2006/437/EC: Commission Decision of 4 August 2006 approving a Diagnostic Manual for avian influenza as provided for in Council Directive 2005/94/EC (notified under document number C(2006) 3477) (Text with EEA relevance)

• Published date: 31 August 2006
• Subject Matter: legislazione veterinaria,legislación veterinaria,législation vétérinaire
• Official Gazette Publication: Gazzetta ufficiale dell’Unione europea, L 237, 31 agosto 2006,Diario Oficial de la Unión Europea, L 237, 31 de agosto de 2006,Journal officiel de l’Union européenne, L 237, 31 août 2006

31.8.2006 EN Official Journal of the European Union L 237/1

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COMMISSION DECISION

of 4 August 2006

approving a Diagnostic Manual for avian influenza as provided for in Council Directive 2005/94/EC

(notified under document number C(2006) 3477)

(Text with EEA relevance)

(2006/437/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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 the second subparagraph of Article 50(1) thereof,

Whereas:

(1) Directive 2005/94/EC provides for certain preventive measures relating to the surveillance and early detection of avian influenza and also minimum control measures to be applied in the event of an outbreak of that disease in poultry and other captive birds.

(2) It is necessary to lay down at Community level diagnostic procedures, sampling methods and criteria for the evaluation of the results of laboratory tests for the confirmation of an outbreak of avian influenza.

(3) Annex VII to Directive 2005/94/EC lays down the functions and duties of the Community reference laboratory for avian influenza in order to coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing that disease. Those functions and duties include the organisation of periodic comparative tests and the supplying of standard reagents at Community level.

(4) Laboratory tests have recently been developed to ensure a quick diagnosis of avian influenza.

(5) The experience gained in the control of avian influenza in recent years has resulted in the identification of the most suitable sampling procedures and criteria for evaluation of the results of the laboratory tests for a proper diagnosis of this disease in different situations.

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

HAS ADOPTED THIS DECISION:

Article 1

The diagnostic manual, as provided for in Directive 2005/94/EC and set out in the Annex to this Decision, is approved.

Article 2

Member States shall apply the diagnostic manual from the date they transpose Directive 2005/94/EC or from 1 July 2007, whichever date is the earlier.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 4 August 2006.

For the Commission

Markos KYPRIANOU

Member of the Commission

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

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ANNEX

DIAGNOSTIC MANUAL FOR AVIAN INFLUENZA

CHAPTER I

Introduction, objectives and definitions

1. In order to ensure uniform procedures for the diagnosis of avian influenza (AI) in the Community, this diagnostic manual sets out: (a) guidelines and minimum requirements for diagnostic procedures, sampling methods and criteria for the evaluation of the results of laboratory tests for a proper diagnosis of AI; (b) the laboratory tests to be used for the diagnosis of AI and the laboratory techniques to be used for the genetic typing of AI virus isolates; (c) minimum bio-safety requirements and quality standards to be observed by the diagnostic laboratories and for the transport of samples.

2. This diagnostic manual is addressed to the authorities responsible for the control of AI. Therefore, it mainly concerns principles and applications of laboratory tests and the evaluation of their results, as well as laboratory techniques.

3.

For the purpose of this diagnostic manual, in addition to the definitions in Article 2 of Directive 2005/94/EC, the following definition also applies: ‘diagnostic specimen’ means any animal material including a whole carcase being transported for diagnostic or investigational purposes, but excluding live infected animals.

4. The confirmation of AI in poultry and other captive birds must be in accordance with the procedures, sampling methods and criteria for the evaluation of the results of laboratory tests set out in this diagnostic manual, and be based on one or more of the criteria in points (a), (b) and (c): (a) the detection of infectious virus, antigen or specific genetic material in samples of poultry or other birds' tissues, organs, blood or excreta; (b) the detection of clinical signs and post-mortem lesions of disease in those birds; (c) the demonstration of a specific antibody response in blood samples of those birds.

5. The confirmation of infection of mammals with an influenza A virus of avian origin which is either highly pathogenic or if low pathogenic of the H5 or H7 subtypes must be based on one or more of the criteria in points (a) or (b): (a) the detection of the AI infectious virus, antigen or specific genetic material in samples of tissues, organs, blood or excreta from mammals; (b) the demonstration of a specific antibody response to AI in blood samples from mammals.

6. The procedures, sampling methods and criteria for the evaluation of the results of laboratory tests must be: (a) those set out in this diagnostic manual; or (b) those authorised by the competent authority provided that: (i) the sensitivity and specificity of the authorised laboratory tests have been demonstrated as being effective following a comparative test organised by the Community reference laboratory for avian influenza (Community reference laboratory); or (ii) where no such evaluation has been organised by the Community reference laboratory for a specific type of laboratory test, the sensitivity and specificity of the authorised laboratory test have been validated by the national reference laboratory so that the laboratory test is fit for the purpose for which it is used; the results of such validation must be submitted to the Community reference laboratory for review.

CHAPTER II

Description of AI with emphasis on differential diagnosis

1. Aetiology and virulence

AI is a highly contagious viral infection caused by viruses of the family Orthomyxoviridae, genus influenzavirus A. Influenza A viruses are the only orthomyxoviruses known to infect birds. Many species of birds have been shown to be susceptible to infection with influenza A viruses; aquatic birds form a major reservoir of such viruses, but the overwhelming majority of isolates have been of low pathogenicity in chickens and turkeys, the main birds of economic importance to be affected by the disease.

Influenza A viruses have antigenically related nucleoproteins and antigenically related matrix proteins, but are classified into subtypes on the basis of the antigenic relatedness of the surface glycoproteins haemagglutinin (HA) and neuraminidase (NA). At present, 16 HA subtypes (H1–H16) and 9 NA subtypes (N1–N9) are recognised. Each influenza A virus has one HA and one NA antigen, apparently in any combination.

Influenza A viruses are divided into two groups on the bases of their ability to cause disease in susceptible poultry:

(a) highly pathogenic avian influenza (HPAI) viruses, which cause an extremely serious disease characterised by generalised infection of the infected poultry, where they may induce very high flock mortality (up to 100 %); and

(b) low pathogenic avian influenza (LPAI) viruses, which cause a mild, primarily respiratory, disease in poultry, unless there is exacerbation by other co-infections or factors.

Wild birds, especially migratory waterfowl, play a very important role as the influenza A virus reservoir, as shown by the isolation of nearly all possible combinations of HA and NA subtypes from wild birds. Generally, except when there has been spill-over of HPAI from infected poultry, only LPAI viruses are detected in wild birds.

Primary introductions of AI viruses to poultry farms most likely originate from direct or indirect contact with wild birds.

In domestic poultry, there is a possibility that such LPAI viruses introduced from a wild reservoir may circulate undetected, as clinical signs are often mild or absent.

Once introduced into poultry, LPAI virus strains of H5 and H7 subtypes may then mutate into HPAI strains. To date, only viruses of the H5 and H7 subtypes have been shown to cause HPAI.

Although it appears that several mechanisms may be responsible for mutation from the LPAI to the HPAI virus, the factors that bring about this mutation are not known. In some instances mutation seems to have taken place rapidly at the primary site after introduction from wild birds, in other instances the LPAI virus has circulated in poultry for months before mutating. Therefore, it is impossible to predict if and when such mutation will occur. However, it may reasonably be assumed that the more widespread the circulation of LPAI in poultry, the higher the chances that mutation to HPAI will occur.

The incubation period is difficult to estimate and probably varies with the strain of virus and host, usually five to six days is quoted, but the range for individual birds is probably from a few hours to about seven days.

2. Clinical signs in birds infected with HPAI virus

The clinical signs are very variable and are influenced by factors such as the virulence of the infecting virus, the species affected, age, sex, concurrent diseases and environment.

Early signs can include inappetence, reduction in water intake and relatively low mortality. However, alternatively the disease may appear suddenly in a flock and many birds may die either without premonitory signs or with minimal signs of depression, inappetence, ruffled feathers and fever. Generally the longer birds survive the more marked are the clinical...