Scientific and Technical Department OIE Regional working group meeting on BSE -TSE, 23 -25 September 2008 Qingdao, People’s Republic of China, Official disease status recognition the framework of BSE risk status recognition Part I Comments (with copyright) / Commentaires (soumis au Copyright) : Dr. Lea Knopf Scientific and Technical Department OIE

Presentation outline – Part I Short overview on OIE and our mandate OIE official BSE risk status recognition – the procedure History disease status recognition Overview on the procedure General conditions for evaluation Main actors in the evaluation process Maintenance of disease status Current situation of OIE BSE risk status in the world

founded in 1924 – predates the UN an intergovernmental organisation headquarters in Paris Regional Representations: Bamako, Beirut, Buenos Aires, Sofia and Tokyo, Sub-regional Offices: Bangkok, Brussels, Gaborone, Panama, Tunis Founded by Member contributions 5 regional representations 2 subregional offices Small team , about 65 persons working in the headquarters

OIE’s objectives Ensure transparency in global animal health situation Collect, analyse and disseminate scientific veterinary information Provide expertise and encourage international solidarity in animal disease control Within its WTO/SPS mandate, Safeguard world trade by publishing health standards for international trade Improve the legal framework and resources of national Veterinary Services To provide a better guarantee of food of animal origin and to promote animal welfare through a science-based approach

OIE Mandate under the WTO, SPS Agreement Achieved through: Science-based provisions Risk assessment Use of international standards (“harmonization”) Transparent procedures Endorsement by all OIE Members Avoid arbitrary levels of protection (“consistency”) Accept “equivalence” Recognize disease- and pest-free areas Notify measures taken (“transparency”) Technical assistance

Recognition of official disease status Goal: Promote Veterinary Services Protect animal (and human) health in international trade Facilitate trade The International Committee adopted that OIE shall officially recognise disease status (countries, zones) for currently 4 diseases Demand for expansion to other diseases (e.g. AI) FMD RP CBPP BSE 2000 1996 2004 2003

History of official disease status recognition I In the early 90’s more and more recommended standards for epidemiological surveillance More descriptions of conditions that a country or zone of a country must meet in order to be recognised as free from a disease or infection Step by step concepts to achieve and declare freedom from specific diseases for trade purposes Mandate to the Scientific Commission to develop a voluntary procedure for official recognition of FMD free Members 1994 at the 62nd General Session a first proposal for the procedure was presented

History of official disease status recognition II Reactions and concerns of Delegates 1995 this process was amended and adopted by the International Committee Specific mandate to the Scientific Commission for judging a declaration of a country or zone relative to its freedom from a given disease First only for FMD, but the importance of including e.g. rinderpest was already recognized at that time OIE has now the sole mandate to officially recognize BSE risk status Consolidation of the procedures adopted in May 2008 (Resolution XXII of the 76th General Session)

Outline disease status recognition “Global trade certificate” Transparency and standardisation Based on OIE standards and guidelines as adopted by all OIE Members Guarantees to trading partners Long term perspective: Documented and updated evidence on disease free situation or BSE risk situation Veterinary Services meet baseline requirements for disease control and trade activities Procedure under the responsibility of the Scientific Commission (focus technical aspects ) Procedure and disease statuses adopted by all OIE Members (focus on policy aspects) Costs for evaluation covered by applicant Member

The procedure: e.g. official BSE risk status recognition General conditions for evaluation and steps Main actors in the evaluation process Maintenance of disease status -OIE procedues to conduct risk assessment :release assessment, exposure asessment -laboratories have to comply to provisions of the Manual /chapter I 1 2

Steps and main actors of the procedure - recognition of official animal disease status OIE Central Bureau Member request ad hoc Group Expert mission Scientific Commission Publication on OIE Website International Committee

Basic requirements for applicants Veterinary services, general requirements Compliance with Chapters 3.1. and 3.2. of the Terrestrial Code on the quality and evaluation of the Veterinary Services; Transparency in the planning and execution of surveillance activities in accordance with Chapter 1.1. of the Terrestrial Code. Continuous compliance with reporting obligations (e.g. WAHIS) 6-monthly animal health reports Annual animal health reports Reporting of unusual animal disease events Payment of annual OIE Member contributions -annually confirm by letter during the month of November whether their status and the criteria by which their status was recognised have remained unchanged

Submission of documentation The OIE Member: Submits the complete documentation (dossier) based on a questionnaire (transparence, completeness of information) The Member has to document that it complies with the disease and category specific provisions of the Terrestrial Code Import and border control Animal movement control Legislation and its implementation Notification Surveillance …. Checks for completeness by OIE Central Bureau Transfer to ad hoc Group of BSE experts for analysis

Principles of Ad hoc Groups: OIE convenes a group of experts to examine specific scientific and technical issues, including official disease status evaluations Internationally recognized expertise concerning the disease or the technical aspect under question Geographically balanced Technically balanced (diagnostics, field, epidemiology, …) Reports serve as guidance for the Specialist Commissions and the International Committee in forming recommendations and taking decisions

BSE risk evaluation, questionnaire Analysis by an ad hoc Group of BSE experts Release assessment importation of MBM or greaves importation of live cattle importation of potentially infected bovine products Exposure assessment origin of bovine carcasses, by-products and slaughterhouse waste, the parameters of the rendering processes and the methods of cattle feed production exposure of cattle to the BSE agent through consumption of ruminant MBM or greaves BSE Awareness programme and other requirements Surveillance programme for BSE BSE history of the Member Recommendation

Disease status evaluation, Sections of other questionnaires (FMD, RP, CBPP) Section 1) General aspects of the country or zone Section 2) Veterinary services and infrastructure Section 3) History of eradication Section 4) - 6) Monitoring and vaccination Diagnosis Surveillance programmes and tools Prevention Section 7) Control measures / contingency planning Section 8) Declaration of the Delegate Section 9) Recovery of status -OIE procedues to conduct risk assessment :release assessment, exposure asessment -laboratories have to comply to provisions of the Manual /chapter I 1 2

The Scientific Commission of OIE Elected for 3 years by the OIE Delegates (International Committee) Analyzes the ad hoc Group’s recommendation and comments Concludes with a recommendation on the status of the applicant OIE Member Asks the country for additional information if required Proposes the updated list (Resolution) for adoption to the International Committee Receives a delegation from the applicant Member country for clarification of open questions if required

The International Committee (Assembly of all Delegates of OIE Members) Members have 60 days for written objections (scientific or technical) Adopts amendments on the procedure once a year Adopts the new resolutions on countries’ BSE risk status And thereby establishes an official list of countries, zones with the respective status (in the form of resolutions)

Maintenance of recognized BSE risk status Annual reconfirmation of status (by November) by letter from the Delegate Requesting specific data to update the risk assessment and original documentation Import data Surveillance efforts Control of ruminant to ruminant feed ban Other requirements depending on experts’ request

New countries applying for an official BSE risk status Trends?

OIE Members’ BSE risk status May 2008 Controlled BSE risk Negligible BSE risk

Thank you for your attention. Questions on the theory of the procedure Thank you for your attention! Questions on the theory of the procedure? Practical implications in relation to BSE standards will be treated in Part II