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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

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EEAs 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.

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Wisdom is to know, that you do not
know (Socrates) An early lesson, lately
forgotten?
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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
  largeand can be reduced by getting market prices
  the regulatory framework right

EEA draft
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Measuring is Not KnowingThe 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

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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)

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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.

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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 peoples motives for
promoting/opposing the PP but their
interests(economic, political, scientific) in
the issue do need declaring.
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Late Lessons CaseStudies Types of Issue

• 1 Biodiversity (Fisheries)
• 1 Pathogen (BSE)
• 2 Physical Agents (Radiation, Asbestos)
• 3 Pharmaceuticals (DES, Beef Hormones,
  Antibiotics in animal feed)
• 7 Chemicals (Benzene, PCBs, Great Lakes
  Pollution. MTBE, CFCs, TBT, SO2)

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Late Lessons An Analysis of 14 False Negative
Case Studies

• False Negatives Whoops! It really is
  dangerous after all!
• False Positives Whoops! It really isnt
  dangerous after all!

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Some more False Negatives Not Studied
Lead Aral Sea Minnamata Bay DBCP Thalidomide Mule spinning oil BCME VCM The Drins Bladder cancer Overhead powerlines DDT
(See Late Lessons Vol 2, 2005)
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Why So Many False Negatives?

• Sound science generates more false negatives
  than false positives ( good science but poor
  public policy)
• Short term economic/political interests can
  dominate longer term, total welfare interests.

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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 societys 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 ?

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• 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

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Antimicrobial Feed Additives (AFA) Chapter An
Early Warning example

• 1969 UK Medical Research Councils 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)

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CFCs Chapter Skin Cancer and Time Lags
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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.

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Towards A Clarification of Key Terms
Source Late Lessons, page 192
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How Can We Respond toIgnorance (Surprises)?

1. 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)
2. 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)
3. 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).

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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 prices to include 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

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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
  OSPARs 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

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(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

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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)
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ON BEING WRONG Environmental and Health Sciences
and Their Directions of Error
SCIENTIFIC STUDIES SOME METHODOLOGICAL FEATURES MAIN1 DIRECTIONS OF ERROR-INCREASES CHANCES OF DETECTING A
Experimental High doses False positive
Studies Short (in biological terms) range of doses False negative
(Animal Low genetic variability False negative
Laboratory) Few exposures to mixtures False negative
Few Foetal-lifetime exposures False negative
High fertility strains False negative (Developmental/reproductive endpoints)
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
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Observational Confounders False positive
Studies Inappropriate controls False positive/negative
(Wildlife Non-differential exposure misclassification False negative
Humans) Inadequate follow-up False negative
Lost cases False negative
Simple models that do not reflect complexity False negative

Both Publication bias towards positives False positive
Experimental And Scientific cultural pressure to avoid false positives False negative
Observational Studies Low statistical power (e.g. From small studies) False negative
Use of 5 probability level to minimise chances of false positives False negative

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

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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

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Its 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.

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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

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(CONT.)

• Bioaccumulation in higher marine animals,
  including sea-food for human consumption, was
  greater than expected
• A highly specific, initially uncommon impact
  (imposex) was quickly linked to one chemical,
  TBT this easily identified linkage is not likely
  for more common impacts on development and
  reproduction in humans e.g. sperm counts, breast
  cancer
• Early restrictive actions in 1982-85 were based
  on a strength of evidence for the association
  only causality and mechanisms of action
  knowledge came much later

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Towards a Clarification of Some Key Terms From
Association to Causation and Mechanisms of
Action
Situation Association Relevant Information Some weak to strong evidence linking an environmental and/or health impact with a stressor (We see that X may cause Y) Time to produce relevant information Weeks to years Years to decades
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Situation Causation Mechanisms of Action Relevant Information Substantial evidence and knowledge linking impacts with stressor (We know that X causes Y) Substantial evidence and knowledge and understanding of the reasons why there is a causal link between an impact and a stressor (We understand why X causes Y) Time to produce relevant information Years to decades Usually Decades
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Applying the Precautionary Principle Key
Decisions

1. Assigning burdens of proof
2. Evaluating the evidence (in a framework)
3. Choosing appropriate level of proof
4. Evaluating the justification / need
5. Assessing alternatives
6. Assessing appropriate policy measures
7. Taking transparent decisions
8. Involving stakeholders in all stages

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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?
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Multi-causality and Complexity
HOST STATE
HOST GENETICS
EXPOSURES/DOSES
EFFECTS
HARM




gt

• 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

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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 Progres
sion to Harm ?
Cure ? Compensate ? Clean up ? Learn from
mistakes ? Warn ?
but which strategies would be most effective?
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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
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• 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)