38th General Session of the EuFMD Commission

Report

38TH GENERAL SESSION OF THE EuFMD COMMISSION FAO HQ, ROME 28-30TH APRIL 2009 • 38TH GENERAL SESSION OF THE EuFMD COMMISSION • REPORT

FAO HQ, ROME, 28-30TH APRIL 2009

38ÈME SESSION GÉNÉRALES DE L'EuFMD

Rapport

SIÈGE DE LA FAO, ROME, 28-30 AVRIL 2009

FAO HQ, ROME, 28-30TH APRIL 2009

Report

38TH GENERAL SESSION OF THE EuFMD COMMISSION

FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS EUROPEAN COMMISSION FOR THE CONTROL OF FOOT-AND-MOUTH DISEASE (EuFMD) Rome, 2009

The designations employed and the presentation of material in this information product do not imply the expression of any opinion whatsoever on the part of the Food and Agriculture Organization of the United Nations (FAO) concerning the legal or development status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or products of manufacturers, whether or not these have been patented, does not imply that these have been endorsed or recommended by FAO in preference to others of a similar nature that are not mentioned. The views expressed in this information product are those of the author(s) and do not necessarily reflect the views of FAO. All rights reserved. Reproduction and dissemination of material in this information product for educational or other non-commercial purposes are authorized without any prior written permission from the copyright holders provided the source is fully acknowledged.

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TABLE OF CONTENTS

LIST OF RECOMMEDATIONS ____________________________________________ On the global FMD situation On FMD control in the European neighbourhood On inter-regional co-operation in FMD control On FMD control in Turkey On FMD control in the Trans Caucasus On the EuFMD activities in support of FMD prevention; I.R of Iran, the South Caucasus countries, Syria and Iraq On Bio-risk Standards for FMD laboratories On Minimum Diagnostic Capacity in EuFMD Member States On the Strategic Plan for the period 2009-2013 On the EuFMD role in development and technical support for a long term FMD control programme in “West EurAsia” in liaison with FAO and OIE On the role of the Commission in relation to FMD control in the Euro-Mediterranean region On the use of decentralized diagnostic test systems for FMD in the European region On the FMD Training Initiative On the Report of the Chairman of the Research group On FMD antigen and vaccine banks On Financial matters including budget for the Commission in 2010-11 On Membership of the Commission, the Election of the Executive Committee and the Research Group of the Standing Technical Committee

1 2 2 3 3 3 4 4 4 4 4 5 5 5 5 6 7 7

REPORT ____________________________________________________________ 8 INTRODUCTION 8 OPENING CEREMONY 8 ITEM 1 - ADOPTION OF THE AGENDA 10 ITEM 2 – GLOBAL FMD SITUATION: REGIONAL TRENDS IN FMD RISK 10 ITEM 3 - FMD CONTROL IN THE EUROPEAN NEIGHBOURHOOD 12 Report of the situation in Georgia, Armenia and Azerbaijan 12 Report of the situation in Iran 13 Report of the situation in Syria and Iraq 14 ITEM 4 – STANDARDS FOR ENDORSEMENT THAT HAVE REGULATORY SIGNIFICANCE FOR EUFMD MEMBER 14 STATES 4.1 Minimum Standards for Laboratories working with Foot-and-Mouth Disease virus in vitro and in vivo 14 4.2 Minimum requirements for Foot-and-Mouth Disease laboratory diagnostic services 15 ITEM 5 - REPORT OF THE EUFMD EXECUTIVE COMMITTEE FOR THE PAST BIENNIUM 15 ITEM 6 - EUFMD STRATEGIC PLAN 2009-2013 16 ITEM 7 – THE EUFMD ROLE IN THE DEVELOPMENT OF A LONG TERM FMD CONTROL PROGRAM IN “WEST EURASIA” 17 ITEM 8 – ROLE OF THE EUFMD COMMISSION IN RELATION TO THE EUROPE- MEDITERRANEAN ANIMAL HEALTH NETWORK (REMSA) IN SUPPORTING IMPROVED FMD CONTROL IN THE REGION 18 ITEM 9 – TECHNICAL ITEMS: GUIDANCE ON THE USE OF THE NEW DECENTRALISED TESTS SYSTEMS IN EUROPEAN SITUATIONS 20 ITEM 10 – FMD TRAINING INITIATIVE 21 ITEM 11 – REPORT ON THE WORK OF THE RESEARCH GROUP OF THE STANDING TECHNICAL COMMITTEE 21 ITEM 12 – FMD ANTIGEN AND VACCINE BANKS: SURVEY OF NATIONAL AND EC BANK HOLDINGS 23 ITEM 13 – FINANCIAL MATTERS 24 ITEM 14 – ELECTION OF THE EXECUTIVE COMMITTEE AND STANDING TECHNICAL COMMITTEE 25 Election of the Standing Technical Committee 26 Membership of the Commission 26 ITEM 15 - READING OF THE REPORT 27 CLOSING CEREMONY 27

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LIST OF APPENDICES

APPENDIX 1 ________________________________________________________ 28 AGENDA OF THE SESSION 28 APPENDIX 2 ________________________________________________________ 29 GLOBAL FMD SITUATION: REGIONAL TRENDS IN FMD 29 J. M. Hammond*, 29 APPENDIX 3 ________________________________________________________ 39 SITUATION OF FMD IN THE MIDDLE-EAST 39 Adel Ben Youssef 39 APPENDIX 4 ________________________________________________________ 43 PROGRESS REPORT FOR TURKEY ON FMD SITUATION AND CONTROL MEASURES 43 H Askaroglu 43 APPENDIX 5 ________________________________________________________ 54 PROGRESS REPORT FOR TRANSCAUCASUS SINCE 37TH SESSION (APRIL 2007) 54 C. Potzsch 54 APPENDIX 6 ________________________________________________________ 67 EUFMD PROJECT IN THE I.R OF IRAN 67 F. Geiger 67 APPENDIX 7 ________________________________________________________ 74 PROGRESS REPORT ON I.R. OF IRAN 74 V. Otarod 74 APPENDIX 8 ________________________________________________________ 78 PROGRESS REPORT FOR SYRIA 78 C. Potzsch 78 APPENDIX 9 ________________________________________________________ 80 PROGRESS REPORT FOR IRAQ 80 Ministry of Agriculture State Company for Veterinary Services (TADS) 80 APPENDIX 10 _______________________________________________________ 84 MINIMUM STANDARDS FOR LABORATORIES WORKING WITH FMDV IN VITRO/IN VIVO 84 Standard adopted by the 38th General Session of the European Commission for the Control 84 of Foot-and-Mouth Disease (EuFMD), 30th April 2009 APPENDIX 11 ______________________________________________________ 108 PPT: MINIMUM STANDARDS FOR LABORATORIES WORKING WITH FMDV IN VITRO/IN VIVO 108 B. Haas 108 APPENDIX 12 ______________________________________________________ 121 PROPOSED MINIMUM REQUIREMENT FOR LABORATORY CONFIRMATION OF FMD 121 EuFMD Secretary 121 APPENDIX 13 ______________________________________________________ 124 REPORT ON THE ACTIVITIES OF THE EUFMD COMMISSION SINCE 37TH SESSION 124 EuFMD Secretary 124 APPENDIX 14 ______________________________________________________ 134 PROGRESS TO IMPLEMENT RECOMMENDATIONS OF THE 37TH SESSION (2007) 134 EuFMD Secretary 134 APPENDIX 15 ______________________________________________________ 143 REVISION OF THE EUFMD STRATEGY PAPER FOR 2009-2013: CHANGES COMPARED TO 2005-2009 143 EuFMD Secretary 143 APPENDIX 16 ______________________________________________________ 156 PROGRESSIVE CONTROL PATHWAY (PCP) AND REGIONAL ROADMAPS: TOWARDS A COMMON FRAMEWORK FOR 156 LONG TERM ACTION AGAINST FMD AT NATIONAL AND REGIONAL LEVELS IN EUR-ASIA AND AFRICA Presentation to the 38th General Session of the EuFMD 156

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APPENDIX 17 _____________________________________________________ 161 DEVELOPMENT OF A ROADMAP FOR THE PROGRESSIVE CONTROL OF FOOT-AND-MOUTH DISEASE IN WEST 161 EURASIA Report of a Workshop held in Shiraz, Islamic Republic of Iran 161 APPENDIX 18 _____________________________________________________ 172 RESEAU EURO–MEDITERRANEEN DE DE LUTTE CONTRE LA FIEVRE APHTEUSE 172 R. Bouguedour 172 APPENDIX 19 _____________________________________________________ 179 IMPROVING FOOT-AND-MOUTH DISEASE SURVEILLANCE AND VACCINE QUALITY ASSURANCE IN EGYPT 179 Y. Basyouni 179 APPENDIX 20 _____________________________________________________ 182 OPTIONS FOR DECENTRALIZED TESTING OF SUSPECTED SECONDARY OUTBREAKS OF FMD 182 Position paper from the EuFMD Standing Technical Committee (Research Group) 182 APPENDIX 21 _____________________________________________________ 192 FOOT-AND-MOUTH DISEASE (FMD) TRAINING COURSES 192 Brochure 192 APPENDIX 22 _____________________________________________________ 195 PPT: EUFMD TRAINING INITIATIVE 195 K. Sumption 195 APPENDIX 23 _____________________________________________________ 199 REPORT FOR THE RESEARCH GROUP FOR 2007-2009 199 A. Dekker 199 APPENDIX 24 _____________________________________________________ FMD ANTIGEN AND FORMULATED VACCINE RESERVES EUFMD SURVEY APRIL 2009 K Sumption

203 203 203 203

APPENDIX 25 _____________________________________________________ FINANCIAL STATEMENT AND REPORT OF THE EUFMD YEARS ENDED 31 DECEMBER 2007-2008 EuFMD Secretary

206 206 206 206

APPENDIX 26 _____________________________________________________ 214 FINANCIAL POSITION OF THE EUFMD COMMISSION: ADMINISTRATIVE BUDGET PAPER FOR 2010-2011 214 EuFMD Secretary 214 APPENDIX 27 _____________________________________________________ 219 LIST OF PARTICIPANTS 219

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LIST OF RECOMMEDATIONS Considering that: 1. The progress on the control of FMD in the near-East was very limited in the past two years, with spread of type A/IRN/05, persistence of the A/EGY/06 strain and type O in most of the region and reservoirs of FMDV type Asia-1 in Pakistan which threaten the wider region; 2. The large investments being made in FMD control in Turkey are at risk from the continued circulation of FMDV in the West Eurasia region; 3. The maintenance of the vaccination buffer zone in the Caucasus has contributed to prevent major epidemics of FMD in the Trans Caucasus, but incursions of infection have occurred recently as a result of the FMD situation in Iran and Turkey and because of the lack of animal movement control between the countries; 4. The recent epidemics indicate that borders in the near-East are still very permeable to animal disease movement over the past few years, and epidemic events have often not been contained, leading to a higher FMD incidence, which poses a risk to Europe; 5. The early detection and warning of new epidemiologic events are a pre-requisite for effective management of FMD; 6. More systematic studies on vaccine suitability, using cross-neutralisation, P1 sequencing and cross-protection studies, are needed; 7. The multiplicity of routes of possible introduction into the European neighbourhood results in a complex and dynamic situation for risk management; 8. The vaccination to live is a preferred policy of a number of European nations if faced with FMD outbreaks, and this policy requires feasible contingency plans and access to stocks of vaccine suitable for use against the epidemic strain, and a suitable exit strategy; 9. Trans-boundary and interregional movements of FMD strains have also occurred in the past two years in other regions, and any increase in incidence of FMD in neighbouring or distant regions may increase the risk of introduction into Europe and its adjacent countries; 10. The high prevalence of FMD in endemic regions increases the risk of introduction of FMD into Europe, direct or via neighbouring countries.

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The Session comes to the following recommendations: On the global FMD situation

Recommends: 1. The continuation of efforts made by the Commission to better identify FMDV threats to Europe by supporting sample submission from high risk regions in the proximity of Europe, specifically to improve submission from countries in the Middle-East, West EurAsia and African proximity including the Sahel zone and West-Africa; 2. That FAO continue to support the OIE/FAO network of FMD reference laboratories for the purpose of improving vaccine matching, and that the FAO Regular Programme continue to fund the network meetings and network work programme; 3. That the Research Group should develop a plan, together with the FAO/OIE lab network, to produce the body of information required to improve the identification of vaccine suitability for the diverse range of topotypes of A and SAT viruses, over the next 2-4 years.

On FMD control in the European neighbourhood

Recommends: 4. That the EuFMD Commission together with FAO, in consultation with OIE and EC, and with the countries involved, actively support the organization of regional meetings of countries in the West EurAsia epidemiologic region that will promote risk based surveillance and FMD control in the neighbourhood of member countries at the Eurasian interface; 5. That as a component of a Global FMD risk reduction under GF-TADs, FAO together with the Commission and in liaison with OIE should promote the long term plan ("Roadmap") for FMD control in the West Eurasia region developed at the Shiraz meeting in November 2008, for the region where Europe and Asia meet, and where appropriate, promote and support surveillance and control measures in accordance with the Progressive Control Pathway for FMD; 6. That the EuFMD together with FAO and OIE supports the establishment of a functional network of FMD laboratories in the West EurAsia region, including those in Pakistan, Iran, Turkey with the FAO/OIE reference laboratories at Pirbright and Vladimir, to promote improved early detection of virus threats, harmonized and better access to virus typing services, and risk communication between the parties; 7. That the Full Length Genome Sequencing will be continued to improve the understanding of the threat of FMD in the West-Eurasia region and to validate the Full Length Genome Sequence approach to identify the scale of under-reported infection; 8. That the EuFMD keeps contact with other regional FMD initiatives for FMD control worldwide, to monitor progress to be able to assess the risk of FMD introduction; 9. That the countries affected by FMD re-evaluate their control measures, particularly the effectiveness of the control of animal movement and marketing from affected areas and regions, and that increased attention is given to the organizational weaknesses that allow FMD to persist and circulate; 10. That the Commission should specifically promote and monitor risk reduction measures which will assist to reduce the FMD risks of transborder movements of animals and products across the Eastern boundaries of Europe, including improved efficiency of vaccination programmes, early warning and response capacity in the border regions, and measures to reduce or mitigate illegal animal movements.

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On inter-regional co-operation in FMD control

Recommends: 11. That under the framework of GF-TADs, and following the principles of the Progressive Control Pathway (PCP) for FMD, the Secretariat work closely with the OIE/FAO Regional Animal Health Centres(RAHCs), to improve the communication of risk information relevant to vaccine selection and other preventive actions, and specifically to assist the efforts of the RAHCs in the middle-East (Beirut) and North Africa (Tunis); 12. That in order to improve the assessment of risk posed by new strains of FMD virus, the Commission should also promote and, where required, support, the gathering of FMD epidemiological information, with priority to areas where suitable vaccines are unknown or unavailable, working through the RAHCs, and with established Global Early Warning System (GLEWS) operated by FAO/OIE/WHO. On FMD control in Turkey

Recommends: 13. That Turkey fully implements the national FMD vaccination plan in the next two years, combined with the implemented animal movement control measures and the national surveillance plan; 14. That Turkey provides information on the progress of vaccination campaigns and serosurveillance findings, at an appropriate administrative scale to the EuFMD regional database on FMD vaccination campaigns, in line with other countries in the region where vaccination has been supported by EuFMD/EC; On FMD control in the Trans Caucasus

Recommends: 15. To continue, on the basis of memoranda of understanding with each country, the current level of project activities in the Trans Caucasus until the next General Session of the Commission in 2011, as a reduction in input would in the current situation be expected to result in a deterioration of the control situation; 16. That the main components of the next Phase of the Trans Caucasus FMD project, should have the objective of supporting countries to progress towards stage 3 (approaching FMD freedom) of the Eurasia roadmap. The importance of these programs should be recognised by the countries in the form of agreements to promote FMD control in each country; 17. That information on vaccination, surveillance and risk relating to Armenia, Azerbaijan, Georgia, Iran, Iraq, Syria and Turkey should be shared;

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On the EuFMD activities in support of FMD prevention; I.R of Iran, the South Caucasus countries, Syria and Iraq

Recommends: 18. That the EuFMD Commission should continue to support the Iranian authorities in their efforts to consolidate the surveillance activities and to improve the early detection and early warning system for FMD; 19. That after review of the situation and the progress made for Phase II of the EuFMD/EC project implemented in I.R of Iran, a follow-on set of activities be identified that will support the progression of Iran in the PCP, will strengthen disease security in border regions, and will address the risk of disease transmission across the Western borders of Iran. The review and proposed activities should be identified for the 78th Executive Committee; 20. That the Commission together with FAO and other regional projects should continue monitor the risk of FMD in the Eastern neighbours of Turkey, and specifically should promote FMD surveillance activities, and should identify the actions required to promote progression in 2009-2010 of surveillance actions in Syria and in Iraq, in line with the PCP; On Bio-risk Standards for FMD laboratories

Recommends: 21. That the "minimum standards for laboratories working with Foot-and-Mouth Disease virus in vitro and in vivo”, including the Annex “minimal standards of biorisk management for laboratories undertaking diagnostic investigations of low-risk samples during an outbreak of FMD" be adopted as the Standard to be applied by EuFMD member countries; On Minimum Diagnostic Capacity in EuFMD Member States

Recommends: 22.

That the document "Minimum diagnostic capacity in EuFMD Member States" be adopted as the Standard to be applied by EuFMD member countries, without prejudice to the requirements of Directive 2003/85;

On the Strategic Plan for the period 2009-2013

Recommends: 23.

That the meeting adopt the "The EuFMD Strategic plan for the period 2009-2013", with the minor modifications proposed by Member States during the Session;

On the EuFMD role in development and technical support for a long term FMD control programme in “West EurAsia” in liaison with FAO and OIE

Recommends: 24.

Adoption of the recommendations from the presentation on the Progressive Control Pathway, specifically: ¾ To support the vision for the West Eurasian region to become free of clinical FMD by 2020; ¾ To commit itself, beginning with the EuFMD Strategic Plan 2009-13, to a long term role in promoting and supporting the implementation of the Regional Roadmap and PCP approach in West EurAsia, with the aim of improving FMD control through progressive application of risk based control measures; ¾ To promote and where required support routine FMD surveillance to monitor progress at national and regional level in FMD control across the West EurAsia region, working with the RAHCs of FAO/OIE; ¾ To organize, in co-ordination with other international agencies and donors, an annual meeting to review progress along the West EurAsia Roadmap.

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38th General Session of the EuFMD – 28-30 April 2009. FAO, Rome

On the role of the Commission in relation to FMD control in the Euro-Mediterranean region

Recommends: 25.

That the EuFMD Commission take up an active, supporting role as a technical body aligned or where appropriate integrated with the REMSA system, and in the framework of the European neighbourhood policy, in support of improved regional surveillance and reporting, co-ordinated sub-regional approaches control of FMD, and increased capacity to prevent and control FMD, working with the RAHCs of FAO/OIE;

26.

That the Commission together with FAO/OIE RAHCs continues to promote sub-regional meetings to improve the prevention, and response to FMD, providing a bridge between EU and non-EU countries in the Euro-Mediterranean region;

27.

That the Commission, working with the RAHCs of FAO/OIE, promotes and where appropriate technically supports the introduction of the PCP approach into other regions posing an FMD threat to Europe, such as Northern, West/Central and East Africa, with the emphasis upon routine surveillance to provide information for international risk assessment as well as for national and regional strategy building;

28.

That technical networking on FMD is encouraged through invitation of FMD scientific experts from each of the Mediterranean countries to participate in the regular Sessions of the EuFMD Research Group.

On the use of decentralized diagnostic test systems for FMD in the European region

Recommends: 29.

That National veterinary authorities review their Contingency Plans and operational manuals and consider if the currently available decentralised tests offer advantages for decision making in the case of secondary outbreaks;

30. That, if governments decide to retain the option of using decentralised tests, they consider the supply chain options in advance; 31.

That further research and product development efforts are encouraged towards type specific tests;

On the FMD Training Initiative

Recommends: 32.

That a field training program on FMD, together with “training bank program” for online resource development, be implemented over the next 3 years and for at lEast 3 trainees per Member State. The valuable contribution of Turkey to this program should be recognized by all Member States;

33.

That training in the use of the tests as part of outbreak investigation should be included in the field-based training programmes organized by the EuFMD Commission;

On the Report of the Chairman of the Research group

The following priorities for the Research Group were accepted: 34. To continue the studies that use FMD full genome sequencing to better understand the epidemiological situation in Turkey/Iran; 35. To develop improved procedures for decision making on selection of new antigens for (European and national) vaccine banks; 36. To develop guidelines for sero-surveillance in support of the objectives of Stages 1,2,3 of the progressive control pathway (PCP); 37. To support the validation of FMD spread models developed in various member countries that are relevant to their contingency plans;

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38. The socio-economic evaluation of FMD control programmes; 39. Validation data of diagnostic kits should be evaluated by the RG and the report should be made available on the EuFMD website; 40. That the decision on the venue for the next Open Session of the Research Group be made by the Executive Committee following consultation with FAO and OIE on holding a joint scientific conference in 2010; On FMD antigen and vaccine banks

Recommends: 41. That holders of national antigen banks review their holdings in relation to the risk associated with current type A strains circulating in the middle-East; particularly A Iran 05 and A Egy 06; 42. That an antigen bank managers forum (including national bank managers of EuFMD member countries) should be established, to establish mechanisms to exchange information and to resolve issues constraining the choice of vaccine strains to include in the banks, the emergency access to antigen stocks held by other banks, and to identify means that would expedite the identification and development of new seed strains/antigens; 43. SAT-2 strains are underrepresented in the vaccine banks, the risk for this should be evaluated by the antigen bank managers’ forum;

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38th General Session of the EuFMD – 28-30 April 2009. FAO, Rome

On Financial matters including budget for the Commission in 2010-11

Recommends: 44.

That the proposed budget for the MTF/INT/011/MUL for 2010-11, be adopted as proposed;

On Membership of the Commission, the Election of the Executive Committee and the Research Group of the Standing Technical Committee

Recommends: 45.

That the Executive Committee should explore the possibilities to increase the membership of the EuFMD Commission, in particular to invite neighbouring European countries that are actively participating in EuFMD programs;

46.

That the Executive Committee and the Secretariat should explore with FAO the possibilities to increase the number of members in the Committee to take into account the recent increase number of member countries.

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REPORT Introduction On behalf of the Director General of FAO, the Session was opened by Mr Samuel Jutzi, Director, Animal Production and Health Division, Agriculture and Consumer Protection Department, FAO.

Opening Ceremony Opening address by Mr Samuel Jutzi: Honourable Vice-Minister of Agriculture of Paraguay, Dr Hammann, Chairman of the EuFMD Commission, Dr de Leeuw, Members of the Executive Committee of the EuFMD, Delegates of the Veterinary Services of member states, Observers of the European Commission and OIE, and delegates of observer countries: It is a great privilege for me to open the 38th Session of the EuFMD Commission, on behalf of the Director-General of FAO, Dr Jacques Diouf, and the Assistant Director General for Agriculture and Consumer Protection, Dr Modibo Traoré.

EuFMD is the first, and thus the oldest and most mature FAO Commission, and my Department is privileged to have hosted this Commission for more than 50 years. This is clear evidence that from the start, Member States of FAO have promoted the international effort to control major trans-boundary animal diseases, in partnership with FAO. The trend of the past few years has been for greater integration and co-ordination of the international efforts, with FAO and OIE working together under the GF-TADs (Global Framework for the Progressive Control of Transboundary Animal Diseases) agreement.

EuFMD has always contributed to the FMD eradication process on the European continent, and FAO has noted with approval the widening of the scope of actions to improve threat detection in regions outside of the member states; these actions are of wider benefit and fit with the need under GF-TADS for improved understanding of FMD in the endemic regions, which assists control.

Second, FAO notes the importance of the first 4 year strategic plan for the Commission, adopted in 2005, under the Presidency of Karin Schwabenbauer, and the strong support and collaboration to implement major elements of the program provided by the EC. The development of a new Strategic Plan, for 2009-2012, is a very important part of the Agenda of the current Session. FAO hopes that the Commission will decide to support actions that not only contribute to FMD risk reduction to Europe but contribute to global control, through support and advocacy for FMD control in wider regions. Of note is the assistance the Secretariat has provided to the design of the progressive Control pathway (PCP) approach, which has assisted to developed Roadmaps for FMD control in West EurAsia and at subregional level in Africa in the past months. FAO considers the Regional Roadmaps are an important mechanism to progress FMD control, with the PCP approach providing a framework for improving capacity to control FMD at national to regional level.

Finally, I draw attention to the impact of the EuFMD Research Group, which through its meetings and working groups continues to provide leadership on technical issues affecting FMD control. The Open Session of the Group provides a meeting for FMD experts from across the world and contributes to building the global level of expertise required to progress FMD control, particularly in endemic regions In conclusion, I would like to single out a few personalities and institutions which have contributed, and continue to contribute, to EuFMD’s success:

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38th General Session of the EuFMD – 28-30 April 2009. FAO, Rome

Dr Peter de Leeuw, for his leadership of the Commission, Dr Aldo Dekker, co-ordinator of the EuFMD Research Group; both Drs Joseph Domenech and Bernard Vallat for reconfirming their trust in EuFMD; the European Commission without whose support EuFMD actions would be very limited. All the Member States of the Commission including the ones contributing to EuFMD’s staff and prominently the Governments of France and Ireland.

I perceive a strong general support for EuFMD and its vision and work programme as the platform for the fight against this devastating disease, and can assure you of all FAO’s support for this important body.

I wish you fruitful and rewarding deliberations in your Session.

Thank you.

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Item 1 - Adoption of the Agenda Dr Peter de Leeuw, Chairman of the EuFMD Commission, welcomed the delegates and proceeded to Item 1; the Agenda (Appendix 1) was adopted as proposed.

(The list of participants is given in Appendix 27.)

Item 2 – Global FMD situation: regional trends in FMD risk Two papers were presented and discussed under this Item; the first was the Report of the FAO World Reference Laboratory (WRL) at Pirbright (Appendix 2), presented by Dr J. Hammond, the second was a paper on the spread of the FMD serotype A in the Middle-East, presented by Dr Ben Youssef (EuFMD Secretariat) (Appendix 3).

Global FMD Situation: regional trends in FMD Dr Hammond provided the WRL report, and highlighted disease events in Asia, Africa and South America, and particularly the recent type A epidemics (China, for the first time in decades, and the A Iran 05 epidemic in the Middle-East), and the continuing problems of diversity of type A and SAT viruses in East Africa.

In 2009, an extraordinary number of samples had been received from the West EurAsia/middleEast, as a result of the spread of the type A Iran-05 lineage.

He thanked EuFMD/FAO for support to sample shipment, and to improving the networking of FMD labs in Pakistan, Iran, Turkey and the WRL which has improved sample flow and ability to track strain emergence.

Following the A Iran 05 epidemic in 2005-6 in Iran/Turkey, new sublineages had emerged and continued to circulate, of note being the A Iran 05 (Bar-08) which was involved in the epidemic affecting Iran, Iraq, Lebanon and Libya in 2009.

He reviewed the vaccine recommendations for the current circulating strains in the region; protection with the vaccine strain A22 Iraq is variable to the current circulating A Iran 05 viruses, and in an emergency situation a high potency formulation is recommended.

The continued circulation of a second type A (A Egy 06) in Egypt between 2006 and 2009 is also a major concern.

The WRL continued to produce for the EuFMD Executive, at six-month intervals, recommendations on virus strains for inclusion in the European banks. In the past two years changes had been made reflecting the type A regional epidemics.

Of importance is the need: • For continued support of the EuFMD/FAO to sample submission, particularly in low surveillance regions of Africa; • For a systematic study on vaccine suitability for the different topotypes (serotypes A and SAT viruses); • To better identify the correlation between vaccine matching and effective coverage in order to advise on vaccine selection for endemic as well as epidemic regions; • To continue epidemiology studies in Turkey/Iran to better identify threats of virus emergence, using full length sequencing.

Finally, he indicated the OIE/FAO FMD lab network support for the concept of addressing the regionally distinct FMDV virus pools, given the specific vaccine required in many of these, through regional lab networks and knowledge base on strain circulation. Of note was the lack of reference labs located within several of these pools, and the need for laboratory twinning and other measures to build regional capacity to identify viral threats.

Spread of the FMD serotype A in the Middle-East Dr Adel Ben Youssef, EuFMD Secretariat, summarized the papers circulated to the Member States as a result of the regional spread of A Iran 05 in January-March 2009.

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38th General Session of the EuFMD – 28-30 April 2009. FAO, Rome

He drew attention to the: • Regional pandemic of type A Iran 05, affecting Iran, Iraq, Turkey, Kuwait, Bahrain, Lebanon and Libya in the first part of 2009; • The severe loss of time (around 2 months) between suspicion and conformation of virus strain, for epidemics in Lebanon and Egypt; • The presence of a second, antigenically distinct type A in the Mediterranean region, with the continued circulation of type A in Egypt in 2009, which apparently had been introduced in 2006 from sub-Saharan Africa.

The epidemic spread of type A suggested the probable spread through live animal trade across land borders and by sea.

He also highlighted how sample shipment from East and West Africa, supported by EuFMD had contributed to improved virus threat detection and had elucidated links between the African virus strains and those in Egypt and Libya. He concluded that efforts should continue given the high diversity of FMDV in parts of East and West Africa and low resources and regional capacity for virus typing at present.

Discussion The issues of vaccine selection for routine use in middle-East, the need for homologous A Iran 05 vaccine seed for European banks, advice on diagnostic test performance of FMDV, and vaccination against serotype Asia-1 were raised.

Dr Paul van Aarle, Intervet, indicated that manufacturers were developing A Iran 05 vaccine, with expectation for first supplies being made in July 09.

The Secretary indicated that FGI-ARRIAH and SAP Institute have produced A Iran 05/A TUR06 vaccines since 2006, and noted the importance of the orders from EC (in Turkey and via FAO in the Caucasus) to bring homologous vaccines to the market. He also brought attention to the work of the Italian/FAO project that had re-confirmed circulation of two lineages of serotype Asia-1 in Pakistan, after a 5 year gap in observation; this vindicated continued use of Asia-1 vaccine in Iran, parts of Turkey and Iraq. Since these strains differed from those in India, this also confirmed the importance of strain circulation within West Eurasia and the focus of the lab network on this region.

Dr Geiger, France, observed that the epidemic in the middle-East in early 2009 followed the season of religious festivals in December.

The Chairman concluded that there was a need for the RG to progress antigenic mapping for type A strains, through a networked project, and similar studies may be needed for SAT2.

Conclusions 1.

2.

3.

4.

5.

6.

The work of the WRL, and that of the OIE/FAO network of FMD Reference Laboratories, has provided essential information to assist the Commission and Member States in their actions against the disease; Sample submission from some regions remains critically low, and the lack of information is a risk to the success of contingency plans against FMD in Europe; The spread of an Indian strain of serotype O from to the Arabian Gulf, and of A Iran 05 to Libya in 2009, illustrates the movement of FMDV between regions is continuing and possibly increasing; The recent and rapid spread of the serotype A Iran 05 (BAR-08) lineage in the middleEast, breaching biosecurity barriers in entering several countries, should be regarded with concern; There is a need to re-enforce the surveillance network to get quality of information in real-time, in particular to bring Iraq, Lebanon and Egypt to the same position as Turkey and Iran; The reservoir of serotype Asia-1 in parts of West Eurasia indicates the need for preventive measures including routine vaccination in Western parts of the region, including Turkey.

Iran and Iraq;

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7.

Guidance is needed on the level of protection obtainable at different potency formulations of the type A vaccines held in the European and national banks, and on priorities for replacement of stocks to counter changes in circulating strains.

Item 3 - FMD control in the European neighbourhood Progress reports were presented on the FMD situation of countries in South-Eastern Europe, with a focus on the risk to FMD control in Turkey, and on situations where support to FMD control had been recommended at the 37th Session and implemented with EC financial support.

Five reports were presented, concerning Turkey, the Trans-Caucasus, Iran, Syria and Iraq.

Reports on the situation in the North African countries and in Egypt were presented under Item 7.

Report of the situation in Turkey (Appendix 4) presented by Dr Askaroglu He reviewed the heavy impact of the major type A (A Iran 05) and O (PanAsiaII incursion) epidemics in 2006-8, with over 1500 outbreaks in 2006 alone, and the continued circulation of both serotypes in Turkey. The situation had improved, for various reasons, in 2008 and Thrace region had remained free of FMD since October 2007. Of particular note was the lack of an upsurge in FMD cases after the kurban bayram festival in December (Note: in contrast to the neighbouring countries to the South/East). This improvement may relate to implementation of new related movement control measures, and an increased vaccination effort, resulting in coverage in autumn 2008 of >90% nationwide, with all regions >85% coverage in the bovine population, and with vaccine purchased with EU support through a tender and supplied by the FMD Institute, Intervet and Merial. Other improvements have been an additional 1500 veterinarians recruited to field stations for implementing vaccination and control measures, and a increased capacity for sero-surveillance, with a national survey undertaken in 2008 following technical advice from EuFMD consultants.

The vision for the next 2 years is to apply for official recognition of FMD freedom with vaccination in Thrace region, to achieve 100% coverage in small and large ruminants by end of 2010, and to identify new zones for FMD freedom. Technical assistance from the EU, as part of the pre-accession project, will assist with identifying the new zones and overall eradication/control policy. Booster vaccinations will be introduced in 2010, if possible, to address lack of durable immunity in young animals, in line with previous EuFMD Commission recommendations.

Discussion On behalf of the Commission, the Chairman congratulated Turkey on the steps taken in the past two years, and noticeable improvement in the control situation, and thanked EC for their support.

Report of the situation in Georgia, Armenia and Azerbaijan The situation report, including progress made through actions supported by EuFMD/EC since 2007, was reported by Dr Potzsch, EuFMD, and given in Appendix 5. It was followed by a short statement made on behalf of the three beneficiary countries by Dr Bejanishvili, Deputy Director for Food Safety and Animal Health, Georgia.

Despite the severe epidemics in 2006-8 in Iran and Turkey, only one outbreak was recorded in the three countries in the past two years (Spring 2007: serotype O PanAsia II in Nagorny Karabakh). This outbreak was not declared to OIE but confirmed by the OIE reference laboratory at ARRIAH. The last notifications to OIE were in 2001 (Azerbaijan), 2002 (Armenia, Georgia). With EC support, a two year EuFMD/EC program to strengthen control was implemented from mid-2007, involving four vaccination campaigns; the project actions/support included: • Provision of trivalent vaccine (A Iran 05, O, Asia1) for use in the buffer zone, numbers of doses increased according to national demands and reassessment of the risk situation; • Improvement of FMD control by revaccination (Armenia and Azerbaijan) and FMD public awareness campaigns (TV broadcasting; Georgia and Armenia);

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• Strengthening of diagnostic and epidemiological capacities; • Training of NCs and national staff in diagnostics, computer use and epidemiology; • National sero-surveillance in the three countries, with a system of regular FMD sero surveillance to identify risk populations; • Regular risk assessments established to guide national and regional decision making; • National project consultants are part of national FMD control decision making, e.g. contingency plans, communication between EuFMD and national VS. The serological studies had demonstrated widespread evidence of NSP positive animals, and not only in border regions; risk factors identified included seasonal movements to pastures, and also the gradation in animal/meat value across region that encouraged transborder movements.

The last main activity of the project will be a simulation exercise for the three countries, to be conducted in first week of May 2009.

The main risks to the national FMD control policy were reviewed, and these include inadequate recognition of the work of the VS and FMD control by governments in particular because of: • No major disease outbreaks reported; • Lack of public health risk; • Low national importance of the livestock industry, mainly subsistence level of large animal husbandry; • No incentives or even penalisation for reporting of FMD or suspicions on all levels, • Poor transparency about the FMD situation.

In Georgia: particular difficulties include national budget cuts for VS, no clear FMD control policy, poor vaccination coverage and no re-vaccination of young stock.

The conclusions of the TransCaucasus project consultants/CVO meeting held 26th April in Rome were given by Dr Bejanishvili, Georgia; the three countries requested a continuation of the project for the next two years, to consolidate the gains in capacity, and support to introduce a full animal identification and registration system in the three countries.

Discussion The lack of a regular vaccination program in Georgia in past two years was noted with concern.

Report of the situation in Iran A report on progress made through actions supported by EuFMD/EC since 2007 was given by Dr Geiger, EuFMD, covering Phase I of the EC supported action (Appendix 6), and by Dr Otarod, Iran Veterinary Organization (IVO), on the current FMD situation and on the progress to implement Phase II (Appendix 7).

From April 2006 (3 years evolution, the start point of EuFMD project), there was an increase in the number of outbreaks both in cattle and sheep and goat due to Type O (PanAsia), from September 2006 and stayed till March 2007. The sub strain responsible for this epidemic was O Pan Asia, followed by an epidemic of type O PanAsia linage 2. From July 2007 onward there was relatively stable situation except for January 2009 where the outbreaks increased due to Type A Iran05, with the most severely affected region in the Western part of Iran.

The progress in Phase I was summarised by Dr Geiger; the support given had assisted early warning of the type O PanAsia II before the epidemic had reached Turkey, had enabled the strengthening of the National Task Force on FMD control, with the result that changes in control strategy had been implemented and build local capacity to investigate outbreaks and to improve lab capacity. Phase II would consolidate these gains, with emphasis on Twinning program for the National Ref Laboratory (CRVL Karaj) with the WRL Pirbright, towards OIE/FAO Ref Lab status, plus application of active and sero-surveillance to monitor success of control measures.

The current Phase is due to be completed in December 2009, but the representative indicated a high interest to continue, with emphasis on improved control in border regions, including a possible buffer zone along the border with Turkey, and in actions that reduce risk from the Eastern countries where FMD is relatively uncontrolled.

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Report of the situation in Syria and Iraq A report on the progress of the technical action in support of surveillance in Syria was presented

by Dr Potzsch (Appendix 8); the support had focused on design of sero-surveillance, and upgrading of the required laboratory facilities. No reports of FMD cases had been made by Syria during the current A Iran 05 epidemic but the country was at risk and the FMDV situation unclear as a result of the situation in Iraq and the unexplained movement of infection to Lebanon.

A report on the epidemic situation in Iraq, and the use made of the emergency vaccine supplied by the EC, was provided to participants (Appendix 9).

Conclusions 1.

2.

3.

4.

5.

6.

7.

8.

The European region remains at risk from at lEast five different virological regions (“virus pools”), whose ecosystems of FMD viruses have high antigenic diversity; Epidemics continue to sweep through partially vaccinated populations in the West EurAsia and middle-East regions, although the higher vaccination coverage achieved in Turkey and Iran, with other measures, appears to have lessened the direct impact; The spread of infection to other countries in the region and into the Mediterranean indicates that FMD is not under control across the region, highlighting the need for commitment to animal movement control and biosecurity at all levels; Identifying feasible control options that will reduce the risk associated with live animal marketing and movement practices in countries affected by FMD epidemics should be given a high priority. Best practices from other countries should be considered; The EU vaccine bank and the EC/FAO agreement on the support to EuFMD have been extremely important in mounting effective and rapid response to FMD emergencies in the region; The networking of FMD laboratories in the West EurAsia laboratory network has assisted to improve timely sample submission and better understanding of the risk of spread of epidemic type A Iran 05 and Asia-1 in the region; Continued close co-operation with Iran, Iraq and Syria is essential as earlier warning of the recent type A Iran 05 epidemic developments could have resulted in emergency measures that would have reduced or prevented the jumps of infection into the Mediterranean region; The support to FMD control in the TransCaucasus appears to have controlled clinical FMD outbreaks and contributed to lack of incursions into the Russian controlled territories. The level of NSP positives in the population of the three countries remains a concern and suggests repeated incursions from endemic countries to the South and East.

Item 4 – Standards for Endorsement that have regulatory significance for EuFMD member states 4.1 Minimum Standards for Laboratories working with Foot-and-Mouth Disease virus in vitro and in vivo (Appendix 10) This Item was opened with a presentation by Dr Haas (FLI, Insel Riems, and EuFMD Standing Technical Committee). He explained that the process of revision of the 1993 Standard had been initiated in September 2007, with a working group comprised of biorisk managers from 5 European high containment FMD laboratories and two vaccine manufacturers; the work had entailed over 350 hours of work from technical inputs from experts, and draft Standard had been sent for consultation to all national reference laboratories before finalisation under the Standing Technical Committee, and thereafter proposed as the revised Standard. All EU Member States had also received the Draft Standard through the Standing Committee procedures. In his presentation (Appendix 11) he indicated the similarities and differences in the new Standard.

The Chairman warmly thanked the Working Group, and in particular Dr Haas, for their outstanding contribution to the improvement of the Standard. There being no technical issues

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raised by members, the Commission unanimously endorsed the Revised Standard, together with the Annex “Minimum Standards of biorisk management for laboratories undertaking diagnostic investigation of low-risk samples during an outbreak of FMD”.

4.2 Minimum requirements for Foot-and-Mouth Disease laboratory diagnostic services Dr Sumption introduced this Item; the issue had arisen in 2007 that national reference laboratories in several non-EU member countries of the EuFMD had not participated in the ring trials (proficiency tests) organized by the CRL/WRL with EuFMD financial support, and in some circumstances access procedures to NRL services capable of confirming FMDV were not in place, severely delaying the testing of samples from suspected outbreaks. The aim of the paper was to harmonize the minimum level of diagnostic service for FMD across Member States, bringing countries in line with the norms of the Directive 2003/85/EC. The Minimum Requirements document (Appendix 12) had been circulated to Member States in March 2009, allowing 45 days for consultation.

The Chairman opened the proposed Standard for discussion; there being no issues raised by Member States, the document was unanimously endorsed.

Item 5 - Report of the EuFMD Executive Committee for the past biennium The Report (Appendix 13) was circulated in advance of the Session, and presented by the Secretary. The activities of the Commission in the biennium followed the recommendations of the 37th Session, and in line with the five categories of action, for project formulation and implementation, as set out in 2005-8 Strategic Plan agreed at the 36th Session. Over half (34) of the 55 recommendations in the 37th Session report have been implemented (completed or ongoing implementation) through activities/actions; 8 were not implemented, and 13 will require follow-up decisions or support to implement. (See Table on Progress to implement recommendations, Appendix 14).

The Report summarised the actions conducted towards the major outcomes expected for the four year period, as agreed at the 36th Session, in respect of: 1.

2.

3.

4.

5.

Improved system for monitoring FMD virus strain circulation; Technical constraints to preferred European FMD control policies reduced; System for professional development in FMD management developed; FMD risk surveillance and management programmes operating in target countries operating; FMD incursions/emergencies rapidly controlled, where supported by specific Commission decisions.

Conclusion The report was endorsed.

Delegates indicated their satisfaction with the progress achieved in the biennium, and congratulated the Chairman and the Executive Committee for their efforts to achieve a balanced program of actions.

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Item 6 - EuFMD Strategic Plan 2009-2013 The Report (Appendix 15) was circulated to Member States in advance of the Session, and presented at the Session by the Secretary; the main elements had been approved by the 77th Executive Committee. He explained that the Strategic Plan 2009-13 follows on from the 4 year strategic plan approved in 2005. The Plan has an importance in setting the priorities for the Commission, which are then to be developed into fundable actions, and a basis for renegotiation of the financial agreement with EC in 2009, providing a mechanism for support of common actions In summary, five priorities for action in the 2009-2013 Plan were proposed, of which three are a direct continuation from the 6 previous priority areas (2005-2009 Plan); regarding the risk situation in South-East Europe, all related activities have been brought under Priority 1: Long term risk reduction in the Turkish neighbourhood through support to the West EurAsia FMD Control Program (Roadmap). A new priority area was proposed, placing emphasis on Global FMD risk information and control program progress monitoring across 7 virus pools.

The Proposed Priorities for action were: 1.

2.

3.

4.

5.

FMD Risk reduction in the Turkish neighbourhood region, in support of the West EurAsia FMD control Roadmap; Viral surveillance for Vaccine bank prioritization; Global FMD risk information and control program progress monitoring across 7 virus pools with priority given to the pools closest to Europe; FMD Training program – a rolling program for the European/EuFMD Member States 4 year rolling program; Technical networking – Euro-Med, West Eurasia region (focus on vaccination performance, FMD risk, surveillance and survey design and in depth technical studies);

For emergency actions, the EC/EuFMD agreement for 2009-2013 should continue to provide flexibility in provision for emergency actions, as per past agreements and reflecting the need to use this source of funds for an efficient, rapid response.

Discussion The representative of France agreed with the Plan, but suggested that actions should be focussed on priority risks for infection; he agreed that actions in the Sahel were justified to protect North African countries which in turn act as a buffer zone for Europe. For the EC, Dr Füessel gave support to the previous statement that support to surveillance in the African proximity was an important part of the surveillance component of the plan. He congratulated the Commission on the proposed Plan and indicated the EC was ready to proceed with the finalisation of the new Agreement with FAO on the support to the Commission activities for the period 2009-12. He did however sound a note of caution that in 2013, a number of changes will be introduced in Community activities on animal health and that cuts could be envisaged, therefore to complete as many priority tasks by the end of 2012.

Dr Pinheiro, Portugal, strongly supported the training programme as part of the Plan, and suggested increased emphasis on this in the first two years.

Dr Gibbens, UK, was pleased to see the Strategic Plan recognises the global threat of FMD, and had three main areas, service to member states, technical co-operation with the near neighbours, and a role to promote global FMD control. He suggested these three Items should be on the Agenda of meetings at lEast for the next 2 years.

It was agreed that a reference to the PVS tool is needed, and the Operational Strategy should better reflect this linkage with OIE. Dr Facelli, Italy, proposed that enlargement of the membership of the Commission be part of the Strategy.

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Conclusions 1.

2.

The EuFMD Strategic Plan for 2009-2013 was unanimously endorsed by the Session. The Secretariat agreed to make the minor changes proposed by delegates; The partnership with EC, which had enabled implementation of major parts of the Strategic Plan 2005-9, had been highly effective and was warmly appreciated by the Member States.

Item 7 – The EuFMD Role in the development of a long term FMD control program in “West Eurasia” In line with recommendations of the 37th Session on the development of a long term FMD control program to reduce the risk to Europe from West Asia, the Secretariat presented two papers, one on the “Progressive Control Pathway (PCP) And Regional Roadmaps: - Towards A Common Framework For Long Term Action Against Fmd At National And Regional Levels In EurAsia And Africa” (Appendix 16), and “Development Of A Roadmap For The Progressive Control Of Foot-and-Mouth Disease In West Eurasia, Report of a Workshop held in Shiraz, Islamic Republic of Iran, November 2008” (Appendix 17).

The Progressive Control Pathway for FMD (PCP-FMD) is an approach developed from recommendations of the meeting of the EuFMD Research group at Erice, for addressing the seven major virus pools through progressive, risk based approaches co-ordinated under regional roadmaps. The PCP approach provides a methodology, developed by EuFMD with FAO, describing a set of control program activity stages that lead to officially recognised FMD freedom; Regional Roadmaps (RR), describe the anticipated progress along the PCP at national and regional level to 2020, and the application of PCP through Regional Roadmaps is the suggested approach of FAO to promote long-term co-ordinated action against FMD, that will be proposed at the OIE/FAO Conference on FMD in Paraguay, June 2009.

The PCP-RR approach was applied first at a four-day Workshop held in Shiraz, Islamic Republic of Iran, organized by FAO in consultation with OIE, and hosted by the Iran Veterinary Organization, and convened as a joint meeting under the FMD projects implemented by the EuFMD Commission (FAO) in Turkey, Trans-Caucasus, Iran and Syria, and the GTFS/INT/907/ITA project for Central Asian countries. Invitations were sent by FAO, on behalf of the two organizations, to the Chief Veterinary Officers (CVOs) and to the FAO national consultants on FMD (EuFMD or GTFS projects). In total, fifteen countries in West EurAsia were represented, with the Russian Federation represented through the OIE Reference Laboratory (FGI-ARRIAH).

The Workshop developed a vision (for West EurAsia free of clinical FMD by 2020) and a roadmap indicating progression of countries along the PCP, and identified the type of regional support required to promote and apply the PCP at regional level; in response to the meeting report, over 50% of countries represented indicated their support by letter from their CVO to the CVO, FAO (Dr Domenech).

A practical follow-up to the Meeting has been improved laboratory networking for Pakistan, Iran, Turkey and the WRL, stimulated by EuFMD Secretariat (West EurAsia FMD lab network), which has generated increased sample submission and sharing of risk information on viral threats.

Discussion Issues raised in discussion included the extent and nature of EuFMD support for regional FMD control initiatives in the neighbourhood and in more distant regions.

Dr Gibbens, UK, agreed that the wider vision for supporting FMD control was in line with the EuFMD Strategic Plan, but was concerned that resources of the Commission were limited and the role should be mainly as a catalyst/enabler to promote change, and leverage other organizations to effective action.

Dr Angot, France, suggested that the EuFMD should work mainly through the GF-TADS framework, and via the FAO/OIE Regional Animal health centres (RAHC). He agreed that West Eurasia is a priority area for EuFMD involvement.

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Dr Domenech, FAO, indicated that this was the mode of operation at present, and expressed gratitude for the work of the Secretariat to promote regional FMD control, through regional meetings under the GF-TADS structures.

Dr Pinheiro, Portugal, voiced support for the vision statement, and suggested that stronger linkage to the PVS approach of the OIE should be part of the Roadmap, to achieve the capacity changes required.

The Chairman, in summing up, proposed that EuFMD should take the lead on the West Eurasia Roadmap, but in other regions the role should be to support not lead the Roadmaps.

General agreement was indicated to this position, and to the proposals before the Session.

The Representative of Turkey voiced strong support for the initiative and indicated willingness to support the Roadmap through hosting the Co-ordination Centre (CC), and particularly to take the lead in laboratory networking for the region. The Representative of Iran re-iterated their strong support for the Roadmap and willingness to host the CC and could provide staff and buildings to for a regional FMD epidemiology unit.

Conclusions 1.

2.

3.

The Progressive Control pathway (PCP) approach was welcomed by the delegates and endorsed by the Session as a tool that could be of great potential significance to development and monitoring of control programs; The PVS tool of the OIE is highly relevant and complimentary to the Regional Roadmaps/ PCP approach and PVS progress should be encouraged as part of the regional programs.

The FMD situation in the West Eurasia region is of high priority for the EuFMD Commission, but progress in other regions will also be necessary to reduce risk to the EuropeMediterranean region.

Item 8 – Role of the EuFMD Commission in relation to the EuropeMediterranean Animal Health Network (REMSA) in supporting improved FMD control in the region The main statement on the status of development of a network for improved co-ordination on animal health (Europe- Mediterranean Animal Health Network (REMSA)) was provided by Dr Füessel, DG-SANCO, European Commission (EC).

He indicated that the EC supports a close cooperation in the field of animal health, and FMD in particular, between EuFMD and countries forming part of the Mediterranean Union within the Barcelona Process. The EC, in particular DG Development, supports activities directed at the control of FMD in sub-Saharan Africa; EuFMD is encouraged to continue its established activities for sampling and characterising of viruses from animals in the Sahel zone to assist the countries in that region in their control measures for FMD, to establish an early warning system for the countries in Northern Africa bordering the Mediterranean Sea and for member countries of EuFMD. Further, the activities of EuFMD which started during the past 2 years in collaboration with other players in sub-Saharan Africa are fully in line with the strategy of "One World One Health" upheld by GF-TADs at its fourth steering committee of 10 March 2009 in Nairobi.

Regarding REMSA, although the Union process for the Mediterranean (UMed) has been delayed due to political problems involved with the Israeli-Palestinian conflict, this does not prevent the actions from taking place at technical level. He indicated that initial indications are that no short-term specific additional financing is expected and it is advisable simply to use as much as possible the tools already existing and financed by the EC or by the MS and to label them with "UMed", in order to prepare more important medium and long term financing.

Moreover, it is not a question inevitably of obtaining more financing but of aligning and harmonizing all the current actions around one or more common strategies. Once these defined strategies are validated, means could be required via the Neighbourhood Policy of the EU (ENP) to implement them.

In essence ("the overall objective") is to obtain: • As reliable and prompt health information as possible; • Surveillance and control strategies harmonised around common objectives; • Sub-regional and regional approaches of the control programmes;

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• Upgrading of veterinary services of the Mediterranean countries.

Regarding the EuFMD, it is instrumental to the EU measures for the control of contagious diseases. Its relatively autonomous financing system, focused on the risk of introduction of the disease in Europe, allows a major adaptability and a great speed of implementation, compared with the financing of traditional technical cooperation.

Moreover, he added, the positioning of the EuFMD within FAO guarantees: • Good visibility in the developing countries; and • A permanent source of information via the networks in place; • While its relative independence enables it to establish the link with other organizations, like the European Commission or the OIE. The activities of EuFMD have been increasingly focused on prevention of FMD, centred on the North-East area of the Mediterranean basin: Balkans, Greece, Bulgaria, European Turkey, then on the Near and Middle East: Asian Turkey, Syria, and even beyond: Iraq, Iran, the Caucasus.

The "overall" character of the action of the EuFMD gradually continues, and it intervenes in fact already, in the Mediterranean region. Its role could be extended for broader cooperation with North Africa, from Egypt to Mauritania. Thus, the integration of the EuFMD tool within the REMSA would allow the guarantee of an excellent data collection on the Foot-and-Mouth Disease, or even coordinated control measures.

Through the EuFMD idea to create a "cordon sanitaire" around Europe, it is clear that it is improvement of animal disease surveillance networks of the animal diseases and a harmonization of the control methods which are sought, and this is indeed the objective of REMSA. Additional Statements Dr Bouguedour, CVO Algeria, made a statement (Appendix 18) on behalf of the North African countries. Six countries, from Mauritania to Egypt, had participated in the Regional Coordination meeting held in Algiers in February, organized by the FAO/OIE RAHC, with EuFMD technical support on the item on FMD. He indicated that FMD continued to be highly important, with two countries having regular outbreaks (Egypt and Mauritania); Libya experienced outbreaks in 2009, but not for 10 years in the other three countries. He considered that the lack of outbreaks in Tunisia, Algeria and Morocco in 2009 reflected better networking, preparedness, and response to information provided by EuFMD and others.

Given the difference in risk, the support required varied between countries. He strongly supported increased technical networking on FMD, addressing issues including improved, harmonized contingency plans, improved sero-surveillance and reporting of results, re-enforced capacity for FMD diagnosis, better co-operation , discussion and response to informal animal movements across borders, and an emergency access to antigens that may allow increased areas to cease vaccination (free of FMD without vaccination).

The viewpoint of Eastern Mediterranean countries in the middle-East region was given by Dr Khoury, Manager, OIE/FAO RAHC Beirut. He indicated that the RAHC supported improved networking, and that the RAHC could as part of the system to deliver assistance and improved co-ordination of FMD control efforts. He requested that EuFMD continued to assist in technical issues at the Annual FMD Roundtable convened by the RAHC. The viewpoint of the Veterinary Services (GOVS) of Egypt was provided by Dr Basyouni (Appendix 19). He thanked the EuFMD for technical support, through FAO, to improved disease surveillance and vaccine quality assurance in Egypt. He stressed that some changes introduced were fragile, such as a reporting network for FMD, and laboratory capacity and QA, and requested continued support to introduce changes and become better networked to technical specialists in the Europe-Mediterranean region.

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Discussion The Chairman thanked the speakers for their contributions and agreed with the position of the EC, that the EuFMD Commission is mature enough to embrace the new structures and contribute in an effective way to ensure the REMSA system, when developed, has a useful role to play on FMD prevention and response. He considered that the Commission should be one of the main actors to ensure that FMD remained high on the Agenda of regional co-ordination meetings, and to assist, where needed, with technical support to countries.

Conclusions 1.

2.

The EuFMD Commission has an important role to play to promote FMD prevention and control capacity in the Europe-Mediterranean region, should continue to work closely and supportively with the RAHC of OIE/FAO in Tunis and Beirut. The process of development of the REMSA network should be closely followed by the Executive Committee; Technical networking on FMD with non-free countries in the region will be to the benefit of all parties involved, and enable sharing of risk information and improved early response to crisis situations.

Item 9 – Technical items: guidance on the use of the new decentralised tests systems in European situations The position paper (Appendix 20) developed by the Research Group was presented by Dr Eoin Ryan, Ireland, and followed from recommendations made at the 37th Session. The paper reviewed options for decentralised use of virus detection techniques on samples from suspected secondary outbreaks of Foot-and-Mouth Disease (FMD). These options have recently been expanded by the advent of new tests including disposable lateral flow devices (LFD) for the detection of viral proteins and reusable after disinfection portable RT-PCR equipment for the detection of viral RNA. These devices may be used on infected farms as pen-side tests, in regional, local or mobile laboratories, or in National Reference Laboratories (NRL). Issues highlighted included validation and quality control, containment needs, availability of test devices and reagents, the decision tree for declaring an outbreak, training issues, and provision of samples for subsequent viral characterization.

Discussion The Chairman thanked the group for the progress to develop the new tools and provide the guidance paper. Discussion points that followed concerned the problem of preclinical diagnosis in herds neighbouring to infected premises; the need for national vs regional stockpiles of tests; the need for serotype specific tests for early warning in countries where multiple serotypes circulate, such as Turkey, and validation of the new tests.

In answer, the current tests have not been developed for pre-clinical diagnosis from blood samples although high sensitivity PCR based tests might in future enable this. Serotype specific tests have not been seen as a high priority for the commercial sector, but are demanded from endemic countries, so a gap exists. Test validation is largely complete but comparative testing, with samples from different lesion ages and with persistently infected animals, is required.

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Conclusions 1.

2.

Tests to confirm the diagnosis of the index case of an outbreak of FMD should continue to be carried out in the National Reference Laboratory (NRL) within the country or in another European member state; The development of LFDs to achieve a similar sensitivity as the antigen detection ELISA, but with the ability to provide a result within less than 30 minutes following the addition of epithelium or vesicular fluid, provides an important new option for decentralised testing for FMD infection.

Item 10 – FMD Training Initiative The item was presented by Dr Sumption (Appendix 21 (brochure) and 22 (ppt)), but preceded by a short video provided by Dr Aleksandra Hari, Slovenia, illustrating her experience of a recent EuFMD mission at which she observed FMD in the field in Turkey and received training on lesion aging, sample collection and diagnostic procedures.

Dr Sumption indicated the initiative was in response to the recommendations of the 37th Session, and the recommendation (of the 76th Session of the Executive) to establish a training fund to assist veterinarians to gain experience in investigation/response to FMD outbreaks. With the support of DG-SANCO and the GDPC, Government of Turkey, a training initiative has been developed that involves both real-time training in field situations and virtual training through development of a training bank of online resources to widen access of trainers, trainees and the wider community.

The response of SCoFCAH to the proposal was to recommend that trainees include, as a priority, experts who are on the CVET list or who are expected to be so in future.

Open questions included the number of trainees per country, and duration of the initiative required to ensure all member states could send trainees.

The initiative was discussed and strong support given for the proposal. There was general agreement on the need to complete the program in about 3 years, and for access of 3 persons per country to the course, thus creating a base of expertise in all countries that should have some impact, and the training of these 3 persons should be at Community expense.

The Chairman warmly thanked the Government of Turkey for their willingness to assist in providing facilities and access for the training course, and to the EC for their support.

Conclusions 1.

The proposed training initiative addresses an important gap in the preparedness of European veterinary services for FMD, and is in line with the 2009-12 Strategic Plan for the EuFMD Commission. It should be implemented as a high priority activity, provide training opportunity for all member states, and have the objective of completion in about 3 years.

Item 11 – Report on the work of the Research group of the Standing Technical Committee Report The Report for the Research Group for 2007-2008 was presented by Dr Aldo Dekker, Chairman of the group (Appendix 23). The Group had held a Closed meeting in Cairo (2007) and an Open Session (and Closed) in Erice, Sicily; several of the working groups had held their own meetings. The Open Session was a major international event, with almost 200 participants, mainly from Europe.

In his report he indicated the priorities for the Group in 2007 had been: • Position paper on the options of decentralized testing; • Minimum Diagnostic capacity in EuFMD Member States for the laboratory confirmation of FMD; • Update security standards for FMD laboratories.

Progress on the above has resulted in the papers presented to the 38th Session.

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In 2008, additional items had been identified for study/action by the Group: • Study on replacing live virus shipment with stabilised viral RNA methods: • In vitro stability study for FMD vaccines; • Study on role of sheep in maintaining or spreading FMD in a temperate European climate with mixed sheep and cattle farms (UK, 2001); • Application of tools for high-resolution FMDV molecular epidemiology in Western EurAsia • Comparative/standardisation study into the relation between antibody response and protection, involving Turkey; • Set up a subgroup addressing the problems with SAT type vaccines in Africa and study the relevance for the EU vaccine bank; • Develop a procedure for decision on advising new antigens for the European and national vaccine banks; • Develop a procedure for decision on advising new antigens for endemic regions; • Evaluate results from the serosurveillance from Caucasus region.

Concept notes were developed for each of the first four of the 2008 items, presented at the 76th Executive, and proceeded to funded actions. Progress will be reported at the 2009 Closed Session of the Group.

He highlighted how the FMD Improcon project, which largely involved group members, had produced 40 peer reviewed papers, of great relevance to the work of the Commission. In 2009, a successor EU project (FMD Disconvac), and should also be of major importance in providing research outputs of relevance to EuFMD member states.

Priorities for 2009-2010 Taking the above into consideration, and given the issues faced by EuFMD to conduct its actions in FMD control, he proposed the major emphasis of the group in 2009-11 should be: 1.

2.

3.

4.

5.

6.

To continue the FMD genome sequencing and related epidemiology studies in Turkey/Iran; To develop a procedure for decision on advising new antigens for (European and national) vaccine banks; To set up guidelines for sero-surveillance to meet objectives of Stages 1,2,3 of the progressive control pathway (PCP); To support validation of FMD spread models developed in various member countries to support their contingency plans; The socio -economic evaluation of FMD control programmes; Validation/guidance on pen-side and other diagnostic tests for FMD.

Location of upcoming meetings Dr Sumption indicated that Slovenia had offered to host the 2009 Closed Session, in September, and that an offer had been received from India (Indian Centre for Agricultural Research, ICAR) to host the 2010 Open Session of the Research Group, in New Delhi. The latter location was of interest given the huge burden of infection in South Asia and the importance of improving dialog with scientists in India and China on FMD research and technical issues.

Discussion The Chairman and the group were congratulated on the report, and warmly thanked for the quality of the work and outputs.

Dr de Leeuw considered that the location of India might have disadvantages and questioned if the location was the most appropriate. Although the Group had held previous meetings in the Americas, these had been lab meetings rather than congresses.

Conclusions 1.

2.

22

The report of the Chairman was endorsed, including the list of six priority topics for the biennium; The location of the next Open Session should be decided after discussion of options, and with FAO and OIE on possibility of joint meetings, and a decision reached by the Executive Committee, if necessary before the next Committee Session.

38th General Session of the EuFMD – 28-30 April 2009. FAO, Rome

Item 12 – FMD antigen and vaccine banks: survey of national and EC bank holdings The report (Appendix 24) of the EuFMD survey of FMD antigen and vaccine bank holdings of member states and neighbouring countries in 2009 was presented by the Secretary. The detailed holdings (number of doses held, or totals for strains) were not presented to the Session for data security reasons. The Questionnaire in English and French was sent to all EuFMD Member States, North African countries and the Russian Federation; positive responses from 10 countries/FMDV bank managers in EuFMD member states/North Africa; responses received from each those which held antigen banks in 2007. Three of the banks are held in non-EU countries.

Only one known supply of vaccine from the vaccine banks had occurred in period 2007-April 2009, for supply to middle-East (Iraq in 2009). The type O and Asia-1 holdings are in line with WRL recommendations made to the 37th Session.

Of concern was that of the eight different type A antigens held in 2009, only 4 banks hold >0.5 million doses of A22 Iraq, a relevant antigen for the current type A Iran 05 epidemic, and none hold a homologous antigen (serotype A Iran 05/A TUR06).

Discussion The need for a Vaccine Bank Managers forum (VBM) was discussed and agreed; such a forum had been initiated under the EC funded co-ordination action on FMD and CSF, with some success, but the project had finished. There remains a need for exchanging information between VBM to avoid duplications or gaps, to find ways to share antigens in crisis situation, and respond earlier to new threats. The EuFMD was suggested as the body to initiate or continue to bring VBM together.

Conclusions 1.

2.

3.

4.

5.

6.

There remains a significant lag in response of vaccine producers and bank managers to change in the antigenic types circulating in the region; WRL recommendations in 2007 for type A22 have not been applied by majority of banks; Lack of a homologous A Iran 05/A TUR06 and thereby places reliance upon A22 Iraq or use of other type A if available at very high potency; The lack of type A Eritrea in any bank is of potential concern, although very high potency type A 22 vaccines held by some banks have been shown to protect against the FMDV type A circulating in Egypt 2006 (and which remains circulating in 2009); Lack of FMDV strains/antigenic types originating from virus pool 2 (South Asia, mainly the Indian pool of FMDV types A, O and Asia-1) or pool 5 (West/Central Africa pool of O, A, SAT1 &2). The risk associated with pool 2 and pool 5 FMD strains needs to be reexamined, as pool 2 has been a source of FMDV for Europe in the past (type A in the Balkans in 1996, and O PanAsia 1 in 2001), and pool 5 viruses have entered North Africa at lEast twice in the past 10 years; SAT 2 antigens: the holding size is generally small and with topotype/strains originating from Southern Africa. Relevance of these holdings to risk from circulating SAT2s is unclear and needs urgent re-evaluation.

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Item 13 – Financial Matters The Income and expenditure statements for the three Trust Funds operated by the Commission were provided by the Administration and Finance Department of FAO, for 2007 and 2008 (Appendix 25).

The budget proposal for contributions to the administration of the Commission by the member countries (to Trust Fund MTF/INT/011/MUL), as agreed by the 74th Executive, was presented by the Secretary (Appendix 26).

Discussion The question was raised by one member state of fixing contributions in euros rather than US dollars, to ensure the countries were clear in their expected level of contribution. Mr David Baugh, Administration and Finance Department, outlined options available to be adopted by the Organization, including splitting contributions in US$ and in euro. He strongly recommended that the implications and procedures to identified and understood before adoption, requiring a paper to be reviewed by the Executive.

Conclusions 1.

The Statements of Account for MTF/INT/011/MUL, MTF/MUL/004/MUL, and MTF/INT/003/EEC for 2007 and 2008 were endorsed; 2. The budget paper for 2010 and 2011 was agreed, as proposed in the paper circulated to member states in advance of the Session, of an annual total contribution by the member countries to MTF/INT/011/MUL of US$547,352, and individual country contributions as indicated in Table 3 of the paper; 3. Currency exchange variations to the US dollar affect the level of contributions by member states, and a review of the feasibility of a split assessment or other option for denominating the contributions in euro and/or dollars should be conducted before the 39th Session.

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Item 14 – Election of the Executive Committee and Standing Technical Committee Election of the Executive Committee Dr Domenech, FAO, took the role of Chairman for the elections. The following were elected unanimously, on the basis of receiving a proposal that was supported by at lEast one additional country nomination, and there being no additional proposed candidates:

Ulrich Herzog, Austria (Chairman) Leif Denneberg, Sweden (Vice Chair) Nigel Gibbens, UK (Vice chair) Members Dr Boinov, Bulgaria Spyros Doudounakis, Greece Carlos Pinheiro, Portugal

PROPOSER United Kingdom

SECONDERS Italy

Denmark

Greece

Germany

Austria

Greece Bulgaria Hungary

Portugal, Cyprus Slovenia

Dr Micovic, Serbia

Austria

Nihat Pakdil, Turkey

Bulgaria

Following the election, the representative of France requested the possibility to attend the Session of the Executive Committee with “Observer” status. No opposition was raised to the proposal. The FAO position, as clarified by the FAO Legal Department, was that the attendance of a representative of the CVO should be at the invitation of the Chairman of the Executive Committee.

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Election of the Standing Technical Committee The proposed list developed by the outgoing Chairman and Executive Committee was endorsed without change:

The proposed list developed by the outgoing Chairman and Executive Committee was endorsed without change: Aldo Dekker (Chairman)

National Reference Laboratory for FMD / Vesicular Diseases, Lelystad, The Netherlands.

Kris de Clercq CODA-

Belgian National Reference Laboratory for FMD/Vesicular Diseases, CERVA-VAR, Belgium.

Georgi Georgiev

National Reference Laboratory for FMD / Vesicular Diseases, Bulgaria.

Stefan Zientara

National Reference Laboratory for FMD / Vesicular Diseases, France.

Bernd Haas

National Reference Laboratory for FMD / Vesicular Diseases, FLI, Germany.

Helen Hondrokouki

National Reference Laboratory for FMD / Vesicular Diseases, Greece.

Donal Sammin

National Reference Laboratory for FMD / Vesicular Diseases, Ireland.

Hagai Yadin

National Reference Laboratory for FMD / Vesicular Diseases, Israel.

Emiliana Brocchi

National Reference Laboratory for FMD / Vesicular Diseases, Brescia, Italy.

Andrzej Kesy

National Reference Laboratory for FMD / Vesicular Diseases, Poland.

Fernando Boinas

Faculty of Veterinary Medicine, Lisbon, Portugal.

Naci Bulut

National Reference Laboratory for FMD / Vesicular Diseases, Turkey.

Jef Hammond

WRL/CRL/NRL for FMD, Pirbright, UK (ex-officio, representing WRL).

David Paton

Institute for Animal Health, Pirbright, UK.

In addition, France proposed an additional member, Pascal Hendrikx, Epidemiologist (Lyon, France); after clarification from the EC that the budget for the additional member would be provided, the proposal for was accepted.

Membership of the Commission The lack of involvement of the Russian Federation in the work of the Commission was raised, given that actions in the Caucasus and West Asia act to reduce risk to Russia and the CIS countries. Several delegates indicated their support for increasing the involvement and membership of the CIS countries, although caution was also expressed as to the distance of some of the CIS countries from the current members and the extent of obligations to assist should outbreaks occur. However, the membership of states neighbouring to current EuFMD members was encouraged, such as Ukraine, Belarus, Russian Federation, Moldova and the TransCaucasus Republics.

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38th General Session of the EuFMD – 28-30 April 2009. FAO, Rome

Item 15 - Reading of the report The Secretariat presented the draft of the final recommendations, which was endorsed subject to the inclusion of the corrections and changes proposed during the reading.

Closing ceremony The Chairman, Dr Herzog, thanked the delegates of the Member States for their support and interest in the programme of the Commission and the EC for its’ continued support to FMD control and to the EuFMD commission’s activities at all levels.

On behalf of the Secretariat, Dr Sumption thanked the outgoing Chairman, Dr de Leeuw, for his outstanding commitment to the work of the Commission and his patient and wise counsel to the Secretariat at all times, and to the Rapporteur group that assisted with the 38th Session.

Dr Herzog thanked the Secretariat, and especially Nadia Rumich, Enrique Anton, and Claudia Ciarlantini, for their perfect work over many months to prepare the Session, while ensuring the main tasks of the Commission in supporting FMD control continued at field level.

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Appendix 1 AGENDA OF THE SESSION

THIRTY-EIGHTH SESSION OF THE EUROPEAN COMMISSION FOR THE CONTROL OF FOOT-AND-MOUTH DISEASE (EuFMD) Rome, Italy 28, 29 (full days) and 30 (half day) April 2009 PROVISIONAL AGENDA

1. Global FMD situation: regional trends in FMD risk; 2. Progress Reports on FMD control in the European neighbourhood: 1) Progress towards long term FMD control in Turkey and its immediate neighbours; 2) Progress towards long term FMD control in the Trans-Caucasus; 3) Progress towards FMD control in Iran and Syria.

3. Standards for endorsement which have regulatory significance across the Member States: 1) Bio-security Standards for FMDV laboratories (Updated Standard for Adoption); 2) Minimum diagnostic capacity in EuFMD member states (Standard for Adoption).

4. Report of the EuFMD Executive Committee for past biennium; 5. Strategic Plan 2009-2013 (including activities for upcoming biennium); 6. The EuFMD role in development and technical support for a long term FMD control in “West EurAsia” (West EurAsia Free of Clinical FMD by 2020); 7. “Euro-mediterranean FMD control network”: vision and modalities, and role of the EuFMD Commission; 8. Technical items: The new decentralised (”penside”) diagnostic test systems : guidance on use in European situations.

This document is printed in limited numbers to minimize the environmental impact of FAO's processes and contribute to climate neutrality. Delegates and observers are kindly requested to bring their copies to meetings and to avoid asking for additional copies.

Most FAO meeting documents are available on the Internet at www.fao.org

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Appendix 2 GLOBAL FMD SITUATION: REGIONAL TRENDS IN FMD J. M. Hammond*, D. P. King, N. J. Knowles, J. Wadsworth, K. G. Swabey, B. Statham, Y. Li, P. Keel, P. Hamblin, G. H. Hutchings, S. M. Reid, K. Ebert, J. M. Stirling, N. P. Ferris, E. Byrom and D. J. Paton1

1

WRLFMD Institute for Animal Health, Asch Road, Pirbright, Surrey, GU24 ONF, UK.

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Appendix 3 SITUATION OF FMD IN THE MIDDLE-EAST (1 April 2009) (Compilation of information from OIE (official notifications), or reports to eufmd/fao by countries or by the FAO/OIE/EC fmd Reference Laboratory, Institute for Animal Health, Pirbright, UK2 Adel Ben Youssef

Serotype A In the first months of 2009, outbreaks of FMD caused by serotype A have been detected in several countries in the Middle East. This serotype is considered endemic in Turkey, Iran and Pakistan, but as a result of genetic and antigenic drift, sweeping regional epidemics occur at intervals. The last major type A change in the region was in 2005-6, when an epidemic of the A Iran 05 strain spread through Iran, Turkey, Pakistan, reaching the Thrace region of Turkey and as far as Jordan. In 2008, a new variant of the type A Iran 05 virus replaced the previous strain in Turkey, and this, and related type A viruses appear to be on the move in the region.

The current situation gives rise to concern, as type A outbreaks have been detected in several countries for the first time in many years. Such international spread indicates a high incidence in source countries, which could lead longer distance spread to free regions, by various routes.

In January and February, more than 130 outbreaks were reported in the central and Southern Iraq, involving a new variant of A Iran 05. An appeal through FAO/EuFMD Commission for assistance was answered by the European Union, which provided 500,000 doses of emergency FMD vaccine (A22 Iraq, O and Asia 1).

In this period the same strain of FMD type A was detected in Bahrain, and then Kuwait, with those identified in Kuwait almost identical to strains found in Iraq in 2009.

In February, the same strain, with close identify to those in Iraq/Kuwait/Iran, was identified in samples submitted by Libya to the FAO World reference laboratory (WRL) at Pirbright. The circumstances that gave rise to the entry of this virus are unclear, but this event represents a major jump for this FMDV strain, suggesting movement through animal trade, as the lack of pigs in Libya makes entry through livestock products unlikely.

This Westward movement of infection into the Mediterranean region should be noted by countries in the European - Mediterranean region.

An intensive collaborative effort (FAO/EuFMD Commission (with support from DG-SANCO), WRL Pirbright, the FMD Institute in Ankara, Turkey, and the Iran Veterinary Organization) is ongoing to better understand the spread of strains in the region. The strain involved in outbreaks in Lebanon is under investigation (since this report was circulated, the WRL also confirmed the strain as A Iran 05), and it should be noted that type O is also endemic in most of the region.

Finally cases of FMD type A (observed 26th January 2009) have been reported to the OIE by Egypt, as a result of an FAO TCP project working with the Egyptian authorities. The strain involved is similar to that identified in 2006 following incursion from East Africa (A/EGY/06). The detection in outbreaks in 2009 suggests establishment of the East African strain in the Mediterranean region.

2

IAH-WRL Reports on FMD strain typing can be found at http://www.wrlfmd.org/fmd_genotyping/

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The above situation, with two (or more) antigenically distinct FMDV type A viruses in the Eastern Mediterranean should be noted by European countries and each country is encouraged to review its current risk management measures.

Annex: • Chronology of recent events; • Map.

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38th General Session of the EuFMD – 28-30 April 2009. FAO, Rome

Chronology of recent FMD events in the Middle-East

Month

Outbreaks

New

declared/detected

continued

events

/WRL report

Turkey and November 08

FAO/Eu-FMD

Iran Bahrain Turkey and

December 08

FAO/Eu-FMD

Iran

(Aïd festival)

WRL report

Jordan Turkey and

Media report FAO/Eu-FMD

Iran Iraq

FAO/Eu-FMD

Bahrain

WRL report

January 09

Lebanon Turkey and

OIE (11 outbreaks) FAO/Eu-FMD

Iran

Most closely type/strain

related virus (WRL)

A/IRAN/05 O MANISA A/IRAN/05

A/PAK/06 A/AFG/07

A/IRAN/05 O MANISA No confirmation A/IRAN/05 O MANISA A/IRAN/05 O not detected A/IRAN/05 probably type O

A/AFG/07 A/IRN/08 pending

A/IRAN/05 O/MANISA A/IRN/09

Iraq

FAO/Eu-FMD

A/IRAN/05

A/BAR/08 A/PAK/06 A/LIB/09

February 09

Kuwait

WRL report

Israel

OIE (7 outbreaks)

A/IRAN/05

A/IRQ/09

O (most probably panasia 2) Libya

WRL report

A/IRAN/05

A/IRQ 09 A/KUW 09 A/IRQ/09

Iran

WRL report

A/IRAN/05

A/LIB/09 A/BAR/08 A/BAR/09

Turkey

FAO/Eu-FMD

Iraq

FAO/Eu-FMD

March 09

A/IRAN/05 O/MANISA

Egypt

OIE/WRL

A/EGY/06

Egypt

OIE/WRL

O

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pending

pending pending

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Appendix 4 PROGRESS REPORT FOR TURKEY ON FMD SITUATION AND CONTROL MEASURES H Askaroglu

Introduction Foot-and-Mouth Disease (FMD) is endemic in the Anatolia Region of Turkey, due to two serotypes. Types O and A have been circulating in the region and cause big economic losses and negative impact on livestock. Outbreaks due to type Asia 1 have not been reported since April 2002 in Turkey. There is no outbreak recorded in Thrace region since October 2007.

Due to the incursion of the virus from outside of the country, two big endemics have been experienced since 2005, which were new genotypes of type A and O viruses, A Iran 2005 and O Pan-Asia II respectively. The former was introduced into the country at the end of the 2005, and resulted in over 1500 outbreaks during 2006. Later, the devastating epidemic was taken under control. The latter was followed end of the year which was also continued occurrence of new outbreaks during the 2007 resulted over the 800 cases all over the country.

This report is looked over impact of those two endemic originated during the last two years and emphasized control measures and activities during the period and next two years.

I. OUTBREAK SITUATION 1.1. FMD situation in 2007 Turkey was got under the high risk with circulating a severe virulent new O subtype, O Pan-Asia strain, because of up-surging this new sub-strain from outside of the country. Epidemiological investigation and molecular epidemiologic studies were indicated that O Pan-Asia sub-strain was introduced to Turkey up to October 2006, beside existed domestic strains O Manisa/ O Alfa 05 topotype, which were caused a few outbreaks before the October 2006. Outbreaks were recorded mostly with type O, a total of 809 outbreaks were detected, 482 of by type O, 56 of by type A and 271 not typed in 2007 (fig.1; Map.1,2 and 3).

Although it was recorded 52 outbreaks with type O in 2006 and those isolates were dropped in O Alfa 05 lineage genetically, the numbers of type O outbreaks were increased at beginning of October 2006. Because of the effects of animals movements during the Kurban Festival (end of the year), viruses were spread all over the country and numbers of outbreaks were reached on pick (119 outbreaks due to the type O) on January 2007. According to genetic analysis of isolates, a new type O Pan-Asia II sub-strain was detected first time at Selvioglu village in Uşak on 8th October 2006. The sequence data which was obtained in Ankara FMD Institute showed that this virus was closely matched with viruses isolated in Iran in 2006. It is uncertain that whether this was index case or not for the new sub-strain. Since Uşak province is located West of Turkey, in Aegean Region, it was probable that it might be occurred another case in East Region of Anatolia, close to Iran border. It is probable that the disease with type O Pan-Asia sub-strain was occurred in another place where is near to border after the entrance into the country. However, it is clear that this was available first evidence indicated genetic changing of circulating viruses. Many further sequence data which was made in Ankara FMD Institute on between October 2006 and March 2007 also supported that O Pan-Asia strain was circulated all over the country. Those studies indicated that the isolates were not only close to Iran isolates but also they were close to isolates of Middle East Region, particularly of Jordan. The recent data made on March showed that isolates collected from Şırnak Province in southEast region of Turkey, near to Iraq/Syria border were close to these lineages.

Although it was detected genetically differences of O virus as Pan-Asia and affected severe clinically on animals, recent available antigenic studies, R Value ELISA, show that there has been no changing antigenically, which O1 Manisa vaccine strain has been covered both substrains. The data for type A 05 Iran outbreaks which detected as limited number in 2007 show that it has been closed to their genetic lineages and given high protection well antigenically.

Since it was existed high level immunity by post infection originated latest two endemics and massive vaccination, the disease was gradually decreased end of the year. In addition of these facts, effective control measures during the whole year and particular control measures before

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and during the Kurban Festival were also implemented in order to detain transmission of existed virus sources. In favour of all those facts, disease was get under the control end of the year.

In 2007, four outbreaks were detected in Thrace Region, because of uncontrolled animal movements after the Kurban Festival. Outbreaks occurred in this region were limited within the village, majority of them within the premises where disease occurred. All cases were controlled successfully without spread the extent of the region by effective measures including stamping out and no outbreaks were recorded within the last trimester of the year.

1.2. Disease situation in 2008 In this year, there was a gradually decreasing the number of the outbreaks and severity of clinical signs. It was not observed shift of outbreaks after the Kurban Festival as usual before, because of effectiveness control measures taken place before and after festival. Overall 253 outbreaks were occurred in Anatolia region of Turkey; 52 of by type O, 143 of by type A and 58 not typed in 2008 (fig.2 and map.4). Although there was significant decreasing of number of outbreaks when compared with 2007, it was observed differences regarding to epidemiological event. While dominating circulated virus type was type O in 2007, majority of outbreaks were recorded due to the type A in 2008. Outbreaks with type O were commonly circulated in limited area, on the contrary type A was dispersed almost all over the region. Because of natural immunity raised from highly common type O outbreaks occurred in previous year, high level protection by effective vaccination and sufficient control measures, type O virus was suppressed which was resulted occurrence limited number of type O outbreaks. After the occurrence 29 outbreaks d to the type O up to June 2008, it was occurred rarely in the summer time with the same type. However, totally not eliminated, rare maintained type A virus was found host receptor availability this time in the same population which was resulted increasing of number of outbreaks by type A during the this year. Genetic and antigenic evolution mainly played a part in this changing. Starting the beginning of the year it was observed gradually genetic diversity and finally detected antigenic changing on July 2008. Since vaccine strain, A22 Iraq, was not protected current circulated field isolates by proofed antigenic characterization study, it was decided changing with A Turkey 2006. However because of limitation of time for adaptation a new strain, autumn vaccination campaign was conducted with old partially protective vaccine strain, A22 Iraq. It was probable that this epidemiological change affected the increasing number of outbreaks.

1.3. Current disease situation In this year (up to 10th April), it has been recorded as a total 45 outbreaks in Turkey; 17 of due to type O, 10 of due to type A and 18 of due to not typed (fig.2 and map.5).

When it has been look over this year situation, it seems number of outbreaks have been decrease sharply and clinical signs in affected population was observed very mild. Disease is not spread all over the premises and all population, only it was limited in young primo-vaccinated population. That observed also a good progress regarding to risk assessment is recorded a few outbreaks the first time after the Kurban festival which were limited in exact area in which Erzurum, Erzincan and some provinces in Inner Anatolia. On the other hand, it seems that there has been a shift on recorded outbreaks on March when compared with previous two months.

When it makes a risk assessment given the facts of the country dynamics of disease pattern, the shift observed on March can be turned to account as usual in spring time of year. Movement of animal to pasture from inside of barn starts this session which causes such a virus transmission. Because of hard climate condition, virus can be maintained easily its live life cycle in such a long winter condition and spread easily by such a movement. Since the time also coincides end of vaccination campaign interval, it is normal to get naïve animals regarding to protection, particularly in young primo-vaccinated animals. These two epidemiological events are help to be formed shift of number of outbreaks in this period of year. It is considered that since vaccination campaign has been started beginning of March, in a short period this shift can be easily suppressed by effective vaccination.

Evaluation of disease situation in this period 1.

44

A good trend was observed in 2009 compared two years. Numbers of outbreaks gradually were decrease. This decline was also observed on number of affected animals. It was observed that disease was not spread to good vaccinated population, particularly in the

38th General Session of the EuFMD – 28-30 April 2009. FAO, Rome

2.

3.

4.

West region. There was no outbreak in Thrace region during the period and also serosurveillance conducted in this region straighten out this observation; Severity of clinical sign was got mild and disease was not extended to all ages of population, generally only observed young primo-vaccinated animals by effective vaccination; There was no indication straighten out by molecular analysis and epidemiological investigation on the new incursion from the outside of the country. However there was a genetic evolution for the circulation of the virus within the country. Both virus types, type O Pan-Asia II and A Iran 05 have been parted sub-lineages as genetically; Antigenic characterization studies showed that A22 Iraq vaccine strain was covered to new introduced type A Iran 05 end of the 2005 (When the virus first time introduced the country). However the type A field isolates were develop evolution in the course of time and it finally was detected antigenic difference on July 2008 which resulted changing the vaccine strain with suitable one, A Turkey 2006.

II. CURRENT CONTROL POLICY Objective of the current control policy That the main objective is to get under control endemic disease situation in order to stop spread of virus and to be ready to implement individual case study which each new outbreak can be investigated and potential source identified.

Elements of control measures 1. Surveillance for borderline: In order to prevent entrance of new virus types into Turkey, a surveillance program has been introduced in the East and the South Eastern border regions; 2. Active and passive surveillance: To identify FMD transmission, active clinical surveillance in case areas and passive surveillance for collection required information and identification of disease pattern is conducted; 3. Diagnosis activities and research: FMD (Sap) Institute, National Reference Laboratory, conducts all research activities regarding to FMD control: a. b. c. d.

4.

Diagnosis; Molecular (genetic) analysis; Antigenic characterization for vaccine matching; Epidemiological investigation for support identification of disease pattern.

Serosurveillance activities: Two main serosurveillance have been implemented: a.

Thrace Serosurveillance;

Objective: 1. To gain free state of FMD in the region, it has been conducted a three years serosurveillance program (2008-2010). b.

1.

2.

3.

Anatolia Serosurveillance Objectives: To provide an estimate of the proportion of seropositivity to non-structural FMD proteins in cattle Anatolia; To assess vaccine efficacy in selected provinces by measuring antibody levels to structural FMD proteins at day 30 post-vaccination in cattle; Vaccination:

Mass vaccination policy is the main element of the control program against FMD. Vaccination Program has been implemented by framework of the European Aid Project (to be described in further chapter) in three years periods, 2008-2010.

Objective of the vaccination is reach to 100% coverage of whole ruminant population. However, because of shortage of the vaccine supply, small ruminants were vaccinated partially in 2008.

•

Vaccination strategy o

Large Ruminant: Application of routine mass vaccination twice a year all large ruminants;

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o

Small Ruminant: Application of routine mass vaccination once a year all small ruminants.

2009 Spring Vaccination Campaign Spring vaccination campaign for 2009 has been started 1st of March and finalized end of the April. It has been planed vaccination for all Large Ruminants population, because of tender schedule, vaccination for small ruminants was postponed to Autumn campaign. Data for vaccination coverage will be submitted the end of the campaign.

4.

Control of Animal Movements • • • •

5.

Through an Acting Order, Provincial Agriculture Directorates have been instructed on the vaccination of at lEast 85% of the bovine population against FMD to maintain herd immunity; The same Acting Order states that animal movements will not be allowed from provinces in which less than 85% of the bovine population has been vaccinated against FMD; Pursuant to Circular Orders numbered 2009/10 and 2009/11, the entry and exit of live ruminants and animal products are prohibited in outbreak areas; Furthermore, according to the Circular Orders indicated above, the entry into Thrace region of bovine, ovine and caprine animals, other than those destined for slaughter, is not allowed.

Outbreak Investigation and case study:

To stop the virus circulation a. b. c. d. e.

Restriction of animal and animal products movements; Quarantine; Ring vaccination; Sampling for type identification and molecular and antigenic characterization; Data collection and reporting.

have been implemented.

Changing of the control policy during the two years: According to objectives of Europe Aid FMD project, some new changing on control measures has been implemented: a.

Up to 2008, vaccination mainly was focused on large ruminants, vaccination of small ruminants was not compulsory and only was applicable on demand in the Anatolia; vaccination has been targeted to cover whole ruminants population since 2008; b. In this new period, vaccination has been implemented as charge of free; c. Pursuant to Cabinet Decision 2009/14850 on the Subvention of the Livestock Breeding Sector, for the purpose of combat with animal diseases, private veterinary practitioners are also appointed in vaccination campaigns; d. Pursuant to the Cabinet Decision indicated above, the subvention of breeder animals is conditional on their being vaccinated against FMD; e. A serosurveillance was implemented first time in Anatolia region in 2008 in order to estimate of the proportion of sero-positivity to non-structural FMD proteins and also this will be continued; f. To prevent virus circulation and eliminate transmission risk, a specific control measures was initiated before and after Kurban festival, particularly design on impermanent animal market, animal movement for festival to big cities and movement of unsold animal. This measures help to reduce the risk for disease transmission particularly to Thrace region.

III. CHANGING IN CAPACITY FOR CONTROL POLICY Ramping up capacity to implement the control policy for FMD in the past 2 years is as follow: a. b.

46

Vaccination coverage has been reached 90% (as overall) from 72% in cattle population campaign in 2008. This is targeted to 100% for 2009 (map 6 and fig. 3); 1/3 population of small ruminants was vaccinated (because of vaccine shortage, not realized the objective, 100%). It will be expected when vaccine for small ruminants will be supplied fully this year, it will be try to realize whole coverage;

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c.

Serosurveillance capacity has been reached to at lEast 60.000 sera once a year from 15.000 sera; A new diagnostic method as alternative to conventional methods, multiplex PCR to allow typing of FMDV was launched at NRL in order to early detection. This method identifies the virus earlier than antigen detection ELISA/VI methods and also reduces negative results from epithelium samples; Over the 1500 new veterinarians were designated for field veterinarian service which helps to achieve more vaccination coverage and the others relevant services.

d.

e.

IV. SUPPORTS PROVIDED BY EuFMD OR EU HAVE ASSISTED THE NATIONAL CONTROL POLICY IN THIS PERIOD. A. Supports by EU a.

Starting in 2008 a new control project (Europe Aid Project for control of Foot and Mouth Disease, Project no: TR 060302) with a budget of 64,692,332 million Euros was initiated for three years.

Objectives of project: Control of FMD in Turkey by mass vaccination policy in accordance with other EU control measures such as animal identification, movement and market.

Activities: Vaccination, Sero-surveillance and Cleaning and Disinfection.

B. Supports by EuFMD a. b. c. d.

Thrace region serosurveillance activities: Financial and technical supports were donated for realization surveillance activities; such as donated serosurveillance materials and technical assistance for design and analysis of surveillance; Anatolia Animal market and Slaughterhouses Serosurveillance: Materials were donated by EuFMD for this study; Outbreak Investigation: To understand and identify the disease spread dynamics and train field vets on the outbreak investigation, a project was conducted by assistance of EuFMD; Epidemiological training course: To develop epidemiological skill and knowledge at General directorate of Control and Protection (GDCP) and Sap Institute, it has been initiated a epidemiology training course.

V. VISIONS ON THE CONTROL POLICY FOR NEXT 2 YEARS 1.

2.

2.

3.

4.

5.

Application to the OIE for the declaration of Thrace as free from FMD with vaccination: It is foreseen that freedom from FMD with vaccination will be attained with the final serosurveillance results obtained, in the General Session of the OIE in May 2010; Further Eradication of FMD in Defined Zones: Based on the reports and conclusions of the EU-funded technical assistance to be received for the OIE application for Thrace, new zones will be determined for the further eradication of FMD in Turkey; Gradual decrease in the number of FMD outbreaks: At the moment it was observed gradual decrease in the number of outbreaks and severity of pathogenicity. Within the next two years, it will be reached the next disease stage described by OIE standards which each new outbreak can be investigated individually and potential source identified.

When it will be reached this stage of disease situation, it will be feasible to conduct stamping out on outbreak area; Number of vaccinated animals: Vaccination coverage will be fully achieved a hundred percent in both ruminant populations the end of the 2010; Number of protected animals: Using high potency vaccine supplied by the project, percentage of protected animals will be realized more than 85 and tried to solve boost vaccination problem in the young cattle population end of the 2010; Number of NSP (+) animals: The results of 2008 Anatolian Serosurveillance showed that overall NSP prevalence was 8,27 and regional distribution were 1.15, 3.47, 4.82, 6.81, 8.40, 10.37 and 17.84 for Marmara, Aegean, Black Sea, the Mediterranean, Inner Anatolia, SouthEast Anatolia and East Anatolia Regions respectively. Same surveillance will be repeated for three years. Considering achievement of indicators mentioned above item.2, 3 and 4 in this chapter, it is nature that these prevalence points will be decreased

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6.

gradually within the next two years. To achieve this, it will be launched a new control strategies particularly in the East, inner and southEast regions in order to stop virus circulation caused this high prevalence; A new project: It will be planed to develop and implement a new project. Objectives and activities of the new project are going to identify by taking into the consideration indicators, outputs and experiences of current applied project.

Vision for next 2-5 years; taking account West Eurasia Roadmap Visions foreseen by expert in the West Eurasia Roadmap Workshop, in Shiraz, Iran November, 2008, for current and future disease situation (estimation made by referenced with description of OIE standards) were as follow: It was made evaluation by zone for Turkey; Thrace and Anatolia regions: a.

Thrace region: Current level was determined as stage 3 and planned to be gained free status with vaccination end of the 2010; b. Anatolia region: Existed disease situation was defined as level 1 or possibly level 2 and planned to be passed through the next levels 2 and 3, end of 2010 and 2014 respectively.

According to latest disease risk analysis, vision made in the workshop is still valid.

VI. RISK ASSESSMENT 1.

2.

3.

According to international epidemiological risk analysis, the new virus incursion is standstill a high risk for Turkey. Since high rate incidence and uncertainty on the diversity of the type A virus have been still existed in the East region and being probability exposures of those sources by dynamic animal movement pattern from the area, it considered that the risk is high; Poor disease awareness and notification existed in the East and southEast Anatolia regions can be assessing another risk assessment for disease control policy; Hard and long winter condition existed in the East of the country help on the maintenance live virus circulation. Already existed virus keeps life cycle without developing infection as a infection source throughout 8 months and finally in the spring time, the virus source causes a new infection by animals moved to pasture and high land; In addition to such a climate condition, current socio-economic structure and animal husbandry system in the East region are played part in negative impacts on the disease control policy.

VII. EUROPE AID PROJECT and WORKPLAN FOR NEXT 6 MONTH a.

As mentioned in Chapter IV, subtitle B, a new project, Europe Aid Project for control of Foot and Mouth Disease, Project no: TR 060302, was initiated for three years. Project details are follow: Budget: 65,000 Euro; 75% of the budget was donated by EU and remained by M.A.R.A Objectives of project: Control of FMD in Turkey by mass vaccination policy in accordance with other EU control measures such as animal identification, movement and market.

Activities: Vaccination, Sero-surveillance and Cleaning and Disinfection.

Outputs of Project: Details gave in Chapter. V. In addition to those, it will be gained more valuable information and experiences by conducting serosurveillance which light the way on further strategies and new projects for disease control

Workplan for next six months: • • • • •

48

Two vaccination campaigns will be realized; 2009 Thrace and Anatolia serosurveillance will be finalized; Training course for vet service will conducted; Project interim reports will be produced after the task force and steering meeting; Laboratory test results and field report for disease situation will be gained.

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ANNEX I

MAPS AND FIGURES

Fig.1: Distribution of numbers of outbreaks by months.

Map 1: Distribution of FMD Type A Outbreaks in 2007.

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Map 2: Distribution of FMD Type O Outbreaks in 2007.

Map 3: Distribution of total (Type A, Type O and untyped) FMD Outbreaks in 2007.

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Disribution of outbreaks z6 z 6 6 z

z 6 z6z6z

6 z z

z 6 6 6 zz 66z z6 z z

z z z z z zz zz 66z z zz z 66 6 z 6 zz 6 z z 66 z

z z 6 z z z z z 6

z z z z z z z 6 z z zzz z

6 zz 666z6 6 6z 6666 z z z z 6 6 z z zz zz z 66 666 z 66 z z zz z z 6 z z z z z zz zz z

z z z6z z z z zz z 6 z z

z z z

z z z z zz z zz z z 6 zz z z z z zz z z z

z

z z z6 z 6

z zzz z 6

Type A:143 Type O:52 Untyped:53

Map.4: Distribution of the 2008 outbreaks by province.

Fig.2: Distribution of number of outbreaks in 2008 and 2009 (up to April).

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z

6

6 z

6 6

z z

6

z

z6 z

6 6 6

6 z

6

6 6

6

z 6 6

z 6

Type A:10 Type O:17 Untyped:18

Map.5: Map distribution of number of outbreaks in 2009, up to April.

Map 6: 2007 Autumn Vaccination Coverage Rate (Cattle) in Turkey.

52

z

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VACCINATION COVERAGE FOR AUTUMN 2008 95

91

89

90

85

90

87

86

REGIONS

PER C EN TA GE

TOTAL

SOUTH EAST ANATOLIA

EAST ANATOLIA

BLACK SEA

INNER ANATOLIA

MEDITERIAN

EAGEN

TRACE VACC. COVERAGE MARMARA

PERCENTAGE

TURKEY VACC. COVERAGE FOR CATTLE (BY REGIONS) 100 90 80 70 60 50 40 30 20 10 0

100 90 80 70 60 50 40 30 20 10 0

97

95

CANAKKALE

EDIRNE

100

ISTANBUL

97

100

98

TEKIRDAG

KIRKLARELI

TOTAL

PROVINCE

Fig. 3: Vaccination coverage for Autumn 2008.

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Appendix 5 PROGRESS REPORT FOR TRANSCAUCASUS SINCE 37TH SESSION (APRIL 2007) “Strengthening Foot-and-Mouth Disease prevention and emergency response capacity in the Trans-Caucasian countries (MTF/INT/003/EEC)” C. Potzsch

1. Report relates to country or countries: Armenia –Azerbaijan –Georgia.

[Report period: April 2007 – present] 2.

Summarize FMD situation in the past two years (the reporting period). What were the major events, such as incursions of new virus types or involvement of previously free regions? What is the trend in 2009 compared to previous two years? Tables of outbreaks by serotype, maps of outbreak distribution are requested as annexes.

Outbreaks: Spring 2007: serotype O PanAsia II in Nagorny Karabakh, sample submission to FGI-ARRIAH in 5/2007.

No other outbreaks have been reported from 4/07 to 4/09.

Last notifications to OIE: 2001 (Azerbaijan), 2002 (Armenia, Georgia).

Media reports/suspicions: Armenia: a cattle disease was reported: • •

In Siunik District, FMD was excluded by the national vet. services (VS), no diagnostic results provided (News agency Regnum, ProMED 29./30.5.07); In Lori Province; diagnosis was blackleg, FMD was excluded by the VS (Hetq Online, ProMED 10./12.7.07).

Georgia: a cattle disease was reported in Akhaltsikhe District; it was diagnosed as necrobacillosis, FMD was excluded by the VS (Interpressnews, 2-8.12.07).

All media reports were followed-up by project staff; FMD was excluded in all cases by the CVOs/National VS. In 2008 and 2009 no (media) reports about FMD were received except some rumours of clinical signs consistent with FMD from Georgia and Armenia in 2008.

NSP baseline survey in the Trans Caucasus (see Annex II) A serological survey was conducted in the cattle population of the three countries. More than 12,000 sera were collected from young animals (aim: ≤18 months) in the vaccination buffer zone and from the rest of the countries. The objective of the national surveys was to estimate the level and describe the geographical distribution of NSP antibodies, to assess the success of the vaccination campaigns in reducing virus exposure, and to identify and quantify risk factors for NSP positive outcomes.

Until reporting date approx. 4000 sera from were not yet tested.

The mean NSP prevalences were highest in Armenia (31%), Azerbaijan (23%) and Nagorny Karabakh (16%); in the surveys carried out in mid 2008 (see map a) & table b)). In later surveys, Georgia (Nov.-Dec. 08) and Nakhichevan (Mar 09) prevalences were lower; 6 and 1% respectively (table b)). Also the follow-up investigations show this trend of decreasing exposure in the previous two to three years. In Azerbaijan where predominantly animals up to one year were included, the NSP prevalence was lower (3% in cattle, 9% in sheep) than in Armenia were older animals were sampled (11% in cattle, 20% in sheep) (see table c).

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The NSP results from the Trans Caucasus are similar to results from a NSP survey carried out in Turkey (see map d)). Although the survey designs differ, mean province/district NSP prevalences and ranges on village level are similar.

During the surveys and follow-up investigations in the Trans Caucasus no FMD or clinical signs of FMD were reported.

These first results indicate continued exposure to FMD virus in the region. The time of highest virus exposure could have occurred 1-2 years prior to the survey (see Annex II, tables b) & c): age of animals). The results could therefore mirror the two major epidemic waves which had hit Iran and Turkey in the two years prior to the surveys.

3.

Summarise the main objectives of the current control policy, and any change in control policy over the past 2 years.

The main objective is to control the incursion and the spread of FMD by mass vaccination I FMD vaccination policy: FMD vaccination is usually more intense in spring than in autumn. In spring movement to pastures starts and herds mix, which poses a high risk of spread of FMD. For vaccination overages in spring and autumn 2008 see Annex I. 1. Spring vaccination: a) The EuFMD project support in the FMD vaccination buffer zone* Georgia, Armenia and Azerbaijan: vaccination of the whole cattle population > 4 months; Armenia and Azerbaijan: revaccination of calves in the buffer zone; Georgia: vaccination of small ruminants. *The EuFMD project buffer zone comprises all border districts of Georgia, Armenia and Azerbaijan with Turkey and Iran. b) National vaccination campaigns, other than supported by the EuFMD project Armenia: vaccination of all small ruminants in the buffer zone; vaccination outside the buffer zone: all cattle and small ruminants only according to availability of funds and the risk situation; Azerbaijan: vaccination of all cattle and small ruminants in- and outside the buffer zone only according to availability of funds and the risk situation; Georgia: vaccination of cattle and small ruminants outside the buffer zone if funds are available and according to the risk situation.

2. Autumn vaccination (only scenarios differing from spring vaccination stated) a) FMD vaccination buffer zone: Georgia: vaccination of small ruminants in the buffer zone according to availability of resources and the risk situation. b) National vaccination campaigns: Armenia: vaccination of most small ruminants in the buffer zone according to availability of funds; Azerbaijan: vaccination of most cattle outside the buffer zone according to availability of funds and the risk situation.

II Change in control policy •

4.

No use of lapinized vaccine since 2008 in Armenia and Georgia, also as a result of project consultations to national decision makers.

Summarise any changes in capacity to implement the control policy for FMD in the past 2 years. These include additional staff, diagnostic facilities, change in vaccine use, etc

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Legislation National FMD contingency plans have been updated or are under development in Armenia and Azerbaijan; new diagnostic capacities are included, Azerbaijan: compensation policy and national budget established.

Vaccination • • •

Increase of vaccine quantity and the buffer zone area by the EuFMD project due to the request from the countries and after reassessing the risk situation (s. 5.); More widespread and regular revaccination of calves every 3 months in Armenia (whole country) and Azerbaijan (buffer zone); Improvement of the cool chain for vaccine storage on central level in Georgia where a cold room was built, and in Armenia and Azerbaijan on district and village level by providing fridges and thermoboxes.

National budgets do not allow purchase of sufficient quantities of quality FMD vaccine for populations most at risk (e.g. buffer zone, • Young animals and traded animals). Without the EuFMD project large parts of these animals would remain unvaccinated.

Strengthening of diagnostic capacity in national labs •

Capacity to carry out NSP testing and to handle large amounts of sera (all countries);

Armenia and Azerbaijan: • • • • • •

Participation in the next WRL proficiency test; Refurbishment and increase of diagnostic capacities of national labs; PCR capacity established (not for FMD currently); In-country training on NSP testing by international consultant; Training on NSP testing and general lab procedures of one Azeri expert in Ankara; On the job training and evaluation during the national NSP survey by international consultant.

Georgia: •

Use of the national lab for project FMD diagnostic work (NSP testing) in spring 2009 for the first time since project start.

Data work and epidemiological capacity Regular reporting of national project consultants; Close cooperation of NCs with epidemiological units of the national VS; Excel training for national project consultant (NC) and laboratory staff (Azerbaijan).

Other issues Armenia and Azerbaijan: • Staff payments and availability of resources have improved on central, district and village level, salaries are still very low and there is especially a lack of transport fuel and basic veterinary equipment on district and village level.

Georgia: • Since mid 2006, border vet. inspectors belong to the Ministry of Finances and are no longer part to the vet. department; communication between the vet. dept. and vet. border inspection has worsened since then. Also as a result of this there is no effective system of border control to prevent introduction of livestock diseases, this situation has not changed since the ASF outbreaks; • The EuFMD project has increased awareness about FMD on the level of MoA and the VS. No FMD vaccination was carried out in spring and autumn 2007. As a result of constant risk communication by the project at lEast in the buffer zone ruminants were vaccinated by central VS and district staff in autumn 2008, in spring 2009 private vets will be hired for vaccination.

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•

There is a lack of state vets and resources on central and district level; and no functioning system of private large animal vets on village level. This results in very limited resources for disease control and surveillance (vets from the central VS have collected the sera).

5.

Summarise how the support provided by EuFMD or EU (EC) has assisted the national control policy in this period.

•

Provision of trivalent vaccine (A Iran 05, O, Asia1) for use in the buffer zone, numbers of doses increased according to national demands and reassessment of the risk situation;

Table1: Delivery of vaccine under the project to the countries (spring 2007-spring 2009).

Vaccination campaign Spring 2007 Autumn 2007 Spring 2008 Autumn 2008 Spring 2009

Azerbaijan

430,000 866,000 867,000 867,000 866,799

Armenia *

Georgia

240,000 287,000 282,000 282,000 282,232

320,000 240,000 40,000 275,000

* Armenia has delivered about 60,000 doses per campaign to Nagorny Karabakh.

• • • • • •

Improvement of FMD control by revaccination (Armenia and Azerbaijan) and FMD public awareness campaigns (TV broadcasting; Georgia and Armenia); Strengthening of diagnostic and epidemiological capacities; Training of NCs and national staff in diagnostics, computer use and epidemiology; Establishing a system of regular FMD sero surveillance to identify risk populations; Regular risk assessments established to guide national and regional decision making; National project consultants are part of national FMD control decision making, e.g. contingency plans, communication between EuFMD and national VS.

Workshops, meetings, trainings • • • • •

National FMD Workshops in Armenia (Nov. 07), Azerbaijan (Dec. 07) and Georgia (Feb. 08); Annual project meetings (Oct. 07, Nov. 08, Apr. 09); Training in NSP serology (Armenia and Azerbaijan, Dec. 07); Training in CEDI testing and lab procedures for one Azeri lab expert at the SAP Institute (Jan 08); Regional simulation exercise (May 09).

Purchases by the project: • • • • • • • • 6.

Freezers each for Armenia & Georgia; Serum collection equipment (vacutainers, needles etc.) for 10,000 sera/country; Lab consumables for serology; NSP antibody detection kits (CEDI) for 10,000 sera/country; Pen side tests for virus detection (Svanodip), 40 tests/ country; Fuel (5000 USD/country) for field surveillance; GIS data layers of Azerbaijan and Georgia; Laptop for NC Azerbaijan.

Outlook for next 2 years: how is the FMD control situation expected to change over next 2 years? Summarise national policy and provide brief details on ongoing or expected investments that will affect FMD control to 2011.

• •

National FMD contingency plans are updated and approved if required; Compliance with the progressive stages in FMD control/West Eurasia Roadmap;

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• •

FMD surveillance and control/vaccination for risk populations like animals moving to seasonal pastures and traded animals; adaptation of legislation and implementation; Georgia: o Increase of staff and resources on VS central level planned for early 2009 was postponed; o Currently an international organizations (World Bank, USDA) advises on animal health strategies and structure of the VS.

West Eurasia Roadmap (Shiraz meeting report) : please summarise the expected progression in next period (2-5 years). [Note The Shiraz report gives the national expected progression based on expert opinion at the meeting, November 2008].

•

• •

7.

Armenia and Azerbaijan: currently stage 2 (self assessment), progression to stage 3 in 2010, priorities: Training in epid. and lab, vaccination continued, provision of kits, Animal ID; Georgia: stage 1 (90%) (self assessment), progression to stage 2 in 2009 and stage 3 in 2012, priorities: Continue vaccine supply, training in epidemiology; All countries have stated their support and commitment to the West Eurasia Roadmap in letters to FAO. Risk situation: what are the main risks to the national FMD control policy? for example: risks of new virus incursions, risks to vet service activities as a result of national budget cuts or changes, lack of community support/civil disturbances etc.

• • • •

Inadequate funding and resource of the VS, worsened by the global financial crisis; Early detection of newly introduced FMDV due to insufficient virus detection and shipment capacities; Fading FMD awareness on all levels since last official notifications were in 2001/2002; Inadequate recognition of the work of the VS and FMD control by governments in particular because of: No major disease outbreaks reported, FMD poses no public health risk, Low national importance of the livestock industry, mainly subsistence level of large animal husbandry.

No incentives or even penalisation for reporting of FMD or suspicions on all levels; Poor transparency about the FMD situation; Georgia: o o o

• • •

o o o 8.

National budget cuts for VS; No clear FMD control policy; Poor vaccination coverage and no re-vaccination of young stock.

Summarise the major issues that EuFMD or other international bodies (FAO/OIE/..) are requested to assist with to achieve progression in FMD control in next 2 year period:

EuFMD • •

Continuation with the project, especially provision of vaccine; Increase epidemiological and diagnostic support, especially training in epidemiology and support with diagnostic methods, especially virus confirmation and SP serology;

Other international bodies • All countries request support in animal identification and registration.

9.

For ongoing EuFMD/EC projects please: a. b.

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indicate expected end of project: June 2009 (MTF/INT/003/EEC); summarise Workplan and expected outputs for next 6 month period (see attached workplan);

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Main issues: • • • • • c.

project end in June 2009; regional simulation exercise (4-8. May 2009) and evaluation of outcomes; continue lab support and training (training in virus confirmation by SAP Institute); collation of diagnostic and field SOPs in a project manual; Funding agency and overall agreed financial support: EC, 2.74 million USD.

International and national professional staff assigned: EuFMD project consultant/regional coordination National project consultants International consultants: lab diagnostics (12/2007) Simulation exercise (5/2009)

Carsten Pötzsch

Azerbaijan Armenia Georgia

Tamilla Aliyeva Satenik Kharatyan Zurab Rukhadze Anne Mayer-Scholl Johannes Fiedler

10. What to recommend To be considered for inclusion in the General Session Recommendations.

•

Continue project activities in all three Trans Caucasus countries, reducing vaccine provision would suddenly increase the risk of outbreaks in the Trans Caucasus: o o o

•

Georgia depends most on the continuation of project activities; the EuFMD project is the only reliable component in national FMD control; Armenia has the highest exposure to FMDV according to the NSP survey in 2007; In Azerbaijan, the richest country in the region, the VS receive insufficient funds for successful national FMD control and surveillance, and Azerbaijan has the highest population of susceptible animals (11.1 mill.), especially small ruminants (8.3 mill.).

Main components of a next FMD control and surveillance project should be: o o o o o o o o o

Vaccination, incl. identification and vaccination of risk; populations, keeping a regional emergency vaccine bank; Applied epidemiology training, incl. clinical training in Turkey and support for quality reports; Lab support: testing for structural protein antibodies and virus confirmation; Regular serological surveillance, including background sero surveillance and surveillance of risk populations; Regular participation of the three national labs in international FMD proficiency tests; Support in increasing FMD public awareness; Policy advise and implementation support on FMD control and risk reduction; Improve understanding of animal movements, incl. economics; Information sharing through the regional FMD database.

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ANNEX I

Vaccination coverage (in %) reported by the national VS in 2008; average and range (in brackets) on district level a) Spring 2008.

Vaccination campaign

Georgia

Armenia * (on region level)

Azerbaijan

Buffer zone, cattle Buffer zone, small ruminants Other areas, cattle

100 (100)

67 (0 – 100)

150 (99 – 203)

99 (77 – 100)

Other areas, small ruminants

67 (0 – 100)

13 (0 – 104)

18 (0 – 43)

129 (60 – 163)

Nagorny Karabakh

99 (88-100)

78 (31 – 109)

83 (42 –100)

105 (67 – 134)

19 (0 – 26)

46 (6 – 119 )

b) Autumn 2008.

Vaccinatio n campaign Buffer zone, cattle Buffer zone, small ruminants Other areas, cattle Other areas, small ruminants

Georgia

Armenia * (on region level)

Azerbaijan

Nagorny Karabakh

93 (77-99)

160 (73 – 201)

98 (84-100)

64 (21-119)

12 (0 – 100)

68 (0 – 114)

14 (0 – 36)

34 (6-85)

1 (0 – 100)

147 (94 – 150)

77 (40 – 100)

1 (0 – 100)

0.3 (0 – 89)

14 (0 – 59)

*Revaccinations (booster vaccinations of young cattle) are included for Armenia.

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ANNEX II NSP serological surveys in the Trans Caucasus 2008/2009 a) Geographical distribution of NSP antibody prevalences in Armenia, Azerbaijan and Nagorny Karabakh (schaded: vaccination buffer zone).

b) Baseline sero survey results.

Azerbaijan (excl.

Nakhichevan) Nakhichevan AR Nagorny Karabakh Armenia

Nb. of cattle sera

Mean NSP prevalence

Range on district level

Range on village level

Sampling date

3363

23%

0-65%

0-86%

7/2008

Age of cattle; mean (±1SD); in months 26.2 (12.040.4)

215

1%

1-2%

0-4%

3/2009

18.2 (9.926.5)

702

16%

0-32%

0-82

6/2008

-

3449

31%

0-83%

0-90%

5-6/2008

12.0 (8.815.2)

Georgia Samtskhe Javakheti

507

6%

0-25%

0-47%

11-12/2008

12.7 (8.317.1)

c) Follow-up investigations.

Azerbaijan cattle sheep cattle sheep

No. of sera

Mean NSP prevalence

Mean NSP prevalence Range on village level

92 cattle 44 sheep

3% 9%

0-14% 0-25%

2/2009

9.8 (7.6-12.0) 8.1 (5.9-10.3)

200 cattle 200 sheep

11% 20%

0-24% 0-36%

2/2009

22.8 (4.5-41.1) 22.7 (3.7-41.7)

Sampling date

Age of animals; mean (±1SD); in months

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d) Geographical distribution of NSP antibody prevalences in border regions of Turkey, Georgia, Armenia, and Azerbaijan (Nakhichevan AR); red: mean NSP prevalence on province or district level, in brackets: range on village level, after semicolon: no of villages with at lEast one NSP positive animal/no. of all villages samples in the province or district.

Time of NSP surveys: In In In In

62

Turkey: Georgia: Armenia: Nakhichevan AR:

Sep.-Nov. 08; Nov.-Dec. 08; May-Jun. 08; Mar. 09.

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ANNEX III Project Workplan 2007-2009 (Annex I, Implementing Agreement /Project Document)

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Appendix 6 EUFMD PROJECT IN THE I.R OF IRAN F. Geiger

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Appendix 7 PROGRESS REPORT ON I.R. OF IRAN Since 37th Session (April 07) V. Otarod

1. Report relates to country or countries: Iran report Apr 06-Mar 09.

2. Summarize FMD situation in the past two years (the reporting period). What were the major events, such as incursions of new virus types or involvement of previously free regions? What is the trend in 2009 compared to previous two years? Tables of outbreaks by serotype, maps of outbreak distribution are requested as annexes.

Since April 2006 (3 years evolution, the start point of EU-FMD project), data show an increase in the NO. Of outbreaks both in cattle and sheep and goat due to Type O disseminated in Animal population. This event started around September 2006 and stayed till March 2007. The sub strain responsible for this epidemic was O Pan Asia. Just a month later there was a transient epidemic again due to O PanAsia that did not last long and returned to normal condition after 2 months which was due to PanAsia linage 2. since July 2007 onward there was not significant changes in the normal condition of outbreaks except for January 2009 where the outbreaks started to increase and showed that to be due to Type A05 which made effects over the Western part of Iran (It is showed perfectly by a movie (herewith the report),made based on monthly reports ). This event coincides with the development of disease due to the same type in South East part of Iraq, although the population was supported by good vaccination coverage but the mild epidemic occurred which may be due to a change in the sub strain of virus .

Accordingly, it is possible to analyze, categorize and interpret the data of outbreaks of 3 years as following and use it as an estimate for future impact of disease:

Lower than 50 outbreaks / month mild condition → low virus circulation→ low risk to develop new strain or new epidemic.

•

50-100 0utbreaks /month Intermediate condition →Increased risk to develop new strain or new epidemic due to: - Reduced immunity level? (In the case of regular vaccination and virus circulation do not mean anything) → probable epidemic mainly due to local stain; - Introduction of new strain:

•

- Legal or illegal importation of affected animals; - Phenomena of: - Shift strain → transient condition → a few outbreaks; - Drift strain → stability in outbreaks for a long time (A 05) →need a new vaccine.

More than 100 outbreaks/month Sever condition → high virus circulation → new epidemic development due to: - Probability of new strain introduction - Continuation of developed drift strain; - In both cases very difficult to control the disease - the future impact of disease is catastrophic.

From Aug 2007 no significant change in the trend of diseases noted, means: - Probably no introduction of new strain; - Probably No mutation or any other changes in the current strains circulating.

- Since Dec 2008 – an increase in the outbreaks of cattle = coincide with Iraq South East epidemic;

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Sheep and goat are less affected than cattle, although their population is 10 times more than cattle;

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Data shows that trend of the disease tend to decrease specially in Sheep & Goat population.

However, recent increase in March 2009 may be due to epidemic of Iraq South East epidemic.

• •

Comparison of outbreaks, outbreaks density (Accumulation points, and limits of virus circulation area show the same pattern of disease dissemination in two alternative years; Results of Active Surveillance show that reporting system activity is reliable as the rate of affection in visited Farms due to active surveillance is approximately same as the rate of diseases in current reporting system (0.006 and 0.008 respectively). This evaluation accredits GIS_Vet.

Regarding the samples gathered, Type O (PanAsia) and A (A05) are dominant types isolated.

Map of the distribution of testes samples (Apr 08- Mar 09) shows the focalization of Type A mainly in North, West and central parts and Type O mainly in Central part and South and to some extent to Eastern areas, although because of huge animal movement and permanent reintroduction of Virus, NO significant conclusion can be retrieve to determine the specific condition for each Type. It should be noted that developing Map for samples is only possible for Year 2008 due to installation of Lab software package at the beginning of this year.

The No of samples are as follow: Sent to WRL • 2007 : 40 samples submitted to WRL – 29, O – 6, A05 – 5, NVD •

2008 : 6 Samples submitted to WRL – 3, A05 – 3, NVD

•

2009 = 29 Samples submitted to WRL in March – 2, O PanAsia II – 27, A05

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Sent to CVL or Razi instituted • •

2007 : 591 A & O 2008 : 325 A & O

3. Summarise the main objectives of the current control policy, and any change in control policy over the past 2 years: • • • •

Decrease in the No. of outbreaks; Prevent the virus circulation to decrease the risk of emergence of new strains; Quarantine measures and animal movement control around outbreaks and in borders; Sanitary and disinfection around outbreaks.

4. Summarise any changes in capacity to implement the control policy for FMD in the past 2 years. These include additional staff, diagnostic facilities, change in vaccine use, etc • • • • •

Use of private sector in vaccination program; Increase the role of private sector in FMD reporting systems; Increase the local vaccine production capacity (Razi institute); Encourage private sector to produce FMD Vaccine; Improvement of standards in CVL regarding facilities and tests.

5. Summarise how the support provided by EuFMD or EU (EC) has assisted the national control policy in this period.

• • •

Implementation of the second phase (2008-2009) of EuFMD Project (signed Sep 2008); Conducting and holding regional meeting and workshop in West Eurasia Roadmap (Shiraz meeting) with participating of 16 countries; Technical supports: o o o o o

Consultancy; on different items of FMD; Training in WRL for CVL staffs; Serum test in Reference Lab; Providing executive facilities (GIS upgrade, lab equipments, GIS Centre supports).

6. Outlook for next 2 years: how is the FMD control situation expected to change over next 2 years? Summarise national policy and provide brief details on ongoing or expected investments that will affect FMD control to 2011: • • • • • •

Vaccination in cattle population: 2 times a year / 6 months interval; Vaccination in sheep & goat population once a year; Implementation of borderline mass vaccination (help the Eastern neighbouring countries in vaccination of their livestock mainly those for export); Try to develop free zone area in Western and Eastern border provinces; Implementation of sero-monitoring in the country for vaccine evaluation and estimating prevalence and incidence of circulating virus; Ongoing GIS upgrade in order to develop capacity for Early Warning System by Dash -Board Techniques.

7. West Eurasia Roadmap (Shiraz meeting report): please summarise the expected progression in next period (2-5 years). [Note The Shiraz report gives the national expected progression based on expert opinion at the meeting, November 2008]: • •

Providing training facility on Epidemiology, vaccinology and laboratory for related staffs; Establishment of website in the field of EuFMD Roadmap for the collaboration and transformation of epidemiological data.

8. Risk situation: what are the main risks to the national FMD control policy? for example: risks of new virus incursions, risks to vet service activities as a result of national budget cuts or changes, lack of community support/civil disturbances etc •

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Illegal animal movement in borderline and inside the country due to economical condition and different meet price;

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• • •

Risks of new virus incursions in the border and villages (different vaccination coverage in the villages and animal husbandry); Lack of community support /civil disturbances especially for small animal stockholders; Lack of vaccine at the time of vaccination period. (Vaccine depot).

9. Summarise the major issues that EuFMD or other international bodies (FAO/OIE/..) are requested to assist with to achieve progression in FMD control in next 2 year period: • • • • •

Regional collaboration for surveillance; Regional communication; Free zone; Border vaccination; Help the countries next to borders to immune their flocks.

10. For ongoing EuFMD/EC projects please: a. b. c. d.

indicate expected end of project: 2013; Summarise Workplan and expected outputs for next 6 month period. Annex1; Funding agency and overall agreed financial support {...}; International and national professional staff assigned.

11. What to recommend • • • • • • •

Rapid Implementation of regional administration for harmonization of activities; Further and deep investigation over the Strains circulating in the region; Try to find improved tests to monitor the disease at field level; Try to find improved tests able to facilitate and advance getting the results; Developing field researches in the countries for better finding the FMD situation at regional level; Providing new funds for continuing the regional projects to eradication with the help of rich countries of the region; Providing ongoing training courses in the field of laboratory and epidemiology for uniformity of information at the level of region.

12. Further information on the matter

This document should be used to elaborate the ppt for the presentation during the meeting

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Appendix 8 PROGRESS REPORT FOR SYRIA C. Potzsch

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Appendix 9 PROGRESS REPORT FOR IRAQ Ministry of Agriculture State Company for Veterinary Services (TADS)

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Appendix 10 Minimum standards for laboratories working with FMDV in Vitro and in Vivo

Appendix 10 MINIMUM STANDARDS FOR LABORATORIES WORKING WITH FMDV IN VITRO/IN VIVO Standard adopted by the 38th General Session of the European Commission for the Control of Foot-and-Mouth Disease (EuFMD), 30th April 2009

Foreword In 1985 the European Commission for the Control of Foot-and-Mouth Disease (EuFMD) at the Food and Agriculture Organization (FAO) of the United Nations adopted a document entitled "Minimum Standards for Laboratories working with FMDV in vitro and in vivo", hereinafter "the FMD-lab standards". This document described a set of precautions to be taken by Foot-andMouth Disease (FMD) laboratories to avoid an escape of virus. It was prepared at a time when the majority of countries on continental Europe employed systematic annual prophylactic vaccination of their cattle. Council Directive 90/423/EEC amending Directive 85/511/EEC on Community control measures for FMD made the above FMD-lab standards a condition for the approval and operation of laboratories handling live FMD virus (FMDV).

Although the above document dealt with all important aspects of FMD containment, it had been found necessary to review it with special reference to the need for more specific technical and general requirements as a consequence of the change in Europe to a policy of non-vaccination.

The security standards as specified in the 1993 revision had to be considered as minimum requirements for FMD laboratories located in FMD-free countries with or without systematic prophylactic vaccination. Article 65 of Council Directive 2003/85/EC on Community measures for the control of FMD and repealing Directive 85/511/EEC makes the FMD-lab standards, as amended in 1993, a condition for the approval and operation of laboratories handling live FMDV. Even in countries where FMD is present it is important to avoid the escape of FMDV from laboratories so the standards in this document are recommended as the minimum for FMD laboratories regardless of the prevailing disease situation. However, countries endemically infected with FMD should use, mutatis mutandis, at lEast the provisions described in “Minimum standards of biorisk management for laboratories undertaking diagnostic investigations of lowrisk samples during an outbreak of FMD", as a guideline to minimize the risk of escape of FMDV, of possibly a different serotype or topotype, from laboratories not meeting the FMD-lab standards.

Following the 2007 FMD outbreak in an EU Member State that was related to virus escape from a laboratory, EuFMD undertook to review, and where necessary to adapt, the aforementioned FMD-lab standards. The present edition of the "Minimum Standards for Laboratories working with foot-and- mouth disease virus in vitro and in vivo" were adopted at the 38th General Session of EuFMD on 29 April 2009 and supersedes the edition adopted by EuFMD in 1985 and revised in 1993.

This document relates to facilities that handle or intend to handle materials containing foot-and –mouth disease virus (FMDV) in a form that could give rise to animal infection (”live FMDV”).

The updating of the FMD-lab standards reflects the changes in the terminology of biorisk management practises, the change in the performance characteristics and standards relating to air filtration, and also addresses concerns relating to security of facilities.

The terminology used and the biorisk management principles incorporated into this document were adapted from the latest available draft of the CEN/CWA “Laboratory Biorisk Management Standard”, Edition April 2008.

Introduction Foot-and-Mouth Disease (FMD) is one of the most contagious diseases known, and manipulating the virus in the laboratory without adequate precautions is a hazard. It has been shown that as few as 10 TCID can be infective to cattle by the airborne route. However, this is under

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experimental conditions and the low infective dose may relate to the relatively large size of aerosol droplets, which can be efficiently contained by HEPA filtration of air exhaust from facilities handling infective FMD virus (FMDV). As a consequence of the low infective dose, laboratories handling FMDV must work under high containment conditions, in which the principle objective of the containment measures is to prevent release of virus that would give rise to animal infection outside of the laboratory (veterinary containment).

The principles on which the containment measures are based are as follows: – FMD virus is an animal health but not a human health hazard; – containment measures for FMDV laboratories will differ in certain respects from those required of high containment facilities handling pathogens which present a significant human health hazard; – effective implementation and maintenance of the containment measures will reduce the risk of an accidental release of virus to a level that can be considered acceptable in a risk management balancing those risks against the expected benefits of the services provided by such laboratory.

The containment measures were prepared on the basis of the documented evidence on the physico-chemical properties of FMDV, its inactivation kinetics, and the form and quantity of FMDV required to infect susceptible species.

Key factors in establishing and implementing a successful containment system include: 1.

Physical and operational barriers to the release of FMDV that involve three containment layers and multiple fail-safe mechanisms as follows:

1.1. Primary containment layer: – Contain the live FMDV at source within closed containers or a class I, II or III safety cabinet, or – In the case of infected animals, contain the live FMDV by physical containment in specially constructed rooms with treatment of all waste and the HEPA filtration of air.

1.2 Secondary containment layer: – Containing FMDV of infected materials and staff working with such materials within a closed and highly controlled physical environment, and – Subject solids, fluids and air to a treatment by validated procedures that will remove or inactivate FMDV; 1.3. Tertiary containment layer: – Prevent contact between the live FMDV and susceptible livestock outside containment by appropriate measures, such as restrictions placed on access of staff to such livestock.

2.

Commitment by senior management: – – –

–

To provide the resources required to attain and maintain the containment measures, including the physical and human environment; To recognise the top priority of the management of the risks associated with facilities handling live FMDV; To establish and maintain a management system and a working culture in the facility that facilitates continual improvement in preventing possible release of virus, the effectiveness of containment processes and root cause analysis of possible release incidents so as to prevent their recurrence; To recognise and promote continual improvement.

General requirements FMD risk management system: Each facility should establish, implement and maintain a FMD risk management system, appropriate to the level of risk associated with each of the mechanisms and routes by which FMDV could escape or be released.

Policy: The management of the facility should have in place a policy that clearly states the FMD risk management objectives and the commitment to improving the FMD risk management performance.

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Risk assessment: To operate a FMD risk management system, a risk assessment system should be in place in order to: – Identify and address the risks (likelihood and extent of impact) of release or escape of FMDV by each facility (plant); – Define the circumstances which would trigger a new or revised assessment, for example plans to construct new or modify existing facilities, changes to the programme, changes to volume of activities, following incidents or as a result of elevated levels of biosecurity threats to the facility.

Hazard identification: The Hazard identification system should identify the situations, and other hazards, associated with the work of the facility that may impact on the risk of FMDV release, including emergencies (such as electrical failure, fire, flood, medical emergencies etc). The requirements in this standard do not necessarily identify all hazards that may occur, but are written to reduce the risk associated with the hazards in facilities handling live FMDV. The main sources of FMDV are: – – – – –

Diagnostic specimens; Infected tissue cultures; Infected laboratory animals, e.g. baby mice and guinea pigs; Laboratory based physical and chemical processing of large quantities of virus, and Infected pigs, cattle, sheep, goats and other susceptible large animals.

The principal routes by which the FMDV may escape or be carried out from laboratories include: – – – – – –

Personnel; Air; Liquid effluent; Solid waste; Equipment, and Samples and reagents.

Although RNA derived from FMDV may still be infectious under very specific conditions, for practical purposes samples can be considered “inactivated” after an approved treatment with an appropriate lysis buffer and a disinfection of the sample tube by an approved method. However, as a precaution, such samples should not be handled without appropriate risk management measures, which must, in particular ensure that such samples are at no stage of processing added to cell cultures or injected into animals, except in laboratories meeting the “Minimum Standards for Laboratories working with Foot-and-Mouth Disease virus in vitro and in vivo", hereinafter "the FMD-lab standards".

Risk control: Under the direct responsibility of the management of each facility (plant), the hazards which could lead to a risk of FMD escape should be identified, quantified, prioritised and control options identified. The requirements indicated in this Standard should be considered a minimum, and do not release the management of each facility from the responsibility to undertake a formal risk assessment process.

Special attention should be given to: – – – – – – – – –

Replacement and reduction in use of live virus where possible; Security and recording of access to the facility; Security check of personnel handling live FMD virus; The responsible behaviour of personnel within and when they leave the laboratory, including the use of changing and showering facilities; The application of rules for primary containment; The maintenance of the physical containment including the air handling systems to ensure a negative air pressure where virus is manipulated and the effective particulate filtration of exhaust air; The decontamination of effluent; The disposal of carcasses in a safe manner; The decontamination of equipment and materials before removal from the restricted area.

Use of alternative procedures: The use of alternative procedures for inactivation of FMD virus to those specified in this Standard is permissible provided that the information from the validation

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of the process has been examined and found equal or superior in performance to those currently specified. Decisions on equivalence of the proposed procedures can be made by national competent authorities. However, national authorities have to inform the EuFMD Standing Technical Committee of such decisions and their scientific basis, which will be reviewed and findings published in the “Report of the Sessions of the EuFMD Standing Technical Committee."

Residual Risk: The residual risk is the risk of a consequential release of FMDV, after application of the control measures. The Biorisk Officer (BRO), management and ultimately the national regulatory body should consider the overall biorisk management system together with the hazard identification and risk control procedures, and identify if there are residual risks requiring either more effective controls to be put into place, or work to be suspended.

Authorization of laboratories in respect to FMD: In respect to work with FMDV, laboratories may be authorized by the competent authorities to carry out one or more of the following types of work: (1) Infection of experimental and/or large animals with FMDV; (2) Activities which produce high amounts of infectious FMDV, e.g. large scale virus production at a capacity that involves more than 10 litres of cell culture; (3) Activities involving the handling, and in particular, the propagation of infectious FMDV, but are limited to 10 litres of cell culture, and during which the FMDV is enclosed in containers which can be effectively autoclaved or disinfected; (4) To test diagnostic samples for antibody to FMDV, by methods that do not involve live FMDV manipulation; (5) To test diagnostic samples for FMDV genome by methods that do not involve live FMDV manipulation (e.g. RT-PCR); (6) To apply on the genome of FMDV methods of molecular biology that do not involve live FMDV manipulation.

Laboratories carrying out the type of work mentioned under points 1, 2 and 3 must comply with the “Minimum Containment Standards for FMD Laboratories”.

In accordance with EU legislation, and in most cases national legislation, the manipulation of live FMDV requires a mandatory authorisation by the competent authority.

The FMDV -associated risk of laboratories not manipulating live FMDV but carrying out the type of work mentioned under points 4, 5 and 6 is usually much lower.

However, authorisation of such facilities also requires a proper risk assessment.

Laboratories that receive samples from areas not free from FMD from susceptible animals should comply with the “Minimum standards of biorisk management for laboratories undertaking diagnostic investigations of low-risk samples during an outbreak of FMD” given in Annex II. SPECIFIC REQUIREMENTS The requirements below are intended to assist self-assessment, bio-risk audit and inspection of facilities.

I.

Management

Specific management requirements: 1.

Bio-risk policy, delegation of responsibilities and communication: The management of a facility is ultimately responsible for biorisks (biosafety and biosecurity) of its premises.

The management should therefore define and document roles, responsibilities and authorities related to biosafety and biosecurity management in a formal policy statement and communicate this to all staff members;

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2.

Formal process of Risk assessment / threat assessment: The management should ensure that a formal process is in place to conduct, review and update a risk assessment. The need for a structured security threat assessment should be considered for each facility;

3.

System for continual improvement: The management should put a system in place to guarantee that biosafety and biosecurity procedures and elements are thoroughly reviewed and audited on a regular basis. Records should be maintained of findings of audits, including actions taken to comply with the containment policy;

4.

Standard operating procedure (SOP): A system should be in place to maintain a complete set of SOPs for all operational processes that are considered critical to the containment of FMDV;

5.

Biorisk Officer(BRO): It is the duty of the management to properly monitor the biosafety and biosecurity by appointing a BRO (Biosafety / Biosecurity Officer), arranging for a deputy or replacement, and creating the necessary framework conditions in the facility.

To ensure that biosafety and biosecurity is given full consideration in its activities the management should carefully define the status, duties and responsibilities of a BRO: (a) The BRO should report directly to the top management representative (DirectorGeneral, site Director or similar) and should have authority to stop the work in the facilities in the event that it is considered necessary to do so; (b) The status of the BRO should ensure his/her independence and the absence of any potential conflict of interest; (c) Adequate financial and personnel resources should be allocated to the BRO to carry out his or her duties; (d) The BRO should have the possibility of a direct link to the competent authorities responsible for the enforcement of biosafety /biosecurity regulations within the country or geographical/administrative area; (e) The BRO should have appropriate training in virology, containment techniques and procedures to fulfil his/her duties. It is to be expected that he/she would also have a broad based knowledge of the FMDV with particular respect to its physicochemical properties, mode of transmission and other topics of relevance to his/her role; (f) The BRO should review regularly both technical reports concerning the various containment facilities as well as data relating to their day to day operation and monitoring. On the basis of such information, the officer should inform senior management of any concerns he/ she may have and as they arrive as well as prepare an annual report on all relevant containment elements of the facilities.

6.

Record keeping – accessibility to live FMDV: Access to live FMDV should be limited to key personnel authorized and adequately instructed by the management. Detailed records of handling live FMDV (eg virus strains and dates used) should be kept and stored at lEast 5 years. Inventory lists including information on the location where a virus strain is stored should be maintained and periodically inspected and crosschecked (previous sentence: Inventory information including the location, the virus strain should be maintained and periodically inspected and crosschecked). (Laboratory books or other daily records of procedures by staff working with FMDV should be in place to enable retrospective analysis of activities for at lEast 12 months;

7.

Accident/incident reporting system: Each facility should have an accident / incident reporting system in place, with a procedure for rating of the risk of the event and a decision making process for recording, reporting and remedial actions. An example of a risk rating system and associated decision tool is given in Section I of ANNEX I;

8.

Accident/Incident review system: there should be a system in place to ensure each incident/accident is reviewed to ensure that the lessons learned have been identified, the type of failing in control measures is recognised, and adequate and proportionate remedial measures set in place. A statistic concerning accidents / incidents should be made available to the management at lEast annually;

9.

Systems to review biorisk changes: changes to the design, operation and maintenance of a facility including biosafety/biosecurity procedures and risk assessment should be reviewed, verified, approved and documented through a formal change control process before implementation. Trigger points for review or drafting of new risk assessments should be identified;

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10. Emergency management plans (contingency plans): types of emergency should be identified, including fire, flooding, loss of essential services, security breaches and major events affecting integrity of buildings, and standard management procedures for each event developed, documented and made permanently available to staff.

11. Access to site: management should implement and document a system for controlling access to areas of the site where the activities of the area pose a potential hazard. There should be physical security measures to restrict access; Management should define the different zones on the site, taking into consideration the hierarchy of risk of activities in each zone. A suggested typology is: RED ORANGE GREEN

[=restricted area = where FMDV is manipulated and/or which contain infected animals] [= support services and access to the restricted area] [general access and administration].

RED, ORANGE and GREEN zones are situated within the controlled area = area within the outer security barrier or fence of the facility.

The minimum requirements are to clearly define and document the zones under control of the BRO, including definition of the outer perimeter of the site, lower risk areas for personnel and plant access, the location and barriers of the laboratories in which FMDV is handled, and the location and access points to waste treatment (including ventilation systems).

II.

Training

12. The organization should ensure that personnel are competent for their designated roles and receive appropriate training on a regular basis. In particular, training requirements and procedures for biosafety and biosecurity related training of personnel should be identified (training programme) and established (training manual) and training records should be maintained; 13. Training content and training tools should be defined taking into account the different target audiences and the individual learning differences within a facility. Training efficacy assessment should be considered wherever possible and appropriate. Training should be reviewed on a regular basis; The BRO should be in charge of providing information and advice on biosafety and biosecurity to laboratory staff, cleaning personnel, visitors, contractors as well as to other persons working either in locations in which FMD is handled or adjacent facilities such as service areas. Personnel should be made aware of the responsibilities, the specific containment features and the risks associated with such activities; 14. Training should be provided on the specific properties of FMD, the primary and secondary containment features and the biosafety / biosecurity procedures pertinent to each facility; 15. All staff members must be appropriately informed and regularly trained in emergency evacuation procedures with special attention being given to security requirements in cases of fire;

III. Laboratory Biosecurity Note:

Additional considerations and notes are given in Sections II and III of ANNEX I.

The objective of Laboratory biosecurity is to protect biological materials containing FMD virus against deliberate removal from the facility.

16. It is part of the duty of care of every facility handling FMDV to ensure that it minimizes the risk of virus misappropriation by intruders and people with access rights to the facility, through measures taken following a formal threat assessment process.

In a threat assessment the critical assets of a facility should be identified and the facilities’ vulnerability to threats should be assessed. Any decision not to undertake such

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an assessment requires documentation and justification. Based on the threat assessment, structural (eg. building design, IT etc.), physical (cameras, fences, access etc.) and organizational (security policy, accessibility etc.) measures should be taken.

17. To comply with point 16, the minimum requirements are: (a)

Security system that is appropriate to detect and alert security to the presence of intruders, with a security plan in place for rapid response to intrusion;

(b)

Entry Recording system: Access to the facility should be recorded to provide an audit trail of who was in the facility at any given time.

18. Threat reduction/control measures: Due to the unpredictability of the actual threat, controls are required to reduce the risk to an acceptable level. These controls should consider structural, physical and organizational measures and must address at lEast the following scenarios: • • •

IV.

Intruder attempting to remove FMDV from the facility by forced or fraudulent entry; Staff member removing FMDV from the facility; Shipment of virus containing materials.

Personnel

19. Control of entry into and exit from the restricted zones (“RED zones”) must take place only through changing and showering facilities. This means a complete change from private or controlled area working clothes to dedicated restricted area working clothes on entry and the reverse process on exit but with a shower before leaving the restricted area; 20. A code of FMDV containment practice, including instructions for entry into and exit from control zones/restricted areas, must be available for all employees and visitors on site; 21. The FMDV containment rules and other relevant documents provided by the management must have been read and signed by each employee at the beginning of their employment. At this time, it should also be made clear to new staff that any violation of such and similar regulations may result in disciplinary actions by the management and the terms of employment should indicate this; 22. Control of access to controlled zones/critical areas: A level of security checks is recommended for all individuals with access to FMDV laboratories or critical plant/service areas of these laboratories. The performance of such checks will depend on the legislation of the country and procedures should have been developed in consultation with the police and relevant government agencies of the country; Access to FMDV containing materials in the laboratory should be restricted to trained and dedicated staff on the basis of legitimate needs. The number of individuals with access to virus storage areas should be kept as small as reasonably possible.

23. Visitors: There must be rules in place governing the access to controlled zones by visitors, covering at lEast the record keeping and the possible use of background checks.

The security system should verify the identity of visitors through use of unique identifiers including passport or ID card details. The reasons for each visit and the responsible person must be recorded; 24. Visitors have to be instructed in the specific containment procedures (eg. decontamination) of each facility before entering the controlled / restricted zones. There must be a system in place that guarantees that these procedures are properly followed; 25. Oversight (mentoring): A system for oversight of new personnel should be established, such that all new staff has someone assigned for oversight who has sufficient understanding of the biosafety rules; 26. A human resources support system should be in place, with appropriate protocols to support staff that may be under pressure that affects their participation in the biosafety practices of the facility; 27. Quarantine: each facility must define and apply quarantine periods for persons authorized to work in each category of controlled zone/restricted area, to reduce the risk that personnel will cause a release of FMD virus as a result of virus carriage on their

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body. A range of quarantine periods depending on the level of exposure to virus.

Depending on the risk assessment application of quarantine rules may be applied to other areas of a facility as well; 28. Persons, including visitors, authorized to enter the FMDV restricted area must agree not to keep any animals which are susceptible to FMD, nor reside on premises where such animals are kept and to abide by minimum standards of quarantine, i.e. no contact with animals susceptible to Foot-and-Mouth Disease for at lEast three days; 29. Personal protective equipment; regular supply of appropriate laboratory clothing for use within the restricted area [“Red zone”];

V.

Facility Design

30. General construction of buildings and their surfaces, including ducting of the air conditioning system: – – –

Maintain inward flow of air through doorways and other openings at all times; Properly maintained condition with a high standard of airtightness; Insect, rodent and bird proof.

31. Windows: – –

Sealed, toughened and preferably double glazed, and able to withstand operating pressures and all but major impact.

Equivalent standard in animal rooms and at a height where animals are not able to break.

32. Doors: –

Warning signs at entrances: ACCESS FOR AUTHORIZED PERSONNEL ONLY BIOLOGICAL HAZARD

–

Access restricted by locked doors where locks are operated from the outside. The advantages of a key-less lock system centrally controlled by the biosafety department should be explored that prevents un authorized cutting of falsified spare keys and allows the biosafety department to reset access rights as necessary;

–

Airlocks provided with airtight doors which are interlocked to prevent opening of both doors simultaneously, in particular following a gaseous decontamination cycle; Doors should be fitted with windows to allow staff outside of a room to see actions inside and provide assistance if necessary.

–

33. Walls, floors, ceilings: –

–

In many respects, the surfaces and material appropriate to Pharmaceutical facilities respecting GMP standards are also relevant to laboratories handling FMD virus. Notably, surfaces should be impervious, smooth, crevice free and easily cleaned and disinfected. Cavities within the fabric of the facility should be avoided (eg cavity walls) unless all penetrations of the walls, floors and ceilings are thoroughly sealed with suitable materials such as silicone mastic. Crevices and joins between surfaces should also be sealed with similar materials. Continuity of seal should be maintained between floors and walls. A continuous cove floor finish up the wall is recommended in particular for areas where major spillages will occur, e.g. animal and post mortem rooms; Sealed (airtight) entry of service lines.

34. Communication: All areas equipped with telephones and, in some areas, cameras, to ensure additional security outside of normal operations and allow staff to report issues including accidents and incidents without leaving work area; 35. Emergency back-up power: The laboratory facility should be equipped with a back-up source of electricity (an emergency generator) which starts with a delay of no more than a few minutes in the event of power failure. Alternatively, it is acceptable if the commercial power supplier is able to guarantee a supply from an alternative source within a few minutes of the main power failure. The delay period that is permissible will depend on the airtightness of the key buildings in the facility where virus in aerosol form

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may be present. In the design of a restricted area facility, special attention should be paid to the critical electrical supply circuits such as air handling systems, cold stores, safety cabinets, and other equipment and installations relating to the security and safety of the facility. There should be no possibility of the emergency supply being diverted from critical circuits by less important demand from non-critical equipment. Thus, the critical supply circuits would include air handling systems, cold stores, safety cabinets and other equipment and installations relating to security and safety of the facility;

VI.

Handling of FMD virus

36. Recording receipt of virus containing materials: A system should be in place for recording receipt of specimens or samples known or reasonably be suspected (to contain FMDV. The accompanying type and strain identification, or such information generated by the laboratory, respectively, should be recorded; 37. Except in cases when this is not technically feasible (e.g. during large animal experiments and post-mortem examinations), materials known or expected to contain FMD virus must either be kept within closed vessels or in devices that in combination with suitable operating procedures will function as primary containment. Such devices should be equipped with suitable filters, for example HEPA filters for which the requirements are defined in the Glossary, or equivalent off-gas or vent filters (primary containment). A suitable disinfectant should be kept close to the work areas such that a spillage can be rapidly dealt with; 38. In areas where only small quantities of virus are handled (10 litres or less of cell culture), liquids and suspensions containing FMDV should be inactivated by a validated procedure, for example, dilution in disinfectants, before disposal into the liquid waste system of the facility; 39. When large quantities of virus are processed (e.g. for vaccine production), it is necessary to transfer virus with a contained system of vessels, pipes and other equipment. To permit fluid transfers, air needs to enter and exit equipment and infectivity must be efficiently removed by a suitably validated procedure. Usually, this is done by filtration and a number of manufacturers supply filters capable of removing FMD virus with very high levels of efficiency. Procedures are also required for decontamination of vessels, pipes and other equipment after the process has finished and before the process is either repeated or items are opened or stripped down for cleaning or maintenance. Usually this will require a chemical decontamination stage followed by steam sterilization; 40. Inoculation of animals, maintenance of infected animals and post-mortem examinations must take place within the restricted area in rooms (normally dedicated animal or postmortem rooms, respectively) that in combination with suitable operating procedures function as a primary containment. [see glossary] Personnel must wear appropriate and comprehensive protective clothing to minimise exposure of body surfaces to virus splashes and aerosols when handling virus suspensions and when inoculating or handling infected animals. On exit from an animal and post-mortem rooms, protective clothes and footwear must be left inside these rooms or in ante-rooms to these rooms. Showering and complete change of clothes is required before the operator can move to an area not operating under a negative pressure/air filtration system; 41. Movement of materials known or expected to contain FMD virus out of one zone (eg laboratory), to another zone (e.g. animal rooms) on the same site must be governed and made by a set of procedures that prevent possible loss or spillage of virus in a nonrestricted area of the facility. As a minimum requirement, such materials are transported between the zones within a leak and break proof container. Staff making such transfers should be fully authorized to do so and be familiar with the emergency response procedures in the event of accident or incident; 42. Laboratory facilities and equipment must be cleaned and appropriately disinfected at regular intervals. In particular, benches and other flat surfaces exposed to virus should be wiped down with a suitable disinfectant as soon as open work has finished;

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VII. Air Handling – Live Virus Facilities Note:

Additional considerations and notes are given in Section VII of ANNEX I.

Ventilation systems 43. Negative pressure ventilation system: All facilities used for the handling of FMDV must operate under a negative pressure ventilation system with HEPA filtration of exhaust air and systems to prevent air escape on the inlet supply; In areas where only small quantities of virus are handled (10 litres or less of cell culture), the minimum negative pressure should be 35 Pa 3but due consideration needs to be given to ensure a gradient from the periphery of the restricted area to the area where virus is handled. From a practical perspective, it is difficult to achieve gradient steps of less than 10 Pa and this will tend to dictate the choice of pressure in the most negative part of the restricted area. For areas where larger quantities of virus are handled such as large scale virus production rooms and large animal rooms, the minimum negative pressure should be 50 Pa. A system should be in place to prevent a positive pressure occurring within the building due failures or faults within the restricted area ventilation system; 44. Exhaust air filtration system: Laboratories:

Double HEPA filtration of exhaust air. Use of a single HEPA filter may be acceptable, provided that it is demonstrated that open work with live virus is at all times restricted to within biological safety cabinets (BSC) which have HEPA filtration of exhaust air, thereby maintaining an effective double HEPA filtration following open work;

Animal rooms

Double HEPA filtration of exhaust air is obligatory;

Production laboratories:

Double HEPA filtration of exhaust air is obligatory.

45. Inlet air supply: A system must be in place to prevent escape of air via the inlet in case of ventilation shut-down. This may be achieved by a single HEPA filter or automatic dampers in the air inlet system; 46. The air pressures within the different rooms of a restricted area should be continuously monitored by manometers and a system must be in place so that staff working in these areas are informed if significant loss of air pressure occurs and the actions to be taken.

Manometers should be labelled to indicate the working pressure and the minimum and maximum limits within which open virus work is permitted. Under any of these alarm conditions, the primary action is to cease all open virus work and secure the workplace by sealing virus containers and disinfection of surfaces and protective clothing. The opening of doors leading to the contained area or to rooms containing infected animals or carcasses should be avoided as far as possible until the pressure difference has been restored; 47. All critical filters (HEPA) should be incorporated into a preventative maintenance programme. In particular, the efficiency of HEPA filters should be checked at lEast once per year, and in line with requirements of EN 14644; 48. When HEPA filters are installed or replaced, an in-situ efficiency test must be carried out by trained personnel with validated equipment. Replacement of HEPA filters must be performed in accordance with an authorized procedure. Strict precautions must be taken to prevent the spread of virus with used filters or contaminated air. Replacement of filters from outside the restricted area must take place after decontamination "in situ" or in "safe change" air-handling units. Filter specifications and test results supplied by the manufacturer should be incorporated into the maintenance records but cannot replace insitu testing because filters may have been damaged during transportation or may not have been fitted into the gaskets properly during installation; 49. Filters must be changed when the pressure difference exceeds certain limits in accordance with the instructions given by the manufacturer, or sooner if the filter fails one of the prescribed efficiency tests. Additionally, it may be necessary to change some filters more frequently if they are subject to high humidity or high particle challenge; 3

1 Pascal (Pa) ≡ 1 N/m2 ≡ 1 J/m3 ≡ 1 kg/(m·s2) ≡ 0.102 mm water column.

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50. Animal rooms – prefilters should be designed in a way that they can be changed without shut-down of the ventilation system; 51. HEPA filters in safety cabinets should also be checked at lEast once per year. Movement of safety cabinets should be accompanied by re-validation of the filter integrity due to possible flexing and movement on the filter cartridge or filter housing; 52. Off-gas or vent filters require testing on installation and at lEast once per year;

VIII.

Waste management

Effluent 53. Effluent from restricted area laboratories and from facilities holding FMD infected or potentially infected animals must be treated in a manner which ensures that there is no residual infectivity in the effluent using a suitable validated procedure. Both heat and chemical treatment may be used to process the effluent provided all of the material in the effluent is exposed to the specific treatment; 54. The treatment must be validated for the highest virus load and the most difficult matrix that can reasonably be expected. The possibility that virus particles may be protected from inactivation by proteins or lipids, and/or by aggregation or precipitation, must be taken into account in the validation process; 55. The entire effluent treatment system must comply with high containment conditions. In every case it must be ensured that no leakage from the primary containment system into the environment can occur; 56. There must be sufficient storage capacity (tanks) for the storage of untreated effluent; 57. The equipment must have automatic monitoring systems to ensure proper function.

These systems must ensure that the required conditions for inactivation of FMDV have been reached before the effluent is discharged. The systems should be continuously monitored and all critical data recorded. The system should be designed in a way that in case of any failure, the likelihood of a release of potentially infectious material is minimised; 58. Treatment options: Heat treatment: FMD virus is quite sensitive to heat at 100°C for 1 hour or an equivalent heat effect has been shown to be sufficient to inactivate FMDV in effluent to the extent that no residual infectivity can be detected. The treatment process should be monitored by multiple, automatic and continuous time and temperature measurements, combined with automatic measurement of flow rates or volumes. Any treatment system must ensure homogeneity of the effluent during the inactivation process. All data relevant to the inactivation process and the release of effluent must be recorded. Critical data measuring and logging equipment must be validated by qualified personnel at lEast annually; Chemical treatment: FMD virus is quite sensitive to acid and alkaline pH conditions.

NaOH or Na2CO3 or other alkaline treatment at pH 12 for at lEast 10 hours has been shown to be sufficient to inactivate FMDV in effluent and are particularly effective because of their action on concentrated biological effluents. As with heat, thorough mixing of the materials must be ensured. The treatment process should be monitored by multiple, automatic and continuous time and pH measurements. After treatment, the materials must be neutralized and the pH checked before the effluent is released. All data relevant to the inactivation process and the release of effluent must be recorded.

Critical data measuring and logging equipment must be validated by qualified personnel at lEast annually.

Solid waste (animal carcasses, feedstuffs, laboratory waste etc.)

59. The principle requirement is on-site inactivation of FMDV in waste using a validated method; 60. These methods include: – Sterilisation by steam using an autoclave (at lEast 115°C for 30 minutes or equivalent heat effect). It is essential that the different autoclave load types (eg

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plastic waste, paper waste, waste liquids) are each validated for the maximum load size with thermocouples at different locations within the load including the centre of the load. Typically, autoclave periods are 30 min or more. Autoclaves should be double-ended so that treated waste does not need to re-enter the restricted area. Autoclaves should be revalidated at lEast annually by experienced personnel. Depending on the national requirements, it may be necessary to dispose of the autoclaved waste by incineration on or off the site; Rendering of carcasses, in compliance with the requirements of Chapter III of Annex V to Regulation (EC) No 1774/2002; – Incineration on site. The incinerators must comply with current safety standards and be fitted with afterburners.

61. Emergency used when breakdown emergency

IX.

procedures: A similar level of safety must be demonstrated for procedures normal waste treatment procedures can not be followed, e.g. because of a of equipment. Emergency procedures must be documented in the laboratory plans, and include procedures for storage until treatment and final disposal;

Equipment and Materials

Laboratory fittings 62. Benches shall be smooth, impervious and resistant for any chemicals used in the facility.

Junction between horizontal and vertical surfaces should be covered; 63. Centrifuges, sonicators, homogenizers and other equipment must be designed so as to contain aerosols or be used within safety cabinets where any aerosols generated will not escape to the atmosphere of the restricted laboratory; Removal of equipment and other material 64. Before removal from restricted areas, equipment must be decontaminated according to the size and use of the equipment: – Either by steam sterilization within an autoclave, at 115°C for 30 minutes, or an equivalent heat effect, or – After surface disinfection, fumigation with formaldehyde (10 g/m3 at 70 % RH) for at lEast 10 minutes or (3 g/m3 for 24 hours or equivalent with other aldehydes, e.g. glutaraldehyde, or ethylene oxide (0.8 g/litre at 50°C for 1.5 hours ).

Equipment, for example contractors' tool boxes, laptops, etc. which is fumigated out of a restricted area should be cleaned and be opened as much as reasonably possible to allow penetration of the gaseous fumigant; or – Thorough washing in an appropriate chemical disinfectant4 such as: 4 % Sodium Carbonate or 10% washing soda (Na2CO3 Dehydrate); 0.5 % caustic soda (NaOH); 0.2 % citric acid; 4 % formaldehyde or equivalent with other aldehydes, e.g. glutaraldehyde; or – An equivalent disinfection protocol officially approved for the purpose.

• • • •

65. Decontamination of clothing before removal from the restricted area for laundry must include a wet heat treatment step (autoclaving at a temperature of at lEast 115°C for 30 min, or equivalent heat effect). A laundry process without autoclavation is permitted if performed on-site in a double-ended pass-through laundry device. Such a laundry process must include a validated alternative inactivation step; 66. Documents should be sent out of the restricted zone preferably in electronic format (fax, scans, electronic documents, e-mails etc.). In case papers have to be taken out of the restricted zone, they must be treated by a validated procedure e.g. autoclaving, irradiation or ethylene oxide treatment. In cases when only low levels of contamination can reasonably be expected and following risk assessment, paper can be sealed and kept at > 20 0C for two years before being taken out of the restricted zone; 4

Note: The efficiency of these chemical disinfectants is considerably improved by the addition of a non-ionic detergent.

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Removal of biological material from the restricted area 67. Before sending non-FMD biological material to another laboratory which lacks the required level of containment, the necessary precautions must be taken to ensure that the material does not contain FMDV; Thus if the source of the biological material is a restricted laboratory area, it is essential that it is subject to an innocuity test to demonstrate freedom from FMDV or a validated treatment that destroys FMDV infectivity; The recipient laboratory must be informed about the potential risk of material coming from a laboratory manipulating FMDV. The recipient laboratory must further sign a statement that it is prepared to receive the material and that it will take the necessary precautions; 68. For the shipment of FMDV containing materials to other laboratories an innocuity test is not required if the material is sent to a high containment laboratory licensed to handle live FMDV; The laboratory which provides FMDV to another laboratory has a duty of care to ensure that the recipient laboratory is authorized to handle FMDV. Before shipment, it has to ask for a statement from the recipient laboratory that it is requesting the virus only for legitimate purposes and will not redistribute the virus to other laboratories without written consent. The sending of materials containing FMDV is subject to international requirements governing transportation; X. Decommissioning containment compartments for maintenance or renovation purposes.

Note: Additional considerations and notes are given in Section X of Annex I. 69. Maintenance or renovation work that may compromise the integrity of the containment barrier thus possibly allowing the escape of air or liquids must be preceded by an assessment of the risk and a safety plan; 70. Decontamination of rooms/compartments, to reduce the risks to an acceptable level, are required before these can be decommissioned permanently or temporarily, for example during renovation; Standard Treatment procedures include fumigation with formaldehyde after making the room effectively air-tight.

71. Waste building materials generated by demolition and redevelopment and other potentially contaminated materials must be treated in a way that any residual infectivity is inactivated. If autoclaving is not feasible, it should be sprayed or fumigated to disinfect surfaces, and then stored on site for 6 months before removal.

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Glossary Terms are in line with the proposed “Laboratory Biorisk Management Standard” (CEN draft document for public comment, 2007-07-25) Biorisk (adapted from OHSAS 18001:2007): combination of the likelihood of the occurrence of an adverse event involving exposure to biological agents and toxins and the consequence (in terms of accidental infection, toxicity or allergy or un authorized access, loss, theft, misuse, diversion or release of biological agents or VBMs) of such an exposure.

Biorisk officer (BRO) or biorisk advisor (Biosafety / Biosecurity Officer): a staff member of an institution who has expertise in the biohazards encountered in the organization and is competent to advise top management and staff on biorisk management issues.

Biosafety (adapted from: WHO/CDS/EPR/2006.6): Laboratory biosafety describes the containment principles, technologies and practices that are implemented to prevent the unintentional exposure to biological agents and toxins, or their accidental release.

Biosecurity (adapted from: WHO/CDS/EPR/2006.6): Laboratory biosecurity describes the protection, control and accountability for valuable biological materials within laboratories, in order to prevent their loss, theft, misuse, diversion of, un authorized access, or intentional release.

Restricted Area: area of the facility where FMDV is manipulated and/or which contain infected animals, bounded by physical barriers to prevent air and fluid escape except through air filtration and waste treatment systems.

Controlled area: area within the outer security barrier or fence of the facility, containing the restricted area, the services for the restricted area, and zones for access and administration.

Open virus work, or open work: describes the handling of materials containing FMDV (usually liquids) in which exposure to room air occurs, for example during the pipetting of liquids into containers, and the subsequent exposure of the liquid handling object (pipettes etc) to air.

Primary containment: measures that contain the live virus at source, within closed containers or within a class I, II or III safety cabinet, or for animals, by physical containment in specially constructed rooms with treatment of all waste including the HEPA filtration of air.

HEPA filter: High Efficiency Particulate Air filter: the classification of HEPA filters is on the basis of efficiency of removal of the most penetrating particle size, and set by international standards (EN1822). In the context of this minimum standard, all HEPA filters must at lEast meet H13 requirements. However in order to increase the margin of safety, H14 filters are recommended.

HEPA filter performance requirements are defined by EN1822; to classify as H13, the filter must remove > 99.95% of particles of the most penetrating particle size (0.3 μm). A leak is defined as penetration > 5 times the required integral efficiency, i.e. 5 times 0.05% = 0.25%. To classify as H14, the filter must remove > 99.995% of particles of the most penetrating particle size (0.3 μm). A leak is defined as penetration > 5 times the required integral efficiency, i.e. 5 times 0.005% = 0.025%

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ANNEX I

ADDITIONAL CONSIDERATIONS AND EXAMPLES

Section I: Establishing an FMD incident risk rating system Each facility should establish a risk rating system and an associated set of incident management procedures, including reporting and responsibilities in the event that a high risk incident occurs.

Risk is the product of consequence and likelihood. The consequence of an FMD escape into susceptible livestock (resulting in an outbreak) is huge.

In establishing a risk rating system, the following factors should be considered: – Where does the incident occur? (for example in an animal room); – What type of event? (for example a visitor leaving without showering); – How much potential virus exposure or loss? (for example number of persons, time or volume); – To where was the virus release? (for example outside of the high containment area, to ruminants, to areas within the perimeter of the facility).

Each facility should establish their own risk rating system, taking into consideration e.g. the history of incidents, estimations of likelihood, objective data, and computer simulations. The risk rating system and reporting requirements should be agreed at the level of the top management of the facility, and reviewed on a regular basis.

Once established, the risk rating system can be used in training of staff on their reporting requirements, setting out the types of event or that should be reported to the line manager and/or biorisk officer.

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Section II: Improvement of biorisk management through analysis of incidents Management should take a high interest in learning from reported incidents. Each may be considered a form of failure or non-conformity to the expected performance of the risk control measures, and occur as a result of failure in the engineering controls and/or personnel related control measures.

The cause of each event may be categorised as: Related to engineering: – – – – –

Hardware (as facilities and equipment); Design (as irrational lay-out and ergonomics); Maintenance (as planning and availability); Procedures (as standard operations and relevance); Defences (as protective equipment and signals).

Related to personnel management: – – – – – –

Error-enforcing conditions (as occupational health and attitude); Housekeeping (as tidiness and discipline); Incompatible goals (as costs and safety); Communication ( as interpretation and point of time); Organization (as responsibilities and authority); Training (as knowledge and experience).

Section III: Threat assessment, reduction and control In deciding upon undertaking a threat assessment, the following should be considered: (a) The threat of criminal use of FMDV for any malicious purpose has to be carefully assessed to determine the additional risk that arises from operating FMDV facilities.

FMDV laboratories have exclusively peaceful objectives concerned with development and implementation of control measures. They are critical for the technical cooperation with veterinary services around the world in order to minimize the economic impact of FMD on livestock and economies. The threat of criminal use of FMDV is subject to major change as the political agenda of terrorist group changes; (b) The threat and consequences of a terrorist attack will vary by country. Because of the transboundary nature of FMD, there is also the possibility that a deliberate release may occur in another, possibly neighbouring, country. For this reason, effective control measures need to be consistently applied throughout all EU member states that operate FMD laboratories; As the motivation for a deliberate release may change unpredictably over a very short period, effective control measures need to be sustained at all times and be sufficiently flexible to allow an enhanced response if required; Facilities permitted to handle FMDV are obliged to prevent illegal access and removal of the virus. As a consequence, such access to laboratory-held virus must be substantially more difficult than acquiring the virus in the field.

Threat reduction/control measures: due to the unpredictability of the actual threat, controls are required to reduce the risk to an acceptable level. These controls should consider structural, physical and organizational measures and must address the following: (c)

Intruder attempting to remove FMDV from the facility by forced or fraudulent entry; Appropriate controls include 1) physical security measures restricting access to authorized staff and contingency plans in the event of intrusion, 2) secure storage of virus containing materials including maintenance of inventories of stocks.

(d) Staff member removing FMDV from the facility; Appropriate controls include 1) vetting of persons before authorisation of access, and escorts for persons allowed temporary access when security clearance is not available; 2) restricted access to FMDV virus material in the lab to trusted staff on the basis of a legitimate need, 3) access to the facility is logged [and records maintained for at lEast

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two years] to provide an audit trail of who was in the facility at any given time. 4) Design of the laboratory or facility such that the number of staff needing to enter the secure areas is limited. Eg some engineering aspects of the design of the facility can be arranged so that certain services can be maintained from outside of the security envelope. (e) Shipment of virus containing materials.

Appropriate controls include standard procedures before authorisation, including receipt of adequate information from the intended recipient of its authority to handle FMDV, and written agreement that the recipient laboratory will not redistribute the virus to other laboratories without applying the same risk assessment and will adhere to relevant national or international legislation relating to shipment and supply of dangerous animal pathogens.

Section VII: Air-handling 1.

Depending on the small animal species, route and nature of infection and method of animal containment and handling, quite high titres of virus in relatively uncontrolled conditions might be produced. Consideration should be given to the appropriate negative air pressure requirements, with 35 pascal negative pressure as the minimum;

2.

Provisions must be in place to ensure that in the restricted area no overpressure is generated. One approach is to interlock the inlet and extract fans so that the most that can occur is that the air supply and extract fails and the negative envelope decays solely depending on the airtightness of the building. An emergency back-up extract fan is recommended so that the negative envelope can be restored in the event of the main extract fan failing and this also should be interlocked to the supply fan to avoid very high negative pressures which may cause damage to the fabric of the building. As an alternative, the air extraction plant can be divided into several parallel sections so that the negative pressure can be maintained if one section fails or is shut down;

3.

It is advisable to have and maintain other filters within the air handling system, notably, prefilters upstream of the HEPA filters. These other filters will conserve the life of the HEPA filters and reduce the need to change at the annual maintenance interval. In properly maintained systems, it is relatively rare to change the terminal extract filter due to the efficiency of particulate removal by all of the filters upstream. However, high levels of humidity will shorten the life expectancy of filters and large amounts of dust generated by nearby building works or other activities will soon blind filters even with efficient prefilters up-stream;

4.

Off-gas or vent filters: This type of filter is often steam sterilised and filter efficiency testing involves different approaches such as the water intrusion test. At the smaller scale, disposal cartridge filters may be appropriate as vent filters to allow gas exchange while preventing virus escape from the container to the laboratory environment;

5.

Although not widely used, sterilisation of extract air may be done by heating the air as it passes through an in-line furnace;

6.

To save energy, air extracted from a restricted area may be partially recirculated into same restricted area provided it passed through a HEPA filter before it re-enters laboratory. However, the advisability of recirculation and the proportion of recirculated will need to be considered against the quality of the air leaving and entering the work place and the activities within the workplace;

7.

In the event that HEPA filters become blocked prematurely (ie prior to annual testing), this does not normally represent a problem in terms of the integrity of the affected filter(s), but it probable that the increased resistance to airflow and consequent problems of balancing the pressures in the different rooms of the restricted area will necessitate changing the affected filters.

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the the air re-

Appendix 10 – ANNEX I

Section X: Decontamination of compartments The compartment must be made airtight to make fumigating possible, if necessary by means of temporary panels.

Formaldehyde procedure: • •

• • •

Check the compartment and accompanying drawings for connections with containment facilities that must be closed. Close down utilities as gas, water, electricity, sewerage, steam and if possible ventilation; Empty the compartment, for example by moving objects to other containment facilities.

Remove porous material. Discard material via validated procedures like autoclaves and formaldehyde airlocks. Open non removable installation parts to make them accessible to vapour; Clean the compartment and disinfect critical points which are possibly contaminated; Prepare the fumigating equipment and shut the compartment airtight; Disinfect (air)ducts and HEPA filters for example separately by injecting formalin: √ Use a fumigating method in conformance with a validated procedure used for formaldehyde airlocks; √ Use bioindicators, (preferably a rapid bioindicator system) to prove the efficacy of the fumigating process; √ Set restrictions for access such as clothing, quarantine for people and demolition material, in order to be able to make corrections in case of accidents.

•

Inspect the maintenance and renovation activities to be performed in the compartment.

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ANNEX II

MINIMUM STANDARDS OF BIORISK MANAGEMENT FOR LABORATORIES UNDERTAKING DIAGNOSTIC INVESTIGATIONS OF LOW-RISK SAMPLES DURING AN OUTBREAK OF FMD

Introduction The following Minimum standards for laboratories undertaking diagnostic investigations during an FMD emergency or during FMD surveillance after an outbreak refer to the laboratories mentioned in point 13 of Annex XV to Council Directive 2003/85/EC. These standards only apply to the use of laboratory tests which do not contain or require live FMD virus for the testing of (a) Blood samples from holdings without clinical signs; (b) Any samples from any holding that have been treated in a way that ensures the inactivation of FMDV infectivity.

Serology by commercially produced FMDV-ELISA kits can be performed in many laboratories, e.g. regional veterinary laboratories, which can process samples with a high throughput. In case of an outbreak, this allows to increase the throughput of diagnostic samples significantly, which will often be a crucial factor for successful disease control and timely recovery of the previously free status.

Blood sampling is often combined with surveillance and staff taking samples may also examine the mouth of possibly infected animals, which may increase the risk of a surface contamination of packing material. This risk, as well as the risk of leakage during transport has to be mitigated by appropriate provisions. The risk of FMD occurring as a result of sero-diagnostic activities within laboratories is associated with escape of virus following receipt of blood samples from viraemic animals. While the likelihood of virus being present in samples originating from holdings without clinical signs during an FMD epidemic generally is moderate to low, it is almost impossible to exclude the presence of FMDV due to the dynamic nature of an epidemic.

However, the maximum virus titres in blood of viraemic animals are much lower then in vesicular material.

Real-time PCR has been introduced in many laboratories, e.g. regional veterinary laboratories, which can process samples with a high throughput. Testing samples that have been treated at the site under suspicion in a way that infectivity is inactivated for FMDV genome in regional laboratories may facilitate a significantly increased sample throughput and a shortened time between sampling and reception of results.

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Requirements for testing samples during an FMD outbreak (for any disease or purpose) Classification of samples and overview on required laboratory Sample FMD Risk Level A

B

C

Origin of samples Holding with signs indicative of FMD

Holding without clinical signs indicative of FMD Holding with or without signs indicative of FMD, samples treated in a way that FMDV infectivity is inactivated FMD free area

Sample Risk High risk, material has to be considered to contain infectious virus Low risk, to be mitigated by appropriate biorisk management measures

No obvious risk

Laboratory Requirements “Infectious FMDV Lab”

“Serology/inactivated sample FMDV Lab”

No specific requirements

Packaging of samples classified as FMD sample risk level B Samples must be put into watertight primary containers (e.g. plastic tubes) and the primary containers must be packed in watertight secondary packaging, which should be a strong crushproof and leak-proof container, with absorbent material that can absorb the entire contents of all the primary containers. The packaging process must include a disinfection of the secondary packaging. The packaging should comply with the European agreement concerning the international carriage of dangerous goods by road (ADR). Samples should be labelled as biological substance, category B (UN3373).

Treatment of samples to inactive FMDV infectivity Samples from holdings with signs indicative of FMD must be treated in a way that FMDV infectivity is inactivated before shipment by a procedure authorized by the competent national authority in order to be permitted to be investigated at a laboratory not meeting the minimum containment standard for FMD laboratories.

Remark: although RNA derived from FMDV, under very specific conditions may still be infectious, for practical purposes samples can be considered “inactivated” after an approved treatment with an appropriate lysis buffer and a disinfection of the sample tube by an approved method. However, as a precaution, such samples should not be handled without appropriate risk management measures. In particular, these risk management measures have to ensure that such samples do not, at any stage of processing, be added to cell cultures or be injected into animals except in laboratories meeting the “MINIMUM STANDARDS FOR LABORATORIES WORKING WITH FOOT-AND-MOUTH DISEASE VIRUS in vitro AND in vivo".

Minimum Requirements for laboratory biorisk management Personnel 1.

A biorisk officer (BRO) and deputy (DBRO) must be designated, and one or both present on-site at all periods in which samples are being received, and contactable at all periods when diagnostic activities are ongoing;

2.

The BRO/DBRO must have sufficient experience and technical training to enable assessment of FMD risk and risk management procedures;

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Appendix 10 – ANNEX II

3.

There must be a designated restricted area or areas with controls in place to limit human access;

4.

Personnel must be authorized to enter the restricted area by the BRO/DBRO;

5.

authorized personnel working in the restricted area must be trained in biorisk management and evidence of the training recorded. Where facilities for the inactivation of waste from the restricted area are located outside of this area, also staff working with such waste must be trained in biorisk management and evidence of the training recorded;

6.

authorized personnel must: – Change clothing before entering and after leaving the restricted area and showerout before leaving the laboratory premises; – For at lEast 3 days after leaving the restricted area not have any contact to animals of susceptible species, nor enter buildings or enclosed fields where animals of susceptible species are kept, and not handle items used in the care of susceptible species.

The agreement of the authorized personnel to these conditions must be recorded and a reminder notice of these conditions placed in a visible location at the exit point of the restricted area;

7.

Entry and exit of personnel to the restricted area should be recorded;

8.

Entry and exit points to the restricted area will be kept to the minimum– preferably a single point of entry/exit;

9.

A step-over line, or other clearly demarcated boundary, shall indicate the exit point;

10. In case the shower facilities are not placed at the border of the restricted area, outer protective garments, including shoes or shoes coverings, shall be removed before exit from the restricted area. All clothing worn in the restricted area must be stored in a secure way, e.g. in designated lockers, until treatment; 11. An incident recording system, SOPs for risk identification and notification procedures and target response time, must be in place to ensure early notification of the authorities responsible for FMD surveillance in the event that: – Samples have been received which are considered FMD sample risk level A; – Samples have been received in unsatisfactory state of packaging.

Buildings 12.

Access doors to the restricted area should display a warning sign that access is restricted to authorized personnel only;

13.

Changing facilities and lockers are required to enable staff to deposit unessential items outside the restricted area;

14.

Entering of the laboratory premise by farmers or staff working on farms should be avoided. If possible, it should be attempted to separate vehicles bringing samples from vehicles entering the premise for other purposes;

15.

Shower facilities must be available onsite, preferably at the border of the restricted area;

16.

Sample reception area: (a) (b)

The restricted area must contain a specified area for reception of packages.

This area must: (i) Be easily disinfected in the event that leakage of samples occurs into packing materials or following opening of the packages; (ii) Be equipped to enable packages considered to potentially contain samples of FMD sample risk level A to be re-packaged into appropriate transport containers for dispatch to laboratories licensed for handling FMD virus, (iii) Have suitable facilities for waste disposal and have hand-washing facilities at exit points.

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17. Sample preparation area: (a)

The restricted area must contain a specified area for serum separation and/or RNA extraction; (b) This area must have suitable facilities for surface disinfection and waste disposal and have hand-washing facilities at exit points.

18. Testing area: (a) (b)

The restricted area must contain a specified area for testing.

This area must have suitable facilities for surface disinfection and waste disposal and have hand-washing facilities at exit points.

19. Sample storage area: (a) The restricted area must contain a specified area for the storage of samples; (b) This area must have suitable facilities for surface disinfection; 20. Communications and reporting office space.

The laboratory must have an adequate provision of office space, computing and communications facilities (e.g. electronic communications, facsimile) to reduce the need to a minimum for staff, papers and physical records to exit the restricted area.

21. Rest rooms: The restricted area should have sufficient rest rooms and lavatory facilities in relation to the staff number expected at peak periods of activity, sufficient to reduce the need to a minimum for staff to exit the restricted area.

22. Location of autoclave: Facilities for wet heat treatment must be present on the site, preferably with sufficient capacity for throughput at the maximum operating capacity of the laboratory.

Waste 23. Liquid waste: (a) (b)

Heat or chemical treatment of all waste water is the preferred treatment, in compliance with the prescribed standards specified for FMD laboratories; Alternatively, or additionally, the laboratory may demonstrate that it has put in place a system for inactivation of virus if present in liquid waste that has contacted risk materials. If treatment of all liquid waste from the restricted area (including waste water from the showers) is not possible, at lEast the ELISA buffers and washing fluids must be collected and treated.

24. Solid waste: (a) (b)

For biological, solid waste, and all solid , disposable materials that have been in contact with specimens, treatment by wet-heat in an autoclave within or at an entrance point to the restricted area is the preferred option.

If such a treatment of all solid waste is not possible, it may be packed into suitable watertight containers and, after spraying of the containers with disinfectant, removed for treatment at a different site.

26. Removal of equipment, materials and clothing from the restricted area: (a) Removal of any material and equipment from the restricted area shall be subject to authorisation by the BRO; (b) The reason for removal, date and destination will be recorded; (c) The BRO will ensure that materials and equipment which has been in contact with risk materials (specimens) will not be removed from the restricted area without a validated treatment to inactivate FMDV. 27. Declassification of the restricted area: (a) A decontamination plan must be agreed with the competent authorities, before restrictions can be lifted; (b) If heat treatment or scanning of all paper from the restricted area is not possible, it should be packed into suitable containers, which should be disinfected and kept under lock for at lEast two years. If the containers have to be opened before, this has to be done in a restricted area meeting the standards described above.

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Appendix 11 PPT: MINIMUM STANDARDS FOR LABORATORIES WORKING WITH FMDV IN VITRO/IN VIVO B. Haas

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Appendix 12 PROPOSED MINIMUM REQUIREMENT FOR LABORATORY CONFIRMATION OF FMD EuFMD Secretary

1. Member States shall ensure that: (a) The veterinary services of the Member State have permanent access to the services of at lEast one Reference Laboratory (RL), either within their territory (National Reference Laboratory -NRL) or in the territory of another state, that is capable of undertaking i. Laboratory tests for the confirmation of FMD virus, and ii. Of undertaking tests for confirming presence of specific antibodies, to a level that is compliant with the Council Directive 2003/85/EC. Different RL maybe utilised to undertake tests for virus and antibody. (b) The RL/NRL for confirmation of FMDV must be capable of achieving a rapid initial diagnosis, and must be suitably staffed and equipped to initiate laboratory procedures within 12 hours of receipt of samples; (c) Provision is made for emergency situations where the FMD diagnostic services of the Reference Laboratory are unavailable through fire, flood or other contingency; (d) The access to services of a Reference Laboratory on their territory is guaranteed by contracts that adequately equip and staff the reference laboratory with the appropriate numbers of trained personnel to carry out the laboratory investigations required, or through contracts established with laboratories in another state to provide the RL services.

2. The functions and duties of Reference Laboratories shall be as follows: 1.

2.

3.

4.

All Reference Laboratories handling live Foot-and-Mouth Disease Virus must operate under high security conditions laid down by the most recent decision of the Sessions of the European Commission for the Control of Foot-and-Mouth Disease (EuFMD)5.

Reference Laboratories undertaking test procedures that do not involve live virus need not comply all requirements of the minimum bio-security standards for laboratories handling live virus, but must operate procedures which ensure that the risks associated with the possible entry of Foot-and-Mouth Disease virus in samples are recognised and effectively contained; Reference Laboratories shall participate AT LEAST ONCE IN EVERY TWO YEARS in the external quality assurance and standardisation exercises organized by the FAO World Reference Laboratory or the European Community Reference Laboratory (if different).

Reference Laboratories shall use tests and standards that meet or exceed the criteria laid down in Annex XIII of the Council Directive 2003/85/EC; Reference Laboratories shall provide the EuFMD Commission on request with data proving that the tests in use meet or exceed the requirements.

Reference texts: • COUNCIL DIRECTIVE 2003/85/EC of 29 September 2003 on Community measures for the control of Foot-andMouth Disease repealing Directive 85/511/ EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (Text with EEA relevance) 5

‘Minimum Standards for Laboratories working with Foot-and-Mouth Disease virus in vitro and in vivo’, European Commission for the Control of Foot-and-Mouth Disease — 26th Session, Rome, 1985, as amended

by Appendix 6 (ii) of the Report of the 30th Session, Rome, 1993. The 2009 amendment to the Standard is also proposed for adoption at the 38th Session.

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Article 68 National Laboratories 1.

Member States shall ensure that: (a) Laboratory testing for Foot-and-Mouth Disease is carried out in laboratories authorized for such testing by the competent authorities; (b) Laboratory testing to confirm the presence of Foot-and Mouth Disease virus or other vesicular disease viruses is carried out in accordance with Article 71 by one of the laboratories listed in Part A of Annex XI; (c) One of the laboratories listed in Part A of Annex XI shall be designated as the national reference laboratory for the Member State on whose territory it is situated, and it shall be responsible for coordinating standards and methods of diagnosis in that Member State; (d) The national reference laboratory carries out at lEast the functions and duties set out in Annex XV; (e) The national reference laboratory referred to in point (c)liaises with the Community Reference Laboratory provided for in Article 69 and in particular ensures the sending of appropriate samples to the Community Reference Laboratory.

2. The national reference laboratory referred to in paragraph 1(c) of one Member State may provide the services of a national reference laboratory to one or more other Member States.

Member States which have no national reference laboratory situated on their territory may use the services of the national reference laboratory in one or more other Member States.

That cooperation shall be formalised in a mutual agreement between the competent authorities of the Member States concerned, which shall be notified to the Commission. Such cooperation shall be listed in the special column in the table in Part A of Annex XI. 3. Member States shall ensure that laboratory investigations provided for in this Directive are first of all carried out to confirm or rule out Foot-and-Mouth Disease and to exclude other vesicular diseases. Where an outbreak of Foot-and-Mouth Disease has been confirmed and the serotype of the virus was identified, that virus shall be antigenically characterised in relation to the reference vaccine strains, where necessary with the assistance of the Community Reference Laboratory. Samples from domestic livestock showing signs of vesicular disease which are negative for Foot-and-Mouth Disease virus and, where relevant, Swine Vesicular Disease virus shall be sent to the Community Reference Laboratory for further investigation.

4. Member States shall ensure that the national reference laboratory on their territory is adequately equipped and staffed with the appropriate numbers of trained personnel to carry out the laboratory investigations required in accordance with this Directive.

• COUNCIL DIRECTIVE 2003/85/EC ANNEX XV FUNCTIONS AND DUTIES OF NATIONAL LABORATORIES The functions and duties of National Laboratories referred to in Article 68 for foot-and-mouth and other vesicular diseases shall be as follows: 1. All National Laboratories handling live Foot-and-Mouth Disease virus must operate under high security conditions laid down in ‘Minimum Standards for Laboratories working with Foot-and-Mouth Disease virus in vitro and in vivo’, European Commission for the Control of Foot-and-Mouth Disease — 26th Session, Rome, 1985, as amended by Appendix 6 (ii) of the Report of the 30th Session, Rome, 1993; 2. National Laboratories must provide an uninterrupted service for diagnosing vesicular viral diseases and must be equipped and skilled for providing a rapid initial diagnosis; 3. National Laboratories must keep inactivated reference strains of all serotypes of Foot-andMouth Disease virus, and immune sera against the viruses, as well as all other reagents

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necessary for a rapid diagnosis. Appropriate cell cultures should be in constant readiness for confirming a negative diagnosis; 4. National Laboratories surveillance;

must

be

equipped

and

skilled

for

large-scale

serological

5. In all suspected primary outbreaks appropriate samples must be collected and quickly transported, according to a set protocol, to a National Laboratory. In anticipation of a suspicion of Foot-and-Mouth Disease, the National Authority shall ensure that the necessary equipment and materials for sample collection and transportation to a National Laboratory are stored in readiness at local sites; 6. Antigenic typing and genomic characterisation must be carried out on all viruses responsible for new incursions into the Community. This can be performed by the National Laboratory, if facilities exist. Otherwise, at the earliest possible occasion, the National Laboratory must send a sample of virus from the primary case to the Community Reference Laboratory for confirmation and further characterisation, including advice on the antigenic relationship of the field strain to vaccine strains in the Community antigen and vaccine banks. The same procedure should be followed for viruses received by National Laboratories from third countries in situations where characterisation of the virus is likely to be of benefit to the Community; 7. National Laboratories should provide disease data to their State Veterinary Service, which shall provide these data to the Community Reference Laboratory; 8. National Laboratories should collaborate with the Community Reference Laboratory in ensuring that members of the field section of State Veterinary Services have the opportunity of seeing clinical cases of Foot-and-Mouth Disease in National Laboratories as part of their training; 9. National Laboratories shall collaborate with the Community Reference Laboratory and other National Laboratories to develop improved diagnostic methods and exchange relevant materials and information; 10. National Laboratories shall participate in external quality assurance and standardisation exercises organized by the Community Reference Laboratory; 11. National Laboratories shall use tests and standards that meet or exceed the criteria laid down in Annex XIII. National Laboratories shall provide the Commission on request with data proving that the tests in use meet or exceed the requirements; 12. National Laboratories should have the competence to identify all vesicular disease viruses and encephalomyocarditis virus in order to avoid delays in diagnosis and consequently in implementing control measures by the competent authorities; 13. National Laboratories shall cooperate with other laboratories designated by the competent authorities for performing tests, for example serological tests, that do not involve handling of live Foot-and-Mouth Disease virus. These laboratories shall not carry out virus detection in samples taken from suspect cases of vesicular diseases. Such laboratories need not comply with the bio-security standards referred to in Annex XII, point 1, but must have established procedures which ensure that the possible spread of Foot-and-Mouth Disease virus is effectively prevented. Samples giving inconclusive results in tests must be transmitted to the National Reference Laboratory for carrying out confirmatory tests.

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Appendix 13 REPORT ON THE ACTIVITIES OF THE EUFMD COMMISSION SINCE 37TH SESSION (BIENNIUM April 2007 - March 2009) EuFMD Secretary

Key Points Member countries 1.

The number of member countries increased by one, to 35, of which 26 are EU members.

The Republic of Latvia joined the Commission in February 2008;

Activities 2.

The activities have followed the recommendations of the 37th Session, and in line with the five categories of action, for project formulation and implementation, as set out in 2005-8 Strategic Plan agreed at the 36th Session;

3.

Over half (34) of the 55 recommendations in the 37th Session report have been implemented (completed or ongoing implementation) through activities/actions, 8 were not implemented, and 13 will require follow-up decisions or support to implement (See Table on Progress to implement recommendations Item 4.1);

4.

As agreed at the 36th Session, the major outputs or outcomes for the four year period should be:

5.

1

Improved system for monitoring FMD virus strain circulation

operational

2

Technical constraints to preferred European FMD control policies

reduced

3

System for professional development in FMD management

developed

4

FMD risk surveillance and management programmes operating in target countries

operating

5

FMD incursions/emergencies rapidly controlled, where supported by specific Commission decisions

controlled

Projects have been operated in support of the above, through a funding agreement between the EC (DG-SANCO) of 8 million € covering the period 2005-8; The funding from SANCO has enabled several major actions (listed in #13) be continued or implemented, focussing on outcomes 4 and 5, aimed at reducing the risk of exotic FMD transmission across the Eurasian borders. Project progress is monitored at the 6 monthly EuFMD Executive Committee Sessions.

6.

The balance in EuFMD activities in the period has been towards operational support to disease surveillance and emergency control in South-East Europe, because of the severe, sweeping regional FMD epidemics with: ¾ ¾ ¾ ¾

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Types A Iran 05 (2005-7); Type A Iran 05 “new variant” (late 2008-report date); The risk of continuation of the A Egypt 2006 epidemic; And a regional epidemic caused by incursion of a new variant of O PanAsia (late 2006 to 2008).

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7.

The EuFMD effort has been co-ordinated with the EC and OIE, and several international meetings have been held to assist countries to combat the type A and type O regional epidemics (Rabat, 2007; Ankara, March 2008; Shiraz, 2008; Lesvos, 2008; Algiers, 2009, Beirut, 2009), in addition to the routine 6 monthly Sessions of the Executive to review the risk situation and the balance of actions;

8.

Maintaining a balanced program, between actions to improve prevention and capacity for containment (outcomes 1-3 in the Plan) and effort to implement field actions/projects including emergency measures (Outputs 4 and 5) has been affected by the high demands of the epidemic/emergency situation;

Progress towards Outcomes ¾ 9.

Monitoring FMD virus strain circulation (Outcome 1) Actions to strengthen EARLY WARNING of new virus threats have been: a. Improved FMD lab networking for Turkey/Iran/Pakistan/Pirbright (West EurAsia FMD lab network) , following the Shiraz meeting in November 2008; this has improved communication on virus threats, vaccine suitability and achieved greater submission/typing; b. African proximity FMD surveillance support: with EC support, sample collection/shipment to the WRL from Egypt, Kenya, Ethiopia, Sudan, Nigeria, and Ivory Coast, has identified a number of virus threats among FMDV recently circulating in these countries; c. Global monitoring and reporting: support to the OIE/FAO FMD laboratory network, with funding (EuFMD and FAO funds) for supporting meetings and annual action plans.

¾

Technical networking to reduce constraints to preferred European FMD control policies (Outcome 2)

10. Technical networking primarily involves the EuFMD Standing technical Committee (Research group), including Sessions, working groups, and commissioned studies: a. Two Closed Sessions of the Research group, in Cairo (2007) and Erice, Sicily (2008), each with around 20 participants; b. One Open Session (Sicily, 2008), a highly successful Open Session on Tools, Ideas and ideals for Global FMD control with almost 200 experts from all regions of the world; c. Under the research group, Working groups or workshops on: i. Revision of the Bio-risk Standards for FMD Laboratories; meetings with > 300 hours of technical input into revision of the EuFMD Standard; ii. Surveillance after emergency FMD vaccination (workshops co-funded with Epizone Project, co-ordinated by Coda-Cerva-VAR, Belgium) with EuFMD funding; iii. Sero-Monitoring of FMD control in Turkey and in the Trans-Caucasus. d. Commissioned studies, as a result of Executive Committee decisions and research group recommendations: i. Full-length sequencing to understand FMD epidemiology in Turkey (IAH Pirbright with SAP Institute, Turkey: 12 months from April 2009); ii. Field trials of the Bioseeq mobile laboratory for FMDV confirmation (with SAP Institute Turkey, in 2009); iii. Review on the vaccination of sheep in emergency situations (to be completed by Sept 2009); iv. Replacement of live virus transport with inactivated virus protocols (Contract with FMD lab, Lindholm , Denmark); v. Study on measuring FMD vaccine thermostability (contract with FMD lab, CVL Lelystad, Netherlands).

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¾ 11.

Training/expertise development in FMD management (Outcome 3) A new initiative has been developed (to be presented at 38th Session) to provide training opportunities for veterinary experts to gain field experience of FMD outbreak investigation, with support of DG-SANCO and GDPC Turkey. The first four field training workshops are planned in June and October 2009, in Eastern Turkey;

12. In parallel, a “training bank” of online resources for use by trainers and trainees in the member states has been established, including an EuFMD wiki-site (http://km.fao.org/eufmd/wiki/Main_Page: Course on Outbreak Investigation) and a bank of movie-clips on aspects of FMD (You-Tube);

¾

FMD risk surveillance and management programmes operating in target countries (Outcome 4)

13. The funding from SANCO has enabled several major actions to be continued or implemented, focussing on outcomes 4, aimed at reducing the risk of exotic FMD transmission across the Eurasian borders. Project progress is monitored at the 6 monthly EuFMD Executive Committee Sessions; In 2007-8 the actions implemented with EC support were: TransCaucasus

Iran

Syria

Turkey

¾

the continuation of a bi-annual vaccination (4 campaigns autumn 2007 to spring 2009) in the buffer zone (BZ) in the Trans-Caucasus on the side of Georgia, Armenia and Azerbaijan; this continues the support given through 2005 to the spring campaign of 2007.Documentation: see Annex I The funding, from November 2005 to September 2008 of Phase I of a project to support the I.R of Iran in surveillance and epidemiology (US$761,000 over 3 years), assisted by a full time consultant seconded by France to FAO and based in Tehran (Francis Geiger). Phase II of this project was signed in September 2008 (operated with unspent funds from Phase I). Documentation : Annex I support was provided for a national FMD sero-survey, with associated laboratory capacity improvement; the project MoU signed in May 2008. Activities should be completed in 2009. Documentation: Annex I support was provided for strengthening outbreak investigation, FMD epidemiology and sero-surveillance, following the type A and O epidemics in 2006: the project operated until March 2008, and provided important recommendations to the pre-accession EC/Turkey FMD project. Documentation: Annex I

FMD incursions/emergencies rapidly controlled, where supported by specific Commission decisions (Outcome 5)

14. FMD emergencies in member states in the period have been in the UK and Cyprus in 2007; the Secretary and Chairman of the research group participated as experts in immediate response missions organized by DG-SANCO to Cyprus in November 2007; a follow-up mission to Turkish controlled areas was organized by EuFMD with EC support, to develop a sero-surveillance plan; 15. The Secretariat has responded to threatening FMD events/incursions in Egypt (missions in 2007 and 2008, and acts as lead technical unit to FAO emergency FMD project 2008present), in Iraq (resulting in EU donation of 0.5 million doses of vaccine, March 2009), in Lebanon and Iran (March 2009). The EuFMD technical committee experts have also helped with FAO and EuFMD (and EC/FVO missions) to FMD affected countries, including the SAT-2 epidemics in Botswana/Namibia in 2008; 16. The Secretariat also attends the daily situation assessment on animal health events, providing guidance to FAO on follow up actions on FMD emergencies;

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Report on management 17. The Secretariat (Secretary and Clerk), funded by members contributions, have acted to implement decisions of the 37th Session and subsequent Executive Committees, assisted by an additional Associate Professional Officer (2005-7: supported by Ireland), and a professional officer from France (November 2008-present). Since staff costs are met by the Commission, almost 100% of the external funding (EC, and FAO) goes to cover the additional costs of the actions - for example in supply of vaccines, diagnostic kits, workshop costs; 18. Under the Implementing Agreement with the EC for activities of the EuFMD Commission, the staff of the EuFMD Secretariat provided the project management and technical backstopping, and have been greatly assisted by the Chairman of the Research Group and the other elected technical experts from member countries who provide technical advice, and assist in missions usually without charge, and through contract services with the specialist institutions such as the FAO World Reference Laboratory in the UK; 19. The co-ordination and co-operation between the EuFMD Secretariat and the counterpart at EC , with the focal point at the FAO/OIE/EC Reference Laboratory for FMD at Pirbright, and the Chairman of the Technical Committee has been excellent, and strongly contributed to effective decision making in crisis situations; 20. The position of the Commission in relation to the FAO Animal Health Service ensures that activities are co-ordinated and informed by FAO involvement in the wider region, and complement and contribute to goals and outputs of the FAO Regular Programme.

Specific Activities6 : 1.

The Executive Committee held three ordinary Sessions, the 75th in London in December 2007, the 76th in Terceira, Portugal, June 2006, and the 77th in Vienna in December 2008. The Reports of the Sessions, are available on the EuFMD website, and have been electronically circulated to the Member States;

2.

The Research Group of the Standing Technical Committee of the Commission held two Sessions during the biennium • •

3.

Closed Session in Cairo, Egypt, in 2007; Open and Closed Sessions at Erice, Sicily, in October 2008.

The EuFMD/EC/OIE Tripartite Group for FMD control in the Southern Balkan region.

Reports are available online at: http://www.fao.org/ag/againfo/commissions/en/eufmd/report_regional.html Two meetings in the period: • • 4.

London, UK, 28 November 2007 (attended by Greece, Bulgaria, EC, OIE, FAO).

Report available online; Lesvos, Greece, 30th October 2008 (attended by Greece, Bulgaria, Turkey, Serbia, OIE, FAO).

Regional FMD control Meetings and Workshops held in the biennium (2007-present)

Reports are available online at: http://www.fao.org/ag/againfo/commissions/en/eufmd/report_regional.html

6

EuFMD organized, co-organized or provided technical leadership/meeting facilitation.

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2009

Middle-East

North Africa

West EurAsia

Africa

2008

Africa

China

2007

Morocco

Jordan

Brussels

5.

5th FAO/OIE Roundtable on FMD Control in the Middle-East. Beirut, 8-9th April 2009. (EuFMD provided technical support, and for participation of WRL, and experts from Turkey, Iran, Iraq ) FAO's Regional Animal Health Centre: First RAHC coordination meeting and roundtable on Foot and Mouth Disease ,Algiers, Algeria February 2009 (EuFMD provided technical expert/presentations on risk to North Africa) Regional meeting on FMD to develop a long term regional control strategy 9-13 November 2008, Shiraz, Islamic Republic of Iran (co- organized by EuFMD and the Italy funded GTFS central Asia FMD project) ( organized by FAO, with OIE and AU-IBAR, facilitated EuFMD Secretariat) Development of a long term action plan (roadmap) for improved surveillance and control of Foot-and-Mouth Disease in Africa, 26-30 January 2009, Nairobi West and Central Africa Laboratory Network annual meeting 1-5 December 2008, Bamako (EuFMD expert participated on FMD surveillance and networking) OIE/FAO Foot-and-Mouth Disease Reference Laboratories Network Lanzhou, China, 15 – 19 September 2008 (EuFMD Secretary participated for FAO) FAO's Regional Animal Health Centre: First RAHC coordination meeting and roundtable on Foot and Mouth Disease ,Rabat, Morocco ,24-26 October 2007 (session organized and supported by two FMD European technical experts provided by EuFMD) 4th FAO/OIE Round Table on FMD Surveillance and Control in the Middle East Amman, Jordan , 5-6 September 2007 (EuFMD co- organized, sponsored WRL, Turkey, iran participation) Workshop on the design and interpretation of post Foot-and-Mouth Disease (FMD)-vaccination serosurveillance by NSP tests. 23-25 October 2007. VAR-CODA-CERVA, Brussels (EuFMD contributed 45,000 US$ to organization of three of these workshops)

Collaboration with the Office International des Épizooties (OIE)

The Commission has worked closely with the OIE: • • • • •

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In FMD control through the Tripartite groups; In co- organization of the FMD roundtable for the Middle-East and Africa; Through the participation of the Secretary, and two members of the Research Group in the OIE ad hoc group vaccine and antigen banks; The OIE has been invited as observer to all EuFMD Sessions, including Closed Sessions of the RG; In the discussions on the development of a Global Initiative on FMD control under the joint FAO: at the Global GF-TADS Steering Committee, and at the European Gf-TADS Steering Committee.

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ANNEX I STATUS OF AGREEMENTS MEMORANDA OF UNDERSTANDING (MOU) WITH NON-MEMBER STATES, AND WITH GOVERNMENTAL BODIES TO UNDERTAKE PROJECTS AND SERVICES UNDER LETTERS OF AGREEMENT EuFMD COMMISSION

1.

Membership of the Commission

As of 1st April 2009, The Commission has 35 Members States (MS). The Republic of Latvia entered as 35th MS on 28 January 2008. Requests for guidance on process for entering into membership received from Estonia and Armenia.

2.

Memoranda of Understanding (MOU) with non-Member States to implement FMD control activities

Under the program of activities agreed in previous Sessions, and with the European Commission (MTF/INT/003/EEC), MOU have been developed in a standard format agreeable to FAO Legal office and TCAP service, for the purpose of reaching agreement with Governments on responsibilities in the implementation of actions details in project documents. Each MOU consists of a first section containing the responsibilities and signatures, and a second part detailing the project document (activities and funding). This mechanism is recommended to ensure greater compliance of recipient states to implement actions agreed under the EuFMD/EC program.

Agreement with EC TransCaucasus: in place for 2.74 million USD June 2007/June09

Iran: Agreement for Phase II (email) Syria

Country

MOU

Status

Georgia

Signature not achieved by 1/4/09.

Armenia

MOU + project document cleared by FAO Legal and TCAP and sent through FAO office for signature As above

Azerbaijan

As above

Iran

As above

Signature not achieved by 1/4/09.

MOU signed September 08

Syria

As above

Signed May 08

Signed 12 May 2008

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Project documents: (available on request from Secretariat) ¾ TransCaucasus Project: Strengthening prevention of FMD and capacity to undertake emergency in the Transcaucasian countries (MTF/INT/003/EEC) Budget:USD 2,740,000; ¾ Iran- Phase II: Combating Foot-and-Mouth Disease through enhanced and coordinated surveillance activities; Phase II (Consolidation phase) of the FMD surveillance centre initiative. (MTF/INT/003/EEC). Budget: US$ 445,000; ¾ Syria: Strengthening active surveillance and veterinary service capacities for Foot and Mouth Disease control in Syria. Budget: US$80,000; 3.

Letters of agreement (LoA) with Governmental institutions to undertake services

Funding source

Activity

Institution

Status -Signed

EC (MTF-INT003-EEC)

Supported FMD sampling in hot-spots

LANADA, Cote d’Ivoire

June 2008

FMD laboratory, KARI, Kenya

July 2008, activities ongoing

NVI, Debre Zeit, Ethiopia

May 2008; activities ongoing.

Trans-Caucasus program, seromonitoring suport Turkey, seromonitoring support Training Course in FMD diagnosis

IZSLER, Brescia

Field Training in Turkey in FMD outbreak investigation Optimised protocols for RNA transfection to replace live virus shipment procedures Regional FMD vaccination information system /database

GDPC, Ankara

Finalization, not yet signed, but has not delayed services.

Signed/completed 2008.

Finalisation stage, expected signed April 09.

Finalisation stage, expected signed April 09.

October 2008, activities ongoing

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SAP Institute IAH Pirbright

Lindholm, Denmark

FLI, Germany

Signed FAOApril 09

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4.

Other

Technical support provided by EuFMD Secretariat to FAO FMD control projects/programmes Advice was requested from the Secretariat from the operational units of FAO involved with implementing FMD projects in Near-East, Asia and Africa.

Region/country

FAO project

Status

Near-East/Lebanon

TCP(e) – TADS control

Ongoing

Near-East/Egypt

TCP(e) –FMD control

Ongoing

Asia/DPR of Korea

TCP(E) – FMD control in N Korea Donor funded emergency program – FMD control /vaccination FAO/EC Contribution agreement for support to SADC/EC FMD control program

Ongoing

Asia/Bangladesh

Southern Africa (SADC)

Extension phase vaccination program 2008 Ongoing

EuFMD guidance/input Selection of consultants, FMD diagnostic supplies Technical advice on workplans, clearance of reports, linkage to EuFMD expertise Clearance of reports, technical advice Technical advice on vaccine selection and program monitoring Selection of consultants, linkage to EuFMD experts, clearance of terms of reference

As of 1st April 2009.

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ANNEX II

STATUS OF TECHNICAL PAPERS AND CONCEPT NOTES PRODUCED BY THE STANDING TECHNICAL COMMITTEE EuFMD COMMISSION

1.

Technical papers produced following recommendations from the Executive Committee (75th Session)

Title

Final Draft Produced

Clearance by Research group (ChairVice Chair)

Circulated to MS (consultation)

Regulatory significance

Revised Containment Standards for FMD laboratories

Yes

Yes

Yes. Sent to all FMD labs and copied to CVOs.

High

Position paper on use of decentralised tests for FMD diagnosis

Yes

Yes

Yes -38th Session

Limited/None (Guidance only)

Guidelines for FMD surveillance procedures in sheep

Yes

Yes

Not unless referenced in EU Directive

Guidelines for FMD surveillance procedures in cattle

Yes

Yes

As above

Minimum diagnostic capacity in EuFMD Member States

Yes

Yes

If adopted in 38th Session across EuFMD MS

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2.

Concept Notes for technical studies developed following the 75th Session and arising from the EuFMD program of activities

A format for concept notes has been developed by the Secretariat to facilitate decisions by the Executive and EC on further action/funding. Guidance/decision is sought on the format and process, and whether a maximum amount (€) should be set beforehand.

Background

Issue

Workshop EuFMD/EC/Turkey, March 2008

Short duration immunity/Stability of FMD vaccines Full-length sequencing to Identifying missing outbreaks/type A epidemiology Whether to include sheep in emergency vaccination programs Quality of contingency planning for FMD

Research Group, Cairo Session 2007 Review of emergency vaccination plans (2006) 37th Session: training requirements of member states.

Problems in UK and Cyprus 2007 in surveillance.

Roadshow concept to join FAO/OIE/EC to address: Low experience with FMD of MS. Optimising surveillance in zones.

Advances in diagnostic options.

Draft produced/cleared RG or Secretariat Yes/Yes

Funding Agreed in principle –EC

Yes/underway

Agreed EC, via Letters of Agreement IAH

Yes/underway

Agreed 76th Session

Yes/cleared Sec.

Yes

76th Session supported development of a Training Fund for in field training. See: #3, Annex II

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Appendix 14 PROGRESS TO IMPLEMENT RECOMMENDATIONS OF THE 37TH SESSION (2007) EuFMD Secretary

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Appendix 15 REVISION OF THE EUFMD STRATEGY PAPER FOR 2009-2013: CHANGES COMPARED TO 2005-2009 EuFMD Secretary

The General Session of the Commission falling every 2 years is an important opportunity for setting direction and priority for actions in each forthcoming biennium. In 2005 the General Session approved a 4 year strategic plan, in order to prepare for longer term goals and in line with the likely 4 year duration of the contract with the European Commission (DG-SANCO) for activities in support of FMD control.

The Strategy was reviewed at the mid-term (2007) and the 2009 General Session provides an opportunity to review progress over 4 years and to update the Strategy for the period 20092013.

Summary of proposed Strategy development: Five priorities for action in the 2009-2013 Plan are proposed, of which three are a direct continuation from the 6 previous priority areas (2005-2009 Plan). The actions in support of FMD risk reduction in South-Eastern Europe remain a very high priority and all related activities are brought under Priority 1: Long term risk reduction in the Turkish neighbourhood through support to the West EurAsia FMD Control Program (Roadmap). A new priority area is proposed, placing emphasis on Global FMD risk information and control program progress monitoring across 7 virus pools.

The Strategy was discussed at the 77th Executive Committee; recognizing in particular the need to protect the investments being made by Turkey with the EU in FMD control, the need to strengthen FMD early warning and risk management in the wider Mediterranean region, and taking into consideration the progress under the first plan, and development in the risk situation and at political level in the main risk areas, the Committee concluded that priorities should be set in relation to: -

-

-

-

The continued risk from countries neighbouring to Turkey, including from the region of the Caucasus, and the opportunity for regional progress in West EurAsia through a progressive control pathway approach; The need to continue the effort on FMDV threat detection (virus intelligence), but to include a new priority of monitoring progress in FMD control in the 7 major virus pools to better inform risk assessment; The need to upgrade efforts on FMD Training as a funded program, reflecting on the lack of facilities to demonstrate FMD in European laboratories and the new tools and opportunities for in country and online training networks; The need for continued technical networking between European experts but with an expanded level of networking with those in FMD endemic and at risk countries in the European neighbourhood, with greater involvement of experts from neighbourhood regions in the Sessions of the EuFMD Standing Technical Committee; this includes the need for a emergency funding of studies of high urgency that are not otherwise supported, on major technical issues.

The Priorities in 1st and 2nd Plans (as agreed by the 77th Executive Committee) are shown in the table below.

First 4 year Plan (2005-2009) Priorities agreed 38th Session

1. FMD risk –Turkey

Second 4 year Plan : 2009-2013 Priorities for action agreed at 77th Executive (significant changes in bold) 1. Risk reduction – Turkish

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neighbourhood/West EurAsia Roadmap.

2. FMD risk – via Caucasus Continued funding provision to be made under the EC/EuFMD agreement 2009-2013.

3. Emergency response – European neighbourhood 4. Viral surveillance prioritization

for

Vaccine

bank

2. Viral surveillance prioritization.

for

Vaccine

bank

3. Global FMD risk information and control program progress monitoring across 7 virus pools.

5. Lack of recent FMD investigation experience in MS

4. FMD Training program - European/EuFMD Member States 4 year rolling program.

6. Technical issues - Vaccination to live

5. Technical networking – Euro-Med, West Eurasia region (focus on vaccination performance, FMD risk, surveillance and survey design and in depth technical studies).

Supporting documentation: The Background context, the case for continuity and change, the financial and operational strategy is given in Annexes I and II.

Summary of the Operational strategy: This should: 1.

2.

3.

4.

5.

Maintain the core functions of the Secretariat as an enabling unit, by agreement of the new budget for contributions for 2010-2011; Build on the strengths of the current partnerships, particularly the long term working relationship with DG-SANCO, with renegotiation of the EC Implementing Agreement to enable emergency actions and improved technical support to FMD programmes – to operate from May 2009; Make greater use of in-house and out-sourced professional support for risk assessment and monitoring, particularly the GLEWS (Global Early Warning System), the Crisis Management centre (CMC –Animal heath), and for project development (formulation) and management –particularly the FAO/OIE Regional Animal Health Centres (RAHCS) and FAO regional Offices (Ankara, etc) ; Work particularly towards supporting progress of long term Regional FMD control Roadmaps, in the regions of greatest importance to Europe, as part of the contribution towards Global Control; Complement the activities and efforts of the major partners, and where required make use of other funding streams to achieve progress.

Supporting documentation Annex 1: Background: the Strategic Context The context –what has changed since 2005?

The New opportunities: 2009-2013 Building on achievements and responding to change Implementing Strategy - connection to the Contribution Agreement with EC Monitoring and evaluation Financial Strategy Summary of the Operational Strategy: Annex II : Summary of Draft Objectives and Outcomes of the Agreement with EC (DG-SANCO)

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ANNEX I Background: the Strategic Context The FMD outbreaks which occurred in the United Kingdom in 2007, and in the UK, Ireland, France and The Netherlands in 2001, had an extreme economic impact that was out of proportion to the animals directly affected; even single outbreaks of FMD in the free countries of Europe have very high impacts for the wider EU as well as the affected Member States, mainly as a result of national, intra-regional and export trade bans.

As a result of the cessation of prevention vaccination in EU members, and in all other (35) EuFMD Member States with the exception of Israel and Turkey at the start of the 1990s, the strategic plan of the Commission has placed its main emphasis being placed on the prevention of incursions from endemic countries and regions neighbouring to Europe. In the period 19962009, FMDV introductions into the European neighbourhood have occurred from 5 of the 7 regional virus pools, with one escape from a laboratory facility (in 2007). Four FMDV types were involved, but multiple subtypes, including at lEast 5 highly diverse type A strains (A (India), A Iran 96, A Iran 99, A Iran 05, A Egy 06).

Incursions of FMDV to western Europe and neighborhood from FIVE virus pools (ecosystems) in the period 1996-2009 2001

2007

2

1?

3 4 5

or

5

4

Type O, Type A, Type Asia-1, Type SAT2 Figure 1. Incursions in the past 12 years; numbers in boxes refer to the putative source regional virus pools, as indicated in Figure 3.

The 1990s saw significant loss of technical expertise in Europe as the experience of FMD control receded, and countries downsized their research and development programmes. In this context significant progress was made on issues relating to emergency vaccination, but mainly by under funded independent groups, and a number of issues were not resolved by the time of the catastrophic events of 2001. Following these events, the call for change at policy level has been unceasing, and the pace of change at international level has increased.

A new Council Directive was passed in the EU in 2003 which significantly increases the options available in emergency management relating to use of vaccination. Reformulation of contingency plans to allow for the new options has significantly increased complexity in decision making. The Directive requires countries to establish expert groups, but although European expertise in FMD management was temporarily revived by the 2001 epidemics, the decline in expertise in most EuFMD member countries is likely to continue with reliance on simulation exercises and practise drills replacing direct experience.

One common recommendation of the reviews post-2001 was that actions were required to improve surveillance and better support management of FMD in the infected areas, to better inform European “risk managers” including those who manage the strategic vaccine reserves.

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This requires an effective support to surveillance in these areas which may be geographically a long way from Europe. In the European region, Turkey continues to have a significant burden of two FMD virus types, particularly in Eastern Anatolia, and is itself at risk from entry of exotic FMDV from its Eastern and Southern borders. Managing the risk to Southern Balkans will be essential but cannot be the only part of the EuFMD strategy while the infection can enter from other areas. The economic development in the Mediterranean basin will also bring challenges and also opportunity for partnership as none of the countries from Morocco in the West, around to Turkey in the East, are officially free of FMD, most are net livestock importers, and repeated outbreaks and incursions of strains into the Eastern Mediterranean in 2007-9 indicate these countries are in the front line with endemic near-East and sub-Saharan regions.

At the same time, the political situation in Europe continues to undergo profound change, with increasing expectation that the EC will manage the risk associated with a higher and more mobile animal and human traffic, and associated with the land borders with “new neighbours”, (Belarus, Ukraine, Russian Federation, Moldova), some of which are not officially free of FMD. The needs of Western Balkans (Croatia, Bosnia-Herzegovina, Serbia and Montenegro, Kosovo, FYR of Macedonia, Albania) must remain also at the fore as FMD has entry occurred in this region in 1996, and because of their important livestock populations.

Intentional introduction of FMDV as an agro-terrorism agent remains a cause for concern, and an added reason for increasing European understanding of the viruses circulating in risk-source areas and for supporting biosecurity and other measures in laboratories and vaccine plants in the wider region.

Above all, FMD remains circulating in around 50 countries, and approximately distributed into 7 “ virus pools” of distinct FMDV strains (Figure 2). Since 2006, an OIE/FAO FMD Laboratory Network has been established, with funding from EuFMD and FAO, to improve harmonization of FMD virus typing surveillance and improve virus threat identification. The WRL Pirbright provides a secretariat and supplies quarterly and annual reports to EuFMD/FAO under Contract.

EuFMD further supports by shipping samples from risk areas, to address critical FMDV information gaps, a service identified as a priority in the 2005 Strategic Plan.

Figure 2. The seven regional FMDV virus pools and the location of OIE, FAO and major national FMD reference centres that contribute to the OIE/FAO FMD Lab network.

The EuFMD Open Session (2008) recommended that a Global Approach to FMD control be based on regionally co-ordinated actions in each of these virus pools, through “Long Term Regional Roadmaps”, and progressive control pathway approach (PCP-FMD). The EuFMD, with FAO and OIE, have used the PCP approach to assist Roadmap development in West Eurasia (15 countries) and in the 4 major regions of Africa. At the minimum, implementation of the Stage 1

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activities should benefit all parties by providing increased awareness of the FMD incidence and risk and provide a base of information needed to formulate national control strategies.

In the global context, FMD has a significant impact in contributing to inefficiency in animal production; in order to combat the raising food prices, livestock production and efficiency must be scaled up to meet the required 50% rise in agricultural production expansion by 2030.

The context –what has changed since 2005?

On the negative side, it can be argued that over the past 4 years, there is either little improvement or deterioration in: • • • •

The risk of spread from the major FMDV virus pools (reservoirs), with exception of South America; Information availability and quality for FMD risk assessment from endemic countries/virus pools; Rate of incursions from West Eurasia and sub-Saharan Africa into the Mediterranean (3 epidemic waves/incursions in 3 years, each affecting multiple countries); Expertise level in FMD investigation/control of European and neighbourhood veterinarians: much the same need for training as in 2005.

On the positive side, there are now improved opportunities for regional programmes on FMD using the progressive control pathway approach, and working through the FAO/OIE Regional Animal Health Centres (RAHCS) and regional offices, and based on the good working relations developed with key countries in the region during 2005-9.

Incursions of FMDV to the European neighborhood (2006-March 2009) -Type O panAsia II epidemic spread in near-east -type A Iran 05 genotype emergence, divergence and spread (2 waves)

2007

3 4 Type O, Type A, Type Asia-1, Type SAT2

Figure 3: The recent epidemic history in the European neighbourhood, highlights the continuing and evolving risk of FMDV, with the highest risk from the West Eurasian virus pool.

FMDV type A and type O have spread in 2006-2009 from East to West, reaching Egypt and in 2009 into Libya. The origins of these emergent strains appear to be in Pakistan-AfghanistanIran. The actions of the EuFMD/EC in 2005-2009 have improved early warning, but so far have not reduced the frequency of incursions reaching Turkey or the other Mediterranean countries.

The Strategic Plan agreed at the 36th Session, for the period 2005-2009 focussed on actions to be taken to achieve outcomes which are useful to member states to help them achieve and maintain FMD freedom, and that the EuFMD should focus on delivery in four key categories of action in the period 2005-8:

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1.

Support to FMD control in “traditional risk areas” - threatening South-Eastern Europe and Turkey; Global FMD observation – virus circulation and risk; Coordination of technical studies to address constraints to policy implementation; Capacity building across Europe– raising and retaining expertise and competence in the scientific basis of FMD control and in best practises in epidemic management.

2.

3.

4.

With support from the EC through an 8 million € agreement, actions were developed, agreed by the Executive Committee and SANCO, and implemented in support of areas 1-3 above, particularly o Support to surveillance and effective response to FMD in the Southern Balkans region (Turkey, mainly to ensure the protection of Greece, Bulgaria of Turkish Thrace); o Implementation of a project for early warning of FMD regional risk events, through supported actions with the Islamic Republic of Iran; o Implementation of the buffer zone (FMD vaccination) with support to surveillance and effective response to FMD risk in countries of the South Caucasus (Georgia, Armenia, Azerbaijan); o Identification and formulation of project actions to control risk in other countries neighbouring to Turkey, and in other FMD risk situations, as required by the emerging situation; o Support to collect and ship FMD samples from risk regions to the WRL, Pirbright.

The epidemic events in the past 3 years in the European neighbourhood provide a strong case for further actions in West EurAsia to reduce the risk to Turkey/Eastern Europe and the Eastern Mediterranean. The introductions in Egypt and Libya in 2006 and 2009 support the case for continued surveillance support to African proximity risk regions; and the events in Cyprus in 2007, a country which had been free of FMD for more than 40 years, highlight the need for maintaining expertise in FMD investigation.

Other relevant changes or developments since 2005: •

•

•

•

• •

•

148

Progress in FMD control in Turkey: under pre-accession support, the initiation of a long term FMD control program (with EU funding for 3 year full vaccination program:20082010), parallel support for implementing the acquis communitaire, improves the likelihood of Thrace region becoming and maintaining FMD freedom; risk to investment of entry from Eastern borders; Caucasus: with EuFMD/EC support, improved capacity for surveillance in ARM, AZB; but unstable situation in GEO; FMDV viral entry detected but contained by vaccination; greater compliance with OIE /EC standards through reduced use of non-OIE standard vaccine (ARM, AZB); First regional meeting in 2008 to plan a 2020 Roadmap for long term control in West EurAsia; 15 countries, good prospect of improved early warning, risk based national control, despite long term risk from unstable countries in the region; Euro-Med developments: improved political level discussions EU and East and Southern Med neighbours; good opportunities for increased EuFMD interaction with middle-East and North Africa: yearly Roundtable meetings, technical support –Egypt, Syria, Lebanon; Technical: need for detailed molecular and field studies to understand where the type A epidemic threat viruses emerge in West EurAsia and achieve early detection/warning; Technical: rapid /pen-side tests now commercially available (Svanova LFD), close to market (mobile molecular lab; Smiths Detection); opportunity to provide each country with FMDV lab confirmation capacity; The contribution of EuFMD research group to global FMD technical progress: with global participation in EuFMD Scientific/Technical meeting (>200 in October 2008).

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The New opportunities: 2009-2013 Political, technical and networking tools provide new opportunities for enhanced effectiveness in the next four years, in particular: 1.

2.

3.

4.

5.

West EurAsia: good opportunity to initiate and influence progressive control of FMD in the 14 countries where Europe meets West Asia/middle-East (2020 Roadmap); Euro-Med FMD control network: opportunity to have Europe, North Africa, and Eastern Mediterranean countries around the table to improve co-operation in surveillance, early response, and planning preventive measures: EuFMD could provide Secretariat, working with FAO/OIE regional centres in Beirut and Tunis; To produce global 6 or 12 month state of FMD control reports, for improved FMD risk analysis : EuFMD support to Member States (6 monthly global risk assessments); To build upon first Phase of the Small grants scheme to promote FMDV collection , typing and information exchange: Africa immediately South of Sahara; For improved training, information exchange and response capacity building, using Web2.0 tools, in-country and laboratory training, building on current partnerships.

Building on achievements and responding to change The 5 priorities for action mainly build on developments made under the first 4 year plan: 1) East EurAsia FMD roadmap – the emphasis is to promote/advocate and technically support countries to development/implement risk reduction programs (builds on current support to neighbours of Turkey); 2) Technical networking – Euro-med region; surveillance, early warning, lab harmonization, training (natural extension of Research Group meetings to include experts from neighbourhood countries); 3) Training program; European/EuFMD member states 4 year rolling program; 4) Viral surveillance for Vaccine bank prioritisation: builds on small grants and support for FMDV submission to WRL/CRL in first Plan, to continue to fill gaps in knowledge for risk assessment on circulating FMDV strains; 5) Global FMD progress monitoring/risk information across 7 virus pools (builds on WRL reporting to EuFMD/FAO/OIE with more regional FMD control program information and analysis).

Continuity and change: relationship between first and second 4 year plans First 4 year Plan (2005-9)

Second 4 year Plan : 2009-2013

Key Problems to address:

Change or continuation? Proposed action

•

•

FMD risk to South-Eastern Europe from FMD in Turkey.

•

Continue, but addressing control in neighbourhood of Turkey: Support the implementation of West EurAsia roadmap, EuFMD to focus activities on neighbouring countries to Turkey If Russian Fed becomes a member then also increase activities in central Asia CIS.

•

Risk of exotic FMD incursions into Turkey/Russian Federation from West Asia via Caucasus.

•

Continue support to Caucasus countries until situation improved in turkey and Iran.

•

Need for immediate technical assistance and provision and supervision of inputs during FMD control operations when emergencies occur.

The problem of vaccine

•

Request EC to maintain the balance in the TF as a strategic reserve.

•

Support lab networking:

•

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•

•

•

selection/bank management because of lack of virus collection in endemic areas, and lack of comparable or timely information exchange between laboratories.

In free countries, declining number of veterinarians with experience and expertise in FMD control operations and related management areas.

Diversity in European region in levels of human resources, in proficiency and resources to undertake surveillance and epidemic management.

Issues constraining selection of “vaccination to live” as a emergency response in countries free without vaccination.

• •

Europe/Iran/Pakistan (West Eurasia) Support surveillance/lab networking Mediterranean region Support sample collection /typing: Sahel

•

Implement Training Programme, train >2 persons from each EuFMD member by 2013. parallel training resource programme (online tools and resources).

• See above , network initiative to make open access to information/training resources.

•

To be continuously reviewed on RG Agenda.

Implementing Strategy - connection to the Contribution Agreement with EC In the period 2005-2008, the main support for implementing activities came from the EC (DGSANCO) via a Contribution Agreement, signed September 2005, for 48 months. Following the 38th Session, a revised Project Document and Contribution Agreement will be prepared.

A draft agreement, based on the proposed Strategic Plan 2009-13, is given in Annex II, with the proposed Logical Framework.

Monitoring and Evaluation The Secretariat will report progress of the different projects to the Executive, donors and partners.

Monitoring of programme development, delivery and impact will be through the Executive Committee every 6 months, at which EC and OIE are represented.

Regional progress reviews in West EurAsia –and the impact and direction of the EuFMD support – should occur every 12 months, under at a proposed Annual Meeting for the 15 veterinary services directly affected.

Global FMD surveillance progress –and contribution of the EuFMD support – will be subject to review at the Annual OIE/FAO FMD Lab network meeting (WRL provide the Secretariat).

Regional FMD situation and progress reviews in the Middle-East and North Africa - should be evaluated at the annual FMD Roundtable meetings organized under the Gf-TADS Regional Animal Health Centres (RAHCs) in Beirut and Tunis, respectively.

Regional meetings for the trans-Caucasus should continue to meet every 12 months to enable OIE, EC, donors and countries in the key risk regions (Caucasus/Turkey/Iran) and Southern Balkans (Turkey, Greece, Bulgaria) to influence project delivery and assist co-ordination of national and international inputs between donors and countries, and provide feedback to the Executive.

The General Session of the Commission in 2011 should review progress at the mid-point of the 4 year plan.

Financial Strategy The strategy from to date can be expressed as:

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1.

2.

3.

4.

Enabling funding, being the contribution of the Member States to fund a full-time technical support unit for project development and implementation in the Secretary and Clerk, and supporting core support functions (contract to WRL for services, part funding standing technical committee meetings, specific workshops identified by the Executive); Extra-budgetary funding for permanent and temporary activities in support of FMD control in the European neighbourhood, via DG-SANCO: Implementing Agreement –8 million USD, 2005-2008, up for re-negotiation for the period 2009-2012; Contributions of technical officers supplied by member countries – in the period 2008-11, the offer by France to supply a professional officer will be extremely helpful; Office space, lighting and other support provided by FAO.

Summary of the Operational Strategy: 1.

2.

3.

4.

5.

Maintain the core functions of the Secretariat as an enabling unit, by agreement of the new budget for contributions for 2010-2011; Renegotiate EC Implementing Agreement to enable emergency actions and improved technical support to FMD programmes - from May 2009; Make greater use of in-house and out-sourced professional support for risk assessment and monitoring, particularly the GLEWS (Global Early Warning System), the Crisis Management centre (CMC –Animal heath), and for project development (formulation) and management– particularly the FAO/OIE Regional Animal Health Centres (RAHCS) and FAO regional Offices (Ankara, etc); Work particularly towards supporting progress of long term Regional FMD control Roadmaps, in the regions of greatest importance to Europe, as part of the contribution towards Global Control; Complement the activities and efforts of the major partners, and where required make use of other funding streams to achieve progress.

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ANNEX II

Summary of Draft Objectives and Outcomes of the Agreement with EC (DGSANCO) “EC Funded Permanent Activities carried out by the FAO European Commission for the Control of Foot and Mouth Disease, 2009-2012".

Project Objectives: The overall objectives of the project are: • To prevent or at lEast minimise the risk of reintroduction of FMD in European member countries of EuFMD; • To contribute to the strengthening of the measures for prevention of FMD in EuFMD member countries; • To help the country concerned to eradicate FMD in the shortest delay possible and with minimal costs for the member countries of EuFMD and for the Contracting Authority, should the disease be introduced into an EuFMD member country.

Expected Outcomes: The expected outcomes of activities supported with funds provided by the Contracting Authority under this Agreement (are shown in the project logical framework), are: 1. The rapid control of FMD incursions/emergencies in member countries or in immediate neighbourhood countries as a result of re-enforced control measures and emergency response capacity; 2. An improved system for monitoring FMD virus circulation is operational and providing valuable information to member states for risk assessment and threat identification; 3. Technical constraints to application of the preferred European FMD control policies are reduced as a result of improved knowledge, peer reviewed studies and published technical opinions; 4. An operational system for providing FMD training for European and neighbourhood region veterinarians that over the 4 year period provides training opportunities for at lEast 2 vets per member state; 5. Reduced risk to europe/turkey as >90% of countries in West eurasia participate in a progressive control roadmap, undertaking risk reduction and incidence monitoring measures, providing a functioning system for assessment of new threats and measuring success of risk based measures.

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LOGICAL FRAMEWORK OF THE PROGRAMME “EC Funded Permanent Activities carried out by the FAO European Commission for the Control of Foot and Mouth Disease, 2009-2012"

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Appendix 16 PROGRESSIVE CONTROL PATHWAY (PCP) AND REGIONAL ROADMAPS: TOWARDS A COMMON FRAMEWORK FOR LONG TERM ACTION AGAINST FMD AT NATIONAL AND REGIONAL LEVELS IN EUR-ASIA AND AFRICA Presentation7 to the 38th General Session of the EuFMD

Summary The Progressive Control Pathway for FMD (PCP-FMD), a set of control program activity stages leading to FMD freedom, and Regional Roadmaps (RR), which describe the anticipated progress along the PCP at national and regional level to 2020, is the suggested approach of FAO to promote long-term co-ordinated action against FMD. The proposal of FAO to the OIE/FAO International Conference on FMD to be held in Paraguay in June 2009, is that the PCP and RR approach be adopted as the international framework for coordinated action under GFTADS, in each of the currently endemic regions. At global level, seven FMD epidemiologic regions are recognised containing specific viral variants which specific targeted vaccines and regional early warning systems (“7 virus pools”), and Regional Roadmaps are suggested as a approach for 5 regions (West EurAsia, South Asia, East Africa, West/central, and Southern Africa) that do not currently have Continental (The Americas) or sub Regional (South-East Asia) FMD Roadmaps.

Role of the EuFMD/European countries - West EurAsia and other Regional Roadmaps Eastern European and Eastern Mediterranean member states are most at risk from the West Eurasian virus pool (Pool 3: types A, O, Asia-1); parts of the region (Egypt/Arabian peninsula) are at high risk from East African pool (pool 4), and North Africa (maghreb) from West/central African pool (pool 5).

Nine European countries are included in the 15 countries directly affected by West Eurasian virus pool, 2 are usually considered Middle-East, and 4 in Asian political regions.

The responsibility is therefore mainly a European one to promote FMD control in this epidemiologic area.

The proposal before the 38th Session, is for the EuFMD to • Support the vision for the West Eurasian region to become free of clinical FMD by 2020; • Commit, beginning with the EuFMD Strategic Plan 2009-13, to a long term role in promoting and supporting the implementation of the Regional Roadmap and PCP approach in West EurAsia, with the aim of improving FMD control through progressive application of risk based control measures ; • Promote and where required support routine FMD surveillance to monitor progress at national and regional level in FMD control across the West EurAsia region, working • Organise, in co-ordination with other international agencies and donors, an annual meeting to review progress along the West EurAsia Roadmap; • Promote and where appropriate technical support the introduction of PCP approach into other regions threatening to Europe, such as Northern, West/central and East Africa, with the emphasis upon routine surveillance to provide information for international risk assessment as well as local strategy building.

Prepared by: Sumption K. (1) , Lubroth J (2) , Ferrari G (2), Potszch C (1) , Domenech J (2) (1) European Commission for the Control of Foot-and-Mouth Disease (EuFMD), FAO, Rome, Italy, (2) EMPRES Animal Health, AGAH, FAO, Rome, Italy

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Figure 1: Progressive Control Pathway for FMD (PCP-FMD): stages 1-3 are activity stages that should lead to the conditions for official recognition of disease freedom (Stages 4-5).

FAO Progressive control pathway - risk reduction approach (under development) •not a top down prescribed approach: but each MS encouraged to develop national risk reduction strategies that are supportive to the regional effort 5

4

3

2

1

0

Officially free without vaccination No circulation / containment zones only

Officially free with vaccination No circulation / containment zones only

Approaching freedom Outbreaks < once / year

Critical points addressed Ð incidence

Critical risk points identified, strategy being developed

Stages 0-3 = infected countries/zones

Risk not controlled Continuous FMDV circulation

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Background – why a regional Roadmap approach?

The challenge of controlling FMD is daunting in Asia and Africa; currently few of the endemic countries currently vaccinate more than a low percentage of susceptible livestock, informal transboundary trade permits rapid, sweeping epidemics , and each of the six regional virus pools contains regionally specific FMDV that require specific, tailored vaccines. In these regions, country capacity to implement control, and incentives for investment, differ widely. Global FMD control, through a set of regional long term actions (Regional Roadmaps) to address the seven regional virus pools was recommended at the FAO/EuFMD global meeting on FMD (Sicily, 2008).

Two regions, South-East Asia and South America, already have established long term Roadmaps, but these are lacking in the remaining 5 virus pools. Within these regions, routine mass vaccination is often not an option for economic reasons, or has been adopted but success in FMD control is only partial because of incursions from neighbouring countries, or insufficient vaccine coverage to break transmission.

Location of the Seven FMDV Virus Pools – focus for Regional Roadmap actions An eighth pool, in Western Europe, has been eradicated through regional actions (EuFMD member states) by the end of the 1970s allowing freedom without vaccination.

The seven major virus pools; basis for action against the regional virus types Continual virus circulation and evolution within regional pools: epidemic jumps to other regions

3

7

2

5 1 4 6

How does the PCP approach fit with the OIE process of recognising FMD freedom?

The PCP approach describes a set of intermediate control stages that should culminate in the preconditions for gaining and maintaining FMD freedom.

The initial stage (Stage 1) is applicable in almost all countries, and aims at gaining the information required to develop a national strategy; both disease incidence, country capacity, and socio-economic drivers. Stage 1 therefore generates significant data of value at national, regional and global level (to free countries on risk). The next two stages focus on progressive application of control measures, leading eventually to a situation where all outbreaks are exogenous (from outside the country) and from which the jump to official recognized disease freedom (Stage 4) could be made.

The PCP approach uses HACCP principles, is non-prescriptive on control options, and has the advantages, in the initial stages, that modest investments could attain information needed for targeting measures (national strategy development).

What are the incentives for countries to participate in the PCP?

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Stages 2 to 3 will depend largely on national investments and economic drivers, but the emphasis on surveillance actions at every stage could result in greater market opportunities, since trade decisions on compartmentalization requirements or commodity based marketing of livestock should be assisted by the risk management information provided. The PCP approach can be used to define activities in projects and for comparative regional evaluation of progress

by Regional Economic or other bodies. Within a region, comparison with the progress of a neighbouring country is also a political driver.

Regional Consultations and Roadmap Workshops The PCP approach has been developed and applied by FAO , working together with the OIE, at regional meetings to develop Regional Long Term Roadmaps in West EurAsia (14 countries: see Figure 3), in Africa (52 countries, 2009) and the Middle-East (10 countries, 2009). The PCP approach involves four sequential stages (Stage 0 to 3) of control within non-free countries, leading to official recognised freedom with or without vaccination (Stages 4 and 5). This paper describes how the PCP approach was used to develop Regional Roadmaps for FMD control up to 2020, in West EurAsia, in Africa (West/Central, East, Southern, North Africa) and in the MiddleEast, through workshops and regional meetings in 2008-9, convened under the GF-TADS framework. Remaining gaps for Roadmap development are in South Asia (SAARC area), and parts of East Asia that are not involved in the SEA program.

Where do we go from here?

The PCP approach, and regional Roadmaps, will be the subject of discuss at the OIE/FAO International Conference on FMD to be held in Paraguay in June 2009.

The PCP approach can be applied at various levels, from individual support projects (supporting one country to undertake Stage 1 sero-surveys and strategy development, for example), can be the basis of regional projects (to support surveillance actions, lab networking etc), and could be the basis for commitment at political levels within regions.

FAO implemented projects in support of FMD surveillance, regional networking etc, are expected to follow the PCP approach and as far as possible stimulate progression of countries along the regional roadmap.

The overall co-ordination of the Roadmaps, and progress monitoring, should be managed by FAO/OIE, under GF-TADS, with global progress monitoring being achieved from the reports of the routine/annual meetings that review the progress of Regional Roadmaps.

In the West Eurasia region, the EuFMD could be a lead body to organize these progress meetings, and thereby contribute to Regional and Global Control.

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Figure 3: Regional Roadmap for FMD control in West EurAsia : with the vision of freedom from clinical disease by 2020.

Stages towards FMD freedom (stage 4 or above).

Countries

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018 2019 2020

Kazakh Kyrgyz Tajik Turkmen

West Eurasia

Uzbek AFG IRN PAK TURKEY Turkish Thrace Syria Iraq Armenia Azerbaijan Georgia

Nat

Zonal

Level 0

Risk not controlled

Level 1

Risk identification and strategy development Basic surveillance

Level 2

Progressive risk reduction

Level 3

Almost free

Level 4

Free with vaccination

Level 5

Free without vaccination

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Appendix 17 DEVELOPMENT OF A ROADMAP FOR THE PROGRESSIVE CONTROL OF FOOTAND-MOUTH DISEASE IN WEST EURASIA

Summary and Recommendations Report of a Workshop held in Shiraz, Islamic Republic of Iran 9-13th November 2008

Convened by FAO as a Joint Workshop of the regional FMD control projects supported

by Italy (GTFS/INT/907/ITA) and EC (MTF/INT/003/EC)

Summary A four-day Workshop was held in Shiraz, Islamic Republic of Iran, organized by FAO in consultation with OIE, and hosted by the Iran Veterinary Organization. The Workshop was convened as a joint meeting under the FMD projects implemented by the EuFMD Commission (FAO) in Turkey, Trans-Caucasus, Iran and Syria, and the GTFS/INT/907/ITA project for Central Asian countries. Invitations were sent by FAO, on behalf of the two organizations, to the Chief Veterinary Officers (CVOs) and to the FAO national consultants on FMD (EuFMD or GTFS projects). In total, fifteen countries in West EurAsia were represented, with the Russian Federation represented through the OIE Reference Laboratory (FGI-ARRIAH).

The Objectives of the Workshop were: 1.

To develop consensus on the vision and long term goals for FMD control in the region, and on the main element of a long term strategy for Foot-and-Mouth Disease control in the West EurAsian FMD ecosystem8; 2.

A secondary objective is to share information on FMD virus circulation within the ecosystem to assist planning of preventive measures in the short-term; Outcome and outlook 3.

8

A vision statement and “West EurAsian FMD Roadmap” were developed, for the progressive control of FMD in the region with the vision of freedom from clinical cases of FMD being achieved by the year 2020;

This can be defined as the area within which a continuous presence of genetically Asia-1 are found and which is affected directly (outbreaks) or indirectly (change sweeping epidemics which emerge within the region or via one or more countries. borders of the area affected by the type A Iran 05 epidemic (2003-8) and type (2006-8).

distinct types A, O and in vaccine strains) by It approximates to the O PanAsia II epidemic

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4.

The realisation of the vision requires a co-ordinated set of national efforts under an overall framework of progressive risk reduction, supported by regional services and sharing of information, technical knowledge, and possible donor support, between countries within the region and which are beneficiaries of the action; 5.

The workshop recommended that at regional level, programs be established to elevate laboratory services, information systems and planning tools, FMD vaccination campaigns and to resolve trans-boundary animal movement issues; a Secretariat should be established to provide co-ordination of these supportive services, and for monitoring and communication of progress; 6.

A framework for monitoring progress was developed, based on indicators of country progress in risk identification and risk management, along a progressive control pathway, with 5 stages (0-4). Despite the great disparity in risk and resources, it was foreseen that all countries should attain at lEast level 3 (FMD under control and approaching disease freedom) by 2020; 7.

The “West EurAsia regional Roadmap” that was developed should, if implemented, benefit countries in Europe by reduced risk from this region. It should also benefit countries in the middle-East which import livestock from the region, especially the Gulf countries, Saudi Arabia and Egypt, which in the recent past have been affected by extension of epidemics from West EurAsia; 8.

In addition, the implementation of the Roadmap should encourage and complement the efforts in the China, India, and South-East Asia to address the problem of FMD in the whole of EurAsia on a long term basis; 9.

The Workshop recommended that at lEast annual meetings be convened by FAO/OIE to monitor progress, with the follow up regional meeting to be held in November 2009; 10. A framework for securing long term national participation in the Roadmap is needed, and it was recommended that a Shiraz declaration, or other instrument, is developed for endorsement by the relevant Ministries in each of the participant countries, ahead of the OIE/FAO International Conference on FMD control planned in June 2009;

Vision for the West Asia Roadmap for FMD Control Regional cooperation among Eurasian countries for the progressive control of FMD through public and private partnerships leading towards freedom of clinical disease by 2020 for regional economic development, food security, and poverty alleviation.

Vision for the West Asia Roadmap for FMD Control Региональная кооперация между Евразийскими странами в целях прогрессивного контроля ящура через общественное и частное партнерство ведет к свободе от клинического проявления болезни к 2020 г. для экономического развития и снижения уровня бедности.

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Position of West EurAsian countries at beginning of the Roadmap

Roadmap to 2020 Stages towards FMD freedom (stage 4 or above).

Countries 2009

2010

2011

2012

2013

2014

2015

2016

2017

2018 2019 2020

Kazakh Kyrgyz Tajik Turkmen

West Eurasia

Uzbek AFG IRN PAK TURKEY Turkish Thrace Syria Iraq Armenia Azerbaijan Georgia

Nat

Zonal

Level 0

Risk not controlled

Level 1

Risk identification and strategy development Basic surveillance

Level 2

Progressive risk reduction

Level 3

Almost free

Level 4

Free with vaccination

Level 5

Free without vaccination

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Recommendations of the West EurAsia Regional Workshop on FMD General 1.

2.

3.

4.

5.

6.

Each country is encouraged to adhere to the principle of initiating actions along the West EurAsia 2020 Roadmap, through a set of sequential activities and stages involving assessment of the risk of FMD, and development and implementation of National FMD Risk Reduction (Control) Programme to manage the risk; Each country should develop a National FMD risk reduction Control Programme in the next twelve months, where they do not exist, and revise legislation where appropriate.

The involvement of the private sector is strongly encouraged in developing such National Plans.

A Secretariat should be established in the Region for the progressive control of Foot-andMouth Disease (with introduction of transboundary animal disease regional issues as needed); such Secretariat could be placed within or become the OIE/FAO Regional Animal Health Centre for the Region; FAO/OIE should assist the development of national and regional expertise on FMD control through establishing regional working groups and networks, especially to build capacity in epidemiology and diagnostic laboratory services; Countries should actively participate in the monitoring or progress and action plans to implement the West EurAsia FMD 2020, involving at lEast an annual progress meeting for decision makers and their technical advisors from each country; Regional working groups should be established, with appropriate levels of support, to improve the capacity of each veterinary service to develop and implement their national risk reduction plans and to safeguard against new epidemics. These are: a. A laboratory working group for virus characterization and vaccine selection; b. A working group to improve planning disease control measures, use of epidemiology and risk analysis; c. Multi-lateral actions to reduce risk associated legal and informal trade across land borders; d. Actions to harmonize, optimize and monitor the use of FMD vaccination across the region; e. Communication, Awareness and Training.

7.

Increased effort should be made by the international agencies, and by the national veterinary Services, to communicate the importance of FMD control and bring attention to the Ministries (of Agriculture and others – Finance, Commerce, Foreign Affairs) to the impact of epidemics and cost of preventive programmes to the public and private across the entire region;

Regional Epidemiology Unit 8.

To Establish a Regional Epidemiological Unit at Secretariat level to interface with existing national epidemiological units to collate and analyse data, and serve as a training facility for advanced epidemiology techniques, including GIS, risk analysis, and modelling;

Diagnostic Laboratory Services 9.

To establish a FMD laboratory network for the West EurAsia region, with the following expectations: a. b. c. d. e.

164

The harmonisation of laboratory procedures to improve the confidence of veterinary services in the results obtained across the region; To improve early detection of emergent viruses, and communicate information to assist the preparedness of each country for epidemic threats; To build expertise in each country, and improve capacity and performance of laboratories across the region; To implement in network members a system for ring (proficiency) testing; That one laboratory will serve as a leading facility for gap analysis, training, and manage proficiency tests (with OIE or FAO reference laboratories), will interface

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with Regional Epidemiological Unit, and host a regional laboratory network website.

FMD Vaccines and Vaccination 10. That a regional vaccination campaign database is developed to assist member countries with standardized country information on vaccination campaigns, coverage of species, epidemiology units across the region at risk; 11. That FMD vaccination campaigns should make increasing use of the targeting of high risk animal populations or sectors for virus transmission, particularly where vaccine is a limited resource and complete population coverage is not affordable or feasible; 12. Each country should ensure vaccines are selected that are appropriate to the expected risk, and so doing should refer to the recommendations of the FAO/OIE FMD laboratory network reports; 13. FAO/OIE should establish a mechanism to guide countries and the Region of the relevant vaccine antigens that should be used, through the regional working group on in conjunction with WRL and Regional Reference Laboratory; 14. Promote and develop synchronised vaccination time tables for application across shared borders, especially where these are of regional priority to prevent epidemic spread; 15. That protocols for post vaccination monitoring are harmonised across the region, and that each veterinary service undertakes an appropriate level of assessment including coverage, determination of effective flock/herd immunity, and duration of immunity; Transboundary animal movement 16. Greater emphasis is encouraged on developing bilateral and multilateral protocols that will: a. b. c.

17.

Legalise animal movements across borders and reduce the associated risk; Manage informal movements, by the provision of holding facilities across border with no negative repercussion to the transporters; Manage the risks of transhumant livestock across common borders, reaching agreement on vaccination, animal identification and other measures.

In support of the above, greater effort should be made to refine understanding of temporal and spatial movements across borders at the local level.

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Appendix 18 RESEAU EURO–MEDITERRANEEN DE DE LUTTE CONTRE LA FIEVRE APHTEUSE Vision du Maghreb R. Bouguedour9

FAO - Eu-FMD Réseau Euro– Euro–medité meditérrané rranéen de de Lutte contre la Fiè Fièvre Aphteuse * Vision du Maghreb * Dr Rachid Bouguedour - Rome - Avril 2009

Le Maghreb est la région regroupant cinq pays : le Maroc, l’Algérie, la Tunisie, la Mauritanie et la Libye. cinq pays forment l’Union Maghrébine Arabe « UMA » , union

Les

politique fondée le 17 Février 1989 et dont le siège est à Rabat (Maroc).

Dans le cadre de l’UMA : ( Convention portant sur la médecine vétérinaire et la coopération dans le domaine de la santé animale. ( Commission ministérielle spécialisée chargée de la sécurité alimentaire, au sein de laquelle a été mis en place, une commission vétérinaire maghrébine permanente en vue de se prémunir contre les maladies animales.

Bovins

Î

>

5 millions

Petits ruminants

Î

>

60 millions

Dromadaires

Î Des centaines de milliers

Situation de la Fièvre Aphteuse au Maghreb

9

Chief Veterinary Officer (CVO) Algeria.

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GCP/RAB/002/FRA (

OSRO/GLO/702/CAN :

:

Renforcement de la surveillance et des systèmes d’alerte pour la Blue Tongue, la Fièvre du Nil Occidental et la Rage au Maroc, en Algérie et en Tunisie. (

OSRO/GLO/601/SWE : ( Projet FAO « Décembre 2009 » financé / Suède; ( Assistance d’urgence pour la prévention et le contrôle de l’IAHP en Asie, Moyen Orient et Afrique du Nord.

GCP/RAB/001/SPA et 002 : (

Projet FAO « 2007-2009 » financé / Espagne;

TCP/MOR/3203 : ( Projet FAO « 2009 – 2010 »; ( Appui d’urgence pour le contrôle de la PPR au Maroc.

( Renforcement de la surveillance et des mesures de lutte contre l’IAHP dans les pays du Maghreb et en Egypte.

Création d’un réseau de laboratoires pour la région du Maghreb (

Lancé dans le cadre des programmes Régionaux de Coopération Technique et du programme régional;

(

Mise en place de réseaux de laboratoires et appui aux réseaux existants.

Programme de formation régional pour renforcement des capacités des laboratoires (

Projet FAO « 2007 – 2010 » financé / Canada; Contrôle et éradication de l’IAHP en Afrique et autres régions.

( (

Projet FAO « 2007 – 2009 »;

MED REO NET (

Coordonné/ CIRAD et financé / l’UE;

(

Surveillance des maladies vectorielles provoquées par le Reovirus (BTV, EHDV, Peste Equine).

RAB CONTROL (

Coordonné/ IPA France, financé par le projet INCO de la CE;

(

Situation épidemiologique de la rage et recherche sur les sérotypes du virus circulant.

le

Lancé en collaboration avec l’UE/DG Recherche.

Les principaux acquis des projets et initiatives AFRA / RAF / 5 / 057 ( Projet AIEA lancé en janvier 2009 pour 05 années; (

Renforcement des capacités de diagnostic et de contrôle des maladies animales transfrontalières en Afrique.

Evaluation PVS/OIE ( Le Maroc, l’Algérie, la Tunisie et la Mauritanie ont fait l’objet d’une évaluation PVS OIE.

176

(

Création d’espace d’échange d’information entre les services vétérinaires des différents pays;

(

Formation laboratoire;

(

Acquisition de matériels de laboratoire;

(

Acquisition de matériels d’appui : GPS, logiciel TAD Info …etc;

des

vétérinaires

y

compris

de

( Meilleure connaissance des points faibles et points forts grâce au PVS/OIE pour nous permettre d’engager les améliorations nécessaires et réduire les écarts.

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1/

Éradication de la fièvre aphteuse à travers :

¾

Harmonisation et coordination des programmes nationaux de lutte;

¾

Mise en place de surveillance sérologiques pour évaluer les programmes de vaccination entrepris par les pays concernés;

¾

Renforcement des capacités de diagnostic de la fièvre aphteuse de certains laboratoires nationaux et régionaux;

¾

Définition et établissement d’une cartographie des mouvements des animaux.

Perspectives

2/ Prévenir la région contre toute nouvelle introduction du virus aphteux par les: ¾

Mise à jour et harmonisation d’intervention d’urgence en réintroduction de la maladie;

des plans cas de

¾ la la

Établissement d’un système d’alerte précoce par mise en place de fermes sentinelles au niveau des zones à risque aux frontières Est et Sud de région;

¾

Renforcement du concept de zones indemnes par l’évaluation du risque d’introduction d’animaux potentiellement infectés;

Instauration d’une unité de coordination et de suivi régionale;

¾

Formation et sensibilisation auprès des différents acteurs : vétérinaires, éleveurs, techniciens,…

Mise en place d’une base de données régionale;

etc.

¾

Création d’une banque régionale de vaccin antiaphteux;

¾ ¾

Même entité épidémiologique; Même statut sanitaire; Risque partagé d’introduction de FA;

Réflexions sur l’Approche Générale Maroc, Algérie et Tunisie

Même répartition du cheptel (Nord et Centre du pays); Partage de pâturages communs aux frontières; Existence de mouvements ancestraux d’animaux, (transhumance et nomadisme).

Ð

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Ce qui implique : Renforcement de la surveillance et du contrôle à l’échelle de la Région;

Les facteurs déterminants pour la mise en place d’un réseau régional (

Géopolitique;

(

Santé animale;

(

Socio-culturel;

(

Santé publique;

(

Economique;

(

Les acquis.

Évaluation des risques d’introduction; Harmonisation des plans d’urgence; Obtention d’un statut officiel (OIE) de pays indemnes avec vaccination ou sans vaccination selon l’état d’avancement des pays.

Conclusion Un réseau euro – méditerranéen de lutte contre la Fièvre Aphteuse, impliquant la rive Sud de l’Europe et le Nord de l’Afrique, nous semble aujourd’hui un projet possible, s’il est suffisamment maturé, notamment avec l’entité épidemiologique homogène que constitue le Maroc, l’Algérie et la Tunisie, à l’étape actuelle.

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Appendix 19 IMPROVING FOOT-AND-MOUTH DISEASE SURVEILLANCE AND VACCINE QUALITY ASSURANCE IN EGYPT Progress of tcp/3105 and perspective on future technical collaboration with european partners Y. Basyouni10

Summary TCP/3105 is an emergency project financed by FAO with of limited duration (initially 12 months). It was initiated in response to FMD in Egypt in 2007 that shown to result from the incursion of type O panAsia II lineage from the middle-East.

The project has demonstrated significant progress in several areas, particularly to overcome barriers to the reporting of FMD, to improve confidence in laboratory test results through harmonisation/proficiency testing involving the 3 main laboratories, and introducing the OIE standard procedure for testing FMD vaccine potency.

In summary, the GOVS desires the fruitful collaboration with European technical partners to be continued, and requires the support of EuFMD/FAO to enable continuation of key activities.

The main objectives of the project were: 1- Developing of standard operating procedures between national labs; 23456789-

Implementation of standard challenge study on the locally produced vaccine for type 'O'; Enhancing of outbreak investigation procedures; Enhancing of friendly reporting system; Developing of direct channel with Pirbright (WRL) to easily sequence and get accurate results about the circulating virus; Technical and training benefits has achieved; Developing of national plan concerning FMD prevention and control; Risk based Serosurveillance plan; Building of outbreak database system by the aid of GIS.

According to the highly appreciated technical cooperation with FAO; GOVS has some Future proposed objectives in close collaboration with FAO: 1.

2.

3.

4.

5.

6.

7.

8.

Strengthening the passive surveillance system for TADs in ruminant livestock.

Strengthening of active surveillance by NSP. Strengthening of outbreak investigation process and capacity building of GOVS preventive medicine staff.

Strengthening of applied field biosecurity.

Enforcing GOVS epidemiology unit role both central and local units.

Capacity building of AHRI diagnostic capabilities Continuous monitoring and evaluation of locally produced vaccine Strengthening of FMD and TADs extension campaigns

With FAO TCP project on FMD and FMD-like diseases, the following achievements were obtained: 1.

2.

10

National labs (AHRI2, VSVRI3 and CLEVB4) and GOVS5 demonstrated effective collaboration; National labs in collaboration with Lelystad Lab in the Netherlands developed SOP’s (for what?) and applied ring trial (ring trial on virus neutralization test (VNT) was conducted for the 3 labs);

Veterinary Services (Govs) Of Egypt.

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3.

Vaccine potency test was conducted according to the OIE Manual for type ‘O’, under supervision of the virus titration, challenge and reading of the results by the FAO consultant; a challenge against type ‘A’ will be conducted in future vaccine evaluation processes by CLEVB and GOVS; 4. GOVS showed significant progress in improving the FMD suspected outbreak investigations, (rapidly responding and OIE reporting in constant manner as well); 5. An SMS bases friendly reporting system was established as follow: 1. Recruitment of private vets as informants; as they are not exposed to penalizations from Vet. Governorate directors.Most of them are involved and trusted by all the owners and farmers, and have a lot of field experience regarding the treatment and diagnosis of infectious diseases; 2. An SMS FMD hotline was estabalished, and declared to the participants of training courses enabling them to share their field information (most of participants were from Vet. Government of local directorates); 3. Extension information and technical advises were sent to the owners and large scale producers, during outbreaks of their neighbours; 4. SMSs were used to directly inform concerned staff of GOVS and AHRI, to take the appropriate actions; 5. These bulk messages of outbreaks enhanced the response of GOVS as they are aware of every received message from the field, step by step; 6. 90% of reported outbreaks were received through this friendly reporting system 7. Local Government Vets are exposed to penalization from local directors, because of their reporting about infectious diseases and FMD in particular so; this SMS network secured them and covered them with a high level of immunity from being known by their managers; 6.

7.

8.

9.

10.

11.

12.

13.

Field vets and local directorates managers are now aware that they have been watched and monitored through the SMS network all over Egypt; not only the five pilot Governorates; the SMS reporting system provides a good level of “”immunity”” for field vets from being known by their bosses, and therefore avoid penalization of reporting; Updating of FMD national plan is in progress based on the real situation in Egypt; GOVS has taken the project as a model and started to conduct its regular annual serosurveillance in NSP ELISA to detect the virus circulation; New sampling technique has been suggested by the project and adopted by GOVS and AHRI e.g. probang sampling to easily collect oropharyngeal samples; The future sample collection by GOVS will be in close collaboration with AHRI to ensure high quality of samples submitted for testing; the project has contributed to building the capacity of national staff throughout training in specialized institutions (Pirbright) as well as on-the job training of the various actors dealing with FMD; the project has created a better cooperation among all government bodies dealing with FMD.

For the above mentioned benefits and for future improvement and progress I suggest the following recommendations: From the experience of this TCP there are several recommended points of interest to be taken in consideration: – Since field vets are underpaid from GOVS against their hard field activities, they are also exposed to penalties from their bosses if there is any suspicion of FMD outbreaks; – And to guarantee their continuity of reporting and field investigation, it is highly recommended to budget the project for the next 5 years, this is just to change the behaviour and culture of local directorate managers and to establish the accreditation of the reporting network to deal with; – More funds to enhance and improve the serosurveillance activities for NSP; – The project extension ensures the continuous international supervision upon locally produced vaccine; this ensures higher level of vaccine quality; – Updating of national labs techniques and diagnostic capabilities; – Quality assurance training for vaccine producers could be conducted by the EuFMD; – With more budgets many defects in vaccination campaigns could be corrected e.g. using one needle to vaccinate all animals in the same village.

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Future ambitions of GOVS: 1- Extension of the reporting network to be regional or may be global (do you mean across Egypt? or across the world? better stick to Egypt first); 2- Trial to declare some Egyptian zones or compartments free from FMD either with vaccination or without; 3- Establishing of sample dispatching system to WRL for regular and constant evaluation of the field isolates.

Acknowledgements I would like to express my sincere appreciation and gratitude to all of you with special attention to Dr Keith Sumption for his continuous support and assistance through the FMD TCP 3105 Egy. I would like to express my gratitude to Dr Kees Maanen, GD labs, the Netherlands (Backstopping officer of the project) for his valuable advice, assistance and his guidance. I am also, very grateful to Dr. Yilma Jobre, ECTAD team leader, FAO Egypt for his supervision and help. I can't also forget to express my sincerest thanks to Mr Toni Ettel, program operations officer, ECTAD, FAO, Egypt; for his valuable help and assistance.

I am also, so grateful to my colleagues in Pirbright lab and Lelystad lab represented in Dr Aldo Dekker their relentless efforts and full cooperation.

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Appendix 20 OPTIONS FOR DECENTRALIZED TESTING OF SUSPECTED SECONDARY OUTBREAKS OF FMD Position paper from the EuFMD Standing Technical Committee (Research Group11).

Executive summary This paper reviews the options for decentralised use of virus detection techniques on samples from suspected secondary outbreaks of Foot-and-Mouth Disease (FMD). These options have been expanded by the advent of new tests including disposable lateral flow devices (LFD) for the detection of viral proteins and reusable after disinfection portable RT-PCR equipment for the detection of viral RNA. LFDs have been developed to achieve a similar sensitivity as the antigen detection ELISA, but with the ability to provide a result within less than30 minutes followingr the addition of epithelium or vesicular fluid. Portable RT-PCR devices are being developed that can detect FMD viral RNA in blood, epithelium or other materials with minimal sample processing and with high sensitivity within 150 minutes. These devices may be used on infected farms as pen-side tests, in regional, local or mobile laboratories, or in National Reference Laboratories (NRL). Advantages and disadvantages of different testing options are considered to facilitate informed decisions on the optimal strategies for different national circumstances.

Issues include validation and quality control, containment needs, availability of test devices and reagents, the decision tree for declaring an outbreak, training issues, and provision of samples for subsequent viral characterisation. Tests to confirm the diagnosis of the index case of an outbreak of FMD should continue to be carried out in the NRL. Recommendations 1.

2.

3.

4.

5.

National veterinary authorities should review their contingency plans and operational manuals and consider if the currently available decentralised tests offer advantages for decision making in the case of secondary outbreaks; An EU or EuFMD diagnostic reagents bank should be established for emergency supply of lateral flow devices (LFD); Further research and product development efforts are encouraged towards type specific tests; Guidelines on test usage should be developed by the Research Group in close collaboration with the Community Reference Laboratory for FMD, after performance testing of the devices for the diagnosis of the infection with the FMD- virus (FMDV) in convalescent and persistently infected animals; Training in the use of the tests as part of outbreak investigation should be included in the field based training programmes organized by the EuFMD Commission.

Introduction When Foot-and-Mouth Disease (FMD) occurs in a country previously recognised as free from the disease, huge emphasis is placed on the accuracy of diagnosis of the first case of the disease in any outbreak and this diagnosis should always be confirmed by a national reference laboratory 11

Working group led by Dónal Sammin1; contributing authors were Nigel Ferris2, Donald King2, Eoin Ryan1,Soren Alexandersen6, Stéphan Zientara3, Bernd Haas4, Hagai Yadin5, and David Paton2 1 CVRL, DAFF Laboratories, Backweston, Celbridge, Co. Kildare, Ireland 2 Institute for Animal Health, Ash Rd., Pirbright, Surrey GU24 0NF, UK. 3 AFSSA, 27-31 Avenue du General Leclerc BP19, Maisons Alfort, 94703, France 4 FLI, Boddenblick 5a, 17493 Greifswald, Insel Reims, Germany 5 Kimron Veterinary Institute, PO Box 12, Beit-Dagan 50250, Israel 6 National Centre for Foreign Animal Diseases, 1015 Arlington Street, Winnipeg MB R3E 3M4, Canada.

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(NRL) or an internationally recognised reference laboratory for FMD. Once the primary outbreak has been confirmed, secondary outbreaks should be rapidly identified in order to support the measures implemented to prevent further spread of the disease. However, confirming suspect cases at an NRL may delay implementation of control measures irrespective of all efforts made to minimise the time required for transport of specimens to the NRL. Alternatively, test systems could be deployed outside of the NRL (i.e. decentralised testing), moving the confirmatory diagnostic process closer to the location of affected animals in any future outbreak. This paper attempts to summarise options that are currently available to detect FMDV in samples from secondary outbreaks of FMD and to address some of the issues that arise if these tests are performed outside of specialized high containment laboratory facilities.

A confusing multiplicity of terminologies has been used to describe the concept of testing for FMD outside of a NRL; the terms “rapid testing”, “penside testing”, “on-farm testing”, “on-site testing”, “field testing”, “devolved testing” and “decentralised testing” have all been used synonymously. Assuming that NRLs are the centres designated for testing within their respective national territories, the term “decentralised testing” will be used throughout this paper to refer to all testing outside these laboratories, including that performed in regional laboratories.

Used with the necessary care, decentralised testing could assist in setting priorities for preemptive culling or emergency vaccination and could support the decision to withdraw a restriction on a holding.

Potential benefits of decentralised testing The drive for decentralised testing followed recognition that the delay in testing samples from suspected outbreaks of FMD caused by lengthy transport times to the NRL could potentially have a considerably negative impact on disease control. The main benefit of decentralised testing, whether on farm or in a regional or local laboratory, is to shorten the time from sampling to test result. This would enable a quicker implementation of the chosen control strategies. The relative speed of decentralised testing systems mean they could also be used to give an early indication of the likely outcome when investigating primary cases, although final confirmation would require full testing in an NRL. A further potential advantage of a decentralised testing strategy is the surge capacity it offers during a major epidemic. In such a case, the NRL may be operating close to its capacity, with the potential for delays in sample testing. Decentralised testing may relieve some of this pressure by facilitating rapid testing of large numbers of diagnostic samples either on-farm or at various regional laboratories, although this would depend on the test system used and the overall control strategy decided by the veterinary authorities.

In order to justify decentralised testing, the significance of the time saved and, if relevant, the capacity for increased testing must outweigh the benefits of maintaining testing in the NRL. Centralised testing has the advantage of an established system, usually with quality assurance standards, and involves personnel who have expertise and experience in their field. A range of tests are usually available at an NRL, which may be employed as appropriate. The decision to use decentralised testing, therefore, should be taken with due regard to the characteristics of the outbreaks and the chosen control strategy, giving appropriate consideration to the overall situation.

Detection of FMD virus – basic principles of currently available test methods The principal laboratory tests for the presence of FMDV are antigen detection ELISA (Ag-ELISA; (Have et al, 1984, Roeder and LeBlanc Smith, 1987, Ferris and Dawson, 1988), virus isolation (VI) and the reverse transcription-polymerase chain reaction test (RT-PCR; Reid et al, 2002; OIE Diagnostic Manual). Each has advantages and disadvantages. Ag-ELISA can only detect virus in samples with a high virus content such as vesicular lesion materials or cell culture supernatant fluids after prior VI. The method takes approximately 4 hours and can identify the

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serotype of FMDV. VI and RT-PCR methods are the most sensitive techniques and can be used to detect FMDV in many types of sample including blood, probang fluids, swabs and milk.

VI requires sensitive cell cultures to be maintained and may take up to 4 days. Ag-ELISA and RT-PCR are more easily automated than VI and more suited to dealing with a high sample throughput. Ag-ELISA and RT-PCR, but not VI, can detect the presence of FMDV regardless of whether live virus is present in samples undergoing testing. Therefore, there is potential to use these methods on samples that have been treated to inactivate FMDV at the point of collection, so that they can be tested in laboratories that do not meet the high containment standards for working with live FMDV. Methods to inactivate FMDV in clinical samples prior to RT-PCR are established, whereas the feasibility of doing this prior to Ag-ELISA is less clear.

Laboratories also undertake a range of serological tests for antibodies to FMDV and these can be helpful in identifying secondary outbreaks of FMD.

Novel portable devices to detect FMD antigen A recent development in FMD diagnostics has been modification of a technology (initially commercialised in human pregnancy diagnostic kits), which is based on the diffusion of coloured, antibody-coated latex beads or colloidal gold particles through a membrane towards an immobilising band of trapping antibody. These tests are referred to as either “(immuno)chromatographic strip tests” or “lateral flow devices” (LFDs). A prototype LFD has been shown to detect FMD virus with approximately equal sensitivity to the Ag-ELISA (Reid et al., 2001) and performed satisfactorily with specimens from two suspected premises during the UK outbreak in 2001 (Ferris et al., 2001). A new, commercially available LFD has been validated recently (Ferris et al, 2008) and was used in the laboratory as an initial rapid test during the 2007 UK FMD outbreak as well as on one farm by a veterinarian to diagnose FMD during that episode (Ryan et al, 2008).

If FMD viral antigen is present in sufficient concentration in the test specimen, a visible line will appear in the “test window” of the device within minutes. The test is thus rapid and easy to perform. However, current formats of this test do not serotype the virus present, although this may be considered of lesser importance in the confirmation of secondary outbreaks. Reading the device result by eye involves a degree of subjectivity; LFD readers are now available, but a requirement for their use could limit availability of the test and add to disease containment concerns. As the sensitivity of these devices is relatively low (as for the Ag-ELISA), they are only suitable for testing epithelial lesion material and vesicular fluid (which is expected to have the highest concentration of virus) and more than one affected animal within any particular group or herd of animals should be sampled and tested (on separate devices) to minimise the risk of a false negative test result.

The initial step in testing epithelial lesion material by any antigen detection method requires disruption of the tissue to release viral antigen, a process performed in the laboratory by grinding the tissue with sterile sand, pestle and mortar. To facilitate field use of LFDs, a simple extraction kit has been developed. The sample is added to a tube for mixing and grinding with sand, buffer and a disposable pestle. Thereafter, the liquid phase can be added directly to the test device. Vesicular fluid, or a swab which has absorbed vesicular fluid, can also be added to the buffer prior to applying to the device.

As for Ag-ELISA, methods to enable clinical samples to be treated at the point of collection so as to inactivate FMDV, without affecting subsequent LFD testing are not established. Work is ongoing to evaluate the possibility of recovering viral RNA or live virus for RT-PCR or VI from used LFDs.

Novel portable devices to perform RT-PCR Several different companies have developed portable PCR equipment in recent years. These platforms are robust and easy to use, having been designed for use by the military (to detect infectious agents such as Bacillus anthracis, spurred on by fears of bio-terrorism). Combined

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with mobile robotic RNA extraction equipment (or simple mechanical shaking devices), this machinery is currently being evaluated for decentralised diagnosis of FMD (King et al., 2008).

Pre-packaged PCR reagents, validated for FMD virus detection, are also commercially available and in future it will be possible to perform the entire RT-PCR process within disposable sealed tubes considerably reducing the risk of cross-contamination, although most systems currently on the market do not perform the nucleic acid extraction step. Unlike laboratory-based RT-PCR methods, only a small number of samples can be processed at once, but results are obtained more quickly.

Alternative methods of nucleic acid amplification have been developed which are isothermal (i.e. do not require thermal cycling and such precise instruments) and some of these processes can be formatted to produce a visible colour change if positive, allowing the test to be read without sophisticated equipment (Dukes et al., 2006; Lau et al., 2008). This could form the basis of a disposable decentralised testing kit; but none of these methods are yet routinely applied in FMD diagnosis.

Current genome detection methods are not typically designed to serotype FMD viruses. Use of a combined testing strategy involving both rapid antigen detection and rapid genome detection provides separate lines of evidence for the presence of infection and hence greater confidence in the diagnosis. However, in practice, this may not always be feasible (e.g. samples such as blood cannot be tested directly by antigen ELISA) and judgement must be used as to the level of certainty required from laboratory confirmation, according to the strength of the available field evidence (i.e. the clinical basis for suspecting FMD) and the consequences of the diagnosis.

Possible rapid testing options for diagnosis of secondary cases OPTION 1: Retain all testing for FMD at the NRL and take steps to expedite transfer of samples to the laboratory. LFDs and rapid, low-throughput RT-PCR stations can be deployed to enable preliminary results to be obtained quickly for selected urgent cases. Advantages of this approach are that testing is performed within specialized (QA-accredited) containment facilities by skilled staff experienced in performance characteristics of the test methods and in the interpretation of the test results. Redundancy in test options allows back-up testing in case of equivocal preliminary results. Automated processes and availability of trained staff means that a high throughput of samples is possible (such as that required for active surveillance programmes). The principal disadvantage is the delay in getting specimens to the laboratory, a problem that may be exacerbated by long journey distances and difficult transport conditions.

OPTION 2: Perform real-time RT-PCR in a local, regional or mobile laboratory using RNA extraction and PCR equipment or using a modularised portable PCR unit. Equipment similar to that used at NRLs could be used for this purpose, although this would be expensive, require highly trained personnel and take a considerable time to establish. The approach might be facilitated if such equipment was used for diagnosis of other diseases between FMD outbreaks and some regional laboratories may already have capacity for this type of testing for endemic diseases. Alternatively, portable/simplified RT-PCR test equipment could be used to provide a low throughput of rapid testing.

OPTION 3a: Use LFDs on the suspect premises. The official veterinarian who will have examined and sampled the suspect animals could perform this method and a test result could be available within 30 minutes providing that a high concentration of antigen is present in the test sample. Where an unexpected result is obtained a repeat test could be done immediately, on the same or additional animals. The low cost of the individual LFDs would facilitate their local distribution in “peacetime”, thus ensuring that devices would be quickly available for suspect cases. They could, for instance, be routinely included in the FMD field investigation kit. The official veterinarian would therefore have them immediately available while on the suspect farm.

OPTION 3b: Use a modularised portable PCR unit on the suspect premises. Following notification of a suspect case, this would require transport of the device to the farm, where it could be used to detect viral genome in blood, epithelium, OP fluid or other samples. A result

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would be available 150 minutes later. The advantage of this approach is that it would be more sensitive than the LFD, while still enabling on-farm testing. A disadvantage is that, due to the cost of these devices, they are likely to be stored in some regional depot rather than one being issued to each official vet. Therefore the device would have to be transported to the suspect farm following a request by the investigating vet. This time delay may be insignificant in some circumstances, but in other instances it may be just as quick to simply transport the samples to a regional or local laboratory (as discussed in option 2 above), or perhaps even the NRL. In the event of a major epidemic, this option would not be as efficient as using portable PCR in a regional/local/ mobile laboratory (option 2). This option depends on such devices becoming available for field use in the future.

Factors influencing the use of decentralised testing There is a trade-off or compromise between proximity of the testing process to the affected animal (allowing for speed of diagnosis) and performing the test in ideal laboratory conditions (ensuring reliability or accuracy of diagnosis). This compromise is summarised in Table 1. Of course, there is nothing to stop the national veterinary authority from applying these various options in series until satisfied that there is sufficient evidence to deem a herd to be infected or free from infection. A potential hierarchy of testing options is illustrated diagrammatically in Figure 1. One crucial point in support of this scheme, which may not be readily apparent from Figure 1, is that the animals which pose greatest risk (because they are likely to be shedding the most virus) would most probably be rapidly identified as positive using on-site tests (Options 3a or 3b) whilst the infected animals that pose lEast risk (as they are shedding the lEast amount of virus) should eventually be identified as positive by the combination of more sensitive test methods which are employed at NRLs (Option 1).

An issue that is sometimes overlooked is that if samples are not submitted to a NRL they may not become available for subsequent analysis; for example for genome sequencing to trace routes of transmission. A possible way of overcoming this problem would be to ensure that either original or prepared samples are sent on to the NRL immediately after local testing.

Alternatively, options 1, 2 and 3a might be conducted in parallel and this would probably provide the optimum balance of speed and reliability but would be unrealistic (overwhelm the NRL), costly and probably unnecessary in a major epidemic, but clearly feasible in smaller clusters of outbreaks such as e.g. the UK 2007 outbreaks.

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Relative ranking of testing process Speed Reliability Throughput

Option

Location

Method

1

NRL

Ag-ELISA and/or rtRT-PCR (Delivery + 1.5 to 5 hrs) §

2-3

1

1

2

Regional or mobile lab.

RT-PCR (Delivery + 1.5 5 hrs)*

2

2

1-3

3a

Suspect premises

LFD (30 minutes)

1

3

1

3b

“

Portable RT-PCR (2.5 hrs)

1-2

2

2-3

§

Assumes conventional testing methods but LFDs and/or portable PCR can also be used at the NRL for occasional (i.e. low throughput) high speed testing of urgent samples; *Depends on the method used Table 1: Relative ranking of different options for diagnosis of secondary cases of FMD during an outbreak (1 = best; adapted from Reid et al., 2006).

Issues that will arise with decentralised testing for FMD The veterinary authority in each country must decide whether and how they would use decentralised testing technologies in the event of any future outbreak. Clearly, the strategy chosen must be appropriate to the circumstances, and so this paper does not intend to be prescriptive, but rather seeks to clarify the issues involved. Some national authorities have already given considerable thought to how they might decentralise testing for FMD (and other OIE-listed diseases) in the event of a future disease outbreak; some examples are summarised at the end of this paper (Annex 1). If a decision is taken to opt for decentralised testing, a number of predictable issues arise; these issues are listed and briefly outlined below. Each of these issues could and should be resolved in “peacetime”. Action points are suggested after each item.

1. Comparative evaluation and field validation of rapid test systems.

Several studies have been conducted in which one or other of the rapid test systems described above have been compared with conventional laboratory-based testing methods for FMD (Reid et al., 2001; Hearps et al., 2002; Callahan et al., 2002, Ferris et al, 2008), demonstrating the efficacy of these methods. However, to the authors’ knowledge, none of the currently available test systems have been fully validated for field use. The authors recommend that the three testing options described above should be applied in parallel and their performance compared in a real “outbreak” situation. A potential opportunity for such field evaluation and validation exists in Anatolia, where FMD is endemic and where such a study could complement other work already in progress in that region to better understand and control the spread of FMD. An LFD supplied by Princeton Biomedical Corporation was employed with limited success during a pilot study on FMD outbreak investigation conducted in Erzurum in 2004 (Bulut et al., 2004). Testing of the LFD device using field samples is currently underway in Turkey.

It is important to note that following a primary diagnosis of FMD in any future outbreak, the NRL must ensure that whatever test system will be applied for diagnosis of secondary outbreaks is capable of recognising the causative strain of the virus.

2. Availability of test devices, reagents and equipment

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Options 3a and 3b require that sufficient LFDs or portable RT-PCR equipment are purchased and stored or that a contract for supply is agreed with a commercial source or that an EU “diagnostics bank” stockpile equipment to be used by member states as required, in advance of an outbreak. Both the shelf-life and cost of devices should be considered when making these arrangements. Option 2 requires that regional or mobile laboratories are equipped with the necessary precision instrumentation; the machinery could be provided in advance (and possibly put to other uses in peacetime) or instruments could be stored at the NRL and delivered to where they are most urgently required during an outbreak (the machines could be relocated during the outbreak as events dictate). With respect to either testing option, commercial companies need incentives to develop, validate, produce and market FMD testing systems during peacetime if such tests are to be commercially available when required during an outbreak. Planning is also required to ensure the logistical pathways to deliver materials for decentralised testing to the field during an outbreak are considered in advance.

Action: representatives of the national veterinary authority should decide in consultation with colleagues in the NRL; EU member states should consult with DG-SANCO on the possibility of LFDs and/or portable PCR units being included in an EU diagnostic reagents bank; the concept of a reagents bank has been the subject of a previous EuFMD position paper by Haas (2003).

3. Determine the levels of proof required to cull a herd or derestrict a herd Who will decide to cull or derestrict a herd? On what basis will this decision be made? Thought should be given as to how decisions will be made at a herd level, and how test results and other evidence (epidemiological and clinical information) will be considered in the decision-making process. It is critical that this is discussed and agreed in advance of an outbreak whilst there is time available for debate.

Action: representatives of the national veterinary authority should discuss with colleagues in the NRL and should attempt to formulate a “decision tree”.

4. Training and/or instruction in the use of rapid test systems Options 3a and 3b require that clearly-written, step-by-step instructions are provided with the test devices, such as those developed by FAO for the use of LFDs in the diagnosis of rinderpest (Roeder, 2002). Option 2 will require staff training.

Action: In the case of commercially-available LFDs, detailed instructions are provided with the devices. Similarly clear instructions should accompany any portable PCR system. The NRL could provide further training and instructions as required.

5. Containment risks and their mitigation It is important to emphasise that personnel entering and leaving livestock holdings, whether for the purposes of clinical surveillance or taking samples from suspect cases, must take the utmost precautions with regard to containment. If containment is insufficiently stringent, there is a risk of spreading the disease further.

Option 3 above does not pose a biosecurity risk (over and above that associated with any field investigation of suspect cases) as the testing is done on the suspect premises and the LFD devices may be discarded or sent to the NRL once the test has been performed. Portable PCR devices must either be used in a way that avoids their contamination or enables decontamination (e.g. complete submersion in disinfectant). Used LFDs and reaction cartridges may be discarded or sent to the NRL once the test has been performed.

Option 2: to avoid the prospect of live FMD virus being handled in non-high-containment laboratory facilities, samples could be treated on collection so as to destroy infectivity whilst preserving and stabilising RNA. However, this may to some degree limit the scope for subsequent characterisation of virus in samples scored as positive. However, such samples may still be subjected to sequence analysis, and work is continuing on protocols for the recovery of infectious virus by transfection of RNA into cell cultures.

As regards option 1, all NRLs for FMD should operate to the prescribed standards (Anon., 1993; Haas 2008).

Action: for option 2, protocols for treatment of samples should be developed and agreed that will ensure loss of infectivity without affecting viral RNA recovery.

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Use of decentralised testing systems in countries with endemic FMD This paper primarily examines the potential uses of decentralised testing in FMD-free developed countries. However, countries with endemic FMD may also find these devices beneficial in FMD control campaigns. Some countries may not have an FMD NRL but have good regional laboratories. In these laboratories, portable RT-PCR devices in which RNA extraction, RT and PCR are carried out within a disposable sealed tube may be useful as an alternative to stationary real time RT-PCR equipment, which can be susceptible to cross-contamination problems if the necessary infrastructure is not available. LFDs could be used in regional or local laboratories as an alternative to antigen ELISA. LFDs and portable RT-PCR devices could be brought onto farms during FMD investigations for rapid and convenient pen-side testing. This could be particularly useful where transport of samples to a regional or national laboratory is difficult or slow. The low cost of LFDs makes them particularly suitable for this role.

A further advantage to using these devices in endemic countries is that operating them is relatively simple. This may help overcome the problem of a lack of specialist or highly-trained staff.

The various scenarios in which these devices may be used would be influenced by the above factors (lack of an NRL, quality of regional lab network, distance from outbreak to laboratory, availability of trained staff) as well as cost and the nature of the FMD control campaign.

Conclusion Decentralised tests for FMDV detection offer considerable benefits for rapid confirmation of secondary outbreaks of FMD, but careful thought and planning are needed for their optimal use.

LFD devices are commercially available; in the face of a future outbreak, there may be pressure to use them. In such a scenario, it would be essential to have planned for their use and considered their role in the decision making process in advance. Early recognition of the disease will remain highly dependent on the awareness, vigilance and goodwill of the farming community and practising veterinarians. Furthermore, the decision to confirm or refute a diagnosis of FMD will continue to require careful assessment of all relevant clinical and epidemiological indicators as well as test results. The services of a NRL will remain indispensable, not only to confirm the primary outbreak and characterise the virus involved, but also to oversee all subsequent testing for the presence of the disease and to co-ordinate if not perform the large-scale serological testing required to substantiate freedom from FMD after an outbreak.

Recommendations: 1. Governments should carefully consider the use of decentralised tests in advance of any outbreak. It is important that decision-making processes and any applicable protocols are decided in the framework of the contingency planning in peacetime, rather than under pressure during an outbreak; 2. If governments decide to retain the option of using decentralised tests, they should consider in advance the necessary supply chain. The options are: (a) Purchase decentralised tests (e.g. LFDs) in bulk and stockpile them; (b) An EU diagnostics bank to purchase devices in bulk and make them available to member states as necessary; (c) Purchase small numbers of devices but with a draw-down contract whereby the supplier would provide a pre-arranged number of devices in bulk in the event of an outbreak.

3.

Current field trial should be continued and their result evaluated and further field testing of the decentralised devices should be carried out.

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References: ▪ Anon (1993). Security standards for FMD laboratories. Report of the 30th General Session of EuFMD, Rome, Italy; Appendix 6, pages 67-78. http://www.fao.org/ag/againfo/commissions/docs/SecurityStandards.pdf

▪ Bulut A, Sammin D, McDonagh O, Dinler U and Unal N (2004). Field evaluation of rapid “penside” tests for FMD antigen and FMDV-NSP antibody; FAO-EuFMD pilot study in Erzurum, Turkey; 12-25 September 2004.

Report of the EuFMD Research Group Closed Session, Chania, Crete, 12-15 October 2004; Appendix 13, pages 98-102. http://www.fao.org/ag/againfo/commissions/docs/greece04/App13.pdf.

▪ Callahan JD, Brown F, Osorio FA, Sur JH, Kramer E, Long GW, Lubroth J, Ellis SJ, Shoulars KS, Gaffney KL, Rock DL and Nelson WM. (2002). Use of a portable real-time reverse transcriptase-polymerase chain reaction assay for rapid detection of Foot-and-Mouth Disease virus. Journal of the American Veterinary Medical Association 220: 1636-1642.

▪ Dukes JP, King DP and Alexandersen S. (2006). Novel reverse transcription loop-mediated isothermal amplification for rapid detection of Foot-and-Mouth Disease virus. Archives of Virology 151: 1093-1106.

▪ Ferris NP and Dawson, M (1988). Routine application of enzyme-linked immunosorbent assay in comparison with complement fixation for the diagnosis of foot-and-mouth and swine vesicular diseases.

Veterinary Microbiology 16: 201-209.

▪ Ferris N, Reid S, Hutchings G, Kitching P, Danks C, Barker I and Preston S. (2001). Pen-side test for investigating FMD. Veterinary Record 148: 823-824.

▪ Ferris NP, Nordengrahn A, Hutchings GH, Reid SM, King DP, Ebert K, Paton DJ, Kristersson T, Brocchi E, Grazioli S and Merza M (2008). Development and laboratory validation of a lateral flow device for the detection of Foot-and-Mouth Disease virus in clinical samples. Accepted for publication in Journal of Virological Methods.

▪ Haas B (2003) A European Diagnostic reagent bank – what should it contain? Report of the EuFMD Research Group Closed Session, Gersensee, Switzerland 16-19 September 2003; Appendix 18, pages 132137.

▪ Haas B (2008) Minimum containment standards for FMD laboratories. Report of the EuFMD Research Group Closed Session, Erice, Sicily, 14-18 October 2008.

▪ Have P, Lei JC, Schjerning-Thiesen K. (1984) An enzyme-linked immunosorbent assay (ELISA) for the primary diagnosis of Foot-and-Mouth Disease. Characterisation and comparison with complement fixation.

Acta Vet Scand. 25(2): 280-96.

▪ Hearps A, Zhang Z and Alexandersen S. (2002). Evaluation of the portable Cepheid SmartCycler real-time PCR machine for the rapid diagnosis of Foot-and-Mouth Disease. Veterinary Record 150: 625-628

▪ King DP, Dukes JP, Reid SM, Ebert K, Shaw AE, Mills CE, Boswell L, Ferris NP (2008). Prospects for rapid diagnosis of Foot-and-Mouth Disease in the field using reverse transcriptase-PCR. Veterinary Record 162:315-6.

▪ Lau L.-T., Reid S. M., King D. P., Lau A. M. –F., Shaw A. E., Ferris N. P., and Yu A. C. –H. (2008) Detection of Foot-and-Mouth Disease virus by nucleic acid sequence-based amplification (NASBA). Veterinary Microbiology 126 (1-3): 101-110.

▪ Reid SM, Ferris NP, Bruning A, Hutchings GH, Kowalska Z and Akerblom L. (2001). Development of a rapid chromatographic strip test for the pen-side detection of Foot-and-Mouth Disease virus antigen. Journal of Virological Methods 96: 189-202.

▪ Reid SM, Ferris NP, Hutching GH, Zhang ZD, Belsham GJ and Alexandersen S. (2002). Detection of all seven serotypes of Foot-and-Mouth Disease virus by real-time, fluorogenic reverse transcription polymerase chain reaction assay. Journal of Virological Methods , 105: 67-80.

▪ Reid SM, Dukes J, Ebert K, Ferris N and King D. (2006). Diagnosis of FMD by RT-PCR: prospects for mobile and portable assays. Report of the EuFMD Research Group Open Session, Cyprus, October 2006 (in preparation).

▪ Roeder PL, Le Blanc Smith PM. (1987). Detection and typing of Foot-and-Mouth Disease virus by enzymelinked immunosorbent assay: a sensitive, rapid and reliable technique for primary diagnosis. Research in Veterinary Science 43: 225-232.

▪ Roeder PL (2002). Pen-side test for the field diagnosis of rinderpest; instructions for use. FAO, Rome, Italy, 2002.

▪ Ryan E, Gloster J, Reid SM, Li Y, Ferris NP, Waters R, Juleff N, Charleston B, Bankowski B, Gubbins S, Wilesmith JW, King DP, Paton DJ (2008). Clinical and laboratory investigations of the outbreaks of Footand-Mouth Disease in Southern England in 2007. Veterinary Record 163:139-47.

▪ Snowdon WA (1966). Growth of Foot-and-Mouth Disease virus in monolayer cultures of calf thyroid cells.

Nature 210: 1079-1080.

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ANNEX I Decentralised FMD testing in France A network of five regional laboratories has been put in place in order to perform FMD serology in the event of a future outbreak. These five laboratories have to participate in an annual ring test organized by the national reference laboratory (NRL), AFSSA, Maisons-Alfort. Moreover, they must test 800 sera per year in order to maintain competence. A similar network of five regional laboratories (each with high containment facilities) is to be put in place for rtRT-PCR testing to detect FMD virus. As for serological testing, these laboratories would have to participate in ringtests organized by the NRL; in addition regional laboratory staff would receive training from the NRL in biosafety measures that have to be followed. Suspected cases of FMD would continue to be sent to the NRL. The regional laboratories would only be authorized to perform rtRT-PCR in the event of FMD being confirmed by the NRL and only in the case of suspected secondary cases. Some of the laboratories have systems in place for collection of samples on farm.

Alternatively, in the case of remote farm locations, a transport system will be put in place to ensure biosecure delivery of specimens to the nearest laboratory. Testing would be performed under the supervision of the NRL and all results would be sent electronically to the NRL for interpretation; no result would be released without NRL authorisation. The extent to which such a system would be used in any future outbreak is difficult to gauge and will depend on such factors as the number of outbreaks and the outbreak locations. Decentralised rtRT-PCR testing is already in place for both bluetongue and avian influenza and has been extensively used for both; a network of ISO-accredited laboratories has been operating under control of the relevant NRL. The requirement for NRL oversight to ensure confidence in test results, imposes an upper limit on the number of laboratories that could be included in such a network.

Decentralised FMD testing in Germany There are three strands to either current contingency plans or applied research for decentralised FMD testing in Germany: (i) in case of an FMD epidemic - serological testing (by NSP ELISA) in laboratories of the German States (“Länder”) using reagents from a national test kit bank and testing sera derived from low risk premises in which no clinical signs of FMD have been seen; (ii) in “normal times” - screening of samples (by qRT-PCR at German State laboratories) to rule out FMD as a potential, but unlikely differential diagnosis, e.g. in suspected cases of bluetongue.

(Note: Where there is a clinical suspicion of FMD, specimens would be delivered with minimum delay by special courier, e.g. police helicopter, to the national reference laboratory FLI, Insel Riems) and (iii) a research project involving the validation of portable PCR machines that might eventually be deployed for use in the field by special task forces with clinical specimens derived from experimentally-infected animals.

Decentralised FMD testing in Israel In Israel FMD control policy consists of annual vaccination (with 150% coverage of the national herd) and quarantine in the event of an outbreak. The main problem in dealing with new outbreaks of FMD is the time interval that elapses between first appearance of clinical signs and first recognition of the disease. Rapid test methods will not necessarily ensure rapid recognition of FMD. Of much greater importance in this regard is that all persons involved with the livestock industry are aware of the disease and remain vigilant (regular training to remind key persons about FMD may be very useful in this regard). An LFD (Svanova), will be distributed this year to all regional veterinary services stations (six throughout the country) and this device will be used to support the local veterinary officer when faced with a clinical suspicion of FMD, in deciding whether or not to place the affected herd under quarantine. This new approach will be used in addition to sending samples to NRL for confirmation by conventional testing methods; the time taken to reach the NRL with samples from anywhere in the country would not exceed four hours.

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Appendix 21 FOOT-AND-MOUTH DISEASE (FMD) TRAINING COURSES Brochure

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Appendix 22 PPT: EUFMD TRAINING INITIATIVE K. Sumption

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Appendix 23 REPORT FOR THE RESEARCH GROUP FOR 2007-2009 A. Dekker

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Appendix 24 FMD ANTIGEN AND FORMULATED VACCINE RESERVES EUFMD SURVEY APRIL 2009 K Sumption

Survey: the Questionaire in English and French was sent to all EuFMD member states, North African countries and the Russian Federation.

Responses: positive responses from 10 countries/FMDV bank managers in EuFMD member states/North Africa; responses received from each those which held antigen banks in 2007.

Three of the banks are held in non-EU countries.

Antigens held: all banks continued to hold type O antigens, and almost all held serotype A and Asia-1 antigens.

Relationship to priority antigens in the WRL recommendations: The type O and Asia-1 holdings are in line with WRL recommendations.

Of the eight different type A antigens held in 2009, only 4 banks hold >0.5 million doses of A22 Iraq, a relevant antigen for the current type A Iran 05 epidemic.

None, as yet, hold a homologous antigen (serotype A Iran 05/A TUR06), although homologous vaccines have been produced and used in the field in Turkey, Trans-Caucasus and Iran since 2006, and vaccine matching results indicate their better expected level of protection compared to A22 Iraq for the strains circulating in the past 6-12 months.

WRL recommend SAT2 Saudi Arabia as high priority, but SAT2 Eritrea or SAT2 ” East Africa” is held in only small quantities by the five of the 10 banks.

Total reported antigen/vaccine holdings: were 2% lower in 2009 than 2007. A significant reduction in type O holdings and increase in SAT2 was reported.

Use of the emergency banks in 2007-9: Only one known supply of vaccine from the vaccine banks in period 2007-April 2009, for supply to middle-East (Iraq in 2009).

Conclusions: ¾ ¾ ¾ ¾

¾

¾

There remains a significant lag in response of vaccine producers and bank managers to change in the antigenic types circulating in the region; WRL recommendations in 2007 for type A22 have not been applied by majority of banks; Lack of a homologous A Iran 05/A TUR06 and thereby places reliance upon A22 Iraq or use of other type A if available at very high potency; The lack of type A Eritrea in any bank is of potential concern, although very high potency type A 22 vaccines held by some banks have been shown to protect against the FMDV type A circulating in Egypt 2006 (and which remains circulating in 2009); Lack of FMDV strains/antigenic types originating from virus pool 2 (South Asia, mainly the Indian pool of FMDV types A, O and Asia-1) or pool 5 (West/Central Africa pool of O, A, SAT1 &2). The risk associated with pool 2 and pool 5 FMD strains needs to be reexamined, as pool 2 has been a source of FMDV for Europe in the past (type A in the Balkans in 1996, and O PanAsia 1 in 2001), and pool 5 viruses have entered North Africa at lEast twice in the past 10 years; SAT 2 antigens: the holding size is generally small and with topotype/strains originating from Southern Africa. Relevance of these holdings to risk from circulating SAT2s is unclear and needs urgent re-evaluation.

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Table 1: Reported holdings (in millions of cattle doses) in 2009. Last column indicates number of banks holding one or more antigens of a serotype.

Total type O A Asia-1 C SAT1 SAT2 SAT3

2009 20.500 37.250 9.500 6.650 3.350 5.000 1.000

2007 24.950 36.400 8.750 6.650 3.250 4.350 1.000

Change -4.45 0.85 0.75 0.00 0.10 0.65 0.00

% -18 2 9 0 3 15 0

Banks 10 9 9 2 3 7 1

Total

83.250

85.350

-2.10

-2

10

Table 2: Antigens held, by virus pool (7 extant virus pools plus the extinct European pool 8).

Note that NO antigens originate from the virus pool 2 (South Asia, mainly the Indian pool of FMDV types A, O and Asia-1) or pool 5 (West/Central Africa pool of O, A, SAT1 &2).

2009 O A Asia-1 C SAT1 SAT2 SAT3 Total

3 8 1 1 2 3 1 18

7 2 3 4 5 6 (South 8 (South (West (East (West (Souther America 2007 Asia) Eurasia) Africa) Africa) n Africa) ) (Europe) O 3 O Taiwan Manisa O BFS 8 A May 97 5 2 1 Shamir 1 C Obb 1 Zim Eritrea/E 3 Saudi ast A Zim/SA 1 SA 17 2 0 8 1 0 2 3 1 Pool 1 (East Asia)

Figure 1: Current FMD virus pools, as recognised by the OIE/FAO FMD ref Lab network (2008).

3

7

2

5 1 4 6

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Appendix 25 FINANCIAL STATEMENT AND REPORT OF THE EUFMD YEARS ENDED 31 DECEMBER 2007-2008 EuFMD Secretary

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Appendix 26 FINANCIAL POSITION OF THE EuFMD COMMISSION: ADMINISTRATIVE BUDGET PAPER FOR 2010-2011 EuFMD Secretary

1. The funding of the administrative activities of the Secretariat of the EuFMD Commission, and of the mandated activities required under the Constitution and for which no other sources of funding are available, is derived from the annual contributions of member countries to Trust Fund MTF/INT/011/MUL; 2. The administration of the Commission is wholly supported from the members’ contributions from MTF/INT/011/MUL. FAO provides office space, lighting and heating, and manages the call for contributions to the member states. In addition, under a separate financial agreement between FAO and the EC, activities on FMD control are financially supported through an 8 m€ agreement (current agreement for 48 months from September 2005) which is handled through Trust Fund MTF/INT/003/EEC. A third TF, for additional contributions by member states for specific actions, is maintained but has not received a contribution in > 6 years. This TF could be useful should MS or non-members wish to support certain actions, parallel to the situation of activities supported by the EC; 3. At the 37th Session, April 2007, the members agreed to contribute a budget of US $528,890 for each year of the biennium, 2008-9; 4. The annual contributions of member countries are agreed at the General Session of the Commission, held every 2 years, and the 38th Session in April 2009 must fix the contributions to be provided in 2010 and 2011. It is the responsibility of the outgoing Executive Committee to propose the administrative budget for the next biennium; 5. The 76th Session in June 2008, in response to the rapid decrease in the projected financial balance as a result of the US$ deprecation against the euro, made recommendations for reducing the costs of the Secretariat, including recruitment of the replacement administrative assistant at the G4 scale; 6. The 77th Executive Committee further reviewed the financial position of the Commission, and on the basis of the paper provided by the Secretariat (Annex 19 of 77th Session report), and on the basis of the provisional 2008 Financial position, recommended the annual budget (contribution of member states) in 2010 and 2011 should be USD 560,623; 7. Following the publication of the Final Financial report for 2008, and in line with recommendations of the 77th Executive Committee, the Secretariat has reviewed the expenditure in 2008, including the impact of the cost saving measures, and has revised the projected costs of the activities of the Secretariat in 2010 and 2011. The Financial position at the end of 2008 was better than expected from provisional report available at the December meeting (by some US$ 75,000); the revised projection of expenditure in 2009, 2010 and 2011 is shown in Table 1; 8. The annual total contribution in 2010-2011 required to cover the expected costs of the Secretariat and the core contracts and functions of the Commission is US$ 547,352. This represents an increase of circa 1.3% p.a for Member States, whereas costs (in US$) because of depreciation of the US$ have risen (in US$ terms) at a higher rate (average of 6.5% in 2006-8); 9. The Secretariat of the Commission is composed of one technical Secretary (P5 scale) and one administrative assistant, and this is considered by the previous General Session to be the minimum required staff number for the Secretariat to perform its functions. The additional Items of annual expenditure comprise contracts (the contract with the WRL Pirbright, at 75,000 US$ per year in 2008 and 2009), a facility to commission contracts for studies as decided by the Executive Committee, and the travel expenses of the Secretariat, and of staff assigned by member states to the Secretariat, and of experts from the Research

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group to attend the Annual meeting and to assist in activities not covered by the EC contract; 10. On the basis of an annual budget of USD 547,352, and on a proportionate rise in contributions by the member nations, the proposed scale of contributions for 2010-11 is shown in Table 3; Budget for 2010-2011 A budget proposal for 2010 and 2011 is made below, based on the following: 11. Salaries: the Secretariat comprises one P5 professional and one administrative assistant (G4/G5 level), the Minimum staff level agreed by previous Sessions; the ceiling on administrative assistant costs was recommended by the 76th Session as costs saving measure. In line with FAO budgetary planning procedures, a 4% figure has been applied for the annual growth in salaries and non-staff costs. Based on the staff in post, staff related costs, and associated Secretariat costs (travel, office, assistance at Sessions) for 2010-11 were estimated (Table 1); 12. Contracts: the budget required for contracts (including WRL contract, in 2009 set at 75,000 US$ per annum) in 2010-11 was set at 100,000 USD/year. This is effectively no change to that agreed in 2007; 13. The allocation in the contracts budget line allows the Executive to take decisions to support actions for which other funds are not available; 14. The priorities for the funds allocated to the Contracts budget line, for workshops, actions requiring consultancies, diagnostic or scientific service contracts, should be decided by the Executive and/or the General Session, whichever comes first; 15. Travel: costs will rise (assumed to double) compared to 2008, since in 2010-2011 an additional professional officer will be supplied by France for surveillance activities in Mediterranean, Middle-East and West Africa. As noted below, some of the travel budget could be used as a contingency fund; 16. General operating costs: these will be kept to the ceiling agreed at the 76th Session, as a cost-saving measure, a reduction compared to 2007-8; 17. Financial risks: The estimates for the euro-related costs (salaries) are uncertain because of the impact of the exchange rate fluctuations; in 2007-8 the budget of the Commission suffered as a result of the high € (with a 19% effective reduction in budget), requiring significant cost saving measures. Given that most expenditure is in €, the argument to fix contributions in € is strong, and has been made at previous General Sessions; 18. Risk mitigation: if required by exception circumstances, such as a devaluation of the US$ by 10%, or substantial underpayments by member states, savings of up to 10% (55,000 US$) could be achieved by drastic reduction in travel, and by a freeze on new short term contracts (for scientific studies). In these circumstances the functions could be continued if other sources (EC) were in agreement to use Trust Fund MTF/INT/003/EEC; 19. Other Risk mitigation measures could include fixing contributions in € for those member states that wish to do so. This option will be discussed further at the 38th Session.

Note regarding Country contributions These are shown in Table 2 and 3.

1. The categorisation of countries used for contributions has been that agreed by the 32nd Session, based on ruminant and pig livestock population, and the Member State contribution to FAO. 2. No change to the categorisation of countries has been proposed by Members. The increase to contributions below has therefore been made pro rata.

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TABLE 1.

EUROPEAN COMMISSION FOR THE CONTROL OF FOOT-AND-MOUTH DISEASE (EuFMD) TRUST FUND 904200 MTF/INT/011/MUL 2010 and 2011 budgets (US$) for approval by the 38th Session Budget for 2008 is from the Final Financial report, for 2009 is predicted expenditure.

2007

2008

2008

2009

2009

Final

Approved

Final

Approved

Predicted

37th

37th

Session

Session

2010

2011

For

For

approval

approval

38th

38th

Session

Session

Secret.

216,796

211048

220,592

219490

229,416

238,592

248,136

Temp.

12,668

30000

7045

33000

5000

5200

5408

109,737

94100

130,809

97900

115000

119600

124384

120,179

96000

(-5852)

96000

97900

100000

100000

39,057

70000

18,603

70000

60000

60000

60000

GOE

70,999

16000

43,941

17000

12000

12480

12979

Expd

747

3600

1573

3600

3600

3744

3894

Assist.

Admin assist.

Contrs Duty Travel

equip.

Non-

333

0

exp.

Equip ment 7500012

Liab.

570,183

12

520748

492,544

536990

522,916

539,616

Contract with IAH-Pirbright (WRL) – liability is for activities performed in 2008.

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554,801

Table 2. Proposed revision in relation to historic levels of contribution, expressed in US$ (top) and euro (below), using exchange rate of 1/1/03, 11/1/05 and 1/1/07, and 31/12/08.

Contr Cat

$ Annual

Annual Cont.

Annual

Annual Contr.

Proposed revision

Contr.,

2004-2005

Contr. 2006-7

2008-9

2010-11

2002 & 2003 1

US$

30500

39,650

41,260

42,374

2

26000 13000

15300

19,890

20,700

21,260

3

7800

9200

11,960

12,450

12,786

4

2600

3000

3,900

4060

4170

496,210

528,890

547,352

TOTAL (US$) EURO

euro

equivalen

euro at 1/1/05

at 1/1/03

Euro at 1/1/07

Euro at 31/12/08

(official e.r.1/07)

(UN Op Ex rate)

ce 1

TOTAL

euro

29,437

30,290

31,358

32,077

2

14,767

15,195

15,732

16,093

3

8,879

9,137

9,462

9,679

4

2,895

2,979

3,086

3,156

368,401

379,076

401,956

414,237

(euro)

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Table 3: Proposed annual contributions (in US$) of member countries to the administrative budget of the EuFMD Commission (MTF INT/011/MTF), for the biennium 2010-11.

MEMBER

LEVEL

COUNTRY

ANNUAL CONTR-

CONTR- 2008-9

PROPOSED CONTR- 2010-11

2006-2007

(to be filled from table 2) ALBANIA

4

3,900

4060

4170

AUSTRIA

3

11,960

12450

12,786

BELGIUM

2

19,890

20700

21,260

BULGARIA

3

11,960

12450

12,786

CYPRUS

4

3,900

4060

4170

4060

CROATIA

4

3,900

CZECH

3

11,960

REPUBLIC

4170 12,786

12450

DENMARK

2

19,890

20700

21,260

FINLAND

3

11,960

12450

12,786

FRANCE

1

39,650

41260

42,374

GERMANY

1

39,650

41260

42,374

GREECE

3

11,960

12450

12,786

HUNGARY

3

11,960

12450

12,786

ICELAND

4

3,900

4060

4170

IRELAND

3

11,960

12450

12,786

ISRAEL

4

3,900

4060

4170

ITALY

1

39,650

41260

42,374

LATVIA

4

4060

4170

LITHUANIA

4

3,900

4060

4170

LUXEMBOURG

4

3,900

4060

4170

FYROM

4

3,900

4060

4170

MALTA

4

3,900

4060

4170

NETHER.

2

19,890

20700

21,260

NORWAY

3

11,960

12450

12,786

POLAND

2

19,890

20700

21,260

PORTUGAL

3

11,960

12450

12,786

ROMANIA

2

19,890

20700

21,260

SERBIA

3

11,960

12450

12,786

MEMBER

LEVEL

COUNTRY

ANNUAL CONTR-

CONTR- 2008-9

PROPOSED CONTR- 2010-11

2006-2007

(to be filled from table 2) SLOVAK R.

3

11,960

12450

12,786

SLOVENIA

4

3,900

4060

4170

SPAIN

2

19,890

20700

21,260

SWEDEN

2

19,890

20700

21,260

SWITZ.

2

19,890

20700

21,260

TURKEY

2

19,890

20700

21,260

U.K

1

39,650

41260

42,374

496,210.00

528,890

547,352

TOTAL

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Appendix 27 LIST OF PARTICIPANTS

DELEGATIONS–EuFMD Member Countries Albania

Bulgaria

Kapllan SULAJ Director of Agriculture, Food and Consumer Protection Ministry of Agriculture, Food and Consumer Protection Sakaderberg Suare, 2 Tirana Tel: +35 542225539 e-mail: k_sulaj@yahoo.com

Georgi Kirilov GEORGIEV Head of Exotic and Emerging Diseases Laboratory of the National Diagnostic and Research Veterinary Medicine Institute 15 A Pencho Slaveikov Blvd Tel: +359 2 834 1004 e-mail: georgivet2@yahoo.com

Austria Ulrich HERZOG Chief Veterinary Officer Austria, Mag. Ministry of Health, Family and Youth 1031 Vienna, Radetzkystr. 2 Tel: +43 1 71100 4824 / Fax: +43 1 7104151 e-mail: CVO-Austria@bmgfj.gv.at Belgium Philippe HOUDART Belgian Federal Agency for the Safety of the Food Chain (FASFC) - WTCIII Kruidtuinlaan 55, 1000 Brussels Tel: +32 2 2118281 Mobile: +32 478 500172 e-mail: philippe.houdart@favv.be Gerard J.A. LAMSENS Deputy CVO FPS – Public Health, Food Chain Safety and Environment Eurostation Bloc II- 7 floor Place Victor Horta 40, bte 10 1060 Brussels Tel: +32 2 5247302 e-mail: Gerard.lamsens@health.fgov.be Kris DE CLERCQ Department of Virology Section Epizootic Diseases CODA-CERVA-VAR Groeselenberg 99 B-1180 Ukkel Tel: +32 2 3790592 / +32 2 3790400 e-mail: kris.de.clercq@var.fgov.be

Ilian BOYKOVSKI Exotic and Emerging Diseases Laboratory of the National Diagnostic and Research Veterinary Medicine Institute 15 A Pencho Slaveikov Blvd Tel: +359 2 9159842 e-mail: ilian.boykovski@nvms.government.bg Croatia Ankica LABROVIC Head of Animal Health MAFRD – Veterinary Directorate Miramarska, 24. Zagreb Tel: + 385 1610 6670 e-mail: labrovic@mps.hr Besi ROIC Croatina Veterinary Institute Savska Cesta 143, Zagreb Tel: + 385 16123 674 Cyprus Charalambos THEODOROU Senior Veterinary Officer Larnaka District Veterinary Office 29, Yiannou Kranioditi Str. 6532 Larnaka Tel: +35724824275 e-mail: ctheodorou@vs.moa.gov.cy Cristina PITTA Cyprus Perm. Representation at FAO

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Czech Republic Milan MALENA Director General (CVO) State Veterinary Administration of the CR Slezská 7 120 56 Prague 2, CR Tel: +420 227 010 142 e-mail: m.malena@svscr.cz; Petr SATRAN State Veterinary Administration of the CR Slezská 7 120 56 Prague 2, CR Tel: +420 227 010 150 e-mail: p.satran@svscr.cz Zbynék SEMERÁD State Veterinary Administration of the CR Slezská 7 120 56 Prague 2, CR Tel: +420 227 010 145 e-mail: z.semerad@svscr.cz Jirí KUPSA State Veterinary Administration of the CR Slezská 7 120 56 Prague 2, CR Tel: +420 227 010 144 e-mail: j.kupsa@svscr.cz Daniela MOYZSOVÁ Andrea PONDELICKOVA Denmark Jan MOUSING Chief Veterinary Officer Ministry of Food, Agriculture and Fisheries MØrkhØj Bygade 19, DK-2860, SØborg Tel: +45 3395 6115 e-mail: jam@fvst.dk Birgit HENDRIKSEN Deputy Chief Veterinary Officer Ministry of Food, Agriculture and Fisheries MØrkhØj Bygade 19, DK-2860, SØborg Tel: +45 3395 6036 e-mail: bh@fvst.dk Tina MØRK Veterinary Officer Ministry of Food, Agriculture and Fisheries MØrkhØj Bygade 19, DK-2860, SØborg Tel: +45 3395 6042 e-mail: tm@fvst.dk Finland / Finlande Katri LEVONEN Senior Veterinary Officer

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Ministry of Agriculture and Forestry Department of Food and Health Marianku 23, Helsinki PO Box 30, FI-00023 Government Tel: +358 9 160 53437 e-mail: katri.levonen@mmm.fi Ulla RIKULA Veterinarian Finnish Food Safety Authority Evira Mustialankatu 3, FI-00790 - Helsinki Tel: +358 20774585 e-mail: ulla.rikula@evira.fi France Jean-Luc ANGOT CVO Directeur général adjoint Direction Générale de l’Alimentation Ministère de l'agriculture et de la pêche 251 rue de Vaugirard 75732 Paris Cedex 15 Tel: +33 (0) 149558177 e-mail: jean-luc.angot@agriculture.gouv.fr Yves LEFORBAN Inspecteur général de santé publique vétérinaire Conseil Général de l’Agriculture de l’Alimentation et des Espaces Ruraux Ministère de l'agriculture et de la pêche 251 rue de Vaugirard 75732 Paris Cedex 15 Tel: +33 (0) 149558129 e-mail: yves.leforban@agriculture.gouv.fr Germany Rolf KRIEGER Head of Department Federal Ministry of Food, Agriculture and Consumer Protection Rochusstr. 1, D-53123, Bonn Tel: + 49228995293502 e-mail: rolf.krieger@bmelv.bund.de Greece Spiridon DOUDOUNAKIS Head of Unit of Animal Diseases Ministry of Rural Development and Food 2, Acharnon Str. 10176 Athens Tel: +30 21 08836420 e-mail: vetserv@ath.forthnet.gr Hungary / Hongrie Lajos BOGNÁR Deputy Chief Veterinary Officer

38th General Session of the EuFMD – 28-30 April 2009. FAO, Rome

Central Agricultural Office H-0124 Budapest, Keleti Károly utca 24 Tel: +36 1 301 336 9498 e-mail: bognarl@oai.hu Iceland .........................

Ireland

Via Giorgio Ribotta 5, 00144 Rome Tel: +39 06 59946744 e-mail: n.santini@sanita.it Latvia ………………………..

Lithuania ………………………..

Michael SHERIDAN Deputy Chief Veterinary Officer Department of Agriculture, Fisheries and Food Kildare St, Dublin 2 Tel: +353 1 6072645 e-mail: michael.sheridan@agriculture.gov.ie

Luxembourg ………………………..

Eoin RYAN Department of Agriculture, Fisheries and Food Kildare St, Dublin 2 Tel: + 353 1 6072732 e-mail: eoin.ryan@agriculture.gov.ie

Malta ..........................

Israel .................................

Italy Romano MARABELLI Head of Departament for Veterinary Public Health, Nutrition and Food Safety.

Ministry of Labour, Health and Social Politics Via Giorgio Ribotta 5, 00144 Rome Tel: +39 06 59946902 e-mail: alimentivet@sanita.it Piergiuseppe FACELLI Chief of International Office Department for Veterinari, Public Health, Nutrition and Food Safety.

Ministry of Labour, Health and Social Politics Via Giorgio ribotta 5, 00144 Rome Tel: +39 06 59946613 e-mail: p.facelli@sanita.it Silvia BELLINI Veterinary Officer Istituto Zooprofilattico Sperimentale della Lombardida e dell’Emilia Romagna Via Banchi, 9. 25124 Brescia Tel: +39 030 2290 366 e-mail: silvia.bellini@bs.izs.it Nicola SANTINI Veterinary Officer of Directorate of Animal Health and VEterinary Medicines.

Ministry of Labour, Health and Social Politics

The former Yugoslav Republic of Macedonia ..........................

(The) Netherlands Peter DE LEEUW Chief Veterinary Officer Department of Food Quality and Animal Health Ministry of Agriculture, Nature and Food Quality The Hague e-mail: p.leeuw2@chello.nl Norway Keren BAR-YAACOV Chief Veterinary Officer Norwegian Food Safety Authority Department of Health and Hygiene PO Box 383, N-2381 Brumunddal Tel: +47 2321 6800 e-mail: kebay@mattilsynet.no Siri Margrete LOTVEDT Senior Veterinary Adviser Norwegian Food Safety Authority Department of Health and Hygiene PO Box 383, N-2381 Brumunddal Tel: +47 5168 4356 e-mail: simlo@mattilsynet.no Poland ………………………..

Portugal Carlos AGRELA PINHEIRO Director General of Veterinary Services

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Largo Academia Nacional de Belas Artes, nº 2 1249-105 Lisboa Tel: +351 21 323 9655 e-mail: dirgeral@dgv.min-agricultura.pt Romania / Romanie ..........................

Serbia ..........................

Slovakia Lubomir JANIUK State Veterinary and Food Service Bratislava Peter JADUD State Veterinary Institute Zvolen Slovenia Breda HROVATIN Head of Animal Health and Welfare Section Veterinary Administration of the Rep. of Slovenia Parmova 53 Tel: +386 1 300 13 06 e-mail: breda.hrovatin@gov.si Aleksandra HARI Veterinary Administration of the Rep. of Slovenia Parmova 53 Tel: +386 1 300 13 24 e-mail: Aleksandra.hari@gov.si Spain ……………………….

Sweden Leif DENNEBERG Chief Veterinary Officer Swedish Board of Agriculture SE-551 82 Jönköping Tel: +46 36 155000 e-mail: leif.denneberg@sjv.se Ulla CARLSSON National Veterinary Institute Head of Department, Process Owner Se-751 89 Upssala, Sweden Tel: +46 18 674 000 E-mail: ulla.carlsson@sva.se Karin AHL

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Swedish Board of Agriculture Head of Dep., Department for Animal Welfare and Health Swedish Board of Agriculture SE-551 82 Jönköping Tel: +46 36 155000 e-mail: karin.ahl@sjv.se Switzerland Josef SCHMIDT Office Vétérinaire Fédéral (OVF) Comité de Direction Secteur Soutien à l’application de la législation Schwarzenburgstrasse 155 CH-3003 Berne Tel: +41 31 3238499 e-mail: josef.schmidt@bvet.admin.ch Turkey Haluk ASKAROGLU General Directorate of Protection and Control Head of Animal Health Department GDCP, Akay Cad.. Ankara Tel: 090 312 418 63 17 A. Naci BULUT FMD Expert Head of the Diagnosis Department FMD Institute Ankara Tel: +90 312 2873600 e-mail: nacib@sap.gov.tr United Kingdom Nigel GIBBENS CVO Defra Area 5B Nobel House 17 Smith Sq. , London SW1P 3JR Tel: +44 207 238 6495 e-mail: Nigel.GIbbens@defra.gsi.gov.uk Emma PAUL Veterinary Adviser Defra Area 5D Nobel House, 17 Smith Sq. SW1P 3JR London Tel: +44 (0) 207 238 5070 e-mail: Emma.Paul@defra.gsi.gov.uk Observers / Observateurs African Union Ahmed EL SAWALHY

38th General Session of the EuFMD – 28-30 April 2009. FAO, Rome

Director - IBAR Interafrican Bureau for Animal Resources Museum Hill, Westland Rd. PO box: 30786 -00100, Nairobi, Kenya Tel: + 254 203674000 e-mail: ahmed.elsawalhy@au-ibar.org Algeria Rachid BOUGUEDOUR Director Ministére de l’Agriculture 12, Boulevard COlonel Amirouche Alger Tel: + 213 (0) 21743434 e-mail: dsval@wissal.dz Armenia Khachik SARGSYAN Head of Scientific Institute of Stock Breeding & Veterinary Nubarashen Plato 2, Yerevan Tel: + 374 1 (0) 473400 e-mail: scsbv@yahoo.com Satenik KHARATYAN FAO National Consultant Erebouni 12, Yerevan Tel: + 374 1 (0) 43 51 28 e-mail: satenik_vet@mail.ru Azerbaijan Tamilla ALIYEVA State Veterinary Service 7a, N. Narimanov Str., Baku City Tel: + 99412 5620245 e-mail: tamilla_aliyeva@list.ru Bosnia-Herzegovina Darko COBANOV Deputy Director State Veterinary Office of Bosnia and Herzegovina Radiceva 8/1 , 71000 Sarajevo Tel: + 387 33 565 702 e-mail: darko.cobanov@vet.gov.ba

Fatoh Mostafa DARWISH General Organization for Veterinary Services Tel: 020233372638 e-mail: fatouhd@yahoo.com Yasser BASYOUNI FMD – TCP Director – FAO 1, Nady Elseid St., Cairo Tel: +20233362159 e-mail: yasser.basyouni@fao.org EFSA Per HAVE Animal Health and Welfare Unit (AHAW) – EFSA Largo Natale Palli, 5A. 43100 Parma Tel: + 39 0521 036 845 e-mail: per.have@efsa.europa.eu European Commission Alf-Eckbert FÜSSEL EC Commission DG SANCO/E2 Health and Consumers Directorate-General, Unit D1 Animal Health and Standing Committees Rue Froissart, 101, 3/67 B-1040 Brussels Belgium Tel: +32 2 2950870 e-mail: Alf-Eckbert.Fuessel@ec.europa.eu

Magdalena ZIETARA

EC Commission Health and Consumers Directorate-General, Unit D1 Animal Health and Standing Committees Rue Belliard, 232, 3/37 B-1040 Brussels Belgium Tel: +32 2 296 58 72 e-mail: magdalena.zietara@ec.europa.eu FVE

China

J. VAARTEN Federation fo Veterinarians of Europe 1, Rue Defacqz B-1000 Brussels Tel: +32 25337020 e-mail: jan@fve.org

M. ZHANG China Permanent Representation at FAO

Georgia

Egypt

Dzasmashvili KOBA Head of Veterinary supervision Dep.

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National Service of Food Safety, Veterinary and Plant protection 15a Tamarashvili str, 0177, Tbilisi Tel: +995 32 392261 e-mail: koba_dzmashvili@fvp.ge

Yong Joo KIM OIE 12, Rue de Prony, 75017 Paris France Tel: +33 (0) 144151863 e-mail: yj.kim@oie.int

Zurab BEN YAN Intervet

Paraguay

Paul VAN AARLE Director Institutional Sales PO Box 31 5830 AA Boxmeer The Netherlands Tel: +31 485585228 e-mail: paul.vanaarle@intervet.com

Armin HAMMAN Viceministro de Ganadería Vicente VERA Director de Investigación y Producción Animal

Iran

Liz CORONEL Ripresentante Permanente Adjunta ante la FAO

Mehdi KHALAJ National Project Coordinator

Prionics

Vahid OTAROD Iran Veterinary Organization Vali-aser Av. S.J. Asadabadi PO Box 14155-6349 Tel: + 98 21 88806409 e-mail: votarod@hotmail.com

Wim SCHIELEN Business Manager Platinastraat 33, NL-8211 AR Lelystad The Netherlands Tel: +31 320 714 003 e-mail: Wim.schielen@prionics.com

Kazakhstan

Somalia

Kalamkas SHAMPIYEVA National Centre Reference, monitoring laboratori diagnostic in methodology in veterinarian Ministry of Agricolture Rep. of Kazakhstan Astana City, 15. Mustafin Str. App 64 Tel: + 7 717 230 14 69 e-mail: kalamkas.Shampiyeva@fao.org e-mail: Kalam62@mail.ru

Awes ABUKAR Somalia Perm. Representation at FAO

Lebanon George KHOURI RAHC – ME Coordinator FAO Tel: +961 70 166 172 e-mail: George.Khoury@fao.org OIE - World Organisation for Animal Health Caroline PLANTE OIE (Sub-Regional Representation in Brussels) Rue Breydel, 40, 1040 Brussels Belgium Tel: + 32 (0) 22358613 e-mail: c.plante@oie.int

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Abshir OSMAN Somalia Perm. Representation at FAO EuFMD Research Group / Aldo DEKKER Chairman of the Research Group Central Veterinary Institute PO Box 65, Lelystad 8200 AB The Netherlands Tel: +31 320 238603 e-mail: aldo.dekker@wur.nl Bernd HAAS Senior Scientist Head NRL FMD FLI, Friedrich-Loeffer- Institute 17493 Greifswald, Germany Tel: + 49 383517-0, -211 e-mail: bernd.haas@fli.bund.de Jef. M. HAMMOND Head of Vesicular Reference Laboratories Head of WRLFMD Institute for Animal Health,

38th General Session of the EuFMD – 28-30 April 2009. FAO, Rome

Pirbright Laboratory Ash Rd, Pirbright, Woking, Surrey GU24ONF UK Tel: +44 (0) 1483 231211 e-mail: jef.hammond@bbsrc.ac.uk Emiliana BROCCHI Istituto Zooprofilattico Sperimentale della Lombardida e dell’Emilia Romagna Via Banchi, 9. 25124 Brescia. Italy Tel: +39 030 2290310 e-mail: emiliana.brocchi@bs.izs.it FAO Samuel C. JUTZI Director Animal Production and Health Division (AGA) Joseph DOMENECH Chief Animal Health Service (AGAH)

Francis GEIGER FAO Consultant Alfort Veterinary College Ecole Nationale Vétérinaire d’Alfort 7. Av. du Général de Gaulle 94704 – Maisons Alfort Cedex France Tel: +33 143 96 7021 e-mail: francis-geiger@fao.org Zurab RUKHADZE Deputy Head of Emergency respond Group NC FAO/FMD project National Service of Food Safety, Veterinary and Plant Protection 15° tamarashvili, str 01777, Tblisi Georgia Tel: + 995 32 397069 e-mail: zurab.rukhadze@fao.org Nadia RUMICH EuFMD Secretariat Tel: +39-06570-55811 e-mail: nadia.rumich@fao.org

Giancarlo FERRARI Project Coordinator (AGAH) EuFMD Secretariat / European Commission for the Control of Foot-and-Mouth Disease (EuFMD) Keith J. SUMPTION Secretary Tel: +39-06570-55528 e-mail: keith.sumption@fao.org Adel BEN YOUSSEF FMD Expert –EuFMD Secretariat Tel: +39 06 570 56811 e-mail: adel.benyoussef@fao.org Carsten PÖTZSCH FMD Surveillance and Control in the Transcaucasus (Armenia, Azerbaijan and Georgia) Germany e-mail: carsten.potzsch@fao.org

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FAO HQ, ROME, 27-28 APRIL 2011

Report

39TH GENERAL SESSION OF THE EUROPEAN COMMISSION FOR THE CONTROL OF FOOT-AND-MOUTH DISEASE (EuFMD)