Technical specifications on training regarding principles and methods of food safety risk assessment 1

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1 TECHNICAL REPORT Technical specifications on training regarding principles and methods of food safety risk assessment 1 European Food Safety Authority 2, 3 European Food Safety Authority (EFSA), Parma, Italy SUMMARY This report sets out technical specifications for risk assessment training developed by the EFSA Working Group on Training Activities on Principles and Methods of Risk Assessment in Food Safety. The technical specifications contain details on the programme and learning objectives of five different training courses specifically tailored for each of the following areas: microbiological risk assessment, chemical risk assessment (food/feed additives, contaminants, pesticides, etc.), pest risk assessment, assessment in the field of nutrition, and risk assessment of GMOs and other biotechnologies. This report also provides recommendations on how to organise these courses in order to train professionals with a scientific background and an interest in food and/or feed safety risk assessment. These technical specifications may prove useful in the preparation of risk assessment training activities under the Better Training for Safer Food (BTSF) programme. KEY WORDS Training, specifications, risk assessment, methods, food safety. 1 On request from EFSA, Question No EFSA-Q , issued on 12 April Correspondence: scientific.cooperation@efsa.europa.eu 3 Acknowledgement: EFSA wishes to thank the members of the Working Group on training activities on principles and methods of risk assessment in food safety for the preparatory work on this output and EFSA staff for the support provided to this output. Suggested citation: European Food Safety Authority (EFSA), 2011; Technical specifications on training regarding principles and methods of food safety risk assessment. [22 pp.]. Available online: European Food Safety Authority, 2011

2 TABLE OF CONTENTS Summary... 1 Table of contents... 2 Background as provided by EFSA... 3 Terms of reference as provided by EFSA... 4 Technical Specifications Introduction Better Training for Safer Food Training and learning objectives of food safety risk assessment training Overall learning objectives Format of the courses Specific learning objectives for the 5 courses Course on Microbiological Risk Assessment (MRA) Course on Chemical Risk Assessment (food/feed additives, contaminants, pesticides, etc.) Course on Pest Risk Assessment (PRA) Course on Assessment in the field of nutrition Course on Risk assessment of GMOs and other biotechnologies Impact General information about the course Target audience Number of participants Language Tutors Location and venue Training materials and tools Certification of attendance and evaluation Fees and costs Registration and self-assessment Service providers Recommended follow-up References Appendix A: Tasks and roles Who does what? Abbreviations

3 BACKGROUND AS PROVIDED BY EFSA Technical specifications risk assessment training The Strategy for Cooperation and Networking points to the necessity of training and calls for a programme of courses on risk assessment, involving experts from Member States, supplemented by a programme of study tours, involving both senior managers and staff directly involved in risk assessment. Another consideration in the Strategy is that the involvement of less experienced experts as observers in the work of the Panels or its Working Groups also provides a mechanism for knowledge transfer. In the process of reviewing EFSA s Strategy for Cooperation and Networking a questionnaire was sent to the Advisory Forum which revealed that the majority considered training activities still to be important, supporting the idea of courses on risk assessment. The Advisory Forum expressed a need to further develop a long-term training programme on risk assessment for experts working in different fields of food safety, especially for new Member States. This point was taken further at another Advisory Forum meeting, where it was concluded that this activity is important, needs to be well defined, and that EFSA should develop it with Member States that already have experience in the area; and consider operating the activity through existing training programmes (e.g. from the European Commission), thereby avoiding duplication. The issue of training is also considered in the EFSA Strategic Plan where it is stated that in order to build capacity EFSA will organise training and build on its existing scientific events to foster greater understanding of risk assessment practices. In the context of ensuring EFSA s engagement in international fora to actively contribute to the development of risk assessment methodologies, one of the initiatives mentioned is organising scientific events and training to consolidate and enhance overall capacity and EFSA s position in the risk assessment community. For the purpose of identifying possible gaps in training on food safety risk assessment and before proposing future actions it was necessary to make an assessment of the availability of such training. In EFSA s recent project report on Training activities on risk assessment in food safety (EFSA, 2009) an analysis of training opportunities in food safety risk assessment is provided, including the outcome of a survey through the Focal Points taking stock of relevant training activities in Member States, as well as an assessment of specific training needs. This report provides an analysis regarding training activities in the areas that fall under EFSA s remit and discusses relevant training activities undertaken by EFSA, the European Commission, Member States as well as other relevant international organisations. Taking into account EFSA s Strategy for Cooperation and Networking, EFSA s Strategic Plan , the recommendations of the Advisory Forum, the interest of EFSA s Scientific Committee and the findings of the survey, the report concludes that there is a need and a wish for additional training on principles and methods of risk assessment addressed to scientists from National authorities involved in food safety risk assessment. The target audience would include experts involved in food safety risk assessment in the Member States, EEA/EFTA Countries as well as Candidate Countries and importantly also EFSA staff members. The set-up of the training should be of a post-graduate nature, aiming not only to improve theoretical knowledge, but also to gain hands-on experience in food safety risk assessment. 3

4 TERMS OF REFERENCE AS PROVIDED BY EFSA Technical specifications risk assessment training The terms of reference for the Working Group are to support EFSA in the development of technical specifications on training regarding principles and methods of food safety risk assessment. These specifications should include recommendations on how the training is best set up in terms of developing different modules and the appropriate duration of the training; the most appropriate professionals to be targeted; what kind of tools and training material are needed; and how EFSA s experts could contribute. The expected deliverable of this mandate will be a technical report on the specifications for training on principles and methods of risk assessment in food safety including recommendations to strengthen training on general food safety risk assessment. 4

5 TECHNICAL SPECIFICATIONS 1. Introduction As stated in the Strategy for Cooperation and Networking EFSA should promote the establishment of courses in risk assessment. EFSA s Advisory Forum, in the context of the review of the above mentioned Strategy, expressed the need to develop a long-term training programme on risk assessment for experts working in different fields of food and feed safety (e.g. chemical and microbiological risk assessment, environmental risk assessment, pest risk assessment, assessment in the field of nutrition, animal health and welfare). In EFSA s recent report on Training activities on risk assessment in food safety an analysis of training opportunities in food safety risk assessment is provided, as well as an assessment of specific training needs in the Member States. The report concludes that there is a need and a wish for additional training on principles and methods of risk assessment addressed to scientists from national authorities involved in food safety risk assessment. Finally, the report recommends to develop a course module on principles of risk assessment in food safety and to explore with the European Commission on how to cooperate on this issue with the Better Training for Safer Food (BTSF) programme. To take this forward, EFSA established a working group on training activities on principles and methods of risk assessment in food safety to develop specifications for training on principles and methods of risk assessment in food safety, involving some EFSA Panel/Scientific Committee members as well as experts from Member States. The current report is drafted, in consultation with relevant units and Panels, under the working assumption that BTSF training activities in will comprise risk assessment training. 2. Better Training for Safer Food Better Training for Safer Food 4 is a Commission training initiative covering food and feed law, animal health and welfare and plant health rules. The BTSF training courses are organised by service providers who are contracted by the Executive Agency for Health and Consumers (EAHC), through public procurement. More information on different roles of BTSF, EAHC, and EFSA are provided as guidance for the reader in Appendix A. This report sets out technical specifications for risk assessment training developed by EFSA that may prove helpful to design the technical details of the coming BTSF risk assessment training activities. 4 For further information on BTSF visit: 5

6 3. Training and learning objectives of food safety risk assessment training 3.1. Overall learning objectives To train professionals with a scientific background and an interest in food and/or feed safety risk assessment in order to expand their theoretical knowledge and practical skills on principles and methods of risk assessment. This hands-on training, by using case-studies, should help to upscale professionals on the principles and methods of risk assessment in food and feed safety to enable them to understand and participate in risk assessments, and to serve as members of various scientific committees and bodies at (inter-)national level. These training courses would therefore indirectly contribute to the harmonisation of risk assessment approaches as well as in building trust amongst Member States authorities in each others risk assessments (EFSA, 2008) Format of the courses Each training course is expected to last for five days and it is recommended to organise 5 courses per year. The number of participants should not be more than 25 per course, to allow for ample interaction between the participants and the trainer(s) as well as amongst the participants themselves. In addition to improving the theoretical knowledge of participants by means of lectures, participants are expected to be split into smaller groups to work on different case-studies and thereby improving their hands-on experience in risk assessment. The setup of a course could be as follows: day 1: introduction to food safety risk assessment; days 2-4: address specific learning objectives including breakout sessions for case studies; morning of day 5: presentation and discussion of certain case studies of the different breakout groups to all participants to assess the learning achieved during the course. It will be the responsibility of the contractor to develop the programme and the format of the training sessions. Monday Course 1 Course 2 Course 3 Course 4 Course 5 Introduction to Introduction to Introduction to Introduction to Introduction to food safety risk food safety risk food safety risk food safety risk food safety risk assessment assessment assessment assessment assessment Tuesday to Microbiological risk assessment Chemical risk assessment in food Pest risk assessment Assessment in Nutrition GMOs and other Biotechnologies Friday Figure 1: Graphic representation of recommended format of the 5 courses 6

7 The first day of each 5-day course will be dedicated to introduce the overall principles in risk assessment, while the remaining four days of the course will go into more detail in one specific area of risk assessment through case studies and hands-on training. First day - Introduction The first day of each course would offer an overall introduction to the principles of risk assessment to provide participants from different backgrounds with the basic understanding of the: Risk Analysis framework (i.e. the 3 pillars of risk analysis: risk assessment, risk management, risk communication); EU regulatory and larger international framework (OIE, Codex, IPPC, FAO/WHO); basic steps in risk assessment (hazard identification, hazard characterisation, exposure assessment, risk characterisation); short history of main developments in the science of risk assessment; introduction to the key concepts and basic risk assessment terminology used throughout the different areas of risk assessment, such as: variability, uncertainty, assumptions, risk-benefit assessment, data collection, inclusion and exclusion of data, dose-response relationship, sensitivity analysis, qualitative and quantitative risk assessment, methods of scientific inference, exposure assessment and importance of food consumption surveys; concepts of the different approaches of risk assessment in the various areas (e.g. chemical vs. microbiological risk assessment). At the end of the overall introduction participants should be familiar with the variety of risk assessments being done in the area of food and feed safety, the reasons for carrying out a risk assessment, to describe the role of substance science and methodological science in risk assessment, the risk science and have a basic notion of the differences of the various models of risk assessment and their applicability and relation to data. Specific areas of risk assessment with case studies After this overall introduction participants will go into more detail in one specific area of risk assessment, used in a particular area of food / feed safety. Each course will deal with one area of food / feed safety. Five different courses are recommended: 1. Microbiological risk assessment 2. Chemical risk assessment (food/feed additives, contaminants, pesticides, etc.) 3. Pest risk assessment 4. Assessment in the field of nutrition 5. Risk assessment of GMOs and other biotechnologies Environmental risk assessment is important in various fields of food and feed safety and will be addressed under the relevant courses. No course is currently foreseen for the area of animal health and welfare, but could be considered in the future should resources become available. Statistical and methodological issues will be overviewed, but are out of the remit of these training courses. 7

8 3.3. Specific learning objectives for the 5 courses The different courses will be structured along the discussion of case-studies (e.g. recent EFSA scientific opinions) including practical exercises for different steps in the risk assessment carried out. For each course specific learning objectives are formulated Course on Microbiological Risk Assessment (MRA) At the end of this course, participants should be able to understand and describe: General concepts, such as: o the methods of scientific inference; o the interplay between idealized models and concrete available data (assumption based vs. data based); o parameter identifiability issues (what can/cannot be known from data); o model fit and model comparison and sensitivity analysis (quality of model); o statistical methods and probability concepts; o aleatory and epistemic uncertainty; o decision analysis (incl. cost-benefit); o data quality (incl. design of experiment, randomized vs. register data quality, survey data). Specific model examples, such as: o farm-to-fork models; o process models; o dose-response models; o growth models; o spatial models; o temporal/time series models; o epidemic models; o hierarchical models. The overall legal framework. Hazard Identification: o statement of problem and scope of risk assessment; o concept of Qualified Presumption of Safety (QPS); o what makes microbiological risk assessment unique (i.e. differences with other risk assessments); o pathogen-product pathway; o data and information on microbial agent, food and process, consumer practice. Hazard Characterisation: o the disease triangle (pathogen virulence-host susceptibility-food matrix); o sources of dose-response data (human volunteer feeding studies, epidemiological data, animal studies, in vitro studies); o modelling dose-response relationship (types of models, selection of dose-response model to be estimated from data); o statistical inference in dose-response modelling and applicability of results to new (even unknown) conditions, different from the reference data set. 8

9 Exposure Assessment: o modelling the production-to-consumption chain; o predictive microbiology-modelling growth, survival and inactivation of microorganisms, statistical inference and applicability of results to new (even unknown) conditions, different from the reference data set; o uncertainty and variability in exposure assessment, deterministic vs. stochastic models, simple vs. structured models, limitations due to data; o sources of data and models, their generality vs. context dependency. Risk Characterisation: o qualitative, semi-quantitative, quantitative outputs; o distinguishing variability and uncertainty; o sensitivity analysis and what if scenarios, including alternative models/assumptions; o model criticism: model fit and model comparison; o applicability and generality of the results, limitations. Risk management aspects specifically related to MRA. Availability and use of existing data, such as: the Food Consumption Database. Examples of case studies that can illustrate the above concepts: EFSA Panel on Biological Hazards (BIOHAZ); Scientific Opinion on Campylobacter in broiler meat production: control options and performance objectives and/or targets at different stages of the food chain. EFSA Journal 2011;9(4):2105. [141 pp.]. doi: /j.efsa Available online: EFSA Panel on Biological Hazards (BIOHAZ); Scientific Opinion on: Quantitative estimation of the public health impact of setting a new target for the reduction of Salmonella in broilers (Gallus gallus). EFSA Panel on Biological Hazards (BIOHAZ); Scientific Opinion on a Quantitative Microbiological Risk Assessment of Salmonella in slaughter and breeder pigs. EFSA Journal 2010; 8(4):1547. [80 pp.]. doi: /j.efsa Available online: Course on Chemical Risk Assessment (food/feed additives, contaminants, pesticides, etc.) At the end of this course, participants should be able to understand and describe: The overall legal framework. Different steps in chemical risk assessment. Chemical risk assessment at national and at international level. Chemical risk assessment approaches in different areas of food and feed safety. Participants may be breaking up in parallel sessions focussing on certain areas of chemical risk assessment (food/feed additives, contaminants, pesticides, etc.). 9

10 Preliminary considerations, including: o problem formulation; o routes of exposure; o differences between types of chemicals in food and feed (additives, residues of pesticides and/or veterinary drugs, environmental contaminants, migrating substances etc.); o fate and behaviour of chemical contaminants. Hazard Identification and Characterisation, including: o basic concepts in toxicology, including: main sources and quality of toxicological data; acute vs. chronic toxicity; threshold approach: ADI/TDI, ARfD, NOAEL, Benchmark dose; non-threshold approaches: extrapolation, MoE; relevance of a Mode of Action for Humans - species differences and intraspecies / human variability; uncertainty assessment safety factors; risk-benefit considerations; Threshold of Toxicological Concern Concept; QSAR, In silico toxicity, read across. o basic knowledge of different endpoints in toxicity studies: toxicokinetics (ADME) and toxicodynamics; histopathology; genotoxicity / carcinogenicity; reproductive and developmental toxicity; neurotoxicity and Immunotoxicity; endocrine effects. Exposure Assessment (focused on intake from consumption of food), including: o collection of consumption data: methodologies (pro et contra); EFSA and WHO databases; extrapolation from crop to crop and from country to country. o collection of chemical occurrence data: random or targeted sampling; monitoring, control and/or scientific data; EFSA and WHO database; quality of collected data (accreditation); handling of left-censored data; uncertainty; extrapolation from crop to crop and from country to country. o exposure estimations: point estimates probabilistic estimates; acute and chronic exposure; combined exposure to multiple chemicals and/or from multiple sources (e.g. cumulative/aggregate exposure, mixtures); uncertainties - sensitivity analyses. 10

11 Risk Characterisation, including: o Hazard Index; o the Margin of Exposure (MoE) approach; o uncertainty analyses. MRL-setting difference to health based guidance values (e.g. ADI, ARfD). Examples of case studies that can illustrate the above concepts: EFSA Panel on Plant Protection Products and their Residues (PPR); Scientific Opinion on Risk Assessment for a Selected Group of Pesticides from the Triazole Group to Test Possible Methodologies to Assess Cumulative Effects from Exposure through Food from these Pesticides on Human Health. EFSA Journal 2009; 7 (9); [187 pp.]. doi: /j.efsa Available online: Statement of EFSA; Potential risks for public health due to the presence of nicotine in wild mushrooms. The EFSA Journal (2009) RN-286, doi: /j.efsa r. Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to 2-Isopropyl thioxanthone (ITX) and 2- ethylhexyl-4-dimethylaminobenzoate (EHDAB) in food contact materials. The EFSA Journal (2005) 293, doi: /j.efsa EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Flavouring Group Evaluation 30 (FGE.30): 2-Methoxy-4-(prop-1-enyl)phenyl 3-methylbutyrate from chemical group 17. EFSA Journal 2010;8(9):1787. [36 pp.]. doi: /j.efsa Available online: EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Bisphenol A: evaluation of a study investigating its neurodevelopmental toxicity, review of recent scientific literature on its toxicity and advice on the Danish risk assessment of Bisphenol A. EFSA Journal 2010; 8(9):1829. [116 pp.]. doi: /j.efsa Available online: EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on Marine biotoxins in shellfish Domoic acid. The EFSA Journal (2009) 1181, doi: /j.efsa EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Scientific Opinion on the use of cobalt compounds as additives in animal nutrition. EFSA Journal 2009;7(12):1383. [45 pp.]. doi: /j.efsa Available online: Risk Assessment of food additives (Relevant example from an EFSA opinion) Risk Assessment of environmental contaminants (EFSA opinions on risk assessment of Dioxin, PCBs and other POPs can be used) Course on Pest Risk Assessment (PRA) At the end of this course, participants should be able to understand and describe: The overall legal framework. Data requirements for pest risk assessment. 11

12 The different steps in pest risk assessment: o problem formulation: PRA initiated by the identification of a pathway; PRA initiated by the identification of a pest; PRA initiated by the review or revision of a policy. o assessment of introduction and spread of organisms harmful to plants and/or plant products: probability of entry of a pest; probability of establishment (climatic suitability); probability of spread (host availability). o assessment of potential consequences associated with the introduction and spread of harmful organisms: impact on crop yields; environmental side effects. Identification of appropriate risk management options: o options for consignments; o options for the prevention or reduction of infestation in the crop. Assessment of the effect of risk management options on the level of risks. Principal requirement for documentation of pest risk assessment process and submission of dossiers. Examples of case studies that can illustrate the above concepts: for full pest risk assessment: EFSA Panel on Plant Health (PLH); Risk assessment of the oriental chestnut gall wasp, Dryocosmus kuriphilus for the EU territory and identification and evaluation of risk management options. EFSA Journal 2010; 8(6):1619. [114 pp.]. doi: /j.efsa Available online: EFSA Panel on Plant Health (PLH); Risk assessment of Gibberella circinata for the EU territory and identification and evaluation of risk management options. EFSA Journal 2010; 8(6):1620. [93 pp.]. doi: /j.efsa Available online: how to assess the probability of entry of a pest: EFSA Panel on Plant Health (PLH); Scientific Opinion on a technical file submitted by the Japanese Authorities to support a derogation request from the EU import requirements for bonsai and topiary trees that are host plants of Anoplophora chinensis. EFSA Journal 2010;8(10):1849. [13 pp.]. doi: /j.efsa Available online: Course on Assessment in the field of nutrition At the end of this course, participants should be able to understand how risk assessment in nutrition is similar to but also differs from other risk assessments, and describe: The overall legal framework. 12

13 The specificities of risk assessment in nutrition, i.e. assessed and managed either at the level of nutrients and/or at the level of foods. The risk assessment model in nutrition: o concepts, terminologies and methods: defining Dietary Reference Values (DRV); nutrient based goals and objectives; food based dietary guidelines (FBDG). o hazard identification and hazard characterisation including intake-response assessment (NOAEL, LOAEL, benchmark intake, uncertainty factors, upper intake, identification of vulnerable subgroups). The specificities and challenges of nutrient risk assessment: o essential and non-essential nutrients, i.e. assessment of insufficiency and excess (absolute and/or relative) vs. assessment of excess only; o risk assessment of macronutrients; o risk assessment of micronutrients: specific aspects of the derivation of a health-based guidance value (UL) for a nutrient compared to health-based guidance values (such as Acute Reference Dose (ARfD), Acceptable Daily Intake (ADI), Tolerable Daily Intake (TDI)) for (non-nutritive) chemicals; interpreting observed intakes in relation to DRVs: probabilistic and cut-off methods. o risk assessment of novel foods (including assessment of risk of change in diet composition due to introduction of novel food into existing diet). Dietary intake assessment: o advantages and limits of different methods for dietary surveys: 24-hr recall, food diaries, food frequency questionnaires; o food datasheets, household budget surveys, use of anthropometric and biomarkers; o translation into nutrient intakes: correction of raw data for usual intakes, use and limits of food composition tables, statistical treatment (single endpoints vs. distribution). Risk characterisation (e.g. strengths and weaknesses of the estimates, qualitative vs. quantitative). Tools for modelling different management options: diet modelling, linear programming, Monte-Carlo simulation. Examples of case studies that can illustrate the above concepts: with regard to real exposure: EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on Dietary Reference Values for fats, including saturated fatty acids, polyunsaturated fatty acids, monounsaturated fatty acids, trans fatty acids, and cholesterol. EFSA Journal 2010; 8(3):1461. [107 pp.]. doi: /j.efsa Available online: calcium/vitamin D 13

14 with regard to envisaged exposure: EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the safety of 'Sardine Peptide Product'. EFSA Journal 2010; 8(7): [17 pp.]. doi: /j.efsa Available online: Plant Sterols and Blood Cholesterol - Scientific substantiation of a health claim related to plant sterols and lower/reduced blood cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006. The EFSA Journal (2008) 781, doi: /j.efsa Course on Risk assessment of GMOs and other biotechnologies At the end of this course the participant should be able to understand and describe: The overall legal framework. The scope of applications of GM technology and other modern biotechnologies (e.g. cloning, synthetic biotechnology) in the food and feed sectors: o techniques covered by modern biotechnology; o applications of GM technology: «input traits» vs. «output traits»; food/feed purposes vs. non-food/feed purposes; o in the case of GM plants, the different scopes of application («food containing or consisting of GM plants, food produced from GM plants or containing ingredients produced from GM plants, GM plants for feed use, feed containing or consisting of GM plants, feed produced from GM plants, import and processing, seeds and plant propagating material for cultivation in Europe»). The specificities of the risk assessment approach when applied to food and feed derived from modern biotechnology. Concepts of: o whole food /feed assessment; o history of safe use; o substantial equivalence (for input traits); o comparative analysis (including concepts of comparators and conventional counterpart, key nutrients, toxicants). Appropriate statistical principles and methods for the comparative analysis of food/feed: o difference and equivalence tests; o food and feed composition databases; o natural variation. The principles and methods of hazard identification and characterisation when applied to whole food/feed: o identification of newly inserted genes and gene products; gene expression / suppression; o toxicity and allergenicity assessment; o feeding studies (with laboratory and target animals) for the safety and nutritional assessment of food/feed derived from GM plants; o intended vs. unintended effects; 14

15 o scope and interplay between molecular characterisation, compositional and agronomic characterisations in the identification of unintended effects of GM plants and products. The exposure assessment in the context of the evaluation of food and feed derived from GM plants. Risk characterisation, including uncertainty analysis (quantifiable statistical uncertainty, knowledge gaps due to hypothesis formulation, publication bias, etc.). Risk mitigation (risk management). The two approaches of post-market monitoring: case-specific monitoring (of identified risks) and general surveillance (of unidentified risks). The rationale and methodology of the environmental risk assessment (ERA) of GMOs: o scopes of application, including or not cultivation in EU; o problem formulation and assessment endpoints in the ERA; o data collection and modelling in the development of GMO ERA; o interplay between EU regulations in the case of herbicide-tolerant GM crops. Examples of case studies that can illustrate the above concepts: Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the safety of foods and food ingredients derived from herbicide-tolerant genetically modified maize NK603, for which a request for placing on the market was submitted under Article 4 of the Novel Food Regulation (EC) No 258/97 by Monsanto. The EFSA Journal (2003) 9, doi: /j.efsa Scientific Opinion of the Panel on Genetically Modified Organisms on applications (EFSA-GMO- NL and EFSA-GMO-RX-NK603) for the placing on the market of the genetically modified glyphosate tolerant maize NK603 for cultivation, food and feed uses and import and processing, and for renewal of the authorisation of maize NK603 as existing product. The EFSA Journal (2009) 1137, doi: /j.efsa Scientific Opinion of the Panel on Genetically Modified Organisms on applications (EFSA-GMO- RX-MON810) for the renewal of authorisation for the continued marketing of (1) existing food and food ingredients produced from genetically modified insect resistant maize MON810; (2) feed consisting of and/or containing maize MON810, including the use of seed for cultivation; and of (3) food and feed additives, and feed materials produced from maize MON810, all under Regulation (EC) No 1829/2003 from Monsanto. The EFSA Journal (2009) 1149, doi: /j.efsa Impact Participants having successfully completed the course are expected to have a thorough understanding of the following: the Codex Working Principles for Risk Analysis; 15

16 the risk assessment workflow in EFSA; key concepts and basic risk assessment terminology; different approaches of risk assessment in use in the various areas (e.g. chemical vs. microbiological risk assessment); hands-on experience in performing and understanding risk assessments in a specific area of food/feed safety. Overall such training course provides an excellent opportunity for exchanging views and concepts in risk assessment and to build a network of European risk assessors. Participants of such training courses could become potential candidates of various scientific committees and bodies at (inter-)national level and could potentially become trainers themselves in their home country. 5. General information about the course 5.1. Target audience The course is targeted towards post-graduate and mid-career professionals: from the EU Member States, the EU candidate countries, and the EEA/EFTA countries; having an academic background (university degree or PhD) in life-science related areas, including Toxicology, Ecotoxicology, Environmental Sciences, Chemistry, Biochemistry, Food Technology, Pharmacology, Veterinary Medicine, Human Medicine, Pharmacy, Biology, Agronomy/Agricultural Science, Food Microbiology, Epidemiology, Occupational Medicine, Public Health or in areas related to public health; preferably, having 2-3 years of relevant professional experience in the field of risk analysis in the agrifood area, in particular in risk assessment of food and feed, in one or more of the following areas: hazard identification, hazard characterisation, exposure assessment and risk characterisation; having a position at European or national/governmental public organisation (e.g. food and feed safety authority or university); having a thorough knowledge of spoken and written English Number of participants In order to achieve the best results from the training courses the attendance should not be more than 25 participants for each training session. The service provider shall ensure the highest possible mix of participants concerning their geographical distribution and gender at each training session. The composition of a training session could be approximately as follows: 20 participants from the EU Member States; 3 participants from the EU candidate countries; 2 participants from the EEA/EFTA countries; gender balance. 16

17 The European Commission in consultation with EFSA should have the final say on the list of participants who will benefit from this training Language It is recommended that the training courses would be given in English and all training materials and tools would be made available in English Tutors Each training course would be facilitated by experienced tutors having worked in the area of food / feed risk assessment for at least 5 years and shall be appointed by the service provider. Tutors should preferably come from different EU Member States and have experience in teaching or providing training. Furthermore, on request of the European Commission or EFSA, the panel of tutors may include Commission officials, EFSA Panel experts and/or EFSA staff. Guest lectures may be provided by members of the EFSA Scientific Committee or Scientific Panels. The guest lectures would focus on specific case studies that would assist participants in solving the different coursework assignments and exercises Location and venue Similar to other BTSF training courses the course on risk assessment is recommended to be organised in various locations in the European Union. It shall be the task of the service provider to identify appropriate and fully equipped training venues with PCs and IT facilities in the locations where the training sessions would be provided. Upon selection of the locations the service provider shall take into consideration an equal geographical distribution among the different EU Member States. One potential location could be Parma, in Italy, where EFSA s seat is located. This could facilitate the participation of EFSA Scientific Committee and/or Scientific Panel members, who often attend Panel or Working Group meetings in Parma. This would make it possible to invite some EFSA experts to present case studies on a topic of interest to participants. In addition, it would also make it possible for a limited number of EFSA staff to attend some of these training courses to strengthen working relationships between participants and EFSA Training materials and tools The service provider shall prepare all training materials and tools (including audio- and visual material) to fully reach the training objectives. It is important that the training materials among the different courses are compatible and not in contradiction. The programme and technical specifications shall be reviewed biannually 5 ; both from an administrative and content point of view, taking into account the feedback of participants. For a wide dissemination it is recommended to make the training material available free of charge, possibly in the form of booklets, CR-ROM and/or through a dedicated website set up and maintained by the service provider. This way the training material would be available also to those who have not been admitted to a course and such material could also be used at risk assessment training courses at national level. In bringing the self-learning initiative one level further, video or audio recording certain presentations should be considered. 5 The contract with the service provider(s) of the BTSF training courses is normally signed for two years. 17

18 It shall be the responsibility of the service provider to make available the course material to all training participants at least 10 working days prior to the commencement of the each training session, so participants can come well-prepared Certification of attendance and evaluation At the end of the training course a certificate will be issued to all active participants. The issuance of the course certificates shall be coordinated by the service provider. Each training course will be evaluated by means of a questionnaire filled in by participants either at the end of the training or 1-2 weeks after the training course Fees and costs The course would be provided free of charge for scientists from national public authorities (e.g. national food and feed safety authorities or public academia) in EU Member States, the EU candidate countries, and the EEA/EFTA countries engaged in the risk assessment of food and feed safety Registration and self-assessment Those interested in participating in a training course would have to register via the BTSF National Contact Points (that are in place in the EU Member States, EU candidate countries and the EEA/EFTA countries). The EFSA national Focal Points may be useful in assisting in the registration process. It is recommended that as part of the registration applicants would be required to fill in an on-line self-assessment questionnaire in order to test proficiency in English and basic knowledge on risk assessment, as well as to provide a brief motivation on why they are interested to attend the course. Applications would be screened also by a Steering Group, composed of Commission and EFSA staff. It is recommended that such a Steering Group would meet at certain intervals to discuss issues as registration, evaluation, etc Service providers The tender specification published by BTSF would specify in detail the terms and conditions for responding to the call. Service providers may apply on their own, in collaboration with other service providers by submitting a joint tender (via a consortium) or by submitting a tender with subcontracting. To ensure consistency between the different courses in terms of terminology, course material and teaching methods it is recommended that all courses should be developed through one call (i.e. one service provider or consortium), and that the applicant can show to have experience in risk assessment, and would be able to provide proper tutors with the necessary training experience. RECOMMENDED FOLLOW-UP It is recommended to maintain contact with course participants after completion of the course. One way of doing so is to establish an alumni network where members of the alumni network could be: (i) given access to EFSA s Information Exchange Platform; (ii) invited to join the EFSA Expert Database, (iii) or be invited to relevant scientific events organised by EFSA. Such an alumni network would not only bring course participants closer to the different activities undertaken by EFSA and the EU Member States, but would also foster communication and networking amongst course participants also after the course. 18

19 From 2014 (following the experience of the first 2 years) it is recommended to deliver the different risk assessment courses in an e-learning format complementary to the standard training format. These e-courses would be shorter compared to the standard courses, with the objective to provide a basic understanding of key terms, concepts and approaches used in the risk assessment of food and feed. It is recommended that EFSA is involved in the development of these e-learning courses. As the BTSF programme is geared towards participants from EU Member States, candidate countries and EEA/EFTA countries and not to EFSA staff it is recommended that EFSA may organise similar training for EFSA scientific staff to ensure the continuous development of its staff in need of risk assessment training. The course material developed under the BTSF framework could be used for such in-house trainings that could be opened also to external scientists participating in EFSA s work (e.g. working groups). 19

20 REFERENCES EFSA (European Food Safety Authority), ESCO Report: Fostering Harmonised Risk Assessment Approaches in Member States. Available on accessed on EFSA (European Food Safety Authority), Project Report: Training activities on food safety risk assessment. Available on accessed on

21 APPENDIX A: TASKS AND ROLES WHO DOES WHAT? Normally, the role of BTSF and the Executive Agency for Health and Consumers (EAHC) would be to: launch call for tenders for the organisation and implementation of this training within the framework of BTSF; supervise service provider in the preparation of training materials and tools (including audio- and visual material); supervise service provider in the organisation and implementation of the training course; monitor the number of applications received and approve list of candidates admitted to the course in consultation with the Steering Group; ensure biannual review and continuous development of the technical specifications from an administrative point of view. Normally, the role of the service provider would be to: prepare the on-line registration questionnaire to test proficiency in English and basic knowledge on risk assessment; manage the registration of candidates and short-list suitable candidates for approval by the Steering Group; appoint qualified tutors to give the course; identify suitable locations/venues for the course (by taking into consideration an equal geographical distribution among the different EU Member States); prepare all training materials and tools (including audio- and visual material) by following the BTSF/EFSA training objectives; organise and implement the training course both from and administrative and scientific point of view; coordinate the issuance of training certificates; evaluate each training course by means of a questionnaire filled in by participants at the end of the training. Normally, the role of EFSA would be to: be an active member of the Steering Group; ensure biannual review and continuous development of the technical specifications from a content point of view (including new case studies or topics); provide proposals for the improvement of the course materials and tools (including audio- and visual material) prepared by the service provider; identify and invite EFSA experts to give presentations on selected topics; provide meeting rooms for courses taking place at the EFSA premises in Parma. 21

22 ABBREVIATIONS ADI ADME ARfD BIOHAZ BTSF CEF Codex CONTAM DRV EAHC EEA EFSA EFTA ERA ESCO EU FAO FBDG FEEDAP GM GMO IPPC IT LOAEL MoE MRA MRL NDA NOAEL OIE PC PCB PLH POP PPR PRA QPS QSAR TDI UL WHO acceptable daily intake absorption, distribution, metabolism, and excretion acute reference dose EFSA Panel on Biological Hazards Better Training for Safer Food EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids Codex Alimentarius EFSA Panel on Contaminants in the Food Chain Dietary Reference Values Executive Agency for Health and Consumers European Economic Area European Food Safety Authority European Free Trade Association environmental risk assessment EFSA Scientific Cooperation Project European Union Food and Agriculture Organization food based dietary guidelines EFSA Panel on Additives and Products or Substances used in Animal Feed genetically modified genetically modified organism International Plant Protection Convention Information Technology lowest observable adverse effect level Margin of Exposure microbiological risk assessment maximum residue limit or level EFSA Panel on Dietetic Products, Nutrition and Allergies no observed adverse effect level World Organisation for Animal Health personal computer poly-chlorinated biphenyl EFSA Panel on Plant Health persistent organic pollutant EFSA Panel on Plant Protection Products and their Residues pest risk assessment Qualified Presumption of Safety quantitative structure-activity relationship tolerable daily intake upper limit World Health Organisation 22