COUNCIL DIRECTIVE 92/35/EEC of 29 April 1992 laying down control rules and measures to combat African horse sickness

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community and in particular Article 43 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae (4) seeks to liberalize the movement of equidae on Community territory; whereas, under Article 5 (4) thereof, Community measures must be introduced to harmonize rules for controlling and measures to combat African horse sickness;

Whereas such measures will make it possible to ensure rational development of the farming sector and contribute to the protection of animal health in the Community;

Whereas an outbreak of this disease can quickly assume epizootic proportions, causing mortality and disturbance which may severely reduce the profitability of livestock production;

Whereas control measures must be taken as soon as the presence of the disease is suspected and whereas immediate and effective action must be implemented as soon as it is confirmed in order to guarantee animal health protection in the Community;

Whereas the measures to be taken must aim at preventing the spread of African horse sickness; whereas the movement of animals liable to transmit the infection must be strictly controlled and insects must be eradicated from infected holdings;

Whereas the conditions under which vaccination against African horse sickness may be carried out and the rules governing such vaccination must be specified;

Whereas, in order to ensure more effective control of the disease, action should be taken to establish protection and surveillance zones, taking into account geographical, administrative, ecological and epizootiological factors;

Whereas a thorough epizootiological inquiry is essential in order to prevent any spread of the disease;

Whereas Article 3 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (5) applies in the event of the occurrence of African horse sickness,

HAS ADOPTED THIS DIRECTIVE:

Article 1

This Directive lays down control rules and measures to combat African horse sickness.

Article 2

For the purposes of this Directive, the definitions given in Article 2 of Directive 90/426/EEC shall apply as and where necessary.

However, holding means holding within the meaning of Directive 90/426/EEC and nature reserves in which equidae live in freedom.

Furthermore:

(a) owner or keeper means any natural or legal person(s) having ownership of the equidae or charged with their keep, whether or not for finanical reward;

(b) vector means an insect of the imicola Culicoides species or any other Culicoides insect liable to transmit African horse sickness, identifiable under the procedure provided for in Article 19, following the opinion of the Scientific Veterinary Committee;

(c) confirmation means the declaration, by the competent authority, of the presence of African horse sickness, based on laboratory results; however, in the event of an epidemic the competent authority may also confirm the disease on the basis of clinical and/or epidemiological results;

(d) competent authority means the central authority of a Member State responsible for carrying out veterinary checks or any veterinary authority to which it has delegated that responsibility;

(e) official veterinarian means the veterinarian appointed by the competent authority.

Article 3

Member States shall ensure that the occurrence or suspicion of African horse sickness is subject to compulsory and immediate notification to the competent authority.

Article 4

1. Where a holding contains one or more equidae suspected of being infected with African horse sickness, Member States shall ensure that the official veterinarian immediately sets in motion official means of investigation to confirm or rule out the presence of the said sickness.

2. From the moment when the suspected infection is notified, the official veterinarian shall:

(a) have the suspect holding(s) placed under official surveillance;

(b) initiate:

(i) an official census of the species of equidae, stating in the case of each species the number of equidae already dead, infected or liable to be infected, and the updating of that census to take account of equidae born or dying during the period of suspicion; the information in the census must be produced on request and may be checked at each inspection;

(ii) a census of places likely to facilitate the survival of the vector or to accommodate it and the use of appropriate means of eradicating insects in such places;

(iii) an epizootiological inquiry in accordance with Article 7;

(c) regularly visit the holding(s), when he shall:

(i) examine each equid kept there;

(ii) carry out a detailed clinical examination or an autopsy on the suspect or dead animals and take the samples necessary for laboratory examinations;

(d) ensure that:

(i) all equidae on the holding(s) are kept in their living quarters or in other places protected against the vector;

(ii) all movement of equidae to or from the holding(s) is prohibited;

(iii) appropriate means of eradicating insects are employed in and around the buildings housing the equidae;

(iv) the carcases of equidae which have died on the holding are destroyed, disposed of, burnt or buried in accordance with Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedstuffs of animal or fish origin and amending Directive 90/425/EEC (6).

3. Pending the introduction of the official measures referred to in paragraph 2, the owner or keeper of any animals suspected of having the disease shall take all the necessary precautionary action to ensure compliance with paragraph 2 (d).

4. The competent authority may apply any of the measures provided for in paragraph 2 to other holdings should their location, their geographical situation or contacts with the holding where the disease is suspected give reason to suspect possible contamination.

5. Apart from the provisions of paragraph 2, specific provisions may be laid down in accordance with the procedure referred to in Article 19 for nature reserves in which equidae live in freedom.

6. The measures covered by this Article shall be officially discontinued only when the competent authority no longer suspects the presence of African horse sickness.

Article 5

Vaccination against African horse sickness may be practised solely in accordance with the provisions laid down in this Directive.

Article 6

1. Where the presence of African horse sickness is officially confirmed, the official veterinarian:

(a) shall proceed immediately with the killing under official control of any equidae on the infected holding which are infected with or present clinical symptoms of African horse sickness;

(b) shall arrange for the destruction, disposal, burning or burial of the carcases of the aforesaid equidae in accordance with Directive 90/667/EEC and/or;

(c) shall extend the measures laid down in Article 4 to holdings situated within a 20 km radius (included in the protection zone) around the infected holding(s);

(d) shall proceed, in the zone laid down in (c), with the systematic vaccination of all equidae using a vaccine authorized by the competent authority, and shall identify them by a clear, indelible mark applied by an approved method in accordance with the procedure laid down in Article 19. However, on the basis of the epizootiological, meteorological, geographical or climatological circumstances, the vaccination requirements may be waived by the competent authority. The competent authority shall inform the Commission thereof;

(e) carry out an epizootiological enquiry in accordance with Article 7.

2. The competent authority may extend the measures provided for in paragraph 1 beyond the zone referred to in point (c) thereof if, on account of the geographical, ecological or meteorological situation or of movements to or from the holding where the disease has been confirmed, there are grounds for suspecting an extension of African horse sickness. It shall inform the Commission accordingly.

3. Where the zone referred to in paragraph 1 is situated in the territory of more than one Member State the competent authorities of the Member States concerned shall collaborate in defining this zone. If necessary, the latter shall be defined under the procedure laid down in Article 19.

Article 7

1. The epizootiological inquiry shall cover:

- the length of time during which African horse sickness may have existed on the holding,

- the possible origin of the African horse sickness on the holding and the identification of other holdings on which there are equidae which may have become infected or contaminated from the same source,

- the presence and distribution of disease vectors,

- the movement of equidae to or from the holdings concerned or any carcases of equidae removed from them.

2. In order to provide full coordination of all measures necessary to ensure eradication of African horse sickness as quickly as possible and for the purpose of carrying out the epizootiological inquiry, a crisis unit shall be established.

The general rules concerning national crisis units and Community crisis units shall be adopted by the Council, acting on a proposal from the Commission.

Article 8

1. The Member States shall ensure that, in addition to the measures referred to in Article 6, the competent authority establishes a protection zone and a surveillance zone. The establishment of the zones shall take account of the geographical, administrative, ecological and epziootiological factors connected with African horse sickness and of the control structures.

2. (a) The protection zone shall consist of a part of Community territory with a radius of at least 100 km around the entire infected holding.

(b) The surveillance zone shall consist of a part of Community territory extending at least 50 km beyond the protection zone, in which no systematic vaccination has been carried out in the last 12 months.

(c) Where such zones are situated on the territory of several Member States, the competent authorities of the Member States concerned shall collaborate in order to define the zones referred to in (a) and (b). However, if necessary, the protection zone and the surveillance zone shall be defined in accordance with the procedure laid down in Article 19.

3. At the duly substantiated request of a Member State a decision may be taken in accordance with the procedure laid down in Article 19, with a view to amending the demarcation of the zones defined in paragraph 2, taking into account:

- their geographical situation and ecological factors,

- the meteorological conditions,

- the presence and distribution of the vector,

- the results of the epizootiological studies carried out in accordance with Article 7,

- the results of the laboratory examinations,

- the application of the control measures, in particular the insect eradication measures.

Article 9

1. Member States shall ensure that the following measures are applied in the protection zone:

(a) all holdings containing equidae within the zone are identified;

(b) the official veterinarian conducts:

- periodic visits to all holdings containing equidae,

- a clinical examination of the said equidae including, if necessary, the collection of samples for laboratory examination; a record of visits and findings must be kept;

(c) equidae leave the holding on which they are kept only for transport directly under official supervision for emergency slaughter to a slaughterhouse located in that zone or, if that zone has no slaughterhouse, to a slaughterhouse in the surveillance zone designated by the competent authority.

2. In addition to the measures provided for in paragraph 1, a decision to carry out systematic vaccination of equidae against African horse sickness and to identify them in the protection zone may be taken under the procedure laid down in Article 19.

Article 10

Member States shall ensure that:

1. the measures provided for in Article 9 (1) apply in the surveillance zone. However, if the surveillance zone has no slaughterhouse, the equidae may be slaughtered in the protection zone in a slaughterhouse designated by the competent authority;

2. all vaccination against African horse sickness is prohibited in the surveillance zone.

Article 11

The period of application and maintenance of the measures provided for in Articles 6, 8, 9 and 10 shall be determined by the procedure laid down in Article 19. The period may in no case be less than 12 months where vaccination has been carried out in accordance with Articles 6 (1) and 9 (2).

However, notwithstanding Articles 9 (1) (c) and 10 (1):

(a) equidae from the protection zone and from the surveillance zone may be transported under official supervision and under the conditions laid down in Article 5 (3) of Directive 90/426/EEC to the quarantine station referred to in Article 5 (3) (d) of that Directive;

(b) movements of equidae within zones of the same status shall be subject to authorization from the competent authorities on the basis of the following rules:

(i) equidae shall:

- undergo a prior official check,

- require identification, and

- be accompanied by an official document;

(ii) Member States shall ensure, in all events, that equidae vaccinated less than 60 days previously cannot leave the holding on which they were at the time the vaccination was carried out;

(iii) Member State shall inform the Commission within the Standing Veterinary Committee on measures taken in this field.

Article 12

Where the African horse sickness epizootic is exceptionally serious in a particular region, any additional measures to be taken by the Member States concerned shall be adopted in accordance with the procedure laid down in Article 19.

Article 13

Member States shall ensure that the competent authority takes all necessary and appropriate measures for all persons established in the protection and surveillance zones to be fully informed of the restrictions in force and to take the steps necessary for the appropriate implementation of the measures in question.

Article 14

1. In each Member State, a national laboratory shall be designated to carry out the laboratory examinations stipulated in this Directive. These national laboratories and their powers and duties are listed in Annex I to this Directive.

2. The national laboratories listed in Annex I shall liaise with the Community reference laboratory referred to in Article 15.

Article 15

The Community reference laboratory for African horse sickness is named in Annex II. Notwithstanding the provisions of Decision 90/424/EEC, and in particular Article 28 thereof, the functions and duties of the laboratory shall be defined in Annex III.

Article 16

Experts from the Commission may, in so far as is necessary for the uniform application of this Directive and in cooperation with the competent authorities, make on-site checks. To this end they may, by inspecting a representative percentage of holdings, verify whether the competent authorities are monitoring compliance with the provisions of this Directive. The Commission shall inform the Member States of the results of the checks carried out.

A Member State in the territory of which an inspection is being carried out shall give all necessary assistance to the experts in carrying out their duties.

The general rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 19.

Article 17

1. Each Member State shall draw up a contingency plan, specifying how it will implement the measures laid down in this Directive.

This plan should allow access to facilities, equipment, personnel and all other appropriate materials necessary for the rapid and efficient eradication of the disease.

2. The criteria to be applied for drawing up the plans referred to in paragraph 1 are laid down in Annex IV.

Plans drawn up in accordance with these criteria shall be submitted to the Commission not later than three months after this Directive takes effect.

The Commission shall examine the plans in order to determine whether they permit the desired objective to be attained and shall suggest to the Member State concerned any amendments required, in particular to ensure that they are compatible with those of the other Member States.

The Commission shall approve the plans, if necessary amended, in accordance with the procedures laid down in Article 19.

The plans may subsequently be amended or supplemented in accordance with the same procedure to take account of developments in the situation.

Article 18

The Annexes shall be amended by the Council, acting on a proposal from the Commission.

Article 19

1. Where the procedure defined in this Article is to be followed, the chairman shall refer the matter without delay to the Standing Veterinary Committee set up by Decision 68/361/EEC (7), hereinafter referred to as 'the committee', either on his own initiative or at the request of a Member State.

2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States shall be weighted in the manner set out in that Article. The chairman shall not vote.

3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.

(b) If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.

If, within three months of the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission save where the Council has decided against the said measures by a simple majority.

Article 20

The Member States shall bring into force, the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 December 1992. They shall forthwith inform the Commission thereof.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such a reference shall be laid down by the Member States.

Article 21

The Commission shall submit to the Council, before 1 October 1993 and based on acquired experience, a report on the application of this Directive together with any appropriate proposals.

Article 22

This Directive is addressed to the Member States.

Done at Luxembourg, 29 April 1992.

For the Council

The President

Arlindo MARQUES CUNHA

(1) OJ No C 312, 3. 12. 1991, p. 12.(2) Opinion delivered on 10 April 1992 (not yet published in the Official Journal).(3) Opinion delivered on 29 April 1992 (not yet published in the Official Journal).(4) OJ No L 224, 18. 8. 1990, p 42. Directive as last amended by Decision 92/130/EEC (OJ No L 47, 22. 2. 1992, p. 26).(5) OJ No L 224, 18. 8. 1990, p. 19. Decision as last amended by Regulation (EEC) No 3763/91 (OJ No L 356, 24. 12. 1991, p. 1.).(6) OJ No L 363, 27. 12. 1990, p. 51.(7) OJ No L 255, 18. 10. 1968, p. 23.

ANNEX I

A. LIST OF NATIONAL LABORATORIES FOR AFRICAN HORSE SICKNESS

Belgium

Institut National de Recherche Vétérinaire (INRV),

Groeselenberg 99, 1180 Bruxelles

Nationaal Instituut voor Diergeneeskundig Onderzoek (NIDO),

Groeselenbergstraat 99, 1180 Brussel

Denmark

Statens Veterinaere Institut for Virusforskning,

Lindholm, 4771 Kalvehave

Germany

Bundesforschungsanstalt fuer Viruskrankheiten der Tiere,

Paul-Ehrlich-Strasse, 7400 Tuebingen

France

Laboratoire Central de Recherches Vétérinaires,

22, rue Pierre Curie,

BP 67, 94703 Maisons Alfort Cedex

Greece

Institut de fièvre aphteuse et des maladies exotiques du Centre des Instituts

Vétérinaires d'Athènes,

Rue Neapoleos 25, KA 15 310 Aghia Paraskevi, Athens

Ireland

Central Veterinary Research Laboratory,

Department of Agriculture and Food,

Abbotstown, Castleknock, Dublin

Italy

Istituto Zooprofilattico Sperimentale dell'Abruzzo e del Molise,

Via Campo Boario, Teramo

Luxembourg

Laboratoire de Médecine Vétérinaire de l'État,

54, Avenue Gaston Diderich, L-Luxembourg

Netherlands

Centraal Diergeneeskundig Instituut,

Lelystad

Portugal

Laboratório Nacional de Investigaçao Veterinária,

Estrada de Benfica No 102, Lisboa

Spain

Laboratorio de sanidad y producción animal,

Ministerio de Agricultura, Pesca y Alimentación,

28110 Algete, Madrid

United Kingdom

Institute of Animal Health,

Ash Road, Pirbright, Woking, Surrey GU 24 ONF

B. FUNCTIONS AND DUTIES OF THE NATIONAL LABORATORIES FOR AFRICAN HORSE SICKNESS The national laboratories for African horse sickness are responsible for coordinating the standards and diagnostic methods laid down in each diagnostic laboratory of the Member State, for the use of reagents and for the testing of vaccines. To this end, they:

(a) may provide diagnostic reagents to diagnostic laboratories requesting them;

(b) will control the quality of all diagnostic reagents used in that Member State;

(c) will arrange comparative tests periodically;

(d) will hold isolates of African horse sickness virus from cases confirmed in that Member State;

(e) will ensure the confirmation of positive results obtained in regional diagnostic laboratories.

ANNEX II

COMMUNITY REFERENCE LABORATORY Laboratorio de sanidad y producción animal,

Ministerio de Agricultura, Pesca y Alimentación,

28110 Algete, Madrid - España.

ANNEX III

THE FUNCTIONS AND DUTIES OF THE COMMUNITY REFERENCE LABORATORY FOR AFRICAN HORSE SICKNESS The Community reference laboratory has the following functions and duties:

1. to coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing African horse sickness, specifically by:

(a) typing, storing and supplying strains of African horse sickness virus for serological tests and the preparation of antiserum;

(b) supplying standard sera and other reference reagents to the national reference laboratories in order to standardize the tests and reagents used in each Member State;

(c) building up and maintaining a collection of African horse sickness virus strains and isolates;

(d) organizing periodical comparative tests of diagnostic procedures at Community level;

(e) collecting and collating data and information on the methods of diagnosis used and the results of tests carried out in the Community;

(f) characterizing isolates of African horse sickness by the most up-to-date methods available to allow greater understanding of the epizootiology of African horse sickness;

(g) monitoring developments in African horse sickness surveillance, epizootiology and prevention throughout the world;

2. to assist actively in the diagnosis of African horse sickness outbreaks in Member States by receiving virus isolates for confirmatory diagnosis, characterization and epizootiologial studies;

3. to facilitate the training or retraining of experts in laboratory diagnosis with a view to the harmonization of techniques throughout the Community;

4. to carry out a mutual and reciprocal exchange of information with the world laboratory for African horse sickness designated by the International Office of Epizootics (IOE), in particular with regard to developments in the world situation concerning African horse sickness.

ANNEX IV

CRITERIA FOR CONTINGENCY PLANS Contingency plans shall meet at least the following criteria:

1. the establishment of a crisis centre on a national level, which shall coordinate all control measures in the Member State concerned;

2. a list shall be provided of local disease control centres with adequate facilities to coordinate the disease control measures at a local level;

3. detailed information shall be given about the staff involved in control measures, their skills and their responsibilities;

4. each local disease control centre must be able to contact rapidly persons/organizations which are directly or indirectly involved in an outbreak;

5. equipment and materials shall be available to carry out the disease control measures properly;

6. detailed instructions shall be provided on action to be taken, including means of disposal of carcases, on suspicion and confirmation of infection or contamination;

7. training programmes shall be established to maintain and develop skills in field and administrative procedures;

8. diagnostic laboratories must have facilities for post-mortem examination, the necessary capacity for serology, histology, etc., and must maintain the skills for rapid diagnosis (to that end arrangements should be made for rapid transportation of samples);

9. details shall be provided of the quantity of African horse sickness vaccine estimated to be required in the event of a reinstatement of emergency vaccination;

10. provisions shall be made to ensure the legal powers, necessary for the implementation of the contingency plans.