Commission Decision

of 12 December 2002

on introducing vaccination to supplement the measures to control infections with low pathogenic avian influenza in Italy and on specific movement control measures

(notified under document number C(2002) 5051)

(Text with EEA relevance)

(2002/975/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market(1), as last amended by Directive 2002/33/EC of the European Parliament and of the Council(2), and in particular Article 10(4) thereof,

Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market(3), as last amended by Directive 92/118/EEC(4), and in particular Article 9(4) thereof,

Having regard to Council Directive 92/40/EEC introducing Community measures for the control of avian influenza(5), and in particular Article 16 thereof,

Whereas:

(1) During 1999 and 2000 Italy has experienced outbreaks of highly pathogenic avian influenza of subtype H7N1 with devastating economic losses for the poultry industry. Prior to the epidemic a virus of low pathogenicity had been circulating in the area.

(2) During monitoring for avian influenza the presence of low pathogenic avian influenza virus of subtype H7N3 was detected in the regions of Veneto and Lombardia in October 2002.

(3) Currently the control of low pathogenic avian influenza infections is not covered by Community legislation.

(4) The Italian competent veterinary authorities have taken control measures to avoid the spread of disease to other areas; however the infection cannot be contained sufficiently.

(5) Low pathogenic virus may mutate to highly pathogenic virus and may cause severe disease outbreaks.

(6) During the previous avian influenza epidemic in Italy a vaccination programme was approved by the Commission in connection with intensive monitoring and certain provisions for intra-Community trade in live poultry and poultry products.

(7) As a follow-up of the vaccination campaign certain measures concerning movement restrictions for intra-Community trade of live poultry and poultry products were maintained by the adoption of Commission Decision 2002/552/EC(6).

(8) The experience of the Italian vaccination campaign suggests that this has successfully stopped the spread of the low pathogenic avian influenza virus.

(9) Avian influenza virus subtype H7N3 is responsible for the current infections, whereas the previous epidemic was caused by an H7N1 virus subtype.

(10) The infection occurs at present in an area of Italy with dense poultry population.

(11) In this context vaccination can be an effective tool to supplement disease control measures against avian influenza.

(12) Where vaccination against avian influenza is practised movement restrictions for vaccinated poultry have to be implemented.

(13) Italy has presented a vaccination programme to supplement the measures to control avian influenza in a limited area of Italy including specific movement restrictions.

(14) Italy has authorised the use of two inactivated vaccines against avian influenza for the implementation of the programme. For the initial phase a homologous vaccine is obtained from the master seed strain CK/Pak/1995-H7N3 and for the following period starting from early 2003 a heterologous vaccine with the master seed strain A/CK/Italy/AG-473/1999-H7N1 shall be used.

(15) Within a technical working group meeting the vaccination programme presented by Italy was reviewed.

(16) Monitoring on vaccinated and unvaccinated poultry flocks shall be continued including the use of the serological test (iIFA-test) which had been approved by Commission Decision 2001/847/EC(7).

(17) Italy shall introduce specific movement restrictions related to vaccination of poultry and to intra-Community trade.

(18) For reasons of clarity Decision 2002/552/EC should be repealed as its provisions are superseded by this Decision.

(19) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

The vaccination programme against avian influenza presented by Italy is hereby approved and shall be carried out in the area described in Annex I.

Article 2

The restrictions on movements of live birds, hatching eggs, table eggs and fresh poultry meat into, out of and within the area described in Annex I shall apply as laid down in the vaccination programme referred to in Article 1.

Article 3

1. No live birds and hatching eggs coming from and/or originating from the area described in Annex I shall be dispatched from Italy.

2. Live birds and hatching eggs coming from and/or originating from the territory of Italy outside the area described in Annex I can only be dispatched from Italy if:

- no contacts or other epidemiological links in relation to avian influenza have been established between the holding of origin and with a holding or a hatchery situated in the area described in Annex I, and

- the holding of origin is not located in any of the restriction zones established by the competent authority in relation with avian influenza.

3. No table eggs derived from poultry vaccinated against avian influenza and originating from the area described in Annex I, shall be dispatched from Italy.

Article 4

Animal health certificates accompanying consignments of live birds and hatching eggs from Italy shall include the words: "The animal health conditions of this consignment are in accordance with Decision 2002/975/EC".

Article 5

1. Fresh meat of poultry must be marked in accordance with Article 5 of Council Directive 91/494/EEC(8) and shall not be dispatched from Italy if it is derived from:

(a) poultry vaccinated against avian influenza;

(b) avian influenza seropositive poultry flocks destined for slaughter under official control in accordance with the vaccination programme referred to in Article 1;

(c) poultry originating from holdings located in a restriction zone, which shall be established based on a minimum radius of three kilometres around any poultry farm infected with low pathogenic avian influenza in accordance with the provisions laid down in the vaccination programme referred to in Article 1.

2. By derogation from paragraph 1(a) and (b), fresh meat from turkeys vaccinated against avian influenza with a heterologous vaccine of subtype (H7N1) shall not be marked in accordance with Article 5 of Council Directive 91/494/EEC and can be dispatched to other Member States, provided that the meat comes from slaughter turkey flocks which:

(i) have been regularly inspected and tested with negative results for avian influenza as laid down in the approved vaccination programme, with particular attention to be paid to the sentinel birds.

For the testing of:

- vaccinated birds, the iIFA-test shall be used,

- sentinel birds, either the Haemagglutination-Inhibition Test (HI), the AGID-test or the ELISA-test shall be used. However, the iIFA-test shall also be used if necessary;

(ii) have been clinically inspected by an official veterinarian within 48 hours before loading, with particular attention to be paid to the sentinel birds;

(iii) have been tested serologically with negative results at the National Laboratory for avian influenza, by using the sampling and testing procedure laid down in Annex II to this Decision;

(iv) must be sent directly to a slaughterhouse designated by the competent authority and be slaughtered immediately after arrival. The birds shall be kept separated from other flocks not complying with the present provisions.

3. Fresh turkey meat fulfilling the requirements as set out in paragraph 2 shall be accompanied by the health certificate laid down in Annex VI of Directive 71/118/EEC(9), which shall include under point IV(a) of the certificate the following attestation of the official veterinarian:

"The turkey meat described above is in accordance with Decision 2002/975/EC".

Article 6

Italy shall ensure that in the area described in Annex I:

1. Only disposable packaging material, or packaging material which can be effectively washed and disinfected, is used for the collection, storage and transport of table eggs.

2. All means of transport used for transporting poultry, hatching eggs, table eggs and poultry feedstuff must be cleaned and disinfected immediately before and after each transport with disinfectants in accordance with the methods of use approved by the competent authority.

Article 7

Movements of live poultry and hatching eggs coming from areas of Italy outside the area described in Annex I to other Member States shall only be allowed following five days advance notification to the central and local veterinary authorities of destination. The notification shall be dispatched by the competent veterinary authority.

Article 8

1. Italy shall notify to the Commission and to other Member States the date of the commencement of the vaccination, at least one day in advance.

2. The provisions of the Articles 2 to 7 shall be enforced from the date of the commencement of the vaccination.

Article 9

1. Italy shall, at six-month intervals, present a report containing information on the effectiveness of the vaccination programme referred to in Article 1.

2. This Decision, and in particular the period of time during which the movement restrictions provided for in Articles 2 to 7 shall continue to apply after the completion of the vaccination programme, shall be reviewed accordingly.

Article 10

Decision 2002/552/EC is repealed.

Article 11

This Decision is addressed to the Member States.

Done at Brussels, 12 December 2002.

For the Commission

David Byrne

Member of the Commission

(1) OJ L 224, 18.8.1990, p. 29.

(2) OJ L 315, 19.11.2002, p. 14.

(3) OJ L 395, 30.12.1989, p. 13.

(4) OJ L 62, 15.3.1993, p. 49.

(5) OJ L 167, 22.6.1992, p. 1.

(6) OJ L 180, 10.7.2002, p. 24.

(7) OJ L 315, 1.12.2001, p. 61.

(8) OJ L 268, 24.9.1991, p. 35.

(9) OJ L 55, 8.3.1971, p. 23.

ANNEX I

VACCINATION AREA

Veneto region

Verona province

The vaccination area comprises the territory of the following municipalities:

Albaredo d'Adige

Angiari

Arcole

Belfiore

Bevilacqua

Bonavigo

Boschi Sant'Anna

Bovolone

Buttapietra

Calmiero area to the south of the A4 motorway

Casaleone

Castel d'Azzano

Castelnuovo del Garda area to the south of the A4 motorway

Cerea

Cologna Veneta

Colognola ai Colli area to the south of the A4 motorway

Concamarise

Erbè

Gazzo Veronese

Isola della Scala

Isola Rizza

Lavagno area to the south of the A4 motorway

Minerbe

Monteforte d'Alpone area to the south of the A4 motorway

Mozzecane

Nogara

Nogarole Rocca

Oppeano

Palù

Peschiera del Garda area to the south of the A4 motorway

Povegliano Veronese

Pressana

Ronco all'Adige

Roverchiara

Roveredo di Guà

S. Bonifacio area to the south of the A4 motorway

S. Giovanni Lupatoto area to the south of the A4 motorway

S. Martino Buon Albergo area to the south of the A4 motorway

S. Pietro di Morubio

Salizzole

Sanguinetto

Soave area to the south of the A4 motorway

Sommacampagna

Sona area to the south of the A4 motorway

Sorgà

Trevenzuolo

Valeggio sul Mincio

Verona area to the south of the A4 motorway

Veronella

Vigasio

Villafranca di Verona

Zevio

Zimella

Vicenza province

The vaccination area comprises the territory of the following municipalities:

Agugliaro

Albettone

Alonte

Asigliano Veneto

Barbarano Vicentino

Campiglia dei Berici

Castegnero

Lonigo

Montegalda

Montegaldella

Mossano

Nanto

Noventa Vicentina

Orgiano

Poiana Maggiore

S. Germano dei Berici

Sossano

Villaga

Padova province

The vaccination area comprises the territory of the following municipalities:

Carceri

Casale di Scodosia

Este

Lozzo Atestino

Megliadino S. Fidenzio

Megliadino S. Vitale

Montagnana

Ospedaletto Euganeo

Ponso

S. Margherita d'Adige

Saletto

Urbana

Lombardia region

Mantova province

The vaccination area comprises the territory of the following municipalities:

Acquanegra Sul Chiese

Asola

Bigarello

Canneto Sull'oglio

Casalmoro

Casaloldo

Casalromano

Castel D'ario

Castel Goffredo

Castelbelforte

Castiglione Delle Stiviere

Cavriana

Ceresara

Gazoldo Degli Ippoliti

Goito

Guidizzolo

Mariana Mantovana

Marmirolo

Medole

Monzambano

Piubega

Ponti Sul Mincio

Porto Mantovano

Redondesco

Rodigo

Roncoferraro

Roverbella

San Giorgio Di Mantova

Solferino

Villimpenta

Volta Mantovana

Brescia province

The vaccination area comprises the territory of the following municipalities:

Acquafredda

Alfianello

Azzano Mella

Bagnolo Mella

Barbariga

Bassano Bresciano

Berlingo

Borgo San Giacomo

Borgosatollo

Brandico

Brescia area to the south of the A4 motorway

Calcinato area to the south of the A4 motorway

Calvisano

Capriano del Colle

Carpendolo

Castegnato area to the south of the A4 motorway

Castel Mella

Castelcovati

Castenedolo area to the south of the A4 motorway

Castrezzato

Cazzago San Martino

Chiari

Cigole

Boccaglio

Cologne

Comezzano-Cizzago

Corzano

Dello

Desenzano del Garda area to the south of the A4 motorway

Erbusco area to the south of the A4 motorway

Fiesse

Flero

Gambara

Ghedi

Gottolengo

Isorella

Leno

Lograto

Lonato area to the south of the A4 motorway

Longhena

Maclodio

Mairano

Manerbio

Milzano

Montichiari

Montirone

Offlaga

Orzinuovi

Orzivecchi

Ospitaletto area to the south of the A4 motorway

Palazzolo sull'Oglio area to the south of the A4 motorway

Pavone del Mella

Pompiano

Poncarale

Pontevico

Pontoglio

Pozzolengo area to the south of the A4 motorway

Pralboino

Quinzano d'Oglio

Remedello

Rezzato area to the south of the A4 motorway

Roccafranca

Roncadelle area to the south of the A4 motorway

Rovato area to the south of the A4 motorway

Rudiano

San Gervasio Bresciano

San Paolo

San Zeno Naviglio

Seniga

Torbole Casaglia

Travagliato

Trenzano

Urago d'Oglio

Verolanuova

Verolavecchia

Villachiara

Visano

ANNEX II

SAMPLING AND TESTING PROCEDURE

1. Introduction and general use

The developed indirect Immunofluorescence Assay (iIFA-test) is aimed at the differentiation between vaccinated/field exposed and vaccinated/non field exposed turkeys in the framework of a "DIVA" (Differentiating Infected from Vaccinated Animals) vaccination strategy using a heterologous subtype vaccine from the H7N3 field virus subtype.

2. Use of the test for the purpose of dispatching fresh turkey meat from the vaccination area in Italy to other Member States

Meat originating from turkey flocks vaccinated against avian influenza may be dispatched to other Member States provided that:

Blood samples shall be taken by the official veterinarian:

- from each group of turkeys destined for slaughter, which are kept in the same building of the holding in question,

- within 48 hours before sending the animals to the slaughterhouse,

- from at least 10 vaccinated animals chosen at random from each group.