COUNCIL DIRECTIVE 93/53/EEC of 24 June 1993 introducing minimum Community measures for the control of certain fish diseases
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 fish are listed in Annex II to the Treaty; whereas the marketing of fish constitutes an important source of revenue for the aquaculture sector;
Whereas it is necessary to establish at Community level the control measures to be taken in the event of outbreaks of disease, in order to ensure rational development of the aquaculture sector and to contribute to the protection of animal health in the Community;
Whereas it is necessary, for diseases to be covered, to refer to the lists laid down in Annex A to Council Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and products (4);
Whereas an outbreak of such diseases can quickly take on epizootic proportions, causing mortality and disturbances on a scale liable to reduce severely the profitability of aquaculture;
Whereas control measures must be taken as soon as the presence of such a disease is suspected so that immediate and effective action can be implemented as soon as its presence is confirmed;
Whereas such measures must be aimed at preventing the spread of the disease, in particular by carefully controlling movements of fish and products liable to spread the infection;
Whereas the prevention of diseases in the Community must normally be based on a non-vaccination policy;
Whereas a thorough epizootiological investigation is essential to prevent any spread of the diseases; whereas the Member States must establish special units for that purpose;
Whereas, in order to ensure an effective system of control, diagnosis of the diseases must be harmonized and carried out under the auspices of responsible laboratories, the coordination of which may be carried out by a reference laboratory designated by the Community;
Whereas, in order to ensure uniform implementation of this Directive, a Community inspection procedure should be established;
Whereas common measures for the control of the diseases form a minimum basis for maintaining a uniform standard of animal health;
Whereas Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (5), and in particular Article 5 thereof, applies in the event of an outbreak of one of the diseases listed in Annex A to Directive 91/67/EEC;
Whereas the Commission should be entrusted with the task of adopting the necessary implementing measures; whereas, for that purpose, a procedure should be established to bring about close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I General provisions
Article 1
This Directive defines the minimum Community measures for the control of the fish diseases referred to in Annex A, lists I and II, to Directive 91/67/EEC.
Article 2
For the purposes of this Directive, the definitions laid down in Article 2 of Directive 91/67/EEC shall apply as necessary.
In addition, the following definitions shall apply:
1. list I diseases: fish diseases referred to in Annex A, list I, to Directive 91/67/EEC;
2. list II diseases: fish diseases referred to in Annex A, list II, to Directive 91/67/EEC;
3. fish suspected of being infected: fish showing clinical signs or post-mortem lesions or dubious reactions in laboratory tests giving rise to reasonable suspicion of the presence of a list I or list II disease;
4. infected fish: fish in which the presence of a list I or list II disease has been officially confirmed as the result of a laboratory examination or, in the case of ISA, as the result of a clinical examination and a post-mortem examination;
5. farm suspected of being infected: farm containing fish suspected of being infected;
6. infected farm: farm containing infected fish; also farm which has been evacuated but not yet disinfected.
Article 3
Member States shall ensure that all farms rearing or keeping fish susceptible to list I or list II diseases:
1. are registered by the official service; this registration must be kept constantly up to date;
2. keep a record of:
(a) live fish, eggs and gametes entering the farm, containing all information relating to their delivery, their number or weight, their size, their source and their suppliers;
(b) live fish, eggs and gametes leaving the farm, containing all information relating to their dispatch, their number or weight, their size and destination;
(c) observed mortality.
This record, which shall be open to scrutiny by the official service whenever the latter so requests, must be regularly updated and shall be kept for four years.
Article 4
Member States shall ensure that it is compulsory for the suspected presence of any of the list I and list II diseases to be notified as soon as possible to the official service.
CHAPTER II Control measures for list I diseases
Article 5
1. When fish on a farm are suspected of being infected with a list I disease, Member States shall ensure that the official service immediately activates official investigation arrangements to confirm or rule out the presence of the disease, including clinical examination; in particular, it must take, or have taken, the samples necessary for laboratory examination.
2. As soon as the suspected presence of the disease is notified, the official service shall have the farm placed under official surveillance and shall in particular require that:
(a) an official census be made of all species and categories of fish and that, in respect of each of these, the number of fish already dead, infected or suspected of being infected or contaminated be recorded; the census must be kept up to date by the owner or keeper to take account of the increase in the population or new mortality observed during the period of suspected infection; the information in the census must be produced on request and may be checked at each inspection;
(b) no fish, whether alive or dead, or eggs or gametes enter or leave the farm without the authorization of the official service;
(c) the disposal of dead fish or their offal be carried out under the supervision of the official service;
(d) the entry or exit of feedingstuffs, utensils, objects or other substances such as waste, liable to transmit disease be subject, if necessary, to authorization by the official service, which shall lay down the conditions required to prevent the spread of the pathogen;
(e) the movement of persons to or from the farm be made subject to authorization by the official service;
(f) the entry or exit of vehicles to or from the farm be made subject to authorization by the official service, which shall lay down the conditions required to prevent the spread of the pathogen;
(g) appropriate means of disinfection be used at the entrances end exits of the farm;
(h) an epizootic investigation be carried out in accordance with Article 8 (1);
(i) all of the farms situated in the same water catchment area or coastal area be placed under official surveillance, and no fish, eggs or gametes leave these farms without the authorization of the official service; in the case of extensive water catchment areas or coastal areas, the official service may decide to limit this measure to a less extensive area close to the farm suspected of being infected, if it considers that this area affords maximum guarantees for the prevention of the spread of the disease;
if necessary, the official services of neighbouring Member States or third countries must be informed of the suspected case; in that event, the official services of the Member States involved shall take appropriate action to apply the measures laid down in this Article.
Where necessary, specific measures may be taken in accordance with the procedure laid down in Article 19.
3. Until such time as the official measures laid down in paragraph 2 are enforced, the owner or keeper of any fish in which disease is suspected shall take every appropriate measure to ensure compliance with paragraph 2, except for (h) and (i) thereof.
4. The measures referred to in paragraph 2 shall not be withdrawn until the suspicion of disease has been officially ruled out.
Article 6
As soon as the presence of a list I disease has been officially confirmed, Member States shall ensure that the official service orders that, in addition to the measures listed in Article 5 (2), of the following measures be applied:
(a) in an infected farm:
- all fish must be immediately withdrawn,
- in the case of inland farms all pools must be drained for the purposes of cleaning and disinfection,
- all eggs and gametes, dead fish and fish showing clinical signs of disease shall be regarded as high-risk material and must be destroyed under the supervision of the official service, in accordance with Directive 90/667/EEC (6),
- all live fish shall either be killed and destroyed under the supervision of the official service in accordance with Directive 90/667/EEC, or else, in the case of fish which have reached commercial size and show no clinical sign of disease, be slaughtered under the supervision of the official service for marketing or processing for human consumption.
In the latter case, the official service shall ensure that the fish are immediately slaughtered and gutted, that these operations are carried out in conditions such as to prevent the spread of pathogens, that the fish waste and offal are regarded as high-risk material and are submitted to a treatment to destroy pathogens in accordance with Directive 90/667/EEC and that the used water is submitted to a treatment which inactivates any pathogens it may contain;
- after removal of the fish, eggs and gametes, ponds, equipment and any material liable to be contaminated must be cleaned and disinfected as soon as possible following the instructions established by the official service in such a way as to eliminate any risk of the agent of the disease spreading or surviving. The procedures for cleaning and disinfecting an infected farm shall be determined in accordance with the procedure laid down in Article 19,
- any substances which might be contaminated, referred to in Article 5 (2) (d), must be destroyed or treated in such a way as to ensure the destruction of any pathogen present,
- an epizootic investigation must be carried out in accordance with Article 8 (1) and the provisions of Article 8 (4) must be applied; this investigation must include the taking of samples for laboratory examination;
(b) all farms situated in the water catchment area or in the coastal zone in which the infected farm is situated shall undergo health inspections; if these inspections reveal positive cases, the measures provided for under (a) of this paragraph shall be applied;
(c) the repopulation of the farm shall be authorized by the official service following satisfactory inspection of the cleaning and disinfection operations and at the end of a period deemed adequate by the official service to ensure eradication of the pathogen, and of other possible infections in the same water catchment area;
(d) it application of the measures laid down under (a), (b), (c) and (d) of Article 5 (2) requires the cooperation of the official services of other Member States, the official services of the Member States concerned shall collaborate to ensure compliance with the measures laid down in this Article.
Where necessary, appropriate additional measures shall be adopted in accordance with the procedure laid down in Article 19.
Article 7
Where fish from the wild and not belonging to any farm or fish in lakes, ponds or other installations intended for angling or holding ornamental fish are infected or suspected of being infected, Member States shall ensure that appropriate measures are taken. Member States shall inform the Commission and the other Member States, in the Standing Veterinary Committee, of the measures they have taken.
Article 8
1. The epizootic investigation shall deal with:
- the likely length of time during which the disease may have existed on the farm before being notified or suspected,
- the possible origin of the disease on the farm and the identification of other farms on which there are eggs and gametes and fish of susceptible species which may have become infected;
- the movement of fish, eggs or gametes, vehicles or substances and persons likely to have carried the agent of the disease to or from the farms in question,
- the possible existence of carriers of the disease, and their distribution.
2. If the epizootic investigation reveals that the disease could have been introduced from another water catchment area or another coastal area, or could have been transferred to another water catchment area or another coastal area as a result of a contact arising from the movement of fish, eggs or gametes, animals, vehicles or persons, or in any other way, the farms belonging to such water catchment areas and coastal areas shall be considered suspect and the measures laid down in Article 5 shall apply. If the presence of the disease is confirmed, the measures laid down in Article 6 shall apply.
3. If the epizootic investigation reveals that the cooperation of the official services of other Member States is required, the official services of the Member States concerned shall take all necessary measures to ensure compliance with the provisions of this Directive.
4. A crisis unit shall be established in order to provide full coordination of all measures necessary to ensure eradication of the disease as quickly as possible and for the purpose of carrying out the epizootic investigation.
The general rules concerning national crisis units and the Community crisis units shall be laid down by the Council, acting by a qualified majority on a proposal from the Commission.
5. The Council, acting by a qualified majority on a proposal from the Commission drawn up on the basis of the opinion of the Scientific Veterinary Committee to take account, in particular, of scientific and technological developments, shall review the provisions of this Article before 31 December 1996.
CHAPTER III Control measures for list II diseases
Article 9
1. Where a list II disease is suspected and/or confirmed in an approved zone or on an approved farm situated in a non-approved zone, an epizootic investigation shall be carried out in accordance with Article 8. Member States wishing to regain their status defined in accordance with Directive 91/67/EEC must comply with the provisions of Annexes B and C to that Directive.
2. If the epizootic investigation reveals that the disease could have been introduced from an approved zone or from another approved farm, or could have been transferred to another approved farm as a result of the movement of fish, eggs or gametes, vehicles or persons, or in any other way, those zones or farms shall be considered suspect and the appropriate measures shall apply.
3. The official service may, however, authorize the fattening of fish to be slaughtered until they reach commercial size.
Article 10
1. Where a non-approved farm situated in a non-approved zone contains fish suspected of being infected with a list II disease, Member States shall ensure that the official service:
(a) immediately sets in motion official means of investigation to confirm or rule out the presence of the disease including, where necessary, the taking of samples for examination in an approved laboratory;
(b) carries out or causes to be carried out an official census of the infected farms, this census being regularly updated;
(c) places, or causes to be placed, the infected farms under official supervision, in order to ensure that, by way of derogation from Article 3 (1) (c) of Directive 91/67/EEC, the only movements authorized from infected farms are live fish or eggs or gametes intended either for other farms infected by the same disease or for slaughter for human consumption.
2. Member States may, for a fixed period, set up under the supervision of the official service an optional or compulsory programme for the eradication of list II diseases in non-approved farms or in non-approved zones. During this period, the introduction into a zone or farm subject to such a programme of live fish, eggs or gametes from infected farms or farms of unknown health status shall be forbidden.
These programmes, which will be set up on the basis of general criteria to be determined before the date specified in Article 20 in accordance with the procedure laid down in Article 19, will be submitted to the Commission for scrutiny, and approved and where necessary amended in accordance with that same procedure.
After the period referred to in the first subparagraph, Member States which have recourse to this procedure shall inform the Commission and the other Member States, within the Standing Veterinary Committee, of the results obtained.
3. By 31 December 1996, the Commission shall submit to the Council a report, drawn up after obtaining the opinion of the Scientific Veterinary Committee, taking into account experience gained and scientific and technical developments and accompanied, where appropriate, by proposals for a review of the provision of this Article, in particular with regard to the placing on the market of infected live fish, and their eggs or gametes, intended for farming or fattening, and with regard to the carrying out of an epizootiological investigation in non-approved zones where a disease is suspected on a non-approved farm. The Council shall act by a qualified majority on any such proposals and the latter shall be put forward taking into account the conclusions of the report.
4. Any detailed rules for implementing paragraphs 1 and 2 shall be adopted by the Commission, as and when required, in accordance with the procedure laid down in Article 19.
CHAPTER IV Final provisions
Article 11
1. Sampling and laboratory testing for the presence of list I and list II diseases shall be carried out using the methods established in accordance with Article 15 of Directive 91/67/EEC.
2. Testing for the presence of disease or pathogens shall be carried out by a laboratory approved by the official service. Laboratory testing shall, if necessary and especially on the first appearance of the disease, identify the type, sub-type or the variant of the relevant pathogen, which must be confirmed by the national reference laboratory and may be confirmed, if necessary, by the Community reference laboratory referred to in Article 13.
Article 12
1. Member States shall ensure that in each Member State a national reference laboratory is designated, with facilities and expert personnel enabling it to show at all times, and especially when the disease in question first appears, the type, sub-type and variant of the relevant pathogen and to confirm results obtained by regional diagnostic laboratories.
2. The national laboratories designated for the diseases in question shall be responsible for coordinating diagnostic standards and methods, and for the use of reagents.
3. The national laboratories designated for the diseases in question shall be responsible for coordinating the diagnostic standards and methods laid down by each laboratory for diagnosis of the disease in question within the Member State. To this end, they:
(a) may provide diagnostic reagents to laboratories approved by the Member State;
(b) shall control the quality of all diagnostic reagents used in the Member State;
(c) shall periodically arrange comparative tests;
(d) shall hold isolates of the pathogen of the disease from cases confirmed in the Member State;
(e) shall ensure confirmation of positive results obtained in diagnostic laboratories approved by the Member State.
4. However, by way of derogation from paragraph 1, Member States which do not have a national laboratory competent as regards the disease in question may use the services of a national laboratory with competence in the matter in another Member State.
5. The list of national reference laboratories for fish diseases is set out in Annex A.
6. The national laboratories designated for the diseases referred to shall cooperate with the Community reference laboratory referred to in Article 13.
7. The detailed rules for implementing this Article shall be adopted by the Commission under the procedure laid down in Article 19.
Article 13
1. The Community reference laboratory for fish diseases is indicated in Annex B.
2. Without prejudice to Decision 90/424/EEC, and in particular Article 28 thereof, the functions and duties of the laboratory referred to in paragraph 1 of this Article shall be those laid down in Annex C.
Article 14
1. Vaccination against list II diseases in approved zones or in approved farms situated in non-approved zones, in zones or farms which have already begun the approval procedures laid down by Directive 91/67/EEC, and against list I diseases, shall be forbidden.
2. The Council, acting by a qualified majority on a proposal from the Commission, shall by 30 June 1996, review the provisions of this Article, in particular with regard to laying down specific conditions for the use of vaccines and to take account of developments in scientific and technological research into vaccination.
Article 15
1. Each Member State shall draw up a contingency plan specifying how it will implement the measures laid down in this Directive in the event of an outbreak of a list I disease.
This plan must allow access to facilities, equipment, personnel and all other appropriate structures necessary for the rapid and efficient eradication of the outbreak.
2. The general criteria to be applied for drawing up those plans are set out in Annex D.
Member States may, however, confine themselves to the application of the criteria specific to the diseases concerned, where the general criteria have already been adopted in the context of the submission of plans relating to the application of measures for the control of another disease.
The Commission may, in accordance with the procedure laid down in Article 19, amend or supplement those criteria, taking into account the specific nature of the disease.
3. Plans drawn up in accordance with the criteria set out in Annex D shall be submitted to the Commission no later than six month after the date on which this Directive is brought into effect.
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 the plans of the other Member States.
The Commission shall approve the plans, amended if necessary, in accordance with the procedure laid down in Article 19.
The plans may subsequently be amended or supplemented, in accordance with the same procedure, to take into account developments in the situation.
Article 16
Commission experts may, in collaboration with the competent authorities, and in so far as is necessary to ensure uniform application of this Directive, make on-the-spot checks. In order to do that, they may check a representative percentage of holdings to see whether the competent authorities are checking that these holdings 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 detailed rules for implementing this Article shall be determined in accordance with the procedure laid down in Article 19.
Article 17
The 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 18
Annexes B, C and D shall be amended, as and when required, by the Council acting by a qualified majority on a proposal from the Commission, in particular in order to take into account developments in research and in diagnostic procedures.
Annex A may be amended as and when required in accordance with the procedure laid down in Article 19.
Article 19
1. Where the procedure laid down in this Article is to be followed, the Chairman shall, without delay, refer the matter to the Standing Veterinary Committee, 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 of the measures to be taken. The Committee shall deliver its opinion on the 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 20
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1994. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, they shall contain a reference to this Directive or 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.
2. However, from the date laid down in paragraph 1, Member States may, subject to the general rules of the Treaty, maintain or apply in their territory stricter provisions than those laid down by this Directive. They shall notify the Commission of any such measure.
3. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive.
Article 21
This Directive is addressed to the Member States.
Done at Luxembourg, 24 June 1993.