L.S. 437.105(R) Regoli li Jistabbilixxu Regoli ta’ Kontroll u Miżuri għall-Marda Afrikana taż-Żwiemel Imħassrin bl-Avviż Legali 77 tal-2025

(1)The title of these rules is the African Horse Sickness (Control Rules and Measures) Rules.

(2)The scope of these rules is to transpose Council Directive 92/35/EEC establishing control rules and measures to combat African horse sickness. Furthermore, these rules are intended to harmonise effective control measures to eradicate such disease for the purpose of intra-Community trade and imports of equidae from third countries, and should be read without prejudice to the Animal Health Conditions governing the Movement and Import from Third Countries of Equidae Rules, transposing European Union Council Directive 90/426/EEC on animal health conditions governing the movement and import from third countries of equidae. 2.

(1)Unless otherwise provided in these rules, the definitions prescribed in the Act and those contained in the Animal Health Conditions governing the Movement and Import from Third Countries of Equidae Rules shall mutatis mutandis apply, unless they are inconsistent with these rules. Citation and scope. S.L. 437.60 Interpretation. S.L. 437.60

(2)For the purpose of these rules and unless the context otherwise requires: "the Act" means the Veterinary Services Act; "African horse sickness (AHS)" means a highly infectious and deadly disease, which commonly affects horses, mules, donkeys and zebras, and which is not directly contagious, but is known to be spread by insect species; "census" means an official count of animal population carried out at set intervals commonly known as animal disease surveillance prevention and control system in animal population carried out by: (

1. a)collecting complete information including updated records of livestock production data, disease registries, specific reports and disease notification systems; (
2. b)obtaining a good knowledge of livestock production data, including livestock population, which is important for assessing the status of national, regional and continental food security; and (
3. c)providing guidelines on identification and traceability of live animals for the direct or indirect benefit of such data; such methodology facilitates the competent *These rules have been repealed by Legal Notice 77 of 2025. Cap. 437. 2 [ S.L.437.105 AFRICAN HORSE SICKNESS (CONTROL RULES AND MEASURES) authority to carry out its mandates and responsibilities with regard to animal health. The purpose of the census also aids the competent authority to plan properly on how to combat animal diseases affecting equidae in Malta in order to tackle the disease; "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; " c o n f i r m a t i o n " m e a n s t h e d e c la r a t i o n , b y t h e c o m p e t e n t authority, of the presence of African horse sickness, based on laboratory results, which disease however, in the event of an epidemic, the competent authority may also confirm on the basis of clinical and, or epidemiological results; "crisis centre" means an animal disease crisis management centre 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 centre aims at: (
4. a)strengthening of disease intelligence and emergency preparedness; (
5. b)supporting broad communication; awareness creation and risk (
6. c)analyzing the social and economic consequences of both the disease and its control; (
7. d)strengthening field surveillance, laboratory capabilities, global surveillance and early warning capabilities; (
8. e)advising the government and building capacities on disease surveillance prevention and control programmes; "the Director" means the Director General responsible for veterinary services or any veterinarian officer nominated by him; "epidemic inquiry" means an inquiry carried out in relation to an epidemic outbreak of disease in an animal population, often with the implication that it may extend to humans, and which primarily affects livestock and can cause disease in a large number of domestic animals and among humans who are exposed to diseased animals; "equidae" means wild or domesticated animals of the equine or asinine species, (including zebras) or the offspring of crossings of such species; "holding" means an agricultural or training establishment, a stable, or any premises or facilities in which equidae are habitually kept or bred, for whatever use, and natural reserves in which AFRICAN HORSE SICKNESS (CONTROL RULES AND MEASURES) [ S.L.437.105 equidae live in freedom; "importation" means the transfer of animals and their products from a third country to a Member State; "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; "M e m b e r St a t e" m e an s a s t a t e w h i c h i s a m e m b e r o f t h e European Union; "Member State of destination" means such Member State to which: (
9. a)for the purpose of intra-Community trade, equidae are transported either directly from another Member State, or from another Member State after being imported from a third country; (
10. b)for the purpose of importation, equidae are transported directly from a third country; "official veterinarian" means the veterinarian designated by the competent authority of Malta or any person summoned to act on his behalf, or the veterinarian nominated by the competent authority of another Member State or of a third country; "owner or keeper" means any natural or legal person having ownership of the equidae or charged with their keep, whether for financial remuneration 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 whose aim and scope is inter alia to: (
11. 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; (
12. 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 3 4 AFRICAN HORSE SICKNESS (CONTROL RULES AND MEASURES) [ S.L.437.105 they arise in the production of food; "third country" means a state which is not a member of the European Union; " t h e Tr e a t y " m e a n s t h e Tr e a t y o n t h e E u r o p e a n U n i o n establishing the European Community as amended by the Lisbon Treaty of 2007, and as may be subsequently amended; "vector" means a disease-transmitting organism which for the purpose of African horse sickness is known to be an insect of the Culicoides imicola species or any other Culicoides insect liable to transmit African horse sickness, identifiable under the procedure provided in the definition "Standing Committee on the Food Chain and Animal Health" in rule 2

(2), following the opinion of the Scientific Veterinary Committee. Applicability. 3.

(1)The provisions of these rules apply in particular to the following criteria: (

1. a)to liberalize the movement of equidae in the Community both for the purpose of intra-Community trade between Member States and imports from third countries while introducing Community measures to harmonize rules for controlling the disease and create measures, including the carrying out of a detailed epizootiological enquiry, to combat African horse sickness; (
2. b)to make it possible to ensure rational development of the farming sector and contribute to the protection of animal health in Malta when it is the Member State of destination; (
3. c)to eliminate as far as possible an outbreak of such disease which may quickly assume epizootic proportions, causing mortality and disturbance which may severely reduce the profitability of livestock production; (
4. d)to prevent the spread of African horse sickness where the movement of animals is liable to transmit the infection and which shall be strictly controlled, and insects shall be eradicated from infected holdings; (
5. e)to specify rules governing conditions under which vaccination against African horse sickness may be carried out and to ensure that such conditions are being complied with; (
6. f)to ensure more effective control of the disease by taking all necessary actions in order to establish protection and surveillance zones.

(2)The competent authority shall apply all such necessary administrative measures conforming to the requirements of the Stand ing Com mi ttee of t he F ood Chain and Anim al H ealth according to the requirements of these rules, to ensure that there is no breach thereof, and also to reduce the risk for final consumers and any additional risk to animals and to the environment. AFRICAN HORSE SICKNESS (CONTROL RULES AND MEASURES) [ S.L.437.105 5

(3)These measures shall include the direct confiscation of the product, the suspension of the activities carried out by the authorised provide r when these are creat in g a risk t o fi nal consumers and to the environment, and the forfeiture of any authorisation, licence or permit in terms of article 60 of the Act in addition to the application of any other administrative penalty in terms of article 61 of the Act. 4.

(1)Where a holding contains one or more equidae suspected of being infected with African horse sickness, the competent authority shall ensure that the official veterinarian sets out immediately official means of investigation to confirm or rule out the presence of the said sickness.

(2)From the moment when the suspected infection is notified, the official veterinarian shall: (

1. a)have the suspect holding(
2. s)placed under official surveillance; (
3. b)initiate: (
4. i)an official census of the species of equidae, stating in the case of each species the number of equidae already dead, infected or liable to be infected, and the updating of that census to take account of equidae born or dying during the period of suspicion; the information in the census shall be produced on request and may be checked at each inspection; (
5. ii)a census of places likely to facilitate the survival of the vector or its accommodation and the use of appropriate means of eradicating insects in such places; (iii) an epizootiological inquiry in accordance with rule 6; (
6. c)regularly visit the holding(s), whereby he shall: (
7. i)examine each equidae kept there; (
8. ii)carry out a detailed clinical examination or an autopsy on the suspect or dead animals and take the samples necessary for laboratory examinations; (
9. d)ensure that: (
10. i)all equidae on the holding(
11. s)are kept in their living quarters or in other places protected against the vector; (
12. ii)all movement of equidae to or from the holding(
13. s)is prohibited; (iii) appropriate means of eradicating insects are employed around and in the buildings housing the equidae; Holdings suspected of infection by African horse sickness. 6 AFRICAN HORSE SICKNESS (CONTROL RULES AND MEASURES) [ S.L.437.105 (
14. iv)S.L. 504.37 the carcasses of equidae which have died on the holding are destroyed, disposed of, or burnt in accordance with the provisions of Council 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)Pending the introduction of the official measures referred to in sub-rule

(2), the owner or keeper of any animals suspected of having the disease shall take all the necessary precautionary actions to ensure compliance with sub-rule

(2)(d).

(4)The competent authority may apply any of the measures provided for in sub-rule

(2)to other holdings should their location, their geographical situation or contacts with the holding where the disease is suspected give reason to suspect possible contamination.

(5)Without prejudice to the provisions set out in sub-rule

(2), specific provisions for nature reserves in which equidae live in freedom may be prescribed in accordance with the procedure provided in the definition "Standing Committee on the Food Chain and Animal Health" in rule 2

(2).

(6)The measures covered by this rule shall be officially discontinued only when the competent authority no longer suspects the presence of African horse sickness. Vaccination against and confirmation of African horse sickness. 5.

(1)Vaccination against African horse sickness may be practiced solely in accordance with the provisions provided in these rules.

(2)Where the presence of African horse sickness is officially confirmed, the official veterinarian shall: (

1. a)proceed immediately with the killing under official control of any equidae on the infected holding, which are infected or present clinical symptoms of African horse sickness; (
2. b)coordinate and monitor the destruction, disposal, burning or burial of the carcases of the aforesaid equidae in accordance with Directive 90/667/EEC; and, or (
3. c)extend the measures prescribed in rule 4 to holdings situated within a 20 km radius (included in the protection zone) around the infected holding(s); (
4. d)proceed, in the protected zone mentioned in paragraph (c), with the systematic vaccination of all equidae using a vaccine authorized by the competent authority, and shall identify them by a clear, indelible mark applied by an approved method in accordance with the procedure provided in the definition "Standing Committee on the Food Chain and Animal Health" in AFRICAN HORSE SICKNESS (CONTROL RULES AND MEASURES) [ S.L.437.105 7 rule 2

(2). However, on the basis of the epizootiological, meteorological, geographical or climatological circumstances, the vaccination requirements may be waived by the competent authority. The competent authority shall inform the Commission thereof; (e) carry out an epizootiological enquiry in accordance with rule 6.

(3)The competent authority may extend the measures provided for in sub-rule

(2), beyond the protected zone referred to in paragraph (c) thereof if, on account of the geographical, ecological or meteorological situation or of movements to or from the holding where the disease has been confirmed, there are grounds for suspecting an extension of African horse sickness, and shall inform the Commission accordingly.

(4)Where the zone referred to in sub-rule

(2)is situated in other Member States the competent authority shall collaborate with other Member States in defining such zone. If necessary, the zone shall be defined in accordance with the procedure provided in the definition "Standing Committee on the Food Chain and Animal Health" in rule 2

(2). 6.

(1)The epizootiological inquiry shall cover: (

1. a)the length of time during which African horse sickness may have existed on the holding; Epizootiological inquiry. (
2. b)the possible origin of the African horse sickness on the holding and the identification of other holdings on which there are equidae which may have become infected or contaminated from the same source; (
3. c)the presence and distribution of disease vectors; (
4. d)the movement of equidae to or from the holdings concerned or any carcases of equidae removed from them.

(2)In order to provide full coordination of all measures necessary to ensure eradication of African horse sickness as quickly as possible and for the purpose of carrying out the epizootiological inquiry, a crisis centre shall be established. 7.

(1)The competent authority shall ensure that, in addition to the measures referred to in rule 5, it establishes a protection zone and a surveillance zone. The establishment of the zones shall take account of the geographical, administrative, ecological and epizootiological factors in relation to African horse sickness and of the control structures.

(2)The protection zone shall consist of a part of the territory of Malta with a radius of at least 100 km around the entire infected holding and the surveillance zone shall consist of a part of the territory of Malta extending at least 50 km beyond the protection zone, in which no systematic vaccination has been carried out in the last twelve months. Additional measures and control structures taken by the competent authority. 8 AFRICAN HORSE SICKNESS (CONTROL RULES AND MEASURES) [ S.L.437.105

(3)Where such zones are situated in other Member States, the competent authority shall collaborate with such other Member States in order to define the zones referred to in sub-rule

(2). However, if necessary, the protection zone and the surveillance zone shall be defined in accordance with the procedure provided in the definition "Standing Committee on the Food Chain and Animal Health" in rule 2

(2). At the request of the competent authority, which request shall be duly substantiated, a decision may be taken in accordance with the procedure provided in the definition "Standing Committee on the Food Chain and Animal Health" in rule 2

(2), with a view to amend the demarcation of the zones defined in sub-rule

(2), taking into account: (

1. a)their geographical situation and ecological factors; (
2. b)the meteorological conditions; (
3. c)the presence and distribution of the vector; (
4. d)the results of the epizootiological studies carried out in accordance with rule 6; (
5. e)the results of the laboratory examinations; (
6. f)Measures to be applied in the protection zone by the competent authority. the application of the control measures, in particular the insect eradication measures. 8.

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

1. a)all holdings containing equidae within the zone are identified; (
2. b)the official veterinarian conducts: (
3. i)periodic visits to all holdings containing equidae, (
4. ii)a clinical examination of the said equidae including, if necessary, the collection of samples for laboratory examination; a record of visits and findings shall be kept; (
5. c)equidae leave the holding on which they are kept only for transport directly under official supervision for immediate slaughter to a slaughterhouse located in that zone or, if that zone has no slaughterhouse, to a slaughterhouse in the surveillance zone designated by the competent authority.

(2)In addition to the measures provided for in sub-rule

(1), a decision to carry out systematic vaccination of equidae against African horse sickness and to identify them in the protection zone, may be taken under the procedure provided in the definition "Standing Committee on the Food Chain and Animal Health" in rule 2

(2). Measures applied by the competent authority in the surveillance zone. 9. The competent authority shall ensure that: (a) the measures provided for in rule 8

(1)apply in the surveillance zone. However, if the surveillance zone has no slaughterhouse, the equidae may be slaughtered AFRICAN HORSE SICKNESS (CONTROL RULES AND MEASURES) [ S.L.437.105 9 in the protection zone in a slaughterhouse designated by the competent authority; (b) all vaccination against African horse sickness shall be prohibited in the surveillance zone. 10.

(1)The period of application and maintenance of the measures provided for in rules 5, 7, 8 and 9 shall be determined according to the procedure provided in the definition "Standing Committee on the Food Chain and Animal Health" in rule 2

(2). The period may in no case be less than twelve months where vaccination has been carried out in accordance with rules 5

(2)and 8

(2).

(2)However, notwithstanding rules 8

(1)(c) and 9(a), equidae from the protection zone and from the surveillance zone may be transported under official supervision and under the conditions prescribed in regulation 5

(3)(iv) of the Animal Health Conditions governing the Movement and Import from Third Countries of Equidae Rules, to the quarantine station referred to in regulation 5

(3)(

1. iv)of those regulations and movements of equidae within zones of the same status shall be subject to authorization from the competent authority on the basis of the following rules: Application and maintenance of measures and control conditions in relation to the movement of equidae. S.L. 437.60 (
2. a)equidae shall: (
3. i)undergo a prior official check; (
4. ii)require identification in accordance with Commission Regulation EC504/2008 implementing Council Directives 90/426/EEC and 90/427/EEC as regards methods for the identification of equidae and which finds its legal basis in the Trade with Member States in Equidae (Zootechnical and Genealogical Conditions) Regulations and the Animal Health Conditions governing the Movement and Import from Third Countries of Equidae Rules; and (iii) be accompanied by an official document; S.L. 437.11 S.L. 437.60 (
5. b)the competent authority shall ensure, in all events, that equidae vaccinated less than sixty days previously cannot leave the holding on which they were at the time the vaccination was carried out; (
6. c)the competent authority shall inform the Commission on measures taken in this field. 11. Where the African horse sickness epizootic is exceptionally serious in a particular region, any additional measures to be taken by the competent authority shall be adopted in accordance with the procedure provided in the definition "Standing Committee on the Food Chain and Animal Health" in rule 2

(2). Additional measures in relation to serious African horse sickness to be taken by the competent authority. 12. The competent authority shall take all necessary and appropriate measures for all persons established in the protection and surveillance zones to be fully informed of the restrictions in force and to take the steps necessary for the appropriate Public information regarding restrictive measures. 10 [ S.L.437.105 AFRICAN HORSE SICKNESS (CONTROL RULES AND MEASURES) implementation of the measures in question. Designation of a national reference laboratory. 13.

(1)The competent authority shall designate a National Reference Laboratory as specified in Schedule I(A) to carry out the laboratory examinations provided for in these rules, and shall make the details of that laboratory, and any subsequent changes thereto, available to the 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" in rule 2

(2).

(2)The functions and duties of the National Reference Laboratory designated in accordance with sub-rule

(1)are set out in Schedule I(B).

(3)The National Reference Laboratory designated in accordance with sub-rule

(1)shall liaise with the Community Reference Laboratory specified in Schedule II(A). On site checks and inspections. 14.

(1)Experts from the Commission may, in so far as is necessary for the uniform application of these rules and in cooperation with the competent authority, make on-site checks. To this end they may, by inspecting a representative percentage of holdings, verify whether the competent authority is monitoring compliance with the provisions of these rules.

(2)When an inspection referred to in sub-rule

(1)is being carried out, the competent authority shall give all necessary assistance to the experts in carrying out their duties. The general rules for implementing this rule shall be adopted in accordance with the procedure provided in the definition "Standing Committee on the Food Chain and Animal Health" in rule 2

(2). Criteria for contingency plans. 15.

(1)The competent authority shall draw up a contingency plan, specifying how it shall implement the measures prescribed in these rules. This plan shall allow access to facilities, equipment, personnel and all other appropriate materials necessary for the rapid and efficient eradication of the disease.

(2)The criteria to be applied for drawing up the plans referred to in sub-rule

(1)are established in Schedule III. The plans may subsequently be amended or supplemented in accordance with the same procedure to take account of developments in the situation. Offences and penalties. 16.

(1)Any person who fails to abide by these rules shall be guilty of an offence in terms of the Act and the provisions and measures of rule 3

(2)and

(3)shall apply to it.

(2)Any right given to the competent authority under these rules to apply all such necessary measures prescribed in rule 3

(2)and

(3)shall be given to the competent authority without prejudice to other criminal procedures which may be taken under the Act or any other law when a person commits an offence by failing to abide by these rules. AFRICAN HORSE SICKNESS (CONTROL RULES AND MEASURES) [ S.L.437.105 11 SCHEDULE I A. NATIONAL REFERENCE LABORATORY FOR AFRICAN HORSE SICKNESS The National Reference Laboratory for African Horse Sickness in Malta is the National Veterinary Laboratory situated in Abattoir Street, Albertown, Marsa. B. FUNCTIONS AND DUTIES OF THE NATIONAL REFERENCE LABORATORY FOR AFRICAN HORSE SICKNESS The National Reference Laboratory for African Horse Sickness sh all be responsible for coordinating the standards and diagnostic methods prescribed by the Community Reference Laboratory, for the use of reagents and for the testing of vaccines. To this end, such National Reference Laboratory: (

1. a)may provide diagnostic reagents to the Community Reference Laboratory, when the latter so requests; (
2. b)shall control the quality of all diagnostic reagents used in Malta; (
3. c)shall arrange comparative tests periodically; (
4. d)shall hold isolates of African Horse Sickness virus from cases confirmed in Malta; (
5. e)shall ensure the confirmation of positive results obtained. SCHEDULE II A. COMMUNITY REFERENCE LABORATORY The Community Reference Laboratory for African Horse Sickness is: Laboratorio de sanidad y producción animal, Ministerio de Agricultura, Pesca y Alimentación, 28110 Algete, Madrid - España. B. THE FUNCTIONS AND DUTIES OF THE COMMUNITY REFERENCE LABORATORY FOR AFRICAN HORSE SICKNESS The Community reference laboratory has the following functions and duties: 1. to coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing African Horse Sickness, specifically by: (
6. a)typing, storing and supplying strains of African Horse Sickness virus for serological tests and the preparation of antiserum; (
7. b)supplying standard sera and other reference reagents to the national reference laboratories in order to standardize the tests and reagents used in each Member State; (
8. c)building up and maintaining a collection of African Horse Sickness virus strains and isolates; (
9. d)organizing periodical comparative tests of diagnostic procedures at Community level; (
10. e)collecting and collating data and information on the methods of diagnosis used and the results of tests carried out in the Community; 12 [ S.L.437.105 (
11. f)AFRICAN HORSE SICKNESS (CONTROL RULES AND MEASURES) characterizing isolates of African Horse Sickness by the most up-to-date methods available to allow greater understanding of the epizootiology of African Horse Sickness; (
12. g)monitoring developments in African Horse Sickness surveillance, epizootiology and prevention throughout the world. 2. To assist actively in the diagnosis of African Horse Sickness outbreaks 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 techniques throughout the Community. 4. To carry out a mutual and reciprocal exchange of information with the world laboratory for African Horse Sickness designated by the International Office of Epizootics (IOE), in particular with regard to developments in the world situation concerning African Horse Sickness. SCHEDULE III CRITERIA FOR 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 Malta; 2. a list shall be provided of local disease control centres with adequate facilities to coordinate the disease control measures at a local level; 3. detailed information shall be given about the staff involved in control measures, their skills and their responsibilities; 4. each local disease control centre must be able to contact rapidly persons or 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, including means of disposal of carcases, on suspicion and confirmation of infection or contamination; 7. training programmes shall be established to maintain and develop skills in the field and to develop administrative procedures; 8. diagnostic laboratories shall have facilities for post-mortem examination, the necessary capacity for serology, histology, etc., and shall maintain the skills for rapid diagnosis (to that end arrangements should be made for rapid transportation of samples); 9. details on the quantity of African Horse Sickness vaccine estimated to be required in the event of a reinstatement of emergency vaccination, shall be provided; 10. provisions shall be made, to ensure the legal powers necessary for the implementation of the contingency plans.