‘ Late lessons from early warnings the precautionary principle 1896-2000’

1. ‘Late lessons from early warnings the precautionary principle 1896-2000’ David Gee, Coordinator, Emerging Issues and Scientific Liaison, EEA European Parliament Meeting, Dec 11th ,2003

2. EEA’s main Tasks • To provide the Community and member countries with information needed to: • identify, frame, prepare and implement sound and effective environmental policy measures • monitor, evaluate and disseminate actual and expected results of such measures to clients and the public • To establish and coordinate the European environment information and observation network (EIONET), for the collection, assessment and sharing of data with European Commission services, EEA member countries and international organisations.

3. “Wisdom is to know, that you do not know” (Socrates) An early lesson, lately forgotten?

4. Chemicals – the dearth of data • Toxicity Of 2,500 high production volume chemicals, only 14 % have sufficient data for a minimal OECD risk assessment • Exposure There is very little data on exposure levels for ecosystems and people, particularly sensitive groups (e.g. children) • External environmental costs Little data – but the costs of ill health, environmental damage, fires/explosives, etc., are large–and can be reduced by getting market prices & the regulatory framework right EEA draft

5. Measuring is Not Knowing:The Marine Environment and the Precautionary Principle Context 1 “The enormous number of papers in the marine environment means that huge amounts of data are available, but …we have reached a sort of plateau in …the understanding of what the information is telling us …. We… seem not to be able to do very much about it or with it. This is what led to the precautionary principle, after all – we do not know whether, in our studied ecosystem, a loss of diversity would matter, and it might”. Marine Pollution Bulletin, Vol 34, No. 9, pp. 680-681, 1997

6. The precautionary Principle: The working definition used in the “Late Lessons” Report “A general rule of public policy action to be used in situations of potentially serious or irreversible threats to health or the environment, where there is a need to act to reduce potential hazards before there is strong proof of harm, taking into account the likely costs and benefits of action and inaction” (Source: “Late Lessons” Report, Introduction, p. 13)

7. “Towards a Common Understanding of the Precautionary Principles” • The Precautionary Principle is: • NOT a prediction- it is a process that may/may not lead to exposure reduction measures. • NOT the same as “prevention” which is concerned with “known” risks”. “Precaution” = Uncertain/unknown hazards/risks. Eg.bans on asbestos or smoking in 1950/60s would have involved both Precaution and Prevention but bans in 2003 are Prevention only because risks are well known. (See “Late Lessons”, P192) • NOT based on “zero risks” but aims to achieve lower/more acceptable risks/hazards with lower overall costs, both quantifiable and non-quantifiable. • NOT proof against mis-use or bad decision making (as with any other policy tool). • NOT same as “risk assessment”: it is broader, deeper, supplementary to R.A.

8. 6.NOT oblivious of costs of all kinds, and in both directions (i.e. of acting or not acting to reduce risks/hazards), including “secondary” costs/benefits.  7. NOT one sided – it applies to substitutes/alternatives too: and it promotes innovation and combats monopolies such as asbestos, CFCs, PCBs, antibiotics in animal feed, etc.  8. NOT based on anxiety/emotion- but uses the best of the “systems sciences” of complex processes to make, hopefully,wiser decisions.  9. NOT a guarantor of “consistency” or “predictability” between cases – each case is different/ has different facts. (as with legal cases)  10. NOT affected by people’s motives for promoting/opposing the PP – but their “interests”(economic, political, scientific) in the issue do need declaring.

9. Late Lessons: An Analysis of 14 ”False Negative” Case Studies ”False Negatives” = Whoops! It really is dangerous after all! “False Positives” = Whoops! It really isn’t dangerous after all!

10. Why So Many ”False Negatives”? • ”Sound science” generates more false negatives than false positives (= goodscience but poor public policy) • Short term economic/political interests can dominate longer term, total welfare interests.

11. ‘Late Lessons’ is based on case studies Structured around 4 questions: • When were the first scientifically based early warnings ? • When and what were the main actions, or inactions, by society’s actors ? • What were the costs and benefits (all kinds) of the actions/inactions; and • What lessons can be drawn that may help improve decisionmaking and reduce overall costs ?

12. What about ”False Positives”? • Harder to prove • Failed to find authors for them • “Secondary Benefits” often make them worthwhile eg. Y2K “bug” • Vol 2 of “Late Lessons” will have a “false Positive” chapter

13. Antimicrobial Feed Additives (AFA) Chapter – An “Early Warning” example: 1969 – UK Medical Research Council’s Swann Committee: • ‘Despite the gaps in our knowledge .. We believe … on the basis of evidence presented to us, that this assessment is a sufficiently sound basis for action .. The cry for more research should not be allowed to hold up our recommendations’ • ‘Sales/use of AFA should be strictly controlled” via tight criteria, despite not knowing mechanisms of action, nor foreseeing all effects’ • ‘More rewarding to improve animal husbandry than to feed diets containing AFA’ Source: (HMSO, UK, Nov. 1969)

14. CFCs Chapter: Skin Cancer and Time Lags

15. Twelve Late Lessons fromEarly Warnings A ”Identify/Clarify the Framing and Assumptions” • Manage “risk”, “uncertainty” and “ignorance” • Identify/reduce “blind spots” • Assess/account for all pros and cons • Analyse/evaluate alternative options • Take account of stakeholder values • Avoid “paralysis by analysis” by acting to reduce hazards via the precautionary principle.

16. Situation State and dates of knowledge Examples of action Risk ‘Known’ impacts; ‘known’ probabilities e.g. asbestos Prevention: action taken to reduce known hazards e.g. eliminate exposure to asbestos dust Uncertainty ‘Known’ impacts; ‘unknown’ probabilities e.g. antibiotics in animal feed and associated human resistance to those antibiotics Precautionary prevention: action taken to reduce exposure to potential hazards Ignorance ‘Unknown’ impacts and therefore ‘unknown’ probabilities eg the ‘surprises’ of chlorofluorocarbons (CFCs) and asbestos mesothelioma cancer Precaution: action taken to anticipate, identify and reduce the impact of ‘surprises’ Towards A Clarification of Key Terms Source: ‘Late Lessons’, page 192

17. How Can We Respond to“Ignorance” (“Surprises”)? • Use intrinsic parameters as proxies for unknown but possible impacts (e.g. persistence and/or bioaccumulation potential of chemical substances. (See Case Studies on PCBs, MTBE, CFCs, TBT) • Reduce specific exposures to potentially harmful agents on the basis of credible ‘Early Warnings’ of initial harmful impacts (thus limiting the size of any other ‘surprise’ impacts from the same agent, e.g. the asbestos cancers that followed asbestosis; and PCB neurotoxicological effects that followed wildlife impacts). (See 5 other responses to “ignorance” in “Late Lessons” supplementary report, EEA 2003) • Promote a diversity of robust and adaptable technological and social options to meet needs (which limits technological ‘monopolies’ such as asbestos, CFCs, PCBs etc., and therefore reduces the scale of any ‘surprise’). EEA draft

18. Lesson 3: Assess, justify and account for all pros and cons • Including their distribution; and ‘secondary’ benefits and costs • Include effects of innovation and technological change, as well as social impacts of technology choices • Product pricestoinclude full costs of production, use & disposal (the 'polluter pays principle') • This maximises efficiency, stimulates innovation and minimises environmental and health burdens • Precautionary costs should not greatly outweigh the benefits;the proportionality principle

19. Lesson 4: Evaluate alternative means of providing services • Avoid Substance ‘monopolies’ that stifle innovation (see Asbestos, CFCs, PCBs, AFA) • Stimulate available alternatives (see antimicrobials, asbestos, radiation, CFCs) • (The principle of substitution, now part of OSPAR’s Strategy on Hazardous Substances requires a comparative assessment of alternative means of providing services; as does the EU Biocides Directive) • But use precaution, eco-efficiency and diversity with substitutes, too

20. (CONT.) B ”Broaden Assessment Information” • Identify/reduce interdisciplinary obstacles to learning • Identify/reduce institutional obstacles to learning • Use “lay”, local and specialist knowledge • Identify/anticipate “real world” conditions • Ensure regulatory and informational independence • Long term monitoring/research

21. Less Hubris, more Humility? “Misplaced certainty about the absence of harm played a key role in delaying preventive actions in most of the case studies” (Preface, ‘Late lessons from Early Warnings: the Precautionary Principle 1896-2000’)

22. ON BEING WRONG: Environmental and Health Sciences and Their Directions of Error 1 Some features can go either way (e.g.inapproriate controls) but most of the features mainly err in the direction shown in the table EEA draft

23. EEA draft

24. Levels of proof - some examples • Beyond all reasonable doubt • Reasonable certainty • Balance of probabilities/evidence • Strong possibility • Scientific suspicion of risk • Negligible/insignificant EEA draft

25. Endocrine Disrupting Substances (EDSs):Some difficult features • Timing of the dose • Mixtures • Natural and synthetic EDSs • ”Hormonal imprinting” • Endocrine systems ”cross-talk” • Generational impacts • Impacts/Adverse impacts • Adverse impacts due to imbalance between opposing affects in complex systems EEA draft

26. It’s the Timing of the Dose that Makes the Poison for Developmental and Reproductive Harm • ”The time of life when exposures take place may be critical in defining dose-response relationships of EDSs for breast cancer as well as for other health effects” (WHO/IPCS ”State of the Science of EDSs”, 2002) • DES • DDT • TBT • Thalidomide • Etc. EEA draft

27. ”TBT Antifoulants: A Tale of Ships, Snails and Imposex” (Chapter 13) • An increased appreciation of scientific complexity and indeterminacy accompanied the unfolding of the TBT impacts story. • Very low doses caused adverse impacts (i.e. in parts/trillion) • High exposure concentrations were found in unexpected places e.g. the marine microlayer EEA draft

28. Towards a Clarification of Some Key Terms: From ”Association” to ”Causation” and ”Mechanisms of Action” EEA draft

29. EEA draft

30. Applying the Precautionary Principle: Key Decisions • Assigning burdens of proof • Evaluating the evidence (in a framework) • Choosing appropriate level of proof • Evaluating the justification / need • Assessing alternatives • Assessing appropriate policy measures • Taking transparent decisions • Involving stakeholders in all stages EEA draft

31. “Man has lost the capacity to foresee and forestall....he will end up destroying the earth.” - Albert Schweitzer Will this prediction come true ? Or could the precautionary principle help us to foresee and forestall Hazards… using the best of systems science whilst stimulating innovation? EEA draft

32. Multi-causality and Complexity HOST STATE HOST GENETICS EXPOSURES/DOSES EFFECTS HARM + = = > + • Multiple exposures/doses • Via several exposure routes (skin, inhalation, ingestion) • Environmental – indoor • Environmental – outdoor • Occupational • Low doses and/or peaks • 24 hours continuous • Or single dose at critical times • Pre- and post-natal doses • Lifetime and cumulative • ‘target’ organ dose • Biologically effective dose • Often unknown doses • Genotypes and phenotypes • Nutritional status • Immune status • Health status (lifestyle) • Age • etc. • Initiating • Promoting • Retarding • Suppressing • Causing • Changes in • Cells, tissues, • Hormones • Organs • Functions; • ‘normal’ • ‘distributions of bio-functions. • Infections • Skin • Cancer • Neurotoxicity • Respiratory • Circulatory • Reproductive • Other adverse developmental impacts

33. Possible strategies for avoiding, reducing and compensating harm ... HOST GENETICS HOST STATE EXPOSURES EFFECTS HARM Genetic Engineering ? Remove ‘sensitive’ Groups from Exposure ? Improve Nutrition ? Promote good health ? Vaccinate ? Reduce ? Eliminate ? Predict ? Identify earlier ? Stop/slow Progression to Harm ? Cure ? Compensate ? Clean up ? Learn from ‘mistakes’ ? Warn ? but which strategies would be most effective?

34. Illustrative Multi-causality: Childhood asthma illustration ‘ HOST GENETICS HOST STATE EXPOSURES HARM + + = + + = 25% 25% 50% 100% e.g. Allergic sensitivity e.g. Nutritional and immune status • 30% indoor • e.g. • Mites10% • Pets 5% • Passive smoking 5% • NOx 5% • Damp 5% • 20% outdoor • Pollen 10 % • Industrialpollution 5% • Trafficpollution 5% • Asthmacaused/Aggravated in somechildren 30% indoor e.g. • Mi tes 10% • Pets 5% • Passive sm ok in g 5% • NO 5% X • Da mp 5% 20% outdoor e.g. • Pollen 10% • Industrial po on 5% • c

35. …’Reducing traffic pollution’ may be a very cost effective policy action on asthma; given • Inter-linked causal chains • Less dependence on individual behaviour change • Cost effectiveness/distribution • Large secondary benefits e.g. reduced traffic congestion, accidents; community fragmentation; CO2 etc. (‘multi-pollutant, multi-effects strategy)