# L_2007258EN.01003101.xml

| 4.10.2007 | EN | Official Journal of the European Union | L 258/31 |
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4.10.2007

EN

Official Journal of the European Union

L 258/31

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COMMISSION DECISION

of 24 September 2007

on emergency vaccination of poultry in Italy against low pathogenic avian influenza

(notified under document number C(2007) 4393)

(Only the Italian text is authentic)

(2007/638/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC (1), and in particular, Article 54(2) thereof;

Whereas:

| (1) | Directive 2005/94/EC sets out the minimum control measures to be applied in the event of an outbreak of avian influenza in poultry or other captive birds. |
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(1)

Directive 2005/94/EC sets out the minimum control measures to be applied in the event of an outbreak of avian influenza in poultry or other captive birds.

| (2) | Under Commission Decision 2005/926/EC of 21 December 2005 on introducing supplementary measures to control infections with low pathogenic avian influenza in Italy and repealing Decision 2004/666/EC (2) Italy carried out vaccination against low pathogenic avian influenza until the end of 2006. |
| --- | --- |

(2)

Under Commission Decision 2005/926/EC of 21 December 2005 on introducing supplementary measures to control infections with low pathogenic avian influenza in Italy and repealing Decision 2004/666/EC (2) Italy carried out vaccination against low pathogenic avian influenza until the end of 2006.

| (3) | Since May 2007 outbreaks of low pathogenic avian influenza have occurred in parts of Northern Italy and measures in accordance with Directive 2005/94/EC have been taken to control the spread of the virus. |
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(3)

Since May 2007 outbreaks of low pathogenic avian influenza have occurred in parts of Northern Italy and measures in accordance with Directive 2005/94/EC have been taken to control the spread of the virus.

| (4) | In July and August 2007 an increase of low pathogenic avian influenza outbreaks in particular of the subtype H7 has been observed and further outbreaks of that disease continue to be detected. A small number of outbreaks caused by the low pathogenic avian influenza subtype H5 have been reported. |
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(4)

In July and August 2007 an increase of low pathogenic avian influenza outbreaks in particular of the subtype H7 has been observed and further outbreaks of that disease continue to be detected. A small number of outbreaks caused by the low pathogenic avian influenza subtype H5 have been reported.

| (5) | In its scientific opinions on the use of vaccination to control avian influenza issued by the European Food Safety Authority in 2005 (3) and 2007 (4) the Animal Health and Welfare Panel stated that emergency and preventive vaccination against avian influenza is a valuable tool to complement the control measures for that disease. |
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(5)

In its scientific opinions on the use of vaccination to control avian influenza issued by the European Food Safety Authority in 2005 (3) and 2007 (4) the Animal Health and Welfare Panel stated that emergency and preventive vaccination against avian influenza is a valuable tool to complement the control measures for that disease.

| (6) | The outbreaks of low pathogenic avian influenza in Italy concern a densely populated poultry area and the epidemiogical situation is still evolving. |
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(6)

The outbreaks of low pathogenic avian influenza in Italy concern a densely populated poultry area and the epidemiogical situation is still evolving.

| (7) | The Italian authorities have carried out a risk assessment and identified a particular risk for further spread of the virus in the areas concerned. Italy has, therefore, by letter dated 7 September 2007, submitted an emergency vaccination plan to the Commission for its approval. |
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(7)

The Italian authorities have carried out a risk assessment and identified a particular risk for further spread of the virus in the areas concerned. Italy has, therefore, by letter dated 7 September 2007, submitted an emergency vaccination plan to the Commission for its approval.

| (8) | The Commission has examined that plan together with Italy and is satisfied that it conforms with the relevant Community provisions. In the light of the development of the epidemiological situation in Italy, it is appropriate to approve the emergency vaccination plan submitted by Italy to supplement the control measures taken by that Member State and to introduce certain restrictions on movements of poultry, hatching eggs of poultry and day-old chicks and certain poultry products. |
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(8)

The Commission has examined that plan together with Italy and is satisfied that it conforms with the relevant Community provisions. In the light of the development of the epidemiological situation in Italy, it is appropriate to approve the emergency vaccination plan submitted by Italy to supplement the control measures taken by that Member State and to introduce certain restrictions on movements of poultry, hatching eggs of poultry and day-old chicks and certain poultry products.

| (9) | According to the vaccination plan, Italy intends to vaccinate certain poultry categories following the Differentiating Infected from Vaccinated Animal (DIVA) strategy using both monovalent vaccines directed against avian influenza virus of subtype H7 and bivalent vaccines against H7 and H5 subtypes. |
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(9)

According to the vaccination plan, Italy intends to vaccinate certain poultry categories following the Differentiating Infected from Vaccinated Animal (DIVA) strategy using both monovalent vaccines directed against avian influenza virus of subtype H7 and bivalent vaccines against H7 and H5 subtypes.

| (10) | Only vaccines authorised in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (5) or Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (6) should be used. |
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(10)

Only vaccines authorised in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (5) or Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (6) should be used.

| (11) | In addition, surveillance and monitoring of vaccinated and unvaccinated poultry flocks as set out in the emergency vaccination plan should be carried out. |
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(11)

In addition, surveillance and monitoring of vaccinated and unvaccinated poultry flocks as set out in the emergency vaccination plan should be carried out.

| (12) | The measures provided for in Decision 2005/926/EC are no longer appropriate and that Decision should therefore be repealed. |
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(12)

The measures provided for in Decision 2005/926/EC are no longer appropriate and that Decision should therefore be repealed.

| (13) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(13)

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

Subject matter, scope and definitions

1.   This Decision lays down certain measures to be applied in Italy where emergency vaccination is carried out in certain poultry holdings at particular risk for introduction of avian influenza, including certain restrictions on movements and dispatch of poultry, hatching eggs of poultry and day-old chicks and certain products derived thereof.

2.   This Decision shall apply without prejudice to the measures taken by Italy in accordance with Directive 2005/94/EC to control outbreaks of low pathogenic avian influenza.

Article 2

The emergency vaccination plan

1.   The plan for emergency vaccination against low pathogenic avian influenza in Italy, as submitted by Italy to the Commission on 7 September 2007 (‘the emergency vaccination plan’) is approved.

2.   Italy shall carry out the emergency vaccination plan in the areas listed in Annex I (‘the emergency vaccination area’).

It shall ensure that the emergency vaccination plan is implemented effectively.

3.   The Commission shall publish the emergency vaccination plan on its website.

Article 3

Vaccines to be used

Italy shall ensure that poultry is vaccinated in accordance with the emergency vaccination plan with one of the following types of vaccine authorised in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004:

| (a) | an inactivated heterologous vaccine of avian influenza subtype H7; or |
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(a)

an inactivated heterologous vaccine of avian influenza subtype H7; or

| (b) | a bivalent inactivated heterologous vaccine containing both avian influenza subtypes H5 and H7. |
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(b)

a bivalent inactivated heterologous vaccine containing both avian influenza subtypes H5 and H7.

Article 4

Restrictions on movements of poultry

1.   The competent authority shall ensure that poultry that come from and/or originate from holdings in Italy where emergency vaccination has been carried out (‘emergency vaccination holdings’) are not moved to other parts of Italy or dispatched to other Member States.

2.   By way of derogation from paragraph 1 poultry for slaughter that come from and/or originate from emergency vaccination holdings may be moved to other parts of Italy or dispatched to other Member States, where the poultry originate from flocks which:

| (a) | before loading have been examined with favourable results in accordance with point 1 of Annex II, and |
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(a)

before loading have been examined with favourable results in accordance with point 1 of Annex II, and

| (b) | are dispatched to a slaughterhouse:






  (i) | within Italy and are slaughtered immediately upon arrival; or |
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(b)

are dispatched to a slaughterhouse:

(i)

within Italy and are slaughtered immediately upon arrival; or

| (ii) | in another Member State following the agreement of the Member State of destination and are slaughtered immediately upon arrival. |
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(ii)

in another Member State following the agreement of the Member State of destination and are slaughtered immediately upon arrival.

Article 5

Restrictions on movements of hatching eggs of poultry

The competent authority shall ensure that hatching eggs of poultry that come from and/or originate from emergency vaccination holdings are moved to other parts of Italy or dispatched to other Member States, only where the hatching eggs:

| (a) | originate from flocks which have been examined with favourable results in accordance with point 2 of Annex II; |
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(a)

originate from flocks which have been examined with favourable results in accordance with point 2 of Annex II;

| (b) | have been disinfected before movement or dispatch in accordance with a method approved by the competent authority; |
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(b)

have been disinfected before movement or dispatch in accordance with a method approved by the competent authority;

| (c) | are transported directly to the hatchery of destination; |
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(c)

are transported directly to the hatchery of destination;

| (d) | are traceable within the hatchery. |
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(d)

are traceable within the hatchery.

Article 6

Restrictions on movements of day-old chicks

The competent authority shall ensure that day-old chicks that come from and/or originate from emergency vaccination holdings are moved to other parts of Italy or dispatched to other Member States, only where the day-old chicks:

| (a) | originate from hatching eggs of poultry which satisfy the conditions set out in Article 5; |
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(a)

originate from hatching eggs of poultry which satisfy the conditions set out in Article 5;

| (b) | are placed in a poultry house or shed where there are no resident poultry. |
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(b)

are placed in a poultry house or shed where there are no resident poultry.

Article 7

Health certification for intra-Community trade of consignments of poultry, hatching eggs of poultry and day-old chicks

The competent authority shall ensure that health certificates for intra-Community trade in poultry, hatching eggs of poultry and day-old chicks that come from and/or originate from Italy include the words:

‘The animal health conditions of this consignment are in accordance with Decision 2007/638/EC’.

Article 8

Restrictions on movements of table eggs

The competent authority shall ensure that table eggs that come from and/or originate from emergency vaccination holdings are moved to other parts of Italy or dispatched to other Member States, only where the eggs:

| (a) | originate from flocks which have been examined with favourable results in accordance with point 2 of Annex II; |
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(a)

originate from flocks which have been examined with favourable results in accordance with point 2 of Annex II;

| (b) | are directly transported to:






  (i) | a packing centre designated by the competent authority and are packed in disposable packaging and comply with the biosecurity measures required by the competent authority, or |
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(b)

are directly transported to:

(i)

a packing centre designated by the competent authority and are packed in disposable packaging and comply with the biosecurity measures required by the competent authority, or

| (ii) | an establishment for the manufacture of egg products as set out in Chapter II of Section X of Annex III to Regulation (EC) No 853/2004 where they are to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004. |
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(ii)

an establishment for the manufacture of egg products as set out in Chapter II of Section X of Annex III to Regulation (EC) No 853/2004 where they are to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004.

Article 9

Restrictions on movements of poultrymeat, minced meat, meat preparations, mechanically separated meat and meat products consisting of or containing poultrymeat

1.   The competent authority shall ensure that poultrymeat that comes from and/or originates from emergency vaccination holdings is moved to other parts of Italy or dispatched to other Member States, only where the meat is:

| (a) | obtained from poultry that complies with Article 4; |
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(a)

obtained from poultry that complies with Article 4;

| (b) | produced in accordance with Annex II and Sections II and III of Annex III to Regulation (EC) No 853/2004 and subject to controls in accordance with Sections I, II, III, and Chapters V and VII of Section IV of Annex I to Regulation (EC) No 854/2004. |
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(b)

produced in accordance with Annex II and Sections II and III of Annex III to Regulation (EC) No 853/2004 and subject to controls in accordance with Sections I, II, III, and Chapters V and VII of Section IV of Annex I to Regulation (EC) No 854/2004.

2.   The competent authority shall ensure that minced meat, meat preparations, mechanically separated meat and meat products consisting of or containing poultrymeat that come from and/or originate from emergency vaccination holdings are moved to other parts of Italy or dispatched to other Member States, only where such products are produced:

| (a) | from meat that complies with paragraph 1; |
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(a)

from meat that complies with paragraph 1;

| (b) | in accordance with Sections V and VI of Annex III to Regulation (EC) No 853/2004. |
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(b)

in accordance with Sections V and VI of Annex III to Regulation (EC) No 853/2004.

Article 10

Monitoring and surveillance

Monitoring and surveillance of vaccinated and unvaccinated poultry flocks, as set out in the emergency vaccination plan, shall be carried out.

Article 11

Reports

Italy shall submit to the Commission a preliminary report on the implementation of the emergency vaccination plan by 1 November 2007 at the latest, and thereafter submit quarterly reports within one month of the end of each quarter.

The Commission shall ensure that the Standing Committee on the Food Chain and Animal Health is informed of those reports.

Article 12

Review of measures

The measures provided for in this Decision shall be reviewed in the light of the development of the epidemiological situation in Italy and any new information that becoms available.

Article 13

Repeal

Decision 2005/926/EC is repealed.

Article 14

Applicability

This Decision shall apply from 24 September 2007 until 31 March 2008.

Article 15

Addresses

This Decision is addressed to the Italian Republic.

Done at Brussels, 24 September 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 10, 14.1.2006, p. 16.

1

(2)  
  OJ L 337, 22.12.2005, p. 60.

2

(3)  The EFSA Journal (2005) 266, 1-21; Animal health and welfare aspects of Avian Influenza.

3

(4)  The EFSA Journal (2007) 489, Scientific Opinion on ‘Vaccination against avian influenza of H5 and H7 subtypes in domestic poultry and captive birds’.

4

(5)  
  OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58).

5

(6)  
  OJ L 136, 30.4.2004, p. 1. Regulation as last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).

6

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ANNEX I

EMERGENCY VACCINATION AREA

Veneto Region

| Verona Province |
| --- |
| ALBAREDO D'ADIGE | |
| ANGIARI | |
| ARCOLE | |
| BELFIORE | |
| BONAVIGO | |
| BOVOLONE | |
| BUTTAPIETRA | |
| CALDIERO | 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 | |
| SALIZZOLE | |
| SAN BONIFACIO | area to the south of the A4 motorway |
| SAN GIOVANNI LUPATOTO | area to the south of the A4 motorway |
| SANGUINETTO | |
| SAN MARTINO BUON ALBERGO | area to the south of the A4 motorway |
| SAN PIETRO DI MORUBIO | |
| SOAVE | area to the south of the A4 motorway |
| SOMMACAMPAGNA | area to the south of the A4 motorway |
| 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 | |

Verona Province

ALBAREDO D'ADIGE

ANGIARI

ARCOLE

BELFIORE

BONAVIGO

BOVOLONE

BUTTAPIETRA

CALDIERO

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

SALIZZOLE

SAN BONIFACIO

area to the south of the A4 motorway

SAN GIOVANNI LUPATOTO

area to the south of the A4 motorway

SANGUINETTO

SAN MARTINO BUON ALBERGO

area to the south of the A4 motorway

SAN PIETRO DI MORUBIO

SOAVE

area to the south of the A4 motorway

SOMMACAMPAGNA

area to the south of the A4 motorway

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

Lombardy Region

| Brescia Province |
| --- |
| ACQUAFREDDA | |
| ALFIANELLO | |
| BAGNOLO MELLA | |
| BASSANO BRESCIANO | |
| BORGOSATOLLO | |
| BRESCIA | area to the south of the A4 motorway |
| CALCINATO | area to the south of the A4 motorway |
| CALVISANO | |
| CAPRIANO DEL COLLE | |
| CARPENEDOLO | |
| CASTENEDOLO | area to the south of the A4 motorway |
| CIGOLE | |
| DELLO | |
| DESENZANO DEL GARDA | area to the south of the A4 motorway |
| FIESSE | |
| FLERO | |
| GAMBARA | |
| GHEDI | |
| GOTTOLENGO | |
| ISORELLA | |
| LENO | |
| LONATO | area to the south of the A4 motorway |
| MANERBIO | |
| MILZANO | |
| MONTICHIARI | |
| MONTIRONE | |
| OFFLAGA | |
| PAVONE DEL MELLA | |
| PONCARALE | |
| PONTEVICO | |
| POZZOLENGO | area to the south of the A4 motorway |
| PRALBOINO | |
| QUINZANO D'OGLIO | |
| REMEDELLO | |
| REZZATO | area to the south of the A4 motorway |
| SAN GERVASIO BRESCIANO | |
| SAN ZENO NAVIGLIO | |
| SENIGA | |
| VEROLANUOVA | |
| VEROLAVECCHIA | |
| VISANO | |
| Mantova Province |
| CASTIGLIONE DELLE STIVIERE | |
| CAVRIANA | |
| CERESARA | |
| GOITO | |
| GUIDIZZOLO | |
| MARMIROLO | |
| MEDOLE | |
| MONZAMBANO | |
| PONTI SUL MINCIO | |
| ROVERBELLA | |
| SOLFERINO | |
| VOLTA MANTOVANA | |

Brescia Province

ACQUAFREDDA

ALFIANELLO

BAGNOLO MELLA

BASSANO BRESCIANO

BORGOSATOLLO

BRESCIA

area to the south of the A4 motorway

CALCINATO

area to the south of the A4 motorway

CALVISANO

CAPRIANO DEL COLLE

CARPENEDOLO

CASTENEDOLO

area to the south of the A4 motorway

CIGOLE

DELLO

DESENZANO DEL GARDA

area to the south of the A4 motorway

FIESSE

FLERO

GAMBARA

GHEDI

GOTTOLENGO

ISORELLA

LENO

LONATO

area to the south of the A4 motorway

MANERBIO

MILZANO

MONTICHIARI

MONTIRONE

OFFLAGA

PAVONE DEL MELLA

PONCARALE

PONTEVICO

POZZOLENGO

area to the south of the A4 motorway

PRALBOINO

QUINZANO D'OGLIO

REMEDELLO

REZZATO

area to the south of the A4 motorway

SAN GERVASIO BRESCIANO

SAN ZENO NAVIGLIO

SENIGA

VEROLANUOVA

VEROLAVECCHIA

VISANO

Mantova Province

CASTIGLIONE DELLE STIVIERE

CAVRIANA

CERESARA

GOITO

GUIDIZZOLO

MARMIROLO

MEDOLE

MONZAMBANO

PONTI SUL MINCIO

ROVERBELLA

SOLFERINO

VOLTA MANTOVANA

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ANNEX II

EXAMINATION, SAMPLING AND TESTING PROCEDURES IN RELATION TO MOVEMENTS REFERRED TO IN ARTICLES 4, 5 AND 8

Point 1

Before movement of poultry for slaughter referred to in Article 4(2) the official veterinarian must carry out:

| (a) | a check of the production and health records of the holding; |
| --- | --- |

(a)

a check of the production and health records of the holding;

| (b) | a clinical inspection in each production unit, including an evaluation of its clinical history and clinical examinations of the poultry within 72 hours prior to the time of departure with particular attention to the sentinel birds; |
| --- | --- |

(b)

a clinical inspection in each production unit, including an evaluation of its clinical history and clinical examinations of the poultry within 72 hours prior to the time of departure with particular attention to the sentinel birds;

| (c) | the collection of the following samples:






  — | vaccinated poultry: 20 blood samples for using an appropriate DIVA strategy assay within 72 hours prior to the time of departure; |
| --- | --- | --- |

(c)

the collection of the following samples:

—

vaccinated poultry: 20 blood samples for using an appropriate DIVA strategy assay within 72 hours prior to the time of departure;

| (d) | the collection of the following samples, where the result of the checks and clinical inspection and examinations referred to in (a), (b) and (c) are not satisfactory:






  — | sentinel birds: 20 tracheal/oro-pharyngeal and 20 cloacal swabs and 20 blood samples for serology using the HI test within 72 hours prior to the time of departure. |
| --- | --- | --- |

(d)

the collection of the following samples, where the result of the checks and clinical inspection and examinations referred to in (a), (b) and (c) are not satisfactory:

—

sentinel birds: 20 tracheal/oro-pharyngeal and 20 cloacal swabs and 20 blood samples for serology using the HI test within 72 hours prior to the time of departure.

Point 2

Before the first movement and thereafter at least every 30 days of hatching eggs and table eggs referred to in Articles 5 and 8, the official veterinarian must carry out:

| (a) | a clinical inspection of the parent or layer poultry in each production unit, including an evaluation of its clinical history and clinical examinations of the sentinel birds present in those flocks; |
| --- | --- |

(a)

a clinical inspection of the parent or layer poultry in each production unit, including an evaluation of its clinical history and clinical examinations of the sentinel birds present in those flocks;

| (b) | the collection of 10 blood samples from sentinel birds. However, if necessary, 20 samples for testing with the iIFA-test shall also be taken. |
| --- | --- |

(b)

the collection of 10 blood samples from sentinel birds. However, if necessary, 20 samples for testing with the iIFA-test shall also be taken.

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