Final
Draft Proposal for a
COUNCIL DIRECTIVE
of
on Community measures for the control of foot‑and‑mouth disease and amending Directive 92/46/EEC
EXPLANATORY MEMORANDUM
1. Introduction
1.1. Foot-and-mouth disease is a highly contagious viral disease of predominantly cloven-hoofed animals, which was for the first time described in Italy in the 16th century. Due to its exceptional economic importance, foot-and-mouth disease is listed at the top of the list A diseases of the Office International des Epizooties (OIE).
1.2. Foot-and-mouth disease is not dangerous for humans but may in exceptionally rare cases affect them, causing light and transitional clinical symptoms.
2. Global Foot-and-Mouth disease situation
2.1. Foot-and-mouth disease continues to be endemic in third countries neighbouring the Member States or candidate countries. Acute outbreaks of foot-and-mouth disease were reported in certain Balkan countries in 1996, Transcaucasia since 1997 and certain Maghreb states in 1999. The Community supplied vaccine and vaccination equipment to these countries to quickly eradicate the disease. New topotypes and exotic strains of foot-and-mouth disease virus continue to emerge in Turkey due to virus introduction from areas further east.
2.2. A substantial part of these activities has been carried out in close co-operation with international institutions, first of all the European Commission for the Control of Foot and Mouth Disease (EUFMD), a statutory body of the Food and Agriculture Organization (FAO) of the United Nations (UN). By adopting Decision 2001/300/EC the Commission formalised its long-standing co-operation with the EUFMD and signed an Implementing Agreement on the use of the Trust Fund for permanent activities of that organisation, maintained by EUFMD and replenished by the Commission for many years.
2.3. In 2000 and 2001 outbreaks have also been reported in countries previously free of foot-and-mouth disease infection. Where the disease affected third countries exporting fresh meat to the Community, such imports were suspended until the health situation improved and appropriate Community measures were adopted to allow such imports to continue under reinforced conditions which prevented the introduction of virus onto Community territory through such imports.
2.4. The global foot-and-mouth disease situation calls for a permanent disease awareness and prophylactic and preventive measures are necessary to avoid the incursion of foot-and-mouth disease virus onto community territory and into Community livestock herds from adjacent countries or through imports of live animals or products of animal origin.
3. History of Control measures in Member States
3.1. The Community measures for the control of foot-and-mouth disease are laid down in Directive 85/511/EEC[1], as last amended by the Act of Accession of Austria, Finland and Sweden[2]. The prohibition of prophylactic vaccination introduced by Council Directive 90/423/EEC[3] effectively facilitated the improvement of the health status of the Community livestock and thereby contributed to free trade in susceptible live animals and products derived from such animals.
3.2. Since the establishment of the single market and due to an overall satisfactory health status in livestock herds in the Member States, the movement and exchange of animals and animal products has increased substantially and certain regions of the EU developed into densely populated livestock areas. Under these conditions an outbreak of foot-and-mouth disease can quickly take on epizootic proportions, causing disturbances on a scale liable to reduce sharply the profitability of farming of susceptible domestic animals as a whole, and in particular pigs and ruminants, and possibly requiring substantial financial resources for compensation of affected farmers and application of control measures.
3.3. Since 1 January 1992, the date prophylactic vaccination was prohibited throughout the Community, outbreaks of foot-and-mouth disease have been reported in Italy in 1993 and Greece in 1994, 1996 and 2000 due to incursion from third countries, which were successfully controlled by applying the measures provided for in Directive 85/511/EEC, including stamping out of infected or contaminated herds and strict enforcement of movement controls.
3.4. In 2001 a major foot-and-mouth disease epidemic occurred in the United Kingdom. More than 2000 holdings in the United Kingdom were affected. Related to the movement of sheep prior to the detection of the first outbreak in the United Kingdom, a limited number of holdings in France, Ireland and the Netherlands were also infected. A large number of animals had to be slaughtered and destroyed in all affected Member States and the economic losses affected not only the farming, but also the whole rural community in the affected parts of the Community. For the first time since 1991 a Member State, the Netherlands, had recourse to emergency vaccination carried out in accordance with Directive 85/511/EEC. However, for reasons of international trade restrictions the vaccinated animals were subsequently killed in order to re-establish the health status of the country without delay.
3.5. During the past decade the Community experienced outbreaks and in some cases epidemics of classical swine fever, a contagious viral disease in domestic and feral pigs. This disease and in particular the epidemic in 1997/1998 led to heavy economic losses for the Community, the Member States concerned and the farming community due to the killing and destruction of large numbers of animals, as well as in some cases long lasting restrictions on trade in porcine animals and products. However, the overall economic, social and animal welfare implications were far exceeded by the 2001 foot-and-mouth disease epidemic, notably because foot-and-mouth disease affects more than one species, in particular bovine animals, and is far more contagious and easily spread by wind and fomites.
4. Preparation of a review of control measures for foot-and-mouth disease
4.1. Already in the light of the experience gained with classical swine fever, the measures provided for in Directive 85/511/EEC were considered incomplete. For this reason the Commission together with laboratory experts, epidemiologists and representatives of the veterinary administrations of all Member States commenced in 1998 an in-depth review of the measures provided for by that Directive and implementing Decisions based on the Directive. In addition a special working group of the Scientific Veterinary Committee produced a report on emergency vaccination against foot-and-mouth disease in 1999.
4.2. Those working groups unanimously supported the Commission’s view that there is a need to modify some of the measures so far adopted to take account of the most recent scientific development in this field, the experience gained in eradicating important contagious diseases and the technical developments in laboratory diagnosis and in particular with regard to vaccination.
4.3. Based on expert advice, a draft proposal for a new Council Directive on control measures for foot-and-mouth disease had been prepared by the Commission services when on 20 February 2001 the first outbreak was notified of what should become one of Europe’s most severe foot-and-mouth disease epidemics.
4.4. During that epidemic, which lasted about one year until the foot-and-mouth disease free status of the Community was re-established by the OIE, the Community as a whole and not only the affected Member States experienced severe restrictions on internal and international trade and movement of susceptible animals and products derived from such animals.
4.5. The classical swine fever epidemic and the recent foot-and-mouth epidemic also revealed that a disease control policy based entirely on stamping out of infected and contaminated animals is questionable from an ethical and environmental point of view and is publicly less and less accepted.
4.6. The 2001 FMD crisis was managed in close co-operation between the Commission and the Member States by adopting and continuously adapting protective measures reinforcing and supplementing the provisions of Council Directive 85/511/EEC. These protective measures took full account of the measures agreed previously in expert groups established in 1998 to review the current Community control measures for foot-and-mouth disease. Thereby additional and valid experience has been gained in the Member States in application of certain measures included in the present draft proposal.
4.7. When the crisis came to an end, an International Conference on the Prevention and Control of Foot-and-Mouth Disease was organised jointly by the Belgian Presidency of the Council and the Commission in December 2001 in order to draw the first conclusions from the 2001 outbreak. The conference called upon the Commission to submit suitable legislative proposals to prevent such outbreaks in future and, if they would occur, to minimise the adverse economic effects. Amongst other things it was requested that emergency vaccination should become a viable option of disease control, taking into account technical developments in laboratory diagnosis. It was also requested that the international trade standards should be reviewed so as to limit the economic consequences affecting adversely countries which had recourse to emergency vaccination.
4.8. During 2001 and in particular following the conference, a series of activities has started in Member States, in the Commission and within the framework of international organisations, to review the adopted approach in relation to this disease and to improve the instruments to prevent and where necessary to control the disease.
4.9. During the year 2001 important modifications have been made to international animal health standards, notably the description of tests for the detection of antibodies against non-structural proteins in the 4th Edition of Manual of Standards for Diagnostic Tests and Vaccines of the OIE , published in August 2001.
4.10. The second important modification are the amendment to the OIE Animal Health Code adopted at the 70th General Session in 2002. These amendments require to describe the health status of a country not only on the basis of absence of clinical signs but also on substantiated by laboratory testing evidence of absence of foot-and-mouth disease infection. Under the condition of previous vaccination, such laboratory testing should include the detection of antibodies against non-structural proteins, thereby integrating the tests described in the Manual of Standards into the Animal Health Code. Consequently, the foot-and-mouth disease and infection free status of a country that had recourse to emergency vaccination in combination with stamping out of infected herds and post-vaccination serological surveillance using tests for the detection of antibodies against non-structural proteins in vaccinated animals would be re-established six months after the last outbreak or after the completion of vaccination what ever event occurs latest. Thereby emergency vaccination would become an option to control foot-and-mouth disease.
4.11. In 2002 a Temporary Committee on Foot-and-Mouth Disease has been established by the European Parliament to look into the 2001 foot-and-mouth disease crisis and to draw general conclusions on the future control strategies. The conclusions of that Committee will have to be considered in the text of the new Directive to be adopted finally.
4.12. The Commission considers that the internationally recognised status of “Free from foot and-mouth disease without vaccination” applied by the OIE to all Member States is an achievement which has facilitated the establishment of the single market and opens trade opportunities for all Member States.
For technical and economical reasons the Commission and the Member States decided not to divert from the current policy banning prophylactic vaccination. The most important of these reasons being that foot-and-mouth disease is not endemic on Community territory and therefore an exotic disease as many other animal diseases prevalent elsewhere in the world. If virus was accidentally introduced onto Community territory, it might originate from various endemic regions in the world. Given the nature of the virus and in particular its antigenical diversity this situation would render any prophylactic vaccination with a set of vaccine strains chosen in advance a costly and eventually ineffective measure and hence increase the risks of undetected spread of infection in an inadequately vaccinated population.
Neither the above mentioned international conference, nor the Temporary Committee of the European Parliament suggested to revert to a policy of prophylactic vaccination, while at the same time requesting to move emergency vaccination from a measure of last resort more to the forefront of control strategies in conjunction with measures to prevent virus introduction onto Community territory and into susceptible livestock and to enhance the capacity of Member States to respond to a possible outbreak.
5. General features of the proposal
5.1. The present proposal, although its preparation started well before the events of 2001, is therefore also a consequence of the lessons learned during this crisis. However, due to the nature of the disease, there is no perfect solution which could fully accommodate all of the economic, environmental and the ethical desires of civil society and therefore this proposal can only present the best currently available compromise.
5.2. The structure of the proposal tries to follow the sequence of events should an outbreak occur and contains in its final part the measures to be taken in order to prepare for an outbreak.
5.3. As soon as the presence of the disease is suspected rapid action must be taken so that immediate and effective control measures can be implemented once its presence is confirmed. Such measures must be modulated by the competent authorities and in some cases extended to large geographic and administrative areas depending on the epidemiological situation in the Member State concerned. It must also be possible to apply a preventive stamping out programme to reduce the number of susceptible animals in the vicinity of an outbreak.
5.4. Rapid and detailed diagnosis of the disease and identification of the relevant virus are of paramount importance and should be carried out under the auspices of responsible laboratories which must be networked between themselves and the co-ordination of which should be ensured by a reference laboratory designated by the Commission after consultation of the Member States in the Standing Committee on the Food Chain and Animal Health. Contrary to previous expert advice and in line with policy pursued by the Commission over the past decade, the 2001 outbreak confirmed that laboratory capacity, expertise and sound scientific competition in the field of foot-and-mouth disease diagnosis must be maintained in as many Member States as possible.
5.5. It is necessary to prevent any spread of the disease as soon as an outbreak occurs by carefully monitoring movements of animals and the use of products liable to be contaminated and, where appropriate in exceptional severe cases, particularly in densely populated livestock areas, by vaccination. At the same time, it should be acknowledged that there are sufficiently effective tools to prevent the spread of virus when healthy animals from herds outside the restricted areas are slaughtered or their milk is processed in establishments situated within zones restricted for disease reasons.
5.6. Applying the principles of regionalisation with regard to the control measures allows the implementation of strict control measures in a certain part of the Community without endangering general Community interests.
5.7. Although the silent form of foot-and-mouth disease in sheep has been well documented for a long time, the extent to which this species was involved in and contributed to the spread of foot-and-mouth disease in the United Kingdom in 2001 was unexpected and overwhelmed those in charge of controlling the disease. The involvement of sheep in the epidemic necessitated the elaboration of principles for serological surveillance prior to releasing restrictions imposed on holdings situated in certain zones and for the re-establishment of the disease and infection free status of a country.
5.8. To guard against emergencies, the Community has established reserves of inactivated foot-and-mouth disease virus antigen stored at designated antigen banks. Transparent and efficient procedures must be established to guarantee access to the antigen without undue delay. In addition, certain Member States have established and maintain national vaccine and antigen banks. In order to protect Community livestock and based on risk assessment, provision must be made to assist adjacent third countries infected by or at risk of foot-and-mouth disease, in particular as regards the emergency supply of antigen or vaccines. However, following recent political developments and in particular the events of 11 September 2001, more consideration must be given to aspects of agro-terrorism which requires a higher degree of confidentiality as far as details of antigen stocks are concerned. Consequently provisions must be made to derogate from certain Commission procurement procedures and to limit access to essential information.
5.9. In accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products[4] foot-and-mouth disease vaccines have been subject to marketing authorisation granted by Member States.
5.10. Article 8 of Directive 2001/82/EEC provides for emergency situations, where the administration to animals of susceptible species of vaccines against foot-and-mouth disease may be authorized, even if this vaccine was not granted marketing authorisation in the Member State concerned. Given the rapid variation of antigen required to produce an effective protection of animals of susceptible species in case of emergency, it appears appropriate to maintain that emergency clause.
5.11. However, in close co-operation between the European Agency for the Evaluation of Medicinal Products (EMEA), the OIE, the Research Group of the European Commission for the Control of Foot and Mouth Disease (EUFMD) of the Food and Agriculture Organization (FAO) of the United Nations (UN) and the European Commission, the foot-and-mouth disease monograph of the European Pharmacopoeia is being modified so as to lay down standards for vaccines against foot-and-mouth disease which would incorporate essential requirements for the purity of such vaccines necessary to perform a test for the identification of infected animals within a vaccinated animal population.
5.12. The presence of an entirely non-vaccinated population of susceptible livestock in Member States requires permanent disease awareness and preparedness. Detailed contingency plans have proven to be an effective tool to counteract the occurrence of the disease. Such contingency plans have to be reviewed regularly in the light of the results of real-time alert exercises in the Member States, and close co-operation between Member States in such exercises should be encouraged. Such contingency plans, when reviewed in the light of this Directive, must however include provisions on the use of emergency vaccination. Furthermore contingency plans are crucial in ensuring that environmental protection considerations are integrated in case of an outbreak. Those plans shall establish a well-structured and organised collaboration that will apply between veterinary and environmental competent authorities so that actions to address veterinary and environmental safety issues are appropriately co-ordinated.
5.13. In order to ensure close co-operation between the Member States and the Commission in controlling foot-and-mouth disease and taking into account the nature of the disease, the Commission should be empowered to modify and adapt certain technical aspects of the control measures by the procedure of the Standing Committee on the Food Chain and Animal Health in accordance with the procedures for the exercise of implementing powers conferred on the Commission laid down in Council Decision 1999/468/EC[5].
5.14. Articles 11, 12, 13, 14 and 15 of Council Decision 90/424/EEC of 26 June on expenditure in the veterinary field[6], as last amended by Council Regulation (EC) No 1258/1999[7], apply in the event of the occurrence of foot-and-mouth disease and for the Community aid to be granted to liaison and reference laboratories and antigen and vaccine banks. Any Community compensation to Member States for financial expenditures relating to control measures in case of outbreaks of foot-and-mouth disease should be subject to scrutiny with regard to application of at least the minimum requirements laid down in this Directive.
Draft Proposal for a
COUNCIL DIRECTIVE
of
on Community measures for the control of foot‑and‑mouth disease and amending Directive 92/46/EEC
(Text with EEA relevance)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 37 (3) thereof,
Having regard to the proposal from the Commission[8],
Having regard to the opinion of the European Parliament[9],
Having regard to the opinion of the Economic and Social Committee[10],
Having regard to the opinion of the Committee of the Regions[11],
Whereas:
(1) One of the Community's tasks in the veterinary field is to improve the state of health of livestock, thereby increasing the profitability of livestock farming and facilitating trade in animals and animal products.
(2) Foot-and-mouth disease is a highly contagious viral disease of biungulates. Although foot-and-mouth disease has no public health importance, due to its exceptional economic importance, it is on the top of list A diseases of the Office International des Epizooties (OIE).
(3) Foot-and-mouth disease is a compulsorily notifiable disease and outbreaks must be notified by the Member State affected to the Commission and other Member States in accordance with Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community[12].
(4) The Community measures for the control of foot-and-mouth disease are laid down in Directive 85/511/EEC of 18 November 1985 introducing Community measures for the control of foot-and-month disease[13].
(5) Following the adoption of Council Directive 90/423/EEC of 26 June 1990 amending Directive 85/511/EEC introducing Community measures for the control of foot-and-month disease, Directive 64/432/EEC on animal health problems affecting intra-Community trade in bovine animals and swine and Directive 72/462/EEC on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat or meat products from third countries[14] prophylactic vaccination against foot-and-mouth disease was prohibited throughout the Community as of 1 January 1992.
(6) Preventive measures are necessary to avoid the incursion of foot-and-mouth disease onto Community territory and into Community livestock from neighbouring countries or through the introduction into the Community of live animals and products of animal origin. There is no indication that any of the outbreaks of foot-and-mouth disease reported since the prohibition of prophylactic vaccination can be attributed to imports in accordance with Community legislation and subject to veterinary checks at border inspection posts established in accordance with Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC[15], and Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries[16].
(7) Under the conditions of the single market and the overall satisfactory health status of livestock herds, the exchange of animals and animal products has increased substantially and certain regions of the Community have densely populated livestock areas.
(8) The foot-and-mouth disease epidemic in certain Member States in 2001 demonstrated that due to intensive movement of and trade in animals susceptible to foot-and-mouth disease, an outbreak can quickly take on epizootic proportions, causing disturbances on a scale liable to reduce sharply the profitability of farming of animals of susceptible species and other parts of the rural economy and also requiring substantial financial resources to compensate farmers and the application of control measures.
(9) During the 2001 foot-and-mouth disease crisis, the Commission reinforced the Community control measures for foot-and-mouth disease laid down in Directive 85/511/EEC by adopting protective measures in accordance with Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market[17], and Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market[18].
(10) In 2001, the Commission also adopted Decisions on the conditions for the use of emergency vaccination in accordance with Directive 85/511/EEC. Those conditions were laid down taking account of the recommendations in the report of the Scientific Committee on Animal Health and Animal Welfare on the strategy for emergency vaccination against foot and mouth disease of 1999[19].
(11) This Directive should take into account the report of expert groups from Member States on a review of Community legislation on foot-and-mouth disease of 1998[20], which reflects the experience gained by Member States during the classical swine fever epidemic in 1997, and the conclusions of the International Conference on the Prevention and Control of Foot-and-Mouth Disease held in Brussels in December 2001[21].
(12) The resolution of the European Parliament on the foot-and-mouth disease epidemic in 2001 in the European Union[22], and the conclusions of the Temporary Committee on Foot-and-Mouth Disease of the European Parliament should be taken into account in this Directive.
(13) The recommendations in the Report of the Thirtieth Session of the European Commission for the Control of Foot and Mouth Disease of the Food and Agriculture Organisation on minimum standards for laboratories working with foot-and-mouth virus in vitro and in vivo of 1993,[23] should be taken into account.
(14) This Directive should also take into account the changes made in the Animal Health Code and the Manual of Standards for Diagnostic Tests and Vaccines of the OIE.
(15) It is necessary that action be taken as soon as the presence of the foot-and-mouth disease is suspected so that immediate and effective control measures can be implemented once its presence is confirmed. Such measures should be modulated by the competent authorities depending on the epidemiological situation in the Member State concerned. However, such measures should also be reinforced by specific protection measures established in accordance with Community legislation.
(16) A rapid and detailed diagnosis of the disease and identification of the relevant virus should be carried out under the auspices of a network of national laboratories in the Member States. Where necessary, co-operation between the national laboratories should be ensured by a Community reference laboratory designated by the Commission in accordance with the procedure of the Standing Committee on the Food Chain and Animal Health established by Regulation (EC) No 178/2002 of the European Parliament and the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[24].
(17) With regard to the differential laboratory diagnosis for foot-and-mouth disease account must be taken of Commission Decision 2000/428/EC of 4 July 2000 establishing diagnostic procedures, sampling methods and criteria for the evaluation of the results of laboratory tests for the confirmation and differential diagnosis of swine vesicular disease[25].
(18) Community measures for the control of foot-and-mouth disease should be based first of all on depopulation of the infected herd. The killing of infected and contaminated animals of susceptible species should be carried out without delay in accordance with the provisions of Council Directive 93/119/EEC of 22 December 1993 on the protection of animals at the time of slaughter or killing[26].
(19) It is necessary to integrate environment protection aspects in the event of a foot-and-mouth disease outbreak, in particular by establishing close co-operation between the veterinary and environment competent authorities. Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control[27] requires an integrated environmental permit for installations for the disposal or recycling of animal carcasses and animal waste with a specified treatment capacity.
(20) It is necessary to prevent any spread of the disease as soon as an outbreak occurs by carefully monitoring movements of animals and the use of products liable to be contaminated, and where appropriate, in particular in densely populated livestock areas, by emergency vaccination.
(21) Cleansing and disinfection should be an integral part of the Community control policy for foot-and-mouth disease. The use of disinfectants must be in compliance with the provisions of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market[28].
(22) Semen, ova and embryos collected from animals of susceptible species infected with the foot-and-mouth disease virus may contribute to the spread of the disease and should therefore be subject to restrictions in addition to those animal health conditions laid down for intra-Community trade in the following Directives:
Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of deep-frozen semen of domestic animals of the bovine species[29];
Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importations from third countries of embryos of domestic animals of the bovine species[30];
Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC[31].
(23) In the event of an outbreak it may be necessary to apply control measures not only to infected animals of susceptible species, but also contaminated animals of species not susceptible to the disease, notably poultry, which may be mechanical vectors for the virus. During the 2001 foot-and-mouth disease epidemic, restrictions were also applied on the movement of equidae coming from holdings keeping animals of susceptible species or neighbouring such holdings and specific certification, in addition to the requirements of Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae[32], was required in order to control trade in equidae from Member States affected by foot-and-mouth disease.
(24) With regard to animal health, the conditions governing placing on the market, trade and imports into the Community of animal products intended for human consumption are laid down in the following Directives:
Council Directive 64/433/EEC of 26 June 1964 on health conditions for the production and marketing of fresh meat[33];
Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community trade in fresh meat[34];
Council Directive 77/99/EEC of 21 December 1976 on health problems affecting the production and marketing of meat products and certain other products of animal origin [35];
Council Directive 80/215/EEC of 22 January 1980 on animal health problems affecting intra-Community trade in meat products[36];
Council Directive 91/495/EEC of 27 November 1990 concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat[37];
Council Directive 94/65/EC of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparations[38];
(25) Those Directives are being replaced. In order to ease reference, the treatment of meat and meat products from animals of susceptible species required to ensure the destruction of possible foot-and-mouth disease virus is specified in the Annexes VII to IX which are based on the provisions of the those Directives and comply with recommendations of the OIE.
(26) Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk based products[39] provides for the treatment of milk from animals kept within the perimeters of surveillance zones established in accordance with Community control measures for foot-and-mouth disease. The requirements of that Directive are not sufficient, as they do not provide for treatment of milk from protection zones and from vaccinated animals. In addition, the treatment for milk for human consumption provided for in that Directive exceeds the requirements of the code of the OIE on destruction of foot-and-mouth disease virus in milk and results in logistic problems in disposal of substantial quantities of milk refused by dairy plants. More detailed provisions on the collection and transport of milk from animals of susceptible species in areas subject to control measures for foot-and-mouth disease should be included in this Directive. The treatment of milk and milk products specified in Annex IX of this Directive complies with recommendations of the OIE for the destruction of possible foot-and-mouth disease virus in milk and milk products. Council Directive 92/46/EEC should be amended accordingly.
(27) With regard to products of animal origin account should be taken of Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC[40]. Certain provisions of Council Directive 92/118/EEC have been included in Regulation (EC) No 1774/2002 of the European Parliament and the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption[41].
(28) The application of the principles of regionalisation should allow the implementation of strict control measures, including emergency vaccination, in a defined part of the Community without endangering general Community interests.
(29) Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine[42] provides for the definition of regions. Commission Decision 2000/807/EC of 11 December 2000 laying down the codified form and the codes for the notification of animal diseases pursuant to Council Directive 82/894/EEC and repealing Decisions 84/90/EEC and 90/442/EEC[43] specifies administrative areas in Member States related to disease control measures and disease notification.
(30) To guard against emergencies, the Community has in accordance with Council Decision 91/666/EEC of 11 December 1991 establishing Community reserves of foot-and-mouth disease vaccines[44], established reserves of inactivated foot-and-mouth disease virus antigen stored at designated premises, and the Community antigen and vaccine bank. Transparent and efficient procedures should be established to guarantee access to the antigen without undue delay. In addition, certain Member States have established and maintain national antigen and vaccine banks.
(31) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products[45] requires that, with only minor exceptions, all veterinary medicinal products that are placed on the market within the Community hold a marketing authorisation. In addition, that Directive lays down the criteria for the granting of a marketing authorisation for veterinary medicinal products, including immunological veterinary medicinal products. That Directive authorises Member States to permit release onto their market of a product without a marketing authorisation in the event of a serious epidemic under certain conditions. Foot-and-mouth disease has the potential for a serious epidemic. Given the rapid variation of antigen required to produce an effective protection of animals of susceptible species in case of emergency, vaccines against foot-and-mouth disease qualify for the derogation provided for in that Directive.
(32) The Community Reference Laboratory should advise the Commission and the Member States on the need for vaccines and antigens, in particular where virus strains are detected against which the vaccines produced on the basis of those antigens stored in the Community antigen and vaccine bank do not provide sufficient protection.
(33) As a matter of precaution, in relation to the risks of a deliberate release of foot-and-mouth disease virus, it is appropriate to apply specific procedures to the procurement of antigens for the Community antigen and vaccine bank and to the publication of certain details relating to disease control measures.
(34) The presence of an entirely non-immune population of susceptible livestock in Member States requires permanent disease awareness and preparedness. The need for detailed contingency plans has been proven once more during the 2001 foot-and-mouth disease epidemic. At present, all Member States have contingency plans approved by Commission Decision 93/455/EEC of 23 July 1993 approving certain contingency plans for the control of foot-and-mouth disease[46]. Such contingency plans should be reviewed regularly, among other things, in the light of the results of real-time alert exercises carried out in the Member States, the experience of the 2001 epidemic and in order to include measures to protect the environment. Member States should be encouraged to organise and carry out such exercises in close co-operation and across borders.
(35) In order to protect Community livestock and based on risk assessment, provision should be made to assist neighbouring third countries infected by or at risk of foot-and-mouth disease, in particular as regards the emergency supply of antigen or vaccines. However, such provisions should apply without prejudice to agreements concluded between the third country concerned and the Community on access to the Community antigen and vaccine bank.
(36) Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field[47], applies in the event of the occurrence of foot-and-mouth disease and provides for Community aid to be granted to reference laboratories and antigen and vaccine banks. Any Community compensation paid to Member States for financial expenditures relating to control measures in the case of outbreaks of foot-and-mouth disease, should be subject to scrutiny regarding compliance with at least the minimum requirements laid down in this Directive.
(37) In order to ensure close co-operation between the Member States and the Commission in controlling foot-and-mouth disease and taking into account the nature of the disease, the Commission should be empowered to modify and adapt certain technical aspects of the control measures. Where necessary, the Commission should base any such modifications or amendments on the results of a veterinary inspection mission carried out in accordance with Commission Decision 98/139/EC of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in the Member States[48].
(38) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission[49].
(39) The Member States should lay down rules on penalties applicable to infringements of the provisions of this Directive and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive.
(40) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of maintaining and in the event of an outbreak of quick recovery of a foot-and-mouth disease and infection free status of all Member States to lay down rules on the measures to increase disease preparedness and to control outbreaks if they occur as quickly as possible, if necessary by emergency vaccination, and to limit the adverse effects on the production of and trade in livestock and products of animal origin. This Directive does not go beyond what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty.
HAS ADOPTED THIS DIRECTIVE:
Chapter I
Subject matter, scope and definitionsArticle 1
Subject matter and scope
1. This Directive sets out:
(a) the minimum control measures to be applied in the event of an outbreak of foot-and-month disease of whatever type of virus;
(b) certain preventative measures aimed at increasing awareness and preparedness of the competent authorities and the farming community for foot-and-mouth disease.
2. Member States shall remain free to take more stringent action in the field covered by this Directive, and in particular with regard to Articles 35 and 43.
Article 2
Definitions
For the purposes of this Directive the following definitions shall apply:
(a) “animal of a susceptible species” means any domestic or wild animal of the suborders Ruminantia, Suina, and Tylopoda of the order Artiodactyla present on a holding;
(b) “holding” means any agricultural or other premises located in the national territory of a Member State where animals of susceptible species are being bred or kept on a permanent or temporary basis. However, this definition does not include living areas for humans on such premises, 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 Article 10 inapplicable.
(c) “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;
(d) “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;
(e) “competent authority” means the authority of a Member State competent to carry out veterinary or zootechnical checks or any authority to which it has delegated that competence;
(f) “official veterinarian” means the veterinarian designated by the competent authority of the Member State;
(g) “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 appropriate legislation in the Member State concerned;
(h) “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 this Directive, 14 days for bovine and porcine animals, and 21 days for ovine and caprine animals and any other animal of susceptible species;
(i) “animal suspected of being infected” means any animal of a susceptible species or carcass exhibiting clinical symptoms or showing post-mortem lesions or reactions to laboratory tests which are such that the presence of foot-and-mouth disease may reasonably be suspected;
(j) “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;
(k) “case of foot-and-mouth disease” or “animal infected with foot-and-mouth disease” means any animal of a susceptible species or carcass of such animal in which
– clinical symptoms or post-mortem lesions consistent with foot-and-mouth disease have been officially confirmed, or
– the presence of the foot-and- mouth disease has been officially confirmed as the result of a laboratory examination carried out in accordance with Annexes XIII and XIV.
(l) “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 Annex I.
(m) “primary outbreak” means the outbreak within the meaning of Article 2 (d) of Directive 82/894/EEC;
(n) “killing” means the killing of animals within the meaning of Article 2 (6) of Directive 93/119/EEC;
(o) “slaughter” means the slaughter within the meaning of Article 2 (7) of 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 foot-and mouth disease virus, including slaughter for reasons of animal welfare;
(p) “processing” means one of the treatments for high risk material laid down in Regulation EC No 1774/2002 of the European Parliament and the Council laying down health rules concerning animal by-products not intended for human consumption, applied in such a way as to avoid the risk of spread of foot-and-mouth disease virus;
(q) “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 Article 45 in order to prevent the spread of foot-and-mouth disease into the free zone where no restrictions are applied in accordance with this Directive;
(r) “region” means an area as defined in Article 2 (2) (p) of Directive 64/432/EEC;
(s) “sub-region” means an area specified in the Annex to Decision 2000/807/EC;
(t) “Community antigen and vaccine bank” means appropriate premises designated in accordance with this Directive for the storage of Community reserves of both concentrated inactivated antigen of the foot and mouth disease virus for the production of foot-and-mouth disease vaccines and veterinary immunological products (vaccines) reconstituted from such antigens and authorised in accordance with Directive 2001/82/EC;
(u) “emergency vaccination” means vaccination in accordance with Article 50 (1);
(v) “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;
(w) “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;
(x) “catering waste” means all waste food originating in restaurants, catering facilities and kitchens, including central kitchens and household kitchens.
Chapter II
Control of outbreaks of foot-and-mouth diseaseSection 1
Notification of foot-and-mouth diseaseArticle 3
Foot-and-Mouth Disease Notification
1. Member States shall ensure that:
(a) foot-and-mouth disease is listed by the competent authority as a compulsorily notifiable disease;
(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 authorities or the official veterinarian the presence or suspected presence of foot-and-mouth disease and keep animals infected with foot-and-mouth 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;
(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 authorities any knowledge of the presence or suspected presence of foot-and-mouth disease they have obtained prior to official intervention within the framework of this Directive.
2. Without prejudice to existing Community provisions on notification of outbreaks of animal disease, the Member State on whose territory an outbreak of foot-and-mouth disease is confirmed shall give notification of the disease and provide information and written reports to the Commission and the other Member States in accordance with Annex II.
Section 2
Measures in case of suspicion of an outbreak of foot-and-mouth diseaseArticle 4
Measures in case of suspicion of an outbreak of foot-and-mouth disease
1. Member States shall ensure that the measures provided for in paragraphs 2 to 6 are carried out where a holding contains one or more animals suspected of being infected or of being contaminated.
2. The official veterinarian shall immediately activate official investigation arrangements under his supervision to confirm or rule out the presence of the foot-and-mouth disease and, in particular, take the necessary samples, or have them taken, for laboratory examination in accordance with Annex III.
3. The competent authority shall place the holding referred to in paragraph 1 under official surveillance as soon as the suspected infection is notified and shall in particular ensure that:
(a) a census is made of all categories of animals of susceptible species on the holding and that, in respect of each of these categories, the number of animals that are already dead and the animals suspected of being infected or of being contaminated, is recorded;
(b) the census as referred to in point (a) is kept up to date to take account of those animals of susceptible species born or dying during the period of suspicion and such information is produced on request by the owner and checked at each visit by the competent authorities;
(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;
(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 Article 18, and that all animals of susceptible species on the holding are kept in their living quarters or another place where they can be isolated;
(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;
(f) an epidemiological inquiry is carried out in accordance with Article 13.
Article 5
Movements onto and off a holding in case of suspicion of an outbreak of foot-and-mouth disease
1. Member States shall ensure that in addition to the measures provided for in Article 4, all movement onto and off a holding where there is a suspicion of an outbreak of foot-and-mouth disease is prohibited. That prohibition shall apply in particular to:
(a) movement from the holding of meat or carcasses, 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;
(b) movement of animals of species not susceptible to foot-and-mouth disease;
(c) movement of persons onto or out of the holding;
(d) movement of vehicles onto or out of the holding.
2. By way of derogation from the prohibition in point (a) of paragraph 1, the competent authorities 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 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 points (b), (c) and (d) of paragraph 1, the competent authority may authorise such movements onto and off the holding subject to all conditions considered necessary in order to avoid the spread of foot-and-mouth disease virus.
Article 6
Extension of measures to other holdings
The competent authority shall extend the measures provided for in Articles 4 and 5 to other holdings where their location, their construction and layout, or contacts with animals from the holding referred to in Article 4, give reason to suspect possible contamination.
Article 7
Temporary control zone
1. The Competent Authority shall 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. The measures provided for in Articles 4 and 5 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 a Member State for up to 72 hours.
Article 8
Preventive eradication programme
The competent authority may, where epidemiological information or other evidence indicates, implement a preventive eradication programme, including preventive depopulation of holdings of animals of susceptible species likely to be contaminated and, if considered necessary, of epidemiologically linked production units or adjoining holdings.
In that event, the taking of samples and clinical examinations of animals of susceptible species shall be carried out in accordance with Annex III.
The Competent Authority shall notify the Commission prior to the implementation of the measures provided for in this Article.
Article 9
Maintenance of measures
Member States shall not withdraw the measures provided for in Articles 4 to 7 until the suspicion of foot-and-mouth disease has been officially ruled out.
Section 3
Measures in case of confirmation of an outbreak of
foot-and-mouth diseaseMeasures in case of confirmation of an outbreak of foot-and-mouth disease
1. As soon as an outbreak of foot-and-mouth disease is confirmed, Member States shall ensure that, in addition to the measures provided for in Articles 4 to 6 the following measures are also applied without delay on the holding:
(a) All animals of susceptible species on the holding shall be killed on-the-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 Member State concerned shall notify the Commission about the existence of such exceptional circumstances, and the action taken.
(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 Article 13 have been taken in accordance with Annex III, and in sufficient numbers.
The competent authority may decide that Article 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 that Article, provided that appropriate and sufficient numbers of samples needed for the epidemiological inquiry referred to in Article 13 have been taken.
(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 point (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. The disposal of the carcasses shall be carried out preferably by rendering in facilities approved for that purpose. 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 Article 72, and in particular in compliance with Community and National environmental and public health legislation.
(d) All products and substances referred to in Article 4 (3) (c) shall be 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, and disposed of in compliance with Community legislation on waste.
2. After the killing and processing of the animals of susceptible species and the destruction of the substances referred to in Article 4 (3) (c), Member States shall ensure that:
(a) the buildings used for housing the killed animals, their surroundings and the vehicles used for their transportation, as well as all other buildings likely to be contaminated shall be cleaned and disinfected in accordance with Article 11;
(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;
(c) restocking of animals is carried out in accordance with Annex V.
Article 11
Cleansing and Disinfection
1. Member States shall ensure that cleansing and disinfection operations, as integral parts of the measures provided for in this Directive, 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 approved by the competent authority as veterinary hygiene biocidal products in accordance with Directive 98/8/EC, in order to ensure destruction of the foot-and-mouth disease virus.
2. Member States shall ensure that cleansing and disinfection operations are carried out in a way to reduce as much as possible any adverse environmental impact that may arise from such operations.
3. Member States 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. Member States shall ensure that cleansing and disinfection operations are carried out in accordance with Annex IV.
Article 12
Tracing and treatment of products and substances derived from or having been in contact with animals of an outbreak of foot-and-mouth disease
Member States shall ensure that the products and substances referred to in Article 4 (3) (c) of animals of susceptible species collected from an holding where an outbreak of foot-and-mouth 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.
Article 13
Epidemiological inquiry
1. Member States shall ensure that epidemiological inquiries in relation to outbreaks of foot-and-mouth disease are carried out by specifically trained veterinarians on the basis of questionnaires, prepared within the framework of the contingency plans provided for in Article 72, to ensure standardised, speedy and targeted inquiries. Such inquiries shall deal at least with:
(a) the length of time during which the foot-and-mouth disease may have been present on a holding before being suspected or notified;
(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;
(c) the possible extent to which animals of susceptible species other than bovine and porcine animals may have been infected or contaminated;
(d) the movement of persons, vehicles and the substances referred to in Article 4 (3) (c) likely to have carried the foot-and-mouth disease virus to or from the holdings in question.
2. Member States shall inform and regularly update the Commission and the other Member States about the epidemiology and spread of the foot-and-mouth disease virus.
Article 14
Additional measures in case of confirmation of outbreaks of foot-and-mouth disease
1. The competent authority may order that, besides the animals of susceptible species, other animals on the holding where an outbreak of foot-and-mouth disease has been confirmed shall also be killed and disposed of in such a way as to avoid any risk of spreading the foot-and-mouth disease virus and any harm to the environment.
However, the provisions of the first subparagraph shall not apply to animals of species not susceptible to foot-and-mouth disease, in particular equidae and dogs, which may be isolated, effectively cleansed and disinfected, provided that they are individually identified, in the case of equidae in accordance with Community legislation, so as to allow the control of their movement.
2. The competent authority may apply the measures provided for in Article 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 Commission, where possible, prior to implementation. In this event, the measures regarding taking of samples and clinical examinations of animals shall be carried out as set out in Annex III.
3. The competent authority shall immediately upon the confirmation of the first outbreak of foot-and-mouth disease prepare all arrangements deemed necessary for emergency vaccination in an area of at least the size of the surveillance zone established in accordance with Article 21.
Section 4
Measures to be applied in special casesArticle 15
Measures to be applied in case of an outbreak of foot-and-mouth disease in the vicinity or within certain non-farming premises
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 Directive 92/65/EEC and where animals are kept for scientific purposes or purposes related to conservation of species or rare breeds, the Member State concerned 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 paragraph 1, the Member State concerned may decide to derogate from Article 10 (1) (a), provided that basic 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. That decision shall immediately be notified to the Commission.
Article 16
Measures to be applied in slaughterhouses, border inspection posts and means of transportation
1. Where an outbreak of foot-and-mouth disease is confirmed in a slaughterhouse, a border inspection post established in accordance with 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:
(a) all animals of susceptible species in such premises or means of transport are killed without delay;
(b) the carcasses of possibly infected and contaminated animals are disposed of under official supervision in such a way as to avoid the risk of foot-and-mouth disease virus spreading and any risk to the environment;
(c) other animal waste, including offal, of possibly infected and contaminated animals are disposed of under official supervision in such a way as to avoid the risk of foot-and-mouth disease virus spreading and in accordance with Community legislation on waste;
(d) cleansing and disinfection of buildings and equipment, including vehicles or means of transport, takes place under the supervision of the official veterinarian in accordance with Article 11 and with the instructions laid down by the competent authority;
(e) an epidemiological inquiry is carried out in accordance with Article 13.
2. Member States shall ensure that the measures provided for in Article 19 are applied in contact holdings.
3. Member States shall ensure that no animals are reintroduced for slaughter, inspection or transport in the premises or means of transport referred to in paragraph 1 until at least 24 hours after completion of the cleansing and disinfection operations referred to in paragraph 1 (d).
Article17
review of measures
The Commission shall review the situation regarding the special cases referred to in Article 15 in the Standing Committee on the Food Chain and Animal Health at the earliest possible opportunity. The necessary measures to prevent the spread of the foot-and-mouth disease virus, in particular in relation to regionalisation in accordance with Article 45, and to emergency vaccination in accordance with Article 52, shall be adopted in accordance with the procedure referred to in Article 89 (3).
Section 5
Holdings consisting of different epidemiological units and contact holdingArticle 18
Holdings consisting of different epidemiological production units
1. In the case of holdings which consist of two or more separate production units, the competent authority may in exceptional cases, and after considering the risks, derogate from Article 10 (1) (a) as regards healthy production units of such holdings.
2. The derogation provided for in paragraph 1 shall only be granted after the official veterinarian has confirmed at the time of the official investigation referred to in Article 4 (2), that the following conditions to prevent the spread of foot‑and‑mouth disease virus between the production units referred to in paragraph 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:
(a) the structure and size of the premises allow a complete separation of housing and keeping for the animals of susceptible species, including separate air space;
(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;
(c) the machinery, equipment, installations, instruments and disinfection facilities used in the production units are completely separate.
3. In relation to milk, a derogation from Article 10 (1) (d), may be granted to a holding producing milk provided that:
(a) such holding complies with the conditions set out in paragraph 2;
(b) milking in each unit is carried out separately;
(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 Annex IX.
4. Where a derogation is granted in accordance with paragraph 1, Member States shall lay down in advance detailed rules for applying such derogation. The Member States shall notify the Commission of the derogation and provide details of the measures taken.
Contact holdings
1. Holdings shall be recognized 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 Articles 4 (1) or 10 (1) or from a holding referred to in Articles 4(1) or 10 (1) to other holdings.
2. Contact holdings shall be placed under official surveillance in accordance with Article 4 (3) and this surveillance 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 survey requirements provided for in Annex III.
3. The competent authority shall prohibit the removal of animals of susceptible species from contact holdings during a period corresponding to the incubation period specified for the species concerned in Article 2 (h). However, the competent authority may by way of derogation from Article 4 (3) (d) authorise the transport of animals of susceptible species under official supervision directly to a slaughterhouse for the purpose of emergency slaughter.
Prior to granting such derogation, the official veterinarian shall at least carry out the clinical examinations provided for in point 1 of Annex III.
4. Where the competent authority considers that the epidemiological situation permits, it may limit the recognition as a contact holding provided for in paragraph 1, to one identified epidemiological production unit of the holding and to the animals contained therein, provided that the epidemiological production unit complies with Article 18.
5. Where an epidemiological link between an outbreak of foot-and-mouth disease and certain non-farming premises, slaughterhouses, border inspection posts or means of transportation cannot be excluded, Member States shall ensure that the measures provided for in Articles 15 and 16 shall apply to such non-farming premises, slaughterhouses, border inspection posts or means of transportation.
Article 20
Co-ordination of measures
The Commission may review the situation regarding the holdings referred to in Articles 18 and 19 in the Standing Committee on the Food Chain and Animal Health with a view to the adoption in accordance with the procedure referred to in Article 89 (3) of the necessary measures to ensure co-ordination of the measures implemented by the Member States pursuant to Articles 18 and 19.
Section 6
protection and surveillance zonesEstablishment of protection and surveillance zones
1. Member States shall ensure that at least the measures laid down in paragraphs 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 3 km and a surveillance zone based on a minimum radius of 10 km centred on the outbreak of foot-and-mouth disease referred to in paragraph 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 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 co-ordination of all measures necessary to eradicate foot-and-mouth disease as quickly as possible, national and local disease control centres as referred to in Articles 74 and 76 shall be established. For the purpose of carrying out the epidemiological inquiry as provided for in Article 13, those centres shall be assisted by an expert group as provided for in Article 78.
5. Member States 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 paragraph 2 come into force. Such fresh meat, meat products, raw milk and raw milk products shall be treated in accordance with Articles 25, 26 and 27 respectively or detained until possible contamination with the foot-and-mouth disease virus is officially ruled out.
Article 22
Measures to be applied to holdings in the protection zone
1. Member States shall ensure that at least the following measures are applied in the protection zone:
(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 and kept up to date;
(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-and-mouth disease virus possibly present on the holdings, which shall include the inspection of general hygiene and measures to prevent the introduction or escape of foot-and-mouth disease virus ;
(c) animals of susceptible species shall not be removed from the holding on which they are kept.
2. By way of derogation from paragraph 1 (c), animals of susceptible species may be transported directly under official supervision for the purpose of emergency slaughter to 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.
Movement shall be authorised by the competent authority only after an examination by the official veterinarian of all the animals of susceptible species present on the holding has ruled out the presence of animals suspected of being infected or animals suspected of being contaminated. The meat of such animals shall be subject to the measures provided for in Article 25.
Article 23
Gatherings and movement in the protection zone
Member States shall ensure that the following activities are prohibited within the protection zone:
(a) fairs, markets, shows and other gatherings of animals of susceptible species, including collection and distribution;
(b) itinerant service for breeding of animals of susceptible species;
(c) artificial insemination of animals of susceptible species except the artificial insemination carried out by a farmer with semen from animals on his holding.
Article 24
Transport of animals in the protection zone
1. Member States shall ensure that in the protection zone, the transport of animals of susceptible species shall be prohibited. The competent authority may extend such prohibition to:
(a) transport of animals of non-susceptible species out of or into the protection zone, taking into account the restrictions on the transport of equidae set out in point 4 of Annex VI;
(b) transit of animals of all species through the protection zone;
(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.
2. The competent authorities may derogate from the prohibitions in paragraph 1 for:
(a) transit of animals of all species through the protection zone undertaken exclusively via major highways or mainline railways;
(b) animals of susceptible species which have been certified by the official veterinarian as coming from holdings outside the restricted zones 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 veterinary supervision at the slaughterhouse and such decontamination of transport is recorded in the logbook of the means of transport.
Article 25
Measures in relation to fresh meat produced in the protection zone
1. Member States 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. Member States shall ensure that the placing on the market of fresh meat, minced meat and meat preparations from animals of susceptible species produced in the protection zone shall be prohibited.
3. Member States shall ensure that fresh meat, minced meat and meat preparations as referred to in paragraph 1, shall be marked in accordance with Article 5a of Council Directive 72/461/EEC (cross-stamp) and subsequently transported in sealed containers to an establishment designated by the competent authorities for transformation into meat products treated in accordance with Annex VII.
4. By way of derogation, the prohibition provided for in paragraph 1 shall not apply to fresh meat, minced meat and meat preparations which were produced on a date at least 21 days before the estimated date of infection on the holding recorded as the primary outbreak 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 clear mark established in conformity with Community law.
5. By way of derogation, the prohibition provided for in paragraph 2, shall not apply to fresh meat, minced meat or meat preparations obtained from establishments situated in the 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 paragraph 4, or fresh meat, minced meat or meat preparations obtained from animals reared and slaughtered outside the protection zone shall be processed in the establishment;
(c) all such fresh meat, minced meat or meat preparations must bear the health mark in accordance with Chapter XI of Annex I to 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 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 Directive 95/65/EC;
(d) 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 this Directive.
6. Compliance with the conditions in paragraph 5 shall be certified by the competent authority for fresh meat, minced meat and meat preparations intended for intra-Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authority and in the case of intra-Community trade communicate to other Member States and the Commission a list of those establishments which it has approved for the purpose of such certification.
Article 26
Measures in relation to meat products produced in the protection zone
Member States 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.
By way of derogation, this prohibition shall not apply to meat products which have undergone one of the treatments as set out in Annex VII.
Article 27
Measures in relation to milk and milk products produced in the protection zone
1. Member States 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. Member States shall ensure that the placing on the market of milk and milk products from animals of susceptible species produced in the protection zone shall be prohibited.
3. By way of derogation, the prohibition provided for in paragraph 1 shall not apply to milk derived from anima