L.S. 437.50(R) Regoli dwar Miżuri ta’ Kontroll tal-Marda ta’ l-Ilsien u d-Dwiefer Imħassrin bl-Avviż Legali 77 tal-2025

(1)The title of these rules is the Foot-and-Mouth Disease (Control Measures) Rules. Title, scope and applicability.

(2)The scope of these rules is to implement the rules found under European Union Council Directive 2003/85/EC regarding measures for the control of foot-and-mouth disease to be taken in the territory of Malta.

(3)These rules set out: (

1. a)the minimum control measures to be applied in the event of an outbreak of foot-and-mouth disease, of whatever type of virus; (
2. b)certain preventative measures aimed at increasing awareness and preparedness of the competent authorities and the farming community for foot-andmouth disease.

(4)The competent authority shall remain free to take more stringent action in the field covered by these rules. 2. For the purposes of these rules - "animal of a susceptible species" means any domestic or wild animal of the suborders Ruminantia, Suina, and Tylopoda of the order Artiodactyla. For specific measures, notably in application of rule 16

(4), rule 15 and rule 75

(2), other animals, such as for example of the order Rodentia or Proboscidae, may be considered susceptible to foot-and-mouth disease in accordance with scientific evidence; "animal suspected of being contaminated" means any animal of a susceptible species which, according to the epidemiological information collected, may have been directly or indirectly exposed to the foot-and-mouth disease virus; "animal suspected of being infected" means any animal of a susceptible species exhibiting clinical symptoms or showing postmortem lesions or reactions to laboratory tests which are such that the presence of f oot-and -mo uth di sease may reasonably be suspected; "authorisation" means a written authorisation given by the competent authorities, of which the necessary copies must be available for subsequent inspections in accordance with the *These rules have been repealed by Legal Notice 77 of

1. Definitions. 1 2 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) appropriate legislation in Malta; "case of foot-and-mouth disease" or "animal infected with footand-mouth disease" means any animal of a susceptible species or carcass of such animal in which foot-andmouth disease has been officially confirmed, taking into account the definitions in Schedule I, either on clinical symptoms or post-mortem lesions consistent with foot-and-mouth disease have been officially confirmed, or as the result of a laboratory examination carried out in accordance with Schedule XIII; "Community antigen and vaccine bank" means appropriate premises designated in accordance with these rules for the storage of Community reserves of both concentrated inactivated antigen of the foot-and-mouth disease virus for the production of foot-andmouth disease vaccines and veterinary immunological products (vaccines) reconstituted from such antigens and authorised in accordance with European Council Directive 2001/82/EC relating to veterinary medicinal products; Cap.
2. "the competent authority" means the Veterinary Services within Malta as provided under article 2 of the Veterinary Services Act, or any other authority to which such responsibility has been delegated by the Veterinary Services; "emergency slaughter" means the slaughter in emergency cases within the meaning of Article 2

(7)of European Council Directive 93/119/EEC of animals which on the basis of epidemiological data or clinical diagnosis or results of laboratory testing are not considered infected or contaminated with the foot-and-mouth disease virus, including slaughter for reasons of animal welfare; "emergency vaccination" means vaccination in accordance with rule 48

(1); "herd" means an animal or group of animals kept on a holding as an epidemiological unit; if more than one herd is kept on a holding, each of these herds shall form a distinct unit and shall have the same health status; "holding" means any agricultural or other premises, including circuses, located in Malta where animals of susceptible species are being bred or kept on a permanent or temporary basis. However, for the purpose of rule 10

(1), this definition does not include living areas for humans on such premises, unless animals of susceptible species, including those referred to in rule 75

(2), are kept on a permanent or temporary basis therein, slaughterhouses, means of transport, border inspection posts or fenced areas where animals of susceptible species are kept and may be hunted, if such fenced areas are of a size which makes the measures provided for in rule 10 inapplicable; "incubation period" means the length of the time between infection and the occurrence of clinical signs of foot-and mouth disease. Namely, for the purposes of these rules, fourteen days for bovine and porcine animals, and twenty-one days for ovine and caprine animals and any other animal of susceptible species; "killing" means any process which causes the death of an animal; FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 "Member State" means a State which is a Member within the European Community; "official veterinarian" means the veterinarian designated by the competent authority of Malta; "outbreak of foot-and-mouth disease" means a holding where animals of susceptible species are kept, which meets one or more of the criteria set out in Schedule I; "owner" means any person or persons, either natural or legal, having ownership of an animal of a susceptible species, or charged with keeping such animals, whether or not for financial reward; "primary case of foot-and-mouth disease in wild animals" means any case of foot-and-mouth disease which is detected in a wild animal in an area in which no measures are in place in accordance with rule 75

(3)or

(4); "primary outbreak" means an outbreak not epizootiologically linked with a previous outbreak in the same region of Malta as defined in Article 2 of European Council Directive 64/432/EEC or the first outbreak in a different region of Malta; "processing" means one of the treatments for high risk material laid down in European Council Regulation (EC) No 1774/2002, and any implementing legislation thereof, applied in such a way as to avoid the risk of spread of foot-and-mouth disease virus; "protective vaccination" means emergency vaccination carried out on holdings in a designated area in order to protect animals of susceptible species within this area against airborne spread or spread through fomites of foot-and-mouth disease virus and where the animals are intended to be kept alive following vaccination; "region" means that part of the territory of Malta which is at least 2,000 square kilometres in area and which is subject to inspection by the competent authority; "regionalisation" means the delimitation of a restricted zone in which restrictions are applied on the movements of or trade in certain animals or animal products as provided for in rule 43 in order to prevent the spread of foot-and-mouth disease into the free zone where no restrictions are applied in accordance with these rules; "sub-region" means an area specified in the Annex to European Council Decision 2000/807/EC; "suppressive vaccination" means emergency vaccination which is carried out exclusively in conjunction with a stamping-out policy in a holding or area where there is an urgent need to reduce the amount of foot-and-mouth disease virus circulating and to reduce the risk of it spreading beyond the perimeters of the holding or the area and where the animals are intended to be destroyed following vaccination; "wild animal" means an animal of a susceptible species living outside any holding or premises referred to in rules 15 and 16. 3 4 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) CHAPTER II Control of outbreaks of foot-and-mouth disease Foot-and-mouth disease notification. 3.

(1)In Malta: (

1. a)foot-and-mouth disease is listed by the competent authority as a compulsorily notifiable disease; (
2. b)the owner and any person attending animals, accompanying animals during transport or looking after animals shall be obliged to notify without delay to the competent authority or the official veterinarian the presence or suspected presence of foot-and-mouth disease and keep animals infected with foot-andmouth disease or animals suspected of being infected, away from places where other animals of susceptible species are at risk of being infected or contaminated with the foot-and-mouth disease virus; (
3. c)veterinary practitioners, official veterinarians, senior staff of veterinary or other official or private laboratories and any person with a occupational relation to animals of susceptible species or products derived from such animals shall be obliged to notify without delay to the competent authority any knowledge of the presence or suspected presence of foot-and-mouth disease they have obtained prior to official intervention within the framework of these rules.

(2)Without prejudice to existing European Community legislation on notification of outbreaks of animal disease, in case of an outbreak of foot-and-mouth disease or a primary case of footand-mouth disease in wild animals is confirmed, the competent authority shall give notification of the disease and provide information and written reports to the European Commission and the other Member States in accordance with Schedule II. Measures in case of suspicion of an outbreak of footand-mouth disease. 4.

(1)The competent authority shall ensure that the measures provided for in sub-rules

(2)and

(3)are carried out where a holding contains one or more animals suspected of being infected or contaminated.

(2)The competent authority shall immediately activate official investigation arrangements under its supervision to confirm or rule out the presence of the foot-and-mouth disease and, in particular, have the necessary samples taken for the laboratory examinations required to confirm an outbreak in accordance with the definition of outbreak in Schedule I.

(3)The competent authority shall place the holding referred to in sub-rule

(1)under official surveillance as soon as the suspected infection is notified and shall in particular ensure that: (

1. a)a census is made of all categories of animals on the holding and that, in respect of each category of animals of susceptible species, the number of animals FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 5 that are already dead and the animals suspected of being infected or of being contaminated, is recorded; (
2. b)the census as referred to in paragraph (
3. a)is kept up to date to take account of those animals of susceptible species born or dying during the period of suspicion. Such information is produced by the owner on request of the competent authority and is checked by that authority at each visit; (
4. c)all stocks of milk, milk products, meat, meat products, carcasses, hides and skins, wool, semen, embryos, ova, slurry, manure as well as animal feed and litter on the holding are recorded and those records are maintained; (
5. d)no animals of susceptible species enter or leave the holding, except in cases of holdings consisting of different epidemiological production units referred to in rule 17, and that all animals of susceptible species on the holding are kept in their living quarters or another place where they can be isolated; (
6. e)appropriate means of disinfection are used at the entrances and exits of buildings or places housing animals of susceptible species and of the holding itself; (
7. f)an epidemiological inquiry is carried out in accordance with rule 13; (
8. g)to facilitate the epidemiological inquiry, the necessary samples shall be taken for laboratory testing in accordance with point 2.1.1.1 of Schedule III. 5.

(1)The competent authority shall ensure that in addition to the measures provided for in rule 4, all movement onto and off a holding where there is a suspicion of an outbreak of foot-andmouth disease is prohibited. That prohibition shall apply in particular to: (

1. a)movement from the holding of meat or carcasses, meat products, milk or milk products, semen, ova or embryos of animals of susceptible species or of animal feed, utensils, objects or other substance, such as wool, hides and skins, bristles or animal waste, slurry, manure or anything liable to transmit foot-and-mouth disease virus; (
2. b)movement of animals of species not susceptible to foot-and-mouth disease; (
3. c)movement of persons onto or out of the holding; (
4. d)movement of vehicles onto or out of the holding.

(2)By way of derogation from the prohibition in sub-rule

(1)(a), the competent authority may in the event of difficulties in storing the milk on the holding either order that the milk shall be destroyed on the holding, or authorise the milk to be transported under veterinary supervision and only by means of transport suitably equipped to ensure no risk of spreading foot-and-mouth Movements onto and off a holding in case of suspicion of an outbreak of foot-and-mouth disease. 6 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) disease virus from the holding to the nearest possible place for disposal or treatment ensuring destruction of the foot-and-mouth disease virus.

(3)By way of derogation from the prohibitions provided for in sub-rule

(1)(b), (c) and (d), the competent authority may authorise such movements onto and off the holding subject to all conditions necessary in order to avoid the spread of foot-and-mouth disease virus. Extension of measures to other holdings. 6.

(1)The competent authority shall extend the measures provided for in rules 4 and 5 to other holdings where their location, their construction and layout, or contacts with animals from the holding referred to in rule 4, give reason to suspect contamination.

(2)The competent authority shall apply at least the measures provided for in rules 4 and 5

(1)to premises or means of transport referred to in rule 16 should the presence of animals of susceptible species give reason to suspect infection or contamination with the foot-and-mouth disease virus. Temporary control zone. 7.

(1)The competent authority may establish a temporary control zone, where required by the epidemiological-situation, and in particular when that situation involves a high density of animals of susceptible species, intensive movement of animals or persons in contact with animals of susceptible species, delays in suspect status notifications, or insufficient information on the possible origin and ways of introduction of the foot-and-mouth disease virus.

(2)At least the measures provided for in rule 4

(2)and

(3)(a), (

1. b)and (
2. d)and in rule 5

(1)shall be applied to holdings in the temporary control zone where animals of susceptible species are kept.

(3)The measures applied in the temporary control zone may be supplemented by a temporary ban on movements of all animals in a larger area or on the whole of the territory of Malta. However, the ban on movement of animals of species not susceptible to foot-andmouth disease shall not exceed seventy-two hours, unless justified by exceptional circumstances. Preventive eradication programme. 8.

(1)The competent authority may, where epidemiological information or other evidence indicates, implement a preventive eradication programme, including preventive killing of animals of susceptible species likely to be contaminated and, if necessary, of animals from epidemiologically-linked production units or adjoining holdings.

(2)In that event, the taking of samples and clinical examinations of animals of susceptible species shall be carried out at least in accordance with point 2.1.1.1 of Schedule III.

(3)The competent authority shall notify the European Commission prior to the implementation of the measures provided for in this rule. Maintenance of measures. 9. The competent authority shall not withdraw the measures provided for in rules 4 to 7 until the suspicion of foot-and-mouth FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 7 disease has been officially ruled out. 10.

(1)As soon as an outbreak of foot-and-mouth disease is confirmed, the competent authority shall ensure that, in addition to the measures provided for in rules 4 to 6 the following measures are also applied without delay on the holding: (

1. a)all animals of susceptible species shall be killed onthe-spot. In exceptional circumstances the animals of susceptible species may be killed at the nearest suitable place for that purpose under official supervision and in such a way as to avoid the risk of spreading foot-and-mouth disease virus during transport and killing. The competent authority shall notify the European Commission about the existence of such exceptional circumstances, and the action taken; (
2. b)the official veterinarian shall ensure that before or during the killing of the animals of susceptible species all appropriate samples needed for the epidemiological inquiry referred to in rule 13 have been taken in accordance with point 2.1.1.1 of Schedule III, and in sufficient numbers. The competent authority may decide that rule 4

(2)shall not apply in cases of appearance of a secondary source which is epidemiologically linked with a primary source for which samples have already been taken in accordance to that rule, provided that appropriate and sufficient numbers of samples needed for the epidemiological inquiry referred to in rule 13 have been taken; (

1. c)the carcasses of animals of susceptible species which have died on the holding and the carcasses of animals which have been killed in accordance with paragraph (
2. a)shall be processed without undue delay under official supervision in such a way that there is no risk of spreading foot-and-mouth disease virus. Where particular circumstances require the carcasses to be buried or burned, on site or off site, such operations shall be carried out in conformity with the instructions prepared in advance in the framework of the contingency plans referred to in rule 67; (
3. d)all products and substances referred to in rule 4

(3)(c) shall be isolated until contamination can be ruled out, or treated in accordance with the instructions of the official veterinarian in such a way as to ensure the destruction of any foot-and-mouth disease virus, or processed.

(2)After the killing and processing of the animals of susceptible species and the completion of the measures provided for in sub-rule

(1)(d), the competent authority shall ensure that: (

1. a)the buildings used for housing animals of susceptible species, their surroundings and the vehicles used for their transportation, as well as all other buildings and Measures in case of confirmation of an outbreak of foot-and-mouth disease. 8 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) equipment likely to be contaminated shall be cleaned and disinfected in accordance with rule 11; (
2. b)in addition, where there is a reasonable suspicion that the living area for humans or the office area of the holding are contaminated with the foot-and-mouth disease virus, these areas shall also be disinfected by appropriate means; (
3. c)restocking of animals is carried out in accordance with Schedule V. Cleansing and disinfection. 11.

(1)The competent authority shall ensure that cleansing and disinfection operations, as integral parts of the measures provided for in these rules, are adequately documented and are carried out under official supervision and in accordance with the instructions given by the official veterinarian, using disinfectants and working concentrations of such disinfectants officially au th orised and r egi stered for p laci ng o n t he marke t b y the competent authority as veterinary hygiene biocidal products in accordance with European Union Directive 98/8/EC, in order to ensure destruction of the foot-and-mouth disease virus.

(2)The competent authority shall ensure that cleansing and disinfection operations, which shall include appropriate pest control, are carried out in a way to reduce as much as possible any adverse environmental impact that may arise from such operations.

(3)The competent authority shall endeavour to ensure that any disinfectants used, in addition to being able to disinfect effectively, also have the lowest possible adverse impacts on the environment and public health in accordance with best available technology.

(4)The competent authority shall ensure that cleansing and disinfection operations are carried out in accordance with Schedule IV. Tracing and treatment of products and substances in contact with animals of an outbreak. 12. The competent authority shall ensure that the products and substances referred to in rule 4

(3)(c) of animals of susceptible species collected from a holding where an outbreak of foot-andmouth disease has been confirmed and semen, ova and embryos collected from animals of susceptible species present on that holding, during the period between the probable introduction of the disease to the holding and the implementation of official measures, shall be traced and processed or, in the case of substances other than semen, ova and embryos, be treated under official supervision and in such a way as to ensure destruction of foot-and-mouth disease virus and to avoid any risk of it spreading further. Epidemiological inquiry. 13.

(1)The competent authority shall ensure that epidemiological inquiries in relation to outbreaks of foot-andmouth disease are carried out by specifically trained veterinarians on the basis of questionnaires, prepared within the framework of the contingency plans provided for in rule 67, to ensure standardised, speedy and targeted inquiries. Such inquiries shall deal at least with: (

1. a)the length of time during which the foot-and-mouth FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 9 disease may have been present on a holding before being suspected or notified; (
2. b)the possible origin of the foot-and-mouth disease virus on a holding and the identification of other holdings where there are animals suspected of being infected or animals suspected of being contaminated from the same source; (
3. c)the possible extent to which animals of susceptible species other than bovine and porcine animals may have been infected or contaminated; (
4. d)the movement of animals, persons, vehicles and the substances referred to in rule 4

(3)(c) likely to have carried the foot-and-mouth disease virus to or from the holdings in question.

(2)The competent authority shall inform and regularly update the European Commission and the other Member States about the epidemiology and spread of the foot-and-mouth disease virus. 14.

(1)The competent authority may order that, besides the animals of susceptible species, animals of species not susceptible to foot-and-mouth disease on the holding where an outbreak of footand-mouth disease has been confirmed shall also be killed and processed of in such a way as to avoid any risk of spreading the foot-and-mouth disease virus: Additional measures in case of confirmation of outbreaks of footand-mouth disease. Provided that the provisions of this sub-rule do not apply to animals of species not susceptible to foot-and-mouth disease which may be isolated, effectively cleansed and disinfected, and provided that they are individually identified, in the case of equidae in accordance with European Community legislation, so as to allow the control of their movement.

(2)The competent authority may apply the measures provided for in rule 10

(1)(a) on epidemiologically-linked production units or adjoining holdings, where epidemiological information or other evidence give reason to suspect a possible contamination of those holdings. The intention to make use of those provisions shall be notified to the European Commission, where possible, prior to implementation. In this event, the measures regarding taking of samples and clinical examinations of animals shall be carried out at least as set out in point 2.1.1.1 of Schedule III.

(3)The competent authority shall, immediately upon confirmation of the first outbreak of foot-and-mouth disease, prepare all arrangements necessary for emergency vaccination in an area of at least the size of the surveillance zone established in accordance with rule 19.

(4)The competent authority may apply the measures provided for in rules 7 and 8. 15.

(1)Where an outbreak of foot-and-mouth disease threatens to infect animals of susceptible species in a laboratory, zoo, wildlife park, and fenced area or in bodies, institutes or centres approved in accordance with Article 13

(2)of European Directive Measures to be in the vicinity or within certain specific premises. 10 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) 92/65/EEC and where animals are kept for scientific purposes or purposes related to conservation of species or farm animal genetic resources, the competent authority shall ensure that all appropriate bio-security measures are taken to protect such animals from infection. Those measures may include restricting access to public institutions or making such access subject to special conditions.

(2)Where an outbreak of foot-and-mouth disease is confirmed in one of the premises referred to in sub-rule

(1), the competent authority may decide to derogate from rule 10

(1)(a), provided that basic European Community interests, and in particular the animal health status of other Member States, are not endangered and that all necessary measures are in place to prevent any risk of spreading foot-and-mouth disease virus.

(3)The decision referred to in sub-rule

(2)shall immediately be notified to the European Commission. In the case of farm animal genetic resources, this notification shall include a reference to the list of premises established in accordance with rule 72

(2)(f), by which the competent authority has identified these premises in advance as breeding nucleus of animals of susceptible species indispensable for the survival of a breed. Measures to be applied in slaughterhouses, border inspection posts and means of transportation. 16.

(1)Where a case of foot-and-mouth disease is confirmed in a slaughterhouse, a border inspection post established in accordance with European Union Council Directive 91/496/EEC or in a means of transport, the competent authority shall ensure that the following measures are carried out in relation to the affected premises or means of transport: (

1. a)all animals of susceptible species in such premises or means of transport shall be killed without delay; (
2. b)the carcasses of the animals referred to in paragraph (
3. a)shall be processed under official supervision in such a way as to avoid the risk of foot-and-mouth disease virus spreading; (
4. c)other animal waste, including offal, of infected or suspected of being infected and contaminated animals shall be processed under official supervision in such a way as to avoid the risk of foot-and-mouth disease virus spreading; (
5. d)dung, manure and slurry shall be subject to disinfection and shall only be removed for treatment in accordance with point 5 of Section II in Part A of Chapter III of Annex VIII to European Regulation No 1774/2002; (
6. e)cleansing and disinfection of buildings and equipment, including vehicles or means of transport, shall take place under the supervision of the official veterinarian in accordance with rule 11 and with the instructions laid down by the competent authority; (f)

(2)an epidemiological inquiry shall be carried out in accordance with rule 13. The competent authority shall ensure that the measures FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 11 provided for in rule 18 are applied in contact holdings.

(3)The competent authority shall ensure that no animals are reintroduced for slaughter, inspection or transport in the premises or means of transport referred to in sub-rule

(1)until at least twenty-four hours after completion of the cleansing and disinfection operations referred to in sub-rule

(1)(e).

(4)Where required by the epidemiological situation, in particular where contamination of animals of susceptible species in holdings adjacent to the premises or means of transport referred to in sub-rule

(1)must be suspected, the competent authority shall ensure that by way of derogation from the definition of a ‘holding’ in rule 2, second sentence, an outbreak is declared on the premises or means of transport referred to in sub-rule

(1), and the measures provided for in rules 10 and 19 are applied. 17.

(1)In the case of holdings which consist of two or more sep arate p rod uctio n un its, the comp etent autho rit y m ay, in exceptional cases and after considering the risks, derogate from rule 10

(1)(a) as regards production units of such holdings not affected by foot-and-mouth disease.

(2)The derogation provided for in sub-rule

(1)shall only be granted after the official veterinarian has confirmed at the time of the official investigation referred to in rule 4

(2), that the following conditions to prevent the spread of foot-and-mouth disease virus between the production units referred to in sub-rule

(1), have been in place for at least two incubation periods prior to the date the outbreak of foot-and-mouth disease was identified on the holding: (

1. a)the structure, including the administration, and size of the premises allow a complete separation of housing and keeping for the distinct herds of animals of susceptible species, including separate air space; (
2. b)the operations on the different production units, and in particular stable and pasture management, feeding, removal of dung or manure are completely separated and carried out by different personnel; (
3. c)the machinery, working animals of species not susceptible to foot-and-mouth disease, equipment, installations, instruments and disinfection facilities used in the production units are completely separate.

(3)In relation to milk, a derogation from rule 10

(1)(

1. d)may be granted to a holding producing milk provided that: (
2. a)such holding complies with the conditions set out in sub-rule

(2), and (

1. b)milking in each unit is carried out separately, and (
2. c)depending on the intended use, the milk is subject to at least one of the treatments described in Part A or Part B of Schedule IX.

(4)Where a derogation is granted in accordance with sub-rule

(1), the competent authority shall lay down in advance detailed rules for applying such derogation. The competent authority shall Holdings consisting of different epidemiological production units. 12 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) notify the European Commission of the derogation and provide details of the measures taken. Contact holdings. 18.

(1)Holdings shall be recognised as contact holdings where the official veterinarian finds, or considers on the basis of confirmed data, that the foot-and-mouth disease virus may have been introduced as a result of the movement of persons, animals, products of animal origin, vehicles or in any other way either from other holdings onto a holding referred to in rules 4

(1)or 10

(1)or from a holding referred to in rules 4

(1)or 10

(1)to other holdings.

(2)Contact holdings shall be subject to the measures provided for in rules 4

(3)and 5 and these measures shall be maintained until the suspected presence of foot-and-mouth disease virus on these contact holdings has been officially ruled out in accordance with the definition in Schedule I and the survey requirements provided for in point 2.1.1.1 of Schedule III.

(3)The competent authority shall prohibit the removal of all animals from contact holdings during a period corresponding to the incubation period specified for the species which has to undergo an ‘emergency slaughter’ in terms of the definition in rule 2. However, the competent authority may, by way of derogation from rule 4

(3)(d), authorise the transport of animals of susceptible species u n d e r o ff i c i a l s u p e r v i s i o n d i r e c t l y t o t h e c l o s e s t p o s s i b l e designated slaughterhouse for emergency slaughter. Prior to granting such derogation, the official veterinarian shall at least carry out the clinical examinations provided for in point 1 of Schedule III.

(4)Where the competent authority considers that the epidemiological situation permits, it may limit the recognition as a contact holding provided for in sub-rule

(1), to one identified epidemiological production unit of the holding and to the animals contained therein, provided that the epidemiological production unit complies with rule 17.

(5)Where an epidemiological link between an outbreak of foot-and-mouth disease and premises or means of transportation referred to in rules 15 and 16 respectively cannot be excluded, the competent authority shall ensure that the measures provided for in rule 4

(2)and

(3)and in rule 5 shall apply to such premises or means of transportation. The competent authority may decide to apply the measures provided for in rule 8. Establishment of protection and surveillance zones. 19.

(1)The competent authority shall ensure that, without prejudice to measures provided for in rule 7, at least the measures laid down in sub-rules

(2),

(3)and

(4)are taken immediately after an outbreak of foot-and-mouth disease is confirmed.

(2)The competent authority shall establish a protection zone based on a minimum radius of three kilometres and a surveillance zone based on a minimum radius of ten kilometres centred on the outbreak of foot-and-mouth disease referred to in sub-rule

(1). The geographical delimitation of those zones shall take account of administrative boundaries, natural barriers, supervision facilities and technological progress which makes it possible to predict the FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 13 probable dispersion of the foot-and-mouth disease virus by air or any other means. That delimitation shall be reviewed, if necessary, in the light of such elements.

(3)The competent authority shall ensure that the protection and surveillance zones are marked by posting signs of sufficient size on roads entering the zones.

(4)In order to ensure full coordination of all measures necessary to eradicate foot-and-mouth disease as quickly as possible, national and local disease control centres as referred to in rules 69 and 71 shall be established. For the purpose of carrying out the epidemiological inquiry as provided for in rule 13, those centres shall be assisted by an expert group as provided for in rule 73.

(5)The competent authority shall without delay trace animals dispatched from the zones during the period of at least twenty-one days before the estimated date of earliest infection on a holding in the protection zone and they shall inform the competent authorities in other Member States and the European Commission about their results from tracing of animals.

(6)The competent authority shall collaborate in tracing fresh meat, meat products, raw milk and raw milk products derived from animals of susceptible species originating in the protection zone and produced between the date of estimated introduction of the foot-and-mouth disease virus until the date the measures provided for in sub-rule

(2)come into force. Such fresh meat, meat products, raw milk and raw milk products shall be treated in accordance with ru les 2 3, 24 and 2 5 respecti vel y o r detai ned un til p ossibl e contamination with the foot-and-mouth disease virus is officially ruled out. 20.

(1)The competent authority shall ensure that at least the following measures are applied in the protection zone without delay: (

1. a)the registration of all holdings with animals of susceptible species and the establishment of a census of all animals present on these holdings shall be carried out as soon as possible and kept up to date; (
2. b)all holdings with animals of susceptible species shall periodically undergo a veterinary inspection, carried out in such a way as to avoid the spread of foot-andmouth disease virus possibly present on the holdings, which shall include in particular the relevant documentation, notably the records referred to in paragraph (
3. a)and the measures applied to prevent the introduction or escape of foot-and-mouth disease virus and which may include clinical inspection as described in point 1 of Schedule III or taking of samples from animals of susceptible species in accordance with point 2.1.1.1 of Schedule III; (
4. c)animals of susceptible species shall not be removed from the holding on which they are kept.

(2)By way of derogation from sub-rule

(1)(c), animals of Measures to be applied to holdings in the protection zone. 14 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) susceptible species may be transported, under official supervision f o r t h e p u r p o s e o f e m e rg e n c y s l a u g h t e r, d i r e c t l y t o a slaughterhouse situated inside the same protection zone or, if that zone has no slaughterhouse to a slaughterhouse outside the zone designated by the competent authority in means of transport cleansed and disinfected under official control after each transport operation.

(3)The movement referred to in the sub-rule

(1)shall only be authorised if the competent authority is satisfied, on the basis of a clinical examination in accordance with point 1 of Schedule III by the official veterinarian of all the animals of susceptible species present on the holding and after evaluation of epidemiological circumstances, that there is no reason to suspect the presence of infected or contaminated animals on the holding. The meat of such animals shall be subject to the measures provided for in rule

1. Movement and transport of animals and their products in the protection zone.
2. The competent authority shall ensure that the following activities are prohibited within the protection zone: (a) movement between holdings and transport of animals of susceptible species; (b) fairs, markets, shows and other gatherings of animals, including collection and dispersion of susceptible species; (c) itinerant service for breeding of animals of susceptible species; (d) artificial insemination of and collection of ova and embryos from animals of susceptible species. Additional measures and derogations. 22.

(1)The competent authority may extend the prohibitions in rule 21 to: (

1. a)movement or transport of animals of non-susceptible species between holdings situated within the zone or out of or into the protection zone; (
2. b)transit of animals of all species through the protection zone; (
3. c)events with gatherings of people with possible contact with animals of susceptible species, where there is a risk of spreading the foot-and-mouth disease virus; (
4. d)artificial insemination of, or collection of ova and embryos from, animals of species not susceptible to foot-and-mouth disease; (
5. e)movement of means of transport designed for the transportation of animals; (
6. f)the slaughter on the holding of animals of susceptible species for private consumption; (
7. g)transport of goods referred to in rule 31 to holdings keeping animals of susceptible species.

(2)The competent authority may authorise: (

1. a)the transit of animals of all species through the FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 15 protection zone undertaken exclusively via major highways; (
2. b)the transport of animals of susceptible species which have been certified by the official veterinarian as coming from holdings outside the protection zone and transported on designated routes directly to designated slaughterhouses for immediate slaughter, provided that the means of transport are cleansed and disinfected after delivery under official supervision at the slaughterhouse and such decontamination of transport is recorded in the logbook of the means of transport; (
3. c)the artificial insemination of animals on a holding carried out by the personnel of that holding by use of semen collected from animals on that holding or semen stored on that holding or semen delivered from a semen collection centre to the outside perimeter of that holding; (
4. d)the movement and transport of equidae taking into account the conditions set out in Schedule VI; (
5. e)the transport, under certain conditions, of goods referred to in rule 31 to holdings keeping animals of susceptible species. 23.

(1)The competent authority shall ensure that the placing on the market of fresh meat, minced meat and meat preparations, derived from animals of susceptible species originating in the protection zone, shall be prohibited.

(2)The competent authority shall ensure that the placing on the market of fresh meat, minced meat and meat preparations from animals of susceptible species produced in establishments situated in the protection zone, shall be prohibited.

(3)The competent authority shall ensure that fresh meat, minced meat and meat preparations as referred to in sub-rule

(1), shall be marked in accordance with European Union Council Directive 2002/99/EC and subsequently transported in sealed containers to an establishment designated by the competent authorities for transformation into meat products treated in accordance with point 1 in Part A of Schedule VII of these rules.

(4)By way of derogation, the prohibition provided for in subrule

(1)shall not apply to fresh meat, minced meat and meat preparations which were produced on a date at least twenty-one days before the estimated date of earliest infection on a holding in the protection zone and which since production have been stored and transported separately from such meats produced after that date. Such meats must be readily distinguished from meats not eligible for dispatch outside the protection zone by means of a clear mark estab lish ed i n con form it y w it h Eu ro pean Com m un ity legislation.

(5)By way of derogation, the prohibition provided for in subrule

(2), shall not apply to fresh meat, minced meat or meat preparations obtained from establishments situated in the Measures in relation to fresh meat produced in the protection zone. 16 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) protection zone under the following conditions: (a) the establishment shall be operated under strict veterinary control; (b) only fresh meat, minced meat or meat preparations as described in sub-rule

(4), or fresh meat, minced meat or meat preparations obtained from animals reared and slaughtered outside the protection zone or from animals transported to the establishment and slaughtered therein in accordance with the provisions in rule 22

(2)(

1. b)shall be processed in the establishment; (
2. c)all such fresh meat, minced meat or meat preparations, must bear the health mark in accordance with Chapter XI of Annex I to European Union Council Directive 64/433/EEC or in the case of meat from other biungulates the health mark provided for in Chapter III of Annex I to European Union Council Directive 91/ 495/EEC, or in the case of minced meat and meat preparations the health mark as provided for in Chapter VI of Annex I to European Union Council Directive 94/65/EC; (
3. d)during the whole production process all such fresh meat, minced meat or meat preparations must be clearly identified, and transported and stored separately from fresh meat, minced meat or meat preparations which are not eligible for dispatch outside the protection zone in accordance with these rules.

(6)Compliance with the conditions in sub-rule

(5)shall be certified by the competent authority for fresh meat, minced meat and meat preparations intended for intra-European Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authority and, in the case of intra-European Community trade, communicate to other Member States and the European Commission a list of those establishments which it has approved for the purpose of such certification.

(7)Derogation from the prohibition provided for in sub-rule

(1)may be granted subject to specific conditions adopted in accordance with European Union legislation, in particular with regard to the health marking of meat produced from animals of susceptible species originating in protection zones maintained for more than thirty days. Measures in relation to meat products produced in the protection zone. 24.

(1)The competent authority shall ensure that the placing on the market of meat products produced from meat derived from animals of susceptible species originating in the protection zone shall be prohibited.

(2)By way of derogation, the prohibition in sub-rule

(1)shall not apply to meat products which have either undergone one of the treatments as set out in point 1 in Part A of Schedule VII or which have been produced from meats referred to in rule 23

(4). FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 25.

(1)The competent authority shall ensure that the placing on the market of milk derived from animals of susceptible species originating in the protection zone and of milk products produced from such milk shall be prohibited.

(2)The competent authority shall ensure that the placing on the market of milk and milk products from animals of susceptible species produced in an establishment situated in the protection zone shall be prohibited.

(3)By way of derogation, the prohibition provided for in subrule

(1)shall not apply to milk and milk products derived from animals of susceptible species originating in the protection zone which were produced on a date at least twenty-one days before the estimated date of earliest infection on a holding in the protection zone and which since production have been stored and transported separately from milk and milk products produced after that date.

(4)By way of derogation, the prohibition provided for in subrule

(1)shall not apply to milk derived from animals of susceptible species originating in the protection zone and milk products produced from such m ilk which have undergone one of the treatments as set out in Parts A or B of Schedule IX, depending on the use of the milk or milk products. The treatment shall be carried out under the conditions set out in sub-rule

(6)in establishments referred to in sub-rule 5 or, if there is no establishment situated in th e p r ot ect io n zon e, i n est abl i shm en ts sit ua ted o ut sid e th e protection zone under the conditions set down in sub-rule 8.

(5)By way of derogation, the prohibition provided for in subrule

(2)shall not apply to milk and milk products which have been prepared in establishments situated in the protection zone under the conditions set out in sub-rule

(6).

(6)Establishments referred to in sub-rules

(4)and

(5)shall comply with the following conditions: (

1. a)the establishment shall be operated under permanent and strict official control; (
2. b)all milk used in the establishment shall either comply with sub-rules

(3)and

(4)or the raw milk shall be obtained from animals outside the protection zone; (

1. c)during the whole production process the milk shall be clearly identified and transported and stored separately from raw milk and raw milk products which are not destined for dispatch outside the protection zone; (
2. d)transport of raw milk from holdings situated outside the protection zone to the establishments shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, and which have had no subsequent contact with holdings in the protection zone keeping animals of susceptible species.

(7)Compliance with the conditions in sub-rule 6 shall be certified by the competent authority for milk intended for intraEuropean Com mu nity trade. Th e co mpetent authority shall 17 Measures in relation to milk and milk products produced in the protection zone. 18 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) supervise the control of compliance undertaken by the local veterinary authority and, in the case of intra-European Community trade, communicate to other Member States and the European Commission a list of those establishments which it has approved for the purpose of such certification.

(8)Transport of raw milk from holdings situated within the protection zone to establishments situated outside the protection zone and the processing of that milk shall be subject to the following conditions: (

1. a)processing in establishments situated outside the protection zone of raw milk produced from animals of susceptible species kept within the protection zone shall be authorised by the competent authorities; (
2. b)the authorisation shall include instructions on and designation of the transport route to the designated establishment; (
3. c)transport shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, which are constructed and maintained in such a way that there is no leakage of milk during transport and which are equipped to avoid aerosol dispersion during the loading and unloading of the milk; (
4. d)before leaving the holding from where milk of animals of susceptible species was collected the connection pipes, tyres, wheel cases, the lower parts of the vehicle and any spillage of milk are cleansed and disinfected and after the last disinfection and before leaving the protection zone the vehicle had no subsequent contact with holdings in the protection zone keeping animals of susceptible species; (
5. e)the means of transport are strictly assigned to a defined geographical or administrative area, they are marked accordingly and may only be moved to another area after cleansing and disinfection under official supervision.

(9)The collection and transport of samples of raw milk of animals of susceptible species from holdings situated in the protection zone to a laboratory other than a veterinary diagnostic laboratory approved for diagnosis of foot-and-mouth disease and the processing of the milk in such laboratories shall be forbidden. Measures in relation to semen, ova and embryos collected from animals of susceptible species in the protection zone. 26.

(1)The competent authority shall ensure that the placing on the market of semen, ova and embryos derived from animals of susceptible species originating in the protection zone shall be prohibited.

(2)By way of derogation, the prohibition provided for in subrule

(1)shall not apply to frozen semen, ova and embryos collected and stored at least twenty-one days before the estimated date of earliest infection with the foot-and-mouth disease virus on a holding in the zone. FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 19

(3)Frozen semen collected in accordance with European Community legislation after the date of infection referred to in subrule

(2), shall be stored separately and shall only be released after: (

1. a)all the measures relating to the outbreak of foot-andmouth disease have been removed in accordance with rule 36, and (
2. b)all animals accommodated in the semen collection centre have undergone a clinical examination, and samples taken in accordance with point 2.2 of Schedule III have been subjected to a serological test to substantiate the absence of infection in the semen collection centre concerned, and (
3. c)the donor animal has been subjected with negative result to a serological test for the detection of antibodies against the foot-and-mouth disease virus on a sample taken not earlier than 28 days after the collection of the semen. 27.

(1)The competent authority shall ensure that the transport and distribution of dung or manure from holdings and premises or means of transport referred to in rule 16 situated in the protection zone where animals of susceptible species are kept, shall be prohibited within the protection zone.

(2)By way of derogation from the prohibition in sub-rule

(1)the competent authority may authorise the removal of manure of animals of susceptible species from a holding situated in the protection zone to a designated plant for treatment in accordance with point 5 of Section II in Part A of Chapter III of Annex VIII to European Regulation 1774/2002 or for intermediate storage.

(3)By way of derogation from the prohibition in sub-rule

(1)the competent authority may authorise the removal of manure of animals of susceptible species from holdings situated in the protection zone which are not subject to the measures provided for in rules 4 or 10 for distribution on designated fields under the following conditions: (

1. a)the entire volume of manure has been produced at least twenty-one days before the estimated date of earliest infection on a holding in the protection zone and the manure or dung is distributed close to the ground and in sufficient distance from holdings keeping animals of susceptible species and immediately incorporated into the ground, or (
2. b)in the case of manure from bovine animals or pigs: (
3. i)an examination by an official veterinarian of all the animals on the holding has ruled out the presence of animals suspected of being infected with the foot-and-mouth disease virus, and (
4. ii)the entire volume of manure has been produced at least four days prior to the examination referred to in sub-paragraph (i), and (iii) the manure is incorporated into the ground on Transport and distribution of dung and manure of animals of susceptible species produced in the protection zone. 20 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) designated fields close to the holding of origin and in sufficient distance to other holdings keeping animals of susceptible species in the protection zone.

(4)The competent authority shall ensure that any authorisation to remove dung or manure from a holding keeping animals of susceptible species is subject to stringent measures to avoid spread of the foot-and-mouth disease virus, in particular by ensuring cleansing and disinfection of the leak-proof transport vehicles after loading and before leaving the holding. Measures in relation to hides and skins from animals of susceptible species in the protection zone. 28.

(1)The competent authority shall ensure that the placing on the market of hides and skins of animals of susceptible species originating in the protection zone, shall be prohibited.

(2)By way of derogation, the prohibition as provided for in sub-rule

(1)shall not apply to hides and skins which either: (a) were produced at least twenty-one days before the estimated date of infection on the holding referred to in rule 10

(1), and that have been stored separately from hides and skins produced after that date; or (b) comply with the requirements laid down in point 2 in Part A of Schedule VII. Measures in relation to sheep wool, ruminant hair and pig bristles produced in the protection zone. 29.

(1)The competent authority shall ensure that the placing on the market of sheep wool, ruminant hair and pig bristles originating in the protection zone shall be prohibited.

(2)By way of derogation, the prohibition as provided for in sub-rule

(1)shall not apply to unprocessed wool, hair and bristles which: (a) were produced at least twenty-one days before the estimated date of infection on the holding referred to in rule 10

(1)and have been stored separately from wool, hair and bristles produced after that date; or (b) comply with the requirements laid down in point 3 in Part A of Schedule VII. Measures in relation to other animal products produced in the protection zone. 30.

(1)The competent authority shall ensure that the placing o n t h e m a r k e t o f a ni m a l p r o d u c t s d e r i v e d f r o m a n i m a l s o f susceptible species not referred to in rules 23 to 29 shall be prohibited.

(2)By way of derogation, the prohibitions provided for in subrule

(1)shall not apply to products referred to in sub-rule

(1)which: (a) either have been produced at least twenty-one days before the estimated date of infection on the holding referred to in rule 10

(1)and have been stored and transported separately from products produced after that date, or (

1. b)have undergone the treatment in accordance with point 4 in Part A of Schedule VII, or FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 21 (
2. c)for specific products, comply with the appropriate requirements in points 5 to 9 in Part A of Schedule VII, or (
3. d)are composite products which are not subject to further treatment containing products of animal origin which either have undergone a treatment ensuring destruction of possible foot-and-mouth disease virus or have been obtained from animals not subject to restrictions under the provisions of these rules, or (
4. e)are packed products intended for use as in-vitro diagnostic or laboratory reagents. 31.

(1)The competent authority shall ensure that the placing on the market of feed, forage, hay and straw originating in the protection zone shall be prohibited.

(2)By way of derogation, the prohibition provided for in subrule

(1)shall not apply to feed, forage, hay and straw: Measures in relation to feed, forage, hay and straw produced in the protection zone. (a) produced at least twenty-one days before the estimated date of infection on holdings referred to in rule 10

(1), and stored and transported separately from feed, forage, hay and straw produced after that date; or (

1. b)intended for use within the protection zone, subject to authorisation by the competent authorities; or (
2. c)produced on premises not keeping animals of susceptible species; or (
3. d)produced in establishments not keeping animals of susceptible species and sourcing the raw material from premises referred to in paragraph (
4. c)or from premises situated outside the protection zone.

(3)By way of derogation, the prohibition provided for in subrule

(1)shall not apply to forage and straw produced on holdings keeping animals of susceptible species which comply with the requirements in point 1 in Part B of Schedule VII. 32.

(1)Any derogation from the prohibitions provided for in rules 22 to 31 shall be granted by a specific decision of the competent authority only after it has satisfied itself that all relevant requirements have been met for a sufficient period before the products leave the protection zone, and that there is no risk of spreading the foot-and-mouth disease virus. Granting of derogations and additional certification.

(2)Any derogation from the prohibitions provided for in rules 23 to 31 requires, in the case of intra-European Community trade, additional certification by the competent authority.

(3)Detailed rules for the implementation of the measures provided for in sub-rule

(2)may be adopted in accordance with the European Community legislation. 33. In addition to the measures applicable in the protection zone in accordance with these rules, the competent authority may take additional national measures which are deemed necessary and proportionate to contain the foot-and-mouth disease virus taking Additional measures applied by the competent authority in the protection zone. 22 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) into account the particular epidemiological, animal husbandry, commercial and social conditions prevailing in the affected area. The competent authority shall inform the European Commission and the other Member States about such additional measures. Removal of measures in the protection zone. 34.

(1)The competent authority shall ensure that the measures applied in the protection zone are maintained until the following requirements have been met: (a) at least fifteen days have elapsed since the killing and safe disposal of all the animals of susceptible species from the holding referred to in rule 10

(1)and the completion of the preliminary cleansing and disinfection on that holding, carried out in accordance with rule 11; (b) a survey has been concluded with negative results in all holdings keeping animals of susceptible species and situated within the protection zone.

(2)After the removal of the measures specific to the protection zone, the measures applied in the surveillance zone as provided for in rules 35 to 40, shall continue to apply for at least fifteen days until those measures are removed in accordance with rule 42.

(3)The survey referred to in sub-rule

(1)(b) shall be carried out to substantiate the absence of infection and at least in compliance with the criteria of point 1 of Schedule III and shall include the measures provided for in point 2.3 of Schedule III based on the criteria set out in points 2.1.1. and 2.1.3. of Schedule III. Measures to be applied to holdings in the surveillance zone. 35.

(1)The competent authority shall ensure that the measures provided for in rule 20

(1)are applied in the surveillance zone.

(2)By way of derogation from the prohibition provided for in rule 20

(1)(

1. c)and where there is no or insufficient slaughter capacity available within the surveillance zone, the competent authorities may authorise the removal from holdings situated in the surveillance zone of animals of susceptible species for transporting them directly and under official supervision for slaughter to a slaughterhouse located outside the surveillance zone, subject to the following conditions: (
2. a)the records referred to in rule 20

(1)have been subjected to official control, and the epidemiological situation of the holding does not indicate any suspicion of infection or contamination with the foot-and-mouth disease virus, and (

1. b)all the animals of susceptible species on the holding have been subjected with negative result to an inspection by the official veterinarian, and (
2. c)a representative number of animals, taking into account the statistical parameters in point 2.2 of Schedule III, has been subjected to thorough clinical examination to rule out the presence or suspicion of clinically infected animals, and (
3. d)the slaughterhouse is designated by the competent FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 23 authority and located as near to the surveillance zone as possible, and (
4. e)the meat produced from such animals shall be subject to the treatment specified in rule 37. 36.

(1)The competent authority shall ensure that animals of susceptible species shall not be removed from holdings within the surveillance zone.

(2)By way of derogation, the prohibition provided for in subrule

(1)shall not apply to movement of animals for one of the following purposes: Movement of animals of susceptible species within the surveillance zone. (

1. a)for leading them without coming into contact with animals of susceptible species of different holdings to pasture situated within the surveillance zone not earlier than fifteen days after the last outbreak of footand-mouth disease has been recorded in the protection zone; (
2. b)for transporting them directly, and under official supervision, for the purpose of slaughter to a slaughterhouse located inside the same zone; (
3. c)for transporting them in accordance with rule 35

(2); (d) for transporting them in accordance with rule 22

(2)(a) and (b).

(3)Movements of animals provided for in sub-rule

(2)(a) shall be authorised by the competent authority only after an examination by an official veterinarian of all the animals of susceptible species on the holding, including testing of samples taken in accordance with point 2.2 of Schedule III, has ruled out the presence of animals suspected of being infected or animals suspected of being contaminated.

(4)Movements of animals provided for in sub-rule

(2)(b) shall be authorised by the competent authority only after the measures provided for in rule 37

(2)(

1. a)and (
2. b)have been completed with satisfactory results.

(5)The competent authority shall without delay trace animals of susceptible species dispatched from the surveillance zone during a period of least twenty-one days before the estimated date of earliest infection on a holding in the surveillance zone and they shall inform the competent authorities in other Member States about their results from tracing animals. 37.

(1)The competent authority shall ensure that the placing on the market of fresh meat, minced meat and meat preparations derived from animals of susceptible species originating in the surveillance zone and of meat products produced from such meats shall be prohibited.

(2)The competent authority shall ensure that the placing on the market of fresh meat, minced meat, meat preparations and meat products from animals of susceptible species produced in establishments situated in the surveillance zone shall be prohibited. Measures to be applied to fresh meat of animals of susceptible species originating in the surveillance zone and meat products produced from such meat. 24 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)

(3)By way of derogation, the prohibition provided for in subrule

(1)shall not apply to fresh meat, minced meat and meat preparations which were produced on a date at least twenty-one days before the estimated date of earliest infection on a holding in the corresponding protection zone and which since production have been stored and transported separately from such meats produced after that date. Such meats must be readily distinguished from meats not eligible for dispatch outside the surveillance zone by means of clear mark established in conformity with European Community legislation.

(4)By way of derogation, the prohibition provided for in subrule

(1)shall not apply to fresh meat, minced meat and meat preparations which were produced from animals transported to the slaughterhouse under conditions at least as strict as provided for in rule 35

(2)(

1. a)to (
2. e)under the condition that the meat is subject to the measures provided for in sub-rule

(5).

(5)By way of derogation, the prohibition provided for in subrule

(2), shall not apply to fresh meat, minced meat or meat preparations obtained from establishments situated in the surveillance zone under the following conditions: (

1. a)the establishment shall be operated under strict veterinary control; (
2. b)only fresh meat, minced meat or meat preparations as described in sub-rule

(4)and subject to the additional conditions provided for in Part B of Schedule VIII or obtained from animals reared and slaughtered outside the surveillance zone or obtained from animals transported in accordance with the provisions in rule 22

(2)(

1. b)shall be processed in the establishment; (
2. c)all such fresh meat, minced meat or meat preparations must bear the health mark in accordance with Chapter XI of Annex I to European Union Council Directive 64/433/EEC or in the case of meat from other biungulates the health mark provided for in Chapter III of Annex I to European Union Council Directive 91/ 495/EEC, or in the case of minced meat and meat preparations the health mark as provided for in Chapter VI of Annex I to European Union Council Directive 95/65/EC; (
3. d)during the whole production process all such fresh meat, minced meat or meat preparations must be clearly identified, and transported and stored separately from fresh meat, minced meat or meat preparations which are not eligible for dispatch outside the surveillance zone in accordance with these rules.

(6)By way of derogation, the prohibition provided for in subrule

(1), shall not apply to meat products produced from fresh meat obtained from animals of susceptible species originating in the surveillance zone which was marked with the health mark provided for European Union Council Directive 2002/99/EC and transported under official supervision to a designated establishment for FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 25 treatment in accordance with point 1 in Part A of Schedule VII.

(7)By way of derogation, the prohibition provided for in subrule

(2), shall not apply to meat products produced in establishm ent s situated i n the surveillance zone and either complying with the provisions in sub-rule

(6), or produced from meat complying with sub-rule

(5).

(8)Compliance with the conditions in sub-rules

(5)and

(7)shall be certified by the competent authority for fresh meat, minced meat and meat preparations intended for intra-European Community trade. The competent authority shall supervise the control of compliance undertaken by the Veterinary Services and in the case of intra-European Community trade communicate to other Member States and the European Commission a list of those establishments which it has approved for the purpose of such certification.

(9)Derogation from the prohibition provided for in sub-rule

(1)may be granted subject to specific conditions adopted in accordance with European Community legislation, in particular with regard to the health marking of meat produced from animals of susceptible species originating in surveillance zone maintained for more than thirty days. 38.

(1)The competent authority shall ensure that placing on the market of milk derived from animals of susceptible species originating in the surveillance zone and of milk products produced from such milk shall be prohibited.

(2)The competent authority shall ensure that the placing on the market of milk and milk products from animals of susceptible species produced in the surveillance zone shall be prohibited.

(3)By way of derogation, the prohibition provided for in subrule

(1)shall not apply to milk and milk products derived from animals of susceptible species originating in the surveillance zone which were produced on a date at least twenty-one days before the estimated date of earliest infection on a holding in the corresponding protection zone and which since production have been stored and transported separately from milk and milk products produced after that date.

(4)By way of derogation, the prohibition provided for in subrule

(1)shall not apply to milk derived from animals of susceptible species originating in the surveillance zone and milk products produced from such m ilk which have undergone one of the treatments as set out in Parts A or B of Schedule IX depending on the use of the milk or milk products. The treatment shall be carried out under the condition set out in sub-rule

(6)in establishments referred to in sub-rule

(5)or, if there is no establishment situated in th e su r vei l la nc e zo ne , i n e sta bl i s hm e nt s de s i gn a t e d b y t h e competent authorities and situated outside the protection and surveillance zones.

(5)By way of derogation, the prohibition provided for in subrule

(2)shall not apply to milk and milk products which have been prepared in establishments situated in the surveillance zone under Measures to be applied to milk and milk products of animals of susceptible species produced in the surveillance zone 26 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) the conditions set out in sub-rule

(6).

(6)Establishments referred to in sub-rules

(4)and

(5)shall comply with the following conditions: (

1. a)the establishment shall be operated under strict veterinary control; (
2. b)all milk used in the establishment shall either comply with sub-rule

(4)or be obtained from animals outside the surveillance and protection zone; (

1. c)throughout the production process the milk shall be clearly identified and transported and stored separately from milk and milk products which are not destined for dispatch outside the surveillance zone; (
2. d)transport of raw milk from holdings situated outside the protection and surveillance zone to the establishments shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, and which have had no subsequent contact with holdings in the protection and surveillance zones keeping animals of susceptible species.

(7)Compliance with the conditions in sub-rule

(6)shall be certified by the competent authority for milk intended for intraEuro pean Com muni ty trade. The competent authority shall supervise the control of compliance undertaken by the Veterinary Services and, in the case of intra-European Community trade, communicate to other Member States and the European Commission a list of those establishments which it has approved for the purpose of such certification.

(8)Transport of raw milk from holdings situated within the surveillance zone to establishments situated outside the protection and surveillance zones and the processing of that milk shall be subject to the following conditions: (

1. a)processing in establishments situated outside the protection and surveillance zones of raw milk produced from animals of susceptible species kept within the surveillance zone shall be authorised by the competent authorities; (
2. b)the authorisation shall include instructions on and designation of the transport route to the designated establishment; (
3. c)transport shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, which are constructed and maintained in such a way that there is no leakage of milk during transport and which are equipped to avoid aerosol dispersion during the loading and unloading of the milk; (
4. d)before leaving the holding from where milk of animals of susceptible species was collected, the connection pipes, tires, wheel cases, the lower parts of the vehicle and any spillage of milk are cleansed and disinfected FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 27 and after the last disinfection and before leaving the surveillance zone the vehicle had no subsequent contact with holdings in the protection and surveillance zones keeping animals of susceptible species; (
5. e)the means of transport are strictly assigned to a defined geographical or administrative area, they are marked accordingly and may only be moved to another area after cleansing and disinfection under official supervision.

(9)The collection and transport of samples of raw milk of animals of susceptible species from holdings situated in the surveillance zone to a laboratory other than a veterinary diagnostic laboratory approved for diagnosis of foot-and-mouth disease and the processing of the milk in such laboratories shall be subject to official authorisation and measures to avoid any spread of possible foot-and-mouth disease virus. 39.

(1)The competent authority shall ensure that the transport and distribution of dung or manure from holdings and other premises such as those mentioned in rule 16 situated in the surveillance zone where animals of susceptible species are kept shall be prohibited within and outside that zone. Transport and distribution of dung and manure of animals of susceptible species produced in the surveillance zone.

(2)By way of derogation from the prohibition provided for in sub-rule

(1)the competent authorities may in exceptional circumstances authorise the transport of dung or manure in means of transport thoroughly cleansed and disinfected prior to and after use for distribution in designated areas within the surveillance zone and at sufficient distance to holdings where animals of susceptible species are kept under the following alternative conditions: (

1. a)either an examination by an official veterinarian of all the animals of susceptible species on the holding has ruled out the presence of animals suspected of being infected with the foot-and-mouth disease virus and the manure or dung is distributed close to the ground to avoid the generation of aerosols and immediately ploughed into the ground, or (
2. b)a clinical inspection by an official veterinarian of all the animals of susceptible species on the holding has been carried out with negative result and the manure is injected into ground, or; (
3. c)manure is subject to the provision of rule 27

(2).

1. The competent authority shall ensure that the placing on the market of products of animal origin other than those referred to in rules 37 to 39 shall be subject to the conditions provided for in rules 26 and 28 to
2. Measures in relation to other animal products produced in the surveillance zone.
3. In addition to the measures provided for in rules 35 to 40, the competent authority may take additional national measures which are deemed necessary and proportionate to contain foot-andmouth disease virus taking into account the particular ep idemi ological, anim al husbandry, comm ercial and soci al Additional measures applied by the competent authority in the surveillance zone. 28 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) conditions prevailing in the affected area. Where specific measures to restrict the movement of equidae are considered necessary, such measures shall take into account those provided for in Schedule VI. Removal of measures in the surveillance zone. 42.

(1)The competent authority shall ensure that the measures applied in the surveillance zone are maintained until the following requirements have been met: (a) at least thirty days have elapsed since the killing and safe disposal of all animals of susceptible species from the holding referred to in rule 10

(1)and the completion of the preliminary cleansing and disinfection on that holding, carried out in accordance with rule11; (

1. b)the requirements provided for in rule 34 have been met in the protection zone; (
2. c)a survey has been concluded with negative results.

(2)The survey referred to in sub-rule

(1)(c) shall be carried out to substantiate the absence of infection in the surveillance zone in compliance with the criteria of point 1 of Schedule III and shall include the measures provided for in point 2.4 of Schedule III based on the criteria of point 2.1 of Schedule III. Regionalisation. 43.

(1)Without prejudice to European Union Council Directive 90/425/EC, and in particular Article 10 thereof, where the foot-and-mouth disease virus appears to be spreading despite the measures taken in accordance with these rules and the epizootic becomes extensive and in any case when emergency vaccination is implemented, the competent authority shall ensure that Malta is regionalised into one or more restricted and free zones.

(2)The competent authority shall notify to the European Commission without delay the details of the measures implemented in the restricted zone and the European Commission shall review, where necessary amend, and endorse the measures in accordance with European Community legislation.

(3)Without prejudice to the obligation of the competent authority to regionalise referred to in sub-rule

(1), regionalisation, and the measures to be applied within the restricted zone, may be decided in accordance with the procedure established in rule 78

(2). This decision may extent its effects to neighbouring Member States not infected at the time the measures are taken.

(4)Prior to the delimitation of the restricted zone, a thorough epidemiological assessment of the situation shall be carried out, especially with respect to the possible time and probable location of introduction, the possible spread and the probable period of time necessary to eradicate the foot-and-mouth disease virus.

(5)The restricted zone shall as far as possible be delimited on the basis of administrative boundaries or geographical barriers. Regionalisation shall take as its starting point larger administrative units rather than regions. The restricted zone may be reduced in the light of the results of the epidemiological inquiry provided for in rule 13, to an area of the size not less than a sub-region, and where FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 29 necessary the surrounding sub-regions. In the event of the foot-andmouth disease virus spreading, the restricted zone shall be enlarged by including additional regions or sub-regions. 44.

(1)Where regionalisation is applied, the competent authority shall ensure that at least the following measures are taken: Measures applied in a restricted zone of Malta. (

1. a)control within the restricted zone of transport and movement of animals of susceptible species, animal products and goods and of the movement of means of transport as potential carriers of foot-and-mouth disease virus; (
2. b)tracing and marking in accordance with European Community legislation of fresh meat and raw milk and as far as possible other products in stock not eligible for dispatch outside the restricted zone; (
3. c)specific certification of animals of susceptible species and products derived from such animals and health marking, in accordance with European Community legislation, of products for human consumption intended and eligible for dispatch outside the restricted zone.

(2)Where regionalisation is applied, the competent authority shall ensure that at least the animals of susceptible species dispatched from the restricted zone to other Member States during the time between the date of estimated introduction of the foot-andmouth disease virus until the date regionalisation is implemented shall be traced, and such animals shall be isolated under official veterinary control until possible infection or contamination is officially ruled out.

(3)The competent authority shall collaborate in tracing fresh meat and raw milk and raw milk products derived from animals of susceptible species produced in the restricted zone between the date of estimated introduction of the foot-and-mouth disease virus until the date regionalisation is implemented. Such fresh meat shall be treated in accordance with point 1 in Part A of Annex VII, and raw milk and milk products shall be treated in accordance with Part A or B of Schedule IX depending on the use, or detained until possible contamination with the foot-and-mouth disease virus is officially ruled out.

(4)Specific measures, in particular in relation to health marking of products derived from animals of susceptible species originating in the restricted zone and not intended for placing on the market outside the restricted zone may be adopted in accordance with Article 4

(3)of European Union Council Directive 2002/99/EC. 45.

(1)Without prejudice to European Community legislation on identification of domestic bovine, ovine and caprine animals and swine, the competent authority shall ensure that in the event of an outbreak of foot-and-mouth disease on their territory animals of susceptible species shall only leave the holding on which they are Identification of animals of susceptible species. 30 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) kept, if they are identified in such a way as to enable the competent authorities to trace rapidly their movements and their holding of origin, or any holding from which they have come. However, for special cases referred to in rule 15

(1)and rule 16

(1), the competent authority may, in certain circumstances and having regard to the health situation, authorise other ways of rapidly tracing the movement of those animals and of their holding of origin, or of any holding from which they hav e come. The arrangements for identifying such animals or for tracing their holdings of origin shall be determined by the competent authority and notified to the European Commission.

(2)The measures taken by the competent authority on additional, permanent and indelible marking of animals for the particular purpose of control of the foot-and-mouth disease, and in particular in case of vaccination carried out in accordance with rules 50 and 51, may be modified in accordance with rule 77

(2). Movement control in case of an outbreak of footand-mouth disease. 46.

(1)The competent authority shall ensure that, in the event of an outbreak of foot-and-mouth disease in Malta the following measures to control movement of animals of susceptible species are applied in the restricted zone established in accordance with rule 43: (

1. a)owners shall supply the competent authority, on request of that authority, with appropriate information concerning animals entering or leaving their holding. That information shall, in relation to all animals of susceptible species, include at least the details required by Article 14 of European Union Council Directive 64/432/EEC; (
2. b)persons engaged in the transport or marketing of animals of susceptible species shall supply the competent authority, on request of that authority, with appropriate information concerning the movements of such animals which they have transported or marketed. That information shall include at least the details required by Articles 12

(2)and 13

(1)(b) of European Union Council Directive 64/432/EEC.

(2)The competent authority may extend some or all the measures provided for in sub-rule

(1)to a part or the entire free zone. Use, manufacture, sales and controls of the vaccines. 47. The competent authority shall ensure that: (

1. a)the use of foot-and-mouth disease vaccines and the administration of hyperimmune sera against foot-andmouth disease are prohibited on their territory except as provided for in these rules; (
2. b)the production, storage, supply, distribution and sale of foot-and-mouth disease vaccines are carried out under official control; (
3. c)the marketing of foot-and-mouth disease vaccines is under the supervision of the competent authorities in accordance with European Community legislation; FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 (
4. d)the use of foot-and-mouth disease vaccines for purposes other than to induce active immunity in animals of susceptible species, notably laboratory investigations, scientific research or testing of vaccines, is authorised by the competent authorities and carried out under appropriate bio-security conditions. 48.

(1)The competent authority may decide to introduce em ergency vaccination w her e at l east one of t he f ollowing conditions applies: (

1. a)outbreaks of foot-and-mouth disease have been confirmed and threaten to become widespread in Malta where such outbreaks have been confirmed; (
2. b)other Member States are at risk due to the geographical situation of or the prevailing meteorological conditions in relation to reported outbreaks of footand-mouth disease in Malta; (
3. c)other Member States are at risk due to epidemiologically relevant contacts between holdings on their territories and holdings keeping animals of susceptible species in Malta where there are outbreaks of foot-and-mouth disease; (
4. d)the territory of Malta is at risk due to the geographical situation or the prevailing meteorological conditions in a neighbouring third country where there are outbreaks of foot-and-mouth disease.

(2)When deciding on the introduction of emergency vaccination, consideration shall be given to the measures provided for in rule 15 and to the criteria listed in Schedule X.

(3)The decision to introduce emergency vaccination shall be adopted in accordance with European Community legislation.

(4)The decision referred to in sub-rule

(3)to introduce emergency vaccination on its own territory may be requested: (a) either by the competent authority referred to in subrule

(1)(a), or (b) by a Member State referred to in sub-rule

(1)(b), (c) or (d).

(5)By way of derogation from sub-rule

(3), the decision to introduce emergency vaccination may be taken by the competent authority and implemented in accordance with these rules, after a written notification to the European Commission which shall include the specifications provided for in rule 49.

(6)If the competent authority introduces emergency vaccination in accordance with sub-rule

(5), that decision shall be immediately reviewed in the Standing Committee on the Food Chain and Animal Health and European Community measures shall be adopted in accordance with the procedure referred to in rule 78

(2). Decision on introducing emergency vaccination. 31 32 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)

(7)By way of derogation from sub-rule

(4), a decision to introduce emergency vaccination in Malta referred to in sub-rule

(1)(a) may be adopted in concertation with the affected Member State in accordance with European Community legislation on the European Commission’s own initiative, if the condition in sub-rule

(1)(a) and sub-rule

(1)(b) apply. Conditions for emergency vaccination. 49.

(1)The decision to introduce emergency vaccination in accordance with rules 48

(3)and

(4)shall specify the conditions under which such vaccination shall be carried out and these conditions must specify at least: (

1. a)the delimitation in accordance with rule 43 of the geographical area in which emergency vaccination is to be carried out; (
2. b)the species and the age of the animals to be vaccinated; (
3. c)the duration of the vaccination campaign; (
4. d)a specific prohibition on movements of vaccinated and non-vaccinated animals of susceptible species and their products; (
5. e)the special additional and permanent identification and special registration of the vaccinated animals pursuant to rule 45

(2); (f) other matters appropriate to the emergency situation.

(2)The conditions for emergency vaccination as provided for in sub-rule

(1), shall ensure that such vaccination is carried out in accordance with rule 50, irrespective of whether the vaccinated animals are subsequently slaughtered or stay alive.

(3)The competent authority shall ensure that an information programme shall be put in place to inform the public about the safety of meat, milk and dairy products from vaccinated animals for human consumption. Protective vaccination. 50.

(1)Where the competent authority applies protective vaccination it shall ensure that: (

1. a)the vaccination zone shall be regionalised in accordance with rule 43, where necessary in close cooperation with neighbouring Member States; (
2. b)vaccination shall be carried out swiftly and in conformity with the rules of hygiene and bio-security so as to avoid the spread of foot-and-mouth disease virus; (
3. c)all measures applied in the vaccination zone shall be carried out without prejudice to the measures provided for in these rules; (
4. d)where the vaccination zone includes parts of or the entire protection or surveillance zone: (
5. i)the measures applicable for the protection zone or surveillance zone in accordance with these rules shall be maintained within that part of the FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 33 vaccination zone until such measures have been removed in accordance with rule 34 or rule 42; (
6. ii)after the measures applied in the protection zone and surveillance zone have been removed, the measures applicable for the vaccination zone, as provided for in rules 52 to 56, shall continue to apply.

(2)The competent authority applying protective vaccination shall ensure that the vaccination zone is surrounded by a surveillance area (surveillance zone as defined by OIE) of at least 10 kilometres width from the perimeters of the vaccination zone: (

1. a)in which vaccination is prohibited; (
2. b)in which intensified surveillance is carried out; (
3. c)in which the movement of animals of susceptible species is subject to controls by the competent authorities; (
4. d)which remains in place until the foot-and-mouth disease and infection free status is recovered in accordance with rule 59. 51.

(1)The competent authority shall notify the European Commission if it decides in accordance with rule 48 and taking into account all relevant circumstances, to introduce suppressive vaccination and shall provide details of the control measures to be taken which shall include at least those provided for in rule 19. Suppressive vaccination.

(2)The competent authority shall ensure that suppressive vaccination is carried out: (

1. a)only within a protection zone; (
2. b)only on clearly identified holdings subject to the measures provided for in rule 10

(1)and in particular paragraph (a) thereof: Provided that, for logistical reasons and by way of derogation from rule 10

(1)(a), the killing of all animals on such holdings may be delayed as long as necessary to comply with European Community legislation and the provisions of rule 10

(1)(c). 52.

(1)The competent authority shall ensure that the measures provided for in sub-rules

(2)to

(6)are applied in the vaccination zone during the period from the beginning of the emergency vaccination until at least thirty days have elapsed following the completion of such vaccination.

(2)Movement of live animals of susceptible species shall be prohibited between holdings within and out of the vaccination zone: Provided that by way of derogation from such prohibition provided for herein, and after clinical inspection of such live animals and the herds of origin or dispatch of those animals, the competent authority may authorise their direct transport for imm ediate slaugh ter in a slaughterhouse designated by t he Measures applicable in the vaccination zone during the period from the beginning of emergency vaccination until at least thirty days have elapsed following the completion of such vaccination (Phase 1). 34 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) competent authority and situated within the vaccination zone or in exceptional cases close to that zone.

(3)Fresh meat produced from vaccinated animals slaughtered during the period referred to in sub-rule

(1)shall: (

1. a)bear the mark provided for in European Union Council Directive 2002/99/EC and European Community legislation; (
2. b)be stored and transported separately from meat not bearing the mark referred to in paragraph (a), and shall subsequently be transported in sealed containers to an establishment designated by the competent authorities for treatment in accordance with point 1 in Part A of Schedule VII.

(4)Milk and milk products produced from vaccinated animals may be placed on the market within or outside the vaccination zone, provided that, depending on the final use for either human consumption or non-human consumption, it has undergone at least one of the treatments referred to in Parts A and B of Schedule IX. The treatment shall be carried out under the conditions set out in sub-rule

(5)in establishments situated in the vaccination zone or, if there is no establishment in that zone, in establishments situated outside the vaccination zone to which the raw milk is transported under the conditions set down in sub-rule

(7).

(5)Establishments referred to in sub-rule

(4)shall comply with the following conditions: (

1. a)the establishment shall be operated under permanent and strict official control; (
2. b)all milk used in the establishment shall either comply with sub-rule

(4)or the raw milk shall be obtained from animals outside the vaccination zone; (

1. c)during the whole production process the milk shall be clearly identified and transported and stored separately from raw milk and raw milk products which are not destined for dispatch outside the vaccination zone; (
2. d)transport of raw milk from holdings situated outside the vaccination zone to the establishments shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, and which have had no subsequent contact with holdings in a restricted zone keeping animals of susceptible species.

(6)Compliance with the conditions in sub-rule

(5)shall be certified by the competent authority for milk intended for intraEuro pean Com muni ty trade. The competent authority shall supervise the control of compliance undertaken by the Veterinary Services and in the case of intra-European Community trade communicate to other Member States and the European Commission, a list of those establishments which it has approved for the purpose of such certification.

(7)Transport of raw milk from holdings situated within the vaccination zone to establishments situated outside the vaccination FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 zone and the processing of that milk shall be subject to the following conditions: (

1. a)processing in establishments situated outside the vaccination zone of raw milk produced from animals of susceptible species kept within the vaccination zone shall be authorised by the competent authorities; (
2. b)the authorisation shall include instructions on and designation of the transport route to the designated establishment; (
3. c)transport shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, which are constructed and maintained in such a way that there is no leakage of milk during transport and which are equipped to avoid aerosol dispersion during the loading and unloading of the milk; (
4. d)before leaving the holding from where milk of animals of susceptible species was collected, the connection pipes, tires, wheel cases, the lower parts of the vehicle and any spillage of milk are cleansed and disinfected and after the last disinfection and before leaving the vaccination zone the vehicle had no subsequent contact with holdings in the vaccination zone keeping animals of susceptible species; (
5. e)the means of transport are strictly assigned to a defined geographical or administrative area, they are marked accordingly and may only be moved to another area after cleansing and disinfection under official supervision.

(8)The collection and transport of samples of raw milk of animals of susceptible species from holdings situated in the vaccination zone to a laboratory other than a veterinary diagnostic laboratory approved for diagnosis of foot-and-mouth disease and the processing of the milk in such laboratories shall be forbidden.

(9)The collection of semen for artificial insemination from donor animals of susceptible species kept in semen collection centres situated within the vaccination zone shall be suspended. By way of derogation from the prohibition provided for herein, the competent authorities may authorise the collection of semen at semen collection centres within the vaccination zone for the production of frozen semen, subject to the following conditions: (a) it is ensured that the semen collected during the period referred to in sub-rule

(1)is stored separately for at least thirty days, and (b) prior to dispatch of the semen:

(1)either the donor animal has not been vaccinated and the conditions of rule 26

(3)(

1. b)and (
2. c)apply, or

(2)the donor animal has been vaccinated following a negative test for antibodies against foot-and- 35 36 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) mouth disease virus carried out prior to vaccination; and (

1. i)a negative result has been achieved in a test for the detection of either virus or viral genome or an approved test for the detection of antibody against nonstructural proteins, carried out at the end of the quarantine period for the semen on samples taken from all animals of susceptible species present at that time on the semen collection centre, and (
2. ii)the semen complies with the conditions of Article 4

(3)of Chapter II of European Union Council Directive 88/407/EEC.

(10)Collection of ova and embryos from donor animals shall be prohibited.

(11)The placing on the market of products of animal origin other than those referred to in sub-rules

(9)and

(10)shall be subject to the conditions provided for in rules 28, 29, 30 and 39. Measures applicable in the vaccination zone during the period from emergency vaccination until the survey and the classification of holdings are completed (Phase 2). 53.

(1)The competent authority shall ensure that the measures provided for in sub-rules

(2)to

(5)are applied in the vaccination zone during a period starting not earlier than thirty days from the date of completion of emergency vaccination and terminating with the completion of the measures provided for in rules 54 and 55.

(2)Movement of animals of susceptible species between holdings within and out of the vaccination zone shall be prohibited.

(3)By way of derogation from the prohibition provided for in sub-rule

(2), the competent authorities may authorise direct transport for immediate slaughter of animals of susceptible species from holdings referred to in rule 55

(5)to a slaughterhouse situated within or out of the vaccination zone on the following conditions: (

1. a)during transport and in the slaughterhouse those animals shall not come into contact with other animals of susceptible species; (
2. b)the animals shall be accompanied by an official document certifying that all animals of susceptible species on the holding of origin or dispatch have undergone a survey provided for in rule 54

(2); (

1. c)the transport vehicles shall be cleansed and disinfected before loading and after the animals have been delivered, with the date and time of the cleaning and disinfection being recorded in the logbook of the means of transport; (
2. d)the animals shall have passed the ante-mortem health inspection at the slaughterhouse during the twentyfour hours before slaughter and have in particular undergone examination for mouth and feet disease and not shown signs of that disease.

(4)Fresh meat, excluding offal, produced from vaccinated FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 large and small ruminants during the period referred to in sub-rule

(1), may be placed on the market within and outside the vaccination zone under the following conditions: (

1. a)the establishment shall be operated under strict veterinary control; (
2. b)only fresh meat, excluding offal, which was subjected to the treatment described in points 1, 3 and 4 in Part A of Schedule VIII or fresh meat obtained from animals reared and slaughtered outside the vaccination zone shall be processed in the establishment; (
3. c)all such fresh meat shall bear the health mark in accordance with Chapter XI of Annex I to European Union Council Directive 64/433/EEC or, in the case of meat from other biungulates, the health mark provided for in Chapter III of Annex I of European Union Council Directive 91/495/EEC, or, in the case of minced meat and meat preparations, the health mark provided for in Chapter VI of Annex I of European Union Council Directive 94/65/EC; (
4. d)throughout the production process the fresh meat shall be clearly identified, and transported and stored separately from meat of different animal health status in accordance with these rules.

(5)Compliance with the conditions in sub-rule

(4)shall be certified by the competent authority for fresh meat intended for intra-European Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authorities and, in the case of intra-European Community trade, communicate to other Member States and the European Commission a list of those establishments which it has approved for the purpose of such certification.

(6)Fresh meat produced from vaccinated porcine animals slaughtered during the period referred to in sub-rule

(1)shall bear the health mark provided for in European Union Council Directive 2002/99/EC and shall be stored and transported separately from meat not bearing that mark and subsequently be transported in sealed containers to an establishment designated by the competent authorities for treatment in accordance with point 1 in Part A of Schedule VII.

(7)Milk and milk products produced from vaccinated animals may be placed on the market within or outside the vaccination zone, provided that depending on the final use for either human consumption or non-human consumption it has undergone at least one of the treatments referred to in Parts A and B of Schedule IX. Such treatment shall have been undergone in an establishment located within or outside the vaccination zone in accordance with the provisions in rule 52

(4)to

(8).

(8)For the collection of semen, ova and embryos from animals of susceptible species, the measures provided for in rule 52

(9)and

(10)shall continue to apply. 37 38 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES)

(9)The placing on the market of products of animal origin other than those referred to in sub-rules

(4),

(6),

(7)and

(8)shall be subject to the conditions provided for in rules 28, 29, 30 and 39. Clinical and serological survey in the vaccination zone (Phase 2-A). 54.

(1)The competent authority shall ensure that the measures provided for in sub-rules

(2)and

(3)are applied in the vaccination zone during a period starting not earlier than thirty days from the date of completion of emergency vaccination and terminating with the completion of a clinical and serological survey.

(2)A survey shall be carried out with the aim to identify herds of animals of susceptible species that had contact with the footand-mouth disease virus without showing overt clinical signs of the foot-and-mouth disease. That survey shall include a clinical inspection of all animals of susceptible species in all herds in the vaccination zone, and laboratory testing in accordance with subrule

(3).

(3)Laboratory testing shall be carried out by use of tests complying with the criteria for diagnostic tests as set out in Schedule XIII and approved in accordance with the procedure referred to in rule 77

(1), and shall comply with one of the following conditions: (

1. a)testing for infection with the foot-and-mouth disease virus, either by an assay for antibodies against nonstructural proteins of the foot-and-mouth disease virus, or by another approved method, shall meet criteria for sampling on holdings set out in point 2.2 of Schedule III. Where the competent authority use in addition sentinel animals, the conditions for restocking of infected holdings in Schedule V shall be taken into account; (
2. b)testing for antibodies against non-structural proteins of the foot-and-mouth disease virus shall be carried out on samples taken from all vaccinated animals of susceptible species and their non-vaccinated offspring in all herds in the vaccination zone. Classification of herds in the vaccination zone (Phase 2-B). 55.

(1)The competent authority shall ensure that the holdings containing animals of susceptible species (a) are classified according to the outcome of the survey referred to in rule 54

(2)and the criteria set out in Schedule I; (b) comply with the measures set out in sub-rules

(2)to

(4).

(2)Holdings containing at least one animal suspected of being infected and where the presence of foot-and-mouth disease virus is confirmed in accordance with the criteria laid down in Schedule I shall be subject to the measures provided for in rules 10 and 19.

(3)Holdings containing at least one animal of susceptible species suspected of being infected through previous contact with t he fo ot-an d-m out h di sease vi rus b ut wh ere furt her t est ing including all animals of susceptible species present on the holding, FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 39 confirmed the absence of circulating foot-and-mouth disease virus, shall be subject to at least the following measures: (a) animals of susceptible species on the holding shall:

(1)either be killed and the carcasses processed, or

(2)the animals shall be classified and (i) the animals positive to at least one of the approved tests referred to in rule 54

(3)shall be killed and their carcasses processed, and (

1. ii)the remaining animals of susceptible species on the holding shall be slaughtered under conditions authorised by the competent authority; (
2. b)cleansing and disinfection accordance with rule 11; of the holdings in (
3. c)restocking of animals in accordance with Schedule V.

(4)The competent authority shall ensure that the following measures are applied to products derived from animals of susceptible species and produced during the period referred to in rule 54

(1): (a) fresh meat produced from the animals referred to in sub-rule

(3)(a)

(2)(ii) shall be subject to rule 53

(4), for meat from ruminants, and in rule 53

(6), for meat from porcine animals, respectively; (b) milk and milk products produced from the animals referred to in sub-rule

(3)(a)

(2)(ii) shall undergo at least one of the treatments specified in Parts A and B of Schedule IX depending on the intended use and in compliance with the provisions in rule 52

(4)to

(8).

(5)Animals of susceptible species on holdings where the presence of previous or present infection with the foot-and-mouth disease virus has been officially ruled out in accordance with rule 54

(3)may be subject to the measures provided for in rule 56. 56.

(1)The competent authority shall ensure that the measures provided for in sub-rules

(2)to

(6)are applied in the vaccination zone after the completion of the measures laid down in rule 55 and until the foot-and-mouth disease and infection-free status has been recovered in accordance with rule 57.

(2)The competent authority shall ensure that movement of animals of susceptible species between holdings situated in the vaccination zone is subject to authorisation.

(3)Movement of animals of susceptible species out of the vaccination zone shall be prohibited. By way of derogation from this prohibition, direct transport to a slaughterhouse for immediate slaughter of animals of susceptible species may be authorised under the conditions provided for in rule 53

(3).

(4)By way of derogation from the prohibition in sub-rule

(2), the competent authorities may authorise the transport of unvaccinated animals of susceptible species in accordance with the Measures applicable in the vaccination zone after the completion of the survey and the classification of holdings until the foot-and-mouth disease and infection free status is recovered (Phase 3). 40 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) following provisions: (

1. a)within twenty-four hours of loading, all animals of susceptible species on the holding have been subjected to clinical examination and have not shown clinical signs of foot-and-mouth disease, and (
2. b)the animals have completed a standstill on the holding of origin of at least thirty days during which no animal of susceptible species has been introduced onto the holding, and (
3. c)the holding of origin is not situated in a protection or surveillance zone, and (
4. d)the animals intended for transport were either individually subjected with negative results to tests for the detection of antibodies against the foot-and-mouth disease virus at the end of the isolation period, or a serological survey was completed on that holding in accordance with point 2.2 of Schedule III irrespective of the species concerned; (
5. e)the animals were not exposed to any source of infection during their transportation from the holding of origin to the place of destination.

(5)Non-vaccinated offspring of vaccinated dams shall be p rohi bited from leaving the h oldi ng o f origi n un less b eing transported to: (

1. a)a holding within the vaccination zone of the same health status as the holding of origin; (
2. b)a slaughterhouse for immediate slaughter; (
3. c)a holding designated by the competent authority, from which the offspring are to be sent directly to the slaughterhouse; (
4. d)any holding, after having obtained a negative result in a serological test for the detection of antibody against the foot-and-mouth disease virus carried out on a sample of blood taken prior to dispatch from the holding of origin.

(6)Fresh meat produced from unvaccinated animals of susceptible species may be placed on the market inside and outside the vaccination zone under the following conditions: (a) either the measures provided for in rule 55

(3)have been completed in the entire vaccination zone or the animals are transported to the slaughterhouse under the conditions provided for in sub-rule

(3)or

(4)(d), and; (

1. b)the establishment shall be operated under strict veterinary control; (
2. c)only fresh meat produced from animals referred to in paragraph (
3. a)or from animals reared and or slaughtered outside the vaccination zone or fresh meat referred to in sub-rule

(8)shall be processed in the FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 establishment; (

1. d)all such fresh meat shall bear the health mark in accordance with Chapter XI of Annex I to European Union Council Directive 64/433/EEC or in the case of meat from other biungulates, the health mark provided for in Chapter III of Annex I of European Union Council Directive 91/495/EEC, or in the case of minced meat and meat preparations the health mark provided for in Chapter VI of Annex I of European Union Council Directive 94/65/EC; (
2. e)throughout the production process the fresh meat shall be clearly identified, and transported and stored separately from meat of different animal health status in accordance with these rules.

(7)Fresh meat produced from vaccinated animals of susceptible species or from non-vaccinated seropositive offspring of vaccinated dams slaughtered during the period referred to in subrule

(1)shall bear the health mark provided for in European Council Directive 2002/99/EC and shall be stored and transported separately from meat not bearing that stamp and subsequently be transported in sealed containers to an establishment designated by the competent authorities for treatment in accordance with point 1 in Part A of Schedule VII.

(8)By way of derogation from sub-rule

(7), fresh meat and trimmed offal produced from vaccinated large and small ruminants or their non-vaccinated seropositive offspring may be placed on the market within and outside the vaccination zone under the following conditions: (

1. a)the establishment shall be operated under strict veterinary control; (
2. b)only fresh meat excluding offal, which was subjected to the treatment described in point 1, 3 and 4 in Part A of Schedule VIII or fresh meat referred to in sub-rule

(6)or produced from animals reared and, or slaughtered outside the vaccination zone, are processed in the establishment; (

1. c)all such fresh meat shall bear the health mark in accordance with Chapter XI of Annex I to European Directive 64/433/EEC or in the case of meat from other biungulates the health mark provided for in Chapter III of Annex I to European Directive 91/495/ EEC, or in the case of minced meat and meat preparations the health mark provided for in Chapter VI of Annex I to European Directive 94/65/EC; (
2. d)throughout the production process the fresh meat shall be clearly identified, and transported and stored separately from meat which is of different animal health status in accordance with these rules.

(9)By way of derogation from sub-rule

(7), fresh meat from vaccinated porcine animals and their non-vaccinated seropositive offspring, produced during the period from the beginning of the 41 42 [ S.L.437.50 FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) survey until the measures provided for in rule 55 have been completed in the entire vaccination zone and until at least three months have elapsed after the last outbreak recorded in that zone, may only be placed on the national market of Malta within and outside the vaccination zone under the following conditions: (a) the establishment shall be operated under strict veterinary control; (b) only fresh meat from animals originating in holdings complying with the conditions in rule 55

(5)or fresh meat obtained from animals reared and slaughtered outside the vaccination zone are processed in the establishment; (c) all such fresh meat shall bear a health mark to be decided in accordance with Article 4

(3)of European Directive 2002/99/EC; (d) throughout the production process the fresh meat shall be clearly identified, and transported and stored separately from meat of different animal health status in accordance with these rules.

(10)A Member State other than the territory of Malta may request a decision in accordance with European Community legislation to extend the marketing of the meat referred to in subrule

(9)to its territory or part of its territory under conditions to be laid down under the same procedure.

(11)The rules for dispatch from the vaccination zone of fresh meat from vaccinated porcine animals produced after the period referred to in sub-rule

(9)until free status has been regained in accordance with rule 59, shall be decided in accordance with the procedure provided for in rule 78

(2).

(12)Compliance with the conditions provided for in sub-rule

(6), sub-rule

(8)and where applicable under the provisions of subrule

(10), shall be certified by the competent authority. The competent authority shall supervise the control of compliance undertaken by the Veterinary Services and shall in the case of intraEuropean Community trade communicate to other Member States and the European Commission a list of those establishments which they have approved for such certification.

(13)By way of derogation from sub-rule

(8)a special health mark which cannot be confused with the health mark referred to in sub-rules

(8)(c) and

(9)(c), may be decided in accordance with the procedure referred to in rule 78

(2)for fresh meat of ruminants not subjected to the treatment in accordance with Part A of Schedule VIII, and minced meat and meat preparations produced from such meat, which are intended for placing on the market in a specific region of Malta.

(14)Milk and milk products produced from vaccinated animals may be placed on the market within and outside the vaccination zone, provided that depending on the final use for either human consumption or non-human consumption, it has undergone at least one of the treatments referred to in Parts A and B of Schedule IX. FOOT-AND-MOUTH DISEASE (CONTROL MEASURES) [ S.L.437.50 43 Such treatment shall have been undergone in an establishment located in the vaccination zone or in accordance with the provisions in rules 52

(4)to

(7).

(15)The collection and transport of samples of raw milk of animals of susceptible species, from holdings situated in the surveillance zone to a laboratory other than a veterinary diagnostic laboratory approved for diagnosis of foot-and-mouth disease, and the processing of the milk in such laboratories, shall be subject to official authorisation and to appropriate measures to avoid any possible spread of foot-and-mouth disease virus.

(16)The placing on the market of products of animal origin other than those referred to in sub-rules

(6)to

(11)and

(13)to

(15)shall be subject to the conditions provided for in rules 28, 29, 30 and

2. The foot-and-mouth disease and infection free status of Malta or a region thereof shall be recovered in accordance with the procedure referred to in rule 78

(2), taking into account the conditions referred to in rules 58 and 59. Recovery of the foot-and-mouth disease and infection free status. 58.

(1)When Malta has been regionalised in accordance with rule 43, it shall recover its previous foot-and-mouth disease and infection free status following the control and eradication of one or more outbreaks of foot-and-mouth disease without vaccination under the following conditions: Recovery of status following eradication of footand-mouth disease without emergency vaccination. (

1. a)all the measures provided for in rules 34 and 42 have been completed, and (
2. b)at least one of the following conditions applies: (
3. i)the relevant recommendations in the foot-andmouth disease Chapter, as last amended, of the Animal Health Code of the OIE are met; (
4. ii)at least three months have elapsed after the last recorded outbreak of foot-and-mouth disease and clinical and laboratory surveillance carried out in accordance with Schedule III has confirmed the absence of infection with the footand-mouth disease virus in Malta or region concerned.

(2)Decisions on recovering a foot-and-mouth disease and infection-free status shall be adopted in accordance with the procedure referred to rule 78

(2). 59.

(1)Malta, or any region thereof regionalised in accordance with rule 43, shall recover its previous foot-and-mouth disease and infection free status f ollo win g th e cont ro l and eradication of one or more outbreaks of foot-and-mouth disease with vaccination under the following conditions: (a) all the measures provided for in rules 34, 42, 52, 53, 54 and 55 have been completed, and (b) at least one of the following conditions ap