S.L. 437.48 ст. 9Compulsory national control programme for contagious diseases.

(1) On the basis of a Veterinary Services proposal, the

Minister in charge of Agriculture may define, by virtue of an implementing regulation a compulsory national control programme for one of the contagious diseases listed in Annex E (II) to Directive 64/432/EEC for all of the territory of Malta. The said programme shall be submitted to the European Commission and outlined in particular:

(a) the distribution of the disease in the Member State,

(b) the reasons for the programme, taking into consideration the importance of the disease and the programme’s likely benefit in relation to its cost,

(c) the geographical area in which the programme will be implemented,

(d) the status categories to be applied to the animal establishments, the standards which must be attained in each category, and the test procedures to be used,

(e) the programme monitoring procedures, the results of which must be supplied at least annually to the Commission,

(f) the action to be taken if, for any reason, an establishment loses its status,

(g) the measures to be taken if the results of the tests carried out in accordance with the provisions of the programme are positive.

(2) The Commission shall examine the programmes presented by the Member States. Programmes as referred to in subregulation

(1) may be approved in compliance with the criteria laid down in paragraph I in accordance with the procedure provided for in Article 17 of the European Union Council Directive 64/432/EEC. According to the same procedure, the additional guarantees, general or limited, which may be required in intra-Community trade, shall be defined at the same time or at the latest three months after approval of the programmes. Such guarantees must not exceed those which the Member State implements nationally.

(3) Programmes submitted by Member States may be amended or supplemented in accordance with the procedure laid down in Article l7 of the European Union Council Directive 64/432/EEC. Amendments or additions to programmes which have already been approved or to guarantees which have been defined in accordance with subregulation (2) may be approved under the same procedure.

(4) The dispatching of pigs intended for breeding or production destined for the Member States or regions free of Aujeszky’s disease listed in Annex I of Commission Decision 2001/618/EC and coming from the territory of Malta or region not listed in that Annex is authorised subject to the following conditions:

(a) Aujeszky’s disease must be compulsorily notifiable in Malta or regioro of origin;

(b) a plan for the control and eradication of Aujeszky’s disease, fulfilling the criteria laid down in the first paragraph of this regulation, must be in place in Malta or regions of origin under the supervision of the Veterinary Services. Appropriate measures on pig transport and movements must be in place according to this plan for preventing a spread of disease between holdings of a different status;

(c) with regard to the holding of origin of the pigs:

(i) no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous twelve months in the holding in question;

(ii) no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous twelve months in the holdings located in an area of 5 km surrounding the holding of origin of the pigs; however, this provision shall not apply if, in these latter holdings, disease monitoring and eradication measures have been regularly applied under the supervision of the Veterinary Services and in accordance with the eradication plan referred to in paragraph (b), and these measures have effectively prevented any spread of disease to the holding in question;

(iii) vaccination against Aujeszky's disease has not been carried out for at least twelve months;

(iv) the pigs have been subjected on at least two occasions at a distance of at least four months to a serological survey for the presence of ADV-gE or ADV-gB or ADV-gD antibody or to the whole Aujeszky's disease virus. This survey must have shown the absence of Aujeszky’s disease and that vaccinated pigs have been free from gE antibodies;

(v) no pigs have been introduced from holdings of a lower animal health status as regards Aujeszky’s disease in the previous twelve months, unless they have been tested for Aujeszky’s disease with negative results;

(d) the pigs to be moved:

(i) have not been vaccinated;

(ii) have been kept isolated in accommodation approved bv the Veterinary Services, during the thirty days prior to movement, and in such a way that any risk of spreading Aujeszky’s disease to these pigs is prevented;

(iii) must have lived in the holding of origin or in a holding of an equivalent status since birth, and have remained in the holding of origin for at least: - thirty days, in the case of pigs intended for production; - ninety days, in the case of pigs intended for breeding, have been subjected with negative results to at least two serological tests for ADV-gB or ADV-gD or the whole Aujeszky’s disease virus, at a distance of at least thirty days between each test. However, in case of pigs less than four months old, the serological test for ADV-gE may also be used. Sampling for the last test must be performed within fifteen days prior to shipment. The number of pigs tested in the isolation unit must be sufficient to detect:

(i) 2% seroprevalence with 95% confidence in the isolation unit in case of pigs intended for production;

(ii) 0,1% seroprevalence with 95% confidence in the isolation unit in case of pigs intended for breeding. However, the first of the two tests shall not be necessary if:

(i) in the framework of the plan referred to in paragraph (b), a serological survey has been carried out in the holding of origin between forty-five and seventeen days prior to shipment, demonstrating the absence of Aujeszky’s disease antibodies and that vaccinated pigs have been free from gE antibodies;

(ii) the pigs to be moved have lived in the holding of origin since birth;

(iii) no pigs have moved on to the holding of origin while the pigs to be moved have been kept in isolation.

(5) The dispatching of pigs intended for slaughter destined for the Member States or regions free of Aujeszky’s disease listed in Annex I of Commission Decision 2001/618/EC and coming from Malta or region not listed in that Annex, is authorised subject to the following conditions:

(a) Aujeszky’s disease must be compulsorily notifiable in Malta or region of origin;

(b) a plan for the control and eradication of Aujeszky’s disease is in place in Malta or regions of origin of the pigs, fulfilling the criteria laid down under European Union Law;

(c) all the pigs in question must be transported directly to the slaughterhouse of destination and either:

(i) they come from a holding which fulfils the conditions required by European Union Law, or

(ii) they have been vaccinated against Aujeszky’s disease at least fifteen days prior to their shipment and come from a holding of origin where: - in the framework of the plan referred to in paragraph (b), Aujeszky’s disease monitoring and eradication measures have been regularly applied under the supervision of the Veterinary Services for the previous twelve months; - they had remained for at least thirty days before dispatch and where no clinical or pathological evidence of this disease has been detected at the moment of completion of the health certificate referred to in regulation 5, or - they have not been vaccinated and they proceed from a holding where: 1. in the framework of the plan referred to in paragraph (b), Aujeszky’s disease monitoring and eradication measures have been regularly applied under the supervision of the Veterinary Services in the previous twelve months and no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous six months; 2. vaccination against Aujeszky’s disease and introduction of vaccinated pigs have been forbidden by the Veterinary Services, since the holding is in the process of reaching the highest status as regards Aujeszky’s disease in accordance to the plan referred to in paragraph (b); 3. they have lived for at least ninety days before dispatch.

(6) Pigs intended for breeding destined for the Member States or regions listed in Annex II of Commission Decision 2001/618/ EC, where approved Aujeszky’s disease eradication programmes are in place, must either:

(a) come from Member States or regions listed in Annex I of Commission Decision 2001/618/EC, or

(b) come from:

(i) Member States or regions listed in Annex II, and

(ii) a holding which fulfils the requirements of subregulation (4)(c); or

(c) fulfil the following conditions:

(i) Aujeszky’s disease must be compulsorily notifiable in Malta or region where pigs are originating,

(ii) a plan for the control and eradication of Aujeszky’s disease is in place in Malta or region of origin, which fulfils the criteria laid down in subregulation (4)(b),

(iii) no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous twelve months in the holding of origin of the pigs in question,

(iv) the pigs must have been isolated in accommodation approved by the Veterinary Services for the thirty days immediately prior to movement and kept isolated in such a way that any risk of spreading of Aujeszky’s disease is prevented,

(v) the pigs must have been subjected, with negative results, to a serological test for the presence of gE antibodies. Sampling for the last test must be performed within fifteen days prior to shipment. The number of pigs tested must be sufficient to detect 2% seroprevalence with 95% confidence in these pigs,

(vi) the pigs must lave lived in the holding of origin or in a holding of an equivalent status since birth, and have remained in the holding of origin for at least ninety days.

(7) Pigs intended for production destined for the Member States or regions listed in Annex II of Commission Decision 2001/ 618/EC, where approved Aujeszky’s disease eradication programmes are in place, must either:

(a) come from Member States or regions listed in Annex 1 of Commission Decision 2001/618/EC, or

(b) come from:

(i) Member States or regions listed in Annex II Commission Decision 2001/618/EC, and

(ii) a holding which fulfils the requirements of subregulation (4)(c), or

(c) fulfil the following conditions:

(i) Aujeszky’s disease must be compulsorily notifiable in Malta or region of origin;

(ii) a plan for the control and eradication of Aujeszky’s disease is in place in Malta or region of origin, which fulfils the criteria laid down in subregulation (4)(b);

(iii) no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded in the previous twelve months in the holding of origin of the pigs in question;

(iv) a serological survey for Aujeszky’s disease, demonstrating its absence and that vaccinated pigs have been free from gE antibodies, has been carried out in the holding of origin and between forty-five and one hundred and seventy days prior to shipment;

(v) the pigs must either have lived in the holding of origin since birth or have remained in such holdings for at least thirty days after introduction from a holding of an equivalent status, where a serological survey equivalent to the one referred to in sub-paragraph (iv) has been carried out.

(8) The serological tests carried out to monitor or detect Aujeszky’s disease in pigs in accordance with these regulations must meet the standards laid down in Annex III to the European Union Commission Decision 2001/618/EC.

(9) Without prejudice to Article 10(3) of Directive 64/432/ EEC, information of the occurrence of Aujeszky’s disease, including details of the monitoring and eradication programmes in operation in Malta where monitoring and eradication programmes will be in place, must be provided at least annually by the Veterinary Services in accordance with the uniform criteria laid down in Annex IV to Commission Decision 2001/618/EC.

(10) Without prejudice to the provisions laid down in Community legislation concerning health certificates, before the completion, for animals of the porcine species destined for Member States or regions listed in Annex I or II to Commission Decision 2001/618/EC, of section C of the health certificate required by Directive 64/432/EC, the official veterinarian shall ascertain:

(a) the status of the holding and of the Member State or region of origin of the pigs in question as regards Aujeszky’s disease;

(b) in case the pigs are not originating from a Member State or a region free of the disease, the status of the holding and of the Member State or regions of destination for the pigs in question as regards Aujeszky’s disease;

(c) the compliance of the pigs in question with the conditions laid down in Commission Decision 2001/ 618/EC.

(11) For animals of the porcine species destined for Member States or regions listed in Annex I or II, European Union Commission Decision 2001/618/EC, the certification under subregulation (10) shall be completed and supplemented as follows:

(a) in the first indent, after the word "disease:" the word "Aujeszky" must be added;

(b) in the second indent, reference shall be made to Commission Decision 2001/618/EC. In the same line, the number of the Article of Commission Decision 2001/618/EC, which is relevant for the pigs in question, shall be quoted between brackets.

(12) The Veterinary Services must ensure that when pigs destined for Member States or regions listed in Annex I or II to Commission Decision 2001/618/EC are transported, they shall not come in contact with pigs of different or unknown status, as regards Aujeszky’s disease, during transport or transit.