Explanatory Memorandum to COM(2002)736 - Community measures for the control of foot and mouth disease - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2002)736 - Community measures for the control of foot and mouth disease. |
|---|---|
| source | COM(2002)736  |
| date | 13-12-2002 |
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.
Contents
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.
3.1. The Community measures for the control of foot-and-mouth disease are laid down in Directive 85/511/EEC i, as last amended by the Act of Accession of Austria, Finland and Sweden i. The prohibition of prophylactic vaccination introduced by Council Directive 90/423/EEC i 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.
4.1. 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.
5.1. 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 i 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 i.
5.14. Articles 11, 12, 13, 14 and 15 of Council Decision 90/424/EEC of 26 June on expenditure in the veterinary field i, as last amended by Council Regulation (EC) No 1258/1999 i, 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.