Open risk assessment Lecture 1: Introduction ‏

1. Jouni Tuomisto KTL, Finland Open risk assessment Lecture 1: Introduction‏

2. 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. Hand signs • A question or comment about… • Beyond my understanding • I agree • I disagree • Move forward

4. 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. 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. Limited area of application • Only a few chemical groups require pre-market RA: • Pesticides, drugs, food additives • 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. 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. Importance of boundaries • Risk-benefit analysis of farmed salmon (Tuomisto et al, Science 2004)‏

9. 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 • 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. Major chemical reviews in IRIS

11. Deliberate biases towards "safety" • Approaches to minimize the false negative error • Reference dose=NOAEL/UFa/UFi • BMDL: lower CI of the benchmark dose • LMS (q1*): 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. On whose side does the problem fall? • Risk-benefit analysis of farmed salmon (Tuomisto et al, Science 2004)‏

13. Communication problems • Science-policy: "Decision-makers want clear numbers, not distributions" • Policy-science: "The Commission wants to promote distributions; this is an educational issue." • Science-stakeholders: The assessments are not easily available in the format meaningful for the stakeholders

14. Lack of acceptability among stakeholders • Stakeholders may not accept • the premises (e.g. giving monetary values to health) • the group that did the assessment (the energy company about nuclear waste disposal) • the involvement of the public (we were not heard in our own cause) • the handling of the contributions (our comments did not have any impact)

15. Why is risk assessment needed in the future? • The real problems in the future are NOT those that the current risk assessment was developed for: • Drugs • Pesticides • Food additives • It is needed because it would be nice to do something useful for the real risks of the future. The risks that are so complex that no single expert is an expert in all parts of the issue. These risks are such as...

16. Climate change • Uppsala glacier, Patagonia, Argentina: above, in 1928 and below, in 2004.

17. Fine particle air pollution

18. Energy efficiency

19. Urban living environment

20. Drinking water amount and quality

21. Biodiversity

22. Population growth

23. Global environmental taxes

24. 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 What is needed from the new assessment?

25. 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

26. Pyrkilo • Jouni Tuomisto (1997): It is possible to develop such a system, pyrkilo, that transforms ideas, information, and people's opinions into a description that tends to converge towards scientific validity. • After several years of work, the Heande website was opened Sept 2006.

27. Open assessment • The objectives: • Find solutions to ALL the challenges at the same time • Systematize and "industrialize" the risk assessment • Maintain high scientific quality • The current situation: there are suggestions available to all challenges listed within the open assessment • 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

28. What is the acceptability of the idea of open assessment? • Poll (informal, based on observations of 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

29. 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…

30. Leonardo's parachute ca. 1500 • first applications in 20th century

31. Bayes' theorem ca. 1750 • Reverend Thomas Bayes published the Bayes' theorem in ca. 1750 • first real applications in 1960's

32. What is the potential for mass collaboration in environmental health risks? • 6,000,000,000 people in the world • 1,000,000,000 of them have access to Internet • 10,000,000 of them are seriously thinking about environmental and/or health problems: ”What could I do?” • 1,000,000 of them can speak English • 100,000 of them have a good background for the work (e.g. university degree) • 10,000 of them are willing to spend 1 h/week on this • 250 person-weeks/week work force available

33. How would the world look like with full-scale open assessments? • The turnover of scientific information speeds up • Scientific information is easily available in a readily useful form always, from anywhere, and in your own language. • Time is spent on solving problems, not on talking about solving them. • People start to respond to the politicians suggesting something stupid: ”Did you not even check Heande?”

34. 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

35. The ORA report

36. Falsification • Karl Popper (1902-1994)‏ • Science consists of statements (theories) 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. Bayes' theorem • Thomas Bayes (1702-1761)‏ • A posterior probability given new data can be calculated from a prior and the likelihood of the data

38. Decision theory • Howard Raiffa • Decision analysis is a rational method for making decisions. In addition, the use of subjective (Bayesian) probabilities in decision analysis should be promoted.

39. 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. 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. Argumentation • Frans van Eemeren • Disputes can be solved by using formal argumentation that consists of attacks and defends of a specified statement

42. PSSP • Veikko Pohjola • A system can effectively be described using two kinds of objects: processes and products that are produced by these processes. Each object has attributes purpose, structure, state, and performance.

43. 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

44. 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.

45. 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.