MEMO/01/123 Brussels, 12 December 2001 Questions and Answers on Foot-and-Mouth Disease (FMD) What is the current situation with regard to FMD outbreaks in the EU? No new outbreak has occurred in the UK since 30 September 2001. Thus, the disease has most likely been successfully eradicated again in the EU. Foot and mouth disease (FMD) broke out in the UK in February this year. Further outbreaks occurred also in Ireland, France and in the Netherlands. The eradication efforts succeeded at a very heavy cost. Over 4 million animals were killed and destroyed and there was serious disruption in the affected countries. Prior to this year, there had been minor outbreaks only notably in the eastern parts of Greece close to the Turkish border in 1994, 1996 and 2000 and in Italy in 1993. Being free from major infectious and contagious diseases is not only the optimal health status for animals contributing to their wellbeing and good veterinarian practice, but also of vital economic importance. Ireland, France and the Netherlands have officially regained their disease-free status at the meeting of the FMD and other Epizootics Commission of the OIE on 17-19 September 2001. What are the European Commission and the national authorities doing to combat FMD? All Member States invested huge resources in combating the recent outbreak and remain vigilant. There was and is a very high level of solidarity and co-operation between Member States in these difficult circumstances. The Commission’s objective has been to act decisively and quickly to help the Member States to eradicate foot and mouth disease. There are no less than 57 decisions on protective measures adopted by the Commission to date, in close coordination and co-operation with the Member States, mainly on restriction of movements of animals. The Commission acted immediately on receipt of new information and with as much transparency as possible. The initially adopted restrictions on the dispatch from Great Britain of live susceptible animals and untreated products from such animals have been eased in the light of progress in eradicating the disease. In particular, restrictions in relation to areas that either had never experienced an outbreak during this epidemic or have not reported outbreaks for more than 3 months have been dropped. Exports of live pigs – a susceptible species which was only occasionally involved in this epidemic – will resume shortly subject to conditions regarding health guarantees and movement controls. This process of gradual lifting of the restrictions in the light of the progress made in Great Britain will continue until the infection has been confidently eradicated. What is the EU policy on combating FMD? FMD is, according to the classification of the OIE, the economically most important infectious livestock disease. While it is usually a disease of low mortality in animals and has no public health relevance it has important consequences for animal welfare and production. Clinically diseased animals normally suffer quite seriously, especially animals of highly productive breeds and there are important losses of growth and milk production. One of the EU´s tasks in the veterinary field is to improve the state of health of livestock. To protect the more than 300 million susceptible animals which are vulnerable to the FMD virus requires effective measures reducing the risk of virus introduction and spread. Trade with third countries not free of FMD is restricted to products which have been treated against the virus. Strict border controls for imports are applied to avoid contracting the FMD-virus from affected third countries. Swill feeding as a possible route of passing on the virus has been increasingly forbidden. In the case of an outbreak, the Community measures are directed to re-establish the disease and infection free status of affected Member States or regions thereof within the shortest possible delay and with a minimum of adverse effects. The most effective means of doing so is to kill and destroy infected or potentially infected animals so as to reduce the amount of virus in the environment and the number of susceptible animals directly exposed to it. Vaccination can be used, subject to certain conditions, as a complementary tool to reduce the virus production by infected animals. There is a consensus on this objective in all Member States. The FMD policy is laid out in Directive 85/511/EEC. What lesson has the EU learnt from the recent outbreak? Illegal imports of contaminated meat in connection with illegal swill feeding appears to be the most likely origin of this outbreak. There are very strict controls on imports which have been very successful in maintaining the EU's high animal disease status. "Swill" for feeding to pigs, can only be produced from food fit for human consumption (i.e. from restaurants, canteens etc.) and after heat treatment by licensed operators. Moreover, waste from aircraft, ocean-going vessels etc. must be destroyed. Ensuring the respect of these rules and controlling their correct implementation is the task of national authorities. However, to prevent any fraud and illegalities, the EU has decided to ban in a first step swill (pig) feeding and in a second step to ban feeding in general catering waste. This will come into force in October 2002. 2 Additionally, the Commission is currently carrying out a very thorough examination of all the contributory factors to the recent outbreak and its consequences. This will include: Weaknesses in traceability of animals and especially of sheep; - Animal transport and especially measures which allow live animals from different Member States to cross-contaminate one another; - Vaccination and whether there needs to be a departure from the current prohibition of prophylactic vaccination to generalised vaccination. And, if so, in what circumstances and on what conditions; - Sanitary controls on imports, bearing in mind that the existing EU provisions are adequate, if respected, not only to keep out the virus but also to ensure public health requirements are respected; - Research into new vaccines which would effectively prevent vaccinated animals becoming carrier animals, which would be effective against all or at least several serotypes and induce a protective immunity within a shorter period after administration. Further development of discriminatory tests, which the Commission has already supported during the several years, would allow vaccinated animals to be easily distinguished from infected animals not only on a herd base as the current tests do but on an individual basis. This could greatly increase the scope for protective vaccination. - Further discussions in the relevant international bodies, especially in the OIE, on the adaptation of the animal health code. An opportunity for a full discussion will arise from the revision of the existing legislation on FMD which the Commission is currently preparing. This work had already begun long before the current outbreak. What is the EU legislation on vaccination against FMD? Prophylactic vaccination is not permitted under the present legislation. However, emergency vaccination as a complementary measure to eradicate the disease is provided for in EU legislation. The Netherlands did partly make use of a Commission Decision authorising vaccination conditions. Vaccination was also authorised in the UK but was not taken up. Why do vaccinated animals still need to be slaughtered and destroyed? EU legislation has no provisions on the handling of vaccinated animals, except that they may not be sent to another Member State. However, products of vaccinated animals can be allowed for trade within the internal market after undergoing special treatment. Killing and destruction is therefore not required for the health of the vaccinated animals nor for public health reasons. But vaccinated animals may become infected and the lack of clinical signs may hide the infection thereby contributing to the spread of the virus. Under a zero-risk approach the EU has so far considered this unacceptable. Even when using marker vaccines the problem remains that vaccination does not necessarily protect from infection. 3 Freedom of disease might be achieved through large-scale vaccination, freedom of infection can only be ascertained by a non-vaccination policy! From the above it is evident that killing and destruction is required in the case of « suppressive vaccination » carried out within or very close to infected premises pending the safe killing and destruction of the animals. This is necessary because the likelihood of infection in vaccinated animals increases the shorter the distance to the infected premises. With the available classical testing methods, it is impossible to distinguish between an animal which has been vaccinated against FMD and one which is infected. « Protective vaccination » does not require the killing and destruction of the animals concerned. Following the build-up of sufficient immunity the meat and milk of such vaccinated animals may be used on the local market under certain conditions that would ensure that any possible virus in such products was destroyed. However, to avoid the problems arising from the inability to distinguish vaccinated from infected animals, very strict controls on the movements of vaccinated animals and their products are necessary to ensure that the disease does not spread The Scientific Veterinary Committee of the EU proposed in 1997 a scenario whereby using a discriminatory test to distinguish between infected and vaccinated animals, these animals could be kept alive, subject to certain restriction of their movement. However the discriminatory tests were not recognized by OIE neither as an analytical method nor in the context of trade associated certification. This situation has changed and is under ongoing discussion. The principles of testing for non-structural proteins are since August 2001 laid down in the OIE Manual of Standards for Diagnostic Tests and Vaccines. Expert groups of the OIE are currently discussing the integration of these tests into the OIE Code for surveillance purposes. If such tests are to be recognised to detect virus circulation, even in vaccinated animals, such tests carried out on a strict statistical base may in future facilitate the release of restrictions on vaccinated animals and their products in a shorter delay than currently foreseen (1 year). But a definitive solution cannot be envisaged before the General Assembly of OIE in May 2002. What kind of emergency vaccination has been approved during the recent FMD outbreak? The Commission and the Member States had decided to approve vaccination, in certain clearly defined circumstances, in the Netherlands and in the United Kingdom. The decision in relation to the Netherlands allowed « suppressive vaccination » as described above because the Netherlands had insufficient capacity to carry out killing and slaughter with the speed necessary to prevent the further spread of the disease. The Netherlands was also been authorised to use « protective vaccination » for cattle in the Oene region. Vaccination had to be clearly entered on the passports of the cattle concerned. Any vaccinated cattle would not have been able to move from the vaccination zone for at least one year after the last outbreak in that area. 4 However, the Netherlands did not use the possibility of keeping these vaccinated cattle alive, because of the related restrictions. The decision in relation to the United Kingdom also provided for « protective vaccination ». It allowed in principle the vaccination of cattle only in the counties of Cumbria and Devon. Other species were not to be vaccinated but pre-emptively killed in a certain radius around infected premises. However, the movement of these vaccinated animals, by and large dairy cows, would have been effectively confined to the regions concerned. And there would also have been important restrictions on the movement of their milk and milk products and – when eventually slaughtered – of meat and meat products from these animals. The UK also decided not to make use of this exceptional possibility to vaccinate. Why did the EU not authorise more widespread use of “preventive vaccination” during the recent outbreak? Because it was not requested. Only the Netherlands and the UK had requested authorisation for vaccination of farm animals and these requests were approved. Formal requests from other Member States had not been received as preventive vaccination was not considered necessary or appropriate in the recent circumstances by these other Member States. Why doesn't the EU give up its general prohibition on the use of vaccines against FMD? Vaccination appears an attractive alternative to killing and destroying animals. But the reality is far different. Even if calls for general vaccination make the headlines, there is still no widespread support for such a policy, neither from the Member States, not the European Parliament nor from the farming community at large. In reality vaccination is a very complex issue. What are the problems with shifting towards a vaccination policy? There are important limitations to a possible vaccination policy. Vaccinated animals are not necessarily disease free - the antibodies that build up through vaccination can hide the actual presence of FMD virus in an animal. There is no test approved and internationally recognised to distinguish individually vaccinated animals from infected animals. Vaccinating animals therefore does not guarantee that the disease does not persist in the animal population. In fact, third countries which do vaccinate on a preventive basis because FMD is endemic on their territory regularly see new outbreaks of FMD due to the variability of the virus. Even when using marker vaccines the problem remains that vaccination does not necessarily protect from infection; - Vaccination is only effective in relation to the strain of FMD concerned and offers no protection against other strains of the virus. There are seven serotypes of FMD, each with several sub-strains. Any vaccination is effective for a limited period only and has to carefully target the correct strain. As the disease is not endemic in the EU, the selection of the appropriate vaccine strain would be a pure lottery. Even a "cocktail" of vaccines administered could not protect against all sub-strains of FMD; 5 - There are significant logistical and cost implications in vaccination of a livestock population of over 300 million susceptible animals (cattle, sheep, pigs) in the EU which would all need to be vaccinated twice a year to give full coverage; - The Member States agreed to harmonise the health status throughout the Community at the highest international recognised level and this is « FMD free without vaccination » a status desperately aimed for by many countries in the world. In those Member States where prophylactic vaccination was practised in the past small ruminants and pigs were usually not included in the vaccination programme and outbreaks were recorded despite vaccination; - Finally, the loss of the EU's non-vaccination status would involve substantial losses in trade to third countries which insist on importing from foot and mouth free countries only. The EU could only export products which are treated against the virus. The status of "FMD-free without vaccination" is attributed by the International Organisation on Animal Health (OIE) in Paris. Only 1/3 of the world is approximately FMD-free. See also: http://www.fao.org/ag/AGA/AGAH/EUFMD/fmdmaps/default.htm In the light of these circumstances, there is still a consensus that eradication of the present outbreak, without use of generalised vaccination, was the best course of action. Large-scale vaccination will only be considered if a foot and mouth epidemic cannot be brought under control in any other way. This was not the case with the last outbreak. Is intensive farming at the origin of the disease? All contributory factors must be considered but very simplistic explanations for very complex problems should be avoided. FMD was eradicated in the EU in the late 80's which permitted an end to vaccination in 1991. Since 1991, there have only been outbreaks in Italy (1993), Greece (animal incursions from Turkey) and now in the UK. This is a very successful record given that prior to 1991, FMD outbreaks were commonplace resulting in huge trade, income and vaccination costs. Moreover: - FMD is most prevalent in countries/regions where agriculture is very "traditional" Middle East/North Africa/Turkey/South America. Conversely, outbreaks are extremely rare in the OECD countries which have the most intensive agriculture; - Similarly, FMD was much more prevalent in the EU in the past, when agriculture was less intensive, than at present. There have only been a handful of cases since 1991 - in Italy (1993) and in Greece (2000). 6 Is the large-scale transport of animals the cause of the recent outbreak? Clearly, any process which brings animals from different herds together in a single place or exposes them to large numbers of other animals increases the potential for the spread of disease. But: - Most trade in meat and meat products is in carcass form and the number of animals in long distance transport is in constant decline ever since refrigeration allowed animal carcasses to be transported over long distances; - Regulations exist to minimise the potential spread of disease in transport, including "no-exit" provisions on transport to abattoirs, tracability of livestock movements through the ANIMO system, disinfection of lorries and livestock marts, health certification of animals etc; - There will always be a need for long distance transport of specialised livestock (breeding stock, racehorses etc.). However, it remains a Commission objective to further reduce the level of long distance animal transport and to improve the welfare conditions of animals in transport. Moreover, a number of important restrictions on animal movements introduced during the recent outbreak remain in place. Is there financial compensation available to producers? Yes, the Commission provides compensation, up to 60%, towards the costs of animals destroyed, disinfection etc under an Emergency Veterinary Fund. An advance of 400 Mio € will be provided from the budget 2001, with 355 Mio € foreseen for the UK, 39 Mio € for the Netherlands, 2 Mio € for Ireland and 3 Mio € for France. A further 400 Mio € are already earmarked for 2002. The total amount which will be paid depends upon the receipt and acknowledgement of all requests for compensation. It takes however years until the final balance is made and settled. 7