Late lessons from early warnings the precautionary ... A Clarification of Key Terms ... • ‘More rewarding to improve animal husbandry ... husbandry and antimicrobials or GM Lesson

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‘‘ Late lessons from early warnings Late lessons from early warnings

the precautionary principle the precautionary principle

18961896--2000’2000’

David Gee, Emerging Issues and Scientific Liaison EEA Austrian Government EU Presidency Conference, Vienna

April 18-19 2006

The Role of Precaution in GMO PolicyThe Role of Precaution in GMO Policy

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EEA’s main TasksEEA’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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“Precaution, whether or not described as a formal

‘principle’ has served mankind well in the past and the

history of public health instructs us to keep the spirit of

precaution alive and well”.

John Graham, Administrator, Office of Information and Regulatory Affairs, OMB,

Washington, in “Europe’s Precautionary Principle: promise and pitfalls”, J of Risk

Research, Vol 5, No 4, Oct 2002., P375.

Precaution is not a new idea

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Key Features of ‘Knowing’ and not knowing:

1. ‘Knowing is contingent’: Today’s certainties can be tomorrow’s

mistakes

2. ‘Uncertainties’ due to ‘gaps in knowledge’, are different from..

3. ‘Ignorance’ where we don’t know what we don’t know, which is one

source of…

4. ‘Surprises’; which can also come from ‘mistaken knowledge’,

neglected/marginalised knowledge and gaps in knowledge.

5. Boundaries between ‘knowledge’, ‘no knowledge’ and ‘gaps in

knowledge’ are fuzzy and dynamic. As ‘knowledge’ expands…

6. More research can increase and decrease uncertainties and ignorance.

‘The more we know, the more we don’t know’ is common….

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Towards A Clarification of Key TermsTowards A Clarification of Key Terms

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), pre

1974.

Precaution: action taken to anticipate,

identify and reduce the impact of

‘surprises’

Source: ‘Late Lessons’, page 192

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Measuring is Measuring is not not the same as Knowing:the same as Knowing:

egeg The Marine Environment and the The Marine Environment and the

Precautionary PrinciplePrecautionary Principle

“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 PP provides justification for public policy actions in

situations of scientific complexity, uncertainty and

ignorance - which we can assume to be more normal

than abnormal - where there may be a need to act in

order to avoid, or reduce, potentially serious or

irreversible threats to health or the environment, using

an appropriate level of scientific evidence, (which does

not need to be direct) and taking into account the likely

pros and cons of action or inaction. The systematic and

accountable consideration of alternatives is also an

essential component of rational precaution”

A definition of the PP based on “Late Lessons”

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‘‘Late Lessons’ is based on case studiesLate Lessons’ is based on case studies

Structured around 4 questions:

• When were the first 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 decision- making and reduce overall costs ?

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LateLate LessonsLessons: An : An AnalysisAnalysis ofof 14 ”False Negative” 14 ”False Negative”

Case StudiesCase Studies

”False Negatives” = Whoops! It really is dangerous after all!

(Citizens pay most of the costs of being wrong…..)

“False Positives” = Whoops! It really isn’t dangerous after all!

(Producers pay most of the costs of being wrong….)

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Early warnings about TEL in petrolEarly warnings about TEL in petrol

• 1922 W.Clark,US Public Health Service: ”TEL is a serious menace to public health..on busy thoroughfares it is highly probable that the lead oxide dust will remain in the lower stratum”

• 1922 H.S. Cummings,US Surgeon General: ”since lead poisoning is of the cumulative type resulting from the daily intake of minute quantities,it seems pertinent to inquire whether there might not be a decided health hazard”.

• 1924 5 TEL production workers die of lead poisoning• 1925 Yandell Henderson, chair Medical Research Board,US

Aviation Service: ”it seems likely that the development of lead poisoning will come on so insidiously that leaded gasoline will be in nearly universal use…before the public and the government awaken to the situation”

over half a century before TEL was regulated

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WhyWhy So So ManyMany ”False Negatives”?”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.

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ON BEING WRONG: ON BEING WRONG: EnvironmentalEnvironmental and and HealthHealth SciencesSciences

and and TheirTheir DirectionsDirections ofof ErrorError

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

•False negative (Developmental/reproductive endpoints)

(continues � )

•High fertility strains

•False negative•Few Foetal-lifetime exposures

•False negative•Few exposures to mixturesLaboratory)

•False negative•Low genetic variability(Animal

•False negative•Short (in biological terms) range of doses

Studies

•False positive

•False negative

•High doses

•Small nos. of animals.

Experimental

MAIN1 DIRECTIONS OF ERROR-INCREASES CHANCES OF DETECTING A:

SOME METHODOLOGICAL FEATURES

SCIENTIFIC STUDIES

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•False negative•Use of 5 % probability level to minimise chances of false positives

•False positive•Publication bias towards positivesBoth

•False negative•Scientific cultural pressure to avoid false positives

Experimental

And

•False negative•Low statistical power (e.g. From small studies)

Observation

Studies

•False negative•Simple models that do not reflect complexity

•so direct effects-inidcators only

•False negative•Lost cases

•False negative•Inadequate follow-upHumans)

•False negative•Non-differential exposure misclassification

(Wildlife &

•False positive/negative•Inappropriate controlsStudies

•False positive•ConfoundersObservation

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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 Antimicrobial Feed Additives (AFA) Chapter –– An An

“Early Warning” example: “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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“Benzene”

”...one of the lessons to be learned is that

consensus organisations in the process of

developing exposure limits for chemicals should

maintain distance from the producers of chemicals

and their ”consultants” when evaluating evidence

for the diseases of concern”.

Peter Infante, ”Late lessons from early warnings”

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MTBE

”The key question on principle is: does persistency

alone, without indication of other adverse effects, give

reason to apply the precautionary principle? It seems

reasonable to conclude that systematic, comprehensive

and thorough investigations into all known possible

adverse effects should be exercised before any release

of large volumes of a persistent chemical into the

environment”.

Poul Harremous, ”Late lessons from early warnings”

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PCBs

”By the 1930s there was already evidence, some at

a low level of proof, that PCBs could poison

people. This information was largely retained

within the industry, and does not appear to have

been widely circulated”.

”The application of the precautionary principle at

that time would have prevented the toxic legacy

that now exists”.

Janne Koppe, ”Late lessons from early warnings”

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””TBT TBT AntifoulantsAntifoulants: A Tale : A Tale ofof ShipsShips, , SnailsSnails

and and ImposexImposex” (” (ChapterChapter 13)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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Endocrine Disrupting Substances (Endocrine Disrupting Substances (EDSsEDSs):):

Some difficult featuresSome difficult features

• Timing of the dose

• Mixtures and Multi- causality

• Natural and synthetic EDSs

• ”Hormonal imprinting”

• Endocrine systems ”cross- talk”

• Generational impacts

• Impacts/Adverse impacts

• Adverse impacts due to imbalance between opposing effects in complex systems – ie, ‘new’ forms of causality

• ie, deriving RA approach from familiar entities (chemicals here) may be misleading

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Some problems with 2 of the main Bradford Hill “Criteria” Some problems with 2 of the main Bradford Hill “Criteria” for Distinguishing “Association” from “Causation”. (1965)for Distinguishing “Association” from “Causation”. (1965)

• "Consistency" (of research across studies)

• Not robust - can easily lead to false negatives because complexity, multi- causality, and genetic/host variability invites ‘inconsistency’.

• "Consistency in nature does not require that all, or even a majority of studies find the same effect. If all studies of lead showed the same relationship between variables, one would be startled, perhaps justifiably suspicious"(Needleman, 1995)

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TwelveTwelve LateLate LessonsLessons fromfrom

EarlyEarly WarningsWarnings

A ”Identify/Clarify (’Test’) Framing and Assumptions

1. Manage “risk”, “uncertainty” - and conditions of “ignorance”

2. Identify/reduce “blind spots” (pluralist critique)

3. Assess/account for all pros and cons

4. Analyse/evaluate alternative options

5. Take account of stakeholder inputs – accountably!

6. Avoid “paralysis by analysis” by acting to reduce potential hazards via the precautionary principle.

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(Twelve Late Lessons.... CONT(Twelve Late Lessons.... CONT.).)

B ”Broaden Assessment Information”

7. Identify/reduce interdisciplinary obstacles to learning – and reporting

8. Identify/reduce institutional obstacles to learning – and reporting

9. Take account of salient non- scientific knowledge

10.Identify/anticipate “real world” conditions

11.Ensure regulatory and informational independence – and accountability/transparency

12.Long term monitoring/research

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How Can We Respond toHow Can We Respond to

“Ignorance” (“Surprises”)?“Ignorance” (“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. Develop means to assess quality/maturity of basic scientific knowledge on which innovation in Q is founded

3. be as inclusive as possible about potential knowledge-inputs: even if this takes time

4. 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 following asbestosis; PCB neurotoxicological effects following wildlife impacts). (See 5 other responses to “ignorance” in “Late Lessons” supplementary report, EEA 2004)

5. 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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• Avoid Substance ‘monopolies’ that stifle innovation (seeAsbestos, CFCs, PCBs, AFA)

• Stimulate available alternatives (see antimicrobials, asbestos, radiation, CFCs)

(The principle of substitution, now part of OSPAR’sStrategy 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

• And don’t assume only technical fixes – e.g. animal husbandry and antimicrobials or GM

Lesson 4: Evaluate alternative means

of providing services