4th OIE/FAO-APHCA Regional Workshop on BSE and Other Prion Diseases Seoul, Republic of Korea, 24-26 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

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

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

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

Outline of the procedure 1. 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

Evolution OIE BSE risk determination 2004-2006: 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”

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

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

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

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

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 !

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

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

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

Numbers of applications for official BSE risk status evaluation preliminary estimations

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

News from the 77th General Session May 2009

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

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

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 11.6.14.; blood and blood by-products, no stunning process leading to contamination

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

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

Scrapie distribution (2008)

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

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.

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)

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

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

Thank you for your attention! Questions ? Discussion