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Real Decree 245 / 1995, Of 17 Of February, By Which Is Set The Program Coordinated Of Fight, Control And Eradication Of The Disease From Aujeszky.

Original Language Title: Real Decreto 245/1995, de 17 de febrero, por el que se establece el programa coordinado de lucha, control y erradicaciĆ³n de la enfermedad de Aujeszky.

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TEXT

The Aujeszky's disease, as provided for in the Epizootic Act of 20 December 1952 and in the Regulation of 4 February 1955 which develops it, constitutes at the moment one of the major health problems affecting the Community pig sector, with significant negative economic impacts on it. This situation has led to a number of programmes for the eradication and control of this disease having been initiated in various Member States of the European Community, with positive regions of Aujeszky's disease in the Community. some of them. This situation could lead to difficulties for the free movement of live animals of the porcine species in the near future, since they are areas of different health status, and these difficulties are increased with the introduction of new programmes in other Member States.

Consequently, it is necessary to establish a programme laying down the bases and to coordinate actions throughout the territory of the State as set out in the Commission Decision of 2 April 1993 on the additional guarantees in relation to Aujeszky's disease in respect of pigs intended for certain parts of the territory of the Community and in the Commission Decision of 11 December 1992 on supplementary guarantees concerning the Aujeszky's disease to be offered by pigs intended for Member States or to free regions of the disease.

In the proceedings of this Royal Decree, the Autonomous Communities have been consulted and the sectors affected have been heard.

This Royal Decree is dictated by article 149.1.16. of the Constitution, which attributes to the State exclusive competence in the field of bases and general coordination of health.

In its virtue, on the proposal of the Minister of Agriculture, Fisheries and Food, in agreement with the Council of State and after deliberation of the Council of Ministers, at its meeting of 17 February 1995,

D I S P O N G O:

Article 1. Object.

This Royal Decree aims to establish a coordinated program applicable in the phases of prevention, control, control and eradication of Aujeszky's disease.

Article 2. Definitions.

For the purposes of this Royal Decree, the following definitions shall

:

1. Holding: any establishment or construction, and in the case of outdoor farming, any place where animals of the porcine species are kept, reared or handled.

2. Exploitation free of Aujeszky's disease: it is considered as an operation free of Aujeszky's disease that it meets the requirements laid down in Chapter I of Annex A to this Royal Decree.

3. Officially free exploitation of Aujeszky's disease: a holding meeting the requirements of Chapter II of Annex A to this Royal Decree.

4. Local veterinary unit (UVL): any geographical area under the control of the same Official Veterinary Service.

5. Local veterinary unit free of Aujeszky's disease: any local veterinary unit meeting the requirements laid down in Chapter I of Annex A to this Royal Decree.

6. Local veterinary unit officially free of Aujeszky's disease: any local veterinary unit meeting the requirements laid down in Chapter II of Annex A to this Royal Decree.

Article 3. Mandatory notification of the disease.

Aujeszky's disease, within the phases of prevention, control and control of the same, must be notified to the competent organ of the corresponding Autonomous Community.

The competent authority of the Autonomous Community shall communicate it to the Ministry of Agriculture, Fisheries and Food for the purposes of its coordination powers.

Article 4. Vaccination.

1. The use and possession of vaccines against Aujeszky's disease whose viral antigen contains the glycoprotein gI + is prohibited throughout the territory of the Spanish State.

2. The vaccines to be used in pigs shall be those which satisfy the requirements laid down in Annex B. The use of such vaccines shall always be made under the knowledge of the competent bodies of the Autonomous Communities.

3. Compulsory vaccination of all breeding animals shall be established at least three times a year and of all bait animals at least once between 10 and 12 weeks of life.

Any future reproductive animal must have been vaccinated at least twice before entering the reproductive cycle with a range of one month.

Except as provided for in the two preceding paragraphs to animals belonging to local holdings or veterinary units which are officially free of Aujeszky's disease or are in the process of obtaining such health status.

4. In those holdings of closed-loop production as free of Aujeszky's disease which do not introduce animals of any other origin into the baiting, the bait animals shall be exempted from vaccination, provided that they are not In addition to the mandatory serological control, a serological control shall be carried out every six months of 60 animals with negative results.

Article 5. Health status.

1. In order for a holding to be qualified as a health authority against Aujeszky's disease, the competent authorities of the Autonomous Communities must be requested.

To be able to obtain any of the health qualifications against this disease, local farms and veterinary units must comply with the requirements set out in Annex A to this Royal Decree.

2. The artificial insemination centres which supply the seminal doses to any other holding must be qualified as a whole against Aujeszky's disease.

3. The established health and special health protection farms referred to in Royal Decree 791/1979 of 20 February on the control of the fight against African swine fever and other pig diseases must be qualified as In the case of Aujeszky's disease, they must comply with the provisions of this Royal Decree.

Article 6. Health advocacy groups.

The health defense groups established in accordance with the provisions of Royal Decree 791/1979 of 20 February, will have to adapt their health program to the provisions of this Royal Decree.

In addition, they shall submit to the competent bodies of the Autonomous Communities a health programme which aims to ensure that the holdings of the health defence group obtain the health status. in the face of Aujeszky's disease.

Article 7. Movement of animals.

1. In order to introduce animals on an officially free holding of Aujeszky's disease, they must either be officially free or subject to an individual serological control with negative results as regards the use of Aujeszky's disease. presence of antibodies against the GI + of Aujeszky's disease virus.

2. Animals intended for a holding free from Aujeszky's disease may only be introduced into the Aujeszky's disease if they come from a holding that is free or officially free or if they have undergone serological control with results. The invention also concerns the presence of antibodies against the GI + of the Aujeszky's disease virus.

3. Animals intended for a holding without a health status as against Aujeszky's disease shall comply with the vaccination guidelines laid down in Article 4.

Players, in addition to complying with the above paragraph, shall be subjected to a serological control with negative results as regards the presence of antibodies against the GI + of Aujeszky's disease or to proceed from holdings which are free or officially free.

4. Data relating to vaccination against Aujeszky's disease or health status shall be recorded in the guide of origin and health for the purposes of animal health, where appropriate.

Article 8. Serological control.

By the competent bodies of the Autonomous Communities, serological checks will be carried out in order to know the epidemiological situation of the disease.

The viral antigen for serological testing shall meet the requirements set out in Annex C.

Additional disposition first. Basic character.

This Royal Decree is of a state basic law and is dictated by the provisions of Article 149.1.16. of the Constitution, which confers exclusive competence on the State in the field of General coordination of health.

Additional provision second. National Reference Centre.

The National Reference Centre for Aujeszky's disease shall be the one indicated in Annex D to this Royal Decree.

Additional provision third. Adaptation of the programme to certain breeds.

The competent bodies of the Autonomous Communities will be able to adapt the programme established in this Royal Decree to Iberian pigs and their crosses.

Additional provision fourth. Amendment of Royal Decree 791/1979 of 20 February.

The references in Royal Decree 791/1979 of 20 February on the control of the fight against swine fever and other diseases of cerda cattle are referred to the Ministry of Agriculture, Fisheries and Food. They shall be understood as being carried out by the competent authorities of the Autonomous Communities.

Single transient arrangement. Time limits for regulatory compliance.

1. A period of six months from the date of entry into force of this Royal Decree is hereby established for the fulfilment of the provisions of Article 5 (2).

2. A period of 30 months shall be established from the entry into force of this Royal Decree in order to comply with Article 5 (3).

3. A period of eighteen months shall be established from the entry into force of this Royal Decree for the fulfilment of the provisions of Article 7.

4. Holdings wishing to qualify as officially free shall have a period of four months from the date of entry into force of this Royal Decree in order to apply for such qualification to the competent bodies of the Communities. Autonomous.

Final disposition first. Faculty of development.

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

Final disposition second. Entry into force.

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

Given in Madrid on February 17, 1995.

JOHN CARLOS R.

The Minister of Agriculture, Fisheries

and Power,

LUIS MARIA ATIENZA SERNA

ANNEX A

CHAPTER I

Swine holding and local veterinary unit (UVL) free from Aujeszky's disease

A) Obtaining the title.

A local farm or veterinary unit shall be listed as free from Aujeszky's disease when:

1. No animal has presented clinical signs of the disease for the last 12 months.

2. No serological control has been performed on all breeding animals of the holding or unit with negative results as regards the presence of antibodies against the GI + of Aujeszky's disease virus.

3. A serological control with negative results regarding the presence of antibodies against the GI + of the Aujeszky's disease virus has been performed in 30 bait animals if the operation is closed.

4. A vaccine program with licensed vaccines is maintained.

5. After performing the serological tests only exist on the holding or animal unit born in it or come from holdings with the same or higher health status.

B) Title maintenance.

For the maintenance of the rating, a serological control of the players will be required at least once a year. The number of samples investigated per holding shall be as follows:

1. On holdings with less than 25 players, all players

2. On holdings between 26-100 players, 25 samples

3. On holdings with more than 100 players, 30 samples

The animals checked each year must be different, if any. In each investigation, all animals will be checked for new income on the holding.

The title can only be preserved if the results of those tests are negative.

c) Suspicion or occurrence of Aujeszky's disease.

1. The presence of clinically ill or serologically positive animals at the GI + will lead to the temporary suspension of the rating on the holding concerned.

2. This shall be recovered after all the animals concerned have been slaughtered and after a serological check has been carried out in 100 per 100 of the animals with negative results.

D) Introduction of animals.

For the introduction of pigs into an Aujeszky disease-free operation, the following requirements shall be met:

1. Good to proceed from a holding with the same or higher health level with respect to the disease, or

2. Well, have been subjected to an individual serological control with a negative result.

In both cases, the animals must be individually identified in such a way that the holding of provenance is always known.

E) Change of qualification.

A pig holding may be classified as officially free of Aujeszky's disease when it complies with the requirements laid down in Chapter II of Annex A.

CHAPTER II

Swine holding and local veterinary unit (UVL) officially free of Aujeszky's disease

A) Obtaining the title.

The porcine holding in which the following disease shall be officially recognised as Aujeszky's disease:

1. No clinical signs of Aujeszky's disease have been presented since at least the last 12 months.

2. No animals vaccinated against Aujeszky's disease are not found for at least the last 12 months.

3. A serological control with negative results as regards the presence of antibodies against the GI + and gII of Aujeszky's disease virus has been performed in all breeding animals of the holding.

4. No serological control has been carried out on 30 bait animals with negative results as regards the presence of antibodies against the GI + of Aujeszky's disease virus if the operation is in a closed cycle.

5. After performing the serological tests there are only animals born in the holding or coming from holdings with the same health status.

B) Title maintenance.

An annual test shall be required in accordance with the percentage set out in Chapter I (B) of this Annex. In each investigation, all animals will be checked for new income on the holding.

The title can only be preserved if the results of those tests are negative.

c) Suspicion or occurrence of Aujeszky's disease.

1. The presence of clinically ill or serologically positive animals shall result in the temporary suspension of the rating of the holding concerned.

2. That qualification shall be recovered after all the animals concerned have been slaughtered and after two serological checks at 60-day intervals with negative results. The first of these checks will be 100 per 100 of the number of staff, and in the second only 30 per 100 of the players and 30 per 100 of the bait animals.

D) Introduction of animals.

Those animals which come from a holding which is officially free of Aujeszky's disease or which are officially free of Aujeszky's disease may be introduced into a pig holding officially free of Aujeszky's disease. have been subjected to an individual serological control with a negative result.

ANNEX B

Characteristics to be collected by vaccines used in the control and eradication of Aujeszky's disease:

A) All viruses used in the development of vaccines against Aujeszky's disease shall be negative (gI-).

(B) Biological products manufactured for the Community market shall be responsible for and be controlled in accordance with the provisions of the European Pharmacopoeia rule in all of its paragraphs, with the exception of the latter of power, for which a moratorium is established, in order to study the protocol of this test which elucidates:

1. Antigen or virus suitable for discharge.

2. His title.

3. Route of inoculation.

4. Maximum acceptable excretion period of the virus of discharge in vaccinated animals.

C) Vaccines manufactured under these conditions will specify in their labelling the gI negativity of the vaccine strain used.

ANNEX C

The viral antigen must meet the standards, sensitivity and specificity requirements set out below in order to be authorised for serological testing.

a) The sensitivity should be such that the following Community reference sera provide a positive result.

1. Community reference number ADV1 at a dilution of 1:8.

2. EU reference number ADV-gI A.

3. EU reference number ADV-gI B.

4. EU reference number ADV-gI C.

5. EU reference number ADV-gI D.

6. EU reference number ADV-gI E.

7. EU reference number ADV-gI F.

b) The specificity must be such that the following community reference sera provide a negative result:

1. EU reference number ADV-gI G.

2. EU reference number ADV-gI H.

3. EU reference number ADV-gI J.

4. EU reference number ADV-gI K.

5. EU reference number ADV-gI L.

6. EU reference number ADV-gI M.

7. EU reference number ADV-gI N.

8. EU reference number ADV-gI O.

9. EU reference number ADV-gI P.

10.Serum community reference ADV-gI Q.

c) To control the batches, the Community reference serum ADV1 must provide a positive result with a dilution of 1: 8 and the community reference serum ADV-gI K a negative result.

d) The Laboratory of Animal Health and Production in Barcelona will be responsible for supplying the Community reference sera.

ANNEX D

National Reference Center for Aujeszky's Disease

National Laboratory of Animal Health and Production of Algette.

Carretera de Algete, Km. 5,400. 28110 Algete (Madrid).