1. National Public Health Institute, Finland www.ktl.fi Open risk assessment Lecture 1: Introduction ‏ Jouni Tuomisto KTL, Finland

2. National Public Health Institute, Finland www.ktl.fi Guidance for the workshop Forget everything you knew about risk assessment (RA)  you won't need it because our focus is different During this week, we will describe a new approach to risk assessment. Ask briefly – use hand signs –Write questions down –Thorough discussions should happen on Heande All questions answered by the following day Don't panic!

3. National Public Health Institute, Finland www.ktl.fi Hand signs A question or comment about… Beyond my understanding I agree I disagree Move forward

4. National Public Health Institute, Finland www.ktl.fi Outline What is wrong with the current risk assessment? Why risk assessment is needed in the future? What is needed from the new risk assessment? Can it work? What are the highlights of the workshop?

5. National Public Health Institute, Finland www.ktl.fi What is wrong with the current risk assessment? Limited area of application Lack of flexibility and breadth Inefficiency and slowliness of the process Deliberate biases towards "safety" Communication problems Lack of acceptability among stakeholders

6. National Public Health Institute, Finland www.ktl.fi Limited area of application Only a few chemical groups require RA: –Pesticides, drugs, wood preservatives –This will improve with Reach but not disappear RA not triggered for many important "natural" exposures: –Traditional foods and food items vs. GMO –Environmental exposures: moldy buildings vs. PM Often limited to situations where the release links to someone's economic interest  Who can and should trigger a RA?

7. National Public Health Institute, Finland www.ktl.fi Lack of flexibility and breadth Each discipline has developed an own framework –Scientific opinions on food issues by EFSA –Chemical risk assessment for pesticides –Safety assessment for drugs –Life cycle assessment for consumer products –Environmental impact assessments for major construction sites –"Not tested with animals" for cosmetics  Is this just cultural diversity or a problem of administration and a health hazard?

8. National Public Health Institute, Finland www.ktl.fi Role of value judgements Risk-benefit analysis of farmed salmon (Tuomisto et al, Science 2004) ‏

9. National Public Health Institute, Finland www.ktl.fi Inefficiency and slowliness of the process Inefficiency: it takes a lot of person-months to complete –A lot of expensive expert work –The risk assessments done are not available for others in a useful format –#Instead: the costs of a RA on…? Slowliness: it takes a lot of calendar months to complete –The process has data collection, systematic literature searches, public hearings, reviews, scientific advisory panels… –The dioxin RA by the U.S.EPA: a draft was published 1996 a second draft was published 2000 …we are still waiting for the final version  With the same money, there could be more better RAs

10. National Public Health Institute, Finland www.ktl.fi Major chemical reviews in IRIS

11. National Public Health Institute, Finland www.ktl.fi Deliberate biases towards "safety" Approaches to minimize the false negative error –Reference dose=NOAEL/UF a /UF i –BMDL: lower CI of the benchmark dose –LMS (q 1 * ): linearized multistage Poorly known chemicals are perceived worse than well known major hazards  The problems tend to fall out of YOUR mandate (to others to solve (or ignore))

12. National Public Health Institute, Finland www.ktl.fi Communication problems #"Decision-makers want clear numbers, not distributions" "The Commission wants to promote distributions; this is an educational issue." The assessments are not easily available in the format meaninigful for the stakeholders

13. National Public Health Institute, Finland www.ktl.fi Lack of acceptability among stakeholders #

14. National Public Health Institute, Finland www.ktl.fi Why risk assessment is needed in the future? Simply because it would be nice to do something useful for the risks related to these issues…

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

16. National Public Health Institute, Finland www.ktl.fi Fine particle air pollution

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

18. National Public Health Institute, Finland www.ktl.fi Urban living environment

19. National Public Health Institute, Finland www.ktl.fi Drinking water amount and quality

20. National Public Health Institute, Finland www.ktl.fi Biodiversity

21. National Public Health Institute, Finland www.ktl.fi What is needed from the new assessment? Limited area of application  Adoptable by any area of administration or policy-making Lack of flexibility and breadth  Fully scalable to very simple and very complex questions Inefficiency and slowliness of the process  Info structured & directly reusable  Delegation, non-experts included  Routines automated Deliberate biases towards "safety"  Best estimates (incl uncertainty) used Communication problems  Everything available for clarification questions Lack of acceptability among stakeholders  Stakeholders must have a say on everything in advance  Value judgements included in the assessment

22. National Public Health Institute, Finland www.ktl.fi Open assessment The objectives: –Find solutions to ALL the challenges at the same time –Systematize and "industrialize" the risk assessment The current situation: there are suggestions available to all challenges –Many of the suggestions have not been tested in practice –Not everything will probably work  However, there is already a critical mass of solutions available so that full-scale testing can be started  Further problems should be solved as they appear

23. National Public Health Institute, Finland www.ktl.fi What is the acceptability of the idea of open assessment? Poll (informal based on several audiences): –30 % think it is a stupid idea –50 % think it cannot work –15 % find it interesting, but… –5 % are fond of the idea YOU are the 5% of the poll

24. National Public Health Institute, Finland www.ktl.fi Can open assessment work? I am convinced it can work I am convinced the remaining problems can be solved However, this does not mean that it WILL succeed, at least in our time…

25. National Public Health Institute, Finland www.ktl.fi Leonardo's parachute #1500 –  first applications in 20th century

26. National Public Health Institute, Finland www.ktl.fi Bayes' theorem 17.. Reverend Bayes published the Bayes' theorem in 17.. –  first applications in 1970's

27. National Public Health Institute, Finland www.ktl.fi How would the world look like with full- scale open assessments? #Eduskunnassa kaikki wikittävät #Samanlaiset menetelmät käytössä riippumatta sovellusalueesta ja maasta The turnover of scientific information speeds up

28. National Public Health Institute, Finland www.ktl.fi Open assessment The research question for the (pyrkilo) method: –"How can scientific information and value judgements be organised for societal decision-making in such a way that open participation is possible?" Full range of development –a new ontological foundation –strictly object-oriented approach –a new structure for information objects –traditional RA methods for processing information, but organised in a more systematic way –tools that enable open collaboration –data sources that are directly available and applicable

29. National Public Health Institute, Finland www.ktl.fi Major theses about open assessment Open assessment is about information processing. The information is about the real world. The information is organised as variables. The work of performing assessments is describes as processes. #Kuva prosessista product -process

30. National Public Health Institute, Finland www.ktl.fi Better approaches than their alternatives –Describing issues: graph theory (Bayesian belief nets) –Describing uncertainties: Bayesian probability theory –Propagating uncertainties: Monte Carlo –Resolving disputes: pragma-dialectical argumentation theory –Expressing values: Utility theory –Optimising: decision analysis

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

32. National Public Health Institute, Finland www.ktl.fi Role of scientific and non-scientific issues Risk-benefit analysis of farmed salmon (Tuomisto et al, Science 2004) ‏ Value of scientific and non-scientific information in decision-making

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

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