1. Legal framework of TSE surveillance 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 PhD

2. Contents Initial: legislation BSE Consolidation: notifiable diseases Integration: passive surveillance Integration: Reg. 999/2001/EC Amendments Summary

3. Initial legislation BSE Emergence of BSE in cattle in the UK in the late 80s Progressive enactment of measures in the EU: prevention and control via trade restrictions The first legislative act linked to TSE started in 1989 -Ban of UK beef/live cattle (Decision 89/469/EEC): trade restrictions of certain live cattle from UK to the other MS, export of cattle born before July 1988 -Ban of UK cattle products, specified risk material (SRM) (Decision 90/1990/EEC): brains, spinal cord, thymus, tonsils, spleen, intestines derived from bovine animals aged more than six months at slaughter.

4. Consolidation: BSE as notifiable disease First indigenous case of BSE (OIE) 1986: UK 1989: Ireland, NI 1990: Switzerland 1991: France 1994: Portugal 1997: Belgium, Luxembourg, Netherlands, 1998: Lichtenstein 2000: Denmark, Germany, Spain 2001: Austria, Czech Rep., Finland, Greece, Italy, Slovakia, Slovenia, 2002: Poland 2006: Sweden 2014: Romania All outbreaks of BSE must be notified (Decision 90/134/EEC) Differentiation between surveillance and control: Passive surveillance SRM and trade restrictions Commission Decision 96/385/EC approved the UK’s plan for the eradication of BSE Passive surveillance insufficient to describe epidemiological situation

5. Consolidation: Scrapie as notifiable disease Present in sheep population for +350 years Most of European countries had national legislation before 1991 Scrapie compulsorily notifiable disease in all MSs (Directive 91/68/EEC) Year Scrapie became notifiable 1970: Sweden 1974: Romania 1980: Finland 1987: Cyprus 1988: Denmark 1990: Luxemburg, Belgium 1991: Italy 1993: UK, Netherlands 1996: Portugal 1997: France, Greece

6. Integrating TSE passive surveillance Epidemio-surveillance of TSE (Decision 98/272/EC) Requirements for the detection of both BSE in cattle and scrapie in ovine and caprine animals. –Awareness for vets, breeders, keepers, slaughterhouse staff… –Obligation to notify to the competent authorities and investigate the suspected presence of any TSE in any animal species –Native-born animals showing clinical TSE-like signs plus high-risk categories: animals from countries with indigenous TSE, animals consuming potentially contaminated feedstuffs, and animals with TSE-infected parents –Report to the EU Standing Veterinary Committee

7. Minimum number based on population size Initial minimum number of clinical suspects investigated 100,000 (cattle >20 m.o.a. or SR > 10m.o.a.) – 10 tested 40,000.000 (cattle >20 m.o.a. or SR > 10m.o.a.) – 433 tested Regulation 999/2001/EC: any animal suspected of being infected by a TSE: under restriction until results of clinical and epidemiological examination Tested using a rapid screening and confirmatory tests by approved laboratories by National Reference Lab. Integrating TSE passive surveillance

8. Integration: Reg. 999/2001/EC Until July 2001: passive epidemio-surveillance for TSEs and limited active surveillance for BSE Need for a comprehensive active surveillance system for BSE and scrapie Objective: The purpose of the TSE surveillance in the EU is mainly to monitor the BSE epidemic, not to detect new cases. Integration all measures for the prevention, control and eradication of TSE.

9. Integration: Reg. 999/2001/EC “The TSE Regulation”: framework for all measures related to the monitoring, prevention and control of TSE in the EU: –notification of clinical suspects –monitoring of animal TSE –feed ban, –SRM removal –movement restrictions and other measures for suspect and confirmed cases –Intra-community trade –placing on the market of animal products and export –Reference labs, sampling and testing After many subsequent amendments, still in force today

10. BSE: surveillance streams in cattle Cattle slaughtered for human consumption (SHC) Initial quotas of SHC + NSHC + emergency slaughter based on cattle populations - 100,000 – 950 animals tested - 12,000.000 – 13,500 animals tested Quota based on age of cattle at slaughter: –> 30 m.o.a. For certain MSs possible derogation up to 48 m.o.a. –> 48 m.o.a. From 1 January 2009 (Decision 2008/908/EC) –> 72 m.o.a. from 1 July 2011 (Decision 2011/358/EC) –discontinued from 1 January 2013 Regulation 2245/2003/EC: all SHC tested Amendments if MS which can demonstrate improvement of the BSE situation (Regulation 571/2008/EC)

11. BSE: surveillance streams in cattle At-risk animals Cattle not slaughtered for human consumption (NSHC) Fallen stock. Quota based on age of cattle at death. –> 30 m.o.a. Regulation 999/2001/EC –> 24 m.o.a. (48m). Derogations. Regulation 1248/2001/EC –> 48 m.o.a. (2009) but >24 if not from one of 17 MSs Regulation 2245/2003/EC: all NSHC tested

12. BSE: surveillance streams in cattle At-risk animals Special emergency slaughter: for certain MSs possible derogation up to 48 m.o.a. –From January to June 2001: all animals over 30 months of age –From July to December 2001: all animals over 24 months of age Animals with clinical signs at AM inspection: > 24 m.o.a. For certain MSs possible derogation up to 48 m.o.a. BSE eradication measures: feed cohorts: all cattle one year +/- raised with BSE case

13. Scrapie: surveillance streams in SR S&G slaughtered for human consumption (SHC) Quota based on population. Testing of SR >18 m.o.a. or more than two permanent incisor teeth Initial quotas based on population (Reg.1248/2001/EC): 5,000 – 4750 animals tested >2.200.000 – 14930 animals tested “If population of ewes put to the ram / goats which have already kidded or mated exceeds 750,000 animals – min. 10,000” (Regulation 2245/2003/EC) All animals > 18 months in MS with minor populations

14. Scrapie: surveillance streams in SR S&G not slaughtered for human consumption (NSHC) Fallen Stock. Quota based on population. Testing of SR >18 m.o.a. or more than two permanent incisor teeth. Regulation 2245/2003/EC and Regulation 727/2007/EC Ewe populationMinimum sample size Goat populationMinimum sample size >750,00010,000>750,0005,000 >250,000-750,0001,500>100,000-750,0001,500 40,000-250,000500 - 100% up to 50040,000-100,000500 - 100% up to 500 <40,000100 - 100% up to 100<40.00050 - 100% up to 50

15. Integration: Reg. 999/2001/EC: amendments Survey of prion protein genotypes of sheep breeds (Decision 2002/1003/EC) Increased monitoring in goats: first natural BSE case in a goat in France. 2005 (Regulation 214/2005/EC) Mandatory discriminatory testing for BSE of TSE cases detected in SR (Regulation 36/2005/EC). Only MSs with major ovine/caprine population must test SHC in SR from 1 July 2007 (Regulation 727/2007/EC): 10,000 if population >750,000

16. Surveillance of Chronic wasting disease (CWD) Emergence of CWD in the USA led the EC to investigate the presence of the disease in MS A survey for chronic wasting disease (CWD) in cervids was carried out during 2006-2008. Decision 2007/182/EC). No positive cases were found. TSE Regulation includes a provision requiring the examination of TSE suspicion in all animal species. Active monitoring in species other than bovine, ovine, caprine and cervid animals is voluntary

17. Summary Evolution of the legal framework of TSE surveillance along new scientific knowledge Initial control and prevention focused on BSE Notifiable disease status for TSEs: EU level and national legislation. Implications for detection and control. Passive surveillance Reg. 999/2001/EC: integration of surveillance streams and prevention and control

18. Summary Active surveillance still in place with subsequent multiple amendments. Reduction of testing number of animals Epidemiological assessment of the diseases. Monitor trends. Not specifically to detect new cases Due to changes in prevalence and diminishing risk to public health, relaxation in surveillance efforts. Watch out this space