Foot-and-Mouth Disease (Control Measures) Rules, 2005 (L.N. 305 of 2005)

B 4393 L.N. 305 of 2005 VETERINARY SERVICES ACT (CAP. 437) Foot-and-M outh Disease (Control M easures) Rules, 2005 IN exercise of the pow ers conferred by article 5(1) of the V eterinary Services A ct, the M inister for R ural A ffairs and the Environm ent has m ade the follow ing rules> 1. (1) The title of these rules is the Foot-and-M outh D isease (C ontrol M easures) R ules, 2005. (2) The scope of these rules is to define the C om m unity control m easures to be applied in the event of outbreaks of foot and m outh disease, w hatever the type of virus concerned, in accordance w ith C ouncil D irective 85#511#EEC of the 18th N ovem ber, 1985. 2. For the purposes of these rules, the follow ing definitions shall apply. “anim al of a susceptible species” m eans any dom estic or w ild rum inant or sw ine present on a holding< “receptive anim al” m eans any anim al of a susceptible species w hich is not vaccinated, or w hich is vaccinated but w hose im m unisation cover is considered to be inadequate by the com petent authority< “infected anim al” m eans any anim al of a susceptible species> (a) in w hich clinical sym ptom s or post-m ortem lesions w hich m ay arise from foot-and-m outh disease have been ascertained, or (b) in w hich the presence of foot-and-m outh disease has been officially ascertained follow ing a laboratory exam ination< “anim al suspected of being infected” m eans any anim al of a susceptible species show ing clinical sym ptom s or post-m ortem lesions w hich are such that the presence of foot-and-m outh disease m ay reasonably be suspected< Title and scope. Interpretation. B 4394 “animal suspected of being contaminated” means any animal of a susceptible species which may according to the epizootiological information collected have been directly or indirectly exposed to the foot-and-mouth virus< “holding” means an agricultural establishment or officially supervised dealer’s premises, in which animals for breeding, production or slaughter are regularly kept or bred< “animal for slaughter” means a bovine animal or swine intended to be taken on arrival in the country of destination direct to a slaughterhouse, or to a market adjoining a slaughterhouse under whose rules all animals may be removed, in particular after the market, only to a slaughterhouse approved for this purpose by the competent central authority. In the latter case, the animals must be slaughtered at that slaughterhouse not later than seventy-two hours after arriving at the market< “animals for breeding or production” means bovine animals and swine other than those referred to in the definition ‘animal for slaughter’, including those intended for breeding, milk or meat production< “tuberculosis-free bovine animal” means a bovine animal which satisfies the conditions laid down in Annex A (I) (1) of Directive 64#432#EEC< “officially tuberculosis-free bovine herd” means a bovine herd which satisfies the conditions laid down in Annex A (I) (2) of Directive 64#432#EEC< “brucellosis-free bovine animal” means a bovine animal which satisfies the conditions laid down in Annex A (II) (1) of Directive 64#432#EEC< “officially brucellosis-free bovine herd” means a bovine herd which satisfies the conditions laid down in Annex A (II) (A) (2) of Directive 64#432#EEC< “brucellosis-free bovine herd” means a bovine herd which satisfies the conditions laid down in Annex A (II) (A) (3) of Directive 64#432#EEC< “brucellosis-free swine” means swine which satisfy the conditions laid down in Annex A (II) (B) (1) of Directive 64#432#EEC< B 4395 “officially brucellosis-free swine herd” means a swine herd which satisfies the conditions laid down in Annex A (II) (B) (2) of Directive 64#432#EEC< “epizootic free area” means an area 20 km in diameter in which, according to official findings, for at least thirty days prior to loading there has been> (i) no incidence of foot-and-mouth disease, in the case of bovine animals< (ii) no incidence of foot-and-mouth disease, swine fever or contagious swine paralysis (Teschen disease) in the case of swine< “compulsorily notifiable diseases” means the diseases listed in Annex E of Directive 64#432#EEC< “official veterinarian” means the veterinarian designated by the competent authority< “exporting country” means the Member State from which bovine animals and swine are sent to another Member State< “country of destination” means the Member State to which bovine animals and swine are sent from another Member State. 3. The Veterinary Services shall take all the necessary provisions to ensure that the presence, or suspected presence, of foot-and-mouth disease is compulsorily and immediately notifiable to the competent authority, in accordance with Directive 82#894#EEC. 4. (1) The Veterinary Services shall take all the necessary provisions to ensure that, where a holding contains one or more animals suspected of being infected or of being contaminated with foot-and mouth disease, official means of investigation to confirm or rule out the presence of the disease are set in motion immediately and, in particular, that the official veterinarian takes the necessary samples, or has them taken, for laboratory examination. As soon as the suspected infection is notified, the competent authority shall have the holding placed under official surveillance and shall in particular order that> (a) a census be made of all categories of animals of susceptible species and that, in respect of each of these categories, the number of animals already dead, infected or liable to be infected or contaminated be recorded< the census must be kept up to date to take account of animals born or dying during the period of Notification to the competent authority. Suspected infected holdings. B 4396 suspicion< the information in the census must be produced on request and may be checked at each visit< (b) all animals of susceptible species on the holding be kept in their living quarters or some other place where they can be isolated< (c) no animals of susceptible species enter or leave the holding< (d) no animals of other species enter or leave the holding without the authorisation of the competent authority< (e) all movement from the holding of meat or carcasses of animals of susceptible species or of animal feed, utensils, objects or other substance, such as wool or waste or rejected matter, liable to transmit foot-and-mouth disease be prohibited, unless authorised by the competent authority< (f) the movement of milk from the holding be prohibited< in the event of difficulties in storing the milk on the holding, the competent authority may authorise the milk to be moved from the holding under veterinary supervision to a treatment establishment in order that it may be given heat treatment ensuring the destruction of the foot-and-mouth virus< (g) the movement of persons to or from the holding be made subject to authorisation by the competent authority< (h) the entry or exit of vehicles to or from the holding be made subject to authorisation by the competent authority which shall lay down the conditions necessary in order to avoid propagation of the foot-and-mouth virus< (i) appropriate means of disinfection be used at the entrances and exits of buildings housing animals of susceptible species and of the holding itself< (j) an epizootiological inquiry be carried out in accordance with rules 7 and 8 hereof. (2) The competent authority may extend the measures provided for in sub-rule (1) hereof to adjoining holdings should their location, their configuration, or contacts with animals from the holding where the disease is suspected, give reason to suspect possible contamination. B 4397 (3) The measures referred to in sub-rules (1) and (2) shall not be withdrawn until the suspicion of foot-and-mouth disease has been officially ruled out. 5. As soon as it has been confirmed that one or more of the animals defined in rule 2 (c) are on a holding, the competent authority shall introduce the following measures> (1) the official veterinarian shall take adequate samples or has them taken for examination by the laboratory referred to in Schedule A to these rules, where these samples and examinations have not been taken or carried out during the period of suspicion in accordance with sub-rule 4 (1) hereof< (2) in addition to the measures listed in sub-rule 4 (1) , the following measures are taken without delay> (a) all animals of susceptible species on the holding shall be slaughtered on the spot under official supervision in such a way as to avoid all risk of spreading the foot-and-mouth virus< (b) after being slaughtered, the aforementioned animals shall be destroyed under official supervision in such a way that there is no risk of spreading the foot-and-mouth virus< (c ) meat of animals of susceptible species coming from the holding and slaughtered during the period between the probable introduction of the disease to the holding and the implementation of official measures shall, wherever possible, be traced and destroyed under official supervision in such a way as to avoid any risk of spreading the foot-and-mouth virus< (d) the carcasses of animals of susceptible species which have died on the holding shall be destroyed under official supervision in such a way as to avoid any risk of spreading the foot-and-mouth virus< (e) any substance referred to in sub-rule 4 (1)(e) shall be destroyed or treated in such a way as to ensure the destruction of any foot-and-mouth virus present< all treatment must be carried out in accordance with the instructions of the official veterinarian< (f) milk and milk products shall be destroyed in such a way as to avoid any risk of spreading the foot-and-mouth virus< Measures to be introduced on infected holdings. B 4398 (g) after elimination of the animals of susceptible species and of the substances referred to in sub-rule 4 (1)(e) the buildings used for housing, their surroundings and the vehicles used for their transport and all equipment likely to be contaminated shall be cleaned and disinfected in accordance with rule 10< (h) no animals of susceptible species shall be reintroduced to the holding until at least 21 days after completion of the cleaning and disinfection operations carried out in accordance with rule 10 hereof< (i) an epizootiological inquiry shall be carried out in accordance with rules 7 and 8 hereof< (3) the provisions of paragraph (1) hereof shall not apply in the case of appearance of a secondary source which is linked epidemiologically with a primary source for which samples have already been taken< (4) the competent authority may extend the measures provided for in paragraph (1) to adjoining holdings should their location, their configuration, or contacts with animals from the holding where the disease has been recorded give reason to suspect possible contamination. 6. (1) (a) In the case of holdings which consist of two or more separate production units, the competent authority may derogate from the requirements of sub-rule 5 (2) (a) and (b) as regards healthy production units of a holding which is infected, provided that the official veterinarian has confirmed that the structure and size of these units and the operations carried out there are such that they are completely separate as regards housing, keeping and feeding, so that the virus cannot spread from one to another. (b) The same measures and the possibility of derogating from the requirements of sub-rule 5 (2)(f) may be extended to holdings producing milk, provided that, in addition, milking in each unit is carried out quite separately. (2) (a) W here recourse is had to the provisions of sub rule (1), the competent authority shall ensure that the rules they apply include, at least, the following> (i) the derogation available in sub-rule 6 (1) shall only be granted following an individual assessment of the holding in question carried out by an official veterinarian at the time of the H oldings consisting of two or more units. B 4399 official investigation to confirm or rule out the presence of foot and-mouth disease, (ii) this assessment shall take into account all conditions and situations pertaining to the possible spread of foot-and-mouth disease. (b) (i) In granting the derogation referred to in paragraph (a), the competent authority shall take all the necessary provisions to ensure that there is no more risk of foot-and-mouth disease virus spreading between separate production units on a holding than of it spreading between separate holdings. (ii) Intensively managed production units containing healthy animals shall conform to the following requirements> (a) they shall be constructionally separate from those which contained infected animals with no communication or common air space between them, (b) they shall have separate stores for equipment, fodder, effluent and, where appropriate, milk, (c) they shall have individual disinfection facilities at entrances and exits, (d) they shall have their own personnel, (e) further, there shall have been no exchange of farm machinery or other equipment between infected and healthy units nor shall there have been an exchange of animals, animal products, animal feed, utensils, objects or other substances such as wool or waste or rejected matter liable to transmit foot-and-mouth disease from infected to healthy units. (c) The conditions laid down in paragraph (b) hereof shall have been in place, to the satisfaction of the official veterinarian, prior to the date on which one or more infected animals as defined in sub-rule (2) (c) were present on the holding, taking into account the likely incubation period of the disease. 7. The epizootiological inquiry shall deal with> (a) the length of time during which the foot-and-mouth disease may have existed on the holding before being notified or suspected< the possible origin of the foot-and-mouth disease on Epizootiological inquiry. B 4400 the holding and the identification of other holdings on which there are animals of susceptible species which may have become infected or contaminated from the same source< (b) the movement of persons, vehicles and substances referred to in sub-rule 4 (1)(e) likely to have carried the foot-and mouth virus to or from the holdings in question. 8. (1) (a) Where the official veterinarian finds, or considers on the basis of confirmed data, that foot-and-mouth disease could have been introduced from other holdings on to the holding referred to in rule 4, or from the latter holding on to other holdings as a result of the movement of persons, animals or vehicles or in any other way, those other holdings shall be placed under official surveillance in accordance with rule 4 and this surveillance shall not be lifted until the suspected presence of foot-and-mouth disease on the holding referred to in rule 4 has been officially ruled out. (b) Where the official veterinarian finds, or considers on the basis of confirmed data, that foot-and-mouth disease could have been introduced on to the holding referred to in rule 5 from other holdings as a result of the movement of persons, animals or vehicles or in any other way, those other holdings shall be placed under official surveillance in accordance with rule 4. (c) Where the official veterinarian finds, or considers on the basis of confirmed data, that foot-and-mouth disease could have been introduced from the holding referred to in rule 5 on to other holdings as a result of the movement of persons, animals or vehicles or in any other way, those other holdings shall become subject to the provisions of rule 4. (2) When a holding has been subject to the provisions of sub-rule (1), the competent authority shall prohibit removal of animals from the holding other than for transport directly to a slaughterhouse under official supervision for the purpose of emergency slaughter during a 15-day period in the case of holdings referred to in sub-rule (1) (a) and (b) and a 21-day period in the case of holdings referred to in sub rule (1) (c) respectively. Prior to granting such authorisation, the official veterinarian must have carried out an examination of the herd and confirmed that none of the animals is suspected of being infected. (3) Where it considers that conditions permit, the competent authority may limit the measures provided for in sub-rule (1) (a) and (b) to a part of the holding and the animals contained therein, provided Cross-holding infections. B 4401 that the animals there have been housed, kept and fed completely separately. 9. (1) (a) The Veterinary Services shall take all the necessary provisions to ensure that, once the diagnosis of foot-and-mouth disease has been officially confirmed, a protection zone based on a minimum radius of 3 kilometres and a surveillance zone based on a minimum radius of 10 kilometres is established around the infected holding. (b) The definition of zones shall take account of natural boundaries, supervision facilities and technological progress which makes it possible to foresee the possible dispersion of the virus by air or any other means and will have to be reviewed, if necessary, in the light of such elements. (2) (a) The following measures shall be applied in the protection zones> (i) a census of all the holdings with animals of susceptible species must be carried out, (ii) holdings which are the subject of such a census must periodically undergo a veterinary inspection, (iii) animals of susceptible species may not be removed during the first 15 days from the holding on which they are kept except to be transported directly under official supervision for the purpose of emergency slaughter to a slaughterhouse located in that zone or, if that zone has no slaughterhouse under veterinary supervision, to a slaughterhouse designated by the competent authority. Such movement may be authorised by the competent authority only after examination by the official veterinarian of all the animals of susceptible species on the holding has ruled out the presence of suspected animals< (iv) itinerant service for breeding shall be prohibited< (v) artificial insemination shall be prohibited during the first 15 days except where it is carried out by the farmer with sperm that is on the farm or with sperm delivered directly by an insemination centre< (vi) fairs, markets, shows or other gatherings of susceptible animals, including collection and distribution, shall be prohibited< Protection zone. B 4402 (vii) without prejudice to the case provided for in the second sentence of sub-paragraph (iii), the transport of animals of susceptible species shall be prohibited, except for transit by major highways or mainline railways. (b) The measures applied in the protection zone shall be maintained for at least 15 days after elimination of all the animals referred to in rule 5 from the holding and the carrying out on that holding of preliminary cleaning and disinfection operations in accordance with rule 10. However, the measures described in sub-rule (3) hereof for the surveillance zone shall remain in force in the protection zone for the period provided for in sub-rule (3) (b) hereof. (3) (a) The following measures shall be applied in the surveillance zone> (i) a census shall be taken of all holdings having animals of susceptible species< (ii) the movement of animals of susceptible species on public roads shall be prohibited except for the purpose of leading them to pasture< (iii) the transport of animals of susceptible species within the surveillance zone shall be subject to the authorisation of the competent authority< (iv) the animals may not be removed from the surveillance zone during the first 15 days. Between the 15th day and the 30th day, the animals may not be removed from the said zone except to be transported under official supervision directly to a slaughterhouse for the purpose of emergency slaughter. Such transport may be authorised by the competent authority only after the official veterinarian has carried out an examination of all the animals concerned and confirmed that none of the animals is suspected of being infected< (v) itinerant service for breeding shall be prohibited< (vi) fairs, markets, shows and other gatherings of susceptible animals shall be prohibited. (b) The measures in the surveillance zone shall be kept in force for at least 30 days after the elimination of all the animals referred to in rule 5 from the holding and the carrying out on that holding B 4403 of preliminary cleaning and disinfection operations in accordance with rule 10. 10. (1) The disinfectants to be used and their concentrations are officially approved by the competent authority. (2) The cleaning and disinfection operations are carried out under official supervision, in accordance with the instructions given by the official veterinarian. 11. (1) Laboratory testing to detect the presence of foot-and mouth disease are carried out by the national laboratory indicated in Schedule B to these rules. This laboratory testing should, if necessary and especially on the first appearance of the disease, show the type, subtype or, where appropriate, the variant of the relevant virus which may be confirmed, if necessary, by a reference laboratory designated by the community. (2) The national laboratories referred to in sub-rule (1) liase with a reference laboratory designated by the European Community. 12. The Veterinary Services shall take the necessary provisions to ensure that> (a) when animals of susceptible species are moved out of the holding on which they are kept, they are identified in such a way as to enable their holding of origin, or the holding from which they have come, and their movements to be traced rapidly. However, for certain categories of animals and without prejudice to measures concerning tracing of pigs for the control of classical swine fever, the competent authority may, in certain circumstances and having regard to the health situation, authorise other ways of rapidly tracing their holding of origin, or the holding from which they have come, and their movements. The arrangements for identifying the animals or for tracing the holding of origin shall be determined by the competent authority< (b) the owner or keeper of the animals is required to supply the competent authority, on request by that authority, with information concerning animals entering or leaving his holding< (c) all persons engaged in the transport or marketing of animals of susceptible species are able to supply the competent authority with information concerning the movements of animals which they have transported or marketed and to furnish all the details concerning such information. Cleaning and disinfection operations. Testing in laboratory. Provisions to be taken by Veterinary Services. B 4404 13. (1) (a) The use of foot-and-mouth vaccines, the manipulation of foot-and-mouth virus for research, diagnosis and, or manufacture of vaccines is prohibited. (b) The storage, supply, distribution and sale of foot and-mouth vaccines shall be carried out under official control. (2) Notwithstanding the provisions of sub-rule (1) concerning the use of foot-and-mouth disease vaccine, it may be decided, when foot-and-mouth disease has been confirmed and threatens to become extensive, that emergency vaccination using technical procedures guaranteeing the animals total immunity may be introduced provided that basic community interests are not endangered. In this case, the measures to be taken shall include> (a) the extent of the geographical area in which emergency vaccination is to be carried out, (b) the species and the age of the animals to be vaccinated, (c) the duration of the vaccination campaign, (d) a specific standstill of vaccinated animals and their products, (e) the special identification and special registration of the vaccinated animals, and (f) other matters appropriate to the emergency situation. The decision to introduce emergency vaccination shall be taken in collaboration with the Member States. This decision shall have particular regard to the degree of concentration of animals in certain regions and the need to protect special breeds. Foot-and-mouth vaccines. B 4405 SCHEDULE A (Rule 5) Commercial laboratory authorised to handle live foot-and-mouth disease virus for vaccine production intended for Malta Rhônemerieux, Pirbright laboratory, Ash Road, Pirbright, Woking, Surrey. B 4406 SCHEDULE B (Rule 11) National laboratory authorised to handle for Malta live foot-and-mouth disease virus Institute for Animal Health, Pirbright, Woking, Surrey. Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta Mitbug[ fl-Istamperija tal-G vern — Printed at the Government Printing Press Prezz 56ç – Price 56c