re: efsa -manuals for reporting on food borne outbreaks and … · 2013-04-22 · campylobacter:...

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81A rue de la Loi (bte 9) - 1040 BRUXELLES, Belgique Tel: 32 (0) 2 230 46 03 - Fax: 32 (0) 2 230 94 00 E-mail: [email protected] – Web: www.uecbv.eu 1 Summary EN: 1. The new manual providing specific guidance for reporting on food-borne outbreaks under the framework of Directive 2003/99/EC has been published. It includes the description of the structure and scope of the reporting system for food-borne outbreaks. 2. The new Reporting Manual providing guidance for reporting on zoonoses, zoonotic agents and antimicrobial resistance in animals, food and feed under the framework of Directive 2003/99/EC has been published. 3. The annual report on zoonosis for the year 2011 has been published. A total of 5,648 food-borne outbreaks were reported in the European Union, resulting in 69,553 human cases, 7,125 hospitalisations and 93 deaths. Campylobacter: human campylobacteriosis in the European Union increased. With 220,209 confirmed cases, it is the commonly reported zoonosis. Salmonellosis: 95,548 confirmed human cases were reported in 2011, a decrease of 5.4%. Listeria: 1,476 confirmed human cases were reported in 2011. The number of listeriosis cases in humans decreased slightly as compared with 2010. Escherichia coli, VTEC: A total of 9,485 confirmed verotoxigenic Escherichia coli infections were reported in 2011, which was a 2.6-fold increase as compared to 2010. Tuberculosis (M. bovis): the number of confirmed human cases in 2011 was 132. This was a decrease as compared to 2010. Yersinia: A total of 7,017 confirmed cases reported in 2011, corresponding to an increase by 3.5% as compared to 2010. Brucella: The number of confirmed brucellosis cases in humans continued to decline, and 330 confirmed cases were reported in 2011. Trichinella and Echinococcus: In 2011, trichinellosis and echinococcosis caused, respectively, 268 and 781 confirmed human cases in the European Union. The number of cases was slightly higher in 2011 as compared to 2010. Rabies: One imported human case of rabies was reported in the European Union in 2011. 4. The European Food Safety Authority was asked to deliver a scientific Opinion on VTEC- seropathotype and scientific criteria regarding pathogenicity assessment. In particular: to review the “seropathotype‟ concept of Karmali and colleagues (2003) and assess whether the pathogenicity can be excluded for defined VTEC serotypes; to justify the statement: “seropathotypes D and E are not HUS-associated and are uncommon in man or only found in non-human sources”; Brussels, 19 th April 2013 UECBV Ref: 3742 RE: EFSA - Manuals for reporting on Food-borne Outbreaks and Zoonoses - Microbiological food safety

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Page 1: RE: EFSA -Manuals for reporting on Food borne Outbreaks and … · 2013-04-22 · Campylobacter: human campylobacteriosis in the European Union increased. With 220,209 confirmed cases,

81A rue de la Loi (bte 9) - 1040 BRUXELLES, Belgique Tel: 32 (0) 2 230 46 03 - Fax: 32 (0) 2 230 94 00

E-mail: [email protected] – Web: www.uecbv.eu

1

Summary EN:

1. The new manual providing specific guidance for reporting on food-borne outbreaks under the framework of Directive 2003/99/EC has been published. It includes the description of the structure and scope of the reporting system for food-borne outbreaks.

2. The new Reporting Manual providing guidance for reporting on zoonoses, zoonotic agents and antimicrobial resistance in animals, food and feed under the framework of Directive 2003/99/EC has been published.

3. The annual report on zoonosis for the year 2011 has been published. A total of 5,648 food-borne outbreaks were reported in the European Union, resulting in 69,553 human cases, 7,125 hospitalisations and 93 deaths.

Campylobacter: human campylobacteriosis in the European Union increased. With 220,209 confirmed cases, it is the commonly reported zoonosis.

Salmonellosis: 95,548 confirmed human cases were reported in 2011, a decrease of 5.4%.

Listeria: 1,476 confirmed human cases were reported in 2011. The number of listeriosis cases in humans decreased slightly as compared with 2010.

Escherichia coli, VTEC: A total of 9,485 confirmed verotoxigenic Escherichia coli infections were reported in 2011, which was a 2.6-fold increase as compared to 2010.

Tuberculosis (M. bovis): the number of confirmed human cases in 2011 was 132. This was a decrease as compared to 2010.

Yersinia: A total of 7,017 confirmed cases reported in 2011, corresponding to an increase by 3.5% as compared to 2010.

Brucella: The number of confirmed brucellosis cases in humans continued to decline, and 330 confirmed cases were reported in 2011.

Trichinella and Echinococcus: In 2011, trichinellosis and echinococcosis caused, respectively, 268 and 781 confirmed human cases in the European Union. The number of cases was slightly higher in 2011 as compared to 2010.

Rabies: One imported human case of rabies was reported in the European Union in 2011.

4. The European Food Safety Authority was asked to deliver a scientific Opinion on VTEC-seropathotype and scientific criteria regarding pathogenicity assessment. In particular:

to review the “seropathotype‟ concept of Karmali and colleagues (2003) and assess whether the pathogenicity can be excluded for defined VTEC serotypes;

to justify the statement: “seropathotypes D and E are not HUS-associated and are uncommon in man or only found in non-human sources”;

Brussels, 19th April 2013 UECBV Ref: 3742

RE: EFSA - Manuals for reporting on Food-borne Outbreaks and Zoonoses

- Microbiological food safety

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81A rue de la Loi (bte 9) - 1040 BRUXELLES, Belgique Tel: 32 (0) 2 230 46 03 - Fax: 32 (0) 2 230 94 00

E-mail: [email protected] – Web: www.uecbv.eu

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to assess an alternative concept based on detection of verocytotoxins, or genes encoding for verocytotoxins, in isolates;

to assess the contribution by VTEC to diarrhoeal cases and to more severe outcomes in the EU, based on hazard identification and characterisation, and under-reporting in EU;

to assess the public health risk associated with the contamination of RTE foods with VTEC, considering either the seropathotype concept or the detection of verocytotoxins or genes encoding the production of such toxins in isolates.

Synthèse FR:

1. Le nouveau manuel fournissant des conseils précis pour la déclaration sur les épidémies d'origine alimentaire dans le cadre de la directive 2003/99/CE a été publié. Il comprend la description de la structure et la portée du système de déclaration des épidémies d'origine alimentaire.

2. Le nouveau manuel sur l’élaboration de rapports fournissant des orientations pour les rapports sur les zoonoses, les agents zoonotiques et la résistance antimicrobienne chez les animaux, alimentation humaine et animale dans le cadre de la directive 2003/99/CE a été publié.

3. Le rapport annuel sur les zoonoses pour l'année 2011 a été publié. Un total de 5.648 foyers d'origine alimentaire ont été signalés dans l'Union européenne, résultant en 69.553 cas humains, 7.125 hospitalisations et 93 décès.

Le Campylobacter: la campylobactériose humaine dans l'Union européenne a augmenté. Avec 220.209 cas confirmés, il s’agit de la zoonose fréquemment rapportée.

La salmonellose: 95.548 cas humains confirmés ont été signalés en 2011, soit une baisse de 5,4%.

Listeria: 1.476 cas humains confirmés ont été signalés en 2011. Le nombre de cas de listériose chez l'homme a diminué légèrement par rapport à 2010.

Escherichia coli, VTEC: Un total de 9.485 cas confirmés d'infection par l’Escherichia coli vérotoxinogène ont été signalés en 2011, soit une augmentation de 2,6 fois par rapport à 2010.

La tuberculose (Mycobacterium tuberculosis ou M. bovis): le nombre de cas humains confirmés en 2011 a été 132. Ce chiffre représente une baisse par rapport à 2010.

1. EFSA - Manual for reporting on Food-borne outbreaks; 2. EFSA - Manual for Reporting on Zoonoses, Zoonotic Agents

and Antimicrobial Resistance; 3. EFSA - ECDC annual report on animal infections transmissible

to humans; 4. EFSA - Scientific Opinion on VTEC-seropathotype and scientific

criteria regarding pathogenicity assessment.

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81A rue de la Loi (bte 9) - 1040 BRUXELLES, Belgique Tel: 32 (0) 2 230 46 03 - Fax: 32 (0) 2 230 94 00

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Yersinia: Un total de 7.017 cas confirmés ont été signalés en 2011, correspondant à une augmentation de 3,5% par rapport à 2010.

Brucella: Le nombre de cas confirmés de brucellose chez l'homme a continué de baisser, et 330 cas confirmés ont été signalés en 2011.

Trichinella et Echinococcus: En 2011, la trichinellose et l'échinococcose ont causé, respectivement, 268 et 781 cas humains confirmés dans l'Union européenne. Le nombre de cas était légèrement plus élevé en 2011 par rapport à 2010.

La rage: Un cas humain importé de rage a été signalé dans l'Union européenne en 2011. 4. L'Autorité européenne de sécurité des aliments a été invitée à rendre un avis scientifique sur le

VTEC-seropathotype et des critères scientifiques relatifs à l'évaluation de la pathogénicité. En particulier:

examiner le concept « seropathotype » de Karmali et ses collègues (2003) et d'évaluer si la pathogénicité peut être exclue pour des sérotypes de VTEC définis;

justifier la déclaration suivante: « les seropathotypes D et E ne sont pas SHU-associés et sont rares chez l'homme ou seulement identifiés dans les sources non-humains »;

évaluer un concept alternatif basé sur la détection des vérocytotoxines, ou des gènes codants pour les vérocytotoxines, dans des isolats;

évaluer la contribution des VTEC à des cas de maladies diarrhéiques et à des résultats plus graves dans l'UE, basés sur l'identification et la caractérisation des dangers, et la sous-déclaration dans l'UE;

évaluer le risque pour la santé publique lié à la contamination des aliments prêts à consommer avec VTEC, considérant soit le concept seropathotype ou la détection des vérocytotoxines ou des gènes codants pour la production de ces toxines dans les isolats.

1. EFSA - Manuel pour l’élaboration des rapports sur les épidémies d'origine alimentaire;

2. EFSA - Manuel pour l’élaboration des rapports sur les zoonoses, les agents zoonotiques et la résistance antimicrobienne;

3. EFSA - Rapport annuel de l’ECDC sur les infections animales transmissibles à l'homme;

4. EFSA – Avis scientifique sur le VTEC-seropathotype et des critères scientifiques relatifs à l’évolution de la pathogénicité.

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EFSA - Manual for reporting on Food-borne outbreaks

On 5th April 2013, EFSA has published the “Manual for reporting of food-borne outbreaks in accordance with Directive 2003/99/EC from the year 2012”. This manual provides specific guidance for reporting on food-borne outbreaks under the framework of Directive 2003/99/EC and it is in particular intended to be used when reporting the data through the web reporting application run by the EFSA. The manual includes the description of the structure and scope of the reporting system for food-borne outbreaks, the definitions used in the system, as well as the variables to be reported on. It gives detailed advice, often through examples, how to report and classify the causative agents, food vehicles, settings, places of origin of problem and the contributory factors. This manual is specifically aimed to guide the reporting of the information deriving from the year 2012.

EFSA - Manual for Reporting on Zoonoses, Zoonotic Agents and Antimicrobial Resistance

On 5th April 2013, EFSA has published the “Manual for Reporting on Zoonoses, Zoonotic Agents and Antimicrobial Resistance”. This Reporting Manual provides guidance for reporting on zoonoses, zoonotic agents and antimicrobial resistance in animals, food and feed under the framework of Directive 2003/99/EC. Some advice is also given on reporting on other pathogenic microbiological agents in food. The objective is to harmonise and streamline the reporting made by the Member States in a way that the data collected would be relevant and easy to be analysed at the European Union level. The manual covers all the agents and items included by the current data collection through the web-based reporting system. Instructions are given on description of the sampling and monitoring schemes, as well as analyses of the results in the national reports. Special reference is made to fields where following of trends would be desirable at the European Union level and where Member States are encouraged to provide data on a regular basis. This manual is specifically aimed to guide the reporting of the information deriving from the year 2012.

EFSA-ECDC annual report on animal infections transmissible to humans

On 9th April 2013, the European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control (ECDC) analysed the information submitted by 27 European Union Member States on the occurrence of zoonoses and food-borne outbreaks in 2011.

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A total of 5,648 food-borne outbreaks were reported in the European Union, resulting in 69,553 human cases, 7,125 hospitalisations and 93 deaths. The most important food sources of the outbreaks were eggs and egg products, followed by mixed food and fish and fish products.

Comparison with 2010:

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Please find below some highlights listed per pathogen:

Campylobacter spp.: In 2011, the notification rate and confirmed number of cases of human campylobacteriosis in the European Union increased as compared to 2010. Human campylobacteriosis continued to be the most commonly reported zoonosis with 220,209 confirmed cases. The number of confirmed cases of campylobacteriosis in the European Union has followed a significantly increasing trend in the last four years, along with a clear seasonal trend. The proportion of Campylobacter-positive food and animal samples remained at levels similar to previous years, with the occurrence of Campylobacter continuing to be high in broiler meat.

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Comparison with 2010:

Salmonellosis spp.: the number of salmonellosis cases in humans decreased by 5.4% as compared to 2010 and by as much as 37.9% as compared to 2007. A statistically significant decreasing trend in the European Union was observed over the period 2008-2011. In total, 95,548 confirmed human cases were reported in 2011. It is assumed that the observed reduction in salmonellosis cases is mainly a result of the successful Salmonella control programmes in poultry populations. In foodstuffs, Salmonella was most often detected in fresh broiler meat. The food categories with highest proportion of products not complying with the European Union Salmonella criteria were minced meat and meat preparations, as well as live bivalve molluscs.

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Comparison with 2010:

Listeria spp.: the number of listeriosis cases in humans decreased slightly as compared to 2010,

and 1,476 confirmed human cases were reported in 2011. As in previous years, a high fatality rate (12.7%) was reported among the cases. Listeria monocytogenes was seldom detected above the legal safety limit from ready-to-eat foods at point of retail. Samples exceeding this limit were most often found in fishery products, cheeses and fermented sausages.

Escherichia coli-VTEC: A total of 9,485 confirmed verotoxigenic Escherichia coli infections were reported in 2011, which was a 2.6-fold increase as compared to 2010. A large number of the cases, 1,006 cases, were also affected by the severe condition, Haemolytic Uraemic Syndrome, in 2011. This was a 4.5-fold increase as compared to 2010, primarily observed in adult cases and

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attributed to the German outbreak. The number of reported cases of verotoxigenic Escherichia coli human cases has been increasing in the EU since 2008. In animals and food, most verotoxigenic Escherichia coli-positive findings were made in cattle and bovine meat, but the bacteria were also detected in some other animal species and foodstuffs.

Compared with 2010:

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Escherichia coli: Twelve Member States reported a total of 60 food-borne outbreaks caused by human pathogenic Escherichia coli (E. coli), excluding three strong waterborne outbreaks. This represents 1.1% of the total number of reported food-borne outbreaks in the EU and an increase of 93.5% as compared to 2010 (31 outbreaks). The overall reporting rate in the EU in 2011 was 0.01 per 100,000 population, which is higher than in 2010 (<0.01), but lower than the reporting rates in the previous years, 2007, 2008 and 2009 (0.02 per 100,000). France and Germany together reported 45.0% of pathogenic E. coli outbreaks. No outbreaks due to human pathogenic E. coli were reported by non-Member States.

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Yersinia spp.: A total of 7,017 confirmed cases of yersiniosis were reported in the European Union in 2011, corresponding to an increase by 3.5% as compared to 2010. There was, however, a statistically significant decreasing five-year trend in the European Union in 2007-2011. Among food and animals, Yersinia enterocolitica was mainly isolated from pig meat and pigs.

Tuberculosis (M.bovis): due to Mycobacterium bovis, in the European Union in 2011, the number of confirmed human cases was 132. This was a decrease as compared to 2010, with a few Member States accounting for the majority of the reported cases. The reported prevalence of bovine tuberculosis in cattle increased slightly at European Union level, although remained at very low level.

Brucella spp.: The number of confirmed brucellosis cases in humans continued to decline, and 330 confirmed cases were reported in 2011 at European Union level. The number of brucellosis-positive sheep and goat herds continued to decrease. Bovine brucellosis decreased only marginally as compared to 2010.

Trichinella spp. and Echinicoccus spp.: In 2011, trichinellosis and echinococcosis caused, respectively, 268 and 781 confirmed human cases in the European Union. Although the number of cases was slightly higher in 2011 as compared to 2010, human trichinellosis cases remained at a low level in the European Union as compared to 2009 and previous years. In 2011, Trichinella was found slightly more often in pigs than it was in 2010. The parasite was more prevalent in wildlife than in farmed animals. The number of confirmed human echinococcosis cases in 2011 increased by 3.3% as compared to 2010, primarily as a result of the increasing number of cases of Echinococcus multilocularis, causing alveolar echinococcosis, being reported in 2011, but also on account of an increase over the last five years. Echinococcus multilocularis was reported mainly in foxes by several central European reporting countries.

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Rabies: One imported human case of rabies was reported in the European Union in 2011. The general decreasing trend in the numbers of reported rabies cases in animals continued in 2011. Rabies was reported mainly in wildlife animal species and sometimes in farm and pet animals in some Baltic and Eastern and Southern European Member States.

Please find here the full report published in 2013, for the year 2011. Please find here the full report published in 2012, for the year 2010.

Please be informed that the Secretary General of UECBV, Mr Jean-Luc Mériaux, gave an interview on this issue on 12th April 2013. He stated that the role of the European red meat sector in spreading food-borne diseases has decreased, even though campylobacter and E. coli have risen. Please find here the complete article.

EFSA- Scientific Opinion on VTEC-seropathotype and scientific criteria regarding pathogenicity assessment

Following a request from the Austrian Federal Ministry of Health, the Panel on Biological Hazards (BIOHAZ) was asked by the European Food Safety Authority to deliver a scientific Opinion on VTEC-seropathotype and scientific criteria regarding pathogenicity assessment. In particular, they asked EFSA:

1. to review the “seropathotype‟ concept of Karmali and colleagues (2003) and assess whether the pathogenicity can be excluded for defined VTEC serotypes;

2. to justify the statement: “seropathotypes D and E are not HUS-associated and are uncommon in man or only found in non-human sources”;

3. to assess an alternative concept based on detection of verocytotoxins, or genes encoding for verocytotoxins, in isolates;

4. to assess the contribution by VTEC to diarrhoeal cases and to more severe outcomes in the EU, based on hazard identification and characterisation, and under-reporting in EU;

5. to assess the public health risk associated with the contamination of RTE foods with VTEC, considering either the seropathotype concept or the detection of verocytotoxins or genes encoding the production of such toxins in isolates.

The 2003 Karmali seropathotype model classifies verocytotoxin-producing Escherichia coli (VTEC) into seropathotypes, based on their reported frequency in human disease, their known association with outbreaks and their severity of the outcome including HUS and HC, and can be summarised as:

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Pathogenicity can neither be excluded nor confirmed for a given VTEC serogroup or serotype based on the seropathotype concept or analysis of the public health surveillance data. During 2007-2010, 13,545 confirmed human VTEC infections were reported in Europe; isolates from 85% of these cases were not fully serotyped and could, therefore, not be classified by using the seropathotype concept.

The seropathotype D covered 5% of human cases that were fully serotyped. The seropathotype group E covered 14 cases (0.7%), defined as non-human only. Around 27% of the cases could not be assigned to a seropathotype group, as these were not listed in the 2003 Karmali paper. There were no HUS cases reported for the serotypes included in groups D and E. There were 17 HUS cases reported that could not be assigned to a group. Most patients (ca. 64%) presented with only diarrhoea. VTEC infection resulted in HUS in around 10% of the cases. Thus, pathogenicity can neither be excluded nor confirmed for a given VTEC serogroup or serotype based on the seropathotype concept or analysis of the public health surveillance data.

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Detection of VTEC is highly dependent on the methods applied to clinical specimens and these vary between different Member States (MSs). It is not possible to fully define human pathogenic VTEC or to identify factors for VTEC that absolutely predict the potential to cause human disease. The detection of verocytotoxins alone, or of genes encoding for such verocytotoxins is not a sound scientific basis for assessing the disease risk to the consumer. There is no single or combination of marker(s) that defines a „pathogenic‟ VTEC. Other virulence gene combinations and/or serotypes may also be associated with severe disease in humans, including HUS. VTEC has been recovered from a range of different animal species and food categories. The most widely used analytical method only aims at detecting VTEC O157, whereas fewer investigations have been conducted with analytical methods aiming at detecting all or selected serotypes of VTEC. On the basis of the proposed provisional molecular classification scheme, any RTE product contaminated with an isolate of one of the VTEC serogroups of group I (O157, O26, O103, O145, O111, O104) in combination with vtx and eae or aaiC and aggR genes should be considered as presenting a potentially high risk for diarrhoea and HUS. For any other serogroups in combination with the same genes, the potential risk is regarded as high for diarrhoea, but currently unknown for HUS. In the absence of these genes, current available data do not allow any inference regarding potential risks.

The BIOHAZ Panel made a series of recommendations relating to public health investigation of VTEC infection, verification and periodic revision of the proposed molecular approach for the categorisation of VTEC strains. The inclusion of aaiC and aggR genes in this approach is due to the 2011 outbreak, which was caused by a highly virulent strain. This was an exceptional event and future surveillance will provide data that may be used to review the inclusion of these virulence factors. Thus, screening VTEC for the presence of aaiC and aggR genes should be performed on isolates from human, food and animal sources, to address this question. Finally, international harmonisation of nomenclature of VTEC and its virulence factors was suggested: using STEC instead of VTEC and stx instead of vtx or vt.