Document VersionPublisher's PDF, also known as Version of record Link back to DTU Orbit Citation (APA): van der Fels-Klerx, H. J., van Asselt, E. D., Raley, M., Poulsen, M., Korsgaard, H. B., Bredsdorff, L., ... Frewer, L. (2015). Critical review of methodology and application of risk ranking for prioritisation of food and feed related issues, on the basis of the size of anticipated health impact. Europen Food Safety Authority. (EFSA Supporting Publications; No. 710E, Vol. 12(1) ABSTRACTThis study aimed to critically review methodologies for ranking of risks related to feed/food safety and nutritional hazards, on the basis of their anticipated human health impact. An extensive systematic literature review was performed to identify and characterize the available methodologies for risk ranking in the fields of feed and food safety and nutritional hazards, as well as the socio-economic field. Risk ranking methods from the environmental field were studied as well to determine whether approaches used in this field could also be applied for ranking human health risks related to feed and food safety and nutritional hazards. The review used a predefined search protocol. It covered the bibliographic databases Scopus, CAB Abstracts, Web of Sciences, and PubMed over the period 1993-2013. All references obtained were stored into an Endnote database and evaluated for their relevance. All references deemed to be relevant were studied in-depth so as to characterize the risk ranking method described. Characteristics of each method were stored in an Excel database. The methods for risk ranking were then grouped into method categories, which were described in general. These groups included: risk assessment, comparative risk assessment, risk ratio method, scoring method, cost of illness, DALY/QALY, willingness to pay, multi criteria decision analysis, risk matrix, flow charts/decision trees and expert judgment methods. Based on the characteristics of the individual methods and the method categories, an overarching framework was developed for selection of the appropriate method(s) that could be used for risk ranking of feed and food related hazards, on the basis of human health impact. This framework has the format of a decision tool, with which -given the characteristics of the risk ranking question at hand -the most appropriate method(s) can be selected. Application of this overall framework to several case studies showed it can be a useful tool for risk managers/assessors to select the most suitable method for risk ranking of feed/food and diet related hazards, on the basis of expected human health impact. © RIKILT, 2015 DISCLAIMERThe present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It...
Currently, risk assessment of nanotechnology-enabled food products is considered difficult due to the large number of uncertainties involved. We developed an approach which could address some of the main uncertainties through the use of expert judgment. Our approach employs a multi-criteria decision model, based on probabilistic inversion that enables capturing experts’ preferences in regard to safety of nanotechnology-enabled food products, and identifying their opinions in regard to the significance of key criteria that are important in determining the safety of such products. An advantage of these sample-based techniques is that they provide out-of-sample validation and therefore a robust scientific basis. This validation in turn adds predictive power to the model developed. We achieved out-of-sample validation in two ways: (1) a portion of the expert preference data was excluded from the model’s fitting and was then predicted by the model fitted on the remaining rankings and (2) a (partially) different set of experts generated new scenarios, using the same criteria employed in the model, and ranked them; their ranks were compared with ranks predicted by the model. The degree of validation in each method was less than perfect but reasonably substantial. The validated model we applied captured and modelled experts’ preferences regarding safety of hypothetical nanotechnology-enabled food products. It appears therefore that such an approach can provide a promising route to explore further for assessing the risk of nanotechnology-enabled food products
Use policyThe full-text may be used and/or reproduced, and given to third parties in any format or medium, without prior permission or charge, for personal research or study, educational, or not-for-pro t purposes provided that:• a full bibliographic reference is made to the original source • a link is made to the metadata record in DRO • the full-text is not changed in any way The full-text must not be sold in any format or medium without the formal permission of the copyright holders.Please consult the full DRO policy for further details. ABSTRACTThe general approach to risk assessment of genotoxic carcinogens has been to advise reduction of exposure to "as low as reasonably achievable/practicable" (ALARA/P). However, whilst this remains the preferred risk management option, it does not provide guidance on the urgency or extent of risk management actions necessary. To address this, the "Margin of Exposure" (MOE) approach has been proposed. The MOE is the ratio between the point of departure for carcinogenesis and estimated human exposure. However, interpretation of the MOE requires implicit or explicit consideration of the shape of the dose-response curve at human relevant exposures. In a structured elicitation exercise, we captured expert opinion on available scientific evidence for low dose-response relationships for genotoxic carcinogens. This allowed assessment of: available evidence for the nature of dose-response relationships at low levels of exposure; the generality of judgments about such dose-response relationships; uncertainties affecting judgments on the nature of such dose-response relationships; and whether this last should differ for different classes of genotoxic carcinogens. Elicitation results reflected the variability in experts' views on the form of the dose-response curve for low dose exposure and major sources of uncertainty and most importantly, query the rigour of the assumption of a linear relationship.Highlights Experts are reluctant to express views on the dose-response curve for genotoxic carcinogens *Manuscript for revision (track changes hidden) Click here to view linked ReferencesPage 2 of 48 The POD can be extrapolated first from high to low dose in animals and then to humans, or vice versa Expert judgement was that the dose-response curve is highly non-linear at human relevant exposures Stochastic events and the distribution of susceptibilities will contribute, to an unknown extent Interpretation of the MOE requires consideration of MOA, species differences and human variability Keywords Dose-response function; expert judgment; genotoxic carcinogens; low dose extrapolation; margins of exposure; risk assessment
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