Beneris (Benefit-risk assessment for food: an iterative value-of-information approach) ‏

1. Jouni Tuomisto KTL, Finland Beneris (Benefit-risk assessment for food: an iterative value-of-information approach)‏

2. Participant name Participant short name Country National Public Health Institute KTL FI Delft University of Technology TUDelft NL Oy Foodfiles Ltd FFiles FI Food Safety Authority of Ireland FSAI IE Technical University of Denmark DTU DK Food Safety Authority of Denmark FVST DK Lendac Ltd Lendac IE Fundación Privada para la Investigación Nutricional FIN ES Partners Participants

3. Objectives (selection)‏ • A framework for handling complicated benefit-risk situations • Benefit-risk analysis methods • Bayesian belief networks (BBN)‏ • Methods for dose-response assessment, combining epidemiological and toxicological data • A result database for information relevant for benefit-risk assessments • Food risks and benefits • To estimate nutrient intakes and food consumption in various subgroups • To identify food consumption patterns and food choices that determine the intake • Dissemination • To integrate results into updated benefit-risk assessments, and evaluate the remaining uncertainties and their importance for decision-making. • To develop an internet interface for publishing risk assessment results. • To develop methods to collect feedback from end-users about benefit-risk analyses.

4. Timeline • Project started April 1, 2006 • Heande website opened September, 2006 • Open Risk Assessment report September, 2007 • Mid-term meeting November 7-9, 2007 • Result database opened January, 2008 • Full case study, fish fall 2008 • Full case study, vegatable spring 2009 • Final project meeting June, 2009 • Project ends September 30, 2009

5. The ORA report

6. Results and deliverables achieved • Bayesian belief network (BBN) on fish prepared • Work on parameter values under way • A methodology report: • Tuomisto and Pohjola: Open Risk Assessment, 2007. • A website for making open assessments: http://heande.pyrkilo.fi • A test database for the data repositoryhttp://www.pyrkilo.fi/resultdb

7. Methods and Approaches • Open assessment • A general assessment method that enables unrestricted participation (i.e. mass collaboration) at all phases of the assessment process • Applies a defined information structure: causal diagrams with variables • Formal argumentation is used to resolve disputes • Bayesian belief networks as the decision support system

8. Case studies • Fish: benefits of nutrients and risks of pollutants in fish • Dioxin, PCB, methyl mercury • Omega-3 fatty acids, selenium, iodine • Cardiovascular and cancer mortality, IQ loss, developmental defects (teeth)‏ • Vegetables: impacts of vegetable-rich and vegetable-poor diets in children • The detailed scoping under way

9. BBN: fish case study

10. Comments on Benefit-risk assessment tiered approach Jouni T. Tuomisto National Public Health Institute (KTL), Finland

11. Important points • Question must be clear and for a need! • Iterative approach • Transparency • Need for procedural decisions acknowledged • Utilises approaches developed in other areas: DALYs, QALYs

12. Comments on procedural decisions • Who actually decides what is needed or sufficient? • About the main questions asked. • About the outcomes considered. • About when the preference between scenarios is clear enough. • What is the basis for these decisions? Are the criteria explicated in an assessment? • Truth should be used as the ultimate criterion

13. Comments on Margin of Exposure (MoE) • DALYs of QALYs can be used in measuring both risks and benefits • The use of MoE is ambiguous and should be discouraged. • 10 % impact on a risk and on a benefit are NOT comparable in any meaningful way.

14. Comments on the process • ”Problem definition is an iterative process.”  If the main question changes, when is the assessment no longer the original assessment? • If the approach is a general approach, it should work fine with risk assessments (no benefits) and benefit assessments (no risks) as well.