1. National Public Health Institute, Finland www.ktl.fi Beneris (Benefit-risk assessment for food: an iterative value-of-information approach) ‏ Jouni Tuomisto KTL, Finland

2. National Public Health Institute, Finland www.ktl.fi Partners Participants ESFIN Fundación Privada para la Investigación Nutricional IELendacLendac Ltd DKFVSTFood Safety Authority of Denmark DKDTUTechnical University of Denmark IEFSAIFood Safety Authority of Ireland FIFFilesOy Foodfiles Ltd NLTUDelftDelft University of Technology FIKTLNational Public Health Institute Country Participant short name Participant name

3. National Public Health Institute, Finland www.ktl.fi 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. National Public Health Institute, Finland www.ktl.fi 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. National Public Health Institute, Finland www.ktl.fi The ORA report

6. National Public Health Institute, Finland www.ktl.fi 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 http://heande.pyrkilo.fi A test database for the data repository http://www.pyrkilo.fi/resultdb http://www.pyrkilo.fi/resultdb

7. National Public Health Institute, Finland www.ktl.fi 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. National Public Health Institute, Finland www.ktl.fi

9. National Public Health Institute, Finland www.ktl.fi Potential synergies and/or overlaps with BRAFO Synergies: –The same aim: method development for benefit-risk analysis –The methods and practices already developed in Beneris are available for Brafo to use –The Heande website is available for doing case studies Overlaps: –Dissemination aims at the same audience?

10. National Public Health Institute, Finland www.ktl.fi SWOT analysis Strengths Tight connections to methodology development in several EU-funded projects: Intarese, Heimtsa, Hiwate, Qalibra Work done on several levels: theoretical foundation, methods and application, computer tools Weaknesses Lack of resources in coordination The combining of different parts together is running late (e.g. nutrient data to Bayesian belief networks) Too much focus on theory, too little on food benefit-risk Opportunities Methods widely applicable: food, environmental health, other domains... Mass collaboration: a quicker and more efficient way of making assessments Result database as an open information source Threats Failure in convergence of project approaches Mass collaboration not accepted as a way to work

11. National Public Health Institute, Finland www.ktl.fi 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

12. National Public Health Institute, Finland www.ktl.fi BBN: fish case study

13. National Public Health Institute, Finland www.ktl.fi Quality of data Large national studies on food intake of children and adults from Finland, Denmark, Ireland, Spain National studies on pollutant concentrations in various foodstuff Exposure-response functions for the endpoints mainly from scientific literature, and also from in- house expert judgement

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

15. National Public Health Institute, Finland www.ktl.fi 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

16. National Public Health Institute, Finland www.ktl.fi 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

17. National Public Health Institute, Finland www.ktl.fi 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.

18. National Public Health Institute, Finland www.ktl.fi 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.