Address https://gelex.eu/eli/EU/doc/http://publications.europa.eu/resource/cellar/6f593024-9ef6-4dfd-80c0-5393be6ebcbf.0006.01@2016-04-21/en

Contents

1. Preamble
2. ANNEX
3. ANNEX I ANIMAL DISEASE INFORMATION
4. ANNEX II MAIN RESPONSIBILITIES 01020304050607080910

ADNS Animal Disease Notification System BSE Bovine spongiform encephalopathy BT Bluetongue CAC Codex Alimentarius Commission ECDC European Centre for Disease Prevention and Control EFSA European Food Safety Authority FAO Food and Agriculture Organisation of the United Nations FVO Food and Veterinary Office Incidence and prevalence The incidence of a disease is the disease occurrence in a defined population over a designated time period (number of new cases). The prevalence of a disease is the disease presence in a defined population in a designated time (actual number of cases). OIE World Organisation for Animal Health PAFF Standing Committee on Plants, Animals, Food and Feed TB Bovine tuberculosis Traces TRAde Control and Expert System TSE Transmissible spongiform encephalopathies WAHIS World Animal Health Information System WHO World Health Organisation Zoonosis Disease or infection that can be transmitted directly or indirectly between animals and humans. The ECA’s special reports set out the results of its performance and compliance audits of specific budgetary areas or management topics. The ECA selects and designs these audit tasks to be of maximum impact by considering the risks to performance or compliance, the level of income or spending involved, forthcoming developments and political and public interest. This performance audit was produced by Audit Chamber I — headed by ECA Member Augustyn Kubik — which specialises in preservation and management of natural resources spending areas. The audit was led by ECA Member Bettina Jakobsen, supported by the Head of her private office, Katja Mattfolk, and Kim Storup, Attaché; Colm Friel, Principal Manager; Armando do Jogo, Head of Task; Xavier Demarche, Manuel Dias, Andreas Dürrwanger, Oana Dumitrescu, Laure Gatter, Mary Kerrigan, Joanna Kokot, Michela Lanzutti, Joachim Otto, Lucia Rosca and Anna Zalega, auditors. From left to right: K. Mattfolk, A. do Jogo, C. Friel, B. Jakobsen, X. Demarche. Animal health has a direct impact on public health, because of food safety issues, and because some animal-borne diseases are transmissible to humans. Furthermore animal disease outbreaks can trigger significant economic costs, through loss of internal EU and export markets, and the direct cost of disease control on the EU and Member State budgets. Animal diseases can spread rapidly, and across borders. The EU has an active animal health policy and finances Member States’ programmes to eradicate, control, and monitor certain animal diseases. These programmes involved EU funding of 1.3 billion euro between 2009 and 2014 and cover actions such as animal vaccination, testing, and compensation for slaughtered animals. Depending on the type of disease, eradication is a complex exercise and can take many years. Therefore, there needs to be a sound approach at EU level, with appropriate programmes implemented by the Member States. The Court examined whether the eradication, control and monitoring programmes adequately contained animal diseases, by assessing the approach taken by the Commission, and Member States’ programme design and implementation. The Court also examined whether the cost-effectiveness of programmes was adequately considered. Overall the Court concluded that the animal disease programmes we examined adequately contained animal diseases. However, as disease outbreaks can always occur the Commission and the Member States should continue to be vigilant. We concluded that the approach taken by the Commission was generally sound, and was supported by good technical advice, risk analysis, and a mechanism for prioritising resources. The Commission provided guidance and facilitated coordination of Member States’ efforts, and established minimum performance criteria to be met by Member State programmes. There have been some notable successes, for example, decreases in cases of bovine spongiform encephalopathy (BSE) in cattle, salmonella in poultry, and rabies in wildlife. We concluded that Member State programmes we examined were generally well designed and implemented, and that Member States had adequate systems to identify animal disease outbreaks and facilitate their eradication. Nevertheless, the cost-effectiveness of programmes is difficult to determine, due to the lack of available models for such analysis. There were examples of insufficiently controlled programmes by the Member States or unreasonably high costs. In some cases in Italy, the amounts paid in compensation to farmers, or the payment reduction imposed by the Commission, provided limited incentive to encourage effective biosecurity measures and the implementation of corrective measures. We noted some specific areas with scope for improvement. The exchange of epidemiological information and the ready access to historic results could be better supported by the relevant information systems, but was in the process of being improved. The audit also found that some programmes should better specify the actions and controls to be implemented. While our assessment of the implementation of specific veterinary programmes was overall positive, the eradication of bovine brucellosis and tuberculosis, and ovine and caprine brucellosis, posed continuing challenges in some Member States. We found that the EU approach for considering diseases in wildlife should be complemented, notably for tuberculosis, and that the lack of certain vaccines can be detrimental to programme effectiveness. The Court recommends that the Commission should:

(a) facilitate the exchange of epidemiological information between Member States;

(b) examine whether the existing set of indicators should be updated to provide better information on veterinary control activities and the cost-effectiveness of programmes;

(c) systematically include, when relevant, the wildlife aspect in the veterinary programmes;

(d) support the availability of vaccines for use by the Member States when epidemically justified.

Animal health directly impacts public health, because some animal diseases are transmissible to humans, and because of food safety issues. Good animal health is also a basic requirement for the EU’s food industry. For many years therefore, the EU has enforced an extensive set of measures to protect animal health. The cost of dealing with emergencies and diseases, if existing measures do not function correctly, can be significant, with loss of internal EU and export markets, costs of disease control on the EU and Member State budgets, and costs to Member State health systems for treating zoonotic diseases (diseases transmissible to humans). The foot and mouth disease outbreak of 2001 which started in the UK but spread to other countries, is estimated to have cost up to 12 billion euros. The BSE crisis of the 1990s, which was also concentrated in the UK, cost over 3 billion euros in the UK alone and significantly decreased both the volumes and prices of EU beef exports. In recent years, no outbreak has arisen which has led to such significant costs. The type and incidence of animal diseases vary across the EU, depending on factors which include climate, farm types, veterinary practices, and animal movements. Some of the main animal diseases are described in Annex I. Moreover, recent outbreaks of African swine fever (Estonia, Latvia, Lithuania and Poland), avian influenza (Germany and Netherlands) or bluetongue (spreading from North Africa and affecting mainly Greece, Spain, Italy, Portugal) all spread quickly across borders. Some animal diseases can spread rapidly (see for example the case of bluetongue in Figure 1) if not quickly detected and effectively treated. Effective veterinary measures contribute to the prevention of such highly contagious diseases, and the avoidance of the necessity for emergency measures. The EU’s animal health legislative framework is complex. It involves hundreds of pieces of legislation, some of them adopted as far back as 1964. A systematic EU approach to animal disease eradication, control and monitoring was first introduced for some diseases in 1977. From 2009, the Council’s Decision on expenditure in the veterinary field, replaced in 2014, sets out the framework for these programmes. The EU’s Animal Health Strategy established goals related to health, economic issues, and farming practices as well as an action plan to achieve them. See Box 1 for details. Source: European Commission, DG Health and Food Safety. The EU Animal Health Strategy 2007-2013 sets out EU goals and actions. This strategy has four main goals:

1. To ensure a high level of public health and food safety by minimising the incidence of biological and chemical risks to humans.

2. To promote animal health by preventing/reducing the incidence of animal diseases, and in this way to support farming and the rural economy.

3. To improve economic growth/cohesion/competitiveness, assuring free circulation of goods and proportionate animal movements.

4. To promote farming practices and animal welfare which prevent animal health-related threats and minimise environmental impacts in support of the EU Sustainable Development Strategy.

These goals were implemented by an action plan of four pillars:

1. Prioritisation of EU intervention.

2. The EU animal health framework.

3. Prevention, surveillance and preparedness.

4. Science, innovation and research.

The Commission (DG Health and Food Safety) is responsible for risk management concerning animal diseases. Member States and EU specialised agencies — the European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control (ECDC) — are responsible for risk assessment. Since 1982, the EU has had a notification system to prevent the spread of certain contagious diseases. Member States are required to notify the Commission of an outbreak using the Animal Disease Notification System (ADNS) as well as its eradication for certain contagious diseases, so as to prevent their spread in EU livestock. The cost of dealing with previous disease outbreaks, together with the risk of dealing with future outbreaks of existing or emerging diseases, demonstrate the importance of the EU’s veterinary measures. The EU funds Member State veterinary programmes for a number of diseases and zoonoses (see Box 2), under the first pillar of the Animal Health Strategy. The objectives of these programmes are:

to progressively eliminate animal diseases and to implement disease monitoring measures in the Member States and the EU as a whole;

to ensure a high level of animal health, public health and consumer protection;

to guarantee a high level of protection of both animal health and public health, to encourage the improvement of the productivity of the livestock sector and to contribute to the economic sustainability of the sectors directly or indirectly affected by an animal disease outbreak.

Eradication programmes: The aim is the biological extinction of an animal disease or zoonosis, finally resulting in a free or ‘officially free’ status of the territory according to Union legislation (e.g. bovine tuberculosis). Control programmes: The aim is to maintain the prevalence of an animal disease or zoonosis below sanitary acceptable levels (e.g. salmonella). Surveillance/monitoring: The aim is to collect and record data in defined populations in order to assess the epidemiological evolution of the disease (e.g. avian influenza). Source:Commission Decision 2008/341/EC. These programmes are categorised as eradication, control, or surveillance programmes, and cover a wide range of measures including vaccination, testing of animals and compensation for slaughtering or culling. Over the period 2009-2014, the EU budget dedicated 1.3 billion euros for these programmes (see Table 1), which forms the bulk of expenditure under the EU food safety budget. The EU financial contribution is usually at the rate of 50 % of the cost incurred by the Member States, up to a maximum amount. Animal diseases and zoonoses which are eligible for EU financial contribution are listed in Annex I to Council’s 2009 Decision and from 2014 in Annex II to Regulation (EU) No 652/2014. Source: DG Health and Food Safety. Programme 2009 2010 2011 2012 2013 2014 2009-2014 % African swine fever 0.1 0.1 0.2 0.9 1.1 0.1 2.3 0.2 % Aujesky's disease 2.8 2.3 0.0 0.0 0.0 0.0 5.2 0.4 % Avian influenza 4.9 4.9 3.5 2.7 2.7 2.6 21.3 1.6 % Bluetongue 112.0 68.2 13.4 3.7 2.5 3.8 203.5 15.4 % Bovine brucellosis 11.8 8.6 10.1 8.0 7.3 10.3 56.0 4.2 % Bovine tuberculosis 26.3 53.4 67.9 70.7 63.9 64.2 346.4 26.2 % Brucellosis melitensis 9.0 7.7 15.9 15.4 15.3 16.2 79.4 6.0 % Classical swine fever 5.1 4.3 3.7 3.4 3.0 2.6 22.1 1.7 % Leucosis (EBL) 3.0 2.4 0.0 0.0 0.0 0.0 5.3 0.4 % Rabies 11.7 15.7 20.9 23.4 19.9 20.4 112.0 8.5 % Salmonellosis 18.6 24.4 25.1 19.2 19.2 21.2 127.8 9.7 % Swine vesicular disease 0.5 0.3 0.7 0.9 1.1 0.8 4.3 0.3 % TSE, BSE and scrapie 61.5 81.8 74.6 54.3 38.9 24.0 335.0 25.4 % Total 267.4 274.1 236.0 202.3 174.9 166.1 1 320.8 100.0 % Annual budget as percentage of total budget for the period 20.2 % 20.8 % 17.9 % 15.3 % 13.2 % 12.6 % 100.0 % Over 50 % of costs are concentrated in four countries (Spain, France, Italy and the United Kingdom) (see Figure 2). Source: DG Health and Food Safety. In practice, it can be very difficult to eradicate animal diseases. For example, bovine tuberculosis and brucellosis have not yet been eradicated in several Member States, although efforts to control or eradicate them have been in place for more than 50 years. The EU started funding programmes to eradicate these diseases in the 1970s, at which time some Member States already had their own national programmes for many years. Table 2 shows that it can take decades to acquire an ‘officially disease free’ status, despite the efforts of Member States and the Commission, and continuing scientific and technical advances. Some countries have however been quicker than others. The continuing presence of such diseases leads to recurring expenditure from the EU budget on the eradication programmes. Source:Commission decisions to fund eradication programmes, and to recognise officially free status, for the audited Member States. Bovine tuberculosis Bovine brucellosis Member State First EU-funded programme Recognition of disease officially free status Number of years to become officially disease free First EU-funded programme Recognition of disease officially free status Number of years to become officially disease free Ireland 1978 Still not disease free 1978 2009 31 Spain 1987 Still not disease free 1987 Still not disease free France 1978 2001 23 1978 2005 27 Italy 1980 Still not disease free 1980 Still not disease free Poland 2004 2009 5 2004 2009 5 Romania No EU-funded programmes Still not disease free No EU-funded programmes, and recognised disease free in 2014 UK 2000 Still not disease free 1978 2015 37 The OIE, the World Organisation for Animal Health, in its 2014 guidelines for animal disease control, highlights the importance of international cooperation and indicates that where possible, countries should act on a regional basis to harmonise disease control programmes. This is important as diseases can be carried across borders, particularly by wildlife. There is no provision in the regulations for the Commission to directly finance veterinary programmes outside the EU. However, Member States can agree veterinary actions (such as vaccination campaigns in a border strip) directly with neighbouring non-EU countries and include the related costs as sub-programmes of their veterinary programmes financed by the Commission. Concerning the rabies programmes, in 2015 there were four sub-programmes performed in non-EU countries: Russia (part of the Finnish programme), Belarus (part of the Latvian and Lithuanian programmes) and Ukraine (part of the Polish programme since 2012). A further five were at the planning stage: Russia (part of the Estonian programme), Ukraine (part of the Hungarian programme), Moldavia (part of the Romanian programme), Bosnia and Herzegovina (part of the Croatian programme) and Belarus (part of the Polish programme). Given the complexity of the various bilateral relationships, ensuring sufficient cooperation for effective implementation of sub-programmes outside the EU can be a challenge. The Commission has taken other measures to harmonise disease control programmes with non-EU countries. DG Neighbourhood and Enlargement Negotiations and DG Health and Food Safety launched an Instrument for Pre Accession project in 2011 to provide support for the control and eradication of animal diseases (e.g. rabies and classical swine fever) in seven beneficiary countries of the western Balkans: Albania, Bosnia and Herzegovina, Croatia, the Former Yugoslav Republic of Macedonia, Montenegro, Serbia and Kosovo. Approximately 100 million euros were available for the project. The Commission (DG Health and Food Safety) manages the ADNS and coordinates emergency measures in the event of an outbreak of a contagious animal disease. The Commission implements veterinary programme expenditures under direct management. DG Health and Food Safety’s Food and Veterinary Office (FVO) verifies that EU requirements for the safety and quality of food, and veterinary measures are being satisfied. A Commission Decision from 2008 sets out the criteria for Member State programmes in order to be approved for EU funding. It provides that in the Member States, the programmes shall be under the control of the central veterinary authority. Programmes should contain targets, with yearly interim targets if the programme is multiannual; and appropriate indicators (such as incidence and prevalence) should be established and reported on. The detailed implementation and management of the programmes, including any sharing of responsibilities between the public and private sector, is a Member State competence. Member States may submit their proposals for programmes to the Commission by 31 May of the previous year. These programmes can be set up as annual or multiannual programmes. The majority of programmes are annual. The Commission assesses the quality of Member States’ proposed programmes using established criteria, and, when epidemically justified, encourages coordination between bordering Member States. Since 2013, the Commission has used expert assistance for this assessment process. The list of programmes is presented to the Member States at the Standing Committee on Plants, Animals, Food and Feed (PAFF). The Commission adjusts the funding allocation for different diseases and Member States each year based on its assessment of evolving needs. Any changes are discussed with the Member States through the PAFF. The Commission’s assessment is based on data submitted by Member States, FVO reports, financial audit reports, and results of a specific Task Force composed of Member State experts. More details of the main responsibilities are set out in Annex II. A Commission Decision from 2008 defines standard reporting requirements, including templates and reporting schedules, to be used by the Member States for reporting to the Commission. During the implementation of the programmes the Member States send an intermediate report which is assessed by the Commission and may result in an amendment of the programme targets and costs, and a reallocation of financial resources between programmes. Final reports and payment applications have to be submitted to the Commission by 30 April of the following year including the assessment of the results achieved and a detailed account of expenditure incurred. The audit examined whether the animal disease eradication, control and monitoring programmes adequately contain animal diseases. The detailed questions were:

(i) Did the Commission have an appropriate approach for the eradication, control and monitoring of animal diseases?

(ii) Did Member States design and implement appropriate programmes to eradicate, control and monitor animal diseases?

(iii) Did the programmes adequately consider cost-effectiveness?

The audit work was performed at the Commission (DG Health and Food Safety) and in seven Member States (Ireland, Spain, France, Italy, Poland, Romania and the United Kingdom), which together represent 72 % of total expenditure, and a variety of different diseases. The views of the organisations of the main stakeholder groups (farmers, veterinary services and laboratories), and an expert panel organised by the Court, were also obtained. The audit examined the Commission’s procedures used to define the strategy and to approve annual and multiannual national programmes submitted by the Member States. This included an examination of relevant opinions and communications from the Commission services (including the FVO), regulatory committees (PAFF, Task Force) agencies (EFSA), and expert reviews initiated by the Commission. In addition to the above programmes, the EU also funds emergency measures to deal with serious outbreaks of animal diseases. The audit did not examine these measures as expenditure represents around 10 % of expenditure on the eradication, control and monitoring programmes. The audit at Member State level examined national strategies for the eradication, control and monitoring of animal diseases, the criteria used by Member States to develop programmes, and how the programmes are implemented in practice. Member States’ competent veterinary authorities, and relevant regional authorities, were visited. The audit included substantive testing in order to check if the funded actions were carried out as planned and costs were reasonable. According to the OIE, the desired goal of a disease control programme should be defined from the outset. While eradication has traditionally been the goal for many disease control programmes, this is not always achievable. Specific objectives and indicators leading to the success of the programme should be established. Figure 3 presents steps for the establishment of a disease control programme. Source: OIE Guidelines for Animal Disease Control, 2014. Given the complex and heterogeneous situation concerning animal diseases in the EU, it is important that the Commission applies a sound framework for prioritising its funding efforts, coordinating Member State efforts, providing guidance and facilitating best practices. This should include appropriate reporting on performance. The audit identified that the Commission’s approach for the eradication, control and monitoring of zoonoses and other animal diseases was generally sound and was supported by appropriate technical advice and risk analysis to deal with evolving risks/outbreaks. The EU’s animal health policy is well developed, with rules for identification, traceability, welfare, outbreaks and sanitary checks. This is also essential for facilitating trade. However, the current EU animal health legislative framework involves almost 50 basic directives and regulations and some 400 items of secondary legislation, some of them adopted as early as 1964. This complex legislative tapestry is scheduled to be consolidated and replaced by a new Animal Health Law, for which a political agreement was reached in June 2015. From 2007, EU eradication, monitoring and control programmes were part of the EU Animal Health Strategy, which expired in 2013 and has not yet been replaced — pending the adoption of the new Animal Health Law. Overall, we considered the Commission’s approach based on funding of priority eradication, control and monitoring programmes at Member State level reasonable. The framework for directing resources to animal disease programmes is based on annual assessments by the Commission of funding priorities (considering issues such as public health impact, production losses, and trade issues), which were discussed with Member State experts. The Commission also has a sound system for assessing the quality of the programmes proposed by Member States, which involves the use of comprehensive assessment criteria covering such aspects as the clarity of programme objectives and management, the historical evolution of the targeted disease, the scientific justification and the efficiency of proposed measures. The criteria for prioritising resources between diseases were not sufficiently developed for the audited programmes. However, with the adoption of an approach to multiannual work programmes for 2016-2017 and the related Commission guidance, this prioritisation is being gradually improved. Animal diseases are not restricted by country borders. Disease can be spread by movements of both farmed and wild animals, as well as other vectors. Programmes would therefore be strengthened by good coordination between countries when epidemically justified. There is, however, no legal requirement for Member States to submit coordinated programmes, nor to work together in their implementation. We found that overall, the Commission provides appropriate guidance to, and facilitates coordination between Member States:

There are regular contacts between the Commission and Member States at the Standing Committee on Plants, Animals, Food and Feed and meetings of Member State Chief Veterinary Officers.

Task Forces bring together Member State experts in specific diseases and make recommendations to improve veterinary programmes.

The Commission uses external experts to review proposed programmes on the basis of comprehensive assessment criteria.

The Commission’s Food and Veterinary Office performs audits in Member States.

The Animal Disease Notification System enables disease outbreaks to be quickly notified.

EU reference laboratories work to standardise and improve methodologies.

The Commission provides training courses to Member State officials.

From 2014, DG Health and Food Safety provided guidance on the use of a new online application, and the standard formats to be used by Member States, required by the regulations, ensure a certain harmonisation and quality.

The existence of an EU co-financing framework provides added incentives for the Member States to eradicate animal diseases including zoonosis and there have been some notable successes. It has also led to a positive impact on the human health situation, with resulting cost savings. For example, EFSA estimated in 2012 that the overall economic burden of human salmonellosis could be as high as 3 billion euros a year. In recent years the number of cases has decreased significantly, as shown in Figure 4. EFSA has concluded that this reduction is mainly the result of successful Member State salmonella disease control programmes in fowl (Gallus gallus), which have reduced the occurrence of salmonella in eggs. Source: DG Health and Food Safety. Another example is rabies where between 2005 and 2014, the total number of rabies cases at EU level has decreased very significantly from 3708 cases to 305 in the EU-28. The measures implemented by the Commission to eradicate BSE in the EU has been particularly successful. The number of BSE cases reduced from more than 2000 cases in 2001, to 10 in 2014, as indicated in Figure 5. The main measures taken include the removal of Specified Risk Material from feed and food chains; a ban on feeding mammalian meat and bone meal to cattle, sheep and goats; and the testing of millions of cattle each year. The frequent updates of legislation in the latest years and research funding have led to a more limited and better targeted testing for BSE. The Commission coordinates well at international level and in particular with the OIE, concerning the categorisation of Member States on the geographical BSE risk level. The programmes for the eradication of bovine tuberculosis also follow a long-term approach, with the trend of disease prevalence decreasing in most Member States. These two diseases represent approximately half of EU programme expenditure (see Table 1). Source: DG Health and Food Safety. Member States are responsible for preparing their eradication, control and monitoring programmes, which address their specific priorities concerning animal diseases based on appropriate indicators. In most cases, Member States have years of experience in dealing with the different animal diseases. The Commission can request, but not force, Member States to propose programmes as well as to change their strategy. Furthermore, when an outbreak posing a risk of cross-border infection occurs, Member States are obliged to implement specific measures provided by the sectorial legislation, whether or not these measures are co-financed by the EU. Member State programmes must meet the minimum criteria established by the Commission in order to be eligible for Community funding. These criteria require the programmes to contain information on, inter alia, objectives, duration, targets, indicators (e.g. disease incidence and prevalence), animal testing, vaccination, and administration. The complexity of the programmes is closely linked to the epidemiological characteristic of the disease concerned. Programmes can comprise a wide range of measures such as: a comprehensive surveillance regime, blood sampling, specific measures for identification of reactors, post-mortem examination, laboratory analysis, compensation schemes for farmers, wildlife surveillance, and computerised systems for the testing and disease management. The Court found that Member States’ programmes we examined are generally well designed and adapted to the epidemiological situation. Approved programmes complied with the required criteria, usually described well the measures to be taken, followed the Commission’s standard templates, and generally led to positive results (see Box 3). The Member States have adequate systems in place to identify animal disease outbreaks in livestock and to facilitate their eradication. The EU TRAde Control and Expert System (Traces) for animal identification and movement control is well-developed and facilitates disease control. TSE programmes are implemented and co-funded by the EU in all Member States and received a large part of the EU funding for veterinary programmes during the audited period (see Table 1). In Ireland, the programme received a total of 17 million euros from 2009 to 2014. While EU funds have been reduced from 4.7 million euros in 2010 to 0.8 million euros in 2014, good performance has been achieved, in particular due to:

Active and passive surveillance systems aimed at detecting BSE cases.

If a case of the disease is identified, epidemiological investigations are carried out and cohort and progeny animals are slaughtered.

Prohibition of feeding products of animal origin to farmed animals.

In 2014, there were no cases of BSE in Ireland. This compares with three cases in 2012 and 2011, and the peak of over 400 cases in the 1990s. The Council Decision on veterinary expenditure required the Commission to report to the European Parliament and the Council every 4 years, on the animal health situation and cost-effectiveness of the implementation of veterinary programmes. OIE guidance provides that the decision on the most appropriate intervention options should take into account cost–benefit considerations as well as zoonotic potential and the likelihood of success of a particular set of disease control measures. As indicated in Table 1, the yearly direct cost to the EU budget of veterinary programmes is of the order of 200 million euros per year. In addition to this, Member States spend a greater amount, to cover both their share of the costs of the funded programmes, and other veterinary action they have determined to be necessary. Furthermore farmers and the food sector bear costs linked to veterinary expenses, herd replacement, reduced production, animal movement restrictions, and lost markets. The potential benefits of programmes can be grouped in two main categories:

The improvement of both public and animal health: reducing disease prevalence/incidence; safeguarding public health (in the case of zoonosis); and fulfilling their role as a key disease prevention/management tool in the context of the EU Animal Health Strategy.

Benefits in economic terms for the EU as whole: protecting the value of the sector; contributing to market stability; ensuring safe trade; increasing extra- EU trade; and reducing human health costs.

In implementing the EU budget, the Commission has to follow the principles of sound financial management, and funded actions should be economical, efficient and effective. This implies that the programme results should be justifiable related to their costs. The Court recognises that it is very difficult in practice to monetise the health benefits deriving from animal health policy, particularly for zoonoses, where the main benefit is the avoidance of human infection and in some cases the saving of lives. The audit noted a lack of available models and economic indicators to allow the Commission to perform a cost-effectiveness analysis of proposed programmes, and consequently the Commission does not perform such an analysis. In its most recent report (2014) on the animal health situation and cost-effectiveness of veterinary programmes, which was required by the underlying Council Decision, the Commission provided information on costs and results. The Commission recognised in this report that there was a need to better demonstrate the cost-effectiveness of veterinary expenditure. In practice, the information contained in the approved programmes and subsequent implementation reports provide detailed information on costs, and also indicators related to activities and performance. While most of the costs (sampling, labs analysis, salary of veterinarians, costs for compensation, etc.) and the qualitative benefit (public health, enhanced export opportunity, etc.) were indicated in programmes, there was a lack of available models and information to assess the cost-effectiveness of financed activities. For example, the EU reaction to the BSE crisis saved lives, contributed to better food safety, improved the quality of controls, and restored consumer confidence — but the cost-effectiveness of the programme cannot be assessed. We also examined whether there was evidence that the costs incurred by the audited programmes were reasonable. The audit noted certain cases, previously identified by the Commission, where some costs were unreasonably high, or not sufficiently controlled by Member States, as illustrated in Box 4. In these cases remedial action has been taken by the Commission.

1. In Poland, the vaccines used in the annual rabies eradication programmes were purchased at regional level. Between 2002 and 2009 the number of detected cases of rabies in the fox population reduced very significantly, from 884 to 6. However, in 2010 and 2011 the number of detected cases rose rapidly again, to 117 and 103 respectively. These were concentrated in the Małopolska and Podkarpackie regions. The average price of one of the vaccines purchased in Poland for use on wild foxes from 2011 to 2013 was significantly higher than the average price paid in the EU, although the volumes of vaccines supplied to Poland were also the highest in the EU (over 10 million doses each year). Given the economies of scale this does not appear logical. The Commission applied financial reductions and requested the Polish authorities to take action to reduce excessive vaccine prices, notably by organising a single national call for tenders.

2. In Romania, the national authorities did not correctly control the implementation of the contracts for the aerial distribution of rabies vaccines for use on wild foxes in 2013 and an insufficient number of vaccines were distributed. Furthermore, the national authorities did not take sufficient samples to test the effectiveness of the vaccination campaign (procedures were improved in 2014). As a consequence, the Commission did not reimburse the vaccination campaign.

The compensation payable to farmers for animals destroyed under disease eradication programmes is required by the legislation not to exceed the market value for healthy animals. This aims at setting a fair compensation level; discouraging fraud; and encouraging the participation of farmers in the programme. However, the EU legislation does not specify how market prices should determine compensation payable; this is determined by Member States in the specific legislation. For example, there is no requirement for Member States to base compensation amounts on the Community scales for the classification of carcasses and their associated prices. Overcompensation may discourage the effective implementation of biosecurity measures. In Italy, the levels of compensation paid for animals destroyed under veterinary programmes were sometimes higher than market prices for healthy animals. For example, in 2012, farmers received an average of 87 euros and up to 111 euros for each sheep destroyed under eradication programmes; but the average market price for carcasses from healthy slaughtered sheep at the time was less than 60 euros. In cases where compensation exceeded the market price, the detection of animal diseases on a farm can be regarded as a windfall opportunity to restock the herd. Furthermore, farmers who might otherwise have valued a ‘disease free’ status may be discouraged from implementing effective biosecurity measures. In the UK, compensation payable for cattle in England is based on average market prices from the previous month. Compensation for cattle in Northern Ireland and Wales is based on individual valuations which generally lead to higher levels of compensation than in England, and which may discourage farmers from implementing effective biosecurity measures. Following an unfavourable assessment of the technical results of the bovine and ovine brucellosis eradication programmes in a region of Italy (Sicily), the Commission imposed payment reductions of over 7 million euros for the years 2005 to 2012. In 2011, the entire brucellosis programme in Sicily was declared ineligible because of non-performance of a vaccination plan. However, by applying the national system of allocation of resources between the regions, the Italian authorities did not pass on this level of reduction to the regional authorities in Sicily, but rather shared it across all Italian regions (the majority of which had implemented the eradication programme properly). Thus, there was a limited incentive for the authorities in Sicily to improve veterinary measures. The following paragraphs set out areas where we consider that there is scope for improvement to the Commission’s approach and to the Member State programmes. Europe’s Animal Disease Notification System (ADNS) is designed to notify standard information on disease outbreaks. It was not designed to have epidemiological management features or to provide historical information and analyse data. It therefore provides little added value when compared with the OIE’s World Animal Health Information System (WAHIS), which all Member States are required to use. These two systems both provide information about the number and location of new outbreaks, but there is no interface between them allowing for an automatic exchange of information. In order to better manage animal health threats, Member States have developed their own information systems dealing with epidemiological data. There is, however, not a common system to facilitate the exchange of information and a better coordination of control activities between Member States. Since 2012, a joint project between the Commission and OIE has worked on linking the ADNS and WAHIS systems with a common interface called Animal Disease Information System (ADIS). A Commission Decision from 2008 sets programme output indicators, which Member States are obliged to report on. In addition, the Commission established a methodology to set performance indicators, which requires Member States to improve their performance in terms of disease prevalence/incidence by a minimum percentage over a specified period. Furthermore, the Commission developed an extensive set of indicators (over 100) which Member States should use. These include output or activity-related indicators, such as the number of animals vaccinated and tests carried out; and also indicators linked to results such as changes in rates of incidence or prevalence. While recognising that there is already an extensive set of indicators, we consider that there is some scope for further improvement, particularly relating to the technical implementation of the programmes. No economic indicators are included that would allow an analysis of the cost-effectiveness of proposed programmes (see paragraphs 41 and 42). The Commission requires Member States to follow a standard template when drafting their veterinary programmes. This includes information on the evolution of the disease in recent years. In addition one of the criteria used by the Commission (see paragraph 28) to assess draft programmes concerns the quality of the data on disease evolution over the last 5 years. We noted that while such historical data was available in most cases, for three of the 24 Member State programmes concerned by the audit, the Commission’s independent evaluators identified that recent draft programmes did not contain enough satisfactory historical information. In these cases, the relevant information was requested by the Commission and provided by the Member States concerned. At the time of the audit the Commission was developing an information system to allow the ready retrieval and analysis of historical information from previous Member State programmes, and introduced a standard electronic reporting system for Member States to send key documents relating to their veterinary programmes. These developments should facilitate the future analysis of programmes. Overall most programmes justified the measures to be taken and the results to be achieved. However, we consider that veterinary measures would benefit from being better described in some programmes as well as the actions taken following FVO recommendations and Task Force advice. In two of the 24 Member State programmes concerned by the audit, the Commission’s independent evaluators made similar remarks. The eradication programmes for some diseases in certain Member States last decades (see paragraph 9). While decreasing, the prevalence of bovine tuberculosis in the UK and Ireland is still relatively high (see Figure 6) compared to other Member States. In the UK, an increase since 2013 of the tuberculosis testing frequency in low incidence areas from once every 4 years to once a year has led to a higher detection of cases. However, there are still significant challenges inherent to the tuberculosis eradication programme in the UK, with a very high incidence in some regions. Source: DG Health and Food Safety. In Italy, ovine and caprine brucellosis are difficult to eradicate due to a lack of full cooperation from farmers in some regions. The generous compensation scheme (see paragraph 45) may also be a factor. However, prevalence at national level is falling, and had reached 1.2 % in 2014, compared with 3.7 % in 2008. Over the same period, prevalence in Sicily decreased from 11.9 % to 3.4 %. We note that the Commission, in its 2014 report to Parliament and Council on the outcome of EU co-financed veterinary programmes, also noted that the results achieved by the UK bovine tuberculosis programme and the Italian brucellosis programmes were a cause of concern. The Court also recognises that the Commission encourages Member States to take action in such cases through the follow up of recommendations made by the Task Force and the FVO. Direct or indirect contacts between wildlife and domesticated animals can lead to the spread of disease, or complicate the effective implementation of animal disease programmes. For example, rabies can be spread from wild foxes, and bovine tuberculosis can be spread by badgers, boar and deer. There are several OIE publications on the monitoring of wildlife diseases, as well as a related international agreement on disease notification. While the purchase of rabies vaccines for wildlife is included in Member State programmes, the EU does not have a specific approach to combat tuberculosis in wildlife. There are no legislative provisions at EU level for tuberculosis eradication in animal species other than cattle (e.g. wild goats, and other wildlife). In particular, in the UK, badgers are protected by national legislation which may complicate the effective implementation of the bovine tuberculosis eradication programme. According to the OIE, the ready availability of suitable veterinary vaccines and antigens is essential for animal health programmes. There are a number of EU initiatives and research projects aimed at detecting emerging viruses and promoting the availability of vaccines. Depending on the disease, there may be very few, if any, suitable vaccines available for use in the EU. However, vaccination is one of the essential tools available to implement an effective ‘prevention is better than cure’ approach. The reasons why vaccines are not always available are complex. Recent research has tended to show that besides the technical difficulties in their development, there is insufficient financial interest for the pharmaceutical industry to seek authorisation to use certain vaccines in the EU. Box 5 illustrates some practical difficulties caused by a lack of suitable vaccines. At European level, there is no legal framework for the joint procurement of vaccines, nor a general bank of vaccine stocks. The process to purchase vaccines following a call for tenders by Member States can take several months, and in the meantime the virus may continue to spread into the animal population. We noted that the new Animal Health Law currently under discussion by the legislative authorities would widen the Commission’s capacity to establish vaccine banks. There are over 20 variants (serotypes) of the bluetongue virus (an insect-borne, viral disease of ruminants). In Italy, six variants have been identified. No polyvalent vaccines (effective against several strains of the virus) are currently recognised in the EU. It is therefore difficult in such cases to envisage the use of vaccines. In France, during the bluetongue crisis of 2008, there were limited stocks of the vaccine. The French authorities therefore had to procure extra supplies urgently. This was both expensive and time consuming, and the national authorities considered that the 520 cases of bluetongue detected in Ile et Villaine may have been avoided if vaccines had been available sooner. At the time of the first bluetongue outbreak serotype S4 in Spain (Extremadura region), not enough vaccine against this serotype was available. Hence, the vaccination campaign was postponed to the following year in order to restrain the disease during the next possible viral propagation period. Animal diseases cause significant economic costs and are a risk to both animal and human health. Diseases can spread across borders, and previous disease outbreaks have cost billions of euros. The EU therefore aims to protect animal health and funds Member States’ programmes to eradicate, control and monitor specific animal diseases. These programmes cover actions such as sampling, laboratory analysis, compensation payments for destroyed animals, and vaccination campaigns. EU expenditure has been decreasing in recent years, and no major crisis comparable to the foot and mouth disease outbreak of 2001 has occurred recently. However, the EU needs to be prepared to deal with future crises, and it can take many years for eradication programmes to result in a disease-free status. The audit examined whether the animal disease eradication, control and monitoring programmes adequately contain animal diseases. This involved examining whether the Commission’s approach was appropriate; whether Member States designed and implemented appropriate programmes, and whether the cost-effectiveness of programmes was adequately considered. Overall the Court concluded that the animal disease programmes we examined adequately contained animal diseases. However, as disease outbreaks can always occur the Commission and the Member States should continue to be vigilant. The Commission’s strategy for the animal disease programmes was generally sound: Commission actions were supported by good technical advice; there was a well-developed policy for animal health; and there was an established framework for prioritising budget resources on priority programmes. The approach taken to eradicate BSE has been particularly successful. Other good examples are the reduction in cases of zoonotic salmonella and rabies. The underlying legislation remained complex, and the prioritisation of funding between diseases was being gradually improved (paragraphs 26 to 33). We found that Member States programmes were generally well designed and implemented. Programmes met the required criteria, and Member States had adequate systems to identify animal disease outbreaks and facilitate their eradication (paragraphs 34 to 36). We found that while the Commission was required to report on the cost-effectiveness of veterinary programmes to the European Parliament and Council, there is a lack of suitable models to do so. Approved programmes and subsequent implementation reports provide information on costs and results, but the cost-effectiveness of programmes is difficult to determine (paragraphs 37 to 42). Concerning costs, the audit noted examples of insufficiently controlled or unreasonably high costs, which were previously identified by the Commission. In some cases in Italy, the amounts paid in compensation to farmers, or the payment reduction imposed by the Commission, had a limited incentive effect to encourage effective biosecurity measures and the implementation of corrective measures (paragraphs 43 to 47). We identified some specific areas with scope for improvement. The exchange of epidemiological information between Member States could be better supported by information systems (paragraphs 49 and 50). The Commission established a detailed set of minimum programme output indicators to be used by the Member States. We found that the information relating to veterinary measures, as well as follow-up action to earlier recommendations by the FVO and Task Force could be better described in some Member State programmes. At the time of the audit, there was not always sufficient readily available historical information on the evolution of diseases. However, a database to record technical programme indicators was being developed, and the Commission had introduced a new electronic reporting system (paragraphs 51 to 53). We noted some programmes where progress was slow: notably the eradication of bovine tuberculosis in the UK and Ireland, and ovine and caprine brucellosis in the south of Italy (paragraphs 54 to 56). Wildlife can spread disease in domestic animals (and indeed people) and therefore needs to be considered when developing an approach to animal health and the funding of animal disease programmes. We found that the EU approach for considering diseases in wildlife should be complemented, notably for tuberculosis (paragraphs 57 and 58). Vaccines are a key tool for certain eradication programmes. The Court noted that depending on the disease, there may be few, if any, suitable vaccines. In particular, we found that the lack of vaccines to treat bluetongue adversely affected programmes in Italy, France and Spain. Furthermore, at the time of the audit, there was no legal framework for the joint procurement of vaccines, nor a general bank of vaccine stocks at European level (paragraphs 59 and 60). In order to further improve the eradication, control and monitoring of animal diseases, the Commission should:

(a) facilitate the exchange of epidemiological information between Member States;

(b) examine whether the existing set of indicators should be updated to provide better information on veterinary control activities and the cost-effectiveness of programmes;

(c) systematically include, when relevant, the wildlife aspect in the veterinary programmes;

(d) support the availability of vaccines for use by the Member States when epidemically justified.

This report was adopted by Chamber I, headed by Mr Augustyn KUBIK, Member of the Court of Auditors, in Luxembourg at its meeting of 3 February 2016. For the Court of Auditors Vítor Manuel da Silva Caldeira President

ANNEX

ANNEX I ANIMAL DISEASE INFORMATION

Source: OIE and EFSA. What is it? How does it spread? What is the public health risk? What are the clinical signs? How is it diagnosed? How can it be prevented or controlled? Avian influenza Avian influenza (AI), caused by the influenza virus Type‘A’, can affect several species of food producing birds (chickens, turkeys, quails, guinea fowl, etc.), as well as pet birds and wild birds with some strains resulting in high mortality rates. The virus has also been isolated from mammalian species including humans, rats and mice, weasels and ferrets, pigs, cats, tigers and dogs. Several factors can contribute to the spread of AI viruses including globalisation and international trade (legally and illegally), marketing practices (live bird markets), farming practices and the presence of the viruses in wild birds. AI viruses can be spread through direct contact with secretions from infected birds, especially faeces or through contaminated feed, water, equipment and clothing. While AI is primarily a bird disease, it can cross from birds to humans. AI viruses are highly species-specific, but have, on rare occasions, crossed the species barrier to infect humans. Transmission to humans has occurred when there is close contact with infected birds or heavily contaminated environments. In the mild form, signs of illness may be expressed only as ruffled feathers, reduced egg production, or mild effects on the respiratory system. In the severe form of the disease, the virus not only affects the respiratory tract, as in the mild form, but also invades multiple organs and tissues that can result in massive internal haemorrhaging. AI may be suspected on the basis of clinical signs and events leading to the disease. Laboratory tests are required to confirm the diagnosis. Around the world, surveillance measures have been put in place to detect the presence of infection in poultry according to OIE standards for the surveillance of AI. African swine fever African swine fever (ASF) is a highly contagious haemorrhagic disease of pigs, warthogs, European wild boar and American wild pigs. All age groups are equally susceptible. With high virulence forms of the virus, ASF is characterised by high fever, loss of appetite, haemorrhages in the skin and internal organs, and death in 2-10 days on average. Mortality rates may be as high as 100 %. The warthog can serve as a natural reservoir of the virus without sign of disease. Spread from this reservoir is via the soft tick Ornithodoros moubata. The tick will ingest the virus when taking a blood meal and then pass it on when feeding on susceptible animals. Biting flies and ticks, contaminated premises, vehicles, equipment or clothing can also spread the virus to susceptible animals. ASF is not a human health threat. The severity and distribution of the lesions also vary according to virulence of the virus. Severe cases of the disease are characterised by high fever and death in 2-10 days on average. The mortality rate can be as high as 100 %. Other clinical signs may include loss of appetite, depression, redness of the skin of the ears, abdomen, and legs, respiratory distress, vomiting, bleeding from the nose or rectum and sometimes diarrhoea. Abortion may be the first event seen in an outbreak. ASF may be suspected based on clinical signs and confirmation must be made through prescribed laboratory tests, particularly to differentiate this disease from classical swine fever (CSF). There is no published treatment or vaccine for ASF. All successful eradication programmes have involved the rapid diagnosis, slaughter and disposal of all animals on infected premises, thorough cleaning and disinfection, disinsectisation, movement controls and surveillance. Brucellosis Brucellosis is a contagious disease of livestock with significant economic impact. The disease is caused by various bacteria of the family brucella, which tend to infect a specific animal species. However, most species of brucella are able to infect other animal species as well. It affects cattle, swine, sheep and goats, camels, equines, and dogs. It may also infect other ruminants, some marine mammals and humans. Brucellosis is typically spread when the animal aborts or gives birth. High levels of bacteria are found in the birth fluids of an infected animal. The bacteria can survive outside the animal in the environment for several months, particularly in cool moist conditions. They remain infectious to other animals which become infected by ingesting the bacteria. The bacteria also colonise the udder and contaminate the milk. Brucellosis is an important disease in wildlife, infecting feral pigs, bison, elk and European hares. The reservoir of disease in wildlife complicates eradication efforts. Brucellosis is a zoonosis highly infectious for humans causing a disease often called undulant fever or Malta fever. Symptoms in humans include intermittent or irregular fever, headache, weakness, profuse sweating, chills, weight loss and general aching. Infections of organs including the liver and spleen may also occur. Veterinarians, farmers, and abattoir workers are vulnerable to infection as they handle infected animals and aborted foetuses or placentae. The disease can also spread to people through consumption of unpasteurised milk coming from infected animals. Typically the disease is mild, with the infected animal showing few signs until she aborts. There may be swelling of the testicles in males, and occasionally the bacteria localises in the joints causing arthritis. The importance of brucellosis is that it causes poor reproductive performance, due to abortions, infertility, retention of placenta, stillbirth or birth of weak offspring. It results in huge economic losses to dairy, sheep, goat and pig farmers. The disease may be suspected based on clinical signs such as abortions, but confirmation is made through serological tests, then with prescribed laboratory tests to isolate and identify the bacteria. Surveillance using serological tests, as well as tests on milk like the milk ring test, can be used for screening and play an important role in campaigns to eliminate the disease. As well, individual animal testing both for trade and for disease control purposes is practiced. Bluetongue Bluetongue (BT) is a non-contagious, viral disease affecting domestic and wild ruminants (primarily sheep and including cattle, goats, buffalo, antelope, deer, elk and camels) that is transmitted by insects, particularly biting midges of the Culicoides species. The virus which causes BT is identified as a member of the Reoviridae family. Twenty-four (24) different serotypes have been identified and the ability of each strain to cause disease varies considerably. In highly susceptible sheep, morbidity can be as high as 100 %. The insect vector is the key to transmission of BT virus between animals. Vectors are infected with BT virus after ingesting blood from infected animals. Without the vector, the disease cannot spread from animal to animal. There is no public health risk associated with BT. In infected sheep, clinical signs vary and can include fever; haemorrhages and ulcerations of the oral and nasal tissue; profuse diarrhoea, vomiting, pneumonia; ‘blue’ tongue as a result of cyanosis (rare); pregnant ewes may abort. BT may be suspected based on typical clinical signs, prevalence of required insect vectors and particularly in areas where the disease is endemic. Laboratory tests are required to confirm the diagnosis. In endemic areas, sentinel monitoring programmes actively sample animals in sentinel herds to monitor for presence of the virus. Vaccination is used as the most effective and practical measure to minimise losses related to the disease and to potentially interrupt the cycle from infected animal to vector. It is essential to use a vaccine designed to provide protection against the specific strain (or strains) of virus of concern in a particular area. Bovine tuberculosis Bovine tuberculosis (TB) is a chronic disease of animals caused by a bacteria called Mycobacterium bovis, (M.bovis) which is closely related to the bacteria that cause human and avian tuberculosis. This disease can affect practically all mammals, causing a general state of illness, coughing and eventual death. The disease is contagious and spread by contact with infected domestic and wild animals. The usual route of infection is by inhaling infected droplets which are expelled from the lungs by coughing. Calves and humans can also become infected by ingesting raw milk from infected cows. Humans can be infected both by drinking raw milk from infected cattle, or by inhaling infective droplets. It is estimated in some countries that up to 10 percent of human tuberculosis is due to bovine TB. TB usually has a prolonged course, and symptoms take months or years to appear. The usual clinical signs include: weakness, loss of appetite, weight-loss, fluctuating fever, intermittent hacking cough, diarrhoea, large prominent lymph nodes. The standard method for detection of TB is the tuberculin test, where a small amount of antigen is injected into the skin, and the immune reaction is measured. Definitive diagnosis is made by growing the bacteria in the laboratory, a process that takes at least 8 weeks. The standard control measure applied to TB is test and slaughter. Disease eradication programmes consisting of post mortem meat inspection, intensive surveillance including on-farm visits, systematic individual testing of cattle and removal of infected and incontact animals as well as movement controls have been very successful in reducing or eliminating the disease. Pasteurisation of milk of infected animals to a temperature sufficient to kill the bacteria has prevented the spread of disease in humans. Bovine spongiform encephalopathy (BSE) BSE is a progressive, fatal disease of the nervous system of cattle. The disease has a long incubation period of 4 to 5 years and there is currently no treatment or vaccine for the disease. BSE is one of a group of diseases known as transmissible spongiform encephalopathy (TSE). Other TSEs include scrapie in sheep, chronic wasting disease (CWD) in deer and elk, and Creutzfeldt-Jakob disease in humans. BSE, like other TSEs, is characterised by the presence of an abnormal infectious protein called a prion in nervous tissue. The subsequent spongy degeneration of the brain results in severe and fatal neurological signs and symptoms. Scientists believe that the spread of this disease in cattle is caused by feeding rendered material from infected cattle or sheep back to other cattle. The prion is resistant to commercial inactivation procedures such as heat, which means that it may not be completely destroyed in the rendering process. There are indications that variant Creutzfeldt-Jakob disease in humans could be caused by the consumption of beef products contaminated by infected nervous tissue or medical devices manufactured from infected animal tissues. Milk and milk products are considered safe. Since the average time between an animal’s infection with the prion and the onset of clinical signs normally ranges from 4 to 5 years, clinical signs of BSE are found in adult animals. Symptoms may last for a period of 2 to 6 months before the animal dies. BSE may be suspected based on clinical signs. Diagnosis can only be confirmed by microscopic examination of brain tissues. Targeted surveillance of occurrences of clinical neurological disease; transparency in reporting findings of BSE; safeguards on importation of live ruminant species and their products, in accordance with the OIE Terrestrial Code; removal of specified risk material (SRM) (brain, spinal column) during slaughter and processing of carcasses; prohibit the inclusion of SRM in animal feeds, thus removing potentially contaminated material from the food chain; humane destruction of all suspected and susceptible animals exposed to contaminated feed; appropriate disposal of carcasses and all animal products; livestock identification to enable effective surveillance and tracing of suspected livestock. Classical swine Fever Classical swine fever (CSF), also known as hog cholera, is a contagious viral disease of domestic and wild swine. It is caused by a virus of the genus Pestivirus of the family Flaviviridae, which is closely related to the viruses that cause bovine viral diarrhoea in cattle and border disease in sheep. There is only one serotype of CSF virus (CSFV). The most common method of transmission is through direct contact between healthy swine and those infected with CSF virus. The virus is shed in saliva, nasal secretions, urine, and faeces. Contact with contaminated vehicles, pens, feed, or clothing may spread the disease. Animals that are chronic carriers of the disease (persistently infected) may show no clinical signs of illness but may shed the virus in their feces. Offspring of infected sows can become infected in the uterus, and can shed the virus for months. It has been proven that in parts of Europe, the wild boar population may play a role in the epidemiology of the disease. Humans are not affected by this virus. Swine are the only species known to be susceptible. In the acute form of the disease, in all age groups, there is fever, huddling of sick animals, loss of appetite, dullness, weakness, conjunctivitis, constipation followed by diarrhoea, and an unsteady gait. Several days after the onset of clinical signs, the ears, abdomen and inner thighs may show a purple discoloration. Animals with acute disease die within 1-2 weeks. Severe cases of the disease appear very similar to African swine fever. Because the clinical signs are not exclusive to CSF, and vary widely, laboratory tests are required to detect antibodies or the virus itself. Treatment is not attempted. In areas where the disease is endemic, vaccination can prevent the spread of the disease. As the disease is brought under control, vaccination ceases, with continued surveillance. In disease-free areas, a stamping out policy is applied consisting of early detection, movement control, proper disposal of carcasses, and cleaning and disinfection. This policy has led to the elimination of CSF from North America, and much of western Europe. Rabies Rabies is a viral disease that affects the central nervous system of warm-blooded animals, including humans. The disease has a long incubation period (6 months) and symptoms may take several weeks to appear after infection. However, once symptoms appear, rabies is always fatal in animals. Rabies is transmitted through the saliva of an infected animal. Infection occurs primarily via bite wounds, or infected saliva entering an open cut or wound or mucous membrane, such as those in the mouth, nasal cavity or eyes. Infection through inhalation of the virus has been documented, for example, in the environment of a densely populated bat cave. The virus will generally remain at the entry site for a period of time before travelling along the nerves to the brain. In the brain, the virus multiplies quickly, resulting in clinical signs. The virus then moves from the brain along nerves to the salivary glands. The period of time before clinical signs appear in an infected animal can vary depending on the strain of virus and entry point. It is thus important to realise that the disease can be transmitted via the saliva of an infected animal to other animals and humans before the onset of clinical signs of the disease in the infected animal. Rabies is regarded as one of the most important zoonotic diseases in the world (a disease which primarily affects animals, but can cause disease in humans). Any encounter with a domestic or wild animal where a bite is received must be investigated. Rabid wild animals lose their natural fear of humans, increasing the risk of encounter. Clinical signs in animals such as excessive salivation, choking or gagging can lead humans to unknowingly risk infection while examining inside the mouth of dogs and livestock searching for a foreign body or attempting to administer medication with bare hands. It is important to immediately wash any bite wound or exposed surface with soap and water and report the incident to a doctor or hospital emergency department. Clinical signs of rabies in animals will vary depending on the effect of the virus on the brain. Typical signs include sudden behavioural changes and progressive paralysis leading to death. In some cases, however, an animal may die rapidly without demonstrating significant clinical signs. In humans, early signs can include fever or headache. As the disease progresses, symptoms may include confusion, depression, sleepiness, agitation or paralysis of the face, throat and neck. Death generally results from progressive paralysis. The disease may be suspected based on clinical signs, however, laboratory tests are required to confirm the diagnosis. Samples taken from dead animals must be sent to competent laboratories for diagnosis. In countries where the disease is endemic, measures are implemented to address and reduce the risk of infection in susceptible populations (wildlife, stray and domestic animals) and create a buffer between the animal source of the disease and humans: Vaccination programmes for domestic animals, wildlife rabies control programmes including vaccination (trap/vaccinate/release or delivery of oral vaccines). Salmonella Salmonella is a bacterium that can cause an illness called salmonellosis in humans. Salmonella is commonly found in the intestines of healthy birds and mammals. In foods, it is most frequently found in eggs and raw meat from pigs, turkeys and chickens. It can spread to humans through contaminated foods. Safe handling of raw meat and other raw food ingredients, thorough cooking and good kitchen hygiene can prevent or reduce the risk posed by contaminated food. Salmonellosis is a zoonosis: a disease or infection that can be transmitted directly or indirectly between animals and humans. If it infects the bloodstream it can be life-threatening. The usual symptoms of human salmonellosis include fever, diarrhoea and abdominal cramps. The symptoms of salmonella in fowl include ruffled feathers, thirst, reluctance to move, and yellow diarrhoea. The disease in fowl may be suspected based on clinical signs, however laboratory tests are required to confirm the diagnosis. A coordinated approach by all EU actors on zoonotic diseases have helped reduce human cases of salmonellosis in the EU by almost one half over 5 years (2004-2009). In 2003, the EU set up an extended control programme for zoonoses, considering Salmonella as a priority. Enhanced salmonella control programmes in poultry were implemented in all EU Member States. Targets were set for the reduction of salmonella in poultry flocks (e.g. laying hens, broilers, turkeys) and pigs. Restrictions were also imposed on the trade of products from infected flocks.

ANNEX II MAIN RESPONSIBILITIES 01020304050607080910

The Commission (DG Health and Food Safety) is responsible for coordinating, assessing and approving Member States’ draft national programmes and providing the financial support for them under direct management. The responsible directorate for veterinary measures is Directorate G — Veterinary and International affairs. A Task Force, operating since 2000, provides expert guidance for disease eradication to the Member States. It is composed of representatives from Member States and the Commission, and has subgroups for the main animal diseases. The Task Force and its subgroups provide an opportunity to share best practice between Member State experts and the Commission. Following subgroup meetings, the Task Force makes specific recommendations to improve Member State programmes. The Task Force meets in plenary session each year. DG Health and Food Safety manages the Animal Disease Notification System (‘ADNS’) and coordinates emergency measures in the event of an outbreak of a contagious animal disease. In addition, DG Health and Food Safety manages the ‘Traces’ system which notifies, certifies and monitors imports, exports and intra-EU cross-border trade in animals and certain animal products. The ADNS is an electronic notification system designed to register and document the evolution of the situation of important infectious animal diseases. It aims to ensure the immediate notification of ‘alert’ messages as well as detailed information about outbreaks of animal diseases in Member States and other countries that are connected to the system. Data is input at country level. The Commission correlates data and transmits the information on primary and secondary outbreaks to the veterinary authorities of the Member States on a daily basis. This enables the veterinary authorities in Member States to assess risks and take necessary actions. The FVO is Directorate F of DG Health and Food Safety. Its main task is to verify that the requirements of Community legislation on the safety and quality of food, veterinary and phytosanitary products are being satisfied. It performs audits in the 28 Member States and in third countries exporting or seeking to export to the EU. It is composed of veterinary professionals, and its inspection/audit tasks are part of an annual work programme that is drawn up on the basis of risk analysis. Its work includes systems evaluations and substantive testing. Each audit results in a report that contains conclusions and recommendations. Auditees are invited to submit an action plan covering all findings of deficiencies. The implementation of this plan is evaluated and monitored. The FVO publishes its audit reports and a summary annual report on DG Health and Food Safety’s website. Member States carry out the actual administration and implementation of the programmes through the relevant national authority. In case of federal or decentralised states, the implementation may be devolved to local level (e.g. in Great Britain responsibility is at county level; in Germany responsibility lies with the Länder). A single application for reimbursement and the final report are presented by each Member State to the Commission. Member States are responsible for the management of their programmes, and the Commission is formally informed of actions taken in the annual report and cost claim. The PAFF is composed of representatives from EU governments. The Committee’s mandate covers general animal health risks and the entire food supply chain from the farm to fork. It is chaired by a European Commission representative. The Commission may consult the relevant committee on measures it is planning to adopt. The Committee can then deliver an opinion on the Commission’s work. EFSA is responsible for evaluating food safety risks and notifying them to the Commission. It is not responsible for risk management. It works closely with national authorities and provides scientific advice on matters linked to food safety. Its scientific advice is an important source of information about risks and an essential element in designing the Commission’s approach to risk management. In terms of animal diseases it is mainly involved in the scientific studies of the disease eradication. Furthermore, it might be consulted in case of emergency measures during a serious outbreak. Other organisations, notably the ECDC, the OIE and the Codex Alimentarius Commission (CAC), set up by the Food and Agriculture Organisation of the United Nations (FAO) and the World Health Organisation (WHO) assess matters related to human and animal health.

Versions

1. 2016-04-21