1. Official BSE risk status recognition News from the General Session
3rd EFSA BSE-TSE Network meeting, Limassol June 2008
Official BSE risk status recognition News from the General Session
Comments (with copyright) / Commentaires (soumis au Copyright) :
Dr. Lea Knopf
Scientific and Technical Department OIE

2. Presentation outline
OIE official BSE risk status recognition – the procedure
History and framework
Evaluation process
New categorizations May 2008
Other News from the General Session May 2008

3. 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

4. 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

5. 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

6. Outline disease status recognition
“Global trade certificate”
Transparency and standardisation
Based on OIE standards and guidelines
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

7. 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

8. The procedure: official BSE risk status recognition
-OIE procedues to conduct risk assessment :release assessment, exposure asessment
-laboratories have to comply to provisions of the Manual /chapter I 1 2

10. Steps of the procedure for the recognition of official animal disease status1.
Intention of OIE Member to apply for official dis. stat. recog. 2.
Detailed documentation from OIE Member to OIE HQ 3.
Examination of data and supporting documents by OIE Central Bureau and experts of an ad hoc Group
If necessary, expert mission to the country 4. 5.
Endorsement of recommendation by the Scientific Commission 6.
Decision of OIE International Committee by consensus – formal resolution 7.
Outcomes published on OIE Web site

11. Basic requirements for applicants
Veterinary services, general requirements
Compliance with Chapter 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 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

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

13. BSE risk evaluation 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
Surveillance programme for BSE
BSE history

14. The Scientific Commission of OIE
Elected by the OIE Members (International Committee)
Analyzes the ad hoc Group’s 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

15. 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)

16. 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
Import data
Surveillance efforts
Control of ruminant to ruminant feed ban
Other requirements depending on experts’ request

17. New countries having an official BSE risk status

18. New applications for ‘negligible BSE risk’ status
New negligible BSE risk

19. New applications for ‘controlled BSE risk’ status
New controlled BSE risk

20. OIE Members’ BSE risk status
June 2008
Controlled BSE risk
Negligible BSE risk

21. News from the 76th General Session May 2008

22. World Animal Health report: BSE

23. Conclusions BSE evolution in the world
Two decades after the first identification of this newly emerging disease, we assist to a regular decline in the number of reported cases of BSE
With the continuation of active surveillance and the ban on feeding cattle with MBM implemented, coupled with the natural elimination of potentially infected cows that were exposed to this contaminated feed, we are approaching the eradication of this disease.
BSE cases between 1989 and 2007
Note: BSE epizootic pick in the United Kingdom preceded the epizootic in the rest of the world by nine years and was of a much greater magnitude, as shown by the different scales used for each curve

24. News Scientific Commission
Review of BSE chapter and appendices for consistency
‘Atypical’ BSE and ‘atypical’ scrapie cases
Drafting of a new scrapie chapter and surveillance guidelines
Development of “short questionnaire” to facilitate annual reconfirmation
Two resolutions consolidating procedure issues (financial and technical)

25. News Terrestrial Code Commission
Gelatine and collagen production (exclusion of skulls and vertebral column, contr. and undeter. BSE risk categories)
Age limit of 30 month maintained (deboned muscle meat – a safe commodity)
Sole reference to BSE and not TSEs anymore
Reference to data for annual reconfirmation of BSE risk status
Separate article for dicalcium phosphate

26. News Biological Standards Commission
New OIE validated test (Prionics® Check WESTERN)
post-mortem diagnosis of BSE in cattle and for the following purposes:
To confirm diagnosis of suspect or clinical cases (includes confirmation of a positive screening test);
To estimate prevalence of infection to facilitate risk analysis and to assist in the demonstration of the efficiency of control policies;
To confirm a non-negative test result obtained during active surveillance with a different type of test.
2008 Revision BSE chapter Manual of Diagnostic Tests and Vaccines

27. Future working programme
Encouraging Members to apply OIE BSE standards
Revise model for required surveillance points
Problems of new cases of BSE and maintenance, suspension and re-instatement of status
Negligible BSE risk category
Controlled BSE risk category
Annual reconfirmation, short questionnaire
Validation additional diagnostic test
Update on 30 month rule for meat (scientific evidence)

28. Thank you for your attention! Questions ?