CONTROL OF CERTAIN ANIMAL DISEASES (AND SPECIFICALLY THE SWINE VESICULAR DISEASE) RULES *

SUBSIDIARY LEGISLATION 437.94

CONTROL OF CERTAIN ANIMAL DISEASES

(AND SPECIFICALLY THE SWINE VESICULAR

DISEASE) RULES *

14th November, 2008

LEGAL NOTICE 287 of 2008, as amended by Legal Notice 267 of 2010.

(1) The title of these rules is the Control of Certain Animal

Diseases (and specifically the Swine Vesicular Disease) Rules.

(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.

(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.

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

For the purpose of these rules -

"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;

"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;

"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;

*These rules have been repealed by Legal Notice 77 of 2025.

"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;

"vector" means 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.

Amended by

L.N. 267 of 2010.

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

te s ti n g s h a ll be d e c i d e d i n ac c o rd a n c e w it h t h e r e le v a n t p r oc e du r e of t he

Community.

4. Confirmation of the presence of swine vesicular disease

By way of derogation from the requirement of the confirmation referred to in the

definition of "confirmation of infection" in rule 2, 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 rule 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. (Deleted by Legal Notice 267 of 2010)

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

CONTROL OF CERTAIN ANIMAL DISEASES

(AND SPECIFICALLY THE SWINE VESICULAR DISEASE)

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 rule 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

out,

- 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

out,

- 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 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

(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.

CONTROL OF CERTAIN ANIMAL DISEASES

(AND SPECIFICALLY THE SWINE VESICULAR DISEASE)

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

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

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).

CONTROL OF CERTAIN ANIMAL DISEASES

(AND SPECIFICALLY THE SWINE VESICULAR DISEASE)

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

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

notified immediately to the competent authority.

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

reference 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;

(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,

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;

(e) 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 (e) 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

CONTROL OF CERTAIN ANIMAL DISEASES

(AND SPECIFICALLY THE SWINE VESICULAR DISEASE)

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.

(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), 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) 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 being i nfected, appropriate action shall be t aken b y 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

separate production units, the competent authority may derogate

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

units of 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), 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

(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 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), 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) 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 ten 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

c o m p e t e n t a u t h o r i t i e s o f t h e M e m b e r St a t e s c o n c e r n e d i n

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 are applied in the 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), 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)

and rule 12(1)(d) are maintained beyond thirty 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 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

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.

(1) The following procedure shall be observed

(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 twenty-one 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

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 responsible for coordinating

standards and diagnostic methods in Malta in

accordance with Schedule III. The competent authority

shall make the details of its national laboratory, and

any subsequent changes thereto, available to the other

Member States and to the public in a manner that may

be specified in accordance with the procedure referred

to in rule 22.

(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), the national

laboratories competent as regards the disease in question, may

provide the services of a diagnostic laboratory.

(5) The competent authority shall maintain updated lists of the

national laboratories referred to in sub-rule (1) and make them

available to the other Member States and to the public.

(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 rule 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)

(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

in rules 18 and 19 as regards the contingency measures to be

adopted by the Member States and so as to take account of the

natural, geographical constraints particular to the French Overseas

Departments, the Azores and Madeira and their remoteness from

the central part of the Community’s territory, Malta shall be

authorized to apply particular control measures specific to each of

the diseases listed in Schedule I.

(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 subrule

(2) and in rule 19, these shall apply mutatis mutandis.

(1) Commission experts may, in collaboration with the

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

uniform application of these rules, make on-the-spot checks. In

order to do this, 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 rule shall be

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

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

Articles 5 and 7 of European Union Decision 1999/468/EC shall

apply.

(2) The period mentioned in Article 5(6) of Decision 1999/468/

EC shall be of three months.

CONTROL OF CERTAIN ANIMAL DISEASES

(AND SPECIFICALLY THE SWINE VESICULAR DISEASE)