Proposal for a COUNCIL DIRECTIVE laying down specific provisions for the control and eradication of bluetongue (presented by the Commission)

EXPLANATORY MEMORANDUM

In the last three months of 1998, there was an outbreak of bluetongue in the Union, on the Greek islands of the south-eastern Aegean.

This is a viral disease transmitted by insects of the genus Culicoides. It results in disease and appreciable mortality among sheep. Cattle are asymptomatic carriers of the virus, but are involved in the disease's life cycle.

This disease poses a serious threat to the Community herd. Furthermore, it is included in List A of the World Organisation for Animal Health (OIE) and its entry into the Union could have international consequences.

Directive 92/119/EEC lays down the measures to control certain diseases, including bluetongue. Nevertheless, the Directive is not well adapted to the fight against bluetongue, because of the disease's specific epidemiological profile.

Control measures have been laid down by Directive 92/35/EEC against another animal disease, African horse sickness, which has a similar epidemiology to bluetongue. Its measures are, in the main, well suited to combating bluetongue.

The purpose of this Directive is to adopt for bluetongue the provisions introduced to control African horse sickness, making whatever amendments are necessary for the target species' specific characteristics.

In particular, Article 6 of Directive 92/35/EEC will now allow a Member State, where weather, geographic and epidemiological conditions so justify, to propose an alternative programme to combat any outbreak of the disease, provided that this programme is adopted by the Standing Veterinary Committee.

Proposal for a COUNCIL DIRECTIVE laying down specific provisions for the control and eradication of bluetongue (Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease [1], as amended by the Act of Accession of Austria, Finland and Sweden, and in particular the second indent of Article 15 thereof,

[1] OJ L 62, 15.3.1993, p. 69.

Having regard to the proposal from the Commission,

(1) Whereas, in accordance with Article 15 of Directive 92/119/EEC, specific measures to control and eradicate bluetongue should be introduced;

(2) Whereas the epidemiological characteristics of bluetongue are comparable to those of African horse sickness;

(3) Whereas the Council has adopted Directive 92/35/EEC laying down control rules and measures to combat African horse sickness [2], as amended by the Act of Accession of Austria, Finland and Sweden;

[2] OJ L 157, 10.6.1992, p. 19.

(4) Whereas, therefore, to combat bluetongue, reference should be made to the overall measures laid down by Directive 92/35/EEC to combat African horse sickness;

(5) Whereas, however, the usual methods for rearing species susceptible to bluetongue require the measures laid down by Directive 92/35/EEC for African horse sickness and equidae to be adapted somewhat;

(6) Whereas rules should be laid down on the movement of susceptible species, their semen, ova and embryos from areas subject to restrictions arising from an outbreak of the disease;

(7) Whereas Article 3 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field [3], as last amended by Decision 94/370/EEC [4] applies in the event of an outbreak of bluetongue;

[3] OJ L 224, 18.8.1990, p. 19.

[4] OJ L 168, 2.7.1994, p. 31.

(8) Whereas a procedure for close cooperation between the Member States and the Commission must be introduced,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 92/35/EEC laying down control rules and measures to combat African horse sickness shall apply mutatis mutandis to bluetongue in species susceptible to this disease, save for the derogations provided for below.

Article 2

By way of derogation from the definitions in the first and second paragraphs of Article 2 of Directive 92/35/EEC, the following definitions shall apply in the case of bluetongue:

- holding: agricultural or other holding where animals of the species susceptible to bluetongue are permanently or temporarily reared or kept, and nature reserves in which animals of the species susceptible to the disease live,

- susceptible species: all ruminants.

Article 3

By way of derogation from Article 4(2)(d)(i) and (iii) of Directive 92/35/EEC, the official veterinarian shall ensure that, should a bluetongue outbreak occur:

as far as point (i) is concerned: all animals of susceptible species are kept on the holding where they are located,

as far as point (iii) is concerned: the animals, the buildings used to house them and their surroundings (in particular habitats in which Culicoides populations thrive) are regularly treated with insecticides. To prevent infestations by the vectors as far as possible, the rate of treatment shall be fixed by the competent authority, taking account of the persistence of the insecticide used and the climatic conditions.

Article 4

Where bluetongue appears, the alternative measures to vaccination listed in Article 6(1)(d) of Directive 92/35/EEC may be adopted by the Commission in accordance with the procedure laid down in Article 9. The measures may be amended by the same procedure.

Article 5

Article 11 of Directive 92/35/EEC shall not apply to bluetongue in sheep. Instead, the following provisions shall apply:

1. The measures laid down in Articles 6, 8, 9 and 10 of Directive 92/35/EEC shall be amended or repealed in accordance with the procedure laid down in Article 9 below, upon presentation of the results of a sero-surveillance programme guaranteeing that viral seroconversion has not occurred after a period in which the disease vectors have been active. A decision to lift the measures may not be taken until 12 months have passed since the final vaccinations, where vaccination has occurred under Articles 6(1) and 9(2).

2. However, notwithstanding Articles 9(1)(c) and 10(1) of Directive 92/35/EEC:

(a) animals of susceptible species may be transported out of the protection or surveillance zones if they meet the following requirements:

(i) they are transported only at certain times of the year, depending on the activity of the insect vectors; the times shall be fixed in accordance with the procedure laid down in Article 9;

(ii) they have been kept for at least 40 days at a quarantine station where they were protected from the insect vectors;

(iii) they have tested negative in two separate tests to detect the presence of the specific bluetongue virus antibodies, such as the immuno-enzymatic competition method or the agar gel immuno-diffusion test, the first test being done at the start of quarantine and the second no sooner than 28 days after the first. Other control methods may be recognised in accordance with the procedure laid down in Article 9, after the Scientific Committee on Animal Health and Welfare has been consulted.

(iv) they must have undergone, before transport, an external pesticide treatment to prevent attacks by vector insects during transport;

(v) they show no clinical sign of bluetongue on the day of transport.

(b) movements of animals of susceptible species within the protection or surveillance zone shall be subject to authorisation from the competent authority, which shall:

(i) refuse authorisation for movements of animals from or to holdings on which it can be concluded from the information available that the virus is active,

(ii) refuse authorisation to move animals vaccinated less than 60 days before.

Article 6

By way of derogation from Annexes I A and II of Directive 92/35/EEC, Annexes I and II to this Directive shall apply in the case of bluetongue.

Article 7

The transport of semen, ova and embryos of susceptible species out of protection and surveillance zones shall be regulated in accordance with the procedure laid down in Article 9.

Article 8

The Annexes to this Directive shall be amended in accordance with the procedure laid down in Article 9.

Article 9

1. The Commission shall be assisted by the Standing Veterinary Committee established by Decision 68/361/EEC in accordance with the procedures laid down in paragraph 2 below.

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 measures 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 205(2) of the Treaty in the case of decisions for which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

3. The Commission shall adopt the measures envisaged if they accord with the opinion of the Committee.

4. If the measures envisaged do not accord with the opinion of the Committee, or if no opinion is delivered, the Commission shall immediately submit to the Council a proposal on the measures to be taken.

5. The Council, acting by qualified majority, shall act on the proposal within 15 days.

If, within that period, the Council indicates by qualified majority that it opposes the proposal, the Commission shall reconsider it. It may present an amended proposal to the Council, re-submit the same proposal or present a legislative proposal on the basis of the Treaty.

If the Council has not adopted the proposed implementing measures or has not indicated its opposition to the proposed implementing measures by the expiry of the time limit, they shall be adopted by the Commission.

Article 10

1. Member States shall adopt and publish before 31 December 1999 the provisions, including any penalties, necessary to comply with this Directive. They shall inform the Commission of them forthwith. They shall apply those provisions with effect from 1 January 2000.

When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

2. Member States shall communicate to the Commission the text of the provisions of national law they adopt in the field governed by this Directive.

Article 11

This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Communities.

Article 12

This Directive is addressed to the Member States.

Done at Brussels,

For the Council

The President

ANNEX I

LISTA DE LOS LABORATORIOS NACIONALES DE LA FIEBRE CATARRAL OVINA

LISTE OVER NATIONALE LABORATORIER FOR BLUETONGUE

LISTE DER FÜR DIE BLAUZUNGENKRANKHEIT ZUSTÄNDIGEN NATIONALEN LABORATORIEN

ÊÁÔÁËÏÃÏÓ ÅÈÍÉÊÙÍ ÅÑÃÁÓÔÇÑÉ ÙÍ ÃÉÁ ÔÏÍ ÊÁÔÁÑÑÏÚÊÏ ÐÕÑÅÔÏ ÔÏÕ ÐÑÏÂÁÔÏÕ

LIST OF THE NATIONAL BLUETONGUE LABORATORIES

LISTE DES LABORATOIRES NATIONAUX POUR LA FIEVRE CATARRHALE DU MOUTON

ELENCO DEI LABORATORI NAZIONALI PER LA FEBBRE CATARRALE DEGLI OVINI

LIJST VAN DE NATIONALE LABORATORIA VOOR BLUETONGUE

LISTA DOS LABORATÓRIOS NACIONAIS EM RELAÇÃO À FEBRE CATARRAL OVINA

LUETTELO KANSALLISISTA LAMPAAN BLUETONGUE-TAUTIA VARTEN NIMETYISTÄ LABORATORIOISTA

FÖRTECKNING ÖVER NATIONELLA LABORATORIER FÖR BLUETONGUE

Belgique/ Centre d'Etudes et de Recherches

België Vétérinaires et Agrochimiques (CERVA)

99, Groeselenberg

B - 1180 Bruxelles

Tel: 32 (2) 375 44 55

Fax: 32 (2) 375 09 79

E-mail: piker@var.fgov.be

Danmark Danish Institute for Virus Research

Lindholm

DK- 4771- Kalvehave

Denmark

Tel: 45.55.86.02.00

Fax: 45.55.86.03.00.

E-mail: sviv@vetvirus.dk

Deutschland Bundesforschungsanstalt für Viruskrankheiten der Tiere -

Anstaltsteil Tübingen

Postfach 1149

72001 Tübingen

PD Dr. Büttner

Tel: 07071 - 967 255

Fax: 07071 - 967 303

Ellas Ministry of Agriculture,

Centre of Athens Veterinary Institutions,

Virus Department,

25, Neapoleos Str.,

15310 Ag. Paraskevi,

Athens

Tel: 00 30 1 6011499/6010903

Fax: 00 30 1 6399477

España Centro de Investigación en Sanidad Animal INIA-CISA.

D. Jose Manuel Sánchez Vizcaino

Carretera de Algete-El Casar, km 8, Valdeolmos

20180 MADRID

Tel: 91 6202216

Fax: 91 6202247

E-Mail: vizcaino@inia.es

France CIRAD-EMVT

Campus international de Baillarguet

B.P. 5035

34032 MONTPELLIER CEDEX 1

Tlf: 04 67 59 37 24

Fax: 04 67 59 37 98

E-mail: bastron@cirad.fr

Ireland Central Veterinary Research Laboratory

Abbotstown

Castleknock

Dublin 15

Tel: 00 353 1 607 26 79

Fax: 00 353 1 822 03 63

E-mail: reillypj @indigo.ie

Italia C.E.S.M.E. presso I.Z.S.,

Via Campo Boario- 64100 Teramo

Tel: 0861.332216

Fax: 0861.332251

E-mail: Cesme@IZS.it

Luxembourg Centre d'Etudes et de Recherches

Vétérinaires et Agrochimiques (CERVA)

99, Groeselenberg

B - 1180 Bruxelles

Tel: 32 (2) 375 44 55

Fax: 32 (2) 375 09 79

E-mail: piker@var.fgov.be

Nederland ID-DLO

Edelhertweg 15

8219 PH Lelystad

Tel: 0320 - 238238

Fax: 0320 - 238050

E-mail: E-mail: postkamer@id.dlo.nl

Österreich Bundesanstalt für Virusseuchenbekämpfung

bei Haustieren

Robert Kochgasse 17

A- 2340 Mödling

Tel: 0043 - 2236 - 46640 - 0

Fax: 0043 - 2236 - 46640 - 941

E-mail: BATSB VetMoedling@compuserve.com

Portugal Laboratório Nacional de Investigaçao Veterinaria

Estrada de Benfica, 701

1549-011 LISBOA

Tel: 351 17115200

Fax: 351 171153836

E-mail: dir.Inlv@mail.telepac.pt

Suomi Danish Institute for Virus Research

Lindholm

DK- 4771- Kalvehave

Denmark

Tel: 45.55.86.02.00

Fax: 45.55.86.03.00.

E-mail: sviv@vetvirus.dk

Sverige National Veterinary Institute

Box 7073

750 07 UPPSALA

United Kingdom Institute for Animal Health

Pirbright Laboratory

Ash Road

Pirbright

Woking

Surrey GU24 ONF

Tel: 01483-232441

Fax: 01483-232448

E-mail: philip-mellor@bbsrc.ac.uk

ANNEX II

LABORATORIO COMUNITARIO DE REFERENCIA DE LA FIEBRE CATARRAL OVINA

EF-REFERENCELABORATORIUM FOR BLUETONGUE

GEMEINSCHAFTLICHES REFERENZLABORATORIUM FÜR DIE BLAUZUNGENKRANKHEIT

ÊÏÉÍÏÔÉÊÏ ÅÑÃÁÓÔÇÑÉÏ ÁÍÁÖÏÑÁÓ ÃÉÁ ÔÏÍ ÊÁÔÁÑÑÏÚÊÏ ÐÕÑÅÔÏ ÔÏÕ ÐÑÏÂÁÔÏÕ

COMMUNITY REFERENCE LABORATORY FOR BLUETONGUE

LABORATOIRE COMMUNAUTAIRE DE REFERENCE POUR LA FIEVRE CATARRHALE DU MOUTON

LABORATORIO COMUNITARIO DI RIFERIMENTO PER LA FEBBRE CATARRALE DEGLI OVINI

COMMUNAUTAIRE REFERENTIELABORATORIA VOOR BLUETONGUE

LABORATÓRIO COMUNITÁRIO DE REFERÊNCIA EM RELAÇÃO À FEBRE CATARRAL OVINA

YHTEISÖN VERTAILULABORATORIO LAMPAAN BLUETONGUE-TAUTIA VARTEN

GEMENSKAPENS REFERENSLABORATORIUM FÖR BLUETONGUE

AFRC Institute for Animal Health

Pirbright laboratory,

Ash road,

Pirbright

Woking, Surrey,

GU24ONF,

United Kingdom

Tel: 01483-232441

Fax: 01483-232448

E-mail: philip-mellor@bbsrc.ac.uk