287 tal-2008 - Regoli tal-2008 dwar Miżuri għall-Kontroll ta’ Ċertu Mard ta’ l-Annimali u Miżuri Speċifiċi relatati mal-Mard Vesikulari tal-Majjal

L.N. 287 of 2008

VETERINARY SERVICES ACT

(CAP. 437)

CONTROL OF CERTAIN ANIMAL DISEASES

(AND SPECIFICALLY THE SWINE VESICULAR DISEASE)

RULES, 2008

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

Veterinary Services Act, the Minister for Resources and Rural Affairs

has made the following rules>-

(1) The title of these rules is Control of Certain Animal Title, scope and

applicability.

Diseases (and Specifically the Swine Vesicular Disease) Rules, 2008.

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

under European Union Council Directive 92#119#EEC introducing

general Community measures for the control of certain animal diseases

and specific measures relating to swine vesicular disease and to include

the amendments made by Commission Directive 2007#10#EC as regards

the measures to be taken within a protection zone following an outbreak

of swine vesicular disease, repealing and replacing the Control of Certain

Animal Diseases (and specifically the Swine Vesicular Disease) Rules, L.N. 366 of 2005.

2005. (3) These rules define the general control measures to be

applied in the event of an outbreak of one of the diseases listed in

Schedule I.

For the purpose of these rules –

LIST OF COMPULSORILY NOTIFIABLE DISEASES

Disease

Maximum incubation period

Rinderpest

21 days

Peste des petits ruminants

21 days

Swine vesicular disease

28 days

Bluetongue

40 days

Epizootic haemorrhagic disease of deer

40 days

Sheep and goat pox (Capripox)

21 days

Vesicular stomatitis

21 days

African swine fever

40 days

Lumpy skin disease

28 days

Rift valley fever

30 days

Definitions.

“animal” means any domestic animal of a species liable to be

directly affected by the disease in question, or any wild vertebrate

animal likely to participate in the epidemiology of the disease, by

acting as a carrier or reservoir of infection<

“confirmation of infection” means the declaration by the

competent authority of the presence of any of the diseases listed in

Schedule I based on laboratory results and in the event of an

epidemic, the competent authority may also confirm the presence

of the disease on the basis of clinical or epidemiological results<

“holding” means any establishment (agricultural or other),

situated in the territory of Malta, in which animals are kept or

bred<

“incubation period” means the period of time likely to elapse

between exposure to the agent of the disease and the onset of clinical

symptoms. The duration of this period shall be that indicated in

Schedule I for the disease in question<

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

European Community<

“official veterinarian” means the veterinarian appointed by

the competent authority<

“owner or keeper” means any person or persons, either natural

or legal, having ownership of the animals, or charged with keeping

the said animals, whether or not for financial reward<

“the competent authority” means the Veterinary Services

within the territory of Malta as provided under article 2 of the

Veterinary Services Act<

“the Commission” means the European Commission within

the Community<

“the Community” means the European Community as

established under the Treaty establishing the European Community<

“vector” any wild vertebrate or invertebrate animal which,

by mechanical or biological means, is liable to transmit and spread

the agent of the disease in question.

SPECIFIC MEASURES TO CONTROL CERTAIN DISEASES

In addition to the general provisions laid down in these rules, the following specific

provisions shall be applicable to swine vesicular disease.

1. Description of the disease

A disease of swine that is clinically indistinguishable from foot-and-mouth disease,

causing vesicles on the snout, lips, tongue and the coronary bands of the digits. The

disease varies considerably in severity and may infect a pig herd without manifesting

itself by clinical lesions. The virus is able to survive for long periods outside the body

even in fresh meat; it is extremely resistant to normal disinfectants and noted for its

persistence and stability over a pH range from 2,5 to 12. Particularly thorough

cleaning and disinfection are, therefore, necessary.

2. Incubation period

For the purpose of these rules, the maximum incubation period shall be considered to

be 28 days.

3. Diagnostic procedures for the confirmation and differential diagnosis of

swine vesicular disease

The detailed methods for the collection of materials for diagnosis, the laboratory

diagnostic tests, detection of antibodies and evaluation of the results of laboratory

testing shall be decided in accordance with the relevant procedure of the Community.

4. Confirmation of the presence of swine vesicular disease

By way of derogation from rule 2(6), the presence of the disease shall be confirmed

(a)

on holdings on which swine vesicular disease virus is isolated either from the

pigs or from the environment;

(b)

on holdings containing pigs which are seropositive for swine vesicular disease

provided those pigs or others on the holdings show lesions characteristic of swine

vesicular disease;

(c)

on holdings containing pigs which show clinical signs of disease or are

seropositive, provided there is a direct epidemiological connection with a confirmed

outbreak;

(d)

on other herds in which seropositive pigs are detected. In the latter case the

competent authority shall, before confirming the presence of the disease, undertake

further investigations, in particular resampling and retesting with an interval of 28

days at least between collections of samples. The provisions of Article 4 shall

continue to apply until such further investigations are completed. If subsequent

investigations show no evidence of the disease, although the pigs are still seropositive,

the competent authority shall ensure that the pigs tested are killed and destroyed under

its supervision or slaughtered under its supervision in a slaughterhouse it has

designated in its national territory.

The competent authority shall ensure that on arrival at the slaughterhouse the pigs are

kept and slaughtered separately from other pigs and that their meat is exclusively used

on the national market.

5. Diagnostic laboratories

Austria: Institut für Fischkunde, Veterinärmedizinische Universität, Wien.

Belgium: Institut national de recherches vétérinaires, Groeselenberg 99, B-1180

Bruxelles.

Denmark: Statens Veterinære Institut for Virusforskning, Lindholm.

Finland: Eläinlääkintä- ja elintarvikelaitos, Helsinki —Anstalten för veterinärmedicin

och livsmedel, Helsingfors.

Germany: Bundesforschungsanstalt für Viruskrankheiten der Tiere, Paul-Ehrlich-

Straße, 7400 Tübingen.

France: Laboratoire central de recherche vétérinaire, Maisons-Alfort.

Greece: Ινστιτούτο Λοιµωδών και Παρασιτικών Νοσηµάτων, Νεαπόλεως 21, Αγία

Παρασκευή·

Ireland: Institute for Animal Health, Pirbright, Woking, Surrey.

Italy: Istituto zooprofilattico sperimentale della Lombardia e dell'Emilia Romagna,

Brescia.

Luxembourg: Institut national de recherches vétérinaires, Groeselenberg 99, B-1180

Bruxelles.

Netherlands: Centraal Diergeneeskundig Institut, Lelystad.

Portugal: Laboratório Nacional de Investigação Veterinária, Lisboa.

Spain: Laboratorio de Alta Seguridad Biológica (INIA), 28130 Madrid.

Sweden: Statens veterinärmedicinska anstalt, Uppsala.

United Kingdom: Institute for Animal Health, Pirbright, Woking, Surrey.

Czech Republic: Státní veterinární ústav Praha, Sídlištní 24/136,165 03 Praha 6.

Estonia: Veterinaar - ja Toidulaboratoorium, Kreutzwaldi 30, 51006 Tartu.

Cyprus: Istituto Zooprofilattico Sperimentale della Lombardia e dell' Emilia

Romagna, Via Bianchi 9, IT - 25124 Brescia.

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

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

Vilnius.

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

Budapest.

Malta: Institute for Animal Health, Pirbright Laboratory, Ash Road, Pirbright,

Woking, Surrey GU24 ONF, United Kingdom.

Poland: Laboratorium Zak³adu Pryszczycy Pañstwowego Instytutu Weterynaryjnego,

ul. Wodna 7, PL-98- 220 Zduñska Wola.

Slovenia: Institute for Animal Health, Pirbright Laboratory, Ash Road, Pirbright,

Woking, Surrey GU24 ONF, United Kingdom.

Slovakia: Institute for Animal Health, Pirbright Laboratory, Ash Road, Pirbright,

Woking, Surrey GU24 ONF, United Kingdom.

6. Community reference laboratory

AFRC Institute for Animal Health,Pirbright Laboratory, Ash Road, Pirbright,

Woking, Surrey GU24 ONF, United Kingdom.

7. Protection zone

1. The size of the protection zone shall be as defined in rule 10.

2. In the case of swine vesicular disease, by way of derogation, the measures in

rule 11 shall be replaced by the following

(a)

all holdings within the zone having animals of susceptible species shall be

identified;

(b)

there shall be periodic visits to holdings having animals of susceptible

species, a clinical examination of those animals including, if necessary, the

collection of samples for laboratory examination; a record of visits and findings

must be kept; with the frequency of the visits being proportional to the

seriousness of the epizootic on those holdings at greatest risk;

(c)

the movement and transport of animals of susceptible species on public or

private roads, excluding the service roads of holdings, shall be prohibited. The

competent authority may, however, derogate from this prohibition for the transit

of animals by road and rail without unloading or stopping;

(d)

however, in accordance with the requirements of the Community, an

exemption may be granted for slaughter pigs coming from outside the protection

zone and on their way to a slaughterhouse situated in that zone;

(e)

trucks and other vehicles and equipment which are used within the

protection zone to transport pigs or other livestock or material which may be

contaminated (e.g. feedingstuff, manure, slurry, etc.) may not leave

(i)

a holding situated within the protection zone;

(ii)

the protection zone;

(iii) a slaughterhouse,

without having been cleaned and disinfected in accordance with the procedures

laid down by the competent authority. Those procedures shall provide in

particular that no truck or vehicle which has been used in the transport of pigs

may leave the zone without being inspected by the competent authority;

(f)

pigs may not be removed from a holding in which they are kept for 21

days after completion of the preliminary cleaning and disinfection of infected

holdings as laid down in Article 16; after 21 days, authorization may be given to

remove pigs from the said holding

(i)

directly to a slaughterhouse designated by the competent authority,

preferably within the protection or surveillance zone, provided that

- an inspection of all the pigs on the holding has been carried

- a clinical examination of the pigs to be moved to slaughter

has been carried out,

- each pig has been marked by ear marking or has been

identified

by any other approved method,

- the pigs are transported in vehicles sealed by the competent

authority.

The competent authority responsible for the slaughterhouse shall be

informed of the intention to send pigs to it.

On arrival at the slaughterhouse, the pigs shall be kept and slaughtered

separately from other pigs. The vehicle and equipment which have been

involved in the transport of the pigs shall be cleaned and disinfected

before leaving the slaughterhouse.

During the pre-slaughter and post mortem inspection carried out at the

designated slaughterhouse, the competent authority shall take into account

any signs relating to the presence of the swine vesicular disease virus.

In the case of pigs slaughtered under these provisions, a statistically

representative sample of bloods shall be collected. In the case of a positive

result which leads to the confirmation of swine vesicular disease, the

measures in 9 (3) will apply;

(ii)

under exceptional circumstances, directly to other premises located

within the protection zone, provided that

- an inspection of all the pigs on the holdings has been carried

- a clinical examination of the pigs to be moved has been

carried out, with negative results,

- each pig has been marked by ear marking or has been

identified by any other approved method;

(g)

fresh meat from the pigs referred to in point (f) (i)

(i)

shall not enter into intra-Community or international trade and shall

bear the health mark for fresh meat provided for in Annex II to Council

Directive 2002/99/EC;

(ii)

shall be obtained, cut, transported and stored separately from meat

intended for intra-Community and international trade and shall be used in

such a way as to avoid it being introduced into meat products intended for

intra-Community or international trade, unless it has undergone a

treatment set out in Annex III to Directive 2002/99/EC.

(h) (i)

by way of derogation from point (g), for meat from pigs referred to

in point (f) (i) Member States may decide to use another identification

mark than the special identification mark set out in Annex II to Directive

2002/99/EC, provided that it is clearly distinguishable from other

identification marks to be applied to pig meat in accordance with

Regulation (EC) No 853/2004 of the European Parliament and the Council

or Commission Regulation (EC) No 2076/2005;

Member States that decide to use the alternative identification mark shall

inform the Commission thereof in the framework of the Standing

Committee on the Food Chain and Animal Health.

(ii)

for the purpose of (i) the identification mark must be legible and

indelible, the characters easily readable and clearly displayed. The

identification mark must have following shape and contain following

indications

XY

XY

XY means the relevant country code provided for in point 6 of Part B of

Section I of Annex II to Regulation (EC) No 853/2004.

1234 means the approval number of the establishment referred to in point

7 of Part B of Section I of Annex II to Regulation (EC) No 853/2004.

3. The measures in the protection zone shall continue to be applied at least until

(a)

all measures laid down in rule 16 have been carried out;

(b)

all the holdings in the zone have undergone

(i)

a clinical examination of the pigs which has revealed that they have

no signs of disease suggesting the presence of swine vesicular disease; and

(ii)

a serological examination of a statistical sample of the pigs without

the detection of antibodies to swine vesicular disease. The programme for

serological screening shall take into account the transmission of swine

vesicular disease and the way in which pigs are kept. The programme

shall be that fixed by the Community.

The examination and sampling referred to in (i) and (ii) shall not take place before 28

days have elapsed after the completion of preliminary cleaning and disinfection

measures at the infected holding.

4. On expiry of the period referred to in point 3, the rules applied to the

surveillance zone shall also apply to the protection zone.

5. Where the prohibitions provided for in point 2 (f) are maintained beyond 30

days because of the occurrence of further cases of the disease and as a result problems

arise in keeping the animals, the competent authority may, following an application

by the owner explaining the grounds for such application and provided that the

official veterinarian has verified the facts, authorise the removal of the animals from a

holding within the protection zone. Points 2 (f) and (h) shall apply mutatis mutandis.

8. Surveillance zone

1. The size of the surveillance zone shall be as laid down in rule 10.

2. In the case of swine vesicular disease, the measures laid down in rule 12 shall be

replaced by the following

(a)

all holdings having animals of susceptible species shall be identified;

(b)

any movement of pigs other than direct to a slaughterhouse from a holding

in the surveillance zone shall be permitted, provided that no pigs have moved

into that holding in the previous 21 days; the owner or the person responsible

for the animals must keep a record of all pig movements;

(c)

the movement of pigs from the surveillance zone may be authorized by the

competent authority, provided that

(i)

an inspection of all pigs on the holding has been carried out with the

48 hours preceding the movement,

(ii)

a clinical examination of the pigs to be moved has been carried out

with negative results in the 48 hours preceding the movement,

(iii) a serological examination of a statistical sample of the pigs to be

moved has been carried out without the detection of antibodies to swine

vesicular disease within the 14 days preceding the movement. However, in

the case of pigs for slaughter, the serological examination may be carried

out on the basis of blood samples taken at the slaughterhouse of

destination designated by the competent authority in its territory. In the

event of positive results confirming the presence of swine vesicular

disease, the measures provided for in point 9(3) shall be applied,

(iv) each pig has been marked with an individual eartag or by any other

approved method of identification,

(v)

trucks and other vehicles and equipment used for the transport of the

pigs must be cleaned and disinfected after each transport operation;

(d)

trucks and other vehicles and equipment used for the transport of the pigs

or other livestock or material that may be contaminated and which are used

within the surveillance zone shall not leave that zone without having been

cleaned and disinfected in accordance with the procedures laid down by the

competent authority.

3. (a)

The size of the surveillance zone may be amended in accordance with the

provisions laid down in rule 10 (3).

(b)

The measures in the surveillance zone shall be applied at least until

(i)

all the measures laid down in rule 16 have been carried out;

(ii)

all the measures required in the protection zone have been carried

out.

9. General common measures

Additional measures in the case of swine vesicular disease shall be applied as follows

1. in cases where the presence of swine vesicular disease is officially confirmed,

Member States shall ensure that, in addition to the measures laid down in rules 4 (2)

and 5, meat of pigs slaughtered during the period between the probable introduction

of disease to the holding and the implementation of official measures is, wherever

possible, traced and destroyed under official supervision in such a way as to avoid the

risk of swine vesicular disease virus spreading;

2. when the official veterinarian has reason to suspect that pigs on any holding

may have been contaminated as a result of the movement of any person, animal or

vehicle or in any other way, pigs on the holding shall remain under the movement

restrictions referred to in rule 9 at least until the holding has undergone

(a)

a clinical examination of the pigs, with negative results;

(b)

a serological examination of a statistical sample of the pigs without the

detection of antibodies to swine vesicular disease in accordance with 7 (3) (b)

(ii).

The examination referred to in (a) and (b) shall not take place until 28 days have

elapsed since the possible contamination of the premises as the result of the

movement of persons, animals, or vehicles, or in any other way.

3. Should the presence of swine vesicular disease be confirmed in a

slaughterhouse, the competent authority shall ensure that

(a)

all pigs in the slaughterhouse are slaughtered without delay;

(b)

the carcases and offal of infected and contaminated pigs are destroyed

under official supervision in such a way as to avoid the risk of swine vesicular

disease virus spreading;

(c)

cleaning and disinfection of buildings and equipment, including vehicles,

take place under the supervision of the official veterinarian, in accordance with

instructions laid down by the competent authority;

(d)

an epidemiological enquiry is carried out in accordance with rule 8;

(e)

no pigs are re-introduced for slaughter until at least 24 hours after

completion of the cleaning and disinfection operations carried out in accordance

with (c).

10. Cleansing and disinfection of infected holdings

In addition to the measures laid down in rule 16, the following measures shall also

apply-

1. Procedure for preliminary cleaning and disinfection -

(a)

As soon as the carcases of the pigs have been removed for disposal, those

parts of the premises in which the pigs have been housed and any other parts of

the premises which have been contaminated during slaughter should be sprayed

with disinfectant, approved in compliance with rule 16, at the concentration

appropriate for swine vesicular disease. The disinfectant used should remain on

the surface for at least 24 hours.

(b)

Any tissue or blood which may have been spilled during slaughter should

be carefully collected and disposed of with the carcases (slaughter should

always be carried out on an impervious surface).

2. Procedure for further cleaning and disinfection -

(a)

All manure, bedding, contaminated food, etc., should be removed from the

buildings, stacked and sprayed with an approved disinfectant. Slurry should be

treated by a method suitable for killing the virus.

(b)

All portable fittings should be removed from the premises and cleansed

and disinfected separately.

(c)

Grease and other dirt should be removed from all surfaces by soaking with

a degreasing agent and then washing with water under pressure.

(d)

A further application of disinfectant should then be made by spraying all

surfaces.

(e)

Sealable rooms should be fumigated.

(f)

Repairs to damaged floors, walls etc. should be agreed following

inspection by an official veterinarian, and carried out immediately.

(g)

Completed repairs should be inspected to ensure that they have been done

satisfactorily.

(h)

All parts of the premises which are completely free of combustible

material may be heat-treated using a flame gun.

(i)

All surfaces should be sprayed with an alkaline disinfectant having a pH

greater than 12,5 or any other approved disinfectant. The disinfectant should be

washed off after 48 hours.

3. Procedure for final cleaning and disinfection -

Treatment with flame gun or alkaline disinfectant (point 2 (h) or (i)) should be

repeated after 14 days.

11. Restocking of infected holdings

In addition to the measures laid down in rule 5(4), the following measures shall apply

1. Restocking should not commence until four weeks after completion of the first

full disinfection of the premises, i.e. step 3 of the cleaning and disinfection

procedures.

2. The re-introduction of pigs shall take account of the type of farming practised

on the holding and must conform to one of the following procedures

(a)

in the case of outdoor pig holdings, restocking shall start with the

introduction of a limited number of sentinel piglets which have been checked

and found negative for the presence of antibodies against swine vesicular

disease virus. The sentinel piglets shall be placed, in accordance with the

requirements of the competent authority, throughout the infected holding and

will be examined clinically 28 days after having been placed on the holding, and

sampled for serological testing.

If none of the piglets shows clinical evidence of swine vesicular disease nor has

developed antibodies against the virus of the disease, full restocking may take

place;

(b)

for all other forms of rearing, the re-introduction of pigs shall take place

either in accordance with the measures provided for in paragraph (a) or by full

restocking, provided that

(i)

all the pigs arrive within a period of eight days and come from

holdings situated outside areas restricted as a result of swine vesicular

disease, and are seronegative,

(ii)

no pig may leave the holding for a period of 60 days after the arrival

of the last pigs,

(iii) the repopulated herd is subjected to a clinical and serological

examination in accordance with the requirements of the competent

authority. That examination may be carried out at the earliest 28 days after

the arrival of the last pigs.

It is compulsory for the suspected presence in the territory of

competent authority

Malta of any of the diseases referred to in Schedule I to be notified

immediately to the competent authority.

Official measures in

COMMUNITY REFERENCE LABORATORIES FOR THE DISEASES

CONCERNED

The functions and duties of the Community reference laboratories for the diseases

concerned shall be

1. to coordinate, in consultation with the Commission, the methods employed in

the Member States for diagnosing the disease concerned, specifically by

(a)

typing, storing and supplying strains of the virus of the relevant disease

for serological tests and the preparation of antisera;

(b)

supplying standard sera and other reference reagents to the national

laboratories in order to standardize the tests and reagents used in the Member

States;

(c)

building up and retaining a collection of virus strains and isolates of the

relevant disease;

(d)

organizing periodic comparative tests of diagnostic procedures at

Community level;

(e)

collecting and collating data and information on the methods of diagnosis

used and the results of tests carried out in the Community;

(f)

characterizing isolates of the virus of the relevant disease by the most up

to- date methods to allow greater understanding of the epizootiology of the

disease;

(g)

keeping abreast of developments in the surveillance, epizootiology and

prevention of the relevant disease throughout the world;

(h)

retaining expertise on the relevant disease virus and other pertinent viruses

to enable rapid differential diagnosis;

(i)

acquiring a thorough knowledge of the preparation and use of the products

of veterinary immunology used to eradicate and control the relevant disease;

2. to assist actively in the diagnosis of outbreaks of the relevant disease in Member

States by receiving virus isolates for confirmatory diagnosis, characterization and

epizootiological studies;

3. to facilitate the training or retraining of experts in laboratory diagnosis with a

view to the harmonization of diagnostic techniques throughout the Community.

(1) When animals on a holding are suspected of being

infected or contaminated with one of the diseases listed in Schedule I,

the official veterinarian shall immediately activate official investigation

arrangements to confirm or rule out the presence of the disease in

question and, in particular, must take or have taken the samples necessary

for laboratory examination. To that end the animals in question may be

transported to the laboratories under the supervision of the competent

authority, which shall take appropriate steps to prevent the disease from

spreading.

(2) As soon as the suspected presence of the disease is

notified, the competent authority shall have the holding placed under

official surveillance and shall in particular require that>

(a) a census be made and recorded of all categories of

animals of susceptible species and that, in respect of each of these

categories, the number of animals already dead, infected or liable

to be infected or contaminated< the census must be kept up to date

to take account of animals born or dying during the period of

suspicion< the information in the census must be kept up to date

and produced on request and may be checked at each visit<

(b) all animals of susceptible species on the holding be kept

in their living quarters or confined in some other place where they

can be isolated taking into account the possible role of vectors,

where appropriate<

(c) no animals of susceptible species enter or leave the

holding<

(d) all movement>

(i) of persons, animals of other species not susceptible

to the disease and vehicles to or from the holding<

(ii) of meat or animal carcases, or of animal feed,

equipment, waste, droppings, litter, manure, or anything liable

to transmit the disease in question<

(e) be subject to authorization by the competent authority,

which shall lay down the conditions for preventing any risk of the

disease spreading< appropriate means of disinfection be installed

at the entrances and exits of buildings or places housing animals

of susceptible species and of the holding itself<

(f) an epizootiological inquiry be carried out in accordance

with rule 8.

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

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

disease is suspected shall take every appropriate measure to ensure

compliance with sub-rule (2), except for paragraph (f) thereof.

(4) The competent authority may apply any of the measures

provided for in sub-rule (2) to other holdings should their location, their

configuration or contacts with the holding where the disease is suspected

give reason to suspect possible contamination.

(5) The measures referred to in sub-rules (1) and (2) shall

not be withdrawn until the suspicion of the presence of the disease has

been ruled out by the official veterinarian.

MINIMUM CRITERIA FOR THE CONTINGENCY PLANS

Contingency plans shall meet at least the following criteria

1. the establishment of a crisis centre on a national level, which shall coordinate all

control measures in the territory of Malta;

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, including means of disposal of carcases;

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

and administrative procedures;

8. diagnostic laboratories must have facilities for post mortem examination, the

necessary capacity for serology, histology, etc., and must maintain the skills for rapid

diagnosis. Arrangements must be made for rapid transportation of samples;

9. details shall be provided of the quantity of vaccine against the disease in

question estimated to be required in the event of recourse to emergency vaccination;

10. provisions shall be made to ensure the legal powers necessary for the

implementation of the contingency plans.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

€3.07

(1) Once it has been officially confirmed that one of the

diseases listed in Schedule I is present on a holding, in addition to the

measures laid down in rule 4(2), the competent authority shall require

application of the following measures>

(a) all animals of susceptible species on the holding shall

be killed on the spot, without delay. The animals which have died

or been killed shall either be burnt or buried on the spot, if possible,

or destroyed in a carcase disposal plant. These operations shall be

carried out in such a way as to minimize the risk of disseminating

the agent of the disease<

(b) any substance or waste, such as animal feed, litter,

manure or slurry, which is liable to be contaminated, shall be

destroyed or treated appropriately. This treatment, carried out in

accordance with the instructions of the official veterinarian, must

ensure that any agent or vector of the agent of the disease is

destroyed<

(c) after carrying out operations listed in paragraphs (a) and

(b) hereof, the buildings used for housing animals of susceptible

species, their surroundings, the vehicles used for transport and all

equipment liable to be contaminated shall be cleaned and

disinfected in accordance with rule 16< and

(d) an epizootiological inquiry shall be carried out in

accordance with rule 8.

(2) When recourse is had to burial, it must be deep enough

to prevent carnivorous animals from digging up the carcases or waste

referred to in sub-rule (1)(a) and (b) hereof and shall be in suitable

ground so as to prevent contamination of water tables or any

environmental nuisance.

(3) The competent authority may extend the measures

provided for in sub-rule (1) to other neighbouring holdings should their

location, their configuration or contacts with the holding where the

presence of the disease has been confirmed give reason to suspect

possible contamination.

(4) The restocking of the holding shall be authorized by the

competent authority, following the satisfactory inspection by the official

veterinarian of the cleaning and disinfection operations carried out in

accordance with rule 16.

Where animals living in the wild are infected or suspected of Animals living in

the wild.

being infected, appropriate action shall be taken by the competent

authority which shall inform the Commission and the other Member

States, of the measures it has taken.

(1) In the case of holdings which consist of two or more Holdings consisting

of two or more

separate production units, the competent authority may derogate from separate production

the requirements of rule 5 (1)(a) as regards healthy production units of units.

a holding which is infected>

Provided that the official veterinarian has confirmed that the

structure and size of these units and the operations carried out therein

are such that they are completely separate as regards housing, keeping,

staff, equipment and feeding, so as to prevent the spread of the agent of

the disease from one unit to another.

(2) Where recourse is had to sub-rule (1) hereof, the rules

laid down in Article 18 (2) of European Union Council Directive

2003#85#EC on Community measures for the control of foot-and-mouth

disease repealing European Union Council Directive 85#511#EEC and

Commission Decisions 89#531#EEC and 91#665#EEC and amending

European Union Council Directive 92#46#EEC shall mutatis mutandis

apply>

Provided that these rules may be amended for the disease in

question according to the European Community requirements in order

to take account of the specific nature of the disease.

(1) The epizootiological enquiry shall deal with>

The epizootiological

enquiry.

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

existed on the holding before being notified or suspected<

(b) the possible origin of the disease on the holding and the

identification of other holdings on which there are animals of

susceptible species which may have become infected or

contaminated<

(c) the movement of persons, animals, carcases, vehicles,

equipment or any other substances likely to have carried the agent

of the disease to or from the holdings in question<

(d) the presence and distribution of disease vectors as

appropriate.

(2) 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

epizootiological enquiry.

(3) The rules concerning national crisis units shall be laid

down according to European Community requirements.

(1) Where the official veterinarian finds, or considers on the

holdings are placed

basis of confirmed data, that disease could have been introduced from

other holdings onto the holding referred to in rule 4 or from the latter

onto other holdings as a result of the movement of persons, animals or

vehicles or in any other way, those other holdings shall be placed under

official surveillance in accordance with rule 4, and such surveillance

shall not be lifted until the suspected presence of disease on the holding

has been officially ruled out.

(2) Where the official veterinarian finds, or considers on

the basis of confirmed data, that disease could have been introduced

from other holdings on to the holding referred to in rule 5 or from the

latter onto other holdings as a result of the movement of persons, animals

or vehicles or in any other way, those other holdings shall be placed

under official surveillance in accordance with rule 4, and such

surveillance shall not be lifted until the suspected presence of disease

on the holding has been officially ruled out.

(3) When a holding has been subject to the provisions of

sub-rule (2) hereof, the competent authority shall keep the provisions of

rule 4 in force on the holding for at least the maximum incubation period

pertaining to each disease following the likely time of introduction of

infection as established by the epizootiological enquiry carried out in

accordance with rule 8.

(4) Where it considers that conditions permit, the competent

authority may limit the measures provided for in sub-rules (1) and (2)

hereof to a part of the holding and the animals contained therein provided

that the holding can satisfy the conditions set out in rule 7, or to animals

of susceptible species only.

(1) Once the diagnosis of one of the diseases in question

has been officially confirmed, the competent authority shall establish

around the infected holding a protection zone with a minimum radius of

three kilometres, itself contained in a surveillance zone with a minimum

radius of 10 kilometres>

Provided that the establishment of the zones must take account

of geographical, administrative, ecological and epizootiological factors

relating to the disease in question, and of monitoring facilities.

(2) Where the zones are situated in the territory of another

Member State, the competent authority shall co-operate with the

competent authorities of the Member States concerned in establishing

the zones referred to in sub-rule (1). If necessary, the protection zone

and the surveillance zone shall be established under the relevant

procedure of the European Community.

(3) The decision to modify (in particular to reduce or

increase, as appropriate) the boundaries of the zones laid down in sub-

rule (1) or the duration of the restriction measures may be decided by

the European Commission according to the relevant procedure of the

European Community, taking into account>

(a)

their geographical situation and ecological factors<

(b) the meteorological conditions<

(c)

the presence, distribution and type of vectors<

(d) the results of the epizootiological studies carried out in

accordance with rule 8<

(e)

the results of laboratory tests<

(f)

control measures actually applied.

(1) The competent authority shall ensure that the following Measures to be

taken in the

measures are applied in the protection zone>

protection zone.

(a) all holdings within the zone having animals of

susceptible species shall be identified<

(b) there shall be periodic visits to holdings having animals

of susceptible species, a clinical examination of those animals

including, if necessary, the collection of samples for laboratory

examination< a record of visits and findings must be kept, with the

frequency of visits being proportional to the seriousness of the

epizootic on those holdings at greatest risk<

(c) the movement and transport of animals of susceptible

species on public or private roads, excluding the service roads of

holdings, shall be prohibited< the competent authority may,

however, grant a derogation from that prohibition for the transit of

animals by road or rail without unloading or stopping<

(d) animals of susceptible species must remain on the

holding on which they are being kept, except those to be transported

under official supervision directly to a slaughterhouse located in

that zone for emergency slaughter or, if that zone has no

slaughterhouse under veterinary supervision, to a slaughterhouse

in the surveillance zone designated by the competent authority>

Provided that such transport may be authorized by the

competent authority only after the official veterinarian has carried

out an examination of all the animals of susceptible species on the

holding and confirmed that none of the animals is suspected of

being infected. The competent authority responsible for the

slaughterhouse shall be informed of the intention to send animals

to it.

(2) The measures applied in the protection zone shall be

kept in force for at least the maximum incubation period pertaining to

the disease in question after animals from the infected holding have

been disposed of in accordance with rule 5 and cleaning and disinfection

operations have been carried out in accordance with rule 16.

(3) Notwithstanding sub-rule (2), where the disease is

transmitted by an insect vector, the competent authority may fix the

duration of the measures and lay down provisions for the possible

introduction of sentinel animals. In such cases, the competent authority

shall forthwith inform the Commission and the other Member States of

the measures they have taken. On expiry of the period referred to in this

rule, the rules applied to the surveillance zone shall also apply to the

protection zone.

(1) The competent authority shall ensure that the following

measures are applied in the surveillance zone>

(a) all holdings having animals of susceptible species shall

be identified<

(b) the movement of animals of susceptible species on public

roads shall be prohibited except for the purpose of leading them to

pasture or animal buildings>

Provided that the competent authority may grant a derogation

from that prohibition for the transit of animals by road without

unloading or stopping<

(c) the transport of animals of susceptible species within

the surveillance zone shall be subject to authorization by the

competent authority<

(d) animals of susceptible species must>

(i) remain inside the surveillance zone for a maximum

incubation period after the most recent recorded case of

disease<

(ii) thereafter, be removed from that zone to be

transported under official supervision directly to a

slaughterhouse designated by the competent authority for

emergency slaughter<

(iii) be transported after being authorized by the

competent authority and only after the official veterinarian

has carried out an examination of all the animals of the

susceptible species on the holding and confirmed that none

of the animals is suspected of being infected.

The official veterinarian responsible for the slaughterhouse shall

be informed of the intention to send animals to it.

(2) The measures applied in the surveillance zone shall be

kept in force for a period at least equal to the maximum incubation

period after animals from the holding have been disposed of in

accordance with rule 5 and cleaning and disinfection operations have

been carried out in accordance with rule 16.

(3) Notwithstanding sub-rule (2) hereof, where the disease

is transmitted by an insect vector, the competent authority may fix the

duration of the measures and lay down provisions for the possible

introduction of sentinel animals. In such cases, the competent authority

shall forthwith inform the Commission and the other Member States,

of the measures they have taken.

(1) Where the prohibitions provided for in rule 11 (1)(d) Removal of animals

and rule 12 (1)(d) are maintained beyond 30 days because of the from

surveillance zone.

occurrence of further cases of the disease and as a result problems arise

in keeping the animals, the competent authority may, following an

application by the owner explaining the gounds for such application,

authorize the removal of the animals from a holding within the protection

zone or the surveillance zone>

Provided that>

(a)

the official veterinarian has verified the facts<

(b) an inspection of all animals on the holding has been

carried out<

(c) the animals to be transported have undergone a clinical

examination, with negative result<

(d) each animal has been marked by ear marking or has

been identified by any other approved method<

(e) the holding of destination is located either in the

protection zone or within the surveillance zone.

(2) All the necessary precautions shall be taken, in particular

by cleaning and disinfecting lorries after transport, to avoid the risk of

spreading the agent of the disease in the course of such transport.

(1) The competent authority shall take all the necessary

Necessary measures

measures to keep at least persons established in the protection and

surveillance zones informed of the restrictions in force and make all

necessary arrangements for the appropriate implementation of those

measures.

(2) Where, in a given region, the epizootic in question is

exceptionally serious, all the additional measures to be taken in the

territory of Malta shall be adopted according to the relevant procedure

of the European Community.

By way of derogation from the general provisions laid down

in these rules, specific provisions relating to the control and eradication

measures for each respective disease are>

(a) for swine vesicular disease, set out in Schedule II for

swine vesicular disease< and

(b) for each of the other diseases listed in Schedule I, adopted

in accordance with the provisions adopted by the European

Community in those matters.

Cleaning,

The following procedure shall be observed –

disinfection and

disinsectization

operations.

(a) the disinfectants and insecticides to be used and, where

appropriate, their concentrations, shall be officially approved by

the competent authority<

(b) the cleaning, disinfection and disinsectization operations

are carried out under official supervision –

(i) in accordance with the instructions given by the

official veterinarian< and

(ii) in such a way as to eliminate any risk of spread or

survival of the agent of the disease<

(c) on completion of the operations in paragraph (b), the

official veterinarian makes sure that the measures have been carried

out properly and that an appropriate period, of not less than 21

days, has elapsed to ensure that the disease in question has been

completely eliminated before animals of susceptible species are

re-introduced.

(2) The procedures for cleaning and disinfecting an infected

holding are–

(a)

for swine vesicular disease, those set out in Schedule

II< and

(b) determined, in the context of preparation of the specific

measures for each disease listed in Schedule I, in accordance with

the requirements of the European Community.

(1) For the purpose of implementation of these rules in the National

laboratories.

Territory of Malta, there shall be designated –

(a) a national laboratory 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

virus and to confirm results obtained in regional diagnostic

laboratories<

(b) a national laboratory at which reagents used in regional

diagnostic laboratories are tested.

(2) The national laboratories designated for each of the

diseases referred to shall be responsible for coordinating diagnostic

standards and methods, and for the use of reagents.

(3) The national laboratories designated for each of the

diseases referred to shall be responsible for coordinating the diagnostic

standards and methods laid down by each laboratory for diagnosis of

the disease in question within the territory of Malta. To this end, they>

(a) may provide diagnostic reagents to national laboratories<

(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 virus of the disease in question

from cases confirmed in the territory of Malta<

(e) shall ensure the confirmation of positive results obtained

in regional diagnostic laboratories.

(4) By way of derogation from sub-rule (1) hereof, the

national laboratories competent as regards the disease in question, may

provide the services of a diagnostic laboratory.

(5) The list of laboratories for swine vesicular disease is

designated in Schedule II.

(6) The national laboratories designated for each of the

diseases referred to shall cooperate with the respective Community

reference laboratories.

(7) The detailed rules for implementing this Article shall

be adopted in accordance with the requirements of the European

Community and under the procedure laid down in article 5(1) of the

Veterinary Services Act.

(1) Vaccination against the diseases listed in Schedule I

may not be carried out except as a supplement to control measures taken

when the disease in question broke out, in accordance with the following

provisions –

(a) the decision to introduce vaccination as a supplement to

control measures shall be taken by the competent authority in

cooperation with the Commission and under its approval<

(b) this decision shall be based on the following criteria in

particular>

(i) the concentration of animals of the species

concerned in the affected zone<

(ii) the characteristics and composition of each vaccine

used<

(iii) the procedures for supervision of the distribution,

storage and use of vaccines<

(iv) the species and age of the animals which may or

must be vaccinated<

(v) the areas in which vaccination may or must be

carried out<

(vi) the duration of the vaccination campaign.

(2) In the cases referred to in sub-rule (1) hereof>

(a) the vaccination or re-vaccination of animals of

susceptible species on the holdings referred to in rule 4 shall be

prohibited<

(b) hyper-immune serum injection shall be prohibited.

(3) In the event of recourse to vaccination, the following

rules shall apply>

(a) all vaccinated animals must be identified by a clear and

legible mark in accordance with a method approved by the

Community<

(b) all vaccinated animals must remain within the

vaccination zone unless sent to a slaughterhouse designated by

the competent authority for immediate slaughter, in which case

the movement of animals may be authorized only after the official

veterinarian has carried out an examination of all the susceptible

animals on the holding and confirmed that none of the animals is

suspected of being infected.

(4) When the vaccination operations have been completed,

movements of animals of susceptible species from the vaccination zone

may be permitted under the relevant procedure of the Community.

(5) The competent authority shall inform the Commission,

on a regular basis, of progress as regards the vaccination measures.

(6) By way of derogation from sub-rule (1), the decision to

introduce emergency vaccination may be taken by the competent

authority, following notification of the Commission, provided that the

fundamental interests of the Community are not affected. That decision,

which must in particular take into account the degree of concentration

of the animals in certain regions, of the need to protect individual breeds

and of the geographical area in which vaccination is carried out, shall

forthwith be re-examined, under the relevant procedure of the

Community and it may be decided to retain, modify or extend the

measures or to bring them to an end.

(1) The competent authority shall draw up a contingency

plan applicable to all the diseases listed in Schedule I, specifying the

national measures to be implemented in the event of an outbreak of any

of these diseases. 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 general criteria to be applied for drawing up the

contingency plans are laid down in points 1 to 5 and 10 of Schedule III,

with points 6 to 9 representing criteria to be adopted according to the

disease concerned>

Provided that the competent authority may confine itself to

applying the criteria laid down in points 6 to 9 where the criteria in

points 1 to 5 and 10 were already adopted when plans were submitted

for the application of control measures for another disease.

(3) Contingency plans drawn up in accordance with the

criteria listed in Schedule III shall be submitted to the Commission>

(4) The contingency plans shall be –

(a) examined by the Commission in order to determine

whether they permit the desired objective to be attained and shall

suggest to the competent authority any amendments required in

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

Member States<

(b) approved by the Commission, if necessary amended, in

accordance with the relevant procedure of the Community<

(c) subsequently be amended or supplemented, in

accordance with the same procedure, to take into account

developments in the situation and the specific nature of the disease

in question.

(1) By way of derogation from the conditions provided for Particular and

specific Control

in Articles 19 and 20 as regards the contingency measures to be adopted measures for each

by the Member States and so as to take account of the natural, disease listed in

Schedule I.

geographical constraints particular to the French Overseas Departments,

the Azores and Madeira and their remoteness from the central part of

the Community’s territory, the Member State concerned shall be

authorized to apply particular control measures specific to each of the

diseases listed in Schedule I to these rules.

(2) Malta shall, within the Standing Veterinary Committee,

inform the Commission and the other Member States of the measures it

has taken in this respect and in particular of the control measures

implemented to ensure that animals from the territories in question or

products from such animals are not dispatched to the other territories of

the Community.

(3) Following the information procedure referred to in sub-

rule 2 and rule 19, these shall apply mutatis mutandis.

(1) Commission experts may, in collaboration with the Necessary measures

competent authorities, and in so far as is necessary to ensure uniform to

application of these

application of these rules, make on-the-spot checks. In order to do this, rules.

they may check a representative percentage of holdings to see whether

the competent authorities are checking that these holdings are fulfilling

the requirements of these rules. The Commission shall inform the

competent authority of the result of the checks carried out.

(2) Whenever a check is being carried out in Malta the

competent authority shall give all the necessary assistance to the experts

in carrying out their duties.

(3) The detailed rules for implementing this Article shall

be determined in accordance with the procedure laid down in rule 22.

(1) Whenever reference is being made to this rule, Articles Provisions to apply

whenever reference

5 and 7 of European Union Decision 1999#468#EC shall apply.

to this rule is being

made.

(2) The period mentioned in Article 5(6) of Decision 1999#

468#EC shall be of three months.