open risk assessment lecture 1: introduction

National Public Health Institute, Finlandww

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http://heande.pyrkilo.fi

Open risk assessment Lecture 1: Introduction

Jouni TuomistoKTL, Finland


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Outline• What are the challenges of the current risk

assessment?• Why risk assessment is needed in the future?• What is needed from the new risk assessment?• Can it work?• Practical examples and links


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Disclaimer• Open (risk) assessment is not officially accepted

method or thinking anywhere• It has been developed in KTL within a risk

research group lead by J.T.• The idea is actively promoted within several EU-

funded research projects (Intarese, Heimtsa, Beneris, Hiwate, Hitea) without official success so far

• The idea is promoted in practice by running a website for open assessments


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What are the challenges of 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


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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?


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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?


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Importance of boundaries• Risk-benefit analysis of farmed salmon (Tuomisto et al, Science 2004)

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If risk managers assume responsibility of total health effect of salmon consumption

If risk managers care only for cancer due to pollutants

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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• A description of work in a form of a report may be available, but the

actual work, i.e., data, calculations, reasoning, and detailed results are not.

• 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


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Major chemical reviews in IRIS

1985 1987 1989 1991 1993 1995 1997 1999 2001 2003 2005 20070

100

200

300

400

500

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Chemicals in IRIS website

The most recent major update

Date of update

Num

ber

of c

hem

ical

s


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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))


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On whose side does the problem fall?• Risk-benefit analysis of farmed salmon (Tuomisto et al, Science 2004)

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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...


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Climate change• Uppsala glacier, Patagonia, Argentina: above, in

1928 and below, in 2004.


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Fine particle air pollution


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Energy efficiency


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Urban living environment


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Drinking water amount and quality


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Biodiversity


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Population growth


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Global environmental taxes


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What is needed from the new assessment?

Stakeholders must have a say on everything in advanceValue judgements included in the assessment

Lack of acceptability among stakeholders

Everything available for clarification questionsCommunication problems

Best estimates (incl uncertainty) usedDeliberate biases towards "safety"

Info structured & directly reusableDelegation, non-experts includedRoutines 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


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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


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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.

• The assessments that are produced using the pyrkilo method we call open assessments.

• After several years of work, the Heande website was opened Sept 2006.


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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 with open assessment: there are suggested methods to all challenges listed previously– 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


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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

• In which category do you fall in?


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Assessment: Gasbus


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Assessments in practice• They look like Wikipedia articles• They are written in much the same way• Substance is on the main page

– Research question– Definition: how to find an answer– Result

• Discussion about the substance is on a separate discussion page– Discussion can be free or structured


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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


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Highlights of the theory behind• The basic principles are

– Open participation at all phases of the assessment– Requirement of scientific method (openness to scientific

critique) at all phases– Reusability of information from one assessment to another

• A uniform information structure is used:– Assessment: specific information need for a policy decision– Variable: a truthful description of a particular part of reality; it is

independent of assessments given its scope.– Both objects have 4 attributes: name, scope (research

question), definition (how to answer), and result


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Assessments are performed openly in the Internet

• Parts needed to run open assessments– Web pages with method descriptions for the

assessors (Guidebook)– Web pages about useful data (Resource Centre)– Web pages about actual assessments

• Descriptions of assessments and models used (Warehouse)• Actual models (Toolbox)• Results of assessments in a uniform structure (Result

database)– Web pages for collaborative work on assessments

(Collaborative workspace)Red parts are officially parts of the Intarese project


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Quality control• Is quality control possible if pages are available for

all to contribute?• Our first thoughts (no experience yet, because

work is practically within research projects)– Pages can be freely added and edited– Advanced pages are protected from direct edits

• Then, the edits are made through an open discussion on a separate page; results are transferred to the actual page

– Very important pages go through a peer review and get a quality label


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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…


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Leonardo's parachute ca. 1500– first applications in 20th century


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Bayes' theorem ca. 1750• Reverend Thomas Bayes published the Bayes'

theorem in ca. 1750

– first real applications in 1960's


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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


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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 assessing solutions to problems, not on talking about assessing them.

• People start to respond to the politicians suggesting something stupid: ”Did you not even check Heande?”


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The ORA report


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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


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Bayes' theorem• Thomas Bayes (1702-1761)• A posterior probability given new data can be

calculated from a prior and the likelihood of the data


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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.


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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


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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


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Argumentation• Frans van Eemeren• Disputes can be solved by using

formal argumentation that consists of attacks and defends of specified statements


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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.


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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


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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.


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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.


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Summary• The purpose of open assessment is to improve

and make more efficient the use of scientific information

• The basic principles are– Open participation at all phases of the assessment– Requirement of scientific method (openness to

scientific critique) at all phases– Reusability of information from one assessment to

another• Researchers are needed to test the ideas of open

assessment• If successful, scientific practices may change


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Practical examples and links• The open website for open assessments:

http://heande.pyrkilo.fi– Case studies (see Category:Risk assessments):

• impacts of bus engine type on health• Farmed salmon: pollutants vs. fish oils• Municipal solid waste incinerator

– Workshop material (February 2008)• Heande: Kuopio Risk Assessment Workshop 2008• This lecture and much more

– To access non-published material:• Create a user account• Fill in the form on “Information about page protection”• Your username will be added to the group of insiders


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Links• Risk assessment workshop

• http://heande.pyrkilo.fi/heande/index.php/Kuopio_Risk_Assessment_Workshop_2008

• Gasbus case on PM and bus engines• http://heande.pyrkilo.fi/heande/index.php/Gasbus_-_health_i

mpacts_of_Helsinki_bus_traffic• Farmed salmon csae

• http://heande.pyrkilo.fi/heande/index.php/Benefit-risk_assessment_on_farmed_salmon

• Guidebook (not openly available)• http://heande.pyrkilo.fi/heande/index.php/Guidebook

open risk assessment lecture 1: introduction

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