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EUROPEAN UNION European Neighbourhood Policy and Partnership Instrument ENPI EU Twinning Project IL / 10 CRIS/2015/356-293 Programme financed by the European Union Strengthening of Israeli veterinary diagnostic capacities AGRICULTURE EUROPEAN UNION EUROPEAN UNION GERMANY WINNING HOLLAND TWINNING EUROPEAN UNION ISRAEL DISEASE CONTROL EUROPEAN UNION ISRAEL TWINNING ERMANY KIMRON VETRINARY THIS PROJECT IS FUNDED BY THE EUROPEAN UNION EUROPEAN ISRAEL KIMRON HOLLAND ISRAEL VETRINARY DIAGNOSTIC HOLLAND GERMANY GERMANY TWINNING ISRAELISRAEL TWINNING EU and Israel Partnership European Neighbourhood Policy EU and Israeli Cooperation in Veterinary Administration and Livestock Development Background to the Twinning Project Animal Disease Status and Animal Health Programmes German-Netherlands Institutions Involved Main Project´s Components and Results The Member States Staff and Key Roles The Beneficiary Country Staff and Key Roles Key Information and Figures Related to the Project Strengthening of Israeli veterinary diagnostic capacities EU and Israel Partnership The EU-Israel Association Agreement (AA) forms the legal basis governing relations between the two parties. It was elaborated within the framework of the Euro-Mediterranean Partnership (Barcelona Process), and came into force in June 2000. The AA features free trade arrangements for industrial goods and concessions for trade in agricultural products – on which a new agreement has been established in 2004. Considering the strategic objectives for EU-Israel cooperation, set out in the European Neighbourhood Policy (ENP) Action Plan from 11 April 2005, both sides want to encourage and support further integration of Israel into European economic and social structures. The ENP Action Plan defines a considerable number of priority areas, including trade and market related regulatory reforms, including sanitary and phyto-sanitary (SPS) issues, with the aim of progressively harmonising regulatory, legislative and administrative frameworks. The implementation of these priorities is supported by the National Indicative Programmes (NIPs). The National Indicative Programme 2011-2013 provides for support to EU acquisrelated activities in key Israeli ministries, including through Twinnings, based on mutually agreed priorities, in any areas covered by the ENP Action Plan, including veterinary matters. The ENP Action Plan includes the will to improve cooperation on sanitary and phyto-sanitary matters as well as on food safety, including activities to strengthen exchange of information with regard to legislation and implementation practices and possibilities to increase convergence of Israeli legislation with EU legislation on sanitary requirements (live animals and animal products). Under the ENP Action Plan “improved cooperation on sanitary and phyto-sanitary matters as well as on food safety” is stipulated, which should be achieved by exploring possible areas of cooperation between Israel and the EU in this field (e.g. legislation, implementing practices), while taking into account different conditions prevailing on both sides and exchanging appropriate information on matters such convergence of Israeli legislation with EU legislation on sanitary requirements (live animals and animal products). This Twinning project aims to strengthen the capacities of the Kimron Veterinary Institute (KVI) in terms of legislation, enforcement and institutional building, to achieve rapid, effective surveillance and control of prevailing animal diseases as well as provision of reliable evidence to certify animals and products of animal origin as safe for human consumption, in compliance with EU and OIE standards. This Twinning project forms a significant contribution to the objectives: trade and internal market issues and improvement of cooperation on sanitary issues, with particular focus on veterinary matters of the EUIsrael ENP Action Plan. Israel will increase compliance with international requirements regarding the monitoring and control of animal diseases and food safety of animal origin products for consumers and will thus contribute to eliminating technical barriers to trade (TBT). European Neighbourhood Policy The European Neighbourhood Policy (ENP) aims at a closer relationship between the enlarged EU and its neighbours for the strengthening of prosperity, stability and security for all. The ENP is extended to the 16 closest neighbours of the EU, Israel being one of them. The policy was set up in a Strategy Paper in May 2004, where concrete terms have been set how the EU proposes to work in close relation with these 16 neighbouring countries. Later the Commission developed further proposals to strengthen the policy in various initiatives and processes. Under the ENP the EU offers its neighbours a privileged relationship which builds on mutual commitment to common values (e.g. democracy and human rights, rule of law, good governance, economic market principles and sustainable development). The ENP offers not only political association but also economic integration, increased mobility and people-to-people contacts, depending on the extent to which these values are shared between the partners. EU and Israeli Cooperation in Veterinary Administration and Livestock Development Concerning agriculture and livestock development, both the Association Agreement and the ENP Action Plan call for collaboration between EU and Israel, among others there is technical assistance and training as one of the main offers established. In recent years, a number of projects financed by different donors have been contributing to the development and strengthening of animal-origin food and feed safety control in Israel. There has been also a Twinning project “Strengthening of the Israeli Veterinary Inspection Authorities for the Animal Health and Livestock Production System”, conducted between November 2011 and July 2013 aiming for an approximation of Israeli legislation on animal feed, animal health and animal welfare to EU legislation and practices. The overall objective of the project was to strengthen the Israeli Veterinary Administration in order to enhance the implementation of animal health and the “farm to fork” food safety policy in a new legislative framework compliant in quality with EU provisions and international standards allowing for the enhancement of food and feed safety and quality. The project aimed finally at multiplying the chances for Israeli products to land on the EU and international markets. The 20-month project focused its activity on capacity building, on re- organization of the Israeli Veterinary Services and Animal Health (IVSAH) of the Ministry of Agriculture and Rural Development (MARD) and on revision of national legislation to be in line or in close approximation with the EU Acquis Communitaire, and was guided, as above mentioned, by the EU’s integrated “from farm to fork” approach. The project promoted and assisted the IVSAH in the starting of a deep reform process oriented to strengthen the control/inspection of food of animal origin for the protection of human health. Reforms in animal feeding production, with the implementation of new inspection and auditing system, were implemented. Main issues that will be addressed in a follow-up project are the following: The current Twinning project has to improve and strengthen the diagnostic and research capabilities of the KVI in the field of infectious diseases and food and feed safety. To create a legal basis for the official role and competency of IVSAH supervising food safety and clinical laboratories, to have effective and documented coordination between IVSAH and Ministry of Health and private laboratories as well as direct flow of information to create a national food safety network. To organize trainings on regular basis in order to guarantee an adequate level of knowledge including adequate sampling and preservation of samples. In this respect a training policy and strategy should be prepared. To strengthen the professional capacities of the Israeli Veterinary Laboratories in epidemiological surveys and risk analysis. Furthermore, a review of the legislation should be in place to clear define the IVSAH as competent authority for products of animal origin and responsible for implementation of veterinary inspection covering all public health issues. Therefore based on the recommendations stated, the objective of the current project is strengthening of the legislative and professional capacities of the Israeli Veterinary Laboratories involved in diagnostic of animal diseases, food and feed analyses and epidemiologic surveys. Background to the Twinning Project Livestock and animal products are of significant economic importance to Israel. Despite the decrease in the number of farmers, agriculture plays a significant role as a major food supplier to the local market and is an important factor in Israeli exports. The majority of Israeli agriculture is mainly based on cooperative settlements: The Kibbutz is a large collective production unit and the Moshav which is based on individual farms yet organized as a cooperative society. The Kibbutzim and the Moshavim currently account for 83% of total agricultural production. The dairy industry is of high quality, is one of the leading sectors in Israeli agriculture and supplies most of the domestic demand for milk and dairy products. The dairy industry is well organized and a manual on Good Farming Practices and Official Controls for Animal (Dairy) Production in Israel is currently being introduced for use following the previous twinning project. Also very well organized is the poultry industry which supports the poultry health system with four laboratories for diagnosis of diseases, supervision and provision of clinical services – including actions for the prevention of diseases - located throughout the country. The Poultry and Dairy Boards have strong positions in the Israeli animal industry and have partially established their own traceability systems for animals and animal products. At least one major cattle slaughterhouse and cutting plant has established its own traceability system for commercial purposes. Pig production is small and only takes place in restricted areas in the Acco and Beer Sheva regions (20 farms in total). Israel is a net importer of live animals and animal products, but the country is at the same time a considerable exporter. The most frequently exported animals and animal products are: one-day chicks, ornamental fish, bumblebees, bull semen milk products, poultry meat and ready-toeat products, fish and honey. Export of agricultural products is mainly to the European Union and the US and the requested laboratory testing are performed at the KVI. Animal disease status and animal health programmes Israel experienced outbreaks of several endemic and epidemic animal diseases in recent years, including among others highly pathogenic avian influenza (HPAI); H5N1; with the most recent recorded outbreaks in 2014 and 2015, Foot-and-mouth disease (FMD); in cattle, sheep and wild animals such as wild boars and gazelles, the last outbreak occurred in 2013, Lumpy skin disease (LSD); the last case being recorded in August 2013, Brucellosis; being endemic, Sheep pox; 2 outbreaks in 2011, last outbreak in late 2014, Peste des petits ruminants (PPR); 1 outbreak in 2012, bluetongue (BTV); is endemic with outbreaks of different serotypes, Newcastle disease virus (NDV); last case in late 2014 and rabies;13 recorded cases in 2014. Some of these diseases have tremendous negative impacts on the total output and price of live animals as well as all related industries, ultimately having a negative influence on domestic consumption and export opportunities. Recently a new programme was implemented in order to reduce brucellosis in small ruminant herds in the Negev by the end of 2016, by vaccinating 80% of herds and conducting inspections for infection in 500 herds. The Israeli Veterinary Services and Animal Health (IVSAH) undertake the identification of ruminants and a variety of compulsory vaccination programmes for FMD, LSD, Brucella abortus (ceased on 01/01/2014), Brucella melitensis, rabies, PPR and sheep and goat pox. All sheep and goats are vaccinated at least annually for FMD, PPR and sheep and goat pox. Female sheep and goats are vaccinated for Brucella melitensis between 2 and 6 months of age, whereby the vaccine is provided for free. Brucella melitensis being a significant zoonotic disease in Israel that infects at least 100 people annually, primarily in the less intensive sectors. All other vaccination of ruminants is done as needed or by request of the farmer. Some vaccinations formerly performed by Field Veterinary Services have been handed over to private veterinarians (such as enterotoxaemia and rabies in ruminants). Anthrax vaccination is mandatory in a herd where an outbreak has been confirmed and 10 years forward. Newcastle disease vaccination in poultry is officially mandated with an extensive and well defined vaccination schedule. Newcastle disease vaccination is performed by accredited private vaccination teams contracted by farmers, or by the farmers themselves. Vaccinations in Israel are done on a fee for service basis. According to a 2011 OIE PVS evaluation report, “despite all vaccination activities and campaigns, there is no systematic analysis of efficacy, efficiency and benefits of programmes, resulting in frustration of some staff and farmers. Most of these programmes reach only a small fraction of the less intensive farmers which contributes to the failure of eradication efforts”. This statement was supported by the recommendations of the OIE’s PVS gap analysis, which was carried out during 2013. KVI divisions have ISO17025 accreditation from the Israeli Laboratory Accreditation Authority (ISRAC) for a limited number of test methods. However, not all test methods on notifiable diseases are ISO 17025 accredited. Human resources in the Israeli Veterinary Services are limited while Israel is increasing the number of live animals. It imports calves and products of animal origin. To cope with this changing situation, the Veterinary Services have to implement risk-based surveillance that will help to decrease the number of samples and introduce testing methods that save on human resources. The Israeli Veterinary Services including the KVI, backed by a governmental decision, are in the process of reforming the existing mechanisms for animal health protection, disease monitoring and control and outbreak management. Special attention is therefore being paid to the following priority areas: •Formulation of a national contingency plan for epidemic and endemic diseases. The plan should include the development of effective mechanisms for early diagnosis, early warning, monitoring and control that are in compliance with the guidelines set by the OIE. •Enhancing the institutional context with a view to fostering publicprivate partnerships in the field of animal diseases, rapid and accurate diagnosis, vaccine development and production, eradication, monitoring and control; •Upgrading human capacities of the diagnostic institute to efficiently plan and carry out reform measures and laboratory techniques and methods; •Improvement of the Veterinary Diagnostic Service delivery through addressing such aspects as technical capability, human and financial capital; •Moving toward scientific capacity building with the eventual aim of establishing focal points of expertise and excellence; and •Development of full compliance of laboratories with OIE and EU guidelines and standards for both terrestrial and aquatic animals. Upgrading the quality control of the diagnostic capabilities of the Israeli Veterinary Services requires both the strengthening and the reorganization of the KVI laboratories to become centres of reference and excellence for food safety, feed safety and the diagnosis of infectious diseases to EU and OIE standards and accreditation by ISO 17025. Also necessary will be the establishment of a network of approved, competent private laboratories to support both farmers and the food and feed industry by developing an appropriate framework of legislation and regulations in compliance with EU requirements/regulations. This network should meet the growing demand to protect animals from existing and emerging diseases, to improve public health in Israel and to enhance export through compliance with export requirements. Other problems involve software and databases, as different databases are not currently integrated or compatible. Some functions that would be beneficial to stakeholders are not accessible The main beneficiary institution of the project is the Kimron Veterinary Institute (KVI). But there will be also cooperation with other institutions involved on veterinary diagnostic. German-Netherlands Institutions Involved The German Federal Ministry of Food and Agriculture (BMEL) will assure the supervision of the implementation of the project, through its specialised Unit 624 – “International Projects, Twinning”. With around 150 successful Twinning projects, the Ministry has a rich experience in the effective and successful implementation of such institutional partnerships. With the implementation of more than 20 Twinning projects in the area of animal health and food safety, the Ministry has extensive experience in exchanging good practices in this field. Friedrich-Loeffler-Institut FLI – Federal Research Institute for Animal Health The work of the Friedrich-Loeffler-Institut (FLI) focuses on farm animal health and welfare and on the protection of humans from zoonoses. These tasks are defined in the Animal Health Act. It does basic and applied research in different scientific fields. As a federal research institute and independent higher federal authority under the Federal Ministry of Food and Agriculture, it has a consultative function which helps provide the scientific basis for political decision-making. The Institute performs epidemiological investigations during outbreaks of animal diseases. It also prepares risk assessments on various infectious diseases of farm animals. Furthermore, it works as national Licensing Authority for products that are not destined for the application in animals (in vitro diagnostics). As the responsible federal institution, it houses more than 75 national reference laboratories for notifiable animal diseases. The reference laboratories clarify suspect cases, provide advice to veterinary authorities and perform ring trials or similar quality assurance measures in the field of animal disease diagnostics in Germany. In addition, it houses international reference laboratories of the OIE for avian influenza, Newcastle disease, bovine herpesvirus infection, brucellosis, chlamydiosis, glanders and rabies. It is also nominated by the FAO to form two FAO Reference Centres, one for influenza in animals and Newcastle disease and one for Classical Swine Fever (CSF). It is also „Collaborating Centre for Zoonoses in Europe“ of the OIE and runs a „Collaborating Centre“ of the WHO for rabies. Central Veterinary Institute of Wageningen UR (CVI) The Central Veterinary Institute of Wageningen UR is one of the institutes that belong to the “DLO Foundation” or “Agricultural Research Service”. DLO consists of a number of specialized institutes for applied research in the domain of healthy food and living environment. DLO collaborates with Wageningen University - under the external brand name “Wageningen University & Research Centre”. CVI, part of Wageningen UR, collaborates with public and private partners to safeguard animal and public health. It contributes to the prevention, eradication and control of animal infectious diseases through research, diagnostics and consultancy. By doing so, it helps to guarantee international trade and to preserve the international top position of the Dutch livestock industry. It works with validated and ISO 17025 accredited laboratory tests to confirm or exclude infection with pathogens. Not only is this important in case of a possible outbreak of a notifiable animal disease, but also to maintain the disease-free status of the Netherlands, and for the issue of export certificates. For the OIE (World Organisation for Animal Health) it is an international reference laboratory for Aujeszky’s disease, CEM (Contagious Equine Metritis) and (together with Utrecht University) Campylobacter. German Federal Institute for Risk Assessment The German Federal Institute for Risk Assessment (BfR) is a German state-owned scientific institution, which was established as an agency under public law during a reform in 2002 in order to strengthen consumer health protection and clearly separate risk assessment and risk communication from risk management. It is a scientifically oriented and independent superior federal authority responsible to the German Federal Ministry of Food and Agriculture. It is independent in its scientific assessments and research. Its main focus is on the assessment of risks in the field of consumer health protection and food and feed safety for man. On the basis of internationally recognised, scientific assessment criteria it prepares expert reports and opinions on the safety of foods, substances and products. Its work is characterised by its scientific, research-based approach. It has substantial laboratory capacities, 17 reference laboratories in the field of food safety and food hygiene are attached, divided into two groups: National Reference Laboratories pursuant to Regulation (EC) 882/2004 and other laboratories with a reference function. All laboratories are accredited in accordance with DIN EN ISO/IEC 17025. The Lower Saxony State Office for Consumer Protection and Food Safety (LAVES) LAVES is the central institution for a complete surveillance of food and feed safety, animal health and welfare, and plant protection in the Federal Land of Lower Saxony gathering surveillance and analysis under one roof. It ensures effectiveness and appropriateness of controls and provides laboratory capacities for state-of-the-art analysis. It has a broad practical experience in sample management and risk oriented control planning and it is in charge of examining all official samples. It offers advice and support to the local authorities within the Federal Land of Lower Saxony. It implements analytical tasks in the field of food and feed, investigations of consumer products, official sections of animals, investigation of hygiene samples, cosmetics and drinking water. It carries out feed surveillance and certifies feed and food companies. Further responsibilities are the surveillance of veterinary drugs, the approval of animal experiments and the surveillance of ecological agriculture. It provides advice for animal trade, animal health issues and technical experts, e.g. for development of killing facilities for animals in case of epizootic diseases. Its tasks cover the animal welfare service and the Veterinary Task Force, e.g. for development of concepts and measures for control and combat of animal epidemics. It combines 6 institutes and laboratories in Lower Saxony, performing analyses like food composition, food residues and contaminants (e.g. drugs, heavy metals), GM food and feed, marine biotoxines etc. The six specialised and accredited laboratories provide state-of-the-art analytical equipment and experts of high class qualifications. All laboratories are accredited in accordance with DIN EN ISO/IEC 17025. Thuringian State Authority for Consumer Protection (TVL) TVL was founded in 1992 and now consists of 7 departments covering health protection, hygiene, epidemiology, environment, food safety, animal health and employment protection. The institute has strong activities in microbiology, in food safety and in animal health facilitating a good collaboration in those fields. So far there is less experience in epidemiology. The laboratory capacities of TVL support the consumer health protection authorities of the Federal States in their surveillance and control activities in the areas of food and feed safety by analyzing all official samples. All laboratories of TVL are accredited. KVI and relevant officials from the Israeli Veterinary Services and the MARD. He will be based at the KVI for the duration of his stay. Main Project´s Components and Results Component Leaders / Mid-Term-Experts Germany and the Netherlands have assembled a group of highly qualified experts versed in establishing and operating similar institutions at national as well as regional (Land) level. They will be available for the implementation of this Twinning project with their expertise and will guarantee the fulfilment of the expected results. The projects organisation and inputs will be made on the basis of three main components and split in several activities according to the goals and results to be achieved by the end of the project. The following components are foreseen: Component 1. “Preparation of selected procedures for the improvement of veterinary diagnostic capacities in compliance with EU and OIE standards” Component 2. “Improvement of the Quality Assurance System at the KVI and in approved private laboratories and drafting of proposals on legal acts on notifiable diseases, monitoring and surveillance programmes, zoonotic diseases (public health) and food safety in accordance with the EU legislation and principles with regard to laboratory activities in the veterinary field” Component 3. “Development of epidemiological capacities enabling science-based risk assessment and risk management of existing and future challenges” Under each of the components study visits for staff of the KVI and attachments to the relevant MS partner institutions are foreseen. The Member States Staff and Key Roles The German Federal Ministry for Food and Agriculture (BMEL) will guarantee full support for a successful outcome of the project. The responsible person within the competent “Unit 624 - International Projects, Twinning” is Mrs. Doreen Frank. The BMEL will assure the overall coordination and assist in the identification of the necessary short term experts. The MS Project Leader (PL) is Prof. Dr. Dr. Thomas C. Mettenleiter, President of the Federal Research Institute for Animal Health FriedrichLoeffler-Institut, (FLI). The MS Junior Project leader from the Netherlands is Dr. Willie Loeffen. a veterinary virologist of the Central Veterinary Institute, Wageningen (CVI), responsible for diagnosis and research on classical and African swine fever, Aujeszky’s disease and swine influenza. The Resident Twinning Adviser (RTA) is Dr. Detlef Höreth-Böntgen, an epidemiologist and veterinarian at the FLI. He will be resident in Israel during the 18 months of the project and will provide day by day coordination of the project. He will call upon experts from the MS partner institutions and will work in close coordination with the scientists at the MS component leaders: Dr. Willie Loeffen (CVI), besides being MS JPL, will also be the MTE for Component 1 Prof. Dr. Roland Körber (Univ. Halle-Wittenberg), will be the MTE for Component 2 Prof. Dr. Franz J. Conraths (FLI), head of the Institute of Epidemiology at FLI will be the MTE for Component 3 Ms Elke Reinking, press liaison officer of FLI, will be the MTE for Visibility Activities The Beneficiary Country Staff and Key Roles The success of Twinning projects requires significant input of BC resources coupled with a solid commitment to achieve results. The Twinning project will be headed by the BC Project Leader Dr. Boris Yakobson who has sufficient authority to administer and properly implement the project in practice. Dr. Yakobson will be together with MS Project Leader Prof. Dr. Dr. Thomas C. Mettenleiter the key figure ultimately responsible for its implementation. In order to ensure a smooth implementation of the project activities, the RTA Dr. Detlef Höreth-Böntgen, will be supported on the day-to-day basis by the RTA counterpart in the BC, namely Dr. Monica Leszkowicz Mazuz. At project level, BC staff will actively participate (i.e. working with the RTA and short term experts, participating in training activities) to implement a particular project component. For a transparent coordination of the three components three BC Component Leaders have been nominated who will work hand in hand with the MS Component Leaders and the RTA team. Component leaders Component 1: Dr. Michel Bellaiche, Director, KVI Component 2: Mrs. Dikla Aviv, Quality Manager, KVI Component 3: Dr. Aniella Gilboa, CVO assistant Mrs Dafna Yurista, Press officer, MOAG responsible for Visibility Activities on BC part Key Information And Figures Related To The Project Total EU budget: € 1,030,000 Beneficiary institutions Kimron Veterinary Institute (KVI), Ministry of Agriculture & Rural Development (MARD), Israel Responsible Institutions The German Federal Ministry for Food and Agriculture (BMEL) The Central Veterinary Institute of Wageningen UR (CVI) Supporting Institutions Friedrich-Loeffler- Institut (FLI), Federal Research Institut for Animal Health Bundesinstitut für Risikobewertung (BfR), German Federal Institute for Risk Assessment The Lower Saxony State Office for Consumer Protection and Food Safety (LAVES) Thuringian State Authority for Consumer Protection (TVL) Mandated Body B.&S.U. Beratungs- und Service-Gesellschaft Umwelt mbH, Germany Duration: 18 months (05. March 2015 – 04. September 20164) Kick-off Meeting: March 26th, 2015 Foreign experts involved: 1 Resident Twinning Advisor, 4 Mid Term Experts, 51 Short Term Experts Missions to be carried out: 99 Study visits to be carried out in a Member State: 6 Number of training sessions: 7 The content of this material does not necessarily represent the official position of the EUROPEAN UNION Edited by Project’s RTA