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BSE classification of countries, Risk assessment, Exposure assessment, Application for determined BSE status Workshop BSE classification of countries, Risk assessment, Exposure assessment, Application for determined BSE status Workshop on Prevention, Control and Eradication of Transmissible Spongiform Encephalopathies (TSE) Serbian Ministry of Agriculture – European Commission Belgrade 1 -2 December 2014 Angel Ortiz Pelaez DVM MSc Ph. D

Contents • • • BSE risk classification: GBR BSE risk classification: OIE, EU Risk Contents • • • BSE risk classification: GBR BSE risk classification: OIE, EU Risk assessment, Exposure assessment Surveillance: score and global points Application for determined BSE status Summary

BSE risk classification: GBR • The absence of confirmed cases did not preclude the BSE risk classification: GBR • The absence of confirmed cases did not preclude the presence of the BSE agent in a country/region • Scientific Steering Committee (SSC): TSE ad hoc working group, on behalf of the EC (1998 -2000 -2002). BSE status can only be based on a risk assessment – “likelihood of the presence of one or more cattle within the native population being infected with BSE agent, at a point in time” • To avoid the introduction of the BSE agent from infected or suspected countries • Basis for trade legislation rules for cattle and their products

BSE risk classification: GBR • Qualitative indicator of risk of harboring undetected cases of BSE risk classification: GBR • Qualitative indicator of risk of harboring undetected cases of BSE • External challenge – “BSE agent is initially introduced into a country's domestic cattle production system through the importation of contaminated feedstuffs or live cattle”. In 2002, imports from all BSE-risk countries (GBR III and IV or with at least one confirmed domestic BSE case • Stability – The ability of the system to cope with such a challenge. A stable system will not allow the BSE agent to propagate and amplify following its introduction, while an unstable system will (Salman et al. 2012)

BSE risk classification: GBR • Four levels of risk GBR level I II IV BSE risk classification: GBR • Four levels of risk GBR level I II IV Presence of one or more cattle clinically or pre-clinically infected Highly unlikely Unlikely but not excluded Likely but not confirmed or confirmed Confirmed, at a higher level • Simplification of a complex reality

64 countries evaluated 64 countries evaluated

External challenge • Two countries level IV: UK and Portugal • All European countries External challenge • Two countries level IV: UK and Portugal • All European countries (MS or not) that submitted the profile were II or III

Stability • Surveillance: reduced risk if cases are identified and excluded • Specified Risk Stability • Surveillance: reduced risk if cases are identified and excluded • Specified Risk Material (SRM): remove infectivity harboring tissues. Fallen stock and emergency slaughter ₒ • Rendering: batch pressure cooking (133 C / 3 bar / 20’) • Feeding: BSE-infected (MBM) not used for to feed cattle Stability Level Feeding / Rendenring / SRM removal Stable Optimally 3 OK Very stable 2 OK / 1 reasonably OK Stable 2 OK / 1 not OK or 1 OK/ 2 reas. OK Neutrally stable Unstable 3 reas. OK or 1 OK / 1 reas. OK and 1 or 2 not OK Unstable 2 reas. OK, 1 not OK Very unstable 1 reas. OK, 2 not OK Extremely All three not OK

From EU to OIE risk assessment • OIE in May 2003: simplify the current From EU to OIE risk assessment • OIE in May 2003: simplify the current international criteria for the classification of countries according to their BSE risk. • Proposal adopted OIE General Session in May 2005. • EU parliament as recommendation by CVOs (2005): harmonization with the OIE guidelines whenever possible • Regulation (EC) No 1923/2006: Regulation (EC) 999/2001 should be adapted to reflect the new internationally agreed categorisation system

From EU to OIE risk assessment • GBR system not an alternative to the From EU to OIE risk assessment • GBR system not an alternative to the OIE system • OIE Terrestrial Animal Health Code: Chapter 11. 4 – – – Assessment of the risk status Risk classification Recommendations Surveillance and score points BSE risk assessment

Assessment of the risk status country/region 1. Risk assessment – Entry assessment: likelihood of Assessment of the risk status country/region 1. Risk assessment – Entry assessment: likelihood of a BSE case has been introduced or is already there: • • • prevalence of BSE importation of meat-and-bone meal or greaves importation of live animals potentially infected with BSE importation of products of animal origin potentially infected with BSE consumption of meat-and-bone meal or greaves of ruminant origin of animal waste, the parameters of the rendering processes and the methods of animal feed production – Exposure assessment: assuming the presence of a risk: • recycling and amplification of the BSE agent : MBM of ruminant origin • use ruminant carcasses (including from fallen stock), by-products and slaughterhouse waste • feeding or not of ruminants with MBM derived from ruminants, • level of surveillance for BSE

Other components of the risk assessment 2. Awareness programme: - for veterinarians, farmers, and Other components of the risk assessment 2. Awareness programme: - for veterinarians, farmers, and workers involved in transportation, marketing and slaughter of cattle - to encourage reporting of all cases showing clinical signs consistent with BSE in target sub-populations 3. Compulsory notification: passive surveillance 4. Approved testing of brain or other tissues collected by surveillance

THE OIE Risk Classification System • Negligible BSE risk – Risk assessment: demonstration managed THE OIE Risk Classification System • Negligible BSE risk – Risk assessment: demonstration managed all risks identified – no BSE cases, only imported BSE cases or indigenous BSE cases born no more recently than 11 years – existing education and reporting program for at least 7 years – MBM not fed to ruminants for 8 years – Surveillance Type B • Controlled BSE risk – Risk assessment: no demonstration managed all risks identified or not for sufficient time – no BSE cases, but not sure MBM has not been fed to ruminants for 8 years existing or education and reporting program not for at least 7 years – or indigenous BSE and MBM not fed to ruminants for 8 years – Surveillance Type A • Undetermined BSE risk

Surveillance and score points • If BSE is present in the country: – cattle Surveillance and score points • If BSE is present in the country: – cattle not exposed to the infective agent; – cattle exposed but not infected; – infected cattle, within one of three stages in the progress of BSE: i) the majority will die or be killed before reaching detectable limit ii) some will progress to a stage at which BSE is detectable by testing before clinical signs appear; iii) the smallest number will show clinical signs. • Surveillance based on four testing categories: – – Fallen stock (ii) Healthy (routine) slaughter (ii) Emergency slaughter (ii or iii) Clinical suspects (iii)

Surveillance and score points • Negligible risk – Type B surveillance – Detection of Surveillance and score points • Negligible risk – Type B surveillance – Detection of BSE prevalence of at least one case per 50, 000 adult cattle, CI 95% • Controlled risk – Type A surveillance – If no identified BSE cases: detection of BSE prevalence of at least one case per 100, 000 adult cattle, CI 95% – If BSE detected: “more intensive surveillance method“

Surveillance and score points • individual “point values”: assigned to each sample tested, risk-based Surveillance and score points • individual “point values”: assigned to each sample tested, risk-based on the tested subpopulation based For comparison of surveillance system among countries: (-) (+)

Surveillance and target points • Target points: total number of points, based on the Surveillance and target points • Target points: total number of points, based on the number of adult cattle in the country and the risk, must be reached to ensure sufficient level of surveillance (A or B). Adult cattle population size (>24 m. o. a. ) Type A surveillance Type B surveillance >1, 000 150, 000 … … … 1, 001 -2, 000 200 100

Risk assessment • Formal application submitted to the OIE (some are available in internet): Risk assessment • Formal application submitted to the OIE (some are available in internet): negligible or controlled • Financial obligations: 4, 500 -9, 000 euros • Review of risk assessment (Standard Operating Procedures): ad hoc group meetings (between August and February). Expert mission if needed • Sent to the OIE Scientific Commission • Declaration of the status and endorsement of the official control programme: annual cycle May (General session) • Recognition of the status internationally • Annual re-confirmation of the status

OIE (2014) OIE (2014)

Resolution No. 18 (82 nd General Session May 2014) Negligible risk: 36 Argentina Australia Resolution No. 18 (82 nd General Session May 2014) Negligible risk: 36 Argentina Australia Austria Belgium Brazil Bulgaria Chile Colombia Croatia Denmark Estonia Finland Hungary Iceland India Israel Italy Japan Korea (Rep. of) Latvia Luxembourg Malta Netherlands New Zealand Norway Panama Paraguay Peru Portugal Romania Singapore Slovakia Slovenia Sweden United States of America Uruguay

Controlled risk: 17 Canada Chinese Taipei Costa Rica Cyprus Czech Republic France Germany Greece Controlled risk: 17 Canada Chinese Taipei Costa Rica Cyprus Czech Republic France Germany Greece Ireland Lichtenstein Lithuania Mexico Undetermined risk: the rest Nicaragua Poland Spain Switzerland United Kingdom

Summary • Two major risk assessment of BSE: EU (GBR) and OIE (Animal Health Summary • Two major risk assessment of BSE: EU (GBR) and OIE (Animal Health Terrestrial Code) • No presence of cases does not preclude the possibility of having BSE (early years of the epidemic) • Harmonization of GBR into OIE system in 2005 • Principles of risk assessment applied: – Likelihood of introduction: external challenge / entry assessment – Ability to propagate: stability / exposure assessment • Negligible / Controlled / Undetermined risk: – – Risk assessment: measures in place Awareness and compulsory notification and investigation Surveillance Type A and B Score points and target points