1. Scientific and Technical Department OIE
Regional working group meeting on BSE -TSE, 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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)

9. 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

10. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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)

20. 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

21. New countries applying for an official BSE risk status Trends?

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

23. 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