COMMISSION DECISION of 11 December 1992 concerning additional guarantees relating to Aujeszky's disease for pigs destined to Member States or regions free of the disease

(93/24/EEC)THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 64/432/EEC (1) of 26 June 1964 on animal health problems affecting intra-community trade in bovine animals and swine, as last amended by Directive 92/65/EEC (2), and in particular Article 10 thereof,

Whereas certain Member States consider their territory or part of their territory is free from Aujeszky's disease and have submitted supporting documentation to the Commission as provided for in Article 10 of Directive 64/432/EEC;

Whereas an eradication programme was undertaken in these Member States or regions for Aujeszky's disease;

Whereas Member States have employed either a vaccination or a stamping-out policy to eradicate Aujeszky's disease;

Whereas the programme is regarded to have been successful in eradicating this disease from these Member States or regions of Member States;

Whereas the authorities of these Member States apply for national movement of pigs for breeding and production rules at least equivalent to those foreseen by the present decision;

Whereas these additional guarantees must not be requested from Member States or regions of Member States which are themselves regarded as free from Aujeszky's disease;

Whereas the opinion of the Scientific Veterinary Committee has been obtained;

Whereas the measures provided for in this decision are in accordance with the opinion of the Standing Veterinary Committee,

HAS ADOPTED THIS DECISION:

Article 1

Pigs intended for breeding coming from other Member States or Regions and destined for Member States or regions where vaccination for Aujeszky's disease is not permitted, listed in Annex I must fulfil the following conditions:

1. Aujeszky's disease must be compulsorily notifiable in the Member State of origin;

2. no clinical, pathological or serological evidence of Aujeszky's disease has been recorded in the herd of origin for the past 12 months;

3. if vaccine for Aujeszkys disease has been used on the herd of origin, only a g1 deleted vaccine shall have been used for the past 12 months;

4. isolation in accomodation approved by the competent authority such that no direct or indirect contact with other pigs is possible for 30 days prior to movement;

5. the pigs have not been vaccinated;

6. the pigs must have been subjected to an Elisa test for the presence of g1 antibody which meets the standards in Annex II of this decision, on sera taken at least 21 days after entry into isolation, with negative results. All animals in isolation must also have given negative results to this test. In the case of pigs aged over four months the test used shall be the whole virus Elisa;

7. the pigs must have remained on the herd of origin since birth or the pigs have remained in the consigning herd for three months and in others of equivalent status since birth.

Article 2

Pigs intended for production coming from other Member States or regions and destined for Member States or regions where vaccination for Aujeszky's disease is not permitted, listed in Annex I must fulfil the following conditions:

1. Aujeszky's disease must be compulsorily notifiable in the Member State of origin;

2. no clinical, pathological or serological evidence of Aujeszky's disease has been recorded in the herd or origin for the past 12 months;

3. the pigs have not been vaccinated;

4. (i) no pre-movement testing shall be necessary if the herd of origin is part of an official monitoring programme where at least 15 % of the breeding animals (or 25 animals, whichever is the greater) are tested over the course of each year. Such testing shall be split into at least three approximately equal divisions each separated by at least two months; movement into such herds shall only be from herds of equivalent or superior status and no clinical case of Aujeszky's disease shall have been recorded within 2 km of the herd of origin for the previous 60 days;

(ii) if the herd of origin is not part of such a monitoring programme the pigs must be segregated prior to movement and the pigs must be sampled in accordance with Annex III within 10 days prior to movement and subjected to a test which meets the standards in Annex II. All animals tested must pass the test.

5. The pigs must have remained in the herd of origin since birth or the pigs have remained in the herd or origin for three months and in herds of equivalent status since birth.

Article 3

The animals mentioned in Article 2 shall be transported directly to the farm of destination and shall remain there until slaughter unless otherwise authorized by the competent authority in the Member State of destination. The competent authority of the Member State of destination may require that all pigs on such premises go directly to slaughter.

Article 4

1. Pigs intended for slaughter coming from other Member States or regions and destined for Member States or regions listed in Annex I must be transported directly to the slaughterhouse of destination.

2. If such pigs have been vaccinated, only a g1 deleted vaccine shall have been used.

3. No clinical, pathological or serological evidence of Aujeszky's disease has been recorded in the herd of origin for the past three months.

4. The pigs must have remained in the herd of origin for the previous 60 days or since birth.

5. Aujeszky's disease must be notifiable in the Member State of origin.

Article 5

1. (a) The health certificate provided for in Annex F to Directive 64/432/EEC must be completed by the following for pigs destined for Member States or Regions listed in Annex 1 from other Member States or regions;

'Pigs in accordance with Commission Decision 93/24/EEC of 11 December 1992 concerning Aujeszky's disease. In the case of pigs for breeding the test used was the whole virus Elisa/Elisa for g1 antibodies.

(Delete where applicable)'.

(b) Such pigs must not come into contact with pigs of different status during transit.

2. Member States must ensure that similar requirements also apply for movement within their territory to regions listed in Annex I.

Article 6

In derogation to the above Articles, the additional conditions must not be requested by Member States of destination or regions of destination from Member States or Regions listed in Annex I.

Article 7

This Decision shall be reviewed before 31 December 1994.

Article 8

This Decision shall enter into force on 1 January 1993.

Article 9

This Decision is addressed to the Member States.

Done at Brussels, 11 December 1992.

For the Commission

Ray MAC SHARRY

Member of the Commission

(1) OJ No 121, 29. 7. 1964, p. 1977/64.

(2) OJ No L 268, 14. 9. 1992, p. 54.

ANNEX I

Regions free of Aujeszky's disease which do not permit vaccination Denmark: All regions

United Kingdom: All regions in England, Scotland and Wales.

ANNEX II

Protocol for enzyme linked immunosorbent assay (Elisa) for detecting antibodies to Aujeszky's disease virus glycoprotein 1 (ADV-g1) in serum 1. The institutions listed in paragraph 2 (d) shall evaluate Elisa g1-tests and kits against the criteria in paragraphs 2 (a), 2 (b), 2 (c). The competent authority in each Member State shall ensure that only Elisa g1-kits that meet these standards shall be registered. The examinations listed in 2 (a) and 2 (b) must be carried out prior to approval of the test and the examination in 2 (c), at least, must thereafter be carried out on each batch.

2. Standardization, sensitivity and specificity of the test.

(a) The sensitivity of the test must be of such a level that the following Community Reference sera are scored positive:

Community Reference serum ADV1 at 1: 8 dilution,

Community Reference serum ADV-g1 A,

Community Reference serum ADV-g1 B,

Community Reference serum ADV-g1 C,

Community Reference serum ADV-g1 D,

Community Reference serum ADV-g1 E,

Community Reference serum ADV-g1 F.

(b) The specificity of the test must be of such a level that the following Community Reference sera are scored negative:

Community Reference serum ADV-g1 G,

Community Reference serum ADV-g1 H,

Community Reference serum ADV-g1 J,

Community Reference serum ADV-g1 K,

Community Reference serum ADV-g1 L,

Community Reference serum ADV-g1 M,

Community Reference serum ADV-g1 N,

Community Reference serum ADV-g1 O,

Community Reference serum ADV-g1 P,

Community Reference serum ADV-g1 Q.

(c) For batch control, the EC Reference serum ADV1 must be scored positive at a dilution of 1: 8 and the EC Reference serum ADV-g1 K must be scored negative.

(d) The institutes listed below will, in addition, be responsible for checking the quality of the Elisa method in each Member State, and in particular for producing and standardizing national reference sera according to the EC Reference sera.

1. Central Veterinary Laboratory, Weybridge, United Kingdom;

2. École Nationale Vétérinaire, Alfort, France;

3. State Veterinary Virus Research Institute, Lindholm, Denmark;

4. Federal Research Centre, Tubingen, Germany;

5. Centraal Diergeneeskudig Instituut, Lelystad, the Netherlands;

6. Institut National de Recherche Vétérinaire, Uccle, Belgium;

7. Italy;

8. Veterinary Research Laboratory, Dublin, Ireland;

9. Spain;

10. Portugal;

11. Greece;

12. Laboratoire de Médicine Vétérinaire, 54 avenue Gaston Diderich, Luxembourg-ville; Luxembourg.

(e) The Community Reference sera will be supplied by those laboratories listed in paragraph 2 (d) above.

ANNEX III

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