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

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

35. National Public Health Institute, Finland www.ktl.fi Pyrkilo Jouni Tuomisto (1997): It is possible to develop such a system, pyrkilo, that transforms information and people's opinions into a description that tends to converge towards scientific validity

36. National Public Health Institute, Finland www.ktl.fi Falsification Karl Popper (1902-1994) ‏ Science consists of statements (theories) that that can be falsified Science is an evolutionary process where poor theories are falsified The current knowledge consists of those theories that have not (yet) been falsified

37. National Public Health Institute, Finland www.ktl.fi Paradigm shift Thomas Kuhn (1922-1996) ‏ Science progresses in a regular way until too many faults are identified in the current paradigm. Then, there is a period of extraordinary science, which leads into a shift of paradigm

38. National Public Health Institute, Finland www.ktl.fi Bayes' rule Thomas Bayes (1702-1761) ‏ A posterior probability given new data can be calculated from a prior and the likelihood of the data

39. National Public Health Institute, Finland www.ktl.fi Quality of an estimate Roger Cooke The quality of a quantitative estimate (probability distribution) can be evaluated against a golden standard using informativeness and calibration

40. National Public Health Institute, Finland www.ktl.fi Vines in Bayesian belief network Roger Cooke BBNs describe the reality by using conditional probabilities These probability distributions can have any form and they can still be solved analytically, if vines are used

41. National Public Health Institute, Finland www.ktl.fi Argumentation Frans van Eemeren Disputes can be solved by using formal argumentation that consists of attacks and defends of a specified statement

42. National Public Health Institute, Finland www.ktl.fi Wisdom of crowds James Surowiecki A group of people is likely to outperform an individual expert, if they can use individual knowledge, act independently and in a decentralized way, and their opinions are effectively aggregated

43. National Public Health Institute, Finland www.ktl.fi Mass collaboration Don Tapscott, Anthony Williams A large group of unorganised people are able to produce complex artefacts, if the product is information or culture, the work can be chopped into bite-size pieces, and the pieces can be effectively synthesised.

44. National Public Health Institute, Finland www.ktl.fi PSSP Veikko Pohjola The world can effectively be organised by describing it as two kinds of objects: processes, and products that are produced by these processes. Each object has a purpose, structure, state, and performance.

45. National Public Health Institute, Finland www.ktl.fi Web encyclopedias Jimbo Wales Encyclopedia that anyone can edit: It is possible to motivate a very large group in collecting information and write articles about important issues.