Transcript No Slide Title

‘ 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
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.
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“Wisdom is to know,
that you do not know”
(Socrates)
An early lesson, lately forgotten?
3
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
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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
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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:
1.
2.
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)
3.
NOT based on “zero risks” but aims to achieve lower/more acceptable
risks/hazards with lower overall costs, both quantifiable and non-quantifiable.
4.
NOT proof against mis-use or bad decision making (as with any other policy tool).
5.
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 people’s motives for promoting/opposing the PP – but their
“interests”(economic, political, scientific) in the issue do need declaring.
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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 isn’t
dangerous after all!
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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
•
•
•
•
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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 ?
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 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)
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CFCs Chapter: Skin Cancer and Time
Lags
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Twelve Late Lessons from
Early Warnings
A ”Identify/Clarify the Framing and Assumptions”
1.
2.
3.
4.
5.
6.
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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.
Towards A Clarification of Key Terms
Situation
State and dates of
knowledge
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
‘Unknown’ impacts and
therefore ‘unknown’
probabilities eg the ‘surprises’
of chlorofluorocarbons (CFCs)
and asbestos mesothelioma
cancer
Source: ‘Late Lessons’, page 192
Ignorance
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Examples of action
Precaution: action taken to
anticipate, identify and reduce the
impact of ‘surprises’
How Can We Respond to
“Ignorance” (“Surprises”)?
EEA draft
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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’).
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
•
•
•
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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
(CONT.)
B ”Broaden Assessment Information”
7. Identify/reduce interdisciplinary obstacles to
learning
8. Identify/reduce institutional obstacles to
learning
9. Use “lay”, local and specialist knowledge
10. Identify/anticipate “real world” conditions
11. Ensure regulatory and informational
independence
12. 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
SOME METHODOLOGICAL
FEATURES
MAIN1 DIRECTIONS OF
ERROR-INCREASES
OF DETECTING A:
•High doses
•False positive
Studies
•Short (in biological terms) range
doses
•False negative
(Animal
•Low genetic variability
•False negative
•Few exposures to mixtures
•False negative
•Few Foetal-lifetime exposures
•False negative
SCIENTIFIC
STUDIES
Experimental
Laboratory)
•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
EEA draft
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Observational •Confounders
•Inappropriate controls
•False positive/negative
•Non-differential exposure
misclassification
•False negative
•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
Studies
(Wildlife &
Humans)
Observational •Low statistical power (e.g. From
studies)
Studies
•Use of 5 % probability level to
minimise chances of false positives
EEA draft
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•False positive
•False negative
•False negative
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
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Endocrine Disrupting Substances (EDSs):
Some difficult features
•
•
•
•
•
•
•
•
EEA draft
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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
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
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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
EEA draft
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Towards a Clarification of Some Key
Terms: From ”Association” to
”Causation” and ”Mechanisms of Action”
Situation
Relevant Information
Time to produce
relevant
information
“Association”
Some weak to strong evidence
an environmental and/or health
with a stressor
Weeks to years
(“We see that X may cause Y”)
Years to
EEA draft
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Situation
Relevant Information
“Causation”
Substantial evidence and
linking impacts with stressor
(“We know that X causes Y”)
“Mechanisms of
Action”
Time to
relevant
information
Years to
Substantial evidence and
and understanding of the reasons
there is a causal link between an
and a stressor
(“We understand why X causes
Usually
EEA draft
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Applying the Precautionary
Principle: Key Decisions
1.
2.
3.
4.
5.
6.
7.
8.
EEA draft
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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
“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
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Multi-causality and Complexity
HOST
HOST
+ STATE
GENETICS
• Genotypes
and
phenotype
s
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• Nutritional
status
• Immune
status
• Health
status
(lifestyle)
• Age
etc.
+
EXPOSURES/DOSES = EFFECTS
• 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
• Initiating
• Promoting
• Retarding
• Suppressing
• Causing
Changes in
• Cells,
tissues,
• Hormones
• Organs
• Functions;
• ‘normal’
‘distributions
of biofunctions.
=> HARM
•
•
•
•
•
•
•
•
Infections
Skin
Cancer
Neurotoxicity
Respiratory
Circulatory
Reproductive
Other adverse
developmenta
l impacts
Possible strategies for
avoiding, reducing and
compensating harm
...
HOST
GENETICS
HOST
STATE
EXPOSURES
EFFECTS
Genetic
Engineering ?
Improve
Nutrition ?
Reduce ?
Predict ?
Remove
‘sensitive’
Groups from
Exposure ?
Promote good
health ?
Eliminate ?
Identify earlier ?
HARM
Cure ?
Compensate ?
Vaccinate ?
Clean up ?
Stop/slow
Progression to
Harm ?
Learn from
‘mistakes’ ?
Warn ?
but which strategies would be most effective?
36
Illustrative Multi-causality:
Childhood asthma illustration
‘
HOST
+ HOST
GENETICS
STATE
+ EXPOSURES =
25%
+ 25%
+ 50%
e.g.
e.g.
30%
indoor
30%
indoor
Allergic
sensitivit
y
Nutritional
and
immune
status
e.g.
= 100%
e.g.
• Mites 10%
•Mites10%
• Pets 5%
• •Pets
Passive5%
smoking 5%
•Passive
smoking 5%
• NO X 5%
• Damp 5%
•NOx 5%
20% outdoor
•Damp 5%
e.g.
• 20%
Pollen 10%
outdoor
• Industrial
po
on 5%
•
•Pollen 10 %
c
•Industrial
pollution 5%
•Traffic
pollution 5%
37
HARM
Asthma
caused/
Aggravate
d
in some
children
…’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)
38