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Food Risk Analysis Methodologies

2009-2013 HOLYRISK: Scientific Uncertainty and Food Risk Regulation

<br/>Incertitude Scientifique et Régulation des Risques Alimentaires<br/>

HolyRisk
© Jeanne Rodde
Director: Sandrine Blanchemanche
Co-Director: Ákos Róna-Tas, University of California, San Diego
Partner: The Joint Institute for Food Safety and Applied Nutrition, Washington, D.C.

Grant from the French National Research Agency (ANR)

Contacts: Sandrine Blanchemanche & Ákos Róna-Tas

In collaboration with the Food and Drug Administration (FDA) and University of Maryland Joint Institute for Food Safety and Applied Nutrition - JIFSAN

Abstract

Scientific knowledge became one of the most important prerequisites for making regulatory decisions. Food risk policies are based on the framework of risk analysis which has been an effort to apply universal and formal methods of science to risk assessment and to place societal response to hazards on a scientific footing. As scientific knowledge is never complete, scientific panels are expected to present policy makers with not just what is known but also what is uncertain about a particular risk. For policy decisions the nature and level of the incompleteness of the evidence is of great importance and policy action will always be influenced not just by what seems firmly to be established but also by what is considered uncertain. Recent crises of food safety, such as the BSE disaster and the debate over genetically modified foods highlighted the role of scientific uncertainty in public policy. The role scientific uncertainty plays in policy making is strongly influenced by institutional and regulatory conditions that vary from country to country. The effect of risk assessment on policy is also mediated and articulated by a series of other factors. Risk assessment is often complemented by an economic cost-benefit analysis (CBA), and the two are considered jointly by the policy maker.

Mindful of the practical significance of the problem, major regulatory agencies such as the World Health Organization (WHO) and European Food Safety Authority (EFSA) recently developed guidelines for articulating uncertainty by expert panels. In the US, the Office of Management and Budget issued guidance in 2006 covering various fields including food safety in an effort to standardize the reporting of uncertainty in risk assessment documents. Britain’s Food Standards Agency issued a similar document. Other European countries (including France) have yet to follow suit.

It is not just institutions that addressed this issue. Growing interest in the role of scientific uncertainty in policy making already resulted in a large body of work. The extensive literature, however, is eitherconceptual (offering various ways to classify uncertainty) or normative (prescribing how uncertainty ought to be treated). Except for a few case studies, there has not been any empirical research on how uncertainties of various kinds are actually expressed in risk assessment reports, how prevalent each type is, and what kind of actual consequences they have for future assessments and for the rest of the regulatory process. To better understand the role of science in policy making such an inquiry is necessary.

Our project is a comparative empirical study of the EU and the US that investigates the ways different forms of uncertainty are perceived, handled and expressed by experts throughout the food risk analysis process (risk assessment, risk management and risk communication). We are interested in national (US/EU) differences in the way uncertainty is reported. We are especially curious about how regulatory decisions are influenced by the level and kind of uncertainty embedded in the risk assessment report and how other factors, such as economic dimensions and public involvement are conditioned on the type and extent of uncertainty expressed by the expert panel. We are building a database of relevant documents and coding its content for statistical analysis, as well as for visual representation and decision support. We also plan to conduct a set of in comparative case studies.

The project is interdisciplinary, involving scientists from sociology, economics, risk analysis and computer science. It relies on the building of a database to store risk assessment and management documents. All the partners of the project will be involved in the design and conceptualization of the database and will use it for their own research. The database will provide computer scientists with a unique testing environment where researchers and risk professionals will help calibrate the system. Sociologists will address the substantive questions framing the research using mixed method analysis. They will perform statistical analysis on data stored in the database and conduct a set of comparative case studies. Economists will investigate the role of CBA. Computer scientist will participate in developing 1. the database based on structure and semi-structured information, 2. a coding aid based on machine learning, 3. an “uncertainty navigator,” which is an interactive visual interface that allows efficient navigation in a corpus of annotated documents, and 4. a case-based reasoning system aiding risk managers.

Partners

Social Science Team

David Demortain , Centre for Analysis of Risk and Regulation (CARR), London School of Economics (LSE)

Eve Feinblatt-Mélèze , Met@risk INRA

Nicolas Treich , Toulouse School of Economics (TSE), LERNA INRA

Frederic Vandermoere , Harvard University

Computer Science Team

Caroline Appert , Institut National de Recherche en Informatique et Automatique (INRIA)

Antoine Cornuéjols , AgroParisTech

Juliette Dibie , Met@risk INRA

Liliana Ibanescu , Met@risk INRA

Laurent Orseau, AgroParisTech

Emmanuel Pietriga , Institut National de Recherche en Informatique et Automatique (INRIA)

Lydie Soler , Met@risk INRA

Risk Analysis Team

Elisabeth Calvey, Center for Food Safety and Applied Nutrition (CFSAN/FDA)

Villie Flari, Central Science Laboratory (CSL/UK), Center for Food Safety and Applied Nutrition (CFSAN/FDA)

Steve Gendel, Center for Food Safety and Applied Nutrition (CFSAN/FDA)

Jianghong Meng, Joint Institute for Food Safety and Applied Nutrition (JIFSAN/FDA)

Juliana Ruzante, Joint Institute for Food Safety and Applied Nutrition (JIFSAN/FDA)

Philippe Verger , Met@risk, INRA

Samantha Watters, University of Maryland

Advisory Board

Claudia Heppner, Head of Unit, CONTAM Panel, European Food Safety Authority

Frans Verstraete, European Commission, Health and Consumer Protection Directorate-General, Unit E3: Chemicals, Contaminants and Pesticides

Pascale Parisot, Ministère de l'Agriculture, Direction Générale de l’Alimentation, Head of Bureau de l'Appui Scientifique et Technique

Communication and Publication

S. Blanchemanche, P. Buche et J. Dibie-Barthélemy, E. Feinblatt Mélèze, L. Ibanescu, and A. Rona-Tas (2009). Ontology Building : an Application in Food Risk Analysis. In Proceedings of the 8th International Conference on Terminology and Artificial Intelligence Toulouse (France), TIA 2009, November 18-20, 2009.

A. Rona-Tas, S. Blanchemanche, E. Feinblatt Mélèze (2010). Cognitive demarcation in assessing food risk in the EU and the US : Melamine and listeria, Worshop on Paradigms of Risk Assessment and Uncertainty in Policy Research, may 14-15, 2010, UCSD, La Jolla, CA

A. Rona-Tas (2011) The Science of Uncertainty: Risk Analysis and Food Safety in the EU and the US. Invited lecture at Eotvos University, Budapest, March 23, 2011

Blanchemanche S., (2011). Communicating Uncertainties between Risk Managers and Risk Assessors, Joint Institute for Food Safety and Applied Nutrition Symposium “Mitigating Consequences of an Outbreak/Adverse Effects, Washington, April 27-28, 2011 – Invited Speaker