COUNCIL DIRECTIVE 92/40/EEC of 19 May 1992 introducing Community measures for the control of avian influenza
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas poultry is listed in Annex II of the Treaty; whereas the marketing of poultry constitutes an important source of revenue for the agricultural population;
Whereas, it is necessary to establish at Community level the control measures to be taken in the event of outbreak of the highly pathogenic form of avian influenza, caused by an influenza virus with specific characteristics, and hereinafter termed avian influenza, in order to ensure national development of the poultry sector and contribute to the protection of animal health in the Community;
Whereas an outbreak of avian influenza can quickly take on epizootic proportions, causing mortality and disturbances on a scale liable to reduce sharply the profitability of farming or poultry as a whole;
Whereas action must be taken as soon as the presence of the disease is suspected so that immediate and effective control measures can be implemented when its presence is confirmed;
Whereas it is necessary to prevent any spread of the disease as soon as an outbreak occurs, by carefully monitoring movements of animals and the use of products liable to be contaminated, and where appropriate, by vaccination;
Whereas diagnosis of the disease must be carried out under the auspices of responsible national laboratories, the coordination of which must be ensured by the Community reference laboratory;
Whereas common measures for the control of avian influenza form a basis for maintaining a unified standard with relation to animal health;
Whereas Article 3 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (4) applies in the event of the occurrence of avian influenza;
Whereas it is appropriate to confer upon the Commission the task of taking the necessary applicatory measures,
HAS ADOPTED THIS DIRECTIVE:
Article 1
This Directive defines the Community control measures to be applied in the event of an outbreak of avian influenza in poultry without prejudice to the Community provisions governing intra-Community trade.
This Directive shall not apply where avian influenza is detected in other birds; however, in this case, the Member State concerned shall inform the Commission of any measure it takes.
Article 2
For the purpose of this Directive, the definitions given in Article 2 of Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (5) shall apply as appropriate.
The following definitions shall also apply:
(a) infected poultry shall mean any poultry:
- in which the presence of avian influenza, within the meaning of Annex I, has been officially confirmed following an examination by an approved laboratory, or
- in the case of second and subsequent outbreaks, in which clinical signs or post-mortem lesions consistent with avian influenza are present;
(b) poultry suspected of being infected shall mean any poultry showing clinical signs or post-mortem lesions which are such that the presence of avian influenza may reasonably be suspected or any poultry in which the presence of influenza A virus of subtype H5 or H7 has been demonstrated;
(c) poultry suspected of being contaminated shall mean any poultry which may have been directly or indirectly exposed to the avian influenza virus, or influenza A virus of H5 subtype or H7 subtype;
(d) competent authority shall mean the competent authority within the meaning of Article 2 (6) of Directive 90/425/EEC (6);
(e) official veterinarian shall mean the veterinarian designated by the competent authority.
Article 3
Member States shall ensure that there is compulsory and immediate notification of the suspected presence of avian influenza to the competent authority.
Article 4
1. When poultry in a holding are suspected of being infected or contaminated with avian influenza, Member States shall ensure that the official veterinarian immediately activates official investigation arrangements to confirm or rule out the presence of the disease and, in particular, must take or have taken the samples necessary for laboratory examination.
2. As soon as the suspected infection is notified, the competent authority shall have the holding placed under official surveillance and shall in particular require that:
(a) a record be made of all categories of poultry on the holding showing in respect of each of the categories the numbers of poultry which have died, which show clinical signs, and which show no signs. The record shall be kept up-to-date to include birds born or dying during the period in which there is a suspicion. The data in the record shall be kept up-to-date and be produced on request, and may be checked at each visit;
(b) all poultry on the holding are kept in their living quarters or confined in some other place where they can be isolated and without contact with other poultry;
(c) no poultry enter or leave the holding;
(d) all movement
- of persons, other animals and vehicles to or from the holding,
- of poultry meat or carcases, or of animal feed, implements, waste, droppings, manure litter or anything liable to transmit avian influenza be subject to authorization by the competent authority;
(e) eggs shall leave the holding with the exception of eggs sent directly to an establishment approved for the manufacture and/or processing of egg products under Article 6 (1) of Directive 89/437/EEC (7), and transported under an authorization which has been granted by the competent authority. Such authorization must meet the requirements laid down in Annex I;
(f) appropriate means of disinfection be used at the entrances and exits of buildings housing poultry and of the holding itself;
(g) an epizootiological inquiry be carried out in accordance with Article 7.
3. Until such time as the official measures laid down in paragraph 5 are enforced, the owner or keeper of any poultry in which disease is suspected shall take all reasonable action to ensure compliance with paragraph 2, except for (g) thereof.
4. The competent authority may apply any of the measures provided for in paragraph 2 to other holdings should their location, their configuration or contacts with the holding where the disesase is suspected give reason to suspect possible contamination.
5. The measures referred to in paragraphs 1 and 2 shall not be withdrawn until the suspicion of avian influenza has been ruled out by the official veterinarian.
Article 5
1. Once the presence of avian influenza has been officially confirmed on a holding, the Member States shall ensure that the competent authority requires, in addition to the measures listed in Article 4 (2), the following measures to be undertaken:
(a) all poultry on the holding shall without delay be killed on the spot. The poultry which have died or been killed and all eggs shall be destroyed. These operations shall be carried out in a way which minimizes the risk of spreading disease;
(b) any substance or waste, such as animal feed, litter or manures liable to be contaminated, shall be destroyed or treated appropriately. This treatment, carried out in accordance with the instructions of the official veterinarian, shall ensure the destruction of any avian influenza virus present;
(c) where poultry from the holding have been slaughtered during the presumed incubation period of disease the meat from those poultry shall wherever possible be traced and destroyed;
(d) hatching eggs laid during the presumed incubation period which have been moved from the holding shall be traced and destroyed; but poultry which have already hatched from the eggs shall be placed under official surveillance; table eggs laid during the presumed incubation period which have been moved from the holding shall whereever possible be traced and destroyed, unless they have previously been properly disinfected;
(e) after carrying out operations listed in subparagraphs (a) and (b) the buildings used for housing poultry, their surroundings, the vehicles used for transport and all equipment likely to be contaminated shall be cleaned and disinfescted in accordance with the provisions of Article 11;
(f) no poultry shall be reintroduced to the holding until at least 21 days after completion of operations provided for in subparagraph (e);
(g) an epizootiological inquiry shall be carried out in accordance with Article 7.
2. The competent authority may extend the measures provided for in paragraph 1 to other neighbouring holdings should their location, their configuration, or contact with the holding where the disease has been confirmed give reason to suspect possible contamination.
Article 6
In the case of holdings which consist of two or more separate flocks, the competent authority may, in accordance with criteria set by the Commission under the procedure laid down in Article 21, grant a derogation from the requirements of Article 5 (1), for healthy flocks of a holding which is infected, provided that the official veterinarian has confirmed that the operations carried out there are such that the flocks are completely separate as regards housing, keeping and feeding, so that the virus cannot spread from one flock to another.
Article 7
1. The epizootiological inquiry shall deal with:
- the length of time during which avian influenza may have existed on the holding,
- the possible origin of the avian influenza on the holding and the identification of other holdings on which there are poultry which may have become infected or contaminated from the same source,
- the movement of persons, poultry or other animals, vehicles, eggs, meat and carcases and any implement or substance likely to have carried avian influenza virus to or from the holding in question.
2. In order to provide full coordination of all measures necessary to ensure eradication of avian influenza as quickly as possible and for the purpose of carrying out the epidemiological inquiry, a crisis unit shall be established.
The general rules concerning national crisis units and Community crisis units will be laid down by the Council, acting by a qualified majority proposal from the Commission.
Article 8
1. Where the official veterinarian has reason to suspect that poultry on any holding may have been contaminated as a result of the movement of persons, animals or vehicles or in any other way, that holding shall be placed under official control in accordance with paragraph 2.
2. The purpose of the official control shall be to detect immediately any suspicion of avian influenza, count the poultry and monitor their movements and, where appropriate, to take the action provided for in paragraph 3.
3. When a holding is subject to the official control under paragraphs 1 and 2, the competent authority shall prohibit removal of poultry from the holding other than for transport directly to a slaughterhouse under official supervision for the purpose of immediate slaughter. Before granting such authorization, the official veterinarian must have carried out a clinical examination of all the poultry to exclude presence of avian influenza on the holding. The movement restrictions referred to in this
Article shall be imposed for a period of 21 days from the latest date of potential contamination; however, such restrictions must apply for a period of at least seven days.
4. Where it considers that conditions permit, the competent authority may limit the measures provided for in this Article to a part of the holding and to the poultry contained therein, provided that the poultry there have been housed, kept and fed completely separately by separate staff.
Article 9
1. Once the diagnosis of avian influenza has been officially confirmed, the Member States shall ensure that the competent authority establishes around the infected holding a protection zone based on a minimum radius of three kilometres, itself contained in a surveillance zone based on a minimum radius of 10 kilometres. The establishment of the zones must take account of geographical, administrative, ecological and epizootiological factors relating to avian influenza, and of monitoring facilities.
2. The measures applied in the protection zone shall include:
(a) the identification of all holdings having poultry whithin the zone;
(b) periodic visits to all the holdings having poultry, a clinical examination of those poultry including, if necessary, the collection of samples for laboratory examination; a record of visits and findings must be kept;
(c) the keeping of all poultry in their living quarters or some other place where they can be isolated;
(d) the use of appropriate means of disinfection at the entrances and exits of the holding;
(e) the control of movements of persons handling poultry, poultry carcases and eggs and vehicles carrying poultry, carcases and eggs within the zone; in general, transport of poultry shall be prohibited, except for transit by major highways or railways;
(f) a prohibition on removing poultry and hatching eggs from the holding on which they are kept unless the competent authority has authorized the transport;
(i) of poultry for immediate slaughter to a slaughterhouse preferably located in the infected area or, if that is not possible, to a slaughterhouse designated by the competent authority outside the infected area. The special health mark provided for in
Article 5
(1) of Directive 91/494/EEC (8) must be applied to this poultrymeat;
(ii) of day-old chicks or ready-to-lay pullets to a holding within the surveillance zone at which there are no other poultry. This holding must be placed under the official control provided for in Article 8 (2);
(iii) of hatching eggs to a hatchery designated by the competent authority; before dispatch, eggs and their packing must be disinfected. Movements allowed in (i), (ii) and (iii) shall be directly executed, under official control. They shall be authorized only after the official veterinarian has carried out a health inspection of the holding. The means of transport used must be cleaned and disinfected before and after use;
(g) a prohibition on removing or spreading used litter or poultry manure without authorization;
(h) the prohibition of fairs, markets, shows or other gatherings of poultry or other birds.
3. The measures applied in the protection zone shall be maintained for at least 21 days after the carrying out of preliminary cleaning and disinfection operations on the infected holding in accordance with Article 11. The protection zone shall thereafter be part of the surveillance zone.
4. The measures applied in the surveillance zone shall include:
(a) the identification of all holdings having poultry within the zone;
(b) the control of poultry and hatching egg movement within the zone;
(c) a prohibition on the movement of poultry out of the zone during the first 15 days, except for movement directly to a slaughterhouse outside the surveillance zone designated by the competent authority. The special health mark provided for in Article 3 of Directive 91/494/EEC must be applied to this poultry meat;
(d) a prohibition on the movement of hatching eggs out of the surveillance zone unless to a hatchery designated by the competent authority. Before dispatch the eggs and their packing must be disinfected;
(e) a prohibition on the movement of used litter or poultry manure out of the zone;
(f) a prohibition of fairs, markets, shows or other gatherings of poultry and other birds;
(g) without prejudice to the provisions of (a) and (b), the prohibition of transport of poultry except for transit by major highways or railways.
5. The measures applied in the surveillance zone shall be maintained for at least 30 days after the carrying out of preliminary cleaning and disinfection operations on the infected holding in accordance with Article 11.
6. Where the zones are situated in the territory of more than one Member State, the competent authorities of the Member States concerned shall cooperate in establishing the areas described in paragraph 1. However, if necessary, the protection zone and the surveillance zone shall be established by the procedure provided for in Article 21.
Article 10
Member States shall ensure that:
(a) the competent authority determines the arrangements allowing them to trace the movement of eggs and poultry;
(b) the owner or keeper of poultry is required to supply the competent authority, in response to any request by that authority, with information concerning poultry and eggs entering or leaving his holding;
(c) all persons engaged in the transport or marketing of poultry and eggs are able to supply the competent authority with information concerning the movements of poultry and eggs which they have transported or marketed and to furnish all the details concerning such information.
Article 11
Member States shall ensure that:
(a) the disinfectants to be used and their concentrations are officially approved by the competent authority;
(b) the cleaning and disinfection operations are carried out under official supervision, in accordance with:
(i) instructions given by the official veterinarian,
(ii) the procedure for cleaning and disinfecting an infected holding, as laid down in Annex II.
Article 12
Collection of samples and laboratory testing to detect the presence of avian influenza virus shall be carried out in accordance with Annex III.
Article 13
Member States shall ensure that the competent authority takes all the necessary measures for persons established in the protection and surveillance zones to be informed of the restrictions in force and make all necessary arrangements for the appropriate implementation of the measures in question.
Article 14
1. Member States shall ensure that, in each Member State there is designated:
(a) a national laboratory at which facilities and expert personnel shall be maintained to permit assessment of the pathogenicity of influenza virus isolates, in accordance with Annex III, Chapter 7, and identification of influenza A viruses of H5 or H7 subtypes;
(b) a national laboratory at which reagents for use in regional laboratories are tested;
(c) a national institute or laboratory at which authorized vaccines may be tested in order to verify their conformity with the specifications laid down in the marketing authorization.
2. The national laboratories listed in Annex IV shall be responsible for coordinating standards and methods of diagnosis, use of reagents and testing of vaccines.
3. The national laboratories listed in Annex IV shall be responsible for coordinating the standards and diagnostic methods laid down in each avian influenza diagnostic laboratory within the Member State. To this end:
(a) they may provide diagnostic reagents to national laboratories;
(b) they shall control the quality of all diagnostic reagents used in that Member State;
(c) they shall arrange comparative tests periodically;
(d) they shall hold isolates of avian influenza virus from cases confirmed in that Member State;
(e) they shall ensure the confirmation of positive results obtained in regional diagnostic laboratories.
4. The national laboratories listed in Annex IV shall liaise with the Community reference laboratory referred to in Article 15.
Article 15
The Community reference laboratory for avian influenza is mentioned in Annex V. Without prejudice to the provisions of Decision 90/424/EEC, and in particular Article 28 thereof, the powers and duties of the laboratory shall be those appearing in the said Annex.
Article 16
Vaccination against avian influenza with vaccines authorized by the competent authority may only be used to supplement the control measures carried out when the disease appears and in accordance with the following provisions:
(a) the decision to introduce vaccination to supplement control measures shall be taken by the Commission in collaboration with the Member State concerned, acting in accordance with the procedure laid down in Article 21. This decision shall have particular regard to:
- the concentration of poultry in the affected area,
- the characteristics and composition of the vaccine to be used,
- the procedures for supervision of the distribution, storage and use of vaccines,
- the species and categories of poultry which shall be subject to vaccination,
- the areas in which vaccination shall be carried out.
However, by way of derogation from the first subparagraph, the decision to introduce emergency vaccination around the outbreak may be taken by the Member State concerned, following notification to the Commission, provided the fundamental interests of the Community are not jeopardized. Such decision will be re-examined immediately within the Standing Veterinary Committee in accordance with the procedure provided for in Article 21;
(b) where a Member State is authorized, in accordance with point (a), to have recourse to emergency vaccination on a limited part of its territory the status of the remainder of the territory shall not be affected, provided that the immobilization measures for the vaccinated animals are effective during a period to be determined in accordance with the procedure laid down in Article 21.
Article 17
1. Each Member State shall draw up a contingency plan, specifying the national measures to be implemented in the event of an outbreak of avian influenza.
This plan must allow access to facilities, equipment, personnel and all other appropriate materials necessary for the rapid and efficient eradication of the outbreak.
2. The criteria to be applied for drawing up the plan are laid down in Annex VI.
3. Plans drawn up in accordance with the criteria listed in Annex VI shall be submitted to the Commission not later than six months after this Directive is brought into application.
4. The Commission shall examine the plans in order to determine whether they permit the desired objective to be attained and shall suggest to the Member State concerned any amendments required in particular to ensure that they are compatible with those of the other Member States.
The Commission shall approve the plans, if necessary amended, in accordance with the procedure laid down in Article 21.
The plans may subsequently be amended or supplemented, in accordance with the same procedure, to take into account developments in the situation.
Article 18
1. Commission experts may, in collaboration with the competent authorities, and insofar as is necessary to ensure uniform application of this Directive, make on-the-spot checks. In order to do this, they may check a representative percentage of establishments to see whether the competent authorities are checking that these establishments are fulfilling the requirements of this Directive. The Commission shall inform the Member States of the result of the checks carried out.
A Member State in whose territory a check is being carried out shall give all the necessary assistance to the experts in carrying out their duties.
The general provisions for implementing this Article shall be determined in accordance with the procedure laid down in Article 21.
Article 19
The detailed conditions governing the Community's financial contribution to the measures connected with the application of this Directive are laid down in Decision 90/424/EEC.
Article 20
The Annexes shall be amended, as and when required, by the Council acting by a qualified majority acting on a proposal from the Commission in particular in order to take into account developments in research and in diagnostic procedures.
Article 21
1. Where the procedure laid down in this Article is to be followed, the Standing Veterinary Committee, set up by Decision 68/361/EEC (9), hereinafter referred to as the 'the Committee', shall be informed without delay by its Chairman either on his own initiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the committee a draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
(b) If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission save where the Council has decided against the said measures by a simple majority.
Article 22
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 23
This Directive is addressed to the Member States.
Done at Brussels, 19 May 1992.