Twinning Project Fiche for the “Strengthening of Israeli ... · Twinning Project Fiche for the...

By European Union

Ministry of Agriculture and Rural Development Israeli Veterinary Services and Animal Health

Twinning Project Fiche for the “Strengthening of Israeli

veterinary diagnostic capacities”

May 2014

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Important reminders:

- Any Member State entity that submits a proposal or that is part of the consortium that submits a proposal, if it does not constitute a proper public administration, must be registered as mandated body. Mandated bodies are semi-public bodies assimilated to administrations, as some MS have outsourced or are in the process of outsourcing and privatising parts of their administration. The know-how required for Twinning projects is therefore sometimes located outside the administration. The Commission Headquarters may accept or refuse proposals to be registered as Mandated Body and maintains an open-ended list of semi-public bodies mandated to act in lieu of public administrations. Conditions and means to apply to be on the list are described in the Common Twinning Manual, section 3.3 (http://ec.europa.eu/europeaid/where/neighbourhood/documents/twinning-manual-2012-update-2013-2014-final.pdf) In case of question and to launch the registration procedure, entities that wish to be considered as mandated body must liaise with their National Contact Point (list of NCPs and contacts available at: http://ec.europa.eu/enlargement/pdf/financial_assistance/institution_building/2014/20140429-ncps-ms-april-2014.pdf).

- Proposed Project Leaders and proposed RTA are obliged to have a pre-established, and

not-remote, connections with the administration(s) or mandated body(ies) submitting the proposal or being part of the consortium that submits a proposal;.

Not complying with these conditions will lead to the rejection of the concerned proposal(s).

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Twinning Project Fiche “Strengthening of Israeli veterinary diagnostic capacities”

Contents List of abbreviations .............................................................................................................................3

1 Basic Information ............................................................................................................................5

2 Objectives .........................................................................................................................................5 2.1 Overall Objective .......................................................................................................................5 2.2 Project Purpose ..........................................................................................................................5 2.3 Contribution to the Association Agreement and ENP Action Plan............................................5

3 Description........................................................................................................................................6 3.1 Background and justification .....................................................................................................6 3.2 Linked activities .......................................................................................................................12 3.3 Results......................................................................................................................................13 3.4 Activities ..................................................................................................................................14 3.5 Means/Input from the MS Partner Administration ..................................................................26

4 Institutional Framework ...............................................................................................................28

5 Budget .............................................................................................................................................29

6 Implementation Arrangements ....................................................................................................30 6.1 Implementing Agency..............................................................................................................30 6.2 Main counterparts in the Beneficiary Country.........................................................................30 6.3 Contracts ..................................................................................................................................31 6.4 Project Steering Committee .....................................................................................................31

7 Implementation schedule (indicative) ..........................................................................................31

8 Sustainability..................................................................................................................................31

9 Cross-cutting issues and visibility.................................................................................................32 9.1 Cross-cutting issues..................................................................................................................32 9.2 Communication and Visibility .................................................................................................32

10 Conditionality and sequencing .....................................................................................................33 10.1 Commitment from the KVI......................................................................................................33 10.2 Other inputs from the Beneficiary............................................................................................33 10.3 Assumptions and role of the MARD regarding visibility of the project ..................................33

Annex I: Logframe planning matrix for twinning fiche..................................................................34 Annex II: Indicative implementation schedule ................................................................................43 Annex III: Structural Organisation of VS........................................................................................45 Annex IV: List of research projects implemented by the KVI .......................................................47 Annex V: Animal diseases in Israel and in the Region....................................................................48

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List of abbreviations AA Association Agreement AI Avian influenza ANIHWA Coordination Action funded under the European Commission’s ERA-Net scheme

(Animal Health and Welfare) AP Action Plan BARD United States-Israel Bi-national Agricultural Research and Development Fund BC Beneficiary Country BLV Bovine leukaemia virus BSL Bio-Safety Level BVDV Bovine Virus Diarrhoea Virus CVO Chief Veterinary Officer DVO District Veterinary Office EC European Commission ELISA Enzyme-linked immunosorbent assay EMIDA Coordination Action funded under the European Commission’s ERA-Net scheme

(Emerging and Major Infectious Diseases of Livestock) ENP European Neighbourhood Policy EUD European Union Delegation EUNID European Network for Highly Infectious Diseases FAO Food and Agriculture Organisation of the United Nations FMD Foot-and-mouth disease GIS Geographical Information System HACCP Hazard Analysis and Critical Control Points HPAI Highly pathogenic avian influenza ISO International Organisation for Standardisation ISRAC Israeli Laboratory Accreditation Authority IVSAH Israeli Veterinary Services and Animal Health KVI Kimron Veterinary Institute LSD Lumpy skin disease MARD Ministry of Agriculture and Rural Development of Israel MoH Ministry of Health MS EU Member State NADIR European Network of Animal Disease Infectiology Research Facilities NDV Newcastle disease virus NGO Non-Governmental Organisation OIE World Organisation for Animal Health OVI Objectively Verifiable Indicator PAO Programme Administration Office PCR Polymerase Chain Reaction PL Project Leader PPR Peste des petits ruminants PSC Project Steering Committee PTS Proficiency Testing Scheme PVS Performance of Veterinary Services QA Quality Assurance QM Quality Manager QMS Quality Management System QS Quality System RTA Resident Twinning Adviser SICA Specific International Cooperation Actions SOP Standard Operating Procedure SPS Sanitary and Phyto-Sanitary STE Short-term expert

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VS Veterinary Services TAIEX Technical Assistance and Information Exchange TBT Technical Barriers to Trade ToR Terms of Reference

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1 Basic Information

1.1 Programme: Support to the European Neighbourhood Policy Action Plan (Israel) 2011-2012 1.2 Twinning number: IL/10 1.3 Title: Strengthening of Israeli veterinary diagnostic capacities 1.4 Sector: Veterinary services 1.5 Beneficiary country: Israel 2 Objectives 2.1 Overall Objective

The overall objective is to improve the mechanisms for animal and public health protection from existing and emerging diseases, food-borne pathogens and residues. 2.2 Project Purpose

The project purpose is to strengthen the capacities of the Kimron Veterinary Institute (MARD) and supervision of private accredited laboratories to achieve rapid and effective surveillance and control of animal diseases as well as provision of reliable evidence to certify animals and animal-origin products as safe, especially for human consumption, up to European Union (EU) and World Organisation for Animal Health (OIE) standards. 2.3 Contribution to the Association Agreement and ENP Action Plan

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 Article 46 of the EU-Israel Association Agreement aims at the harmonisation of phyto-sanitary and veterinary services. The policy framework and strategic objectives for EU-Israel cooperation are set out in the EU-Israel European Neighbourhood Policy (ENP) Action Plan adopted on 11 April 2005 and has been renewed several times. The ENP Action Plan has a time frame of three years and provides a general overview of strategic objectives. It is orientated toward encouraging and supporting Israel’s objectives for further integration 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 acquis-related 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. Paragraph 6 of the ENP Action Plan entitled “improve cooperation on sanitary and phytosanitary matters as well as on food safety”, calls for the following actions:

- Explore possible areas of cooperation between Israel and the EC in the field of sanitary issues (e.g. legislation, implementing practices), while taking into account different conditions prevailing on both sides; and

- Exchange information on and, as appropriate, explore possibilities to increase 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 and effective surveillance

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and control of animal diseases as well as provision of reliable evidence to certify animals and animal-origin products as safe, especially for human consumption, up to EU and OIE standards. It comes as a significant contribution to an objective of the EU-Israel ENP Action Plan concerning trade and internal market related issues: improvement of cooperation on sanitary issues, with particular focus on veterinary matters. By developing an up-to-date system for rapid and effective surveillance and control of animal diseases as well as provision of reliable evidence to certify animals and animal-origin products as safe up to EU and OIE standards, 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). 3 Description 3.1 Background and justification

3.1.1 The state of play of the Israeli animal sector

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. Total agriculture output in 2010 was 7.2 billion US dollars (USD). Some 60,000 people (about 3% of the country’s active labour force) were directly employed in agriculture in the same year,

The majority of Israeli agriculture is based on cooperative settlements, which were developed in the early 20th century. The Kibbutz is a large collective production unit: Kibbutz members jointly own the means of production and share social and economic activities. At present, most of the Kibbutz income comes from industrial enterprises owned by the collective unit.

Another type of settlement is the Moshav, which is based on individual farms yet organised as a cooperative society. The Kibbutzim and the Moshavim currently account for 83% of total agricultural production.

Livestock and animal products are of significant economic importance to Israel, representing about 39% of total agricultural output (source: Central Bureau of Statistics of the State of Israel). The most recent estimates on the livestock resources of the country, according to data collected by the Israeli Veterinary Services and Animal Health (IVSAH), are presented in Table 1. Pig production is small and only takes place in restricted areas in the Acco and Beer Sheva regions (20 farms in total). Table 1: A summary of the estimated Israeli livestock population in 2013

Year: 2013 Cattle 480,000 Buffaloes 300 Sheep 435,000 Goats 85,000 Camels 11,000 Pigs 180,000 Equidae 35,000 Birds (poultry)* 45,000,000 Fish (in tonnes) 25,000 Hives 80,000

*At any given time (Source: Israeli Veterinary Services)

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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 organised 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.

Israel has a total annual output of approximately 1,185 million litres of cow milk, 9.8 million litres of sheep milk and 7.9 million litres of goat milk. Milk is produced on 1,010 farms, spread countrywide. The average annual milk yield per cow is approximately 11,291 kg of milk, with 3.26% protein and 3.70% fat.

The poultry sector produces about 1,700 million table eggs, 420,000 tonnes of broiler meat and 90,000 tonnes of turkey meat annually.

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. 3.1.2 Imports and exports of animals and animal products

Israel is a net importer of live animals and animal products, but the country is at the same time a considerable exporter. Export of agricultural products is mainly to the European Community and the US. The most frequently exported animals and animal products are: one-day chicks, ornamental fish, bumblebees, bull semen milk products, poultry meat and ready-to-eat products, fish and honey.

In light of the limited number of entry ports (governmental quarantine stations and authorised quarantine locations) import procedures are used to ensure that imports meet Israeli requirements and regulations. At these locations, blood and other samples are taken from imported animals or goods for subsequent laboratory testing performed at the KVI.

However, staffing is limited on one hand while on the other, Israel is increasing the number of live animals it imports such as calves and products of animal origin. To cope with this changing situation, the Veterinary Services have to i) implement risk-based sampling that will help decrease the number of samples and ii) introduce testing methodologies that save on human resources.

3.1.3 Animal disease status and animal health programmes

The status of a number of significant animal and zoonotic diseases in Israel and surrounding countries is shown in Annex V “Animal Diseases in Israel and in the Region”. Outbreaks of several endemic and epidemic animal diseases in Israel have been recorded, including highly pathogenic avian influenza (HPAI) (H5N1; 2 recorded outbreaks in 2012), Foot-and-mouth disease (FMD) (in cattle, sheep and wild animals such as wild boars and gazelles), Lumpy skin disease (LSD), Brucellosis (e.g. Brucella melitensis in small ruminants), Sheep pox (2 outbreaks in 2011), peste des petits ruminants (PPR; 1 outbreak in 2012), bluetongue (outbreaks of different serotypes), Newcastle disease virus (NDV) and rabies (24 recorded cases in 2012). In 2011, 21 outbreaks of FMD were recorded followed by another 2 outbreaks in 2012. LSD was detected in a high number of milk- and beef-producing cattle in 2012-2013.

Such 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. Therefore, plans have been made 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

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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; the vaccine is provided for free. Brucella melitensis is 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. The policy of indemnity payment was reviewed and it was determined that for the next outbreak, the Ministry of Finance will not pay indemnity if the vaccination is not properly done.

Rabies vaccination of large animals is done on request, primarily along border areas, or within a 10 km radius when a case is diagnosed in the dairy sector. Most cases of rabies occur in the north and along the eastern border with Jordan.

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”.

3.1.4 Israeli legislation, policy in the sector and the Ministry of Agriculture and Rural Development

In Israel, primary legislation is adopted by the General Assembly of the Israeli parliament (Knesset). The secondary-level legislation in the form of regulations submitted by the Ministry of Agriculture and Rural Development (MARD) is adopted by the relevant parliamentary committees. In addition, animal and public health activities are regulated by Procedure Documents amended by the Chief Veterinary Officer (CVO).

The Israeli Veterinary Services, 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 especially regarding diseases such as Foot and Mouth Disease (FMD), Lumpy Skin Disease (LSD), Newcastle Disease (ND) and Highly Pathogenic Avian Influenza (HPAI). The formulation should be such that it will facilitate future “declarations of freedom from disease”. The EU Directive 2003/85/EC on FMD should be followed;

• Enhancing the institutional context with a view to fostering public-private 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

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• 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 reorganisation 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. 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.

3.1.5 Quality System, ISO17025 accreditation and Quality Management

KVI divisions have ISO17025 accreditation from the Israeli Laboratory Accreditation Authority (ISRAC) for a number of test methods, for example:

• PCR assays (e.g. for avian Mycoplasmas, Avian Influenza viruses, Newcastle Disease Virus); • serology methods (Rabies, Mycobacterium avium spp paratuberculosis); • chemical test methods such as LC/MS/MS (antibiotics, histamine detection); • food and feed bacteriological methods (bacterial count, salmonella, listeria in different

matrixes); • staining methods (blood-borne parasites); and • ELISA for bovine spongiform encephalopathy (BSE).

According to a 2011 OIE PVS evaluation report, “however, not all test methods on notifiable diseases are ISO17025 accredited. Another weakness was that the District Veterinary Office (DVO) performed Brucellosis milk ring tests without the benefit of quality assurance. It was recommended to accredit the Milk Quality Control Laboratory to undertake the official National Brucellosis milk ring test with the relevant VS oversight”. Plans have been made to achieve the accreditation of 20% of lab assays performed at the KVI by the end of 2016.

KVI customers include in-house services for the various branches of the IVSAH, the “Hachaklait” (a cooperative society providing veterinary services for cattle, small ruminants and horses), the two regional Poultry Health Laboratories, private veterinary practitioners, farmers and companies producing food products for humans and animals.

Some of the above-mentioned private or public laboratories are already authorised by the Laboratory Authorisation Authority, in accordance with ISO Standard 17025, and other laboratories are currently in the process of being authorised. Besides the KVI, the private labs of the Egg and Poultry Board also participate in a number of international ring trials (Proficiency Testing Schemes or PTS).

The main obstacles to i) the achievement of further ISO17025 accreditation of more test methods; and i) the setting up of Quality Management and a Quality Control system are the lack of human resources (positions, quality and training), an absence of flexibility in employing and terminating employment (employment capacity), budgeting, and the approval of continuing education (management of know-how).

3.1.6 Risk analysis, epidemiology, surveillance and disease control programmes

Israel is situated on the geographical crossroads of three continents: Europe, Asia and Africa. Animal diseases from these three continents can thus be introduced to the country directly. The location of Israel is also a bottleneck for hundreds of species of birds during their annual migration.

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About 500 millions of birds pass over Israel and back each year. Additionally, due to various micro-climates within the country there is a wide range of possibilities of vector survival.

The political status of the area does not allow for good epidemiological data exchange. Furthermore, knowledge about the actions of Veterinary Services in Israel’s neighbouring countries is lacking. Israel is in a uniquely difficult position with regard to the prevention, detection, containment and eradication of transboundary animal diseases due to the presence in the region of several immediate and relatively close-knit neighbouring countries that are at best uncooperative and at worst actively hostile to the very existence of the State of Israel.

Among Israel’s immediate neighbours, however, varying levels of cooperation in livestock disease control exist in the cases of Jordan, Egypt and the Palestinian Authority. No formal contact is possible with the governments of either Lebanon or Syria. Despite the presence of approved border inspection posts (airports, sea ports, land crossings), internal veterinary movement control points, borders of any approved disease control areas (regionalisation/zoning/compartmentalisation), and indicated artificial animal disease control barriers e.g. fences, illegal border crossings still take place which may result in the transmission of diseases from border countries to Israel.

The combination of the factors described above results in a high incidence of new outbreaks of animal diseases including endemic and emerging diseases, thus elevating the transboundary pathogen transfer and load. Poor control of animal diseases in neighbouring countries exerts an increased demand on intensive surveillance, the constant collection of epidemiological data, rigorous risk analysis studies and the implementation of extensive control measures. In the last 2 years, data from epidemiological surveillance programmes were reported on the monitoring of the efficacy of FMD vaccinations (2009 -2010), avian disease surveillance (OIE report July 2010), and vaccination/immunisation campaigns (routine vaccination programmes against OIE List diseases).

However, risk analysis is performed irregularly and constitutes a weak point of the IVSAH; currently, no staff are trained or dedicated to this work. Data management is insufficient and does not provide for real traceability; only animal movements and slaughtering are registered (and only in the case of cattle). The system costs a lot but produces very little reliable information. However, the traceability system appears flexible enough to serve as a platform for improvement. Individual identification of all cattle, sheep and goats is mandatory and managed by the DVOs. Traceability of products of animal origin has been started by some private industries but is not fully coordinated with the VS. Poultry products for domestic consumption are also subject to a traceability system.

Passive surveillance could be possible through an appropriate network of veterinarians from IVSAH or the private sector. However, this would be difficult to implement taking into account the fact that less intensive farmers are not regularly in contact with VS. Active surveillance programmes are implemented for some poultry diseases by Veterinary Services and supported by the Poultry Board.

Active surveillance is also implemented for brucellosis in small ruminants (unvaccinated males). However, there is a lack of active surveillance programmes to assess sanitary status for relevant diseases in wildlife and for brucellosis in beef cattle.

Animal identification has been in place for decades for cattle and small ruminants, primarily in the intensively managed sectors. Most small ruminants from less intensive production systems are identified, but there is no follow-up traceability.

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 (e.g., farmers and private veterinarians cannot access relevant data about their herds) and no cross-cutting analysis is conducted of efficiency, the distribution of resources or the benefits of programmes.

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3.1.7 Shortcomings and OIE PVS evaluation report 2011

An OIE PVS evaluation of IVSAH was implemented in 2011. Results demonstrated a high level of compliance with international standards in most domains, but also highlighted some inconsistencies and the need for improvement in institutional organisation and management. In order to improve the level of compliance, IVSAH requested a PVS Gap analysis mission that was conducted from 11-20 November 2013 by a team of OIE-certified experts. The report of the Gap Analysis mission was sent to Israel on the 7th of March.

Taking into account the national context and national priorities, the following proposals, which also should be taken into account in this Twinning project, have been built in order to allow IVSAH to establish its strategic plan for the next five years:

1) Improve the legal authority of IVSAH to develop clear regulations, procedures and controls in order to facilitate the official delegation to private veterinarians of some official activities:

2) Modify the organisation of IVSAH to improve management and ensure the chain of command and technical independence comply with international standards; and

3) Stabilise the resources of IVSAH without compromising technical independence.

In addition, there is a need to budget for specific long-term investments such as:

1) Improvement of the KVI infrastructure by building post-mortem facilities, a BSL-3 FMD complex, and laboratory animal housing, along with improvement of the lab facilities in general;

2) Provision of PhD training for 5 KVI staff and training of 3 in epidemiology/risk analysis; 3) Provision of funding for disease control programmes in the poultry sector; 4) Updating and integration of databases; and 5) Improvement of international and national expertise.

The reforms should include the following topics:

(a) Development of a national contingency plan for epidemic and endemic diseases including, among others, effective mechanisms for early warning, monitoring, and control that comply with OIE guidelines;

(b) The need to obtain OIE declaration of Israel’s freedom from highly contagious and high impact diseases, in particular LSD, FMD, PPR and NDV;

(c) The need to enhance the institutional and administrative context in order to develop public-private partnerships in animal disease eradication, monitoring and control;

(d) The need for the regular recruitment of new staff into the public sector at central level (KVI), to progressively replace retiring staff and to increase the level of staffing in epidemiology, veterinary public health, border security and traceability;

(e) A reform of the organisational chart of the KVI, which should take into consideration the main functions such as animal health, veterinary public health, risk analysis and epidemiology and data management;

(f) Improvement of the Quality System ISO17025 at the KVI, including the setup of a national Quality Control system mandated to control the quality of test methods performed in Israeli regional and private laboratories;

(g) Risk analysis and emerging issues should be undertaken within a strengthened “epidemiology division” with additional staff and adequate training to provide support to the CVO and other divisions. This unit should also be in charge of developing, monitoring and evaluating the efficacy, efficiency and benefits of all official disease programmes.

Active surveillance programmes should be fully implemented in less intensive production systems and should be developed for relevant diseases, particularly in wildlife and beef production. Early detection should be improved in the less intensive production systems and prevention, control and

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eradication programmes should be assessed in term of efficacy, efficiency and benefit. These programmes should be adapted to reach less intensive production systems in order to ensure success; this may include official delegation to private veterinarians where relevant.

3.2 Linked activities

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. Below is a summary of the main interventions.

Twinning project: “Strengthening of Israeli Veterinary Inspection Authorities for Animal Health and Livestock Production System”

Some of the diseases reported in Israel are zoonotic (transmissible to humans), posing a serious threat to public health. Risks of transmission may be increased by the production system; for example, less than 1/3 of sheep and goats are owned by medium and large farms, with the remaining 2/3 being kept in nomadic production systems, where compliance with bio-security practices is harder to achieve.

The aims of the Twinning project “Strengthening of the Israeli Veterinary Inspection Authorities for the Animal Health and Livestock Production System”, conducted between November 2011 and July 2013 were to approximate Israeli legislation on animal feed, animal health and animal welfare to EU legislation and practices. One of the major recommendations of this Twinning project was to improve and strengthen the diagnostic and research capabilities of the KVI in the field of infectious diseases and food and feed safety.

Tool for the evaluation of performance of Veterinary Services (PVS Tool)

OIE expert missions have been undertaken in the context of PVS and Gap Analysis for Israel. The Twinning project should thus take account of the OIE conclusions and recommendations.

TAIEX expert mission on Support to the Assessment, Design and Planning of a Surveillance Programme of Wildlife Pathogens in Accordance with the “One Health” Concept”

In December 2013 an assessment and definition of the major risk factors regarding wildlife pathogens was undertaken within the framework of a Technical Assistance and Information Exchange (TAIEX) expert mission to prioritise risk factors regarding wildlife pathogens and to produce recommendations for a long-term, economically sustainable wildlife disease monitoring programme. The mission targeted the relationship between wildlife diseases and public health, the categorisation of existing and emerging diseases and methods for their diagnosis, risk analysis of the impact of wildlife diseases on public health, methods of controlling diseases, the proposition of mechanisms for the exchange of information, the development of a network involving a nation-wide epidemiology information system and collaboration with existing EU networks, cooperation and communication among the EU and Israeli professionals involved in the diagnosis, management and control and epidemiology of wildlife diseases, etc. A symposium was organised at the KVI to discuss the current situation, risk-based surveillance strategies with a focus on wildlife, national wildlife disease surveillance and the proposed surveillance programme.

TAIEX expert mission on Official Controls of Food Operators

IVSAH intend to submit an application for a TAIEX expert mission on food safety for representatives of IVSAH and the MoH to assess the chain of transportation and official controls to be performed for food operators. The mission would take place in the middle of 2014.

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Assessment undertaken by the “TANDOO” company of the activities of Veterinary Services

At the beginning of 2014 the “TANDOO” company contracted by the MARD undertook a functional and economical analysis of the activities performed by the KVI and IVSAH. With regard to the tests carried out at the KVI, TANDOO should explore possibilities of delegating some of the activity to private laboratories. The results of the analysis are expected to be received in the third quarter of 2014. Therefore the measures to be carried out under activity 1.9 should be implemented in coordination with the results provided by the “TANDOO” company.

Research projects

As the KVI is also a research body, it actively participates in a number of research projects financed by various sources. At the beginning of 2014 the KVI was actively participating in ten international research projects in the framework of the European Network of Animal Disease Infectiology Research Facilities (NADIR), the Bi-national Agricultural Research and Development Fund (BARD), Animal Health and Welfare (ANIHWA), Emerging and Major Infectious Diseases of Livestock (EMIDA) and Specific International Cooperation Actions (SICA). A complete list of research projects implemented by the KVI is attached in Annex IV.

3.3 Results

Three mandatory results have been identified for the twinning project:

1. Selected procedures for the improvement of veterinary diagnostic capacities in compliance with EU and OIE standards proposed and ready for implementation

Key indicators of achievement:

• Plan to select test methods based on notifiable diseases existing in Israel, number of analyses per year and costs/benefits drafted by the end of month 3;

• Action plan prepared on the reorganisation of the lab structure within KVI and approved by BC authorities by the end of month 7;

• At least 10 procedures for test methods on notifiable and zoonotic diseases in line with the accepted ISO17025 Quality System (QS) principles developed and approved, including number of detailed procedural manuals by the end of month 9;

• Action plan prepared on the drafting of annual national surveillance and monitoring programmes on notifiable diseases, including zoonoses and approved by BC officials by the end of month 16;

• Action plan prepared on drafting annual national programmes on food safety and approved by BC officials by the end of month 17;

• Plan to revise the KVI infrastructure developed by the end of month 8; • At least 6 laboratory employees trained in analytical methods for notifiable diseases by

the end of month 4; • Action plan prepared detailing the necessary steps for the application of a KVI laboratory

to become a regional OIE reference lab, by the end of month 7. • Action plan prepared on the reorganisation of the KVI in view of cooperation with private

companies (labs) and approved by BC officials by the end of month 19.

2. Quality assurance system at the KVI and in approved private laboratories improved and proposals on legal acts on notifiable diseases, monitoring and surveillance programmes, zoonotic diseases (public health) and food safety in accordance with EU legislation and principles with regard to laboratory activities in the veterinary field drafted

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• Plan prepared and presented to MARD by the end of month 7 on reference tasks performed by national reference labs according to international criteria, including a plan to facilitate execution of these tasks by the KVI;

• Proposals for draft legal acts required prepared and discussed with MARD by the end of month 7;

• At least 10 laboratory employees trained in relation to the implementation of PTS performed by national, regional and private labs by the end of month 11;

• Plan to implement proficiency testing schemes’ (PTS) activities at the KVI for notifiable diseases in Israel drafted and number of standard operating procedures (SOPs) developed by the end of month 12;

• Plan drafted for the performance of annual ring trials (PTS) by the end of month 14; • Training Plan (and ISO17025 Handbook) developed by the end of month 7; • At least 10 laboratory employees trained in all aspects of ISO17025, including SOPs,

validation reports, etc. by the end of month 11; • At least 10 laboratory employees trained on Quality Control and Quality Management by

the end of month 17; • Procedures for at least 10 test methods on notifiable/zoonotic diseases developed and

approved, including number of detailed manuals by the end of month 19.

3. Epidemiological capacities developed enabling science-based risk assessment and risk management of existing and future challenges


• At least 8 persons trained on surveillance programmes, risk analysis and animal disease programmes by the end of month 9;

• Definition of surveillance and monitoring programmes for poultry, cattle, camels, sheep, goats and swine according to OIE and EU regulations prepared by the end of month 12;

• Assessment of the existing database and recommendations on the design of a new comprehensive version suitable for the collection and use of epidemiological data prepared and discussed with the BC by the end of month 12;

• At least 8 persons trained in epidemiology, risk assessment and diagnostic methods by the end of month 14;

• At least 8 persons trained in evidence-based decision making by the end of month 14; • At least 8 persons trained on proper control and sample collection by the end of month 15.

3.4 Activities

The Twinning project will allow for the development of a close relationship with a food and veterinary body of an EU Member State1. The listed means and activities are indicative. The exact activities and appropriate implementation methods will be agreed between the partners in the Twinning Contract.

1 Several MS, in case of a consortium.

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General Activities

A.0.1. Kick-off Workshop

Method

The first month of the project will focus on the installation of the Resident Twinning Adviser (RTA) in Israel, who will have to be installed in his/her office at the KVI. The RTA will be introduced to the Beneficiary Country (BC) stakeholders of the project and to RTA counterparts and staff. RTA will hire an RTA Assistant through an appropriate selection procedure.

A one-day kick-off meeting will be organised in the first month with the aim of launching and presenting the project to the stakeholders.

Benchmarks: - Participants identified and attendance list prepared; - Stakeholders informed about the start and detailed content of the project.

Resources: PL, RTA, STEs, interpretation

A.0.2. Final Closing Conference

Method

During the last two months of the project, a closing conference will be organised at which the results of the project will be presented. The state of play in the areas of the project’s interventions will be discussed with the beneficiary, the Israeli Government, civil society and other donors. The conference will be concluded with recommendations for follow-up and lessons learnt.

Benchmarks: - Participants identified and attendance list prepared; - Stakeholders, media and public informed about the results of the project; - Recommendations and lessons learnt formulated and discussed.

Resources: PL, RTA, interpretation

A.0.3. Visibility actions

Method

Throughout the project, the KVI together with the RTA and the MARD Spokesperson team will carry out project communication and visibility measures. Press releases will be issued at least in the beginning and end of the project. Information to mass media will be provided on regular basis about project achievements and most significant results. Project will develop its own web site that will be an integrated part of the MARD web site and will represent all activities held. Information about the project will be regularly, but at least once in every three months, updated on the MARD website. An STE specialised in communication measures will be attracted to assist in the development of the communication measures.

Benchmarks: - Communication plan developed; - Stakeholders, media and public informed about project activities and results.

Resources: RTA, MS STE, BC PL, RTA Counterpart, MARD Spokesperson team,

interpretation, translation, visibility costs EUR 10 000,- Result 1: The following activity group is linked to the achievement of result 1 “Selected procedures for the improvement of veterinary diagnostic capacities in compliance with EU and OIE

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standards proposed and ready for implementation”. This is referred to as Component 1 later in the fiche. 1.1. Drafting of a plan for selection of test methods

Method

A plan is needed to increase the efficiency on test performances. The same test methods e.g. ELISA and PCR test methods are performed by several labs within KVI. All these test methods are performed within each Division of KVI. This plan should also describe the effect of centralising test methods on human capacity. An overview of all test methods performed by the different Divisions, including the number of analyses per year and which test methods are ISO17025-accredited, should be reviewed critically by the key component Member State (MS) short-term expert (STE), Resident Twinning Adviser (RTA), RTA counterpart, Beneficiary Country (BC) project leader (PL) and heads of the Divisions. After the critical review of e.g. the serology, molecular-biology and virology test methods performed at KVI, a election of routine diagnostic test methods should be made. This selection is based on tests that can be performed in one Serology department, one Molecular-biology department and one Virology department at KVI. An additional selection of test methods is required on test methods that need to be performed by a national reference lab (NRL) and test methods that can also be performed by private labs with respect to tests that are related to notifiable diseases and public health. A further selection of test methods can be based on cost/benefit calculations. In addition, a selection of KVI test methods could be made based on tests used for routine or research purposes. A further selection should be made of tests to be ISO17025-accredited by the Israeli Laboratory Accreditation Authority (ISRAC) in accordance with EU and OIE rules. Examples of tests that may require ISO17025 accreditation are test methods on Salmonella and zoonoses and EC regulations no 2074/2005 and 396/2005.

A Joint working group comprised of the RTA, RTA counterpart, BC PL and Division leaders of the KVI will be set up under the leadership of a key component MS STE. The actions set out in the plan should be submitted to the BC authorities for approval.

Benchmarks: - An overview prepared of the existing test methods, including the number of analyses per year and which test methods are ISO17025-accredited;

- A plan to select test methods based on notifiable diseases existing in Israel, number of analyses per year and costs/benefits drafted by the end of month 3.

Resources: RTA, key component MS STE

1.2. Drafting of an action plan for the reorganisation of the lab structure of the KVI

Method

The efficiency of the performance of routine test methods should be reviewed. Clustering of test methods into the same test discipline might be of relevance (i.e. the setup of; i) a Serology Department to cluster the routine serology work that is currently performed in different Divisions of the KVI; ii) a Molecular Biology Department (e.g. for PCR assays) to cluster the routine molecular biology work currently performed in different Divisions of the KVI; and iii) the combination of routine virus culture and virus identification methods within a general Virology Department).

This may result in a more efficient working strategy, including the use of (semi)-automated robotic systems (RNA/DNA extraction machines, ELISA/serum pipetting robots), the use of a single PCR platform, etc., thereby prompting a reduction in personnel/staffing capacity involved in routine analyses. Selection of test methods and clustering of test disciplines should face the difference in biosafety levels for pathogens (BSL2 vs_BSL3, as described in “Clinical Management of Highly

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Infectious Diseases: a EUNID consensus guideline”; European Network for Highly Infectious Diseases).

In addition, the set up of new departments, e.g. an Epidemiology department and a department responsible for the implementation of National Reference Lab (NRL) reference tasks (tasks performed by KVI to support the Quality Control on veterinary diagnosis in Israel) are needed. Reference tasks, such as performing Quality Control audits, preparing national control samples, supporting a national Quality Control system, etc. are tasks related to national labs as seen on international level.

An action plan on the reorganisation of the KVI will be developed. The actions set out in the action plan should be submitted to the BC authorities for approval.

Benchmarks: - Action plan prepared on the reorganisation of the lab structure within KVI and approved by BC authorities by the end of month 7.


1.3. Development of SOPs for test methods

Method

Standard Operating Procedures (SOPs) on test methods in line with the accepted ISO17025 Quality System (QS) principles will be developed and submitted to the BC authorities for adoption. The resulting selection of SOPs will require accreditation by the Israeli Laboratory Accreditation Authority (ISRAC). The need for preparation of Manuals of procedures according to QS principles will be identified and materials developed (e.g. manuals for inspections and sampling, laboratory analytical methods, etc.). Most of these activities will have to be performed by KVI staff and the QM.

Benchmarks: - Gap analysis carried out on SOP’s that are not in line with ISO17025 should be finalised by the end of month 4;

- At least 10 procedures for test methods in line with the accepted ISO17025 Quality System (QS) principles developed and approved by the end of month 9, including detailed procedural manuals.

Resources: RTA, STEs, translation

1.4. Drafting of action plans on the active surveillance and monitoring of animal diseases and food safety

Method

Annual plans are required to monitor notifiable diseases and food safety in Israel. A workshop will be organised for delegates (including, if appropriate, delegates from the MARD and MoH), on the methodology to be used when preparing annual national surveillance and monitoring programmes on notifiable diseases, including zoonoses and on food safety. Training by EU experts is also required to improve knowledge on i) what is important and relevant for a good monitoring programme; and ii) whether Israel currently does too much or not enough. Discussions with other EU partners involved in surveillance and monitoring are required.

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Result 1.4 can be combined with Component 3.

Benchmarks: - Stakeholders informed about the methodology to prepare annual plans; - Action plan prepared on the drafting of annual national surveillance and

monitoring programmes on notifiable diseases, including zoonoses and approved by BC officials by the end of month16;

- Action plan prepared on drafting annual national programmes on food safety and approved by BC officials by the end of month 17.

Resources: RTA, Key component MS STE, STE

1.5. Drafting of a plan for the revision of the KVI infrastructure

Method

The current KVI laboratory building was constructed between 1957 and 1960. An evaluation for revision of the building, with special emphasis on the post-mortem facility, is thus required.

In addition, a plan is needed to revise the current BSL3 unit of the FMD and exotic disease unit in order to make profitable use of the current PL3 (BSL3) facility of the FMD unit for diagnostic purposes, training, and to perform experiments with e.g. BSL-3 pathogens. This is of particular importance given that Israel borders Jordan, Lebanon, Syria, the Palestinian Authority and Egypt, where various exotic animal diseases are present and are of potential danger to Israel. Thus the capacity of the KVI should be strengthened with regard to experiments and diagnosis. The BSL-3 unit can be used to teach vets about the course and diagnosis of exotic diseases, which will lead to an increase in knowledge and capacity at the KVI. A team will be formed between the key component MS STE, STE, RTA counterpart, BC and head of the BSL3 unit. The actions set out in the plan should be submitted to the BC authorities for approval.

Benchmarks: - Plan to revise the current KVI infrastructure with special reference to post-

mortem and PL3 (BSL3) animal facilities of the FMD and exotic disease building to prepare a construction tender developed by the end of month 8.

Resources: RTA, key component MS STE, STE

1.6. Drafting of an action plan to advance the professional skills of laboratory personnel

Method

The STE in collaboration with the key component MS STE, the RTA counterpart and the BC project leader will conduct an assessment of the skills of lab staff. The assessment should focus not only on practical skills but also on theoretical skills. The assessment should include the current gaps as regards notifiable diseases in Israel, threatening emerging diseases such as African Horse Sickness and Rift Valley Fever, and also new techniques to identify diseases with unknown aetiology, e.g. next-generation sequencing.

After the assessment document has been prepared, a workshop will be organised for KVI employees (management and laboratory staff, including relevant staff working at border points and at private and regional labs). Subjects of the workshop should be the recorded gaps, recent case studies, international accreditation procedures, specific training in analytical methods for notifiable diseases, etc. An action plan will be developed to address these gaps. If required, appropriate educational material on relevant issues with practical examples and recent case studies will be prepared.

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Benchmarks: - Assessment of the professional skills of lab technicians carried out; - Action plan to advance the professional skills of lab personnel drafted; - Educational material prepared; - At least 6 laboratory employees trained in analytical methods for

notifiable diseases by the end of month 4; - Questionnaires and certificates issued, cross-checking results obtained.


1.7. Supporting the KVI to prepare documentation for an additional KVI laboratory to become a regional OIE reference laboratory

Method

A document will be prepared to support at least one application of a KVI lab to become a regional OIE reference lab (i.e. rabies). This will be prepared on the basis of legislative EU acts such as the EU Regulations; Directive no 415/2013 on the Responsibilities and tasks of the EU reference laboratory for rabies, additional to those laid down in Article 32(2) of Regulation (EC) no 882/2004 and Directive 2000/ 293/EC. A written document and an action plan detailing the necessary steps for the application will be prepared.

Benchmarks: - Action plan prepared detailing the necessary steps for the application of a KVI laboratory to become a regional OIE reference lab, in view of MARD's application for a KVI laboratory to become a regional OIE reference lab prepared by the end of month 7.


1.8. Drafting of an action plan for the reorganisation of the KVI in view of cooperation with private companies

Method

The budget of the MARD to KVI in general reduces each year, leading to a reduction in human capacity and income through test analyses. If the legal arrangement between the KVI and the Veterinary Services remains the same, the human, knowledge and technical capacity of the KVI will be greatly reduced each year. Over the next 5-10 years, the KVI will thus need extra input into the improvement of both its facilities and its new and young human capital. A Joint working group consisting of the RTA counterpart, the BC PL and delegates of the MARD and MoH (including delegates of the Department of Legal Affairs) will be set up under the leadership of a key component MS STE. The Joint working group will prepare an action plan on the reorganisation of the KVI to implement possible cooperation with private (labs) and/or commercial companies (profit and/or non-profit) based on experiences from other national reference, research and private labs.

During the implementation of this activity, it should be taken into account that at the beginning of 2014 the “TANDOO” company contracted by the MARD undertook a functional and economic analysis of the activities performed by the KVI and IVSAH. With regard to the performance of tests carried out by the KVI, TANDOO should explore the possibilities of delegating some of the activities to private laboratories. The results of the analysis are expected to be received in the third quarter of 2014. Therefore the measures to be carried out under activity 1.8 should be implemented in coordination with the results provided by the “TANDOO” company.

Benchmarks: - Action plan prepared on the reorganisation of the KVI in view of cooperation with private companies (labs) and approved by BC officials by the end of month 19.

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Resources: RTA, key component MS STE, air tickets

1.9. Study visit to two MS on the structure of the veterinary services

Method

A study visit to (preferably) two countries should be organised in order for BC experts to become acquainted with the structure of veterinary services in EU MS, in particular, cooperation with private labs, organise meetings with the appropriate representatives of the Ministry of Agriculture of the MS and to hold discussions on legislation currently in force and the structure of veterinary services and laboratories in EU MS (supporting EC regulations: no 882/2004 and 854/2004).

Benchmarks: - BC experts acquainted with the structure of veterinary services in two EU MS;

- Findings from the study visits used to prepare the action plan on the reorganisation of the KVI under Activity 1.8.

Resources: RTA, air tickets, per diems, small incidental costs

Result 2: The following activity group is linked to the achievement of result 2: “Quality assurance system at the KVI and in approved private laboratories improved and proposals on legal acts on notifiable diseases, monitoring and surveillance programmes, zoonotic diseases (public health) and food safety in accordance with EU legislation and principles with regard to laboratory activities in the veterinary field drafted”. This is referred to as Component 2 later in the fiche.

2.1. Preparation of an official Quality Control system plan with regard to laboratory activities in the national veterinary field

Method

An official plan will be prepared for the MARD on the reference tasks that should be performed by national reference labs to control the quality and measure the performance of labs conducting tests methods related to i) the diagnosis of notifiable diseases and ii) related to monitoring and surveillance programmes. Labs should be ISO17025-accredited and controlled by the national reference laboratory through annual visits, quality control checks and participation in national ring tests (PTS). This plan should meet international standards for reference labs as laid down in e.g. EC Directive 2004/564/EG. The RTA counterpart and BC PL will prepare the plan under supervision of the key component MS STE. The plan will be presented to the MARD by the RTA, RTA counterpart and the key component MS STE. Furthermore, legal acts stipulating that reference tasks should be coordinated by the KVI should be prepared by the MARD. The KVI should be mandated as National Reference Lab (NRL) by the MARD. This will offer KVI the opportunity to implement a Quality Control system within Israel. A Israeli Quality Control system is needed for labs, e.g. private labs performing i) tests on notifiable diseases and ii) tests related to public health, surveillance and control programmes. These labs should participate in a Quality Control systems at national (for test methods performed by private labs in Israel) and/or international level, in case test methods are performed by labs abroad.

Benchmarks: - A plan prepared and presented to MARD by the end of month 7:

1) on reference tasks performed by national reference labs according to international criteria, including a plan to facilitate execution of these tasks by the KVI;

2) to offer the KVI the opportunity to carry out reference tasks proper of a national reference lab according to international standards so as

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to enable it to control private and regional labs on the subject of test performance and quality;

3) indicating that regional and private labs performing tests and/or analyses related to national surveillance and monitoring programmes or notifiable diseases, have to be ISO17025-accredited and controlled annually by the national reference lab.

- Proposals for draft legal acts prepared and discussed with the MARD by the end of month 7.

Resources: RTA, Key component MS STE, STE

2.2. Study visit to a MS on the implementation of reference tasks and proficiency testing

Method

A study visit by BC experts (the QM and a technician) to an EU MS will be organised on; i) the implementation of reference tasks belonging to national institutes and ii) the setting up of proficiency testing, including the necessary controls to check the quality of private and regional labs.

Benchmarks: - BC experts acquainted with the reference tasks belonging to national institutes and setting up of proficiency testing, including the necessary controls to check the quality of private and regional labs;

- Findings from the study visit used to prepare the plans mentioned under Activity 2.1.


2.3. Assessment of existing and future laboratory Quality Control system for private and regional labs

Method

While private labs in Israel are currently equipped to perform tests on notifiable diseases (such as NDV and AI) and test methods related to surveillance or control programmes, there is no Quality Control system in place to require that the quality of test performances be assessed by a national reference lab. Some private and regional labs have implemented a Quality System (QS), but there is no national Quality Control system. STEs will therefore conduct training on the implementation of a national QS, including PTS and Internal Test Controls, as part of the ISO17025 quality procedure. The first theoretical and practical training will be given to KVI management, the QM, and laboratory staff including KVI technicians. The second will be provided to staff at regional and private labs. The RTA counterpart, the BC project leader and the QM will develop a plan to implement PTS activities at the KVI for notifiable diseases in Israel while procedures for use in the implementation of PTS will also be prepared.

Benchmarks: - At least 10 laboratory employees (KVI staff and staff in regional and private labs) trained in relation to the implementation of PTS performed by national, regional and private labs by the end of month 11. The training should also involve a discussion on the role of the KVI with regard to Reference Tasks, such as the organisation of PTS-es, to be performed by KVI.

- At least 10 laboratory employees trained in how to prepare the document on existing laboratory quality controls, including the addressing of current gaps by the end of month 11. Training will be provided on Reference Tasks for national reference labs and on the setup of annual control visits and ring trials (proficiency testing schemes: PTS) for KVI staff;

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- Plan to implement PTS activities at the KVI for notifiable diseases in Israel drafted by the end of month 12;

- SOPs for PTS developed by the end of month 12.


2.4. Drafting of a ring test programme for major animal diseases and identification and mapping of relevant private and governmental laboratories in Israel and laboratories abroad that carry out tests

Method

While the KVI and some private labs already participate in international ring trials (PTS), this is not done for all notifiable diseases and no PTS are performed at national level by private or regional labs. The KVI participates for example in ring trials for BVDV, food microbiology, NDV, AI virus paratbc, rabies, Mg and Ms. Participation is not always annual. Participation in PTS is one of the requirements that must be met to fulfil the ISO17025 QS. The RTA counterpart, BC PL and QM will thus prepare, under the supervision of the key component MS STE, a list of test methods for PTS, including a list of the regional and private labs that should participate. An annual PTS programme document should be submitted for approval to the BC authorities. Communication with the MARD, regional and private labs is needed. This plan should also include the preparation of at least 3 PTS on notifiable diseases.

The RTA counterpart, BC PL and QM will prepare a list of labs located abroad that are involved in the testing of samples from Israel. This may include a list of public and private labs detailing whether or not they are ISO17025-accredited (or would merit ISO17025 accreditation) and whether they are performing test methods related to notifiable diseases and surveillance/monitoring programmes. Private labs abroad should be willing to participate in PTS and control visits performed by the national reference lab.

Contact/communication should be undertaken between these labs, the MARD and corresponding labs.

Benchmarks: - A plan drafted for the performance of annual ring trials (PTS) by the end of month 14;

- Ring tests (PTS) selected for notifiable diseases existing in Israel by the end of month 15;

- Laboratories abroad identified and draft contract prepared for labs abroad that are involved in the testing of samples from Israel to perform tests (for pathogens/compounds) whose implementation is not practical in Israel by the end of month 17.


2.5. Training of laboratory personnel in advanced diagnostic methods, ISO17025 accreditation, quality control and quality management

Method

STEs will conduct a series of training sessions on ISO17025 for KVI management, QM, laboratory staff (including relevant staff working at border points and regional laboratories) and technicians on subjects such as international accreditation procedures, analytical methods, validation studies, etc., according to a Training Plan and will develop appropriate educational material on relevant issues that includes practical examples and recent case studies. This Training plan should result in an increase in the number of ISO17025-accredited test methods at KVI (accredited by the ISRAC) on notifiable diseases and tests related to public health. In addition, the improvement of the QA system at the KVI (improvement of all labs; implementation of annual internal audits, use of Internal Test Controls, etc),

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as described in the EC mission Report: DG (SANCO) 2008-7661-MR, is needed, as is a Quality Management programme at the KVI and a Quality Control system for use in auditing private and regional labs at national level. This QS should include participation in PTS and the use of Internal Test Controls to be performed by regional and private labs at national level.

A questionnaire will be prepared to assess the effectiveness of the training; the results of which should be used for the identification of gaps and thus for the improvement of training material and assessment of the need for further training.

The RTA counterpart, BC PL and QM will develop a Training Plan (and ISO17025 Handbook) with the involvement of MS STEs. The need for preparation of Manuals of procedures according to QMS principles will be identified and materials developed (e.g. manuals for inspections and sampling, for laboratory analytical methods, etc.).

Benchmarks: - Training Plan (and ISO17025 Handbook) developed by the end of month

7; - Educational material prepared and issued; - At least 10 persons from KVI management, lab staff and technicians

trained in all aspects of ISO17025, including SOPs, validation reports, etc. by the end of month 11;

- At least 10 laboratory employees trained on Quality Control and Quality Management by the end of month 17;

- Questionnaires and certificates issued, cross-checking results obtained; - Procedures for at least 10 test methods on notifiable / zoonotic diseases

developed and approved, including detailed manuals, by the end of month 19.


2.6. Study visits to a MS on the quality system, the technical performance of tests and the logistical structure of the lab

Method

Activity 2.6 should be implemented based on gaps identified within the framework of the assessment carried out under Activity 2.3. In addition, study visits in 2.6 are used to support the trainings in Activity 2.5 on the ISO17025 Quality System. Study visits need to be performed also to have an impression on the Quality System that is used in MS labs. The Quality System in MS labs can be used as a "blue print" for the improvement of the Quality System at KVI. Impressions are needed at the beginning of the ISO17025 Quality System improvement. Thus, study visits to an MS for BC experts (technicians, heads of laboratories, QM) will be undertaken in order to study i) the quality system in place; ii) the technical performance of tests performed on notifiable diseases; and iii) the logistical structure of the lab, including practical training on the testing methods to be selected. The programme of each study visit should be carefully planned in advance, using a tailor-made approach for each BC participant. Study visits should be organised in a way to allow each participant to get an in-depth insight into the specific subject and work on practical testing methods along the EU MS experts. The study visits should preferably last for 10 days for each participant.

Benchmarks: - BC experts acquainted with the quality system, the technical performance of tests performed on notifiable diseases and the logistical structure of the lab;

- Findings from the study visits used to prepare the procedures, including detailed manuals, under Activity 2.5.

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Result 3: The following activities group is linked to the achievement of the result 3 “Epidemiological capacities developed enabling science-based risk assessment and risk management of existing and future challenges”. This is referred to as Component 3 later in the fiche.

3.1. Assessment of existing and future epidemiological activities of the KVI

Method

STEs, in cooperation with the RTA counterpart and BC PL and under the supervision of the key component MS STE, will develop a plan to increase the capacity of the staff working with epidemiology issues at the KVI.

STEs will produce the necessary material and will provide theoretical training in the implementation of surveillance programmes, risk analysis and animal disease programmes to KVI staff as well as representatives of the MARD, the MoH, and project leaders of surveillance and monitoring programmes in Israel. Specific cases involving current practices should be discussed and referred to during the seminar by the STEs and BC experts.

Benchmarks: - A plan to increase the capacity of the staff working with epidemiology issues prepared;

- At least 8 persons (KVI staff, representatives of MARD and MoH) trained on surveillance programmes, risk analysis and animal disease programmes by the end of month 9;

- Questionnaires issued, cross-checking results obtained. Resources: RTA, key component MS STE, STEs 3.2. Two study visits to a MS on the implementation of surveillance programmes, risk analysis and animal disease programmes

Method

Study visits by BC employees, who will be trained in epidemiology, to top-level institutes will be organised on detailed practical aspects of the implementation of surveillance programmes, risk analysis and animal disease programmes.

Benchmarks: - BC experts acquainted with practical detailed aspects of the implementation of surveillance programmes, risk analysis and animal disease programmes;

- Findings from the study visits used to revise the existing and introduce new surveillance and monitoring programmes under Activity 3.3.


3.3. Identification of needs for epidemiological activities and risk assessment methods

Method

A number of steps will be implemented. The RTA, assisted by the animal health STE, will support the establishment of a Joint working group, comprising representatives of MARD, representatives of the MoH (when dealing with zoonoses) and the main entities dealing with animal health surveillance and monitoring programmes. Some of the tasks of the working group are to revise (if applicable) the existing animal disease surveillance programmes, to introduce new surveillance and monitoring

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programmes, to describe plans to collate and analyse epidemiological data, to support new control policies and to harmonise procedures on epidemiology. Focus will be on notifiable diseases of cattle, camels, sheep, goats and swine. Surveillance and monitoring programmes for these animal species will be defined according to OIE and EU regulations.

In order to ensure training on epidemiology for central and regional staff, the epidemiology STEs will design and implement a training course, split into two modules, with theoretical and practical components. The participation of animal health experts from neighbouring countries will be encouraged by the MARD.

The IT STE, with the assistance of the animal health STE, will prepare an assessment of the existing databases, particularly as regards their compatibility, in the relevant administrations and bodies and will prepare recommendations on the design of a new comprehensive version, including a compatible dataset for animal disease control, which is specific to the needs of Israel and includes geographical information system (GIS) data. Following finalisation of the recommendations on the new database, the experts will discuss these with the relevant BC representatives.

The legal STE, assisted by the RTA, will design and implement a training course on evidence-based decision making directed at high-level staff working at central level.

STEs will also support the preparation of new animal disease control and eradication policies, in line with international standards, taking into account different husbandry practices (intensive, nomadic), and based on sound evidence and epidemiological data.

Benchmarks: - Overview prepared of epidemiological activities and risk analysis studies on notifiable diseases of cattle, camels, sheep, goats and swine;

- Definition of surveillance and monitoring programmes for poultry, cattle, camels, sheep, goats and swine according to OIE and EU regulations prepared b y the end of month 12;

- Assessment of the existing database and recommendations on the design of a new comprehensive version suitable for the collection and use of epidemiological data prepared and discussed with the BC by the end of month 12;

- At least 8 persons (KVI laboratory personnel and professionals of the Israeli veterinary services) trained in epidemiology, risk assessment and diagnostic methods by the end of month 14;

- At least 8 persons of high-level veterinary staff working at central level trained in evidence-based decision making by the end of month 14.

Resources: RTA, STEs 3.4. Preparation and implementation of training programmes on farm food safety issues for quality assurance of animal management Method The STE will produce the necessary material and conduct a seminar for field staff involved in the collection, storage and transport of samples related to surveillance and monitoring programmes in Israel. The proper collection, storage and transportation of samples will form part of the training provided in epidemiology. Specific cases involving current practices should be discussed and referred to during the seminar by the STE and BC experts. Benchmarks: - At least 8 persons of veterinary field staff involved in the collection,

storage and transport of samples trained on proper control and sample collection by the end of month 15.

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Resources: RTA, STE 3.5 Means/Input from the MS Partner Administration

3.5.1 Profile and tasks of the MS Project Leader (PL)

The Project Leader (PL) should be a high-ranking senior civil servant from the MS-partner administration at a level appropriate for the necessary political dialogue. She/he will coordinate and monitor the overall progress of the project. In particular, the PL will be able to call on short term experts in supporting the efficient implementation of the project and the full support at senior levels within the BC, lead the activities of the project, ensure the achievement of the mandatory results, and will be responsible for the implementation of the activities. She/he will coordinate, from the MS side, the Project Steering Committee meetings, which will be held in Israel every three months.

The PL will be expected to devote a minimum of 3 days per month to the project from his/her home base. In addition, he/she will coordinate, from the MS side, the Project Steering Committee (PSC), which will meet in Israel every three months.

Profile: • The PL should be a high-ranking senior civil servant in a MS Veterinary Administration; • At least 10 years of experience in veterinary laboratory services with good understanding of other

related subjects, such as veterinary diagnosis and the ISO17025 Quality System. He/she must have been in an active management position in an MS laboratory veterinary institution for at least 10 years;

• Experience in the field of institutional issues and organisation/participation in a national veterinary services infrastructure compliant with European requirements for at least 10 years;

• Excellent command of spoken and written English. Tasks: • Overall coordination, guidance and monitoring of the project; • Preparation of project progress reports with the support of the RTA; • Monitoring the timely achievement of project results; • Co-chairing of the project steering committee; and • Provision of legal and technical advice and analysis.

3.5.2 Profile and tasks of the Resident Twinning Adviser (RTA)

One RTA over a period of 18 months, as well as medium-/short-term experts, will implement the above-listed components. The RTA has the responsibility to guide the work of the team and provide support to the KVI, IVSAH and other beneficiaries.

Profile: • Minimum 10 years of experience in veterinary laboratory services, veterinary diagnosis and

management; • Sound comparative knowledge of relevant EU legislative and institutional requirements related to

the various components of this project; • Wide knowledge of related good practice/Acquis communautaire and demonstrated experience in

the implementation of EU legislation; • Solid knowledge of food and feed safety legislation, control methods and procedures; • Previous experience in twinning would be an asset; • Experience in working on similar projects in ENPI countries; • Good training, public speaking, diplomatic and written communication skills; • Excellent computer literacy (Word, Excel, PowerPoint); • Excellent command of spoken and written English;

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• Experience in the implementation of QMS would be an asset.

Tasks: • Overall supervision of the project implementation and coordination of all activities, as well as

management of the project administration; • Coordination of the activities of the team members in line with the agreed work programmes to

enable the timely completion of project outputs; • Provision of technical input to the project and provision of advice in his/her field of expertise; • Liaison with MS and BC PLs and regular contact with the BC RTA counterpart; • Co-preparation of project progress reports together with the MS PL and the RTA Counterpart; • Organisation of monthly monitoring meetings; and • Liaison with other relevant projects and Israeli institutions.

3.5.3 Profile and tasks of the short-term experts

Tasks required of the short-term experts (STEs):

• Terms of Reference (ToR) for STEs will be elaborated by the RTA and agreed with the BC RTA Counterpart before the beginning of each mission and will be sent to the respective STE at least two weeks before the start of the mission to enable preparation;

• The exact number of STEs per activity should be agreed during the contract negotiation process. Profile of the short-term experts: A pool of short-term experts will be in place to ensure the smooth implementation of the project during the overall implementation period. STEs should be identified by the Project Leader/RTA and have to be agreed with the Beneficiary administration during the design and delivery of the project. There shall be 3 suitable key experts proposed for each of the three components identified in the fiche.

The STEs will principally be seconded from the MS government administration, except for specific fields of expertise for which the MS partner might need to outsource expertise from mandated bodies and/or other ministries/authorities.

The STEs (except activity A.03) shall have:

• A university degree in a relevant veterinary field (e.g. Veterinary Faculty); a postgraduate PhD would be an asset;

• Experience in EU and OIE regulations on notifiable diseases, and diseases related to public health and/or food safety;

• A minimum of 10 years of experience in their respective field; and • Excellent command of written and spoken English. In order to achieve result 1, the STEs involved should have experience in: • The drafting of EU and OIE legislation on veterinary diseases; • Management and organisational experience within EU veterinary service bodies; • Conducting impact assessments on veterinary services, diagnostic labs and organisational aspects

of EU veterinary services; and • Good writing and presentation skills and familiarity with various approaches to implementation of

EU legislation. In order to achieve result 2, the STEs should have: • Training and facilitation skills; • Specific knowledge and experience in the setting up and implementing of ISO17025 QS, Quality

Management and Quality Control systems; and • Experience in coaching/mentoring.

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In order to achieve result 3, STEs should have: • Experience in the provision of training in epidemiology and risk assessment; • Experience in the development of veterinary monitoring and surveillance programmes; and • Experience in veterinary services. In addition to their missions to Israel, the short-term experts are expected to contribute actively to the preparation of the foreseen study visits. 4 Institutional Framework

The Israeli Veterinary Services and Animal Health (IVSAH) is an independent unit within the MARD that was established in 1920 under the British Mandate. The IVSAH, which includes the KVI, employs 281 people, of whom 193 are permanent employees and 88 are recruited for specific research and disease eradication programmes. Half of these work in diagnosis and research, while the other half is employed in inspection and control. The Poultry and Dairy Boards also directly employ veterinarians for field work, laboratory and inspection activities. See the IVSAH organisational chart attached in Annex III.

The income generated by identification, vaccination and diagnostic testing is an important source of revenue for veterinary services (VS); in the last 4 years this has accounted for approximately 40% of the operational funding for VS with the remainder coming directly from the national budget.

The main beneficiary institution of the project is the Kimron Veterinary Institute (KVI). The KVI is the diagnostic and research branch of the IVSAH. At local level Field Veterinary Services are organised in six Regional Veterinary Offices and are responsible for the prophylaxis and control of animal diseases. The laboratories at the KVI, as part of IVSAH, are responsible for the diagnosis of notifiable diseases as well as for the testing of feed and food products of animal origin for local, import and export markets. The major functions of the KVI include:

• Diagnosis of animal and zoonotic diseases; • Diagnosis of poisoning and intoxication in animals; • Food safety inspections for biological pathogens, toxins and chemical or antibiotic residues; • Vaccine control; • Production of vaccines, which are economically infeasible for the private sector; • Research supported by local agricultural and international funding agencies and industry; • Dissemination of information to growers and veterinarians; • Instruction and collaborative activities with the Koret School of Veterinary Medicine; • Maintenance of National Reference Laboratories for the diseases Rabies, Botulism and

Brucellosis (recognised by the Israeli Ministry of Health (MoH)). The Food and Feed Safety laboratories for products from animal origin are also recognised as national referent centres;

• Maintenance of National Reference Laboratories for the diseases Avian Influenza (AI) and Newcastle and mycoplasmas of animal origin.

• Maintenance of the International Reference Laboratory for Brucellosis (OIE and FAO). • Laboratory examination of imported and exported feed and food products of animal origin to

be exported to international markets, as a part of the service provided to the Israeli Competent Authority (IVSAH) and to Israeli industry; and

• Diagnosis and reference services for the Palestinian Authority.

The KVI performs laboratory diagnosis of major diseases and has emergency diagnostic protocols for exotic diseases and zoonoses. The KVI has 16 laboratories. The laboratories are organised into 5 divisions: Pathology, Parasitology, Bacteriology, Virology and Poultry and Fish Diseases (see Annex III). Four of the KVI laboratories are also National Reference Laboratories: Rabies, Botulism, Brucellosis, and Food residues.

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The KVI, all of its laboratories, IVSAH and the headquarters of the Field Veterinary Services, as well as its service and administration units and the MARD, are located at the agricultural campus in Bet Dagan. The other Veterinary Field Service units of IVSAH are located at i) six regional veterinary bureaus (Rosh Pina, Akko, Gilboa, Hadera, Kannot and Be’er Sheva) and ii) four quarantine stations for animals other than poultry and birds.

Besides the KVI, as public institute, there are also three other private veterinary laboratories:

- 2 regional Poultry Health Laboratories owned by the Egg & Poultry Board; one in the south and one in the north, which provide diagnostic services to the poultry sector. These private labs perform analyses on e.g. Salmonella and NDV (serology and PCR); and

- 1 laboratory of the Dairy Board that performs analyses on milk quality, somatic cell count (SCC), mastitis and also the detection of antibodies against e.g. BLV and BVDV.

In addition, there is a governmental (MARD) diagnostic laboratory for fish diseases.

For microbiology of feed and food products, there are several private laboratories providing services to the MARD and MoH as regards food safety on the local market.

There is also one private laboratory for parasitology and microbiology, mainly used by dairy farms.

The development of the State prior to the achievement of independence was achieved largely by the establishment of kibbutzim, which were traditionally based on agriculture from the early part of the 20th century onwards. The need for animal health services was soon recognised and a form of livestock health insurance was established by dairy farmers. In a much modified form, the resulting veterinary organisation (Hachaklait Mutual Society for Cattle Veterinary Services in Israel Ltd.) continues to exist, providing clinical services to dairy cattle and beef farms, to sheep and goat farms and to horse owners. There is a close association between the Hachaklait and both the Israel Dairy Board and the Israel Cattle Breeders’ Association, neither of which is a statutory organisation.

The relationship between the Egg and Poultry Board and the public sector is close, with veterinarians of the Board carrying out activities on behalf of the industry and the government. Partnership between the government (IVSAH) and the private veterinary services is particularly strong in the poultry and dairy sectors and provides an adequate basis for the further enhancement of cooperation between the public and private sectors.

The laboratories of the Egg and Poultry Board provide diagnostic services, including tests regarding notifiable diseases such as Avian Influenza (AI) and ND. All test results on notifiable diseases are reported to IVSAH. Suspected cases of AI and ND are confirmed by the poultry division in the KVI.

The other stakeholders (i.e. the MoH, MARD and private or semi-private organisations such as representatives of farm associations, NGOs, private laboratories, veterinarians, etc.) shall be invited to take part in certain meetings and trainings.

5 Budget

The beneficiary will provide contribution in kind in the form foreseen in the Twinning manual. The maximum total budget available for the action is EUR 1,035,284.

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6 Implementation Arrangements

6.1 Implementing Agency

The European Union Delegation (EUD) in Tel Aviv will be responsible for tendering, contracting, payments and financial reporting and will work in close cooperation with the beneficiary.

Contact details for EUD Project Manager: Mr Sebastien LORION Delegation of the European Union to Israel Paz Tower, 16th fl., 5-7 Shoham Street P.O. Box 3513 Ramat Gan 5213603, Israel Tel.: +972 3 600 0918; Fax: +972 3 613 7770 E-mail to: [email protected]

The Programme Administration Office (PAO) in Jerusalem will support the Twinning project implementation process together with the EUD.

Contact details for PAO: Mr. David Nezer First secretary Economic Affairs Division Ministry of Foreign Affairs 9, Yitzhak Rabin Blvd., Jerusalem 91035, Israel Tel.:+972 2 5313461; Fax:+972 2 5303209 E-mail: [email protected]

6.2 Main counterparts in the Beneficiary Country

BC Project leader:

Dr. Boris Yakobson, Head, Rabies laboratory, KVI Tel.: +972 506241352; Fax: +972 39605293 Email: [email protected] Bet Dagan, P.O.Box 12 Israel 50250

RTA Counterpart:

Dr. Monica Leszkowicz Mazuz, expert, Division of Parasitology, KVI Tel.: +972 506241824; Fax: +972 39605293 Email: [email protected] Bet Dagan, P.O.Box 12 Israel 50250

Component leaders:

Result 1: Dr. Michel Bellaiche, Director, KVI Result 2: Mrs. Dikla Aviv, Quality Manager, KVI Result 3: Dr. Aniella Gilboa, CVO assistant

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6.3 Contracts

The project will be implemented through a single Twinning contract.

6.4 Project Steering Committee

A Project Steering Committee (PSC) will be established for the control and supervision of the project activities and mandatory results. The Steering Committee will be co-chaired by the Project Leaders (MS and BC) and should include representatives of both the EUD and PAO. Key stakeholders of the project should be represented as observers (e.g. IVSAH, MARD and MoH). The Steering Committee will meet at regular (quarterly) intervals and will submit by the end of the meeting (as recorded in the minutes) its approval (or not) of the project reports. Official minutes of the PSC meetings will be recorded in English and distributed to all parties within 15 days of the PSC meeting.

7 Implementation schedule (indicative)

7.1 Launching of the call for proposals: May 2014

7.2 Start of the project activities: February 2015

7.3 Project completion: July 2016

7.4 The execution period (legal duration) is 21 months (i.e. 18 months for implementation of the Work Plan (presence of the RTA in Israel) and 3 months for project start and closure2). An indicative implementation schedule is attached in Annex II.

8 Sustainability

The primary issue that may influence sustainability, following project completion and the intended practical implementation and long-term operation of an improved veterinary diagnostic system in Israel, is political will (as represented by the existence of an enabling legislative base and adequate provisions for the funding of system implementation and maintenance defined within State Budget provisions or an expenditure framework).

Sustainability indicators of the improved veterinary diagnostic system will be an approved updated legislative framework, improved procedures and capacity and the establishment of an improved institutional setup. Other linked activities will relate to continued actions by the beneficiary and their relation to on-going developments regarding OIE and sanitary/phyto-sanitary (SPS) requirements.

Other direct sustainability issues relate to beneficiary involvement and contribution to the processes and activities defined within the project, including:

• The Beneficiary administration shall commit to designating a minimum number of project counterparts to work with the EU experts on a part-time basis;

• Throughout the project the Twinning partners will take care to ensure that all training materials and developed procedures are of sufficient quality. This will also be ensured through project monitoring at PSC meetings. Training materials and required procedures will be professionally developed and made available at the KVI for later use;

• The officials benefiting from training by the EU MS partner will provide further training and consultation to their colleagues;

2 The project starts on the date of notification by the EUD of the contract signature and is completed with the final reporting (i.e. reception by

the EUD of the final invoice with expenditure verification by an auditor).

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• The final Conference will be organised at the end of the Twinning project involving all relevant stakeholders and mass media to present the results of the project with practical implications for further follow-up by the BC partner;

• The BC administration will commit itself to lobbying and ensuring active cooperation within the framework of the project with all concerned bodies;

• The BC partner will commit itself to following the strategy for the reinforcement of the veterinary diagnostic capacities of the KVI in order to ensure good governance, improve administrative capacity and minimise the loss of know-how acquired by the Beneficiary during the course of implementation of the project;

• The final report will include a Sustainability plan with specific recommendations for safeguarding the achievement of results in the Beneficiary administration;

• The results of the project, in particular implementation arrangements, may lead to some structural changes and to the reallocation of responsibilities between the KVI and private laboratories and other institutions as appropriate. As a result of the implementing arrangements described in the Action Plan for the reorganisation of the KVI, a definition of the organisation and operation of the various structural units of the KVI will be established, along with further steps to be taken toward enhancing veterinary diagnostic capacities.

9 Cross-cutting issues and visibility

9.1 Cross-cutting issues

Good governance and the principle of equal opportunity will be integrated into all stages of the project implementation. A Project Steering Committee (PSC) will be set up under the leadership of MS and BC PLs to monitor the progress and attainment of results and to apply the most appropriate solutions in case of deviations from the contract. Representatives of the EU Delegation, the PAO and other stakeholders will be invited to participate.

Gender discrimination will be avoided and the principle of equal treatment of men and women in the field of employment and occupation will be integral to the planning and implementation of the project. Experts and employees will be attracted to the project based purely on their professional knowledge and competence. Project activities take into account gender mainstreaming and do not indicate any gender limitations. The activities to be undertaken are equally suited to both genders.

A sustainability plan will be prepared by the end of the project to be followed up by the BC, thereby ensuring the sustainability of project results.

The project has no direct impact on environmental aspects.

9.2 Communication and Visibility

The project shall draw up a communication plan that will ensure visibility for the activities themselves as well as for EU support throughout the implementation of the project. Proposals to be received from MS should include proposals for communication and EU visibility. Based on these, the communication plan will be finalised with the Beneficiary administration, the MS and the EU Delegation in the inception phase of the project3. The Spokesperson team of the MARD should be involved in disseminating information about the project, throughout the preparation and implementation of the project.

3 Rules on visibility for EU projects can be found at: http://ec.europa.eu/europeaid/work/visibility/documents/communication_and_visibility_manual_en.pdf

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10 Conditionality and sequencing

10.1 Commitment from the KVI

In order to ensure successful and timely implementation of the project and coordination with the MS partner, the KVI will provide strong commitment to project results and activities. It will mobilise the necessary experts on the BC side, ensure coordination with other stakeholders involved in the project, (especially the IVSAH and MARD) and provide access to all information necessary to the successful implementation of the project.

The KVI will pursue the adoption of the draft legal acts and the implementation of other documents elaborated during the course of the project in order to ensure the sustainability of project results.

10.2 Other inputs from the Beneficiary

• Air-conditioned and furnished office space at the KVI for the RTA, RTA Assistant and two STEs to work simultaneously;

• Facilities: 3 modern computer workstations, printer, scanner, photocopier, Internet connection, 2 telephone lines, fax machine, meeting table;

• Office running costs: electricity, Internet, telephone lines; • Meeting facilities for work sessions between MS and BC staff; • Training facilities as appropriate; • Funds for central and regional staff travel to seminars and work sessions as appropriate; • Necessary equipment for the implementation of training sessions; • Funds for the execution of ring tests with local and international accredited laboratories under

Activity 2.4, the future design of a new comprehensive version suitable for the collection and use of epidemiological data and the implementation of surveillance and monitoring programmes under Activity 3.3, as well as the future reconstruction of the PL3 (BSL3) animal facilities of the FMD and exotic disease building under Activity 1.5 to ensure sustainability of project results;

• Venues and catering for kick-off and closing events. 10.3 Assumptions and role of the MARD regarding visibility of the project In order for the project activities and recommendations to be continued and implemented on long-term basis, the MARD is expected to take active participation in the Project Steering Committee meetings and undertake the necessary steps for: • reorganisation of the lab structure of KVI; • establishment of an Epidemiology Department; • establishment of a unit responsible for the implementation of reference tasks, if found required

according to the recommendations of the project; • submission of application for an additional laboratory of the KVI to become a regional OIE

reference lab; • participation of the national reference laboratory, as well as regional and private labs, in

international ring trials (PTS) designed and prepared by the national reference lab; • execution of ring tests by the BC with local and international accredited laboratories; • encouraging animal health experts from neighbouring countries to participate in a training course

on epidemiology organised under Activity 3.3. In order to ensure the visibility of the project, it is expected that the Spokesperson team of the MARD will be involved in disseminating information about the project, throughout the preparation and implementation of the project.

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Annex I: Logframe planning matrix for twinning fiche

ANNEX I: LOGFRAME PLANNING MATRIX for twinning fiche: Strengthening of Israeli veterinary diagnostic capacities

Programme name and number: Support to the European Neighbourhood Policy Action Plan (Israel) 2011-2012, Twinning No. IL/10 Total budget: € 1,030,000

Overall objective Objectively verifiable indicators

Sources of Verification Assumptions

Improve the mechanisms for animal and public health protection from existing and emerging diseases, food-borne pathogens and residues

• Legal acts and procedures adopted for more effective surveillance and control of animal diseases to EU and OIE standards;

• Sustainability plan of project results followed.

• Legal acts and procedures • MARD and IVSAH

statistical reports and surveys

• EC annual progress report • Reports of bodies

responsible for trade and veterinary services

• Project reports

N/A

Project purpose Objectively verifiable

indicators Sources of Verification Assumptions

Strengthen the capacities of the Kimron Veterinary Institute (MARD) and supervision of private accredited laboratories to achieve rapid and effective surveillance and control of animal diseases as well as provision of reliable evidence to certify animals and animal-origin products as safe, especially for human consumption, up to EU and OIE standards

• Action plan on the reorganisation of the KVI followed and procedures developed in compliance with EU and OIE standards to raise veterinary diagnostic capacities;

• Plan followed to revise the KVI infrastructure;

• Action plan followed for the drafting of an annual national programmes for laboratory activities based on the active surveillance and monitoring of animal diseases and food and feed safety;

• Plan to improve the skills of lab staff followed;

• One additional KVI lab compliant with the requirements of a regional OIE reference lab;

• Training plan implemented and procedures followed on Quality Control and Quality Management;

• Proposals for eliminating gaps in legislation on notifiable diseases in accordance with EU legislation and principles with regard to laboratory activities in the veterinary field accepted by MARD;

• Selected ring tests (PTS) executed by BC with local and international accredited laboratories;

• Epidemiological capacity development plan for staff followed, defined surveillance and monitoring programmes prepared.

• OIE reports • KVI performance

reports/documents • Project reports • STE reports

• No technical and financial barriers to the adoption of necessary legal acts drafted within the framework of the project;

• No technical and financial barriers to the introduction of further improvements identified in the project;

• Sustainability plan followed by the Beneficiary.

Results Objectively verifiable

indicators Sources of Verification Assumptions

• Selected procedures for the improvement of veterinary diagnostic capacities in compliance with EU and OIE

• Plan to select test methods based on notifiable diseases existing in Israel, number of analyses per year and costs/benefits drafted by

• Project reports • Operational statistical

reports • Training materials

• Availability of human resources with up-to-date technical knowledge;

• Availability of means to perform tests and

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Results Objectively verifiable indicators


standards proposed and ready for implementation

• Quality assurance system

at the KVI and in approved private laboratories improved and proposals on legal acts on notifiable diseases, monitoring and surveillance programmes, zoonotic diseases (public health) and food safety in accordance with EU legislation and principles with regard to laboratory activities in the veterinary field drafted

the end of month 3; • Action plan prepared on the

reorganisation of the lab structure within KVI and approved by BC authorities by the end of month 7;

• At least 10 procedures for test methods in line with the accepted ISO17025 Quality System (QS) principles developed and approved, including number of detailed procedural manuals by the end of month 9;

• Action plan prepared on the drafting of annual national surveillance and monitoring programmes on notifiable diseases, including zoonoses and approved by BC officials by the end of month 16;

• Action plan prepared on drafting annual national programmes on food safety and approved by BC officials by the end of month 17;

• Plan to revise the KVI infrastructure developed by the end of month 8;

• At least 6 laboratory employees trained in analytical methods for notifiable diseases by the end of month 4;

• Action plan prepared detailing the necessary steps for the application of a KVI laboratory to become a regional OIE reference lab, by the end of month 7;

• Action plan prepared on the reorganisation of the KVI in view of cooperation with private companies (labs) and approved by BC officials by the end of month 19.

• Plan prepared and presented to MARD by the end of month 7 on reference tasks performed by national reference labs according to international criteria, including a plan to facilitate execution of these tasks by the KVI;

• Proposals for draft legal acts required prepared and discussed with MARD by the end of month 7;

• At least 10 laboratory employees trained in relation to the implementation of PTS proficiency testing schemes’ (PTS) performed by national, regional and private labs by the end of month 11;

introduce improvements identified;

• Good co-operation among the Israeli public institutions and other stakeholders.

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Results Objectively verifiable indicators


• Epidemiological capacities

developed enabling science-based risk assessment and risk management of existing and future challenges

• Plan to implement activities at the KVI for notifiable diseases in Israel drafted and number of standard operating procedures (SOPs) developed by the end of month 12;

• Plan drafted for the performance of annual ring trials (PTS) by the end of month 14;

• Training Plan (and ISO17025 Handbook) developed by the end of month 7;

• At least 10 laboratory employees trained in all aspects of ISO17025, including SOPs, validation reports, etc. by the end of month 11;

• At least 10 laboratory employees trained on Quality Control and Quality Management by the end of month 17;

• Procedures for at least 10 test methods on notifiable/zoonotic diseases developed and approved, including number of detailed manuals by the end of month 19.

• At least 8 persons trained

on surveillance programmes, risk analysis and animal disease programmes by the end of month 9;



• At least 8 persons trained in epidemiology, risk assessment and diagnostic methods by the end of month 14;

• At least 8 persons trained in evidence-based decision making by the end of month 14;

• At least 8 persons trained on proper control and sample collection by the end of month 15.

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Activities Benchmarks Means Assumptions 0.1. Kick-off Workshop 0.2. Final Closing Conference 0.3. Visibility actions

• Participants identified and attendance lists prepared;

• Stakeholders informed of the start date and detailed content of the project by the start of month 2;

• Stakeholders, media and public informed about the results of the project by the end of month 19;

• Recommendations and lessons learnt formulated and discussed.

• Communication plan developed by the end of month 3;

• Stakeholders, media and public regularly informed about project activities and results.

PL, RTA, 2 STEs (2 days each), interpretation PL, RTA, 2 STEs (2 days each), interpretation RTA, MS STE (10 days),BC PL, RTA Counterpart, MARD Spokesperson team, interpretation, translation, visibility costs EUR 10 000,-

• Good co-operation among the stakeholders;

• Stakeholders are able to allocate sufficient time to participate in project activities.

1.1. Drafting of a plan for selection of test methods

• An overview prepared on the existing test methods, including the number of analyses per year and which test methods are ISO17025-accredited;

• A plan to select test methods based on notifiable diseases existing in Israel, number of analyses per year and costs/benefits drafted by the end of month 3.

RTA, key component MS STE for 1 session of 8 days

• See assumptions under Activities 0.1, 0.2 and 0.3.

1.2. Drafting of an action plan for the reorganisation of the lab structure of the KVI

• Action plan prepared on the reorganisation of the lab structure within the KVI and approved by BC authorities by the end of month 7.

RTA, key component MS STE for 6 sessions of 4 days


1.3. Development of SOPs for test methods

• Gap analysis carried out on month 4;

• Procedures for test methods in line with the accepted ISO17025 Quality System (QS) principles developed and approved by the end of month 9, including detailed Manuals of procedures.

RTA, two STEs for 4 sessions of 4 days each, translation


1.4. Drafting of actions plans on the active surveillance and monitoring of animal diseases and food and feed safety

• Stakeholders informed about the methodology to prepare annual plans;

• Action plan prepared and approved by BC officials on the drafting of annual national surveillance and monitoring programmes on notifiable diseases, including zoonoses by the end of month 16;

• Action plan prepared on preparing annual national programmes on food safety and approved by BC officials by the end of month 17.

RTA, key component MS STE and one STE for 2 sessions of 4 days each


1.5. Drafting of a plan for the revision of the KVI infrastructure

• Plan to revise the current KVI infrastructure with special reference to post-mortem and PL3 (BSL3) animal facilities of the FMD and exotic disease building to prepare a construction tender

RTA, key component MS STE and one STE for 1 session of 4 days each

• See assumptions under Activities 0.1, 0.2 and 0.3;

• No technical and financial barriers to the future reconstruction of the PL3 (BSL3) animal facilities of the FMD and exotic

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Activities Benchmarks Means Assumptions developed by the end of month 8.

disease building to ensure sustainability of project results.

1.6. Drafting of action plan to advance the professional skills of laboratory personnel

• Assessment of the professional skills of lab technicians carried out by the end of month 3;

• Action plan to advances the professional skills of laboratory personnel drafted by the end of month 4;

• Educational material prepared by the end of month 4;

• Laboratory personnel trained in analytical methods for notifiable diseases by the end of month 4;

• Questionnaires and certificates issued, cross-checking results obtained by the end of month 4.

RTA, key component MS STE and one STE for 3 session of 4 days each


1.7. Supporting the KVI to prepare documentation for an additional KVI laboratory to become a regional OIE reference laboratory

• Action plan prepared detailing the necessary steps for the application of a KVI laboratory to become a regional OIE reference lab, in view of MARD's application for a KVI laboratory to become a regional OIE reference lab prepared by the end of month 7.

RTA, key component MS STE for 2 sessions of 4 days


1.8. Drafting of an action plan for the reorganisation of the KVI in view of cooperation with private companies

• Action plan prepared on the reorganisation of the KVI view of cooperation with private companies (labs) and approved by BC officials by the end of month 19.

RTA, key component MS STE for 9 sessions of a total of 26 days. .


1.9. Study visit to two MS on the structure of the veterinary services

• BC experts acquainted with the structure of veterinary services in two EU MS by the end of month 11;

• Findings from the study visits used to prepare the action plan on the reorganisation of the KVI under Activity 1.8.

RTA, 20 per diems, 4 flight tickets, small incidental costs

2.1. Preparation of an official Quality Control system plan with regard to laboratory activities in the national veterinary field

• Proposals for draft legal acts required prepared and discussed with MARD;

• A plan prepared and presented to MARD by the end of month 7:

- on reference tasks performed by national reference labs according to international criteria, including a plan to facilitate execution of these tasks by the KVI; - to offer the KVI the opportunity to carry out reference tasks proper of a national reference lab according to international standards so as to enable it to control private and regional labs on the subject of test performance and quality; - indicating that regional and private labs performing tests

RTA, key component MS STE and one STE for 2 sessions of 3 days each


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Activities Benchmarks Means Assumptions and/or analyses related to national surveillance and monitoring programmes or notifiable diseases have to be ISO17025-accredited and controlled annually by the national reference lab.

2.2 Study visit to a MS on the implementation of reference tasks and proficiency testing

• BC experts acquainted with the reference tasks belonging to national institutes and setting up of proficiency testing, including the necessary controls to check the quality of private and regional labs by the end of month 5;

• Findings from the study visits used to prepare the plans mentioned under Activity 2.1.


2.3. Assessment of existing and future laboratory Quality Control system for private and regional labs

• At least 10 laboratory employees (KVI staff and staff in regional and private labs) trained in relation to the implementation of PTS performed by national, regional and private labs by the end of month 11;

• At least 10 laboratory employees trained by the end of month 11 in how to prepare the document on existing laboratory quality controls, including the addressing of current gaps. Training will be provided on Reference Tasks for national reference labs and on the setup of annual control visits and ring trials (proficiency testing schemes: PTS) for KVI staff;

• Plan to implement PTS activities at the KVI for notifiable diseases in Israel drafted by the end of month 12;

• SOPs for PTS developed by the end of month 12.

RTA, two STEs for 2 sessions of 3 days each, translation


2.4. Drafting of a ring test programme for major animal diseases and identification and mapping of relevant private and governmental laboratories in Israel and laboratories abroad that carry out tests

• A plan drafted for the performance of annual ring trials (PTS) by the end of month 14;

• Ring tests (PTS) selected for notifiable diseases existing in Israel by the end of month 15;

• Laboratories abroad identified and draft contract prepared by the end of month 17 for labs abroad that are involved in the testing of samples from Israel to execute and perform tests (for pathogens and compounds) whose implementation is not practical in Israel.

RTA, key component MS STE, STE for a total of 12 working days

• See assumptions under Activities 0.1, 0.2 and 0.3;

• Funding is made available by the BC for the execution of ring tests;

• No technical and financial barriers identified to the execution of draft contracts to ensure the sustainability of project results.

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Activities Benchmarks Means Assumptions 2.5. Training of laboratory

personnel in ISO17025 accreditation, quality control and quality management

• Training Plan (and ISO17025 Handbook) developed by the end of month 7;

• Educational material prepared and issued;

• At least 10 persons from KVI management, lab staff and technicians trained in all aspects of ISO17025, including SOPs, validation reports, etc. by the end of month 11;

• At least 10 laboratory employees trained on Quality Control and Quality Management by the end of month 17;

• Questionnaires and certificates issued, cross-checking results obtained;

• Procedures for at least 10 test methods on notifiable/zoonotic diseases developed and approved by the end of month 19, including detailed manuals.

RTA, two STEs for a total of 50 days, translation.


2.6. Study visits to a MS on the quality system, the technical performance of tests and the logistical structure of the lab

• BC experts acquainted with the quality system, the technical performance of tests performed on notifiable diseases and the logistical structure of the lab by the end of month 7;

• Findings from the study visits used to prepare the procedures, including detailed manuals, under Activity 2.5.

RTA, 120 per diems, 10 flight tickets, small incidental costs.

3.1. Assessment of existing and future epidemiological activities of the KVI

• A plan to increase the capacity of the staff working with epidemiology issues prepared by the end of month 9;

• At least 8 persons (KVI staff, representative of MARD and MoH) trained on surveillance programmes, risk analysis and animal disease programmes;

• Questionnaires issued, cross-checking results obtained.

RTA, key component MS STE, STEs for a total of 32 days


• No technical and financial barriers identified to increase the capacity of the staff working with epidemiology issues.

3.2. Two study visits to a MS on the implementation of surveillance programmes, risk analysis and animal disease programmes

• BC experts acquainted with practical detailed aspects of the implementation of surveillance programmes, risk analysis and animal disease programmes by the end of month 10;

• Findings from the study visits used to revise the existing and introduce new surveillance and monitoring programmes under Activity 3.3.


3.3. Identification of needs for epidemiological activities and risk assessment methods

• Overview prepared of epidemiological activities and risk analysis studies on notifiable diseases of cattle, camels, sheep, goats and swine by the end of month

RTA, STEs for a total of 33 days


• Funding is made available by the BC for the implementation of

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Activities Benchmarks Means Assumptions 11;



• At least 8 persons (KVI laboratory personnel and professionals of the Israeli veterinary services) trained in epidemiology, risk assessment and diagnostic methods by the end of month 14;

• At least 8 persons of high-level veterinary staff working at central level trained in evidence-based decision making by the end of month 14.

surveillance and monitoring programmes;

• No technical and financial barriers are identified to the implementation of recommendations on the design of a new comprehensive database suitable for the collection and use of epidemiological data.

3.4. Preparation and implementation of training programmes on farm food safety issues for quality assurance of animal management

• At least 8 persons of veterinary field staff involved in the collection, storage and transport of samples trained on proper controls and sample collection by the end of month 15.

RTA, STE for one session of 2 days


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Annex II: Indicative implementation schedule

Month no 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Project start-up Steering committee meetings General activities 0.1 Kick-off Workshop 0.2 Final Closing Conference 0.3 Visibility actions Component 1: Selected procedures for the improvement of veterinary diagnostic capacities in compliance with EU and OIE standards proposed and ready for implementation

1.1 Drafting of a plan for selection of test methods

1.2 Drafting of an action plan for the reorganisation of the lab structure of the KVI

1.3 Development of SOPs for test methods

1.4 Drafting of action plans on the active surveillance and monitoring of animal diseases and safety

1.5 Drafting of a plan for the revision of the KVI infrastructure

1.6 Drafting of action plan to advance the professional skills of laboratory personnel

1.7 Supporting the KVI to prepare documentation for an additional KVI laboratory to become a regional OIE reference laboratory

1.8 Drafting of an action plan for the reorganisation of the KVI in view of cooperation with private companies

1.9 Study visit to two MS on the structure of the veterinary services

Component 2: Quality assurance system at the KVI and in approved private laboratories improved and proposals on legal acts on notifiable diseases, monitoring and surveillance programmes, zoonotic diseases (public health) and food safety in accordance with EU legislation and principles with regard to laboratory activities in the veterinary field drafted

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Month no 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

2.1 Preparation of an official Quality Control system plan with regard to laboratory activities in the national veterinary field

2.2 Study visit to a MS on the implementation of reference tasks and proficiency testing

2.3 Assessment of existing and future laboratory Quality Control system for private and regional labs

2.4

Drafting of a ring test programme for major animal diseases and identification and mapping of relevant private and governmental laboratories in Israel and laboratories abroad that carry out tests

2.5 Training of laboratory personnel in advanced diagnostic methods, ISO17025 accreditation, quality control and quality management

2.6 Study visits to a MS on the quality system, the technical performance of tests and the logistical structure of the lab

Component 3: Epidemiological capacities developed enabling science-based risk assessment and risk management of existing and future challenges

3.1 Assessment of existing and future epidemiological activities of the KVI

3.2 Two study visits to a MS on the implementation of surveillance programmes, risk analysis and animal disease programmes

3.3 Identification of needs for epidemiological activities and risk assessment methods

3.4 Preparation and implementation of training programmes on farm food safety issues for quality assurance of animal management

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Israel Veterinary Services & Animal Health

Chief Veterinary Officer

Animal Welfare Import Export

Land border crossings

Air and sea ports

Quarantine stations

Chief poultry disease officer

Regional poultry health laboratories

Director of field veterinary services

Rosh Pina

Acco Nazereth

Afula

Hadera

Kanot

Beer Sheva

Small ruminants diseases

Pig diseases

Horse diseases

Director of the Veterinary Institute

Bacteriology

Pathology

Poultry and Fish

Virology

Parasitology

Research farm

Quality assurance

Administration and services

Human resources

Secretarial services

Safety

Archives

Library

Finances

Logistics

Media preparation

Epidemiology Animal feed control

Medicinal products registration &

controlFish/bee diseases

Animal products

Abattoirs and slaughter houses

Annex III: Structural Organisation of VS

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Division of Virology Diagnostic virology laboratory; Vaccine control laboratory; Laboratory for diagnosis of Foot and Mouth Disease including the National FMD Reference

Centre.

Division of Parasitology Parasitology laboratory; Helminthology and Entomology unit.

Division of Pathology Pathology laboratory and necropsy facility; Toxicology laboratory; Laboratory for diagnosis of rabies and National Rabies Reference Centre.

Division of Bacteriology Clinical bacteriology and mycology laboratory; The International Reference Laboratory for Brucellosis; Laboratory for udder health and mastitis control including the National Mastitis Reference

Centre; Reference laboratory for biological residues in animal products; Laboratory for hygiene of food from animal origin and feed; Laboratory for quality of fishery products.

Division of Poultry and Fish Diseases Poultry diseases laboratory including mycoplasma reference centre; Fish disease unit.

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Annex IV: List of research projects implemented by the KVI

Year Project (ANIHWA, BARD etc.) Name of the research 2013-2016 BARD number: IS-4583-13

Identification of the etiological agent of tilapia disease in Lake Galilee

2011-2014 BARD

Cartography of H9 Avian Influenza Virus and its application to vaccine selection

2013-2016 ANIHWA Co-circulation of avian influenza and velogenic Newcastle disease viruses – impact on pathogenesis, immune response and disease prevention.

2009-2014 NADIR Participation in the Network of Animal Disease Infectiology Research Facilities

2011-2014 EMIDA Consortium from the Chief Scientist of the Ministry of Agriculture, Israel, and the Israel Dairy Board

Improved diagnosis and control of bovine mycoplasmosis (Emerging and Major Infectious Diseases of Livestock

2010-2014 BARD Discovery and reconstitution of cross-reactive vaccine targets for H5 and H9 avian influenza.

2011-2014 BARD: US-4378-11

Brucella second messenger coordinates stages of infection

2012-2015 EMIDA (BRUCMEL 273)

Brucella melitensis: biotyping and differential diagnosis

Collaborative Project (Small or medium-scale focused research project) for Specific Cooperation Actions Dedicated to International Cooperation (SICA)

Improvement of current and development of new vaccines for theileriosis and babesiosis among small ruminants

2013-2015 ANIHWA Improved understanding of the epidemiology of peste des petits ruminants

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Annex V: Animal diseases in Israel and in the Region

Domestic Wild Disease Notifiable Status Notifiable Status Note Acarapisosis of honey bees Clinical Disease Not Applicable

Actinomycosis Clinical Disease Not Applicable

American foulbrood of honey bees Clinical Disease Not Applicable

Avian chlamydiosis Clinical Disease Confirmed infection (no clinical disease) Avian encephalomyelitis Clinical Disease Not Applicable

Avian infect. laryngotracheitis Clinical Disease Not reported for this Period

Avian infectious bronchitis Clinical Disease Not reported for this Period

Avian leukosis Suspected (not confirmed) Not Applicable

Avian mycoplasmosis (M.synoviae) Clinical Disease Not reported for this Period

Blackleg Clinical Disease Not Applicable

Bluetongue Clinical Disease Confirmed infection (no clinical disease)

Botulism Clinical Disease Not Applicable

Bovine anaplasmosis Clinical Disease Not reported for this Period

Bovine babesiosis Clinical Disease Not reported for this Period Bovine viral diarrhoea Clinical Disease Not reported for this Period (since 2008 )

Brucellosis (Brucella melitensis) Clinical Disease Not reported for this Period (since 1983 )

Caprine arthritis/encephalitis

Confirmed infection (no clinical disease) Not reported for this Period

Caseous lymphadenitis Clinical Disease Not Applicable

Classical swine fever Not reported for this Period (since 200904 ) Suspected (not confirmed)

Coccidiosis Clinical Disease Not Applicable

Contagious ophthalmia Clinical Disease Not Applicable

Contagious pustular dermatitis Clinical Disease Not Applicable

Enterotoxaemia Clinical Disease Not Applicable

Enzootic abortion (chlamydiosis) Clinical Disease Not reported for this Period

Enzootic bovine leukosis Clinical Disease Not reported for this Period

Equine piroplasmosis Clinical Disease Not reported for this Period European foulbrood of honey bees Clinical Disease Not Applicable

Foot-rot Clinical Disease Not Applicable

Fowl cholera Clinical Disease Clinical Disease

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Domestic Wild Disease Notifiable Status Notifiable Status Note Highly path. avian influenza Clinical Disease Not reported for this Period

Infec bursal disease (Gumboro) Clinical Disease Not reported for this Period

Infectious coryza Clinical Disease Not Applicable

Intestinal Salmonella infections Clinical Disease Not Applicable

Koi herpesvirus disease Clinical Disease Not reported for this Period

Leishmaniosis Clinical Disease Confirmed infection (no clinical disease)

Leptospirosis Clinical Disease Not reported for this Period

Listeriosis Clinical Disease Not Applicable

Maedi-visna Confirmed infection (no clinical disease) Not reported for this Period

Marek’s disease Clinical Disease Not reported for this Period Mucosal disease/DVB Clinical Disease Not Applicable

Mycoplasmosis (M. gallisepticum) Clinical Disease Not reported for this Period

Newcastle disease Clinical Disease Clinical Disease

Nosemosis of bees Clinical Disease Not Applicable Other avian salmonellosis Clinical Disease Not Applicable

Other clostridial infections Clinical Disease Not Applicable

Other pasteurelloses Clinical Disease Not Applicable

Paratuberculosis Clinical Disease Not reported for this Period (since 1983 )

Q fever Clinical Disease Not reported for this Period

Rabies Clinical Disease Clinical Disease

Sheep mange Clinical Disease Not Applicable

Strangles Clinical Disease Not Applicable

Swine erysipelas Suspected (not confirmed) Not Applicable

Theileriosis Clinical Disease Not reported for this Period (since 1983 )

Toxoplasmosis Clinical Disease No information

Transmissible gastroenteritis Suspected (not confirmed) Not reported for this Period

Trichinellosis Not reported for this Period Clinical Disease Turkey rhinotracheitis Clinical Disease Not Applicable

Varroosis of honey bees Clinical Disease Not Applicable

West Nile Fever Clinical Disease Not reported for this Period (since 2008 )

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