COMMISSION DECISION

of 25 June 2010

on the implementation by Member States of surveillance programmes for avian influenza in poultry and wild birds

(notified under document C(2010) 4190)

(Text with EEA relevance)

(2010/367/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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), and in particular Article 10(4) 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:

Avian influenza is an infectious viral disease in birds, including poultry. Infections with avian influenza viruses in domestic poultry cause two main forms of that disease that are distinguished by their virulence. The low pathogenic form generally only causes mild symptoms, while the highly pathogenic form results in very high mortality rates in most poultry species. That disease may have a severe impact on the profitability of poultry farming.

Directive 2005/94/EC sets out measures for the control of outbreaks, in poultry and other captive birds, of highly pathogenic avian influenza (HPAI) and low pathogenic avian influenza caused by avian influenza viruses of the H5 and H7 subtypes (LPAI), as defined in that Directive. Directive 2005/94/EC also provides for certain preventive measures relating to the surveillance and the early detection of avian influenza viruses.

Directive 2005/94/EC provides that compulsory surveillance programmes are to be implemented by the Member States. Those surveillance programmes aim at identifying the circulation of LPAI viruses in poultry, in particular in waterfowl poultry species, before they become widespread in the poultry population, so that control measures can be taken to possibly prevent a mutation into a HPAI virus which might have devastating consequences.

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 current knowledge on the threats posed by wild birds in relation to any influenza virus of avian origin in birds.

Commission Decision 2007/268/EC 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 (3) was adopted in order to lay down guidelines for the implementation of such surveillance programmes.

Since the date of adoption of that Decision, the experience gained in the Member States in carrying out surveillance programmes and advances in scientific knowledge and research conclusions, indicate that certain poultry species and poultry production categories are at a higher risk of becoming infected with avian influenza viruses than others, also taking into account the location of the holding and other risk factors.

The threat of the introduction of the HPAI virus of the H5N1 subtype from South East Asia to Europe by its westward spread during 2005 has prompted the adoption of additional measures for preparedness and early detection of that virus type in poultry and wild birds.

Commission Decision 2005/731/EC of 17 October 2005 laying down additional requirements for the surveillance of avian influenza in wild birds (4) requires that Member States arrange for the notification to the competent authorities of any abnormal mortality or significant disease outbreaks occurring in wild birds and in particular wild water birds. Sampling and laboratory testing for avian influenza virus must also be carried out.

It is appropriate to include the requirements laid down in Decision 2005/731/EC in the present Decision.

From 2006 to 2009, more than 350 000 wild birds have been sampled and tested for avian influenza. On average, surveillance in Member States was carried out by sampling 75 % of live birds and 25 % of sick or dead birds.

More than 1 000 birds found dead or sick have tested positive for HPAI of the H5N1 subtype, while only about five birds sampled as healthy live birds tested positive for that virus during that 4-year period. LPAI subtypes were almost exclusively isolated from samples taken from live birds.

The conclusions drawn up in the annual reports on avian influenza surveillance (5) in the Union compiled by the EU Reference Laboratory (EURL) for avian influenza, the scientific opinions of the European Food Safety Authority (EFSA) (6) , (7) , (8) and the work of the recently established Task Force on Animal Disease Surveillance (TFADS) have highlighted that certain amendments to the current surveillance strategy in poultry and wild birds should be introduced to further foster a risk-based approach which is deemed the most suitable surveillance strategy to inform competent authorities for disease prevention and control purposes aimed at protecting poultry and other captive bird holdings.

Risk-based surveillance should complement early detection systems for avian influenza infection in poultry, such as those already provided for in Article 2 of Commission Decision 2005/734/EC of 19 October 2005 laying down biosecurity measures to reduce the risk of transmission of highly pathogenic avian influenza caused by Influenza virus A subtype H5N1 from birds living in the wild to poultry and other captive birds and providing for an early detection system in areas at particular risk (9) and in Chapter II(2) of the Annex to Commission Decision 2006/437/EC of 4 August 2006 approving a Diagnostic Manual for avian influenza as provided for in Council Directive 2005/94/EC (10) .

The guidelines for surveillance for avian influenza in poultry and wild birds laid down in Decision 2007/268/EC should therefore be reviewed in the light of experience and scientific insight gained and replaced by the guidelines laid down in this Decision.

In the interests of consistency of Union legislation, sampling and laboratory testing should be carried out in accordance with the procedures laid down in Decision 2006/437/EC, unless stated otherwise.

In the interests of consistency of Union legislation, when implementing surveillance programmes in wild birds, full regard should be paid to the requirements of Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (11) in particular as regards the surveillance design and sampling procedures described in Sections 2 and 3 of Part 1 of Annex II to this Decision.

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

Member States shall take the necessary measures to ensure that the competent authorities make appropriate arrangements with wild bird observation and ringing organisations, hunting and other relevant organisations in order to ensure that those organisations are required to notify the competent authorities without delay of any abnormal mortality or significant disease outbreaks occurring in wild birds and in particular wild water birds.

Article 2

1. Member States shall ensure that immediately following receipt by the competent authority of any notification, as provided for in Article 1, and whenever no clear cause of disease other than avian influenza is identified, the competent authority shall arrange for:

appropriate samples to be collected from dead birds and if possible from other birds which have been in contact with the dead birds;

those samples must be subjected to laboratory tests for the detection of the avian influenza virus.

2. Sampling and testing procedures shall be carried out in accordance with Chapters II to VIII of the Diagnostic Manual for avian influenza approved by Decision 2006/437/EC.

3. Member States shall inform the Commission without delay in the event of the laboratory tests provided for in paragraph 1(b) showing positive results for highly pathogenic avian influenza virus (HPAI).

Article 3

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 4

Without prejudice to the requirements provided for in Union legislation, the competent authority shall ensure that all positive and negative results of both serological and virological investigations for avian influenza obtained under the surveillance programmes for poultry and wild birds are reported every 6 months to the Commission. They shall be submitted via the Commission’s online system each year by 31 July for the preceding 6 months (1 January to 30 June) and by 31 January for the preceding 6 months (1 July to 31 December).

Article 5

Decisions 2005/731/EC and 2007/268/EC are repealed.

Article 6

This Decision is addressed to the Member States.

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

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

(3) OJ L 115, 3.5.2007, p. 3.

(4) OJ L 274, 20.10.2005, p. 93.

(5) European Commission website: http://ec.europa.eu/food/animal/diseases/controlmeasures/avian/eu_resp_surveillance_en.htm

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

(7) The EFSA Journal (2008) 715, 1-161, Scientific Opinion on Animal health and welfare aspects of avian influenza and the risks of its introduction into the EU poultry holdings.

(8) The EFSA Journal (2006) 357, 1-46, Opinion on Migratory birds and their possible role in the spread of highly pathogenic Avian Influenza.

(9) OJ L 274, 20.10.2005, p. 105.

(10) OJ L 237, 31.8.2006, p. 1.

(11) OJ L 20, 26.1.2010, p. 7.

ANNEX I

Guidelines on the implementation of surveillance programmes for avian influenza in poultry

1. Objectives of surveillance programmes

The objectives of the surveillance programmes for avian influenza in poultry are to inform the competent authority of circulating avian influenza virus with a view to controlling the disease in accordance with Directive 2005/94/EC by the annual detection through active surveillance for:

(a) low pathogenic avian influenza (LPAI) of subtypes H5 and H7 in gallinaceous birds (namely chickens, turkeys, guinea fowl, pheasants, partridges and quails) and ratites thereby complementing other existing early detection systems;

(b) LPAI of subtypes H5 and H7 and highly pathogenic avian influenza (HPAI) in domestic waterfowl (namely ducks, geese and mallards for re-stocking supplies of game);

2. Surveillance design

Sampling and serological testing in poultry holdings shall be carried out in order to detect the presence of antibodies to avian influenza, as defined in Directive 2005/94/EC.

That active surveillance complements the early detection systems already in place in Member States, as provided for in Decision 2005/734/EC and in Chapter II of the Diagnostic Manual for avian influenza approved by Commission Decision 2006/437/EC (the Diagnostic Manual); in particular those implemented in poultry holdings that are deemed at being at a higher risk for avian influenza introduction.

Two main internationally recognised methods exist for animal disease surveillance: (a) risk-based surveillance; and (b) surveillance based on representative sampling.

2.1. Risk-Based Surveillance (RBS)

RBS shall be the preferred method for the carrying out of surveillance for avian influenza in a targeted and resource efficient way.

Member States choosing that method shall specify the relevant risk pathways for infection of poultry flocks and the sampling frame for poultry holdings identified as being at a higher risk of becoming infected with avian influenza.

The criteria and risk factors listed in Section 4.1 are not exhaustive, but give an indication of how to target sampling and testing of poultry species and poultry production categories in different husbandry systems. Depending of the individual animal health situation in the Member State concerned, they may need to be weighted differently.

2.2. Surveillance based on Representative Sampling

If a Member State is not in a position to carry out a sufficiently evidence based assessment of the risk pathways for infection of poultry flocks on its territory, it shall implement surveillance based on a representative sampling scheme. The number of poultry holdings to be sampled must correspond to those in Tables 1 and 2, depending on the poultry species.

Sampling for serological testing for avian influenza shall be stratified throughout the whole territory of the Member State, so that samples can be considered as representative for the whole of the Member State.

3. Target populations

The sampling of the following poultry species and production categories shall be included in the surveillance programme:

(a) laying hens;

(b) free range laying hens;

(c) chicken breeders;

(d) turkey breeders;

(e) duck breeders;

(f) geese breeders;

(g) fattening turkeys;

(h) fattening ducks;

(i) fattening geese;

(j) farmed game birds (gallinaceous) focusing on adult birds such as breeding birds;

(k) farmed game birds (waterfowl);

(l) ratites.

However, in the following specified exceptional circumstances, the following poultry categories may also be included:

(m) broilers, but only when: (i) they are kept in significant numbers in free range production and (ii) they are considered to pose a higher risk of infection with avian influenza;

(n) backyard flocks: they generally play a minor role in virus circulation and spread and sampling them is resource intensive; however, in certain Member States backyard flocks may pose a higher risk of avian influenza due to their presence in significant numbers, their proximity to commercial poultry holdings, involvement in local/regional trade and other criteria and risk factors as listed in Section 4.1 in particular as regards the species composition.

However, where a well reasoned justification as regards the level of risk is provided for a poultry production category (such as chicken breeders kept under high biosecurity conditions), it may also be omitted from the sampling.

4. Risk-based surveillance (RBS) method

The choice of RBS must be determined by an assessment at Member State level, which shall consider at least the following criteria and risk factors:

4.1. Criteria and Risk factors

4.1.1. Criteria and risk factors for virus introduction into poultry holdings due to direct or indirect exposure to wild birds in particular those of identified ‘target species’

(a) The location of the poultry holding in proximity to wet areas, ponds, swamps, lakes, rivers or sea shores where migratory wild water birds may gather.

(b) The location of the poultry holding in areas with a high density of migratory wild birds, in particular of those birds that are characterised as ‘target species’ (TS) for HPAI H5N1 detection and listed in Part 2 of Annex II.

(c) The location of poultry holding in proximity to resting and breeding places of migratory wild water birds, in particular where these areas are linked through migratory birds’ movements to areas where HPAI H5N1 is known to occur in wild birds or poultry.

(d) Poultry holdings with free range production, or poultry holdings where poultry or other captive birds are kept in the open-air in any premises in which contact with wild birds cannot be sufficiently prevented.

(e) Low biosecurity level in the poultry holding, including the method of storage of feed and the use of surface water.

4.1.2. Criteria and risk factors of virus spread within the poultry holding and between poultry holdings, as well as the consequences (impact) of the spread of avian influenza from poultry to poultry and between poultry holdings

(a) The presence of more than one poultry species in the same poultry holding, in particular the presence of domestic ducks and geese together with other poultry species.

(b) The type of poultry production and the poultry species on the holding for which surveillance data have shown an increased detection rate of avian influenza infection in the Member State, such as duck holdings and poultry intended for re-stocking supplies of game (in particular farmed mallards).

(c) The location of the poultry holding in areas with high densities of poultry holdings.

(d) Trade patterns, including imports and related intensity of movements, both direct and indirect, of poultry and other factors including vehicles, equipment and persons.

(e) The presence of long lived poultry categories and multi-age groups of poultry on the holding (such as layers).

4.2. Targeting of populations at risk

The level of targeting must reflect the number and local weighting of risk factors present on the poultry holding.

The competent authority may consider other risk factors in its assessment in designing its surveillance design which must be duly indicated and justified in their surveillance programme.

4.3. Targeting of poultry holdings to be sampled

Tables 1 and 2 may be used as a basis in order to determine the number of poultry holdings to be sampled per risk population.

5. Representative sampling method

Where representative sampling as referred to in Section 2.2 is carried out, the number of poultry holdings to be sampled shall be calculated based on the figures set out in Tables 1 and 2 according to the poultry species present on the poultry holding.

5.1. Number of poultry holdings to be sampled for serological testing for avian influenza

5.1.1. Number of poultry holdings (except duck, goose and mallard holdings) to be sampled

For each poultry production category, except those of ducks, geese and mallards, the number of poultry holdings to be sampled shall be defined so as to ensure the identification of at least one infected poultry holding where the prevalence of infected poultry holdings is at least 5 %, with a 95 % confidence interval.

Sampling shall be carried out according to Table 1:

Table 1

Number of poultry holdings (except duck, goose and mallard holdings) to be sampled in each poultry production category

Number of holdings per poultry production category per Member State Number of poultry holdings to be sampled Up to 34 All 35-50 35 51-80 42 81-250 53 > 250 60

5.1.2. Number of duck, goose and mallard holdings to be sampled (1)

The number of duck, goose and mallard holdings to be sampled shall be defined to ensure the identification of at least one infected poultry holding where the prevalence of infected poultry holdings is at least 5 %, with a 99 % confidence interval.

Sampling shall be carried out according to Table 2:

Table 2

Number of duck, goose and mallard holdings to be sampled

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

5.2. Number of poultry (birds) to be sampled in the poultry holding

The figures referred to in points 5.2.1 and 5.2.2 apply both to poultry holdings sampled on the basis of risk-based surveillance and on the basis of representative sampling.

5.2.1. Number of birds (except ducks, geese and mallards) to be sampled in the poultry holding

The numbers of birds to be sampled in the poultry holding shall be defined so as to ensure 95 % probability of identifying at least one bird that tests sero-positive for avian influenza, if the prevalence of sero-positive birds is ≥ 30 %.

Blood samples for serological examination shall be collected from all poultry production categories and poultry species from at least 5 to 10 birds (except ducks, geese and mallards) per poultry holding, and from the different sheds, where more than one shed is present on a holding.

In case of several sheds, samples shall be taken from at least five birds per shed.

5.2.2. Number of ducks, geese and mallards to be sampled in the holding

The numbers of ducks, geese and mallards to be sampled in the poultry holding shall be defined so as to ensure 95 % probability of identifying at least one bird that tests sero-positive for avian influenza where the prevalence of sero-positive birds is ≥ 30 %.

Twenty blood samples (2) shall be taken for serological testing from each selected poultry holding.

6. Sampling procedures for serological testing

The time period for sampling in the poultry holding shall coincide with seasonal production for each poultry production category and sampling may also be performed at the slaughterhouse. This sampling practice must not compromise the risk targeted approach according to the criteria and risk factors listed in Section 4.1.

In order to optimise efficiency and also to avoid the unnecessary entry of persons onto poultry holdings, sampling shall, whenever possible, be combined with sampling for other purposes, such as within the framework of Salmonella and Mycoplasma control. However, such combining must not compromise the requirements for risk based surveillance.

7. Sampling for virological testing

Sampling for virological testing for avian influenza shall not be used as an alternative to serological testing and must be performed solely within the framework of investigations to follow-up serological positive testing results for avian influenza.

8. Frequency and period for testing

The sampling of poultry holdings shall be carried out annually. However, on the basis of a risk assessment, Member States may decide to carry out sampling and testing more frequently. The justification for doing so must be detailed in the surveillance programme.

Sampling shall be carried out in accordance with the approved surveillance programme from 1 January to 31 December of the year of implementation of that programme.

9. Laboratory testing

The testing of samples shall be carried out at National Reference Laboratories for avian influenza (NRL) in Member States or by other laboratories authorised by the competent authorities and under the control of the NRL.

Laboratory tests shall be carried out in accordance with the Diagnostic Manual which lays down the procedures for the confirmation and differential diagnosis of avian influenza.

However, if a Member State wishes to use laboratory tests not laid down in the Diagnostic Manual, nor described in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE), those tests must first be deemed fit for that purpose by the EURL, based on validated data, before being used.

All positive serological findings shall be confirmed by the NRL by a haemagglutination-inhibition test, using designated strains supplied by the EURL:

(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.

All positive serological findings must be followed up at the poultry holding by epidemiological investigations and further sampling for testing by virological methods in order to determine, if active infection of avian influenza virus is present on the poultry holding. The conclusions of all those investigations shall be reported to the Commission.

All avian influenza virus isolates shall be submitted to the EURL in accordance with Union legislation according to the functions and the duties of the national reference laboratories as laid down in Annex VIII to Directive 2005/94/EC, unless a derogation has been granted as provided for in paragraph 4(d) of Chapter V of the Diagnostic Manual. Viruses of the H5/H7 subtype shall be submitted to the EURL without delay and shall be subjected to the standard characterisation tests (nucleotide sequencing/IVPI) according to the Diagnostic Manual.

The specific protocols provided by the EURL for the submission of samples and diagnostic material shall be used. The competent authorities shall ensure that there is a good exchange of information between the EURL and the NRL.

(1) A higher level of confidence in detection of duck and goose positive holdings is applied due to the evidence that infected duck and goose holdings are less likely than gallinaceous poultry to be detected by passive surveillance or early detection systems.

(2) The increase in sample size compared to 5.2.1 is necessary due to the lower sensitivity of the diagnostic test when used in waterfowl.