CONTROL AND ERADICATION OF THE BLUETONGUE DISEASE RULES *

SUBSIDIARY LEGISLATION 437.80

CONTROL AND ERADICATION OF

THE BLUETONGUE DISEASE RULES *

19th August, 2005

LEGAL NOTICE 294 of 2005, as amended by Legal Notices 254 of 2010

and 381 of 2012.

(1) The title of these rules is the Control and Eradication of

the Bluetongue Disease Rules.

(2) These rules transpose Directive 2000/75/EC and in

accordance with such Directive lay down rules and measures for

the control and eradication of the swine vesicular disease and the

bluetongue disease. These rules shall lay down improvisions on the

movement of susceptible species and their semen, ova and embryos

from areas subject to restrictions arising from an outbreak of the

disease therein.

For the purposes of these regulations, the following

definitions shall apply

"the Act" means the Veterinary Services Act;

"animal" means any animal belonging to a susceptible species,

excluding wild animals with regard to which specific provisions

may be adopted in accordance with the procedure provided in the

definition "Standing Committee on the Food Chain and Animal

Health" under this rule;

"bluetongue disease" means a non-contagious insect-borne viral

disease of ruminants, mainly sheep and less frequently cattle, such as

goats, buffalos, and antelope, caused by the bluetongue virus which is

transmitted by an insect of the species Culicoides imicola and any

other Culicoides insects, hereinafter referred to as "vectors";

"the Commission" means the European Commission;

"the Community" means the European Community as established

by the Treaty on the European Union as amended by subsequent

treaties;

"the competent authority" means the Department of Veterinary

Services in Malta as established by article 2 of the Act;

"confirmation" means the declaration by the competent authority,

based on laboratory results, that the bluetongue virus is circulating

in a specific area; however, in the event of an epidemic, the

competent authority, may also confirm the presence of the disease

on the basis of clinical and, or epidemiological results;

"holding"means any agricultural or other establishment where

animals of species susceptible to bluetongue are permanently or

*These rules have been repealed by Legal Notice 77 of 2025.

temporarily reared or kept;

"intra-Community trade" means trade between Member States in

animals and their products, a business or occupation to make profit

or gain, particularly in retail or wholesale sales and includes

dealings in a particular business activity;

"live attenuated vaccines" means vaccines which are produced by

adapting bluetongue virus field isolate through serial passages in

tissue culture or in embryonated hens’ eggs;

" M e m b e r St a t e " m e a n s a s t a t e w h i c h i s a m em b e r o f t h e

European Union;

"national crisis unit" means an animal disease crises management

unit or a facility which provides animal disease analysis and

information, and which deploys or sets up international resources

to prevent and contain dangerous animal diseases. Such unit aims

at

(a) strengthening of disease intelligence and emergency

preparedness;

(b) supporting broad

awareness

creation

and

risk

communication;

(c) analyzing the social and economic consequences of

both the disease and its control;

(d) strengthening

field

surveillance,

laboratory

capabilities, global surveillance and early warning

capabilities;

(e) advising the government and building capacities on

disease

surveillance

prevention

and

control

programmes;

"official veterinarian" means the veterinarian designated by the

competent authority;

"owner" or "holder" means any natural or legal person owning

the animals or responsible for their upkeep, whether in return for

payment or not;

"person" means any natural or legal person;

"Scientific Veterinary Committee" means a committee within the

Commission which monitors matters of a scientific nature and

which aim and scope is inter alia to

(a) protect and raise the health status and condition of

animals in the Community, in particular food-

producing animals, while promoting intra-Community

trade and imports of animals and animal products in

accordance with the appropriate health and

zootechnical standards’ improvement and technology

of animal husbandry and international obligations;

(b) analyse scientific and technical questions concerning

all aspects of animal health, hygiene, and animal

diseases;

"Standing Committee on the Food Chain and Animal Health" or

"the Committee" means a Committee made up of the

representatives of Member States, named committee members, who

assist and consult the Commission by delivering an Opinion

regarding safety measures with respect to animal health issues to be

then formally adopted by the Commission in accordance with the

appropriate procedure. Such committee procedure covers the entire

food supply chain, ranging from animal health issues on the farm to

t he p r o d u c t w h i c h a r r i v e s t o t h e f i n a l c o ns u m e r, t h e r e f o r e

significantly enhancing its ability to target risks to health wherever

they arise in the production of food;

"susceptible species" means all ruminants;

"suspicion" means the appearance of any clinical sign suggesting

bl u e t on g ue i n a sus c e p t ib l e s p ecies , toge the r w ith a set of

epidemiological data enabling such a possibility to be reasonably

envisaged;

"vector" means an insect of the species Culicoides imicola or any

other insect of the genus Culicoides capable of transmitting

bluetongue, to be identified n accordance with the procedure

provided in the definition "Standing Committee on the Food Chain and

Animal Health" under rule 2,o n t he adv ice o f t he S cient ifi c

Veterinary Committee.

Any person shall ensure the immediate, compulsory

notification to the competent authority if circulation of the

bluetongue virus is suspected or confirmed.

(1) The competent authority shall ensure that if a holding

located in a region not subject to restrictions within the meaning of

these rules, has one or more animals suspected of being infected

with bluetongue, the competent authority shall ensure that the

official veterinarian immediately implements official methods of

investigation to confirm or rule out the presence of the disease.

(2) The official veterinarian shall, as soon as notification is

given of suspected presence -

(a) place the suspect holding or holdings under official

surveillance;

(b)

(i)

compile an inventory of the animals, indicating

for each species the number of animals already

dead, infected, or likely to be infected and

update this inventory to take account of the

animals which are born or die during the period

in which the disease is suspected, provided that

the data from this inventory must be produced

on request and may be checked during each

visit;

(ii) compile an inventory of places likely to

facilitate the survival of, or the harbouring of the

vector and in particular of the sites conducive to

its reproduction;

(iii) carry out an epidemiological survey in

accordance with rule 7;

(c) make regular visits to such holdings and on each

occasion, conduct a detailed clinical examination or an

autopsy of animals that are dead or suspected of

infection and confirm the disease, if necessary, by

means of laboratory tests; and

(d) ensure that

(i)

any movement of animals from or to such

holdings is prohibited;

(ii) the animals are confined at times when the

vectors are active,where he considers that the

means required for implementing these measures

are available;

(iii) the animals, the buildings used to house them

and their surroundings, in particular habitats in

which the Culicoides populations thrive, are

regularly treated with authorised insecticides;

provided that to prevent infestations by the

vectors as far as possible, the rate of treatment

shall be fixed by the competent authority, taking

account of the persistence of the insecticide used

and the climatic conditions;

(iv)

the carcases of the dead animals at the holding

are destroyed, eliminated, incinerated or buried

in accordance with Regulation EC 1069/2009

laying down Health Rules as regards Animal By-

products and Derived Products not Intended for

Human Consumption and repealing Regulation EC

1774/2002 (Animal by-products Regulation),

which provisions shall be read without prejudice to

the Waste Regulations.

(3) The owner or the holder of any animal suspected of being

infected with the disease, shall take all precautionary measures to

comply with pending implementation of the measures referred to in

sub-rule (2)(d)(i) and (ii)

Provided that the competent authority may apply the

measures referred to in sub-rule (2) to other holdings in the event

that their location, geographical situation or contacts with the

holding where the disease is suspected provides grounds for

suspecting the possibility of contamination.

(4) In addition to the provisions of sub-rule (2), specific

provisions may be laid down, in accordance with the procedure

provided in the definition "Standing Committee on the Food Chain and

Animal Health" under rule 2, for nature reserves in which animals

live freely.

(5) The official veterinarian shall not lift the measures referred

to in this rule until the suspected presence of bluetongue has been

ruled out by the competent authority.

(1) The competent authority may decide to allow the use of

vaccines against bluetongue provided that

(a) such decision is based on the result of a specific risk

assessment carried out by the competent authority;

(b) the Commission is informed before such vaccination is

carried out.

(2) Whenever live attenuated vaccines are used, the competent

authority shall demarcate

(a) a protection zone, consisting of at least the vaccination

area;

(b) a surveillance zone, consisting of a part of the Maltese

territory with a depth of at least 50 kilometres extending

beyond the limits of the protection zone.

(1) When the presence of bluetongue

is

officially

confirmed, the official veterinarian shall

(a) proceed with informing the competent authority, which

shall inform the Commission thereof, with the

slaughter deemed necessary to prevent extension of the

epidemic;

(b) order the destruction, elimination, incineration or

burial of the carcasses of those animals, in accordance

with Regulation EC 1069/2009, which provisions shall

be read without prejudice to the Waste Regulations;

(c) extend the measures provided for in rule 4 to holdings

located within a radius of 20 kilometers (including the

protection zone defined in rule 8) around any such

infected holding;

(d) implement the measures adopted in accordance with the

procedure provided in the definition "Standing

Committee on the Food Chain and Animal Health" under

rule 2, in particular with regard to the introduction of any

vaccination programme or other alternative measures;

(e) carry out an epidemiological survey in accordance

with rule 7. So however that by way of derogation

from paragraph (c), provisions applicable to

movements of animals in the zone may be adopted in

accordance with the procedure provided in the definition

"Standing Committee on the Food Chain and Animal

Health" under rule 2.

(2) The competent authority may extend or reduce the zone

referred to in sub-rule (1)(c), on the basis of epidemiological,

geographical, ecological or meteorological circumstances

established by the competent authority which shall notify the

Commission thereof.

(1) The epidemiological survey shall concern

(a) the duration of the period for which bluetongue may

have been present at the holding;

(b) the possible origin of bluetongue at the holding and the

identification of other holdings, which have animals

that may have been infected or contaminated from the

same source;

(c) the presence and distribution of vectors of the disease;

(d) movements of animals from or to the holdings in

question, or any departure of animal carcasses from

those holdings.

(2) The competent authority shall establish a national crisis

unit, to carry out the overall coordination of all the measures

necessary for ensuring the eradication of bluetongue as soon as

possible and to conduct the epidemiological survey

Provided that general rules concerning the national crisis unit

shall be laid down according to the procedure provided in the

definition "Standing Committee on the Food Chain and Animal

Health" under rule 2.

(1) The competent authority shall ensure that, in addition

to the measures referred to in rule 6, it shall demarcate a protection

zone and a surveillance zone. Demarcation of the zones must take

into account the geographical, administrative, ecological and

epizootiological actors, connected with bluetongue and the control

arrangements.

(2)

(a) The protection zone shall consist of a part of the

Maltese territory having a radius of at least 100

kilometers around the infected holding.

(b) The surveillance zone shall consist of a part of the

Maltese territory with a depth of at least 50 kilometres

extending beyond the limits of the protection zone and in

which no vaccination against bluetongue with live

attenuated vaccines has been carried out during the

previous twelve months.

(c) Where the zones are located on the territory of more

than one Member State, the competent authorities of

the Member States concerned shall cooperate for the

purpose of demarcating the zones referred to in

paragraphs (a) and (b).

(d) However, the protection and surveillance zones shall if

necessary, be demarcated in accordance with the

procedure provided in the definition "Standing

Committee on the Food Chain and Animal Health" under

rule 2.

(3) On receipt of a duly substantiated request from a Member

State, a decision may be taken, in accordance with the procedure

provided in the definition "Standing Committee on the Food Chain and

Animal Health" under rule 2, to change the demarcation of the zones

defined in sub-rule (2), in the light of

(a) their geographical location and ecological factors;

(b) meteorological conditions;

(c) the presence and distribution of the vector;

(d) the results of epizootiological studies carried out

pursuant to rule 7;

(e) the results of laboratory tests;

(f)

the application of counter measures, in particular

disinsectisation.

(1) The competent authority shall ensure that the following

measures are applied in the protection zone

(a) the identification of all holdings with animals inside

the zone;

(b) the implementation by the competent authority of an

epidemio surveillance programme based on the

monitoring of sentinel groups of bovine animals, or, in

their absence, of other species of ruminant and vector

populations; provided that this programme may be laid

down according to the procedure provided in the

definition "Standing Committee on the Food Chain and

Animal Health" under rule 2;

(c) a ban on animals leaving the zone, so however, under

the procedure provided in the definition "Standing

Committee on the Food Chain and Animal Health" under

rule 2, exemptions from the exit ban may be decided

upon, in particular for animals situated in part of the

zone where there is a proven absence of viral

circulation or of vectors.

(2) The competent authority may in addition to the measures

laid down in sub-rule (1), carry out the vaccination of animals

against bluetongue and their identification in the protection zone

which may be decided upon, according to the procedure provided in

the definition "Standing Committee on the Food Chain and Animal

Health" under rule 2, or upon its initiative after informing the

Commission.

(1) The competent authority shall ensure that the measures

provided for in rule 9(1) apply in the surveillance zone.

(2) The competent authority shall prohibit any vaccination against

bluetongue using live attenuated vaccines in the surveillance zone.

The measures taken pursuant to rules 6, 8, 9 and 10 shall be

amended or repealed in accordance with the procedure provided in

the definition "Standing Committee on the Food Chain and Animal

Health" under rule 2.

By way of derogation from rules 9 and 10, the provisions

applicable to movements of animals in and from the protection and

surveillance zones shall be determined in accordance with the

procedure provided in the definition "Standing Committee on the Food

Chain and Animal Health" under rule 2

Provided that when such decision is adopted, the rules

applicable to trade shall be determined in accordance with the same

procedure.

The competent authority shall, if the bluetongue epidemic

is of an exceptionally serious nature, take any additional measures

in accordance with the procedure provided in the definition "Standing

Committee on the Food Chain and Animal Health" under rule 2.

The competent authority shall take all the necessary

measures so that all persons in the protection and surveillance

zones are fully informed of the restrictions in force and shall make

any arrangements that are required for the proper implementation

of the measures in question.

(1) The competent authority shall designate a National

Reference Laboratory responsible for carrying out the laboratory

tests provided for by these rules, and shall make the details of such

laboratory, and any subsequent changes thereto, available to other

Member States and to the public. Detailed rules for the uniform

application of this sub-rule shall be adopted in accordance with the

procedure provided in the definition "Standing Committee on the

Food Chain and Animal Health" under rule 2.

(2) The tasks of the national reference laboratory indicated in

Annex I(A), as designated by the competent authority in accordance

with sub-rule (1) are listed in Annex I(B). Such laboratory shall liaise

with the Community Reference Laboratory referred to in rule 16.

The Community Reference Laboratory for bluetongue is

indicated in Annex II(A) and the tasks of such laboratory are set out in

Annex II(B).

(1) Experts from the Commission may, where necessary in

order to ensure the uniform application of these rules, and in

collaboration with the competent authority, carry out on-the-spot

checks. For this purpose, they may inspect a representative

percentage of holdings in order to verify whether the competent

authorities monitor compliance with the provisions of these rules.

(2) If the Commission carries out a check in accordance with sub-

rule (1), the competent authority shall provide the experts with all the

necessary assistance in the performance of their task. The general

implementing provisions for this rule shall be laid down in accordance

with the procedure provided in the definition "Standing Committee on

the Food Chain and Animal Health" under rule 2.

(1) The competent authority shall draw up a contingency

plan indicating the means by which it applies the measures laid

down in these rules

Provided that this plan must provide for access to plant,

equipment, personnel and any other appropriate facility necessary

for the swift and effective eradication of the disease.

(2) The criteria to be applied for drawing up the plans referred

to in sub-rule (1) are set out in Annex III

Provided that plans drawn up pursuant to these criteria shall

be submitted to the Commission no later than three months after the

entry into force of these rules.

Any detailed provisions necessary for the implementation

of these rules shall be adopted in accordance with the procedure

provided in the definition "Standing Committee on the Food Chain and

Animal Health" under rule 2.

ANNEX I

Amended by

L.N. 254 of 2010.

Substituted by

L.N. 381 of 2012.

A. NATIONAL REFERENCE LABORATORY FOR BLUETONGUE DISEASE

The National Reference Laboratory for Bluetongue disease in Malta is the

National Veterinary Laboratory situated in Abattoir Street, Albertown, Marsa.

B. TASKS OF THE NATIONAL REFERENCE LABORATORY

FOR BLUETONGUE

The National Reference Laboratory for bluetongue shall be responsible for the co-

ordination of the standards and diagnostic methods prescribed by the Community

Reference Laboratory, the use of reagents and the testing of vaccines. To this end

such National Reference Laboratory

(a) may supply diagnostic reagents to

the Community Reference

Laboratory when the latter so requests;

(b) shall check the quality of all the diagnostic reagents used in Malta;

(c) shall organise comparative tests at regular intervals;

(d) shall preserve isolates of the bluetongue virus taken from confirmed

cases in Malta;

(e) shall ensure the confirmation of positive results obtained.

ANNEX II

A. COMMUNITY REFERENCE LABORATORY FOR BLUETONGUE

AFRC Institute for Animal Health

Pirbright Laboratory

Ash Road

Pirbright Woking

Surrey GU24 ONF

United Kingdom

Tel. (44-1483)23 24 41

Fax (44-1483)23 24 48

E-mail: philip-mellor@bbsrc.ac.uk

B. TASKS OF THE COMMUNITY REFERENCE LABORATORY

FOR BLUETONGUE

The Community reference laboratory has the following tasks

1. Coordinating, in consultation with the Commission, diagnostic methods for

bluetongue in the Member States, in particular by

(a) specifying, holding and supplying strains of the bluetongue virus for the

purpose of serological tests and the preparation of antiserum;

(b) the provision of reference sera and other reference reagents to the

national reference laboratories for the purpose of standardizing the tests

and the reagents used in each Member State;

(c) the establishment and conservation of a collection of strains and isolates

CONTROL AND ERADICATION

OF THE BLUETONGUE DISEASE

of the bluetongue virus;

(d) the regular organization of Community comparative testing of

diagnostic procedures;

(e) the collection and collation of data and information concerning the

diagnostic methods used and the results of the tests carried out in the

Community;

(f)

the classification of isolates of the bluetongue virus, using the most

advanced methods,in order to provide a better understanding of the

epizootiology of bluetongue;

(g) monitoring developments worldwide in the area of surveillance,

epizootiology and prevention of bluetongue.

2. Actively assisting in the identification of centres of bluetongue infection in

the Member States by studying viral isolates sent to it for confirmation of

diagnosis,classification and epizootiological studies.

3. Facilitating the provision of training and refresher courses for experts in

laboratory diagnostics with a view to harmonising diagnostic techniques throughout

the Community.

4. Mutual and reciprocal information exchange with the World Bluetongue

Laboratory designated by the International Office for Epizootics (OIE), in particular

concerning global developments with regard to bluetongue.

ANNEX III

MINIMUM CRITERIA APPLICABLE TO CONTINGENCY PLANS

The contingency plans must provide for at least the following

1. The establishment at national level of a crisis unit to coordinate all

emergency measures in the Member State concerned.

2. A list of local emergency centres adequately equipped for the purpose of

coordinating control measures at local level.

3. Detailed information on the personnel responsible for emergency measures,

their qualifications and their responsibilities.

4. The possibility, for each local centre, of swiftly contacting persons or

organisations directly or indirectly affected by an outbreak.

5. The availability of the equipment and materials necessary for the proper

implementation of emergency measures.

6. Precise instructions regarding the steps to be taken, including means of

destroying carcasses, when cases of infection or contamination are suspected and

confirmed.

7. Training programmes for updating and enhancing knowledge of procedures

on the ground and administrative procedures.

8. For the diagnostic laboratories, an autopsy function, the capability required

for conducting serological and histological tests, etc., and the updating of rapid

diagnostic techniques (provisions on the swift transportation of samples should be

laid down for this purpose).

CONTROL AND ERADICATION

OF THE BLUETONGUE DISEASE

9. Information concerning the quantity of vaccines against bluetongue deemed

necessary in case emergency vaccination needs to be reintroduced.

10. Regulatory provisions for implementing the contingency plans.