Measures for the Control of Fish Diseases Rules, 2005

L.N. 354 of 2005

VETERINARY SERVICES ACT

(CAP. 437)

Measures for the Control of Fish Diseases Rules, 2005

IN exercise of the powers conferred by article 5(1) of the Veterinary

Services Act, the Minister for Rural Affairs and the Environment has

made the following rules>-

(1) The title of these rules is Measures for the Control of Title, scope and

applicability.

Certain Fish Diseases Rules, 2005.

(2) The scope of these rules is to implement the rules

contained in the European Union Council Directive 93#53#EEC

introducing minimum Community measures for the control of certain

fish diseases.

(3) These rules define the minimum measures to be carried

out in the territory of Malta for the control of the fish diseases referred

to in Schedule A, lists I and II, to European Union Council Directive

91#67#EEC.

(1) For the purpose of these rules –

NATIONAL REFERENCE LABORATORIES FOR FISH DISEASES

Belgium: CODA — Centrum voor Onderzoek in Diergeneeskunde en Agrochemie

CERVA — Centre d'étude et de recherches veterinaries et agrochimiques

Groeselenberg 99 B-1180 Brussel/Bruxelles.

Czech Republic: Výzkumný ústav veterinárního lékaøství Hudcova 70 621 32 Brno-Medlánky.

Denmark: Statens Veterinære Serumlaboratorium Fødevareministeriet Hangøvej 2 DK-8200 Århus N.

Germany: Bundesforschungsanstalt für Viruskrankheiten der Tiere Boddenblick 5a D-17498 Insel Riems.

Estonia: Veterinaar- ja Toidulaboratoorium Väike-Paala 3 11415 Tallinn.

Greece: Laboratory of Fish Pathology and Bio-Pathology of Aquatic Organisms Centre of Athens

Veterinary Institutes, Institute of Infectious and Parasitic Diseases 25 Neapoleos ST. GR-153 10 Ag.

Paraskevi Attiki.

Spain: Laboratorio Central de Veterinaria de Algete Madrid.

France: Agence française de sécurité sanitaire des aliments (AFSSA) Laboratoire d'études et de recherches

en pathologie des poissons (LERPP) Technopôle Brest Iroise — BP 70 F-29280 Plouzane.

Ireland: Fisheries Research Centre Abbotstown Castleknock Dublin15 Ireland.

Italy: Istituto zooprofilattico sperimentale delle Venezie Via Romea 14/A I-35020 Legnaro, Padova.

Cyprus: Εργαστήριο Αναφοράς για τις Ασθένειες των Ζώων, Κτηνιατρικές Υπηρεσίες, 1417 Λευκωσία

National Reference Laboratory for Animal Health Veterinary Services CY-1417 Nicosia.

Latvia: Valsts veterinarmedicinas diagnostikas centrs Lejupes iela 3 LV-1076 Riga.

Lithuania: Nacionaline veterinarijos laboratorija J.Kairiukšèio g. 10 LT-2021 Vilnius.

Luxembourg: CODA — Centrum voor Onderzoek in Diergeneeskunde en Agrochemie

CERVA — Centre d'étude et de recherches veterinaries et agrochimiques

Groeselenberg 99 B-1180 Brussel/Bruxelles.

Hungary: Országos Állategészségügyi Intézet (OÁI), Pf. 2. Tábornok u. 2. HU-1581 Budapest.

Malta: Istituto Zooprofilattico Sperimentale delle Venezie Legnaro (PD) Italy.

Netherlands: Fish Diseases Laboratory ID-Lelystad Institute for Animal Science and Health Edelhertweg

15PO Box 65 8200 AB Lelystad Nederland.

Austria: Institut für Hydrobiologie, Fisch- und Bienenkunde Veterinärmedizinische Universität Wien

Veterinärplatz 1 A-1210 Wien.

Poland: Laboratorium Zak³adu Chorób Ryb Pañstwowego Instytutu Weterynaryjnego Al. Partyzantów 57

PL-24-100 Pu³awy.

Portugal: Laboratório Nacional de Investigação Veterinária Estrada de Benfica 701 P-1500 Lisboa.

Slovenia: Nacionalni veterinarski inštitut, Gerbièeva 60 SI-1000 Ljubljana.

Slovakia: Štátny veterinárny a potravinový ústav Janoškova 1611/58 026 80 SK-Dolný Kubín.

Finland: Eläinlääkintä- ja elintarvikelaitos (EELA)PL 368 FIN-00231 Helsinki.

Sweden: Statens Veterinärmedicinska Anstalt (SVA) S-751 89 Uppsala.

United Kingdom: CEFAS Weymouth Laboratory Barrack Road Weymouth DT4 8UB United Kingdom.

The Marine LaboratoryPO box 101 Victoria Road Aberdeen AB9 8DB United Kingdom.

Definitions.

“farm suspected of being infected” means a farm containing

fish suspected of being infected<

“fish suspected of being infected” means 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<

“infected farm” means a farm containing infected fish and a

farm which has been evacuated but not yet disinfected.

“infected fish” means 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<

“list I diseases” means fish diseases referred to in Schedule

A, list I, to European Union Council Directive 91#67#EEC<

“list II diseases” means fish diseases referred to in Schedule

A, list II, to European Union Council Directive 91#67#EEC<

“Member State” means a State which is a Member within the

European Community<

“the Community” means the European Community as

established under the Treaty establishing the European Community<

“the official service” means the Veterinary Services within

Malta as provided under article 2 of the Veterinary Services Act<

“third country” means a state which is not a Member within

the European Community.

(2) The definitions laid down in Article 2 of European Union

Council Directive 91#67#EEC shall apply as necessary.

CHAPTER I

General Provisions

COMMUNITY REFERENCE LABORATORY FOR FISH DISEASES

Statens Veterinære Serumlaboratorium

Landbrugsministeriet

Hangøvej 2

8200 Aarhus N

Denmark.

(1) All farms rearing or keeping fish susceptible to list I or

list II diseases shall-

(a) be registered by the official service< this registration must

be kept constantly up to date<

(b) 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>

Provided that 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.

MINIMUM CRITERIA FOR CONTINGENCY PLANS

Contingency plans shall meet at least the following criteria

1. the establishment of a national crisis centre which shall coordinate all control measures in the Member

State concerned;

2. a list shall be provided of local disease control centres with adequate facilities to coordinate the disease

control measures at a local level;

3. detailed information shall be given on the staff involved in control measures, their skills and their

responsibilities;

4. each local disease control centre must be able to contact rapidly persons/organizations which are directly

or indirectly involved in an outbreak;

5. equipment and materials shall be available to carry out the disease control measures properly;

6. detailed instructions shall be provided on action to be taken on suspicion and confirmation of infection or

contamination;

7. training programmes shall be established to maintain and develop skills in field and administrative

procedures;

8. where appropriate, diagnostic laboratories must have facilities for postmortem examination, the

necessary capacity for serology, histology, etc., and must maintain the skills for rapid diagnosis (to this end,

arrangements must be made for rapid transportation of samples);

9. provisions shall be adopted to ensure the legal powers necessary for the implementation of the

contingency plans.

It is compulsory for the suspected presence of any of the list I Notification in case

of suspected

and list II diseases to be notified as soon as possible to the official presence of disease.

service.

CHAPTER II

Control Measures for List I Diseases

CRITERIA FOR VACCINATION PROGRAMMES

Vaccination programmes must contain at least the following information

1. The nature of the disease calling for a request to be made to vaccinate.

2. Information shall be supplied on the coastal and mainland areas, the sites and farms in which vaccination

may be carried out: under no circumstances may vaccination be conducted beyond the limits of the infected

area and, if necessary, the buffer zone established around the infected area.

3. Detailed information on the vaccine to be used, including the type(s) of vaccine which may be used.

4. Detailed information on the conditions for use, frequency of vaccination and the limits on use of the

vaccine (which fish, which cages, etc.).

5. The criteria for ceasing vaccination.

6. Provisions shall be adopted to ensure that a log is kept of past vaccinations (dates, sites and farms in

which vaccination has been conducted, the establishment of a buffer zone, etc.).

7. Measures shall be taken for fish movements to be limited within the vaccination area so as to guarantee

that fish can leave the vaccination area only if they are to be killed for human consumption, or if necessary

to be destroyed.

8. Any other necessary provisions required for vaccination.

(1) When fish on a farm are suspected of being infected with Measures to be

taken in case of

a list I disease, the official service shall immediately activate official suspected presence

investigation arrangements to confirm or rule out the presence of the of list I disease.

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 must 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 rule 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>

Provided that 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>

Provided further that, if the necessity arises, 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 rule.

Where necessary, specific measures may be taken in accordance

with the relevant procedure of the European Community.

(3) Until such time as the official measures laid down in

sub-rule (2) are enforced, the owner or keeper of any fish in which

disease is suspected shall take every appropriate measure to ensure

compliance with sub-rule (2), except for (h) and (i) thereof.

(4) The measures referred to in sub-rule (2) shall not be

withdrawn until the suspicion of disease has been officially ruled out.

As soon as the presence of a list I disease has been officially

confirmed, the official service shall order that, in addition to the measures

listed in rule 5 (2), of the following measures be applied>

(a)

in an infected farm>

(i) all fish shall be withdrawn in accordance with a

scheme established by the official service and approved by

the Commission in accordance with the relevant procedure

of the European Community<

(ii) in the case of inland farms all pools must be drained

for the purposes of cleaning and disinfection<

(iii) 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 European Union Council Directive

90#667#EEC<

(iv) all live fish shall either be killed and destroyed

under the supervision of the official service in accordance

with European Union Council 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>

Provided that 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 highrisk material and are

submitted to a treatment to destroy pathogens in accordance with

European Union Council Directive 90#667#EEC and that the used water

is submitted to a treatment which inactivates any pathogens it may

(v) 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

relevant procedure of the European Community<

(vi) any substances which might be contaminated,

referred to in rule 5 (2) (d), must be destroyed or treated in

such a way as to ensure the destruction of any pathogen

present<

(vii) an epizootic investigation must be carried out in

accordance with rule 8 (1) and the provisions of rule 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 paragraph (a) of this rule 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) if application of the measures laid down under

paragraphs (a), (b), (c) and (d) of rule 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 rule.

Where necessary, appropriate additional measures shall be adopted

in accordance with the relevant procedure of the European Community.

(1) 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,

appropriate measures shall be taken by the official service.

(2) The official service shall inform the Commission and

the other Member States of the measures they have taken.

(1) The epizootic investigation shall deal with>

(a) the likely length of time during which the disease may

have existed on the farm before being notified or suspected<

(b) 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<

(c) 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<

(d) 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 rule 5 shall apply. If the presence of the disease

is confirmed, the measures laid down in rule 6 shall apply.

(3) If the epizootic investigation reveals that the cooperation

of the official services of other Member States is required, the official

service of Malta shall take all necessary measures to ensure compliance

with the provisions of these rules.

(4) A crisis unit shall be established by the official service

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>

Provided that the general rules concerning national crisis unit in

the territory of Malta in accordance with the requirements of the

European Community.

CHAPTER III

Control Measures for List II Diseases

(1) Where a list II disease is suspected and#or confirmed in Epizootic

investigation.

an approved zone or on an approved farm situated in a non-approved

zone, an epizootic investigation shall be carried out in accordance with

rule 8. In the case where Malta wishes to regain its status defined in

accordance with European Union Council Directive 91#67#EEC, Malta

must comply with the provisions of Schedules 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.

(1) Where a non-approved farm situated in a non-approved

zone contains fish suspected of being infected with a list II disease, the

official service shall>

(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 European Union Council 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) For a fixed period, an optional or compulsory

programme for the eradication of list II diseases in non-approved farms

or in nonapproved zones may be set up in the territory of Malta, under

the supervision of the official service and subject to the following

provisions>

(a) 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<

(b) these programmes, which will be set up on the basis of

general criteria determined by the European Community, and will

be submitted to the Commission for scrutiny, and approved and

where necessary amended in accordance with the relevant

procedure of the European Community.

CHAPTER IV

Final Provisions

(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 European Union Council 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 on fish diseases.

(1) A national reference laboratory shall be designated in National reference

laboratory.

Malta, 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 diagnostic laboratories.

(2) The national laboratory designated for the diseases in

question shall be responsible for coordinating diagnostic standards and

methods, and for the use of reagents.

(3) The national laboratory designated for the diseases in

question shall be responsible for coordinating the diagnostic standards

and methods in Malta. To this end, they>

(a) may provide diagnostic reagents to laboratories approved

by the official service<

(b) shall control the quality of all diagnostic reagents used

in Malta<

(c)

shall periodically arrange comparative tests<

(d) shall hold isolates of the pathogen of the disease from

cases confirmed in Malta<

(e) shall ensure confirmation of positive results obtained in

diagnostic laboratories approved by the official service.

(4) By way of derogation from sub-rule (1), if a national

laboratory is not designated in Malta, competent as regards the disease

in question, the official service 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 Schedule A.

(1) Vaccination against list II diseases in approved zones,

in approved farms situated in non-approved zones or in zones or farms

which have already begun the approval procedures laid down by

European Union Council Directive 91#67#EEC and against list I diseases

shall be forbidden.

(2) By way of derogation, vaccination may be authorised

in the case of an outbreak of list I diseases provided the procedures for

vaccination are specified in the approved contingency plans in

accordance with rule 15 and account is taken of the criteria set out in

Schedule D.

(1) The official service shall draw up a contingency plan

specifying how it will implement the measures laid down in these rules

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 Schedule C>

Provided that the official service may confine itself 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. Those criteria may be amended or supplemented,

taking into account the specific nature of the disease and in accordance

with the requirements of the European Community.

(3) Plans drawn up in accordance with the criteria set out in

Schedule C shall be submitted to the Commission.

(4) The plans shall be examined by the Commission in order

to determine whether they permit the desired objective to be attained

and shall suggest to the official service any amendments required, in

particular to ensure that they are compatible with the plans of the other

Member States.

(5) The plans shall be approved by the Commission and

amended, if necessary, in accordance with the relevant procedure of

the European Community>

Provided that the plans may subsequently be amended or

supplemented, in accordance with the same procedure, to take into

account developments in the situation.

Commission experts may, in collaboration with the official On-the-spot

by Commission

service, and in so far as is necessary to ensure uniform application of experts.

these rules, make on-the-spot checks in Malta, as follows>

(a) they may check a representative percentage of holdings

to see whether the official service is checking that these holdings

are fulfilling the requirements of these rules<

(b) the official service shall be informed by the Commission

of the result of the checks carried out<

(c) when a check is being carried out, the official service

shall give all the necessary assistance to the experts in carrying

out their duties.