Annual Report (2011) of EFSA Scientific network for Risk Assessment in Animal Health and Welfare 1

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1 Supporting Publications 2012: EN-262 TECHNICAL REPORT Annual Report (2011) of EFSA Scientific network for Risk Assessment in Animal Health and Welfare 1 European Food Safety Authority 2, 3 European Food Safety Authority (EFSA), Parma, Italy KEY WORDS Animal health and welfare, risk assessment, network, Member States European Food Safety Authority, On request from EFSA, Question No EFSA-Q , approved on 30 March Correspondence: ahaw@efsa.europa.eu 3 [Acknowledgement: EFSA wishes to thank the AHAW Scientific network for risk assessment: Austrian Agency for Health and Food Safety - Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH (Austria), The General Directorate Service Food, Feed and Other Consumption Products DG Animals (Belgium), Bulgarian Food Safety Agency - National Diagnostic and Research Veterinary Medical Institute (Bulgaria), Veterinary Services (Cyprus), Veterinary Scientific Committee - Veterinary Research Institute (Czech Republic), National Veterinary Institute (Denmark), Animal Health and Animal Welfare Dept - Veterinary and Food Board (Estonia), Finnish Food Safety Authority Evira (Finland), Feed and Animal Health Risk Assessment Unit (France), Bundesforschungsinstitut für Tiergesundheit Frierdich-Loeffler- Institut (FLI) (Germany), Laboratory of Animal Husbandry, Department of Animal Production, Ichthyology, Ecology and Environmental Protection, Aristotle University of Thessaloniki (Greece), Central Agriculture Office, Directorate of Animal Health and Welfare (Hungary), Icelandic Food and Veterinary Authority MAST (Iceland), Department of Agriculture, Food and Fisheries (Ireland), Istituto Zooprofilattico Sperimentale Abruzzo e Molise (Italy), The Food and Veterinary Service (Latvia), Lithuanian State Food and Veterinary Service (Lithuania), Administration des services vétérinaires - Ministère de l'agriculture (Luxemburg), Veterinary Affairs and Fisheries Division (Malta), Food and Consumer Product Safety Authority (VWA) (Netherlands), Norwegian Scientific Committee for Food Safety (Norway), National Veterinary Research Institute - Dept of Hygiene of Food of Animal Origin (Poland), Ministry of Agriculture - Veterinary Service of Portugal (Portugal), Romanian National Sanitary Veterinary and Food Safety Authority (Romania), University of Veterinary Medicine and Pharmacy (Slovakia), Ministry of Agriculture (Slovenia), General Adjunto de Sanidad Animal (Spain), National Veterinary Institute (Sweden), Swiss Federal Veterinary Office (Switzerland), Dept. for Environment, Food and Rural Affairs DEFRA (UK), for the preparatory work on this output and the Observers: Icelandic Food and Veterinary Authority MAST (Iceland), Animal Health and Welfare, Norwegian Scientific Committee for Food Safety (Norway)and Swiss Federal Veterinary Office (Switzerland) and the invited speakers Howard Browman, Jeffrey Rushen, Paskal Hendrix for the support provided to this output. Suggested citation: European Food Safety Authority; Annual Report (2011) of EFSA Scientific network for Risk Assessment in Animal Health and Welfare. Supporting Publications 2012 EN-262. [9 pp.]. Available online: European Food Safety Authority, 2012

2 SUMMARY In accordance with EFSA s strategy for cooperation and networking with Member States and Decision concerning the establishment and operation of European Networks of scientific organisations operating in the fields within the Authority s mission two meetings were organised in by EFSA AHAW Unit in Parma in 2011, the first on the 2 and 3 May 2011 and the second on the November Various ways of collaboration and networking within EFSA scope were presented and discussed. Members of the network presented national Risk Assessment activities in the filed of AHAW. Retrospective comparative analysis of risk assessment on Q-fever and Echinococcus was organised and results discussed. Draft guidance on risk assessment for animal welfare and recent development on the topic were presented to the network members. Information was exchanged on activities of network members (EFSA and member states), practical exercises were organised to collect and discuss specific topics. Options for data collection and sharing, communication channels and potential for more topic specific meetings and discussions were identified as very important in future collaboration. Supporting publications 2012:EN-262 2

3 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background as provided by [requestor]... 4 Terms of reference as provided by [requestor]... 4 Activities Follow-up from network meeting in Network meetings The first meeting The second meeting Planned Network activities for Supporting publications 2012:EN-262 3

4 BACKGROUND The European Food Safety Authority (EFSA) is the keystone of European Union risk assessment regarding food and feed safety, animal health and welfare, nutrition, plant protection and plant health. In close collaboration with national authorities and in open consultation with its stakeholders, EFSA provides independent and transparent scientific advice and clear communication on existing and emerging risks associated with the food chain. On request from the European Commission, European Parliament and Member States, or on its own initiative, EFSA provides scientific opinions on issues falling under its remit. The Animal Health and Welfare (AHAW) Panel provides independent scientific advice on all aspects of animal health and animal welfare. Its work primary concerns food producing animals, including fish. The risk assessment approach is based on reviewing scientific information and data, and applying appropriate methodologies to evaluate the risks and consequences of a given hazard. This helps to provide a science-based foundation for European policies and legislation, and supports risk managers in taking balanced and timely decisions. In accordance with EFSA s strategy for cooperation and networking with Member States 4 and Decision concerning the establishment and operation of European Networks of scientific organisations operating in the fields within the Authority s mission 5 a scientific network of risk assessment in animal health and welfare was launched and first meeting organised in Parma on November Two network meetings were organised by EFSA AHAW Unit in Parma in 2011, the first on the 2 and 3 May 2011 and the second on the November TERMS OF REFERENCE The overall objectives of the EFSA Scientific Network for Risk Assessment in Animal Health and Welfare is to enhance cooperation in Member States (MS) and EFSA, to build mutual understanding of risk assessment principles of Animal Health and Welfare and to provide increased transparency in the current process among MS and EFSA. It is expected to promote harmonisation of risk assessment practice and methodologies and reduce the duplication of activities by identifying and sharing current priorities. The specific objectives (Terms ofreference, ToR) of the Network are: 1. ToR1 - To facilitate harmonisation of animal health and welfare assessment practices and methodologies; 2. ToR2 - To enhance exchange of information and data between EFSA and MS; 3. ToR3 - To achieve synergies in animal health and welfare risk assessment activities. EFSA may entrust certain tasks to the Network, in particular, preparatory work for scientific opinions, scientific and technical assistance, and collection of data and identification of emerging risks. 4 EFSA Management Board, Strategy for Cooperation and Networking between the EU Member States and EFSA, a. 5 Rules of Procedures of EFSA Networks (mb item 7 doc 6) Supporting publications 2012:EN-262 4

5 ACTIVITIES 1. Follow-up from network meeting in 2010 In 2010, the Network members confirmed their interest and support to the development of a scientific cooperation framework among EFSA and scientific organisations of EU Member States operating in the fields of animal health and welfare. MS can share data and information by tools which already existent in EFSA: sciencenet web, IEP and s. Presentations at the network meetings may be undertaken by each MS as a useful way of sharing activities carried out at the national level. It was agreed that harmonisation of the procedures and risk assessments (RA) should not be a final goal per se. It is more important to share the risk assessments with all the supportive/background information (questions, assumptions, data collected and considered parameters, models, uncertainties, procedures, etc.) to be able to evaluate, assess and understand why the outputs are significantly different or not. It was advised/agreed to perform comparative analyse of risk assessment developed in some case studies (e.g. Q fever, oyster mortalities or Echinococcosis). The meetings of the Network will be an opportunity for exchange experience, work being developed and to look for opportunities of collaboration on RA related to AH not only with EFSA but also between MS. At the same time it is also a good way to avoid duplication of efforts and to look for synergies. It was agreed to organise a minimum of two meetings per year in order to stimulate an active collaboration inside the Network. 2. Network meetings 2011 There were organised two meetings of EFSA Scientific Network for Risk Assessment in Animal Health and Welfare First meeting The first meeting was held on 2-3 May in Parma and was attended by 17 MS representatives, observers from Switzerland and from Belgium, two observers from the European Commission and one from OIE, two invited speakers (Howard Browman, Jeffrey Rushen) 11 AHAW Panel members and EFSA staff. The following issues were discussed: Networking and cooperation EFSA (AFSCO) presented the strategy adopted by the Management Board in 2006 for networking and cooperation between with Member States. This strategy bears on the Advisory Forum (AF), EFSA Focal Points (FP), EFSA scientific networks, Member State consultations and Art. 36 calls. The aims of the networks is to support EFSA and the Member States in facilitating the development of a scientific cooperation framework through exchange of information, development and implementation of joint projects and exchange of expertise and best practices. Various ways of collaboration and networking within EFSA scope were presented and discussed: dedicated sessions for AHAW questions during the Advisory Forum meetings, participation in projects in line with Art. 36 of Regulation (EC) 178/2002, opportunity to use EFSA sciencenet web, Information Exchange Platform (IEP), monthly reports with summary of recently uploaded information and potential expand of the role of Animal Health and Welfare scientific network for risk assessment. National activities Three members of the network EVIRA (Finland), FLI (Germany) and DTU National Veterinary Institute (Denmark) presented national Risk Assessment activities in the filed of AHAW. The Supporting publications 2012:EN-262 5

6 assessments covered risk of introduction of different pathogens in the EU, analyses of surveillance activities, potential transmissions and spread. The use of different predictive models was presented too. Some problems usually faced at national level were explained and discussed within the network. Suggestions for cooperation were made: mutual information on planed and pending risk assessments (RA) activities, including methodologies in use and data sharing. Retrospective comparative analysis of risk assessment There were presented and discussed the results of a practical exercise of retrospective analysis of risk assessments on the following issues: Q-fever and Echinococcus. The exercise actively involved the participants: Ann Lindberg and Susanna Sternberg (Sweden), Wim Ooms (the Netherlands), Xavier van Huffel (Belgium) and a member of Simon More (AHAW Panel). The main discrepancies among different assessments were presented and discussed. Time frame for work, objective of the assessment, methodology, geographical area of interest, semantics of the uncertainty in the expert statements, data availability and gaps, weight of the literature data, practicality in the recommendations, dialogue between risk assessors and risk managers, possible use of cost-benefits analysis were identified by the exercise and discussed during the meeting. The participants agreed that the retrospective analysis could identify differences in risk questions, as well as in conclusions and recommendations. It is important that the reasons for such differences or eventual discrepancies be understood. Risk assessment for animal welfare - EFSA Guidance Draft guidance on risk assessment for animal welfare and recent development on the topic were presented by members of AHAW Panel (Moez Sanaa and Linda Keeling). Participants were informed that a public consultation on the draft Guidance had been launched on the EFSA website. A workshop was organised including two case studies as practical exercises to facilitate group discussion. A first case study compared two management strategies: use of regular semen versus sexed semen. The second case study presented a situation of transport of fattening lambs from farm to slaughterhouse and it was asked to assess the risk linked to the increase of the density of animals plus the increase of the journey duration. The group discussion focused on factors/ hazards to be considered essential or not, facilitating the dialogue between risk assessors and risk managers, advantages and limitations of Guidance in risk assessment for animal welfare. The discussion also highlighted the need to link with the ammended systematic review methodology when making the literature review. Two invited speakers presented advanced work in the welfare topic in support to the development of a Guidance document in risk assessment for animal welfare. Jeffrey Rushen (Agriculture and Agri-food Canada) presented key points for future developments: the need for community standards to determine the acceptable level of welfare or animal status, the input versus outcome-based indicators, the use of data bases to screen problematic farms, early warning systems to predict poor welfare and the need of behavioural welfare outcome indicators. The possibility to measure positive welfare was delineated, too. Howard Browman (Institute of Marine Research, Norway) presented possible bias in welfare science by 1) ignoring negative experimental results; 2) faith based research by accepting ideas by faith and searching for data which may support these ideas; and 3) HARKing interpretation of the results (HARK: Hypothesis After Results are Known) instead of the hypothetic-deductive approach. Finally, the inflation of the science boundary by including, i.e. social, political or cultural considerations within the label science, was presented and discussed. The participants presented the view that, when finalized by EFSA, the Guidance would need to be used and tested at National level. Supporting publications 2012:EN-262 6

7 The meeting minutes are published on AHAW Network section of EFSA website Second meeting Annual Report (2011) AHAW network The second meeting was held on November in Parma and was attended by 14 MS representatives, an invited speaker (Paskal Hendrix), 3 AHAW Panel members and EFSA staff. The following issues were discussed: Activities of network members Scientific opinions adopted by the AHAW Panel of EFSA, since May 2011 and ongoing activities in November 2011 were presented to the attention of the network. Some scientific topics with potential for including in the management plan 2012 were presented: work on diagnostic test for tuberculosis, Infectious Salmon Anaemia, Leishmaniosis, Echinococcus multilocularis and E. granulosus, animal based measures (beef cattle), fish transport. Other topics were discussed as valuable for scientific collaboration: risk categorisation for aquaculture farms, methodological framework for risk assessments for potentially pandemic flu, transport of fish, update of tick-borne disease database, various systematic literature reviews on animal welfare and health, leishmaniosis. Some examples, on the use of MS data for further AHAW assessment, were given, based on the inputs provided by the members in the IEP on past and ongoing activities on tuberculosis (TB) and foot and mouth disease (FMD). A practical exercise was organised during the network meeting to collect information about: i) national activities in risk assessment in 2011/2012 (recently published RA but not in EFSA IEP platform), ii) any ongoing activities, and iii) planned activities in The objective of the exercise was to define common areas of interest. Some examples, indicated most frequently by the MS in the exercise were discussed (West Nile Virus (WNV), African Horse Sickness (AHS), African Swine Fever (ASF) and Classical Swine Fever (CSF), Welfare. The risk assessment topics of interest raised at the meeting have included analyses on the risk of introduction, spread and potential surveillance activities of diseases considered as threat for some areas in the EU. Early warning systems for animal welfare with potential control on the intervention were presented as novel methods in Ireland and Belgium. Risk assessment and needs for data EFSA presented the generic workflow for risk assessments carried out by AHAW, including the assessment of data needs, data availability and accessibility, data quality and evaluation of data gaps. In order to increase preparedness for future mandates, EFSA awarded an Art. 36 project on data specifications. The project deadline is May Its objectives are to establish a typology of the risk questions in the area of animal health to identify the sources of information and to develop a methodology for data collection including the definition of metadata standards for outcomes values to support data validation and quality assessment and to establish a methodological framework for the use of data in a scientific assessment. Preliminary results concerning the classification of the different risk questions that were received by the AHAW Panel and the type of data needed to answer them were shown. The availability of the different data in the different Member States was presented. Difficulties with collecting this information were discussed, e.g. language problems, lack of standardisation, restricted access to data, lack of scientific pertinence, incompleteness of data, etc. Example for data collection activities at national level Pascal Hendrix presented the French National platform for Animal Health Surveillance and the objectives to analyse the epidemiological information to facilitate risk analysis and management. An analysis tool (OASIS) was developed to analyse the performance and the quality of the existing surveillance systems, enabling the identification of potential weaknesses and the proposal of 6 Supporting publications 2012:EN-262 7

8 recommendations for improving the surveillance systems. The tool is used for analyses in 15 surveillance systems. Some incompatibility of data was recognised at different levels of collected information particularly between regulated and other diseases. Potential improvements are possible improving data sharing between all members of the platform. The Member States listed their top-3 priority areas to focus the activities on in Some examples of topics that were listed several times by different countries were: bee diseases (some examples of data needs: evaluation of toxicity of different pesticides and toxic reference values), wildlife diseases (some examples of data needs: migration of populations, population size, actual disease surveillance data), tuberculosis (data collection on health status, data on diagnostic tools), salmonellosis, use of antibiotics in veterinary medicines, disease categorisation, IBR-BVD, African Swine fever, WNF. The participants presented the view that there is a need to exchange collected data, either with a long lasting data collection framework, or with databases developed for a specific opinion or for other short term purposes. Data collection EFSA (SAS Unit) presented the objectives of the EFSA data collection activities. The data transfer standards were explained. The data submission requirements need to be explained to data providers and developed with a long term view and design that reduces the requirements for updates and new versions. Data should be preferably collected at the lowest level of granularity, which allows answering the maximum of scientific questions. The concept of Data Warehouses was explained. Data warehouses allow accessibility and dissemination within EFSA. An example was given within the animal health remit, namely the tick and tick-borne disease database. EFSA (AFSCO Unit) also presented the report of the discussion group on data collection. The main concerns identified were the differences in food classification; the lack of long term planning for data collection; the lack of harmonisation in ways data collected across different domains; the quality control that was not consistent and duplication of effort being made in making returns; the difficulty of access to data held by EFSA; the lack of interoperability between systems; the lack of central coordination for data returns; inconsistent legal framework for data collection in different domains and the information technology that was not well developed for exchange of information. Improvements would be achieved by development of a 3,5 year medium term data collection plan, establishment of quality checking and control procedures; the development of guidance for analysis of the data and dissemination of the results; work towards harmonisation of data collections within MS under the relevant units responsible in EFSA harmonised transfer of data and protocols to reduce the resource burden in providing data. The network members briefed the other participants on the on-going data collection activities in their institutions. They explained how these data collection activities are organised and what their role is in these activities. The interaction between the data collectors and the actual users of the data, i.e. the risk assessors is of different nature in the different institutions. The need to have the interaction with the data analyst was recognised to be of key importance to make sure that datasets are interpreted and used appropriately for risk assessments, and sometimes this interaction is weak. The participants in the meeting agreed that sharing data is beneficial for all partners involved. It may lead to improving the quality of the data collection system, by taking into account comments of other partners and increasing the transparency how data was collected. However, sharing is often not happening because of the fear of getting extra control measures, economical reasons or just because people do not like to be criticised. The meeting minutes are published on AHAW Network section of EFSA website Supporting publications 2012:EN-262 8

9 3. Planned Network activities for 2012 Annual Report (2011) AHAW network The Network members confirmed their interest and support to the continuous collaborative work and development in EFSA scientific networking on Risk Assessment in Animal Health and Welfare. Organisation of technical meetings and annual meetings as fora of thematic discussions was very appreciated by all members. Continuous exchange of information between the meetings would be valuable for the whole network. In the context of the future organisation of the Network activities in 2012 the Members of the Network highlighted the following issues for consideration: There is need to improve the communication between the network members. The network can be notified when mandates are received, when opinions are adopted, or art. 36 calls for tenders are launched. Similarly, network members agreed to inform each other when a new risk assessment is performed. The practical exercises and discussions at the network meetings indicated clusters of topics of common interest. It was agreed to propose technical meetings on such topics in order to discuss risk questions, methodological approaches and availability of data in member states. Tuberculosis was identified as a first topic of common interest and a technical meeting should be organised early There is a need to clearly specify which data is needed for sound risk assessments. Further discussion and sharing experience on dynamic data use for the purpose of risk assessment may be very useful. Data collection on animal welfare (indicators) may need further developments. A workshop will be organised in the spring of 2012 to address the critical issues of data collection that occur in risk assessments and EFSA outsourced projects in the frame of scientific collaboration. EFSA AHAW Unit is planning to involve the new country (HR) accessing to the EU in 2012 and candidate countries to the EU in the activities of EFSA scientific network on Risk Assessment in Animal Health and Welfare. Supporting publications 2012:EN-262 9