dilutions of these antigens to be used as strong and weak positive controls.

1.2 Isolation of the virus.-The patterns for the detection of foot-and-mouth disease virus to be established by the European Commission shall apply, after consultation with the Community reference laboratory.

In the global OIE/FAO reference laboratory for foot-and-mouth disease, isolated strains of the virus can be obtained from this disease.

The national reference laboratory should ensure that the tissue culture systems it uses for the isolation of the foot-and-mouth disease virus are sensitive to the whole range of serotypes and strains for which the laboratory has a diagnostic capability.

1.3 Methods for the detection of nucleic acids. -Patterns for the detection of foot-and-mouth disease virus RNA to be established by the European Commission shall be applied after consultation with the Community laboratory of reference.

In case of availability by the European Commission, and for future standardisation purposes, comparative tests will be carried out between the national laboratories in relation to the sensitivity of the RNA detection methods.

In addition, taking into account the practical difficulties of maintaining nucleic acids for long periods, the European Commission's forecasts will be applied in the event of a decision to be obtained from the European Commission. Community reference laboratory standard reagents for quality assurance for the detection of RNA from foot-and-mouth disease virus.

1.4 Detection of antibodies (structural proteins).-The patterns for the detection of foot-and-mouth disease virus antibodies to be established by the European Commission will be applied after consultation with the laboratory. Community reference.

In the phase XV of the FAO standardisation exercise on the detection of foot-and-mouth disease antibodies, standard antisera were defined in 1998 for O1-Manisa, A22-Iraq and C-Noville types of foot-and-mouth disease virus.

The European Commission may provide that standard reference sera should be adopted for all major antigenic variants of the foot-and-mouth disease virus as a result of standardisation exercises between the laboratory. Community of reference and national laboratories. These reference sera shall be adopted as patterns to be used by laboratories.

1.5 Antibody detection (non-structural proteins). -Patterns for the detection of foot-and-mouth disease virus antibodies will be established by the European Commission, after consultation with the Community laboratory of reference.

The European Commission may provide for standard reference sera to be adopted as a result of standardisation exercises between the Community reference laboratory and national laboratories. These reference sera shall be adopted as patterns to be used by laboratories.

2. Swine vesicular disease-The diagnosis of swine vesicular disease must be carried out in accordance with Commission Decision 2000 /428/EC of 4 July 2000 laying down diagnostic procedures, sampling methods and criteria for the assessment of the results of laboratory tests for the purposes of confirmation and differential diagnosis of swine vesicular disease.

3. Other vesicular diseases.-The patterns for laboratory diagnosis of vesicular stomatitis or vesicular rash of pigs to be established, if necessary, by the European Commission, shall apply.

The laboratory capacity may be maintained to diagnose vesicular viral diseases other than foot-and-mouth disease and swine vesicular disease, i.e. vesicular stomatitis and vesicular rash of the pigs.

National laboratories that wish to maintain the diagnostic capacity of these viruses can obtain reference reagents from the global reference laboratory for the foot-and-mouth disease of Pirbright, or laboratories. relevant reference of the OIE.

ANNEX XIV

Community antigen and vaccine bank

1. Conditions for the supply and storage of concentrated inactivated antigens to the Community antigen and vaccine bank.

(a) Each antigen shall consist of a single homogeneous batch.

(b) Each lot shall be divided to allow storage in two distinct geographical locations under the responsibility of the designated establishments of the Community antigen and vaccine bank.

(c) The antigen shall meet at least the requirements of the European Pharmacopoeia and the corresponding provisions of the OIE Manual.

(d) The principles of "good manufacturing practice" shall be respected throughout the production process, including the storage and finishing of the reconstituted vaccine from the stored antigens.

e) Unless the text referred to in paragraph (c) provides otherwise, the antigen shall be purified to remove non-structural proteins from the foot-and-mouth disease virus; the purification shall at least ensure that the content of the residual non-structural proteins in vaccines reconstituted from said antigen do not induce detectable levels of antibodies against non-structural proteins in animals that have received an initial vaccination and then one of reinforcement.

2. Conditions for the formulation, finishing, packaging, labelling and delivery of the reconstituted vaccines from concentrated inactivated antigens provided to the Community antigen and vaccine bank.

a) Rapid antigen formulation (supplied by the manufacturer contracted by the European Commission for the Community bank) to constitute a vaccine.

(b) Production of a safe, safe and effective vaccine with a minimum potency of 6 DP50 according to the tests prescribed by the European Pharmacopoeia, and which can be used in the case of emergency vaccination of ruminants and pigs.

c) Ability to formulate from stored concentrated inactivated antigens:

1. º Up to one million doses of vaccine within four days of the request of the European Commission.

2. In addition, up to four million doses of vaccines within 10 days of the request of the European Commission.

d) Rapid packaging, labelling and distribution of the vaccine according to the specific needs of the area where vaccination is to be carried out.

ANNEX XV

Competencies and functions of the national reference laboratory

A. National reference laboratory.-The national reference laboratory for foot-and-mouth disease is the Central Laboratory of Animal Health in Algette (Madrid).

B. Powers and functions of the national reference laboratory.-The powers and functions of the national reference laboratory, in relation to foot-and-mouth disease and other vesicular diseases, shall be as follows:

1. When handling live foot-and-mouth disease virus, it shall operate under the high safety conditions laid down in the minimum standards for laboratories working with the foot-and-mouth disease virus in vitro and in vivo, prepared by the Commission. European for the Fight against Foot and Mouth Disease at its 26.th session, held in Rome in 1985, as amended in Appendix 6 (ii) of the Report of the 30.th Session, held in Rome in 1993.

2. Provide an uninterrupted diagnostic service for vesicular viral diseases, and must have the necessary material and human resources to provide a rapid initial diagnosis.

3. Have inactivated reference strains of all serotypes of foot-and-mouth disease virus, and immune sera against viruses, as well as all other reagents necessary for rapid diagnosis. Adequate cell cultures should be available at all times to confirm a negative diagnosis.

4. To have the necessary material and human resources for large-scale serological surveillance.

5. Appropriate samples shall be taken in all suspected primary foci to be transported rapidly, in accordance with an established protocol, to the national laboratory. In anticipation of a suspicion of foot-and-mouth disease, the competent authorities shall ensure that the equipment and materials necessary for sampling and transport to the national reference laboratory are kept available at local points.

6. Perform the antigenic typing and genomic characterization of all viruses that correspond to new entries in the European Union, if it has facilities. In another case, as soon as possible, send a sample of the virus from the primary case to the Community reference laboratory for confirmation and better characterization, including a report on the antigenic relationship of the field strain with vaccine strains found in the community antigen and vaccine banks. The same procedure should be followed with viruses received in national laboratories from third countries in situations where the characterization of the viruses can be beneficial for the European Union.

7. Transmit to the Community reference laboratory the data communicated by the official laboratories of the Autonomous Communities on the disease.

8. Collaborate with the official laboratories of the autonomous communities, and with the community reference laboratory, to ensure that the members of the field section of the veterinary services of the respective autonomous community have the opportunity to see clinical cases of foot-and-mouth disease in national laboratories as part of their training.

9. Collaborate with the Community Reference Laboratory and other national reference laboratories in other Member States to improve diagnostic methods and to exchange relevant materials and information.

10. Participate in standardisation and external quality assurance exercises organized by the Community Reference Laboratory.

11. Use tests and patterns that meet at least the criteria specified in Annex XIII and communicate to the European Commission, upon request, data showing that the tests used meet at least those criteria.

12. It must be able to identify all vesicular disease viruses and the encephalomyocarditis virus in order to avoid delays in diagnosis and, therefore, in the application of control measures by the competent authorities.

13. Cooperate with the laboratories designated by the competent authorities to carry out tests, such as serological tests, which do not involve the handling of live foot-and-mouth disease viruses.

ANNEX XVI

Alert Plan Criteria and Requirements

The alert plan will be adjusted, at least, to the following requirements:

1. Provisions will be made to ensure the legal capacity necessary for the implementation of the alert plans and to enable a successful and rapid eradication campaign.

2. Provisions should be made to ensure access to emergency funds, budgetary means and economic resources to cover all aspects of the fight against an epidemic of foot-and-mouth disease.

3. A chain of command shall be established to ensure the speed and effectiveness of the decision-making process in relation to epizootic diseases of foot-and-mouth disease.

If appropriate, the chain of command in each autonomous community will be under the authority of a single decision center, of which the head of the veterinary services will be a member, who will be in charge of directing the various strategies to combat the disease and to liaise with the National Committee of the Veterinary Health Alert System.

4. The National Committee of the Veterinary Health Alert System, in the event of a focus, shall coordinate the implementation of all decisions taken at the central decision-making unit. A permanently active coordinator shall be appointed to ensure the rapid establishment of the centre.

5. Detailed plans will be available to enable the autonomous communities to be prepared for the immediate establishment of local centres to combat the disease in the event of an outbreak of foot-and-mouth disease, in order to implement the measures at local level. the fight against disease and the protection of the environment.

6. The national health alert system committee, the local disease control centres and the competent authorities and bodies on the environment shall cooperate to ensure that the measures on the environment are adequately coordinated. veterinary and environmental safety issues.

7. A group of permanently active experts shall be established, in collaboration with other Member States where necessary, with the necessary expertise and assist the relevant authorities in their task of qualitative preparation before the possibility of a focus.

8. Measures will be taken to provide the resources for a rapid and effective campaign, including personnel, equipment and laboratories.

9. A technical manual shall be available in which all activities, procedures, instructions and control measures to be used in relation to an outbreak of foot-and-mouth disease shall be described in a detailed, comprehensive and practical manner.

10. Detailed plans for emergency vaccination should be available.

11. Staff will regularly participate in:

11.1 Training on clinical signs, epizootiological research and the fight against epizootic diseases.

11.2 Real-time alert exercises, performed as follows:

11.2.1 Twice over a period of five years; the first time will be done before three years have been completed since the plan has been approved, or during the five-year period after effective control or eradication of a focus of an epizootic disease.

11.2.3 Or one of the two exercises referred to in paragraph 11.2.1 shall be replaced by a real-time exercise required under emergency plans for other serious epidemics affecting animals. land.

11.3 Training on Communication Capacity to carry out ongoing disease awareness campaigns aimed at the authorities, cattlemen and veterinarians.

12. Alert plans shall be prepared taking into account the resources necessary for the fight against a large number of outbreaks which are likely to occur within a short period of time and are due to different antigenically different serotypes or strains, as could be the case, for example, in Case of intentional release of foot-and-mouth disease virus.

13. Without prejudice to the veterinary requirements, contingency plans shall be prepared to ensure that, in the event of an outbreak of foot-and-mouth disease, a mass disposal of animal carcasses and animal waste may be carried out without endangering health human and applying processes or methods that prevent any avoidable damage to the environment and, in particular:

1. The minimum risk for soil, air, surface water and groundwater, plants and animals.

2. ° Reducing to a minimum the discomforts due to noise or odours.

3. Reducing to a minimum the negative effects for landscapes and places of special interest.

14. Those plans shall include the identification of the appropriate sites and undertakings for the treatment or disposal of animal carcasses and animal waste in the event of a focus.

15. The competent authorities of the autonomous communities, in coordination with the Ministry of Agriculture, Fisheries and Food, shall ensure that the farmers, the rural population and the general population are kept informed. Direct and accessible contact (in particular by means of assistance telephones) should be provided to the inhabitants of the affected areas, as well as information through the national and regional media.

ANNEX XVII

Measures relating to the fight against foot-and-mouth disease in wild animals

Part A. Measures in case of confirmation of the presence of foot-and-mouth disease in wild animals

1. As soon as it is confirmed that a primary case of foot-and-mouth disease has occurred in wild animals of susceptible species and to reduce the spread of the disease, the competent authorities shall immediately proceed to:

a) Notify the primary case in accordance with Annex II.

b) Establish a group of experts composed of veterinarians, hunters and biologists specializing in wild animals and epidemiologists. This group of experts shall assist the competent authority in the following tasks

1. Study the epidemiological situation and define the infected zone, in accordance with the provisions of Part B. 4.b).

2. Determine appropriate measures to be applied in the infected area, in addition to those mentioned in paragraphs (c) and (d). These measures may include the suspension of hunting and the prohibition of the feeding of wild animals.

3. Prepare the eradication plan to be submitted to the European Commission in accordance with the provisions of Part B.

4. Conduct inspections to verify the effectiveness of the measures taken to eradicate foot-and-mouth disease from the infected area.

(c) Immediately take official surveillance of holdings keeping animals of susceptible species in the defined infected area and in particular order that:

1. An official census of all species and categories of animals of susceptible species of all holdings shall be drawn up; the census shall be updated by the owner; the information contained in the census shall be submitted provided that it is requested and its veracity may be checked at each inspection; however, as regards open-air holdings, the first census to be carried out may be carried out on the basis of an estimate.

2. All animals of susceptible species of holdings located in the infected zone shall remain in the premises of stables or in any other place where they may be isolated from wild animals; wild animals must not have access to any material which may subsequently come into contact with animals of susceptible species on the holding.

3. Do not enter or leave the holding of animals of susceptible species, except where permitted by the competent authority, taking into account the epidemiological situation.

4. Appropriate means of disinfection are used in the entrances and exits of the buildings where the animals of susceptible species are housed, as well as those of the holding itself.

5. All persons who come into contact with wild animals observe the relevant hygiene rules to reduce the risk of spreading foot-and-mouth disease, which may also include a ban on persons who have the state in contact with wild animals to enter holdings keeping animals of susceptible species.

6. Test for the presence of foot-and-mouth disease all animals of susceptible species killed or sick of a holding showing symptoms of the disease.

7. Do not enter into a holding that maintains animals of susceptible species no part of a wild animal, whether it has been killed or found dead, or any material or equipment that may have been contaminated with the foot-and-mouth disease virus.

8. Do not leave the infected area animals of susceptible species or their semen, ova and embryos for domestic or intra-Community trade.

(d) Dispose that all wild animals killed or found dead in the defined infected zone are inspected by an official veterinarian and subjected to an examination for the detection of foot-and-mouth disease in order to discard or officially confirm foot-and-mouth disease in accordance with the definition of the focus in Annex I. The carcasses of all wild animals which test positive for foot-and-mouth disease shall be processed under official supervision; where these tests give rise to negative result as regards foot-and-mouth disease, the measures laid down in the Article shall apply. 10.2 of Royal Decree 2044/1994 of 14 October 1994 laying down animal health and animal health conditions for the slaughter of wild game animals and the production and marketing of their meat. Parts not intended for human consumption shall be processed under official supervision.

e) To ensure that the isolated strain of the foot-and-mouth disease virus is subject to the laboratory procedures set out in the diagnostic manual, to identify the genetic type of the virus and its antigenic characteristics in relationship to existing vaccine strains.

2. Where there are cases of foot-and-mouth disease among wild animals in an area of an autonomous community close to the territory of France, Portugal or Andorra, the competent authority of the autonomous community shall notify the Ministry of Agriculture, Fisheries and Food, for the purpose of establishing with the State or States that appropriate collaboration in the establishment of measures to combat the disease may be affected.

Part B. Plans for the Eradication of FMD of Wild Animals

1. Without prejudice to the measures laid down in Part A, the competent authority shall, within 80 days of the confirmation of a primary case of foot-and-mouth disease in wild animals, draw up in writing a plan indicating the following: measures taken to eradicate the disease in the area defined as infected, as well as the measures applied to holdings located in that area, and forward it to the Ministry of Agriculture, Fisheries and Food.

2. Once the plan has been drawn up, it shall be submitted by the Ministry of Agriculture, Fisheries and Food within a maximum of 10 days to the approval of the European Commission, after examination by the European Commission to determine whether it can achieve the desired objectives, which may make the necessary modifications.

The plan may be modified or expanded later to take into account the evolution of the situation.

If these changes affect the redefinition of the infected area, the autonomous communities will immediately inform the Ministry of Agriculture, Fisheries and Food, so that this report will be without delay to the European Commission. and the other Member States.

If the modifications affect other provisions of the plan, the autonomous communities will forward it to the Ministry of Agriculture, Fisheries and Food, for the subsequent transfer by the latter to the European Commission, for the purposes of its examination. and eventual approval.

3. Once approved, the measures contained in the plan referred to in paragraph 1 shall replace the initial measures referred to in Part A on the date to be determined when the approval is granted.

4. The plan referred to in paragraph 1 shall contain information about:

(a) The results of epidemiological investigations and controls carried out in accordance with Part A and the geographical distribution of the disease.

b) The definition of the infected zone within the territory of Spain.

When determining the infected area, the competent authority shall take into account:

1. The results of the epidemiological investigations carried out and the geographical distribution of the disease.

2. The population of wild animals in the area.

3. The existence of natural or artificial obstacles of importance to the movements of wild animals.

(c) The organisation of close cooperation between biologists specialising in wild animals, hunters and their organisations, services for the protection of wild animals and veterinary authorities (animal health and of public health).

d) The information campaign to be carried out to raise awareness among the hunters of the measures to be taken in the context of the eradication plan.

e) The specific activities carried out to determine the number and location of wild animal groups with limited contacts with other groups of wild animals within and around the infected area.

f) The approximate number of wild animal groups mentioned in paragraph e) and their size within and around the infected zone.

g) The specific activities carried out to determine the extent of the infection in wild animals by examination of wild animals killed by hunters or found dead, and by laboratory tests, with the inclusion of epidemiological investigations with stratification for ages.

(h) Measures taken to reduce the spread of the disease due to movements of wild animals or to contacts between groups of wild animals. These measures may include a ban on hunting.

i) Measures taken to reduce the population of wild animals, in particular young animals of susceptible species of the wild animal population.

j) The requirements that hunters must meet in order to prevent the spread of the disease.

k) The method of killing wild animals killed by shot or found dead, which will be based on:

1. º Transformation under official supervision.

2. O inspection by an official veterinarian and laboratory tests as provided for in Annex XIII. The bodies of all wild animals which are positive for foot-and-mouth disease shall be processed under official supervision. Where these tests are negative for foot-and-mouth disease, the measures laid down in Article 10.2 of Royal Decree 2044/1994 of 14 October 1994 laying down animal health and animal health conditions shall apply. applicable to the slaughter of wild game animals and the production and marketing of their meat. Parts not intended for human consumption shall be processed under official supervision.

l) The epidemiological survey carried out on each wild animal of a sensitive species, shot dead or found dead. This survey will include responding to a questionnaire that information on:

1. The geographical area in which the animal was killed or found dead.

2. The date the animal was killed or found dead.

3. º The person who has found or killed the animal.

4. The age and sex of the wild animal.

5. º If the animal has been shot down, the symptoms before the shot.

6. º If the animal has been found dead, the state of the body.

7. The results of lab tests.

8. The surveillance programmes and preventive measures applicable to holdings keeping animals of susceptible species located in the defined infected area and, where appropriate, in surrounding areas, including those which affect the transport and movement of animals of susceptible species within that area, from and to the area; these measures shall include at least the prohibition of the exit of the infected animals of susceptible species, as well as their semen, ova or embryos, for national or intra-Community trade.

(n) the other criteria applied to suspend the measures taken to eradicate the disease from the defined area and the measures applied to holdings in that area.

n) The authority to monitor and coordinate the departments, units, or organs responsible for the execution of the plan.

o) The information system established for the group of experts designated in accordance with Part A. 1.b) to be able to regularly review the results of the eradication plan.

p) The disease monitoring measures to be applied when a period of at least 12 months has elapsed following the verification of the last case of foot-and-mouth disease among wild animals in the infected area defined; these monitoring measures shall be in force for at least another 12 months and shall include at least the provisions already applied in accordance with paragraphs (g), (k) and (l).

5. Every six months, the autonomous community shall forward to the Ministry of Agriculture, Fisheries and Food, for subsequent transfer to the European Commission and the other Member States, a report on the epidemiological situation in the given area. as the results of the eradication plan.