1. 4th OIE/FAO-APHCA Regional Workshop on BSE and Other Prion Diseases
Seoul, Republic of Korea, February 2010
Comments (with copyright) / Commentaires (soumis au Copyright) :
Update on the procedure for official BSE risk status recognition and recent updates in the OIE international standards on BSE and other TSE’s
Dr. Lea Knopf
Scientific and Technical Department OIE

2. Presentation outline OIE official BSE risk status recognition
OIE mandate for disease status recognition
Overview on the procedure
General conditions for evaluation
Difficulties observed in the evaluation of applications
Challenges in maintenance of disease status
News from the 77th General Session
Specialists’ Commissions (BSE and other TSEs
Future working programme

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. 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

5. 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

6. Outline of the procedure1.
OIE Member applies for official dis. stat. recog.by submission of documented evidence 2.
Examination of data and supporting documents by renowned experts (ad hoc Group) reporting to the Scientific Commission
Possibility of sending an expert mission to the country 3. 4.
Endorsement of recommendation on given disease status by the Scientific Commission who update the proposed list 5.
Adoption of the updated list of free Members by the OIE World Assembly by consensus – formal resolution 6.
Outcomes published on OIE Web site

7. Evolution OIE BSE risk determination
: 2 categories (“BSE free”, “prov. BSE free”)
Scientific considerations lead to the 3-category approach
That is risk-based, not prevalence based!
Based on the risk assessment to transmit the BSE agent
Focus on appropriate BSE risk mitigating measures in place
Time period that measures have been implemented (long incubation period BSE)
Absence of BSE difficult to prove (only post-mortem or clinical)
Finding a BSE case does not necessarily alter the risk status or imply trade restrictions, the “risk quality” of the case counts
Since 2007 OIE has the sole mandate for BSE risk status recognition ->no more GBR risk assessments from the EU!
“negligible BSE risk” “controlled BSE risk” “undetermined BSE risk”

8. 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

9. 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

10. BSE risk status evaluation: Difficulties observed I
Release assessment
Specification of potentially infective material of cattle origin
Import controls of feed containing bovine material
Origin of live cattle imported, import conditions
Exposure assessment
Follow up of imported animals
Ways of control of rendering plants
Distinction feed mills ((not) processing ruminant material) and controls
Feed mill controls and follow up of infractions/positive results

11. BSE risk status evaluation: Difficulties observed II
Awareness programme
Evolution and duration (7 years)
Informal versus formal programme
Surveillance
Estimation age categories of tested cattle
Assignment of cattle tested to apporpriate surveillance streams
Detection of clinical suspect animals
Differential diagnosis and testing for BSE
Sufficient surveillance effort over 7 years

12. Goal of BSE Surveillance
Detecting BSE, to a pre-determined design prevalence, in a country, zone or compartment;
Monitoring the evolution of BSE in a country, zone or compartment;
Monitoring the effectiveness of risk mitigation measures (e.g. feed ban);
Supporting a claimed BSE status;
Gaining or regaining a higher BSE status.
! Increase likelihood of finding BSE if present !

13. BSE Surveillance contd 4 cattle subpopulations with a different risk for BSE
Cattle > 30 months of age…
displaying behavioural or clinical signs consistent with BSE (clinical suspects);
that are non-ambulatory, recumbent, unable to rise or to walk without assistance; that are sent for emergency slaughter or condemned at ante-mortem inspection (casualty or emergency slaughter or downer cattle);
which are found dead or killed on farm, during transport or at an abattoir (fallen stock);
Cattle > 36 months of age…
at routine slaughter

14. BSE Surveillance age categories Accumulation of surveillance points
If age categories are unknown, the lowest points are applied

15. Maintenance of recognized BSE risk status Difficulties observed III
Annual reconfirmation of status (by November!)
Signed by the Delegate
Requesting specific data to update the BSE risk assessment
Import data (live cattle, products)
Surveillance efforts
Controls on ruminant to ruminant feed ban
Other requirements depending on experts’ request
Current form for annual reconfirmation still to long, revision to obtain a more concise document are needed
Notification and documentation of occurring new BSE cases

16. Numbers of applications for official BSE risk status evaluation
preliminary estimations

17. OIE Members’ BSE risk status
May 2009
Controlled BSE risk
Negligible BSE risk

18. News from the 77th General Session May 2009

19. News Scientific Commission
Continuous observation of scientific developments on ‘atypical’ BSE and ‘atypical’ scrapie
Review of the provisions on BSE surveillance and the surveillance model
Refinement of the form to facilitate annual reconfirmation of BSE risk status
Follow up on the developments in the epidemiology of CWD (together with the Working Group on Wildlife Diseases

20. News Terrestrial Code Commission I BSE
Gelatine and collagen production (use of skulls and vertebral column, contr. and undeter. BSE risk categories under certain conditions)
Age limit of 30 month removed (deboned muscle meat – a safe commodity)
Sole reference to BSE and not TSEs anymore
Reference to data for annual reconfirmation of BSE risk status
Compliance with import provisions for cattle
BSE case: status of birth cohort with regard to feed ban

21. Safe commodities for trade: BSE NOT dependant on BSE risk status
milk and milk products;
semen and in vivo derived cattle embryos ;
hides and skins;
gelatine and collagen prepared exclusively from hides and skins;
tallow with max. level of insoluble impurities of 0.15% in weight and derivatives made from this tallow;
dicalcium phosphate (with no trace of protein or fat);
deboned skeletal muscle meat (excluding mechanically separated meat)
no stunning process prior to slaughter leading to contamination,
ante-mortem and post-mortem inspections,
avoid contamination with tissues listed in Article ;
blood and blood by-products,
no stunning process leading to contamination

22. Recommendations for trade with cattle and cattle commodities Dependant on BSE risk status, conditions
Live cattle
Fresh meat and meat products
Ruminant derived MBM and greaves
Gelatine and collagen (not of hides)
Certain tallow and tallow derivates
Certain dicalcium phosphate products
Commodities that should not be traded

23. News Terrestrial Code Commission II Scrapie chapter consolidated
Removal semen of goats and sheep from list of safe commodities
Sheep and goat embryos awaiting scientific studies whether safe
Surveillance: Testing of culled or dead on farm sheep and goats >18 months
Inclusion of compartmentalisation
Import of live animals for breeding, only from free establishments

24. Scrapie distribution (2008)

25. Recommendations for scrapie Terrestrial Animal Health Code
No public health risk
No separate provions for atypical scrapie
Free status for country, zone, compartment or establishment
Allowance for historical freedom
Risk assessment
Awareness programme, surveillance (over 7 years)
Ruminant to ruminant feed ban
Risk material specification

26. Safe commodities for trade: Scrapie NOT dependant on Scrapie status
meat (excluding skulls, brains, ganglia and eyes, vertebral column, spinal cord, tonsils, thymus, spleen, intestine, adrenal gland, pancreas, or liver, and protein products derived therefrom);
hides and skins;
gelatine;
collagen prepared from hides or skins;
tallow (max. level of insoluble impurities of 0.15% in weight) and derivatives made from this tallow;
dicalcium phosphate (with no trace of protein or fat);
wool or fibre.

27. News Biological Standards Commission BSE & Scrapie
New OIE validated test (TeSeETM WESTERN BLOT)
Post-mortem diagnosis of TSEs in cattle, in ovine and caprine (BSE and scrapie), and in cervids (Chronic Wasting Disease) and for the following purposes:
To confirm TSE suspected positive samples detected at the screening laboratories in countries with active/passive surveillance programmes. Any sample with a negative result according to the TeSeETM WESTERN BLOT assay interpretation criteria, following a positive rapid test result, should be tested with one of the other OIE certified confirmatory methods, Immunohistochemistry (IHC) or SAF-Immunoblot;
confirm prevalence of infection with one of the TSE associated diseases in the context of an epidemiological survey in a low prevalence country;
To estimate prevalence of infection to facilitate risk analysis, demonstrate efficiency of eradication policies.
Ad 3 (e.g. surveys, implementation of disease control measures)

28. Future working programme
Encourage Members to apply OIE BSE standards
Follow up on the epidemiological trends of TSE’s and decline of BSE prevalence
Revise model for required surveillance points
Refinement problems of new cases of BSE and maintenance, suspension and re-instatement of status
Negligible BSE risk category
Controlled BSE risk category
Annual reconfirmation, revision form for BSE risk status

29. OIE BSE standards: Terrestrial Animal Health Code and Manual of Diagnostic Tests and Vaccines
If applied by Members, the provisions of the OIE standards can …
…manage the human and animal health risks associated with the presence of the BSE agent in cattle (Bos taurus and B. indicus)…
…regardless of an official BSE risk status of the Member concerned

30. Thank you for your attention! Questions ? Discussion