Pre-accession Training on Chemical Risk Assessment 1, 2

Transcription

1 EFSA supporting publication 2013:EN-468 EVENT REPORT Pre-accession Training on Chemical Risk Assessment 1, 2 European Food Safety Authority European Food Safety Authority (EFSA), Parma, Italy ABSTRACT The report presents the overview from the Chemical risk assessment training for the Pre-Accession countries organised under the EFSA Pre-Accession Programme. The objective of the training was to improve the knowledge on chemical risk assessment and to increase the awareness on EFSA s activities in the Pre-Accession countries. The training was given by the tutors from the Danish Technical University (DTU) and EFSA. European Food Safety Authority, Question No EFSA-Q Disclaimer: The views or positions expressed in this publication do not necessarily represent in legal terms the official position of the European Food Safety Authority. The European Food Safety Authority assumes no responsibility or liability for any errors or inaccuracies that may appear. Any enquiries related to this output should be addressed to AFSCO.ENPA@efsa.europa.eu Suggested citation: European Food Safety Authority, Pre-accession training on chemical risk assessment. EFSA supporting publication 2013:EN-468, 8 pp. Available online: European Food Safety Authority, 2013

2 TABLE OF CONTENTS Abstract... 1 Table of contents... 2 Background... 3 Programme... 3 Conclusions and recommendations... 4 Appendices... 5 Appendix A: Agenda... 5 Appendix B: List of participants... 7 Appendix C: Results from the satisfaction survey... 8 EFSA supporting publication 2013:EN-468 2

3 BACKGROUND This training was organised within the EFSA Pre-Accession Programme 2011/2014 for the Candidate and Potential Candidate countries 3 financed by the European Commission under the Instrument for Pre-Accession Assistance (IPA) Component. The overall objective of the EFSA Pre-Accession Programme 2011/2014 is to promote the understanding of EFSA s work, share expertise and create information exchange mechanisms in order to ensure that the national authorities of the beneficiary countries can participate effectively in the activities of EFSA both prior and after the accession to the EU. Participation in this Programme will further enable the beneficiaries to familiarise themselves with the EU policies and working methods particularly focusing on from field to plate integrated approach to food safety. In particular the Programme intends to build on risk assessment capacity in the Pre-Accession countries and this training was the second of five specific risk assessment trainings foreseen to be organised during this Programme. The overall objective of the training was to transfer knowledge and skills on chemical risk assessment to the experts from the Pre-Accession countries. The training tutors were from the Danish Technical University and EFSA. PROGRAMME The training covered the following topics: Introduction to chemical risk assessment; Hazard Identification; Exposure estimates: Consumption and concentration data; Hazard Characterisation; Risk Characterisation. Each day of the training consisted of plenary sessions in which the tutors delivered oral presentations on the topic, giving an overview of the subject and any key issues, followed by case studies in which the concepts dealt with were applied. During the first two days of the training an overview of the general principles in chemical risk assessment and an introduction to risk management and risk communication were presented. The training continued with the presentations explaining the four elements of chemical risk assessment. The concept of ADME (absorption, distribution, metabolism and excretion) in the process of hazard identification was presented. It was shown how to identify and interpret the toxicological data occurrence, and consumption data, and how to apply the appropriate uncertainty factors required in chemical risk assessment. Hazard characterisation process with the focus on quantifying health based threshold (dose response relationship) on the critical effect was presented. A scientist from EFSA's PRAS Unit presented a general overview on EFSA s work and activities, with the special emphasis on chemical risk assessment. The case study work started at the end of the first day and continued during 3 Candidate countries: Former Yugoslav Republic of Macedonia, Montenegro, Serbia and Turkey. Potential Candidate countries: Albania, Bosnia and Herzegovina and Kosovo* (*this designation is without prejudice to positions on status, and is in line with UNSCR 1244 and the ICJ Opinion on the Kosovo Declaration of Independence). EFSA supporting publication 2013:EN-468 3

4 the second day. Opinions and studies on different contaminants were given to the groups with the tasks which consolidated the concepts learned in theoretical lectures. During the third day the case study work was finalised and followed by the group discussion and course evaluation. Presentation of the case study output on a given contaminant was made by the rapporteurs of the group s. Each presentation was followed by a discussion on the outcomes. Evaluation of the course was done by using the list of participant s expectations given at the first day. See Appendix A for the agenda. The audience in this training consisted of 21 representatives from the competent food safety authorities in the 7 Pre-Accession countries. See Appendix B for the list of participants. CONCLUSIONS AND RECOMMENDATIONS This training was developed in order to address the need expressed by the Pre-Accession countries for specific training on principles and methods of risk assessment used in different areas. In particular the training improved the knowledge of the participants on chemical risk assessment and increased the awareness among the participants on EFSA s activities. During the whole training many issues related to chemical risk assessment were brought up. The topics were opened up to general discussion in which general issues or specific problems in Pre- Accession countries were raised and discussed. For most of the topics, participants practiced and implemented the achieved knowledge in practical case studies. The participants were very active during the case work and they had fruitful discussions with the tutors. The participant s background and experience in risk assessment was very diversified, therefore it was concluded that it would be important with second step in the training, which should be more specific and more oriented to the specific countries needs e.g. via TAIEX funded events. At the opening of the training the participants presented themselves briefly to the group and the tutors made a list of expectations proposed by the participants, which was evaluated at the end of the course. It was concluded that all expectations were met, except the one regarding the risk assessment process in the small countries. The training should indirectly contribute to the harmonisation of risk assessment approaches as well as in building trust amongst the Pre-Accession countries, the Member States authorities and EFSA in each others risk assessments. EFSA supporting publication 2013:EN-468 4

5 APPENDICES Appendix A: Agenda Time Activity Tutor From To Registration of participants DAY 1 (2 nd July) Welcome and introduction to the course Annette Petersen / Max Hansen DTU Introduction to chemical risk assessment Max Hansen Content of the session: An overview of the general principles in chemical risk assessment and an introduction to risk management and risk communication. Objectives of the session: To be able to describe the general principles in chemical risk analysis EFSA work on chemical risk assessment Manuela Tiramani - EFSA Coffee break Title of the Session: Hazard Identification - toxicokinetics Max Hansen Content of the session: Presentation of toxicokinetics, including absorption, distribution, metabolism and excretion. Objectives of the session: To be able to explain the main points in the absorption, distribution, metabolism and excretion processes and why it is important in risk assessment Exposure consumption data Annette Petersen Lunch Content of the session: Description of different way to obtain consumption data Objectives of the session: Knowledge of how and where to obtain consumption data as well as the uncertainties in the data Introduction to case-work Annette Petersen / Max Hansen Coffee break Examples of chemical hazards in food and the sources in the chain from farm to fork Annette Petersen Contents of the session: Categories of chemical hazards in the food chain: natural toxins, environmental contaminants, veterinary drugs, pesticides, additives, processing contaminants, migrant from food contact materials Objectives of the session: Knowledge of how contaminants enter the food chain EFSA supporting publication 2013:EN-468 5

6 Case-work Annette Petersen / Max Hansen DAY 2 (3 rd July) Title of the Session: Hazard Characterisation Max Hansen Coffee break Content of the session: Critical effect, dose response relationship, including ADI/TDI, ARfD, NOAEL; benchmark dose, MOE. The participants will work on the project with focus on quantifying health based threshold (dose response relationship) on the critical effect. Objectives of the session: To be able to explain the difference methods of quantifying dose response relationship on the critical effect. To describe hazard characterisation issues in the assigned case Exposure estimates: concentration data Annette Petersen Content of the session: Point estimates, acute and chronic exposure Sampling strategies (monitoring, control etc), quality of data, left-censored data. Uncertainties in data and estimates Lunch Objectives of the session: To explain how occurrence data are collected. To explain uncertainties of occurrence data. Knowledge of different ways to perform estimates of the exposure and uncertainties Genotoxicity and carcinogenicity including coffee break Max Hansen Coffee break Content of the session: Presentation of genotoxicity in relation to cancer and the role of genotoxicity in risk assessment. Objectives of the session: Explain different types of DNA damage. Explain the difference between genotoxic and non genotoxic carcinogens and the implications of these two types of carcinogens in risk assessment Risk Characterisation, risk management and risk communication Max Hansen Content of the session: Examples of risk characterisation, risk management and risk communication Objectives of the session: To understand how a risk assessment can be used in risk management and risk communication Case-work Annette Petersen / Max Hansen DAY 3 (4 th July) :00 Finalisation of case work all Discussion of cases including risk characterisation, risk management and risk communication all Evaluation of the course all Final remarks and good-bye all Lunch EFSA supporting publication 2013:EN-468 6

7 Appendix B: List of participants COUNTRY Title Surname Name Institution ALBANIA Mr BOZHAJ Elsa National Food Authority of Albania ALBANIA Ms DIZDARI Edi National Food Authority of Albania ALBANIA Ms ZEQIRI Alketa National Food Authority of Albania BOSNIA- HERZEGOVINA Ms ISIĆ Amela Food Safety Agency BOSNIA- HERZEGOVINA Ms TOMOVIĆ Dragan Food Safety Agency BOSNIA- HERZEGOVINA Mr MUJKIĆ Maida Food Safety Agency FYROM Ms JANEVSKI Blazho Food and Veterinary Agency FYROM Ms KASUMI Ilir Food and Veterinary Agency FYROM Ms MEHMEDI Agim Food and Veterinary Agency MONTENEGRO Ms ŠUKOVIĆ Danijela Center for Ecotoxicological Research MONTENEGRO Ms JANČIĆ Dejan Center for Ecotoxicological Research MONTENEGRO Ms VUJAČIĆ Aleksandar Institute of Public Health KOSOVO* Mr KADRIU Flamur Kosovo Food and Veterinary Agency KOSOVO* Mr MUSAJ Alush Kosovo Food and Veterinary Agency KOSOVO* Ms GJINOVCI Valdet Kosovo Food and Veterinary Agency SERBIA Ms ANTONIJEVIĆ Biljana SERBIA Ms SAVČIĆ PETRIĆ Snežana SERBIA Mr BRKIĆ Dragica TURKEY Ms ARICAN ÖZNUR Fulya TURKEY Ms KARAGOZ EMIROGLU Zehra TURKEY Ms USLU Hatice University of Belgrade Faculty of Pharmacy Ministry of Agriculture, Forestry and Watermanagement Institute of Pesticides and Environmental Protection Ministry of Food, Agriculture and Livestock Ministry of Food, Agriculture and Livestock Ministry of Food, Agriculture and Livestock EFSA supporting publication 2013:EN-468 7

8 Appendix C: Results from the satisfaction survey Pre-accession training on chemical risk assessment, 2-4 July 2013 On the last day of training, participants were asked to take part in a satisfaction survey, in order to evaluate the training. They were also asked to give their additional comments, remarks and suggestion on future topics for EFSA Pre-Accession Programme. 19 participants answered to the evaluation questionnaire. The survey results show that most of the participants found the overall value of the training to be excellent or very good (see table1). Table 1: Satisfaction survey results Question/Rating Excellent (%) Very good (%) Good (%) Fair (%) Poor (%) Meeting venue and materials Hotel and meeting room Written material The speakers and their presentations Presentation skills Responsiveness to questions Content Audio-visual aid How did this training improve your knowledge on this topic? How was the overall value of training for you? on the right too technical? too basic? Were the speeches level? (%) (%) (%) Did you feel you Yes (%) Partly (%) No (%) had enough opinion? opportunities to express your Participant s suggestion on future topics for the Pre-Accession events: Relation between risk assessment and risk management with the practical work and examples; Advanced training on chemical risk assessment; Exposure assessment. Additional comments and suggestions: With the given number of lectures and cases studies duration of the training should be extended; The audience should be on the same level, for some participants it was to basic for some to advanced, sometimes difficult to follow; To include case studies on the cases that had happened in the Pre-Accession countries (e.g. aflatoxin); Quizzes after the presentations were very appreciated as the short and interactive way of recapitulation. EFSA supporting publication 2013:EN-468 8