Punto di vista dell EFSA e raccolta dati Valentina Rizzi Unit on Biological Monitoring (BIOMO)

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Committed since 2002 to ensuring that Europe s food is safe Punto di vista dell EFSA e raccolta dati Valentina Rizzi Unit on Biological Monitoring (BIOMO) Corso di formazione Gestione per il contenimento ed il controllo delle malattie trasmesse da alimenti (MTA) Torino, 9-10 Aprile 2013

Outline EFSA EFSA s Biological Monitoring (BIOMO) unit EU-wide data collection on zoonotic pathogens Food Borne Outbreaks Data on zoonoses

10 years of EU food safety system Europeans enjoy one of the highest levels of food safety in the world Continued commitment, co-operation and innovation of EU institutions and its independent agencies For 10 years, EFSA has underpinned the EU s decisions on food and feed safety, animal health & welfare, nutrition and plant health

Scientific advice from farm to fork Plant Health Plant Protection Genetically modified organisms Biological food chain hazards Animal health and welfare Animal feed Food chain contaminants Food additives Flavourings and Procesing aids Dietary, nutritional and novel food Committed since 2002 to ensuring that Europe s food is safe Food packaging

Working together, working for Europe 30 national food safety agencies 300 research institutes Over 1500 experts EU Agencies Third country organisations Committed since 2002 to ensuring that Europe s food is safe

EFSA s organisational structure

Outline EFSA EFSA s Biological Monitoring (BIOMO) unit EU-wide data collection on zoonotic pathogens Food Borne Outbreaks Data on zoonoses

Biological Monitoring Unit Activities currently focused on three areas: Annual data collection and reporting on zoonoses, AMR and food-borne outbreaks in EU Survey design and analyses of EU-wide baseline surveys on zoonotic agents in animals and food Meat inspection mandate define epidemiological criteria for adaptations of current meat inspection methodology

EU-wide baseline surveys Fully harmonised, well designed surveys across the EU Member States, duration of 1 year They provide a unique picture (a snapshot) of the baseline values for the food-borne pathogens in animal population and food across the Community Member States obliged to participate, cofinanced by the Commission

EU-wide baseline surveys Objectives and use of data to provide information for setting of reduction targets (e.g. targets for Salmonella ) for consideration of need for risk management measures (Campylobacter, MRSA, Listeria monocytogenes)

EU-wide Baseline Survey analyses carried out by EFSA Salmonella in laying hen holdings published 2006 Salmonella in broiler flocks published 2007 Salmonella in slaughter pigs published 2008 Salmonella in turkey flocks published 2008 Campylobacter in broiler flocks and Campylobacter and Salmonella on broiler carcasses published 2010-2011 Salmonella and MRSA in holdings with breeding pigs published 2010-2011 Listeria in ready-to-eat foods survey analyses ongoing

EUSR: zoonoses data collection Annual data collection based on Directive 2003/99/EC Member States are obliged to submit data on 8 zoonoses and food-borne outbreaks: Salmonella and Campylobacter (+ antimicrobial resistance) Listeria monocytogenes, Brucella, tuberculosis due to Mycobacterium bovis, verotoxigenic Escherichia coli. Trichinella, Echinococcus Data on other zoonoses based on the epidemiological situation in the Member State Currently 7 additional zoonoses covered (e.g. rabies, Q fever) 3 microbiological contaminants EFSA is assigned the task of analysing the data and publishing the two EU Summary Reports 12

EUSR: analyses of the annual monitoring data Comparison of prevalence/proportion positives at different food/animal categories/points of food chain Analyses of trends over the years (in MS/ EU) Analyses of food-borne outbreak data Description of potential sources of human infections (which foodstuffs / animal species) Geographical distributions (maps)

EUSR: reporting scheme in EU

EUSR: zoonoses data collection The EFSA web application, Data Collection Framework and reporting manuals provide the format of the reporting (standardised tables, categorisations of food and animals, definitions)

EUSR 2010 EFSA collects and analyses data on zoonoses and zoonotic agents and foodborne outbreaks and publishes an annual EU Summary Report, in collaboration with the European Centre for Disease Prevention and Control (ECDC) ECDC provides for and analyses the data on human zoonoses cases http://www.efsa.europa.eu/en/efsajournal/pub/2597.htm 16

Outline EFSA EFSA s Biological Monitoring (BIOMO) unit EU-wide data collection on zoonotic pathogens Food Borne Outbreaks Data on zoonoses

New reporting system (EU-FORS)* In the new system EU-FORS, FBOs are classified based on the strength of evidence implicating a suspect food vehicle. Data are to be reported as follows: detailed dataset on outbreaks where suspicion is based on strong evidence; limited dataset on outbreaks where suspicion is based on weak evidence or no particular food vehicle is suspected/ identified. *EU-FORS (European Union Food-borne Outbreak Reporting System) 18

New reporting system (EU-FORS) When and what MSs should report Outbreak Yes Food-borne? Yes No Do not report Suspected food vehicle? Yes No Report limited dataset Strength of evidence implicating food vehicle Strong Weak Report limited dataset Report detailed dataset 19

New reporting system (EU-FORS) What constitutes strong evidence? The nature of evidence linking the consumption of a particular food to being the case in an outbreak can be epidemiological and microbiological. Both epidemiological and microbiological evidences can be strong or weak. The strength of evidence related to an outbreak should be based on an assessment of all available categories of evidence. 20

New reporting system (EU-FORS) What constitutes strong evidence? As a guide: Strong epidemiological evidence is a statistically significant association in a well conducted analytical epidemiological study, or convincing descriptive evidence. Strong microbiological evidence is the identification of an indistinguishable causative agent in a human case and in a food, a food component, or its environment, which is unlikely to have been contaminated coincidentally or after the event, or the identification of a causative agent such as a toxin or bioactive amine in the food vehicle, in combination with compatible clinical symptoms in outbreak cases NB: prior plausibility (evidence from previous outbreaks and studies) alone does not constitute sufficient evidence to implicate a food vehicle. 21

New reporting system (EU-FORS) Categories of evidence Analytical epidemiological evidence Descriptive epidemiological evidence Detection of causative agent in food chain or its environment - Detection of indistinguishable causative agent in humans Detection of causative agent in food chain or its environment - Symptoms and onset of illness pathognomonic to causative agent Detection of causative agent in food vehicle or its component - Symptoms and onset of illness pathognomonic to causative agent Detection of causative agent in food vehicle or its component - Detection of indistinguishable causative agent in humans 22

New reporting system (EU-FORS) Information to be provided Type of outbreak Household: outbreak where all the human cases live in one single household General : outbreak involving human cases from more than one household Unknown Origin of food vehicle Domestic Intra EU trade Imported from outside EU Unknown 23

New reporting system (EU-FORS) Information to be provided Setting Place of exposure to the food vehicle (see specific pick list ) Place of origin of problem: Place where the contributory factors occurred (see specific pick list ) Contributory factors Circumstance that singly or in combination led to the food-borne outbreak (see specific pick list ) Mixed outbreaks (other agent): Free text More information: Free text 24

EU-FORS New technical specifications (published in 2011 1 ). New Manual for reporting of foodborne outbreaks in accordance with Directive 2003/99/EC from the year 2011 (published in 2012 2 ). They have been implemented for reporting 2010 and 2011 data, even though not all MSs were able to implement them. Under revision. 1. http://www.efsa.europa.eu/en/efsajournal/pub/2101.htm 2. http://www.efsa.europa.eu/en/supporting/doc/265e.pdf 25

Food-borne outbreaks (FBOs) in EU, 2011 Unknown Salmonella Bacterial toxins Campylobacter In 2011, 25 MSs and two non-mss reported data Viruses Other causative agents Escherichia coli, pathogenic Other bacterial agents Strong evidence outbreaks Weak evidence outbreaks Parasites Yersinia Number of outbreaks Overall, 5,648 FBOs causing: 69,553 human cases - 7,125 hospitalisations - 93 deaths

Trends in food-borne outbreaks, EU, 2008-2011 Unknown Salmonella Bacterial toxins Campylobacter Viruses Other causative agents Escherichia coli, pathogenic Other bacterial agents Parasites 2008 2009 2010 2011 Yersinia Number of outbreaks

Distribution of strong evidence FBO outbreaks by food vehicle, EU, 2011 Sweets and chocolate, 3.0% Buffet meals, 4.1% Broiler meat (Gallus gallus) and products thereof, 4.7% Pig meat and products thereof, 3.6% Bakery products, 3.6% Fruit, berries and juices and other products thereof, 2.4% Bovine meat and products thereof, 1.9% 21.4% Cereal products including rice and seeds/pulses (nuts, almonds), 1.9% Eggs and egg products N=701 Other or mixed meat and products thereof Vegetables and juices and other products thereof Crustaceans, shellfish, molluscs and products thereof 5.3 % 5.3 % 6.0 % 10.1 % Fish and fish products 13.7 % 13.1 % Other foods Mixed food

Distribution of strong evidence FBO outbreaks by setting, EU, 2011 Residential institution (nursing home, prison, boarding school), 2.4% Temporary mass Take-away or fast-food catering (fairs, outlet, 1.4% festivals), 2.3% Unknown, 2.4% N=701 Disseminated cases, 2.7% School, kindergarten, 4.4% Canteen or workplace catering 5.7 % 11.6 % 34.4 % Restaurant, Café, Pub, Bar, Hotel Other setting 32.7 % Household / domestic kitchen

Distribution of strong evidence FBO outbreaks by food vehicle, EU, 2011 Eggs and egg products Bacillus, 1.3% Staphylococcal toxins, 0.7% Calicivirus, 0.7% Unknown, 2.0% N=150 S.Typhimurium, 2.7% Other Salmonella spp. 20.7 % 72.0 % S. Enteritidis

Distribution of strong evidence FBO outbreaks by food vehicle, EU, 2011 Mixed meals Yersinia, 1.0% Histamine, 1.0% Unknown N=96 Listeria, 1.0% Campylobacter, 2.1% 7.3 % Salmonella Mushroom toxins 5.2 % 21.9 % 12.5 % Bacillus 14.6 % 18.8 % Calicivirus 14.6 % Staphylococcal toxins Clostridium perfringens

Distribution of strong evidence FBO outbreaks by food vehicle, EU, 2011 Fish and fish products N = 71 Wax esters (from fish), 1.4% Anisakis, 1.4% Unknown Calicivirus, 1.4% 8.5 % Marine biotoxins Salmonella 4.2 % 4.2 % 78.9 % Histamine

Distribution of strong evidence FBO outbreaks by food vehicle, EU, 2011 Crustaceans, shellfish, molluscs and products thereof N = 42 Unknown 28.6 % Calicivirus 40.5 % Histamine, 2.4% Bacillus, 2.4% Escherichia coli, pathogenic Salmonella 4.8 % 4.8 % 16.7 % Marine biotoxins

Distribution of strong evidence FBO outbreaks by food vehicle, EU, 2011 Food of non-animal origin

Distribution of strong evidence FBO outbreaks by food vehicle, EU, 2011 Vegetables Mushroom toxins, 2.7% Unknown N=37 Staphylococcal enterotoxins, 2.7% 8.1 % Salmonella Bacillus 8.1 % 21.6 % Clostridium 10.8 % 18.9 % Mycotoxins 10.8 % 16.2 % Escherichia coli, pathogenic Viruses

Distribution of food vehicles in strong evidence FBOs caused by Salmonella, 2011 Vegetables and juices and other products thereof, 2.8% Broiler meat (Gallus gallus) and products thereof, 3.2% Bovine meat and products thereof, 2.8% Buffet meals, 2.5% Dairy products (other than cheese), 2.1% N=283 Other or mixed meat and products thereof, 4.2% Bakery products, 4.2% Pig meat and products thereof, 4.6% 6.7 % 50.5 % Eggs and egg products Sweets and chocolate Mixed food 7.4 % 8.8 % Other food

Distribution of food vehicles in strong evidence FBOs caused by S. Enteritidis, 2011 N=190 Broiler meat (Gallus gallus) and products thereof, 1.6% Bovine meat and products thereof, 3.2% Bakery products Dairy products (other than cheeses), 1.6% 5.3 % 7.4 % Vegetables and juices and other products thereof, 1.6% Buffet meal, 1.6% Mixed food Sweets and chocolate 10.0 % 56.8 % Eggs and egg products 11.1 % Other foods

Distribution of food vehicles in strong evidence FBOs caused by S. Typhimurium, 2011 Broiler meat (Gallus gallus) and products thereof, 3.4% Cheese, 3.4% Crustaceans, shellfish, molluscs and products thereof, 3.4% Vegetables and juices and other products thereof, 3.4% Other foods, 3.4% Pig meat and products thereof N=29 Buffet meals Mixed food 6.9 % 6.9 % 34.5 % Bovine meat and products thereof 6.9 % 13.8 % 13.8 % Meat and products thereof, unspecified Eggs and egg products

Distribution of food vehicles in strong evidence waterborne outbreaks, 2011 Isolated agents Country Setting Calicivirus (including norovirus) Campylobacter - C. jejuni Cryptosporidium hominis Escheria coli, pathogenic - Verotoxigenic E. coli (VTEC) VTEC 0157 Finland Belgium Finland Sweden Ireland Household / domestic kitchen Strong evidence outbreaks N Cases Hospitalised Deaths 3 54 0 0 Additional information In one outbreak, water treatment failure was reported as well as the isolation of Campylobacter. Other setting 1 8 0 0 Temporary mass catering (fairs, 1 64 0 0 Unprocessed contaminated ingredient. festivals) Household / domestic kitchen 1 10 0 0 Disseminated cases 1 20,000 46 0 Household / domestic kitchen 1 3 - - Disseminated cases 1 20 7 0 Group water scheme, ground water. Private group water scheme from ground water source suspected to have been contaminated with anima faeces. Household / domestic kitchen 1 2 0 - Unknown Finland Household / domestic kitchen 1 6 0 0 Water distribution system Total 11 20,167 53 0

Outline EFSA EFSA s Biological Monitoring (BIOMO) unit EU-wide data collection on zoonotic pathogens Food Borne Outbreaks Data on zoonoses

Zoonoses Human zoonoses cases and notification rates, EU, 2011 Campylobacteriosis (N = 220,209) Salmonellosis (N = 95,548) VTEC (N = 9,485) Yersiniosis (N = 7,017) Listeriosis (N = 1,476) Echinococcosis (N = 781) Brucellosis (N = 330) Trichinellosis (N = 268) Tuberculosis causedby M. bovis (N = 132) Rabies (N = 1) 0 5 10 15 20 25 30 35 40 45 50 55 60 Notification rate per 100,000 population

Human Salmonella cases in EU, 2008-2011 Significant decreasing trend in human cases

Virtuous circle Target setting Baseline surveys Prevalence in all MSs National Salmonella Control Programmes (NSCP) in (reservoir) animals containing minimum EU requirements EFSA-ECDC EUSR Approval of NSCPs Onset of NSCPs following-up of trends verification of the achievements of the targets science-based, informed, prioritized risk managing decisions

EU Salmonella targets and harmonized monitoring

Salmonella (5 target serovars) EU reduction target in breeding flocks of Gallus gallus, 2011 Prevalence (%) of positive breeding flocks of Gallus gallus Cyprus Poland Hungary Slovenia Italy +Austria +Bulgaria +Greece +Portugal +Czech Republic +France +Germany +Spain +Belgium +United Kingdom +Denmark +Estonia +Finland +Ireland +Latvia +Lithuania +Netherlands +Romania +Slovakia +Sweden +Iceland +Norway +Switzerland 11 10 9 8 7 6 5 4 3 2 1 0 2011 Target (1%) The EU Salmonella reduction target for the 5 serovars ( 1%) was met in total by 20 MSs and three non-mss

S. Enteritidis S. Typhimurium EU reduction target in laying hen flocks, 2011 Prevalence (%) of positive laying hen flocks +Austria +Bulgaria +Denmark Estonia +Finland +France +Germany +Greece Hungary +Ireland +Luxembourg Netherlands +Romania +Slovakia +Slovenia +Sweden +United Kingdom Czech Republic +Portugal +Italy +Latvia +Belgium +Poland Cyprus +Spain +Lithuania +Malta +Norway +Switzerland +Iceland 11 In 2011: 22 MSs and three non-mss met 2011 targets 10 9 8 7 6 5 4 3 2 1 0 2011 2011 target

S. Enteritis S. Typhimurium EU reduction target in broiler flocks, 2011 Prevalence (%) of positive broiler flocks Cyprus Czech Republic Latvia +Romania +Malta +France +Poland +Austria +Portugal +Hungary +Germany +Belgium +Denmark +Greece +Spain +Slovakia +Netherlands +Slovenia +Sweden +United Kingdom +Italy +Bulgaria +Estonia +Finland +Ireland +Lithuania +Luxembourg +Switzerland +Norway +Iceland 12 10 8 6 2011 target 4 2 0 In total 24 MSs and three non-mss met the target Overall, the occurrence of Salmonella in fresh broiler meat was 5.9 %.

S. Enteritidis S. Typhimurium EU reduction target in breeding turkey flocks, 2011 (second year) Prevalence (%) of positive breeding turkey flocks +Hungary +France +Spain +Bulgaria +Czech Republic +Finland +Germany +Greece +Ireland +Italy +Poland +Slovakia +Sweden +United Kingdom +Iceland +Norway 6 In 2011, 14 MSs and two non-mss the target (all reporting countries) 5 4 3 2010 2011 Target 2 1 0

S. Enteritidis S. Typhimurium EU reduction target in fattening turkey flocks, 2011 Prevalence (%) of positive fattening turkey flocks +Ireland +Denmark Spain +France +Austria +Finland +Poland +Germany +Czech Republic +Hungary +United Kingdom +Portugal +Italy +Belgium +Cyprus +Greece +Latvia +Lithuania +Netherlands +Romania +Slovakia +Slovenia +Sweden +Iceland +Norway +Switzerland In total, 22 MSs and three non-mss met the target 6 5 4 3 Ireland and Denmark met the target as they tested less than 100 flocks and detected only one flock positive 2010 2011 Target 2 1 0

Human Campylobacter cases in EU, 2008-2011 The EU notification rate of confirmed cases of campylobacteriosis has shown a significant increasing trend in the last four years (2008-2011) The proportion of Campylobacter-positive broiler meat samples was 31.3 %

Listeriosis in humans in EU, 2008-2011 No statistically significant EU trend in listeriosis cases between 2008 and 2011 (analysis by week)

Harmonisation of data collection Salmonella, tuberculosis and brucellosis harmonised by EU legislation Harmonisation of monitoring and reporting of other zoonoses to improve the data comparability: Antimicrobial resistance in Salmonella, Campylobacter, commensal E. coli and Enterococci in animals VTEC in animals and food Yersinia in animals Parasites in food/animals Rabies and Q fever in animals Survey methods for food-borne pathogens in foods Vector-borne zoonoses 52

Conclusions The annual Zoonoses Summary Report provides an important overview of the situation and developments in the EU needed by risk managers (Commission, MSs) and risk assessors (EFSA) at the EU level. Further harmonisation of monitoring and reporting will facilitate better interpretation and analyses of the data. Analyses of data at EU level remains a challenge: appropriate statistical methods can be applied to analyse these not fully comparable datasets for trends and spatial analyses.

Thank you for your attention! Ackowledgements Johanna Takkinen and team, ECDC Kris De Smet and team, DG SANCO Pia Mäkelä and team, EFSA Contacts in EFSA zoonoses@efsa.europa.eu http://www.efsa.europa.eu/en/contact/askefsa.htm All our reports are on www.efsa.europa.eu