Commission Decision

of 6 February 2006

on the implementation of survey programmes for avian influenza in poultry and wild birds to be carried out in the Member States in 2006

(notified under document number C(2006) 251)

(2006/101/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 Article 20 thereof,

Whereas:

(1) Decision 90/424/EEC provides for a Community financial contribution for the undertaking of technical and scientific measures necessary for the development of Community veterinary legislation and for veterinary education and training.

(2) The Scientific Committee on Animal Health and Animal Welfare in a report of 27 June 2000 and the EFSA opinion of 20 September 2005 in relation to wild bird species recommended that surveys be carried out on poultry flocks and wild birds for avian influenza, in particular to determine the prevalence of infections with avian influenza virus subtypes H5 and H7.

(3) Council Directive 92/40/EEC of 19 May 1992 introducing Community measures for the control of avian influenza [2] defines Community control measures to be applied in the event of an outbreak of avian influenza in poultry. However, it does not provide for regular surveys of that disease in poultry and wild birds.

(4) Commission Decisions 2002/649/EC [3], 2004/111/EC [4] and 2005/464/EC [5] provided for the submission of surveillance programmes concerning avian influenza by the Member States to the Commission.

(5) Commission Decisions 2002/673/EC [6], 2004/630/EC [7] and 2005/732/EC [8] approved programmes submitted by the Member States for surveys of avian influenza in poultry and wild birds for the periods specified in those programmes.

(6) During those surveys, the presence of different subtypes of H5 and H7 low pathogenic avian influenza viruses has been detected in several Member States. Although the current prevalence of avian influenza viruses can be considered rather low, it is important to continue and to improve the surveillance so as to better understand the epidemiology of the low pathogenic avian influenza viruses and prevent that viruses do not circulate unnoticed in the poultry population. The results of the surveys carried out in the Member States have proven to be very useful in monitoring the presence of avian influenza virus subtypes that could present a substantial risk if they mutated into a more virulent form. Furthermore, it is appropriate to strengthen avian influenza surveillance taking into account the current disease situation in Europe. The total amount of Community contribution to the Member States for these actions should ensure increased surveillance.

(7) Accordingly, Member States should submit their programmes for surveys for avian influenza to the Commission for approval so that the financial assistance by the Community may be granted.

(8) Concerning the surveillance in wild birds, results from ongoing scientific work currently being undertaken by EFSA and DG Environment should be taken into account as it becomes available. These results will also be used to review the present Decision.

(9) All naturally occurring wild birds species in the Community are covered by the protection regime of Council Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds [9] and therefore full regard shall be taken of the requirements of this Directive in any surveillance for avian influenza.

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

HAS ADOPTED THIS DECISION:

Article 1

By 7 February 2006, Member States shall submit for approval to the Commission programmes for the implementation of surveys for avian influenza in poultry and wild birds in accordance with the Annex.

Article 2

The Community’s financial contribution towards the measures provided for in Article 1 shall be at the rate of 50 % of the costs incurred in Member States up to a maximum of EUR 2000000 for the Member States in total.

Article 3

The maximum amounts of the testing costs to be reimbursed shall not exceed:

ELISA test : EUR 1 per test;

agal gel immune diffusion test : EUR 1,2 per test;

HI test for H5/H7 : EUR 12 per test;

virus isolation test : EUR 30 per test;

PCR test : EUR 15 per test.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 6 February 2006.

For the Commission

Markos Kyprianou

Member of the Commission

[1] OJ L 224, 18.8.1990, p. 19. Decision as last amended by the Directive 2003/99/EC of the European Parliament and of the Council (OJ L 325, 12.12.2003, p. 31).

[2] OJ L 167, 22.6.1992, p. 1. Directive as last amended by the 2003 Act of Accession.

[3] OJ L 213, 9.8.2002, p. 38.

[4] OJ L 32, 5.2.2004, p. 20. Decision as amended by Decision 2004/615/EC (OJ L 278, 27.8.2004, p. 59).

[5] OJ L 164, 24.6.2005, p. 52. Decision as amended by Decision 2005/726/EC (OJ L 273, 19.10.2005, p. 21).

[6] OJ L 228, 24.8.2002, p 27. Decision as amended by Decision 2003/21/EC (OJ L 8, 14.1.2003, p. 37).

[7] OJ L 287, 8.9.2004, p. 7. Decision as last amended by 2004/679/EC (OJ L 310, 7.10.2004, p. 75).

[8] OJ L 274, 20.10.2005, p. 95.

[9] OJ L 103, 25.4.1979, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

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ANNEX

PROGRAMMES FOR SURVEILLANCE OF AVIAN INFLUENZA IN POULTRY AND WILD BIRDS TO BE CARRIED OUT IN THE MEMBER STATES IN FEBRUARY-DECEMBER 2006

A. Objectives, general requirements and criteria for the surveys

A.1. OBJECTIVES

1. To detect the incidence of infections with avian influenza virus subtypes H5 and H7 in different species of poultry by repeating previous screening exercises in a modified, more targeted manner.

2. To continue surveillance for avian influenza in wild birds for an early warning system of avian influenza strains that may be introduced into poultry flocks from wild birds.

3. To contribute to the knowledge on the threats of avian influenza to animal health from wildlife.

4. To foster the connection and integration of human and veterinary networks for influenza surveillance.

A.2. GENERAL REQUIREMENTS AND CRITERIA

1. Sampling shall not extend beyond 31 December 2006.

For poultry, sampling shall cover a period appropriate to production periods for each poultry category as required.

2. 31 March 2007 shall be the date for the submission of the final survey results.

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.

4. All results (both serological and virological) shall be sent to the Community Reference Laboratory for Avian Influenza (CRL) for collation. A good flow of information must be ensured. The CRL shall provide technical support and keep an enlarged stock of diagnostic reagents. Antigens for use in the survey shall be supplied to NL’s by the CRL to ensure uniformity.

5. All avian influenza virus isolates shall be submitted to the CRL in accordance with Community legislation. Viruses of H5/H7 subtype shall be submitted without delay and shall be subjected to the standard characterisation tests (nucleotide sequencing/IVPI) according to Directive 92/40/EEC. In addition, the CRL shall require that H5 or H7 positive sera collected from anseriformes be submitted "blind" in order that an archive be established to facilitate future test development.

B. Survey 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.

2. Specific protocols to accompany the sending of material to the CRL and reporting tables for collection of survey data shall be provided by the CRL. In those tables the laboratory testing methods used shall be indicated. The tables provided shall be used to submit results in a single document.

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.

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) 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 [1] 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 to 50 | 35 |

51 to 80 | 42 |

81 to 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 to 60 | 47 |

61 to 100 | 59 |

101 to 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 to 50 blood samples shall be taken for serological testing.

D. Survey for avian influenza in wild birds

D.1. SURVEY DESIGN AND IMPLEMENTATION

1. Liaisons with bird conservation/watching institutions and ringing stations will be necessary. Sampling where appropriate shall be carried out under the supervision of staff from these groups/stations or by hunters.

2. Active surveillance on living or hunted birds shall be targeted on:

(a) the population of wild bird species presenting a higher risk to be identified, based upon:

(i) origin and migratory flyways;

(ii) numbers of wild birds in the Community; and

(iii) likelihood of contact with domestic poultry.

(b) identify sites at risk, based upon:

(i) mixing sites of high number of migratory birds involving different species and in particular those listed in Part F;

(ii) proximity to domestic poultry farms; and

(iii) location along migratory flyways.

Sampling must take account of the seasonality of migration patterns, which may vary in different Member States and the species of birds listed in Annex F.

3. Passive surveillance on wild birds found dead shall primarily target the occurrence of abnormal mortality or significant disease outbreaks in:

(a) wild birds species listed in Part F and other wild birds living in contact with them; and

(b) at sites as referred to in point 2(b)(i).

The occurrence of mortality in several species at the same site shall be an additional factor to be considered.

D.2. SAMPLING PROCEDURES

1. Cloacal swabs for virological examination shall be taken. In addition to "first year" birds in autumn, host species with high susceptibility and increased contact with poultry (such as mallard ducks) may offer the highest chance of success.

2. In addition to cloacal swabs or fresh faeces, tissues (namely the brain, heart, lung, kidney and intestines) from wild birds found dead or shot shall also be sampled for virus isolation and molecular detection (PCR). Molecular techniques shall only be carried out in laboratories able to guarantee quality assurance and using methods recognised by the CRL for avian influenza.

3. Samples shall be taken from different species of free living birds. Anseriformes (waterfowl) and Charadriiformes (shorebirds) shall be the main sampling targets.

4. Swabs containing faeces, or carefully collected fresh faeces shall be taken from wild birds trapped, hunted and found freshly dead.

5. Pooling of up to five samples from the same species collected at the same site and same time may be permitted. It must be ensured when pooling samples that, in case of a positive finding, the individual samples can be retested.

6. Specific care has to be taken for the storage and transport of samples. If rapid transport within 48 hours to the laboratory (in transport medium at 4 °C) is not guaranteed, samples shall be stored and then transported in dry ice at minus 70 °C (temperatures between 4 °C and – 70 °C are advisable only for very short time storage but should be avoided as much as possible).

E. Laboratory testing

1. Laboratory tests shall be carried out in accordance with the diagnostic procedures for the confirmation and differential diagnostic of avian influenza set out in Annex III to Directive 92/40/EEC (including examination of sera from ducks and geese by haemagglutination-inhibition (HI) test).

2. However, if laboratory tests not laid down in Directive 92/40/EEC 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 positive serological findings shall be confirmed by the National Laboratories for avian influenza by an haemagglutination-inhibition test, using designated strains supplied by the Community Reference Laboratory for Avian Influenza:

H5 (a) Initial test using Ostrich/Denmark/72420/96 (H5N2)

(b) Test all positives with Duck/Denmark/64650/03 (H5N7) to eliminate N2 cross reactive antibody.

H7 (a) Initial test using Turkey/England/647/77 (H7N7)

(b) Test all positives with African Starling/983/79 (H7N1) to eliminate N7 cross reactive antibody.

4. All samples collected in the survey for avian influenza in wild birds (Chapter D) shall be tested as soon as possible by PCR for H5 but within two weeks and in case of a positive finding analysis of the cleavage site should 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.

5. Serological surveillance shall not be applied for avian influenza in wild birds.

6. Member States shall report to the Commission the H5 and H7 positive samples detected during their surveillance of poultry and wild birds every two months. This is without prejudice to the obligation of the Member States, laid down in the respective Community legislation, to notify cases of HPAI to the Commission immediately, irrespective of host.

F. Provisional list of wild birds species presenting a higher risk in relation to avian influenza [2]

Latin name | English language name |

1.Anser albifrons | White-fronted goose |

2.Anser fabalis | Bean goose |

3.Anas platyrhynchos | Mallard |

4.Anas strepera | Gadwal |

5.Anas acuta | Northern pintail |

6.Anas clypeata | Northern shoveler |

7.Anas penelope | Eurasian wigeon |

8.Anas crecca | Common teal |

9.Anas querquedula | Garganay |

10.Aythya ferina | Common pochard |

11.Aythya fuligula | Tufted duck |

12.Vanellus vanellus | Northern lapwing |

13.Philomachus pugnax | Ruff |

14.Larus ridibundus | Black-headed gull |

15.Larus canus | Common gull |

[1] OJ L 146, 11.6.1994, p. 17.

[2] This list is not a limitative list but is only meant to identify migratory species that may pose a higher risk for introduction of avian influenza into the Community. It is to be updated continuously following results of scientific studies as they come available.

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