L.S. 437.80(R) Regoli dwar il-Kontroll u l-Iżradikar tal-Marda Bluetongue Imħassrin bl-Avviż Legali 77 tal-2025

(1)The title of these rules is the Control and Eradication of the Bluetongue Disease Rules. Title and scope.

(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. 2. 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or other establishment where animals of species susceptible to bluetongue are permanently or *These rules have been repealed by Legal Notice 77 of 2025. Definitions. Amended by: L.N. 381 of 2012. Cap. 437. 2 [ S.L.437.80 CONTROL AND ERADICATION OF THE BLUETONGUE DISEASE 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: (

1. a)strengthening of disease intelligence and emergency preparedness; (
2. b)supporting broad communication; awareness creation and risk (
3. c)analyzing the social and economic consequences of both the disease and its control; (
4. d)strengthening field surveillance, laboratory capabilities, global surveillance and early warning capabilities; (
5. 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: (
6. a)protect and raise the health status and condition of animals in the Community, in particular foodproducing 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; (
7. 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 CONTROL AND ERADICATION OF THE BLUETONGUE DISEASE [ S.L.437.80 3 "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. 3. Any person shall ensure the immediate, compulsory notification to the competent authority if circulation of the bluetongue virus is suspected or confirmed. Notification of bluetongue virus. 4.

(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. Suspected bluetongue. Amended by: L.N. 381 of 2012.

(2)The official veterinarian shall, as soon as notification is given of suspected presence (

1. a)place the suspect holding or holdings under official surveillance; (
2. b)(
3. 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; (
4. 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; (
5. c)make regular visits to such holdings and on each 4 CONTROL AND ERADICATION OF THE BLUETONGUE DISEASE [ S.L.437.80 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 (
6. d)ensure that: (
7. i)any movement of animals from or to such holdings is prohibited; (
8. 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; (
9. iv)S.L. 504.37 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 Byproducts 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. Vaccination procedure. Substituted by: L.N. 381 of 2012. 5.

(1)The competent authority may decide to allow the use of vaccines against bluetongue provided that: (

1. a)such decision is based on the result of a specific risk CONTROL AND ERADICATION OF THE BLUETONGUE DISEASE [ S.L.437.80 5 assessment carried out by the competent authority; (
2. b)the Commission is informed before such vaccination is carried out.

(2)Whenever live attenuated vaccines are used, the competent authority shall demarcate: (

1. a)a protection zone, consisting of at least the vaccination area; (
2. 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. 6.

(1)When the presence of bluetongue confirmed, the official veterinarian shall: is officially (

1. a)proceed with informing the competent authority, which shall inform the Commission thereof, with the slaughter deemed necessary to prevent extension of the epidemic; (
2. 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; Confirmation of the disease. Amended by: L.N. 381 of 2012. S.L. 504.37 (
3. 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; (
4. 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; (
5. 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. 7.

(1)The epidemiological survey shall concern: (

1. a)the duration of the period for which bluetongue may have been present at the holding; (
2. 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; Epidemiological survey. Amended by: L.N. 381 of 2012. 6 [ S.L.437.80 CONTROL AND ERADICATION OF THE BLUETONGUE DISEASE (
3. c)the presence and distribution of vectors of the disease; (
4. 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. Demarcation of protection and surveillance zones. Amended by: L.N. 381 of 2012. 8.

(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)(

1. 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. (
2. 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. (
3. 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 (
4. a)and (b). (
5. 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: (

1. a)their geographical location and ecological factors; (
2. b)meteorological conditions; (
3. c)the presence and distribution of the vector; (
4. d)the results of epizootiological studies carried out pursuant to rule 7; (
5. e)the results of laboratory tests; CONTROL AND ERADICATION OF THE BLUETONGUE DISEASE (
6. f)[ S.L.437.80 7 the application of counter measures, in particular disinsectisation. 9.

(1)The competent authority shall ensure that the following measures are applied in the protection zone: (

1. a)the identification of all holdings with animals inside the zone; Measures applied in protection zone. Amended by: L.N. 381 of 2012. (
2. 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; (
3. 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. 10.

(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. Measures applied in surveillance zone. Amended by: L.N. 381 of

2. 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
3. Amendments subject to the procedure provided in the definition "Standing Committee on the Food Chain and Animal Health" under rule
4. Amended by: L.N. 381 of
6. 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: Derogation from rules 9 and
7. Amended by: L.N. 381 of
8. Provided that when such decision is adopted, the rules applicable to trade shall be determined in accordance with the same procedure. 8 [ S.L.437.80 CONTROL AND ERADICATION OF THE BLUETONGUE DISEASE Exceptionally serious epidemic. Amended by: L.N. 381 of
10. 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
11. Persons in restricted zone to be informed.
12. 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. National Reference Laboratory. Substituted by: L.N. 254 of 2010; L.N. 381 of
13. 15.

(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

1. Community Reference Laboratory. Substituted by: L.N. 381 of
3. 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). On-spot checks. Amended by: L.N. 381 of
4. 17.

(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 subrule

(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. Contingency plan. Amended by: L.N. 381 of 2012. 18.

(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. CONTROL AND ERADICATION OF THE BLUETONGUE DISEASE [ S.L.437.80 19. 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. 9 Detailed provisions. Amended by: L.N. 381 of 2012. 10 [ S.L.437.80 Amended by: L.N. 254 of 2010. Substituted by: L.N. 381 of 2012. CONTROL AND ERADICATION OF THE BLUETONGUE DISEASE ANNEX I 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 coordination 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: (

1. a)may supply diagnostic reagents to Laboratory when the latter so requests; the Community Reference (
2. b)shall check the quality of all the diagnostic reagents used in Malta; (
3. c)shall organise comparative tests at regular intervals; (
4. d)shall preserve isolates of the bluetongue virus taken from confirmed cases in Malta; (
5. 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: (
6. a)specifying, holding and supplying strains of the bluetongue virus for the purpose of serological tests and the preparation of antiserum; (
7. 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; (
8. c)the establishment and conservation of a collection of strains and isolates CONTROL AND ERADICATION OF THE BLUETONGUE DISEASE [ S.L.437.80 11 of the bluetongue virus; (
9. d)the regular organization of Community comparative testing of diagnostic procedures; (
10. 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; (
11. 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; (
12. 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). 12 [ S.L.437.80 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.