2007D0268 — EN — 10.06.2009 — 001.001

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►B COMMISSION DECISION of 13 April 2007 on the implementation of surveillance programmes for avian influenza in poultry and wild birds to be carried out in the Member States and amending Decision 2004/450/EC (notified under document number C(2007) 1554) (2007/268/EC) (OJ L 115, 3.5.2007, p.3)

Amended by:

Official Journal No page date ►M1 COMMISSION DECISION of 8 June 2009 L 145 45 10.6.2009









▼B

COMMISSION DECISION

of 13 April 2007

on the implementation of surveillance programmes for avian influenza in poultry and wild birds to be carried out in the Member States and amending Decision 2004/450/EC

(notified under document number C(2007) 1554)

(2007/268/EC)







THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field ( 1 ) and in particular the fourth subparagraph of Article 24(2) and Article (10) thereof, 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 ( 2 ) and in particular Article 4(2) thereof, Whereas: (1) Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field lays down the procedures governing the Community’s financial contribution towards programmes for the eradication, control and monitoring of animal diseases. (2) Decision 90/424/EEC, as amended by Decision 2006/53/EC ( 3 ), provides that Community financial assistance may be granted to Member States for those eradication measures carried out by the Member States to combat low pathogenic avian influenza (LPAI) strains known to have the potential to mutate to highly pathogenic avian influenza (HPAI). In addition, Article 24(2) of Decision 90/424/EEC provides that Member States are to submit to the Commission, each year by 30 April at the latest, the annual or multi-annual programmes starting in the following year for which they wish to receive a financial contribution from the Community. (3) Council Directive 92/40/EEC of 19 May 1992 introducing Community measures for the control of avian influenza ( 4 ) defines the Community control measures to be applied in the event of an outbreak of highly pathogenic avian influenza (HPAI) in poultry. However, it does not provide for the control of low pathogenic avian influenza (LPAI) of H5 and H7 subtypes or for regular surveillance of that disease in poultry and wild birds. (4) Since 2002, Member States have been implementing mandatory surveys for avian influenza in domestic poultry by submitting yearly surveillance programmes to the Commission, as provided for in Commission Decisions 2002/649/EC ( 5 ), 2004/111/EC ( 6 ), 2005/464/EC ( 7 ) and 2006/101/EC ( 8 ). (5) Directive 2005/94/EC provides for certain preventive measures relating to the surveillance and early detection of avian influenza. The final date for the transposition of that Directive by the Member States is 1 July 2007 and it provides for the repeal of Directive 92/40/EEC as of that date. (6) The Community measures for the control of avian influenza provided for in Directive 2005/94/EC also cover the control of outbreaks of LPAI caused by avian influenza of H5 and H7 subtypes in poultry. In order to detect the possible circulation of those viruses in poultry flocks, compulsory surveillance programmes are to be implemented by the Member States. Those control measures aim at preventing the spread of LPAI of H5 and H7 subtypes before they become widespread in the domestic poultry population so that the risk of a mutation into HPAI with possibly devastating consequences may be prevented. (7) Directive 2005/94/EC also provides for surveillance programmes to be carried out in wild birds in order to contribute, on the basis of a regularly updated risk assessment, to the knowledge on the threats posed by wild birds in relation to any influenza virus of avian origin in birds. (8) It is important to further strengthen surveillance activities given recent developments as regards the widespread occurrence of HPAI H5N1 in wild birds in Europe, taking into account the results of the surveys carried out in the Member States between 2003 and 2006 and the scientific work recently undertaken by European Food Safety Authority (EFSA) ( 9 ) in collaboration with the ORNIS Scientific Working Group of the European Commission’s Environment Directorate-General. Those bodies will continue their work and outcomes thereof may lead to further updating. (9) When implementing surveillance programmes in wild birds full regard shall be paid to the requirements of Council Directive 79/409/EEC ( 10 ) on the protection and conservation of all naturally occurring wild bird species in the Community. (10) Commission Decision 2004/450/EC of 29 April 2004 laying down standard requirements for the content of applications for Community financing for programmes for the eradication, monitoring and control of animal diseases ( 11 ), lays down standard requirements for the content of applications for Community financing programmes for the eradication, monitoring and control of animal diseases. (11) As Decision 90/424/EC, now provides that a Community financial contribution is to be granted for expenditure incurred by the Member States for the financing of national programmes for the eradication, control and monitoring of certain animal diseases, including avian influenza, Member States may submit to the Commission surveillance programmes for avian influenza for a financial contribution from the Community not later than 30 April each year pursuant to Article 24(2) of Decision 90/424/EEC. Decision 2004/450/EC should be amended to lay down standard requirements for the content of applications for Community financing for avian influenza surveillance programmes. (12) Decision 2004/450/EC should therefore be amended accordingly. (13) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee of the Food Chain and Animal Health, Whereas: HAS ADOPTED THIS DECISION:







Article 1

Approval of surveillance programmes for avian influenza

The surveillance programmes for avian influenza in poultry and wild birds to be carried out by Member States, in accordance with Article 4(1) of Directive 2005/94/EC, shall comply with the guidelines set out in Annexes I and II to this Decision.

Article 2

Amendments to Decision 2004/450/EC

Decision 2004/450/EC is amended as follows:

1. in Article 1, the following point (c) is added: ‘(c) in respect of the animal disease referred to in Annex I, Part C, at least the information set out in Annex IV.’;

2. in Annex I, the following Part C is added: ‘PART C Disease referred to in Article 1(c) avian influenza.’;

3. A new Annex IV, the text of which is set out in Annex III to the present Decision, is added.

Article 3

This Decision is addressed to the Member States.









ANNEX I

Guidelines on the implementation of surveillance programmes for avian influenza in poultry to be carried out in the Member States

A. Objectives, general requirements and criteria for surveillance

A.1. Objectives

Serological surveillance for LPAI subtypes H5 and H7 in poultry shall aim at:

1. Detecting sub-clinical infections with LPAI of subtypes H5 and H7 thereby complementing early detection systems and subsequently preventing possible mutation of these viruses to HPAI.

2. Detecting infections of LPAI H5 and H7 subtypes in specifically targeted poultry populations at specific risk for infection due to their husbandry system or the susceptibility of specific species.

3. Contributing to the demonstration of a free status of a certain country, region or compartment from notifiable avian influenza in the frame of international trade according to OIE rules.

A.2. General requirements and criteria

1. Sampling shall not extend beyond 31 December of the year of implementation of the programme. For poultry, sampling shall cover a period appropriate to production periods for each poultry category as required.

2. In order to save resources, samples collected for other purposes are recommended.

3. Testing of samples shall be carried out at national laboratories for avian influenza (NL) in Member States or by other laboratories authorised by the competent authorities and under the control of the NL.

▼M1

4. The competent authority shall ensure that all positive and negative results of both serological and virological laboratory investigations obtained during surveillance are reported to the Commission through the Commission’s online system. These results must be reported every three months and entered into the online system within four weeks following the end of the three months period.

▼B

5. All avian influenza virus isolates shall be submitted to the CRL in accordance with Community legislation, unless a derogation according to paragraph 4 of Chapter V (Differential diagnosis) in the diagnostic manual laid down in Decision 2006/437/EC ( 12 ) is granted. Viruses of H5/H7 subtype shall be submitted without delay and shall be subjected to the standard characterisation tests (nucleotide sequencing/IVPI) according to that Diagnostic Manual.

6. Whenever possible, NLs shall submit to the CRL, H5 or H7 positive sera collected from Anseriformes in order that an archive be established to facilitate future test development.

B. Surveillance for avian influenza in poultry

1. All positive findings shall be retrospectively investigated at the holding and the conclusions of this investigation shall be reported to the Commission and the CRL.

▼M1

2. Specific protocols to accompany the sending of samples and diagnostic material to the CRL shall be provided by the CRL. A good exchange of information between the CRL and the NL must be ensured. The CRL shall provide technical support and keep an enlarged stock of diagnostic reagents.

▼B

3. Blood samples for serological examination shall be collected from all species of poultry including those reared in free-range systems, from at least 5 to 10 birds (except ducks geese and quail) per holding, and from the different sheds, if more than one shed is present on a holding. In case of several sheds the sample size per holding should be increased appropriately. It is recommended to take at least five birds per shed.

4. Sampling shall be stratified throughout the territory of the whole Member State, so that samples can be considered as representative for the whole of the Member State, taking into account: (a) the number of holdings to be sampled (excluding ducks, geese and turkeys); that number shall be defined so as to ensure the identification of at least one infected holding if the prevalence of infected holdings is at least 5 %, with a 95 % confidence interval (see Table 1); and (b) the number of birds sampled from each holding shall be defined so as to ensure 95 % probability of identifying at least one positive bird if the prevalence of sero-positive birds is ≥ 30 %.

5. Based on a risk assessment and the specific situation in the Member State concerned, the sampling design shall also consider: (a) the types of production and their specific risks, shall be targeted to free range production, outdoor keeping and backyard flocks plus taking into account other factors such as multi-age, use of surface water, a relatively longer life span, the presence of more than one species on the holding or other relevant factors; (b) the number of turkey, duck and goose holdings to be sampled shall be defined to ensure the identification of at least one infected holding if the prevalence of infected holdings is at least 5 %, with a 99 % confidence interval (see Table 2); (c) where significant number of holdings producing game, ratites and quails are present in a Member State they shall be included in the programme. With regard to quails only adult (or laying) breeders shall be sampled; (d) the time period for sampling shall coincide with seasonal production. However, where appropriate, sampling can be adapted to other identified periods at local level, during which time the presence of other poultry hosts on a holding might pose a greater risk for disease introduction; (e) in case a significant number of backyard flocks are present, surveillance could be extended to them; (f) Member States that must carry out sampling for Newcastle disease to maintain their status as Newcastle disease non-vaccinating countries in accordance with Commission Decision 94/327/EC ( 13 ) may utilise these samples from breeding flocks for the surveillance of H5/H7 antibodies.







Table 1 Number of holdings to be sampled of each poultry category (except turkey, duck and goose holdings) Number of holdings per poultry category per Member State Number of holdings to be sampled Up to 34 All 35-50 35 51-80 42 81-250 53 > 250 60







Table 2 Number of turkey, duck and goose holdings to be sampled Number of holdings per Member State Number of holdings to be sampled Up to 46 All 47-60 47 61-100 59 101-350 80 > 350 90

C. Specific requirements for detection of infections with H5/H7 subtypes of avian influenza in ducks, geese and quail

1. Blood samples for serological testing shall be taken preferably from birds which are kept outside in fields.

2. From each selected holding 40-50 blood samples shall be taken for serological testing.

3. In case commercial flocks are not present, surveillance could be carried out on backyard flocks.

D. Laboratory testing

1. Laboratory tests shall be carried out in accordance with the avian influenza diagnostic manual (Commission Decision 2006/437/EC) laying down the procedures for the confirmation and differential diagnosis of avian influenza (including examination of sera from ducks and geese by haemagglutination-inhibition (HI) test).

2. However, if laboratory tests not laid down in the avian influenza diagnostic manual nor described in the OIE Terrestrial Manual are envisaged, Member States shall provide the necessary validation data to the CRL, in parallel to submitting their programme to the Commission for approval.

▼M1

3. All positive serological findings shall be confirmed by the NL by a haemagglutination-inhibition test, using designated strains supplied by the CRL: (a) for H5 subtype: (i) Initial testing using teal/England/7894/06 (H5N3); (ii) Testing of all positives with chicken/Scotland/59(H5N1) to eliminate N3 cross reactive antibodies (b) for H7 subtype: (i) Initial testing using Turkey/England/647/77 (H7N7); (ii) Testing of all positive with African Starling/983/79 (H7N1) to eliminate N7 cross reactive antibodies.

▼B









ANNEX II

Guidelines on the implementation of surveillance programmes for avian influenza in wild birds to be carried out in the Member States

A. Objectives, general requirements and criteria for surveillance

A1. Objectives

Virological surveillance for avian influenza in wild birds aim to identify the risk of introduction of AI viruses (LPAI and HPAI) to domestic poultry by:

— ensuring early detection of HPAI H5N1 by investigating increased incidence of morbidity and mortality in wild birds, in particular in selected ‘higher risk’ species.

— in the event that HPAI H5N1 is detected in wild birds, then surveillance of live and dead wild birds shall be enhanced to determine whether wild birds of other species can act as asymptomatic carriers or ‘bridge species’ (see Part E of this Annex).

— continuing a ‘baseline’ surveillance of different species of free living migratory birds as part of continuous monitoring of LPAI viruses. Anseriformes (water fowl) and Charadriiformes (shorebirds and gulls) shall be the main sampling targets to assess if they carry LPAI viruses of H5 and H7 subtypes (which would in any case also detect HPAI H5N1 and other HPAI, if present). ‘Higher risk species’ must be targeted in particular.

A2. General requirements and criteria

1. Sampling shall not extend beyond 31 December of the year of implementation of the programme.

2. Testing of samples shall be carried out at national laboratories for avian influenza (NL) in Member States or by other laboratories authorised by the competent authorities and under the control of the NL.

▼M1

3. The competent authority shall ensure that all positive and negative results of both serological and virological laboratory investigations obtained during surveillance are reported to the Commission through the Commission’s online system. These results must be reported every three months and entered into the online system within four weeks following the end of the three months period.

▼B

4. All avian influenza virus isolates of cases in wild birds shall be submitted to the CRL in accordance with Community legislation, unless a derogation according to paragraph 4 of Chapter V under Differential diagnosis in the avian influenza Diagnostic Manual laid down in Decision 2006/437/EC is granted. Viruses of H5/H7 subtype shall be submitted without delay and shall be subjected to the standard characterisation tests (nucleotide sequencing/IVPI) according to the said diagnostic manual.

B. Surveillance for avian influenza in wild birds

Design and implementation

Close cooperation with epidemiologists and ornithologists and the competent authority for nature conservation shall be ensured for designing the surveillance, assisting in species identification and optimising sampling. The design of the surveillance shall be adapted to the national situation as regards selection of species to be sampled according to species predominance and bird population sizes. Sampling must consider the seasonality of migration patterns, which may vary in different Member States. It shall take into account the behaviour of bird species as regards migratory flyways, main habitats, gregariousness and degree of mixing during migration and the results obtained from previous surveillance during 2003-2006. In addition, continuous review and feedback will be provided through the AI wild bird surveillance working group who are analysing new data as they become available.

For H5N1 HPAI, all those factors shall be considered in relation to the probability of wild bird exposure to infected poultry and wild birds in outbreak areas and the probability of contact of wild birds with domestic poultry in the poultry husbandry systems in the different Member States.

To assess those probabilities, the decision trees and tables in the opinion of EFSA ( 14 ), which were drawn up in collaboration with the European Commission's Environment Directorate-General can provide an effective tool for Member States’ local risk assessments to adapt to an evolving situation based on a close collaboration and exchange of views between Member States.

Liaisons with bird conservation/watching institutions and ringing stations shall be encouraged. Sampling, where appropriate, shall be carried out under the supervision of staff from these groups/stations, by hunters and other ornithologically skilled persons.

1. Passive surveillance of sick and dead wild birds shall be targeted on: (a) areas where increased incidence of morbidity and mortality in wild birds occurs; (b) areas close to the sea, lakes and waterways where birds were found dead; and in particular when these areas are in proximity to domestic poultry farms; (c) birds belonging to identified ‘higher risk’ species listed in part D and other wild birds living in close proximity with them.

2. In addition, investigations of living and dead wild birds in areas where H5N1 cases have been detected shall ideally be targeted on birds: (a) wild birds or poultry to possibly identify asymptomatic carriers; (b) in areas epidemiologically linked to these cases; (c) coming possibly in close contact to domestic poultry holdings (Protection zone, surveillance zone and area B), which might function as ‘bridge species’, in particular those that are listed in part E.

3. Active surveillance on living and clinically healthy and/or clinically diseased, injured or hunted ( 15 ) birds shall be targeted on: (a) migratory birds belonging to the orders of Anseriformes (water fowl) and Charadriiformes (shorebirds and gulls); (b) at identified areas for concentration and mixing of high number of migratory birds involving different species and in particular when these areas are in proximity to domestic poultry farms; (c) a selection of higher risk species ( 16 ).

Sampling procedures

1. Oropharyngeal and cloacal swabs for virological examination shall be taken from apparently healthy free living birds. If for any reason it is impractical to take cloacal swabs from live birds carefully collected fresh faeces samples may serve as an alternative. However, traceability in case of mixed sites frequented by different bird species must be ensured.

2. Cloacal and tracheal/oropharyngeal swabs and/or tissues (namely the brain, heart, lung, trachea, kidney and intestines) from wild birds found dead or shot shall be sampled for virus isolation and molecular detection (PCR).

3. Specific care has to be taken for the storage and transport of samples. Swabs must be chilled immediately on ice or with frozen gel packs and submitted to the laboratory as quickly as possible. Samples must not be frozen unless absolutely necessary. If available, swabs must be placed in antibiotic or specific virus transport medium so that they are fully immersed. Placing samples in medium for transportation must be done in addition to chilling and not as an alternative to chilling. In the absence of such medium, swabs must be returned to their casing and submitted dry. If rapid transport within 48 hours to the laboratory (in transport medium at 4° Celsius) is not guaranteed, samples shall be immediately frozen, stored and then transported on dry ice. Storage and transport of samples may be affected by a variety of factors so the method selected must be fit for purpose.

4. Sampling procedures shall be carried out in accordance with the avian influenza diagnostic manual (Commission Decision 2006/437/EC) laying down the procedures for the confirmation and differential diagnostic of avian influenza.

C. Laboratory testing

1. Laboratory tests shall be carried out in accordance with the avian influenza diagnostic manual (Commission Decision 2006/437/EC) laying down the procedures for the confirmation and differential diagnostic of avian influenza.

2. However, if laboratory tests not laid down in the avian influenza diagnostic manual nor described in the OIE Terrestrial Manual are envisaged, Member States shall provide the necessary validation data to the CRL, in parallel to submitting their programme to the Commission for approval.

3. All samples collected in the surveillance for avian influenza in wild birds shall be tested as soon as possible by molecular techniques if available and according to the diagnostic manual (Commission Decision 2006/437/EC). These tests shall only be carried out in laboratories able to guarantee quality assurance and using methods recognised by the CRL for avian influenza. In addition, methods used must have produced acceptable results in the most recent comparative ring test of national laboratories. Initial screening using M gene PCR is recommended, with rapid testing of positives for H5 (but within two weeks) and in case of a positive finding analysis of the cleavage site must be undertaken as soon as possible to determine whether or not it has a highly pathogenic avian influenza (HPAI) or a low pathogenic avian influenza (LPAI) motif. If H5 HPAI is confirmed further analysis to determine the N type must be done rapidly (even this can only provide evidence eliminating N1).

4. At the laboratory, pooling of up to five samples taken from the same species collected at the same site and same time may be permitted when it can be ensured that, in case of a positive finding, the individual samples can be identified and retested.

5. Serological surveillance shall not be applied for avian influenza investigations in wild birds because serological methods cannot distinguish between HP and LP strains and antibody findings do not allow inference in relation to the likely location where wild birds might have become infected. However, serological surveillance might be important to study in which resident or migrating bird species H5/H7 viruses are/were prevalent (or endemic). Such analysis shall only be performed by specialised laboratories using a carefully selected panel of antigens to ensure the detection of haemagglutinin specific antibodies (i.e. to eliminate the possibility of interference from N specific antibodies).

D.



List of wild bird species presenting a higher risk in relation to avian influenza (1) Common name Scientific name Bewick's Swan Cygnus columbianus Whooper Swan Cygnus cygnus Mute Swan Cygnus olor Geese Pink-footed Goose Anser brachyrhynchus Bean Goose Anser fabalis Greater White-fronted Goose (European race) Anser albifrons albifrons Lesser White-fronted Goose Anser erythropus Greylag Goose Anser anser Barnacle Goose Branta leucopsis Brent Goose Branta bernicla Red-breasted Goose Branta ruficollis Canada Goose Branta canadensis Ducks Eurasian Wigeon Anas penelope Common Teal Anas crecca Mallard Anas platyrhynchos Northern Pintail Anas acuta Garganey Anas querquedula Northern Shoveler Anas clypeata Marbled Teal Marmaronetta angustirostris Red-crested Pochard Netta rufina Common Pochard Aythya ferina Tufted Duck Aythya fuligula Waders Northern Lapwing Vanellus vanellus Eurasian Golden Plover Pluvialis apricaria Black-tailed Godwit Limosa limosa Ruff Philomachus pugnax Gulls Black-headed Gull Larus ridibundus Common Gull Larus canus (1) This list is not a limitating list but is only meant to identify migratory species that may pose a high risk for introduction of avian influenza into the Community based on their migratory pattern involving areas where H5N1 HPAI has either occurred in wild birds or poultry. It is based on the Scientific opinion on ‘Migratory birds and their possible role in the spread of highly pathogenic avian influenza’ adopted by the Animal Health and Welfare Panel of EFSA on 12 May 2006 and the work carried out by ORNIS Committee and contractors to European Commission’s Environment Directorate-General. However, this list could be updated following results of further scientific studies as they become available and based on the risk assessment carried out by national authorities taking into account their specific ornithological situation.

E.



List of birds living in proximity to domestic poultry (1) Common name Scientific name Probability of contact with poultry Group 1. Species intimately associated with poultry production in Europe Domestic Goose Anser anser domesticus High Domestic Mallard Anas platyrhynchos High Domestic Muscovy Duck Cairina moschata High Feral Pigeon Columba livia High House Sparrow Passer domesticus High Group 2. Species which may share farmland also used by domesticated poultry in north Europe Eurasian Golden Plover Pluvialis apricaria Low Northern Lapwing Vanellus vanellus Medium Black-headed Gull Larus ridibundus High Common Gull Larus canus High Herring Gull Larus argentatus Low Wood Pigeon Columba palumbus High Eurasian Collared Dove Streptopelia decaocto High Ring-necked Pheasant Phasianus colchicus High Larks species Alauda & Galerida spp Low Pipits Low Wagtails Medium Fieldfare Turdus pilaris Medium Redwing Turdus iliacus Medium Black-billed Magpie Pica pica High Eurasian Jackdaw Corvus monedula High Rook Corvus frugilegus Medium Carrion Crow Corvus corone Medium Raven Corvus corax Low Starling Sturnus vulgaris High Spotless Starling Sturnus unicolor High House Sparrow Passer domesticus High Eurasian Tree Sparrow Passer montanus High Finches Medium Buntings Miliaria, Emberiza spp Medium Group 3. Species which may share wetlands also used by domesticated water birds in Northern Europe Egrets Egretta spp. Low Herons Ardea and other spp. Medium Cormorant Phalacrocorax carbo Medium Storks Ciconia spp. Low Mute Swan Cygnus olor Medium Greylag Goose Anser anser Medium Canada Goose Branta canadensis Low Ducks Anas & Aythya spp. Low Mallard Anas platyrhynchos High Common Coot Fulica atra Medium Moorhen Gallinula chloropus Medium (1) This list is not an exhaustive list but is only meant to identify resident or non-migratory European bird species that live in proximity to domestic poultry (especially in NW Europe) and which have the theoretical potential to transfer HPAI H5N1 from potential asymptomatically infected wild birds (‘bridge species’). It is based on the Scientific opinion on ‘Migratory birds and their possible role in the spread of highly pathogenic avian influenza’ adopted by the Animal Health and Welfare Panel of EFSA on 12 May 2006 and the work carried out by ORNIS Committee and contractors by European Commission’s Environment Directorate-General (DG ENV). However, this list could be updated and expanded following results of further scientific studies as they become available. In particular, DG ENV has commissioned Wetland international and EURING to review, update and expand the preliminary analysis of higher risk species and sites in the light of H5N1 outbreaks in Europe in 2006, and to identify other High Risk bird species which might act as ‘bridge species’ between wild birds and poultry and/or humans in different parts of Europe. The results should be available by end of June 2007.









ANNEX III









‘ANNEX IV