National Public Health Institute Finland Open risk assessment

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

National Public Health Institute, Finland Guidance for the workshop www. ktl. fi • 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

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

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?

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

National Public Health Institute, Finland 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: www. ktl. fi – 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?

National Public Health Institute, Finland Lack of flexibility and breadth • Each discipline has developed an own framework – – – www. ktl. fi 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?

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

National Public Health Institute, Finland 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…? www. ktl. fi • 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

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

National Public Health Institute, Finland Deliberate biases towards "safety" • Approaches to minimize the false negative error www. ktl. fi – Reference dose=NOAEL/UFa/UFi – 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))

National Public Health Institute, Finland Communication problems www. ktl. fi • #"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

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

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

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

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

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

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

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

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

National Public Health Institute, Finland www. ktl. fi What is needed from the new assessment?

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

National Public Health Institute, Finland What is the acceptability of the idea of open assessment? • Poll (informal based on several audiences): www. ktl. fi – 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

National Public Health Institute, Finland Can open assessment work? www. ktl. fi • 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…

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

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

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

National Public Health Institute, Finland Open assessment • The research question for the (pyrkilo) method: – "How can scientific information and value judgements be organised for societal decisionmaking in such a way that open participation is possible? " www. ktl. fi • 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

National Public Health Institute, Finland Major theses about open assessment www. ktl. fi • 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

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

www. ktl. fi National Public Health Institute, Finland

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

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

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

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

National Public Health Institute, Finland www. ktl. fi 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

National Public Health Institute, Finland www. ktl. fi Paradigm shift • Thomas Kuhn (19221996) • 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

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

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

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

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

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

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.

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.

National Public Health Institute, Finland Web encyclopedias www. ktl. fi • 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.