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Call 2013: Tenders

Call for tender n° EAHC/2013/BTSF/06: Organisation and implementation of training activities on Principles and methods of food safety risk assessment under the "Better Training for Safer Food" initiative

The present call for tender covers the organisation and implementation of training activities on Principles and methods of food safety risk assessment.

The activity will be addressed to scientists from public institutions involved in food safety risk assessment and focussed on the following fields:

  • Course 1: Microbiological risk assessment;
  • Course 2: Chemical risk assessment in food;
  • Course 3: Pest risk assessment;
  • Course 4: Risk assessment in nutrition;
  • Course 5: Risk assessment in Genetically Modified Organisms and other biotechnologies;
  • Course 6: Risk assessment applied to animal welfare;
  • Course 7: Risk assessment for animal health;
  • Course 8: Environmental Risk Assessment.

The contractor will be requested to organise and implement a total of 16 four-day training sessions which means two sessions per course.

These courses will be held in three or more distinct locations, to be chosen by the Contractor, geographically equally distributed among the different EU Member States.

The topics addressed in Course 1 will include but are not necessarily limited to:

  • Introduction to food safety risk assessment (the 3 pillars of risk analysis, EU and international regulatory framework, basic steps in risk assessment, short history of main developments in the science of risk assessment, introduction to key concepts and basic risk assessment terminology, different concepts of risk assessment);
  • Introduction to microbiological risk assessment (different steps, microbiological risk assessment at national and at international level, approaches in different areas of food and feed safety, problem formulation, routes of exposure) and its legal framework;
  • Hazard Identification
    • Statement of problem and scope of risk assessment;
    • Concept of Qualified Presumption of Safety (QPS);
    • What makes microbiological risk assessment unique (i.e. differences with other risk assessments);
    • Pathogen-product pathway;
    • Data and information on microbial agent, food and process, consumer practice;
  • Hazard Characterization
    • The disease triangle (pathogen virulence-host susceptibility-food matrix);
    • Sources of dose-response data (human volunteer feeding studies, epidemiological data, animal studies, in vitro studies);
    • Modelling dose-response relationship (types of models, selection of dose-response model);
    • Statistical inference in dose-response modelling and applicability of results to new (even unknown) conditions, different from the reference data set;
  • Exposure Assessment
    • Describing and modelling the production-to-consumption chain;
    • Describe the basic processes, such as microbial processes (such as growth and inactivation of microorganisms) and food handling processes (such as cross-contamination), statistical inference and applicability of results to new (even unknown) conditions, different from the reference data set;
    • Qualitative and qualitative (deterministic vs. stochastic) models, simple vs. structured models, limitations due to data;
    • Uncertainty and variability in exposure assessment;
    • Sources of data and models, their generality vs. context dependency;
  • Risk Characterization
    • Qualitative, semi-quantitative, quantitative outputs;
    • Distinguishing variability and uncertainty;
    • Sensitivity analysis and “what if” scenarios;
    • Model criticism: model fit, model comparison and model assumptions;
    • Applicability and generality of results, limitations;
  • Risk management aspects specifically related to microbiological risk assessment;
  • Availability and use of existing data, such as the Food Consumption Database.

The topics addressed in Course 2 will include but are not necessarily limited to:

  • Introduction to food safety risk assessment (the 3 pillars of risk analysis, EU and international regulatory framework, basic steps in risk assessment, short history of main developments in the science of risk assessment, introduction to key concepts and basic risk assessment terminology, different concepts of risk assessment);
  • Introduction to chemical risk assessment (different steps, chemical risk assessment at national and at international level, approaches in different areas of food and feed safety, problem formulation, routes of exposure, differences between types of chemicals in food and feed, fate and behaviour of chemical contaminants) and its legal framework;
  • Hazard Identification and Characterization
    • Basic concepts in toxicology:
      • 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 intra-species/human variability;
      • Uncertainty assessment – safety factors;
      • Risk-benefit considerations;
      • Threshold of Toxicological Concern Concept;
      • QSAR, „In silico“ toxicity, read across;
    • Basic knowledge of different endpoints in toxicity studies:
      • Toxicokinetics and toxicodynamics (ADME);
      • Histopathology;
      • Genotoxicity / carcinogenicity;
      • Reproductive and developmental toxicity;
      • Neurotoxicity and immunotoxicity;
      • Endocrine effects;
  • Exposure Assessment (focused on intake from consumption of food)
    • Collection of consumption data:
      • Methodologies (pro et contra);
      • EFSA and WHO databases;
      • Extrapolation from crop to crop and from country to country.
    • 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;
    • 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;
  • Risk Characterisation
    • Hazard Index;
    • The Margin of Exposure (MoE) approach;
    • Uncertainties analyses;
  • MRL-setting – difference to health based guidance values (ADI, ARfD).

The topics addressed in Course 3 will include but are not necessarily limited to:

  • Introduction to food safety risk assessment (the 3 pillars of risk analysis, EU and international regulatory framework, basic steps in risk assessment, short history of main developments in the science of risk assessment, introduction to key concepts and basic risk assessment terminology, different concepts of risk assessment);
  • Introduction to pest risk assessment (different steps, pest risk assessment at national and at international level) and its legal framework;
  • Data requirements for pest risk assessment;
  • The different steps in pest risk assessment;
    • 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;
    • 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);
    • 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
    • Options for consignments;
    • 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.

The topics addressed in Course 4 will include but are not necessarily limited to:

  • Introduction to food safety risk assessment (the 3 pillars of risk analysis, EU and international regulatory framework, basic steps in risk assessment, short history of main developments in the science of risk assessment, introduction to key concepts and basic risk assessment terminology, different concepts of risk assessment);
  • 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, and its legal framework;
  • The risk assessment model in nutrition
    • concepts, terminologies and methods:
      • defining Dietary Reference Values (DRV);
      • nutrient based goals and objectives;
      • food based dietary guidelines (FBDG);
    • 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
    • essential and non-essential nutrients, i.e. assessment of insufficiency and excess (absolute and/or relative) vs. assessment of excess only;
    • risk assessment of macronutrients;
    • risk assessment of micronutrients;
    • 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
    • advantages and limits of different methods for dietary surveys: 24-hr recall, food diaries, food frequency questionnaires;
    • food datasheets, household budget surveys, use of anthropometric and biomarkers;
    • 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.

The topics addressed in Course 5 will include but are not necessarily limited to:

  • Introduction to food safety risk assessment (the 3 pillars of risk analysis, EU and international regulatory framework, basic steps in risk assessment, short history of main developments in the science of risk assessment, introduction to key concepts and basic risk assessment terminology, different concepts of risk assessment);
  • Introduction to risk assessment in GMOs and other biotechnologies (scope of applications of GM technology and modern biotechnologies, specificities of the risk assessment approach when applied to food and feed derived from modern biotechnology, appropriate statistical principles and methods for the comparative analysis of food/feed) and its legal framework;
  • The principles and methods of hazard identification and characterization when applied to whole food/feed
    • identification of newly inserted genes and gene products; gene expression / suppression;
    • toxicity and allergenicity assessment;
    • feeding studies (with laboratory and target animals) for the safety and nutritional assessment of food/feed derived from GM plants;
    • intended vs. unintended effects;
    • scope and interplay between molecular characterization, 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
    • scopes of application, including or not cultivation in EU;
    • problem formulation and assessment endpoints in the ERA;
    • data collection and modelling in the development of GMO ERA;
    • interplay between EU regulations in the case of herbicide-tolerant GM crops.

The topics addressed in Course 6 will include but are not necessarily limited to:

  • Introduction to risk assessment applied to animal welfare (the 3 components of risk analysis, EU and international regulatory framework, OIE standards for animal welfare, basic steps in risk assessment, short history of main developments in applying risk assessment to animal welfare, introduction to key concepts and basic risk assessment terminology, different concepts of risk assessment);
  • Introduction to risk assessment for animal welfare (different steps, risk assessment at national and at international level, approaches in different areas of animal welfare (husbandry, transport, and slaughter), problem formulation, exposure scenarios);
  • Hazard Identification:
    • Statement of problem and scope of risk assessment;
    • What makes risk assessment for animal welfare unique (i.e. differences with other risk assessments);
    • Data and information on practices related to the risk question;
  • Hazard Characterization
    • The concept of pain and suffering;
    • Evaluating consequences of hazards, intensity and duration;
    • The question of multiple interactions between welfare factors;
    • Genotype by environment interactions;
    • Evidence in animal welfare: data, peer-reviewed literature, and expert opinion (data collection and databases, systematic literature reviews, expert knowledge elicitation);
    • Integrating the use of animal-based indicators and risk assessment: modelling hazard-response relationship;
  • Exposure Assessment
    • Exposure scenarios;
    • Uncertainty and variability in exposure assessment;
    • Sources of data and models, their generality vs. context dependency;
  • Risk Characterization
    • Qualitative, semi-quantitative, quantitative outputs;
    • Distinguishing variability and uncertainty;
    • Sensitivity analysis and “what if” scenarios, including alternative models/assumptions;
    • Model criticism: model fit and model comparison;
    • Applicability and generality of results, limitations;
  • Risk management aspects specifically related to animal welfare risk assessment
    • Availability and use of existing data;
    • Unmitigated versus mitigated risk assessment and assessment of management options.

The topics addressed in Course 7 will include but are not necessarily limited to:

  • Introduction to risk assessment  in the field of animal health (the 3 components of risk analysis, EU and international regulatory framework including the OIE standards and the SPS agreement of the WTO, basic steps in risk assessment, short history of main developments in the science of risk assessment, introduction to key concepts and basic risk assessment terminology, different concepts of risk assessment);
  • Introduction to import risk assessment (different steps, import risk assessment, risk assessment at national and at international level) and its legal framework, examples of risk assessments for animal health;
  • Data requirements for import risk assessment;
  • The different steps in import risk assessment (IRA)
    • Problem formulation:
      • IRA initiated by the identification of a pathway or a commodity;
      • IRA initiated by the identification of a disease or a pathogen;
      • IRA initiated by the review or revision of a policy;
      • Formulation of the risk question(s);
    • Assessment of introduction and spread of a disease or disease agent:
      • Probability of entry;
      • Probability of establishment;
      • Probability of spread (host availability);
    • Assessment of potential consequences associated with the introduction and spread of diseases:
      • Impact on susceptible host population;
      • Economic and environmental side effects;
  • Identification of appropriate risk management options
    • Mitigated versus non-mitigated risk assessment;
    • Options for the risk prevention or risk reduction;
    • Assessment of the effect of risk management options on the level of risks.

The topics addressed in Course 8 will include but are not necessarily limited to:

  • Introduction to food safety risk assessment (the 3 pillars of risk analysis, EU and international regulatory framework, basic steps in risk assessment, short history of main developments in the science of risk assessment, introduction to key concepts and basic risk assessment terminology, different concepts of risk assessmen
  • Introduction on environmental risk assessment (ERA) under the various EU legislation. The course will explain the basics of how to conduct ERA. In particular:
    • looking at the different aspects of the environment and environmental compartments;
    • exercises in problem formulation to better identify the aspects of the environment that need to be protected from harm, according to environmental protection goals as set by EU legislation;
    • how to conduct the selection of non-target organisms for risk assessment evaluation studies, and how to gather relevant evidence. It will include the application and use of statistics to the measurable endpoint results with appropriate interpretation of the biological relevance of statistically significant results;
    • environmental exposure assessment. For each of the environmental compartments, scenario models can be selected to generate data and to link environmental exposure assessment to environmental effects;
    • life-stage analysis. The developmental stages of wildlife are linked with their temporal and spatial distribution Life stage analysis becomes most relevant when exposure patterns are known, and one can investigate whether exposure is likely to have a detrimental effect at a specifically sensitive life stage, with subsequent population level effects, using appropriate modelling tools.

In order to achieve the best results from the training courses, the expected global number is 330 participants for the whole training programme.

The target audience for such a training programme would include experts involved in food safety risk assessment in the Member States as well as Candidate Countries and EEA/EFTA countries. The setup 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.

For more information, please contact EAHC-BTSF-CALLS@ec.europa.eu under the following reference: EAHC/2013/BTSF/06.

The deadline to submit tenders for this procedure is the 27 September 2013.

 

 

Documents

  • Invitation to tender
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