The precautionary principle:

protecting public health, the environment

and the future of our children

Edited by:
Marco Martuzzi and Joel A. Tickner
Keywords
RISK ASSESSMENT
RISK MANAGEMENT
UNIVERSAL PRECAUTIONS
CHILD WELFARE
ENVIRONMENTAL HEALTH
PUBLIC HEALTH
SUSTAINABILITY

ISBN 92 890 1098 3

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Contents
Contributors ............................................................................ i
Acknowledgements................................................................. iv
Foreword ................................................................................. v
Executive summary................................................................. 1
1. Introduction – the precautionary principle: protecting
public health, the environment and the futureof our
children ................................................................................... 7
Marco Martuzzi & Joel Tickner
2. Dealing with uncertainty – how can the precautionary
principle help protect the future of our children?.................... 15
WHO
3. The precautionary principle: a legal and policy history...... 31
Andrew Jordan & Timothy O’Riordan
4. Public health and the precautionary principle ..................... 49
Neil Pearce
5. Why is a precautionary approach needed?.......................... 63
Ted Schettler & Carolyn Raffensperger
6. The precautionary principle in decision-making:
the ethical values..................................................................... 85
Pietro Comba, Marco Martuzzi & Caterina Botti
7. Late lessons from early warnings: improving science and
governance under uncertainty and ignorance.......................... 93
David Gee & Andrew Stirling
8. Applying the precautionary principle in environmental
risk assessment to children...................................................... 121
Philip J. Landrigan & Leonardo Trasande
9. The precautionary principle in environmental science ....... 145
David Kriebel, Joel A. Tickner, Paul Epstein, John Lemons,
Richard Levins, Edward L. Loechler, Margaret Quinn,
Ruthann Rudel, Ted Schettler & Michael Stoto
10. The precautionary principle: a central and eastern
European perspective .............................................................. 167
Janos Zlinszky
11. Implementing precaution: assessment and application
tools for health and environmental decision-making .............. 181
Andrew Stirling & Joel A. Tickner
12. A compass for health: rethinking precaution and its role
in science and public health .................................................... 209
Joel A. Tickner, David Kriebel & Sara Wright
Contributors
Caterina Botti, Department of Philosophy and Social Sciences,
University of Siena, Siena, Italy

Pietro Comba, National Institute of Health, Rome, Italy

Paul Epstein, Center for Health and the Global Environment,

Harvard University Medical School, Boston, Massachusetts,
USA

David Gee, European Environment Agency, Copenhagen,

Denmark

Andrew Jordan, Centre for Social and Economic Research on

the Global Environment (CSERGE), University of East Anglia,
Norwich, England, United Kingdom

David Kriebel, Lowell Center for Sustainable Production,

Department of Work Environment, University of
Massachusetts Lowell, Lowell, Massachusetts, USA

Philip J. Landrigan, Department of Community and

Preventive Medicine, Department of Pediatrics, Mount Sinai
School of Medicine, New York, New York, USA

John Lemons, Department of Life Sciences, University of New

England, Biddeford, Maine, USA

Richard Levins, Department of Population and International

Health, Harvard University School of Public Health, Boston,
Massachusetts, USA

Edward L. Loechler, Department of Biology, Boston

University, Boston, Massachusetts, USA

Marco Martuzzi, WHO European Centre for Environment and

Health, Rome Operational Division, WHO Regional Office for
Europe, Rome, Italy

i
Timothy O’Riordan, Centre for Social and Economic Research
on the Global Environment (CSERGE), University of East
Anglia, Norwich, England, United Kingdom

Neil Pearce, Centre for Public Health Research, Massey

University Wellington Campus, Wellington, New Zealand

Margaret Quinn, Department of Work Environment,

University of Massachusetts Lowell, Lowell, Massachusetts,
USA

Carolyn Raffensperger, Science and Environmental Health

Network, Ames, Iowa, USA

Ruthann Rudel, Silent Spring Institute, Newton,

Massachusetts, USA

Ted Schettler, Science and Environmental Health Network,

Newburyport, Massachusetts, USA

Andrew Stirling, Science and Policy Research Unit, University

of Sussex, Sussex, England, United Kingdom

Michael Stoto, Department of Biostatistics, George

Washington University School of Medicine, Washington,
District of Columbia, USA

Joel Tickner, Lowell Center for Sustainable Production,

Department of Work Environment, University of
Massachusetts Lowell, Lowell, USA

Leonardo Trasande, Center for Children’s Health and the

Environment, Department of Community and Preventive
Medicine, Department of Pediatrics, Mount Sinai School of
Medicine, New York, New York, USA

ii
Sara Wright, Lowell Center for Sustainable Production,
University of Massachusetts Lowell, Lowell, Massachusetts,
USA

Janos Zlinsky, Regional Environmental Center for Central

and Eastern Europe, Budapest, Hungary

iii
Acknowledgements
This publication was conceived and assembled during the
preparation of the Fourth Ministerial Conference on
Environment and Health, Budapest, Hungary, 23–25 June
2004. Discussion and negotiation on the theme of the
precautionary principle was highly stimulating and provided
invaluable intellectual contribution for the development of the
monograph.

We thank David Breuer for editing the text, Rachel Massey for
initially revising the text, Maria Teresa Marchetti for
organizing the publication process and design and Francesco
Mitis for typesetting.

We are grateful to Island Press, the National Institute of

Environmental Health Sciences and Oxford University Press
for granting permission to reproduce Chapters 7, 9 and 12
respectively.

iv
Foreword
Human society has been developing rapidly. In Europe and
elsewhere, industrial, technological and economic development
has created wealth and opportunity. Health has largely
benefited: many people in Europe, although unfortunately not
all, live longer and better than ever before. These positive
trends must be sustained and extended to as many people as
possible.

Technological development has often outpaced scientific

knowledge related to the determinants of health. Increasing
complexity in societal organization multiplies the pathways by
which a variety of agents can affect health, including physical
risk factors such as toxic chemicals or radiation, social
circumstances such as exclusion and deprivation, limited
access to clean natural resources, and the endless
combinations of them all. Decisions taken in domains
apparently distant from health often have the potential to
affect people’s health positively or negatively because of the
great number of connections and exchanges in modern life.
Health is a function of highly complex systems, which can be
unintentionally disrupted in unpredictable ways and result in
adverse health consequences that may be serious and
irreversible.

When solid science is available, health can be protected

effectively through preventive action. However, people must
humbly acknowledge that science has limitations in dealing
with the complexity of the real world and do their utmost to
promote the development and progress of science. While
people strive for better science, how can health be protected?
In particular, how can people ensure that children and future
generations will have the opportunity that many people have
of reaping the benefits of progress and enjoying good health?
This question is difficult. Irreparable mistakes must be
avoided, such as those related to tobacco or asbestos, when
people waited for definitive evidence far too long before
springing to action. Further, irremediable chains of events
leading to health damage must be prevented from being
triggered.

v
Precaution has been at the heart of public health protection
for centuries, and the precautionary principle is indeed related
to acting under uncertainty, an increasingly common
circumstance in these days. The precautionary principle has
been gaining prominence and profile and has become a guiding
principle in modern thinking in environment and health – a
most welcome development for WHO and everyone engaged in
public health. If used intelligently, imaginatively and
daringly, the precautionary principle will support efforts to
strive towards a healthier and safer world. I am glad to
present a book that, we hope, will bring the debate forward.

Roberto Bertollini
Director, Division of Technical Support, Health Determinants
WHO Regional Office for Europe

vi
Executive summary
The purpose of this document is to provide a background
rationale and support to WHO’s working document “Dealing
with uncertainty: how can the precautionary principle help
protect the future of our children?”, prepared for the Fourth
Ministerial Conference on Environment and Health held in
Budapest, Hungary, in June 2004.

Technological developments have provided important benefits

to health and the environment. Energy provision, waste and
water treatment systems, modern housing, transport, modern
food production and distribution systems, immunization, pest
control and telecommunications have played important roles
in improving health and the quality of life while increasing life
expectancy and protecting the environment. Nevertheless,
societal change and rapid technological development over the
last century have also produced an increasing variety of
agents and circumstances whose consequences are partly
unknown, are difficult to predict, and capable of posing
irreversible risks to human health and that of the ecosystem.
While our understanding of environmental and health risks
has advanced greatly, so has the complexity of the factors that
can affect health. Thus, large uncertainties remain of the
effects on health of many activities. Of particular concern are
the health and environmental impacts of technologies that can
affect future generations. A key question is how human
societies can continue to obtain the great benefits of
development while promoting a clean and healthy
environment and ensuring an adequate standard of living in
the future.

As the nature of threats to health and the environment

becomes more complex, uncertain and global in nature, the
precautionary principle is increasingly being debated. The
principle states that in the case of serious or irreversible
threats to the health of humans or the ecosystem,
acknowledged scientific uncertainty should not be used as a
reason to postpone preventive measures.

1
Debate about the precautionary principle is partly a response
to the recognition of the severe social and economic costs of not
taking precautions. Millions of children worldwide have
suffered from neurological damage, diminished mental
capacity and thus the ability to make a living as a result of
exposure to lead from smelters, in paint and in petrol.
Tobacco, asbestos and numerous other agents provide ample
evidence of the high costs associated with waiting for
convincing proof of harm. These cases exemplify the failure of
science and policy to prevent damage to health and ecosystems
and the resulting impacts on health and the economy.

In line with the mandate given by the Third Ministerial

Conference on Environment and Health, WHO has developed
an approach that will promote preventive public health
measures in areas of emerging concern about environmental
impacts on children’s health. The approach focuses on how the
precautionary principle can be applied to the protection of
children’s health and that of future generations. In so doing,
the goal of WHO is to guide and improve decision-making in
environment and health under conditions of uncertainty and
complexity, while stimulating scientific development and more
sustainable forms of economic development. The approach is
sufficiently flexible to be applied by all countries in the WHO
European Region, regardless of their available resources.

Through articles written by leading public and environmental

health scientists, this document outlines a scientific, ethical
and public health approach to applying the precautionary
principle to protect children and future generations. The
report also presents scientific tools for characterizing
uncertain and complex risks, linking these with tools for
cleaner production and innovation in safer technologies and
activities. It builds on the analyses and discussions convened
by the World Health Organization and the European
Environment Agency, among others, concerning lessons
learned from not taking precaution and best practices for
decision-making under uncertainty, and on intensive
discussion with Member States in the preparation of the
Fourth Ministerial Conference on Environment and Health.

2
The findings of the report include the following.

x The concepts of precaution and prevention have

always been at the heart of public health practice.
Public health is inherently about identifying and
avoiding risks to the health of populations, as well as
about identifying and implementing protective
measures. In the past, public health interventions
focused on removing hazards that had already been
identified and “proven” (even if the etiological
mechanisms were not well understood). As “modern”
potential risk factors become more complex and far-
reaching, the precautionary principle addresses
uncertain risks and seeks to shift the ways in which
science informs policy from a strategy of “reaction” to a
strategy of “precaution”. Together with related
approaches such as health impact assessment,
precaution provides a useful means of guiding public
health decisions under conditions of uncertainty, in a
manner that appropriately addresses the issues of
power, ownership, equity and dignity.

x The precautionary principle encourages policy-makers

and public health professionals to consider, in their
approach to public health, how to account for growing
complexity and uncertainty. Substantial evidence
supports the conclusion that contemporary
environmental health risks result from complex
interactions among genetic, nutritional, environmental
and socioeconomic factors. The precautionary principle
can be used to encourage research, innovation and
cross-disciplinary problem-solving in the face of these
complex risks. It serves as a guide for considering the
effects of human activities and provides a framework
for protecting humans, other species and life-
sustaining ecological systems now and in the future.

x The precautionary principle is occasionally portrayed

as contradicting the tenets of sound science and as
being inconsistent with the norms of “evidence-based”
decision-making. These criticisms might be based on

3
 effective misuse of the precautionary principle, but it
is nevertheless important to clarify the role of
environmental science in policy-making.

x Many pressing environmental crises share a

fundamental characteristic: they appear to arise from
disruptions of natural systems or cycles, the behaviour
of which is only partially understood. Two conclusions
may be drawn. First, there is a great need for more
scientific research to fill the gaps in our knowledge.
Second, while waiting for a more complete
understanding we must find ways to make decisions
that are based on the best available evidence, while
acknowledging the uncertainties that remain. Thus,
there is no contradiction between pursuing scientific
progress and taking precautionary action. Indeed,
applying precaution demands more rigorous science in
order to characterize complex risks, clarify gaps in
knowledge and identify early warnings and
unintended consequences of actions. It also means
using science not only for the diagnosis of
environmental hazards but to identify, develop and
assess safer alternatives to potentially harmful
activities.

x Countries whose economies are in transition have

special environment and health problems. The
consequences of past pollution, economic hardship,
poor or even deteriorating public health and the
demands of rapid political, social and economic change
pose additional problems for decision-makers. In such
countries economic priorities may outweigh the need to
protecting health. The precautionary principle is thus
very important here, because it can inform decisions
under the great uncertainty that prevails, can help
build public confidence, can raise research and
innovation capacities, can ensure that mistakes made
in the past in industrialized countries are not
repeated, and can help shift burdens from the public
institutions to those creating the risks.

4
x There is no single recipe for applying precaution.
Applying precaution should encourage decision-
makers to use the broadest possible range of
information, including stakeholders’ views, and to
examine alternative courses of action. Flexibility in
applying precaution is critically important, since each
decision is different – with different types of risk,
evidence, uncertainty, affected communities,
availability of alternatives, and technical and financial
resources. Consistency thus comes from using the
same precautionary framework and process in each
case. What is considered an “acceptable risk” or
sufficient evidence to act is a function not only of the
level of risk and the strength of evidence and
uncertainty, but also of the magnitude, reversibility
and distribution of the risk, the availability of
opportunities to prevent risk, the public’s risk
aversion, society’s culture and values, and the pros
and cons of alternative options.

x These preventive precautionary actions ultimately aim

at continuously reducing and if possible removing
exposures to potentially harmful substances, activities
and other conditions. If progress is to be made in this
direction, one should:

- encourage the replacement of dangerous

substances and activities with less dangerous
substances or technologies where suitable
alternatives are available;

- reconsider production processes, products and

human activities so as to minimize significant
adverse effects on health and the environment,
for example through the use of integrated pest
management strategies, land use planning and
cleaner production;

5
 - establish public health goals for protecting the
health of humans and ecosystems (such as for
reducing blood lead levels or improving
fisheries);

- provide information and education to the

public to promote empowerment and
accountability;

- integrate precautionary considerations into the

research agenda to facilitate rapid
interventions to prevent damage to health; and

- minimize, so far as possible, unintended

adverse consequences that may be caused by
precautionary actions.

The debate around the precautionary principle has provided

many insights relevant to improving public health decision-
making under conditions of uncertainty. It is hoped that this
document will provide an additional basis for approaches to
attaining the concurrent goals of (a) protecting adults,
children and future generations and the ecosystems on which
we depend and (b) enhancing economic development,
sustainability and innovation in science, research and policy.

6
1. Introduction – the precautionary principle:
protecting public health, the environment and
the future of our children

Marco Martuzzi & Joel Tickner

Technological development has provided important benefits

for health and the environment. Energy supply, water and
waste-treatment systems, modern housing, transport, modern
food production and distribution systems, immunization, pest
control and telecommunication have played important roles in
improving health and the quality of life while increasing life
expectancy and protecting the environment. In parallel,
changing societies and rapid technological development over
the 20th century have produced an ever-increasing variety of
agents and circumstances whose consequences are partly
unknown, difficult to predict and capable of posing irreversible
risks to human and ecosystem health. Although
understanding of environmental and health risks has
advanced greatly, so has the complexity of the factors that can
affect health. Thus, great uncertainty remains about the
health effects of many activities. Of particular concern are the
health and environmental effects of technologies that can
affect future generations and their ability to achieve
sustainable development. A key question is how people can
continue to obtain the great societal benefits of development
while promoting a clean and healthy environment into the
future. Reconciling the need to innovate and develop with the
need to protect human health from environmental risks is
therefore essential.

The precautionary principle states that, in cases of serious or

irreversible threats to the health of humans or ecosystems,
acknowledged scientific uncertainty should not be used as a
reason to postpone preventive measures. The principle
originated as a tool to bridge uncertain scientific information
and a political responsibility to act to prevent damage to

7
Martuzzi & Tickner

human health and to ecosystems. The debate around the

precautionary principle is important and challenging, as it
involves fundamental dimensions of human life, such as the
right to health and to a clean environment and the aspiration
for better standards of living. When such elements are
potentially in conflict, such as when precautionary action
might disrupt the free flow of trade, policy development often
becomes controversial.

The quality and relevance of available scientific information is

central to the debate. Currently available methods for
evaluating the risks to human health and ecosystems, mostly
designed to deal with direct associations between exposure
and disease, are often not sufficient for effectively
characterizing complex environmental risks. Limitations in
scientific tools and in the ability to identify or to quantify
causal relationships are occasionally misinterpreted as
evidence of safety. Thus, when proposed or ongoing
technologies or activities entail potential long-term, unknown
adverse health effects, the need for more accurate scientific
information has often been used as a reason for inaction.
Further, government agencies frequently have to wait until
sufficient evidence of harm is established beyond a reasonable
doubt before they can act to prevent harm. This constraint can
result in public health and environmental policies based on
reaction, involving remedial action after a hazard has caused
adverse effects, rather than preventive, precautionary action.
The increasing complexity and uncertainty of risks and the
frequent lack of information on risks as well as the limits of
science and policy structures to adequately address them
require the development of tools to further support decision-
making when health and welfare might be affected.

Failure to take precautionary action can have severe social

and economic costs. Millions of children worldwide have
suffered from nervous system damage, diminished mental
capacity and thus ability to make a living, as a result of
exposure to lead from smelters, in paint and in gasoline.
Tobacco, asbestos and numerous other agents provide ample
evidence of the high costs associated with waiting for
convincing proof of harm. These cases exemplify the failures of

8
 1. Introduction

science and policy to prevent damage to health and ecosystems

and the resulting effects on health and the economy.

This report
In recent years, significant advances have been made in
interpreting and implementing the precautionary principle
and in developing effective scientific and policy structures to
address complex and uncertain risks. However, little attention
has been paid to how precaution can be applied to protecting
children’s health or across countries and regions with differing
technical and economic capacity.

This report provides a background rationale, additional

reference and support to the 2003 WHO working
documentDealing with uncertainty: how can the precautionary
principle help protect the future of our children? (Chapter 2 of
this publication). The WHO working document, as well as this
publication, were prepared for the Fourth Ministerial
Conference on Environment and Health in June 2004 in
Budapest, Hungary. In accordance with the mandate given by
the Third Ministerial Conference on Environment and Health
in 1999, the WHO Regional Office for Europe has investigated
tools and processes to promote protective public health
measures in areas of emerging concern about environmental
effects on children’s health. The approach focuses on how the
precautionary principle can be applied to protecting the health
of children and that of future generations. WHO’s goal in this
undertaking is to guide and improve decision-making in
environment and health in order to protect children and future
generations under conditions of uncertainty and complexity
while stimulating scientific progress and more sustainable
forms of development. The approach is sufficiently flexible to
be applied by all countries in the European Region, regardless
of the resources available.

Through chapters written by leading public health and

environmental health scientists, this report outlines a
scientific, ethical and public health rationale for applying the
precautionary principle to protect children and future
generations. The report also presents scientific tools and
processes for characterizing uncertain and complex risks,

9
Martuzzi & Tickner

linking these with tools for cleaner production and innovation

in safer technologies and activities.

The first part of the report (Chapters 3–6) explores the

foundations; the second part (Chapters 7–12) underlines the
relevance of the precautionary principle with regard to
priorities in environment and health and addresses its
implementation.

Andrew Jordan and Timothy O’Riordan present a historical

perspective on the precautionary principle. Jordan and
O’Riordan note that, although the principle originated in the
social planning principle in Germany, Vorsorgeprinzip, the
form in which it has been adopted in various countries and
international agreements, has necessarily varied based on the
political, economic and legal aspects of each jurisdiction. They
note that the history of the precautionary principle shows a
steady shift towards more internationalized environmental
decision-making and the penetration of environmental and
health principles into non-environmental policy sectors such
as trade, industry and energy production. They outline the
core historical components of the precautionary principle and
note that some of these have been lost in current risk-based
environmental policy debates.

Neil Pearce outlines a public health rationale for precaution.

He argues that the concepts of precaution and prevention have
always been at the heart of public health practice. Public
health inherently means identifying and avoiding risks to the
health of populations as well as identifying and implementing
protective interventions. Pearce notes that, together with
related approaches such as health impact assessment,
precaution provides a useful compass to guide public health
decisions under uncertainty, in a manner that appropriately
addresses issues of power, ownership and, ultimately,
protection of health.

Ted Schettler and Carolyn Raffensperger provide a rationale

of why the precautionary principle is needed in addressing
complex, uncertain environment and health risks, including
the mounting evidence of the effects of human activities on

10
 1. Introduction

ecosystems and health, the complexity of contemporary

environmental health risks and their uncertainty and the
limitations of current risk-based decision-making tools in
preventing complex risks. They note that the precautionary
principle encourages policy-makers and public health
professionals alike to consider how to account for growing
complexity and uncertainty in their approach to public health.

Pietro Comba, Marco Martuzzi and Caterina Botti address the

connections between the precautionary principle and the
underlying ethical values. They argue that, since
precautionary decision-making normally takes into account
questions of the distribution of exposure, vulnerable subgroups
and environmental justice in general, making explicit the
choice of value systems used is important. In particular, when
a utilitarian approach based on maximizing an average
welfare measure is not appropriate, Comba et al. propose an
alternative approach aimed at preventing the worst possible
consequences of any action. Such a principle, the “maximin”
principle, is thus highly consonant with the precautionary
principle.

David Gee and Andy Stirling analyse the lessons learned from
failure to take precautionary action based on early warnings
on a variety of ecosystem and health risks. Based on broad
discussions and research undertaken in the publication of the
European Environment Agency’s Late lessons from early
warnings, Gee and Stirling outline tools and strategies to
improve application of the precautionary principle and
preventive decision-making in the face of uncertain and
complex risks.

Philip J. Landrigan and Leonardo Trasande present a

rationale for the importance of applying the precautionary
principle to the protection of children and future generations.
They note that the rising incidence of preventable
environmentally related chronic diseases among children has
increased the urgency of applying the precautionary principle.
They outline the weaknesses of traditional risk assessment
approaches in capturing the often greater exposure and
susceptibility of children to environmental risks. They

11
Martuzzi & Tickner

conclude that the epidemic of lead poisoning among children

may pale in comparison to the environmental epidemics of the
future if governments do not prudently apply the
precautionary principle to protect the world’s richest resource
– our children.

David Kriebel and colleagues argue that application of the

precautionary principle can lead to sound application of
scientific knowledge and innovations in scientific method.
They note that, although the precautionary principle is
occasionally portrayed as contradicting the tenets of sound
science and being inconsistent with the norms of evidence-
based decision-making, these critiques are often based on a
misunderstanding of science and the precautionary principle.
Kriebel et al. note several ways in which current practice can
work against precautionary decision-making by narrowly
defining hypotheses or failing to address problems from an
interdisciplinary perspective. They outline ways in which
scientific research can be more supportive of acting in the face
of uncertain and complex risks. They conclude that a shift to
more precautionary policies creates opportunities and
challenges for scientists to think differently about the ways
they conduct studies and communicate results.

Janos Zlinsky outlines a central and eastern European

perspective on the precautionary principle. He notes the
unique vulnerability of countries in transition with stresses on
sensitive ecosystems, the effects of past pollution, public
health problems and demands for rapid political, social and
economic change, excessively stretched environment and
health authorities and economic hardship such as foreign debt.
All these factors increase uncertainty in decision-making.
Zlinsky concludes that the precautionary principle is
especially important in countries in transition because it can
allow decisions under the great uncertainty that exists, can
help build public confidence, can raise research and innovation
capacities and can shift burdens from the state to those
creating risks.

Andrew Stirling and Joel Tickner outline assessment schemes

for implementing precaution in practice. They discuss

12
 1. Introduction

decision-making tools and criteria for improving health-

protective decision-making in the face of uncertainty and
complexity. They also present tools to implement
precautionary decisions to protect children and future
generations and to achieve sustainable development. Further,
they explore the notion of alternatives assessment, materials
policy, health impact assessment and public health goal
setting. They argue that a centerpiece of any approach to
precaution and sustainable development has to be seeking
safer alternatives to potentially harmful activities and agents.

Finally, Joel Tickner, David Kriebel and Sara Wright address

how three common criticisms of the precautionary principle
arise from misunderstandings of the relationship between
precautionary policy and science. These misunderstandings
include the notion that precaution stifles innovation, causes
unintended consequences potentially more serious than the
problem that triggered the precautionary action in the first
place and creates false-positives – apparent risks that waste
resources and distract from real problems. In responding to
these critiques, Tickner et al. note that society has not yet
realized the full potential of science-based policy to prevent
damage to ecosystems and health while ensuring progress
towards a healthier and economically sustainable future. They
conclude that interest in precaution provides an opportunity to
move towards a more constructive view of environment and
health policy, reinvigorating the core values and preventive
traditions of public health.

Conclusion: the way forward

The ultimate goals of public health and precaution are to
prevent disease, degradation and threats to human health and
ecosystems in addition to restoring conditions that foster
health. Although human activities cannot be risk-free,
precaution can stimulate more health-protective decision-
making under uncertainty and complexity. Debates over risks
are intrinsically complex, and precaution is not necessarily a
recipe for easy solutions. Further, environment and health
decisions are inevitably political in nature, value-laden and
affect economic interests, and tensions will always exist
between economic interests and other values. Precaution can

13
Martuzzi & Tickner

help to more systematically and broadly clarify risks,

uncertainty and alternatives. Although the concept of
precaution brings this to the forefront, decisions should always
be informed by the best available science, common sense and
community values.

Much work has been done to clarify the role of precaution in

environment and health decision-making and the theoretical
bases of the precautionary principle. This report attempts to
expand on discussions surrounding precaution to date, to
situate these discussions in the context of children’s health
and sustainable development and to provide assessment and
policy tools for applying precaution in practice. There is no
single checklist or strict guidelines on whether and how the
precautionary principle should be applied across decisions or
for a given circumstance. More important is focusing on a
common goal of adaptable tools for protecting and improving
health while stimulating innovation in safer and cleaner
production systems and human endeavours. The heuristic
considerations provided in the WHO paper provide some
general indications on the application of the precautionary
principle that are broadly useful for different types of
environmental risks.

The debate around the precautionary principle has provided

many insights relevant to improving public health decision-
making under uncertainty. We hope that this publication will
provide additional foundations for approaches that achieve the
concurrent goals of protecting children and future generations,
as well as adults and the ecosystems on which humans
depend, while enhancing economic development, sustainability
and innovation in science, research and policy.

14
2. Dealing with uncertainty – how can the
precautionary principle help protect the future
of our children?
Working document (EUR/04/5046267/11, 28 April 2004)
prepared by WHO Secretariat for the Fourth Ministerial Conference on
Environment and Health, Budapest, June 2004

“We will develop initiatives in our countries to give

greater emphasis in all relevant programmes to the need
to prevent the exposure of children to environmental
threats … We request the European Environment and
Health Committee to identify methods and mechanisms
to: promote and encourage public health measures in
areas of emerging concern about environmental impacts
on children’s health, on the basis of the precautionary
principle.”

London Declaration on Action in Partnership (paragraph

50d), adopted at the Third Ministerial Conference on
Environment and Health (London, 16-18 June 1999)

Introduction
1. The precautionary principle has arisen as part of the
discussions on the most effective ways to protect health and the
environment in the face of highly uncertain risks. Since at least
the early 1980s, European policy-making on issues of
considerable concern and acknowledged scientific uncertainty
has progressively adopted precautionary approaches, in order to
achieve high levels of public health, environmental protection
and consumer safety without compromising science or
technological innovation. The European Commission’s
communication on the precautionary principle of February 2000
(Commission of the European Communities) was a first and
critical step in describing the purpose and use of the

15
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precautionary principle in European policy-making over the

previous 20 years.
2. During the past three years there have been significant
developments in the interpretation and application of the
precautionary principle, particularly by the European Court of
Justice (ECJ), the World Trade Organization (WTO), WHO and
some of its Member States. For example, the ECJ cases on
antibiotics in animal feed, the European Environment Agency’s
report Late lessons from early warnings (European
Environment Agency, 2001), and the scientific and constitutional
discussions on the precautionary principle in France have all
considerably enriched debates on its use and application. In
addition, some of these developing insights have been codified in
international agreements signed since 2000, notably the
Cartagena Protocol on Biosafety (Secretariat of the Convention
on Biological Diversity, 2000 ) and the Stockholm Convention on
Persistent Organic Pollutants (United Nations Environment
Programme, 2001). Some of these efforts have raised questions
as to how application of the precautionary principle can more
effectively stimulate decisions aimed at protecting health and
ecosystems under conditions of uncertainty, while stimulating
innovation in science, technology and policy.
3. It therefore seems relevant and timely to extend the
foundations laid by the European Commission’s communication
and to address the broader needs of the 52 Member States in the
European Region of WHO, including countries in transition that
will be represented at the Fourth Ministerial Conference on
Environment and Health in Budapest in 2004.
4. In line with the mandate given by the WHO Third
Ministerial Conference on Environment and Health, protecting
children and future generations from environmental impacts
should be a priority. The precautionary principle can be an
important tool in protecting children from uncertain
environmental risks, as it can be in developing policies to protect
adults. Pursuant to that mandate, this document is the first to
develop an approach that will promote and encourage protective
public health measures in areas of emerging concern about
environmental impacts on children’s health, based on the
precautionary principle. It focuses on how the precautionary
principle can be applied to the protection of children’s health and

16
 2. Dealing with uncertainty

that of future generations. In doing so, the goal of this document

is to orient and improve environment and health decisions
designed to protect children and future generations under
conditions of uncertainty and complexity, while stimulating
more sustainable forms of development. It presents a decision-
making approach to the precautionary principle that is
sufficiently flexible to be applied by all countries in WHO’s
European Region, regardless of their available resources. It
provides technical and policy background to the Declaration due
to be adopted at the Fourth Ministerial Conference on
Environment and Health.
5. In addition, as the policy agenda evolves from
“environment” to “sustainable development”, with the associated
aim of protecting both vulnerable ecosystems and vulnerable
people from inappropriate economic activities, there is a need for
the precautionary principle to evolve in the face of these new
challenges. It is hoped that this document represents another
step in the evolution of the precautionary principle and its use in
Europe by outlining a process, research needs and policy steps
for decision-making aimed more at protecting health under
conditions of uncertainty, while promoting sustainable economic
development.

The context of precautionary action to protect

children
6. The precautionary principle is a tool for policy- and
decision-making designed to ensure that people or entities bear
political responsibility for taking action to prevent damage to
health and ecosystems in the face of uncertain scientific
information about health and ecosystem risks. A common
definition of the principle is to be found in the Rio Declaration on
Environment and Development of 1992: “Where there are
threats of serious or irreversible damage, lack of full scientific
certainty shall not be used as a reason for postponing cost-
effective measures to prevent environmental degradation”.
Based on the European Environment Agency’s work and other
developments in thinking about the precautionary principle, a
broader, more proactive definition of precaution helps clarify its
application to children’s health and sustainable development:
the precautionary principle provides a framework, procedures

17
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and policy tools for public policy actions in situations of scientific

complexity, uncertainty and ignorance, where there may be a
need to act before there is strong proof of harm in order to avoid,
or reduce, potentially serious or irreversible threats to health or
the environment, using an appropriate level of scientific
evidence, and taking into account the likely benefits and
drawbacks of action and inaction.
7. There are many well established environmental risks,
such as unsafe drinking-water, indoor and outdoor air pollution
and inadequate sanitation, which are at present arguably among
the most serious risks to public health. It is important that
public health interventions are strengthened to prevent them.
However, there are other, often highly uncertain and complex
risks associated with industrialization, which affect society at
large and children in particular, such as exposure to dangerous
chemicals, radiation, hazardous waste and industrial pollutants
through food, water, air and direct exposure from everyday
products. These threats can result in effects that take place long
after exposure, making the establishment of causal links all the
more difficult. Exposures to these agents can result in effects
that are irreversible or take many generations to remediate and
are costly to health and the environment. Limitations in the
ability to characterize causal relationships are occasionally
misinterpreted as evidence of safety. Thus, the need for more
accurate scientific information has sometimes been used as a
reason for inaction. The combination of rigid policy structures
requiring strong evidence of risk, social attitudes and
interference by vested interests often result in policy-makers
having to wait unreasonable lengths of time before they can
commit themselves to preventive action. The past cases of lead,
tobacco, asbestos and many other agents provide ample evidence
of the high costs associated with waiting for convincing proof of
harm. It is equally important that inadequate application of the
precautionary principle should not prevent or preclude action
producing important benefits for society.

18
 2. Dealing with uncertainty

8. Protecting children and future generations (as well as

other vulnerable subpopulations) from environmental health
risks is a compelling reason for developing precautionary
approaches that are rational, consistent with available scientific
information, and mindful of society’s needs and values.
Application of the precautionary principle is particularly
appropriate for the protection of children’s health because:
x the science underlying the impacts of environmental
stressors on children (from the stage of the fetus to the
age of 18) is more complex, less researched and less
understood than that of such impacts on adults;

x the likelihood of serious harm to children from such

impacts can be greater than for adults because of their
different and changing stages of biological
development, their behaviour and their greater
exposure in relation to body weight;

x children are involuntarily exposed to a greater

proportion of the risks caused by society’s activities
than adults, yet they have less power to avoid them;

x children benefit proportionally less than adults from

society’s risk-generating activities, such as
employment, car driving, many consumer products,
etc;

x the risks and the benefits of avoided risks have more

time to impact on children and society than on adults;

x many of today’s serious environmental threats, such as

water shortages, climate change, developmental and
reproductive effects of toxic substances, endocrine
disruption and biodiversity loss, may impinge
proportionately more on children and their children
than on this generation of adults.

9. The concept of precaution is premised on the principle of

protecting society from the adverse consequences of erroneous
decisions. Such unintended consequences often affect the most
vulnerable groups in the population, and particularly those who

19
WHO

do not have the power to change their environments. Hence the

special relevance of the precautionary principle for children and
future generations. By applying precautionary approaches to
children and future generations, we are also contributing to
decisions which ensure that all the population is more effectively
protected. An approach designed to stimulate more
precautionary decisions, with the aim of protecting the health of
children and future generations and achieving sustainable
development, is particularly important given the growing
interdependence of global economies and long-term global
threats, such as climate change, caused by industrial and
human activities.

A historical perspective
10. The concept of precaution has a long history in medicine
and public health, but as a principle it was established by the
German Vorsorgeprinzip (literally, the “foresight principle”) to
deal with serious, emerging though not proven risks to
ecosystems and health. It is based on the concept that society
should seek to avoid environmental damage by carefully
planning ahead to stimulate innovation, job creation and
sustainable development. The 1992 Maastricht Treaty on
European Union established precaution, along with prevention
of pollution at source, as central elements of European
environmental health policy. The precautionary principle is now
widely accepted as an underlying principle of international
environmental policy. According to most interpretations of the
principle, precautionary decisions are those that prevent damage
to health or ecosystems in the face of uncertainty, stimulate the
development of more health-protective technologies and
activities, and place greater responsibility on proponents of
potentially damaging activities. The precautionary principle is
particularly relevant to countries with economies in transition
because of their greater political, economic, and social
uncertainties, lower public confidence, lower research and
innovation capacities, and existing high burdens on health and
the environment. With adequate international support, such
countries have a unique opportunity to develop in a more
environmentally sensitive and sustainable manner, avoiding the
problems of the past.

20
 2. Dealing with uncertainty

11. The Treaty on European Union, as amended in 1996,

does not define the “precautionary” and “preventive” policies
that must be adopted. The distinction is important: prevention
consists of actions taken to reduce known risks, while precaution
aims to anticipate and reduce more uncertain risks. This area of
policy-making is constantly evolving in response to new
scientific, technological and political challenges. The European
Commission has published guidelines on the consistent and
proportional application of the precautionary principle, in order
to avoid unwarranted trade restrictions and to help trading
partners better understand European policy-making. In its
communication, the Commission states that application of the
precautionary principle is of critical importance for its policy of
achieving a high level of protection for human health and the
ecosystems, particularly under conditions of uncertainty. The
communication establishes several criteria to be applied in the
risk management phase for deciding on when and how to apply
precaution, such as non-discrimination and consistency of
actions. The communication emphasizes that it is a first step in
an ongoing debate on precaution.
12. The Commission’s approach to application of the
precautionary principle has the advantage of offering a clear set
of guidelines that ensure consistency with international trade
rules, establish a relatively clear threshold for applying
precaution (reasonable scientific grounds for concern), and
identify the aspects that need to be considered before
precautionary actions are undertaken. Importantly, it provides a
policy tool to legitimize timely action when there is reasonable
scientific evidence to cause concern. As it is necessary to ensure
that decisions aimed at protecting health under conditions of
uncertainty are taken, the Commission communication is
focused on responding to potential threats as they arise. To
further address an aspect central to the London Declaration
mandate, i.e. the question of how to create the conditions for
sustainability for current and future generations, it is important
to describe the steps for improving preventive decision-making
under conditions of uncertainty and complexity. Recent
elaborations of the precautionary principle, as well as
innovations in risk assessment and risk management, have
indicated the need to ensure transparency throughout the
decision-making process, to include affected communities in

21
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defining risk assessment questions, and to integrate assessment

of risks with assessment of alternative policy options.
13. Based on these developments in applying the
precautionary principle, developments in risk management, and
the needs of the broader WHO European Region, this document
builds on the European Commission communication by
elaborating, for the first time, a process for applying precaution
to effective protection of the health of children and future
generations and achieving sustainable development. Applying
precaution to achieve more health-protective decisions in this
context requires a set of precautionary considerations
throughout the whole cycle from problem framing, knowledge
production, identification and characterization of risk, risk
management, post-implementation follow-up, identification of
knowledge gaps and research needs and back again. Such
instruments as analysis of alternative courses of action,
expanded scientific tools, incentives for research and innovation
and enhanced public participation can in fact ensure a more
proactive and positive approach to health protection, while
improving decision-making. These steps are outlined in the
following sections.

A proposed framework for applying precaution in the

context of the health of children and future
generations and sustainable development
14. As discussed in the previous section, and given the
increasingly complex nature of risks and the growing
interconnections between people and ecosystems in a globalizing
world, it has become necessary to develop an approach for
applying precaution in decision-making on environmental and
health risks to children. Such an approach should be consistent
with public health values and WHO’s mission to promote health.
The goal of this approach is to describe steps for improving
preventive public health decision-making under conditions of
complexity and uncertainty in a transparent and democratic
manner. It provides guidance for decision-makers and society at
large, so that they can proactively apply precaution to protect
the health of children and future generations and make rational
decisions under conditions of uncertainty. The following
guidelines are designed to be flexible, to outline a series of points

22
 2. Dealing with uncertainty

that should be considered in all good decisions taken under

conditions of uncertainty, and to be widely applicable by
countries with differing levels of resources.
15. Given the complex nature of environmental risks to
children, this approach is necessary to identify and prevent such
risks (particularly those that may occur in the future) more
effectively, characterize uncertainties, and stimulate research
and development of preventive alternatives. Thus, an effective
approach to applying the precautionary principle in these areas
can be based on simple steps, scientific research and policy
actions, such as:
x improving and expanding the range of scientific tools
and perspectives in decision-making; developing
methodologies capable of analysing complex systems,
including cumulative and interactive effects, and their
relationships with health;

x advancing our understanding of the relationship

between ecosystems and human health and the long-
term implications of ecosystem degradation;

x increasing the transparency of decision-making by

more explicitly characterizing the nature and extent of
uncertainties; making scientific and ethical
assumptions explicit; and expanding the range of
stakeholders and values involved;

x strengthening the ability of public health professionals

to identify early warnings of risks and understand the
effectiveness of interventions through the integrated
establishment of surveillance programmes;

x ensuring adequate support for establishing research

and education programmes to identify gaps in
knowledge and develop and implement safer and
cleaner production processes, products, consumption
patterns and preventive interventions.

16. When uncertain and complex risks are being addressed,

attention should not be diverted from existing public health

23
WHO

actions related to well established risks. Indeed, opportunities

for more efficient tools to address both well established and
uncertain risks should be explored. The approach proposed here
is designed to contribute to more efficient preventive action, as it
may be instrumental in anticipating the emergence of possible
threats, through their early identification. It can draw the
attention of scientists and decision-makers to the need to
identify and develop options to anticipate and prevent risks
before they occur. Analysis of alternatives is essential and can
help prevent the often contentious debates over what constitutes
an acceptable level of risk, as well as conflicts between
environment and health protection and economic interests. This
approach thus serves as a “compass”, pointing towards more
health-protective decisions under conditions of uncertainty.
Under this approach, what constitutes a threat to health should
be broadly interpreted, using WHO’s definition of health, to
include aspects such as the indirect effects of interventions or
technologies.

Application of precaution in the context of the health

of children and future generations and sustainable
development
17. Applying this approach should encourage decision-
making using the broadest possible range of information,
stakeholders and scientific and policy tools in identifying and
preventing risks and examining alternative courses of action.
The approach focuses on a series of procedural steps to ensure
sound health and environmental decision-making, examining all
the evidence on threats as a whole and learning from
accumulated experience and understanding. Flexibility in
applying precaution to the area of the health of children and
future generations is critically important, since each decision is
different – with different types of risks, evidence, uncertainty,
affected communities, availability of alternatives, and technical
and financial resources. In this case, consistency comes from
using the same precautionary framework and process in each
case. Although outcomes will differ with the facts of each case,
the approach will be the same. Policy-makers should encourage
entities creating risks to be responsible for providing full
information on those risks and alternatives. The goal is for

24
 2. Dealing with uncertainty

governments and entities handling risks to internalize this

heuristic approach in their decision-making processes,
instituting a precautionary “mindset” with regard to uncertain
environmental and health risks.
18. The steps in such an approach for applying precaution to
the health of children and future generations include:
(i) determining whether an uncertain risk/problem
merits a more thorough review – whether there
is sufficient evidence to indicate a potential
problem, or whether the cost of review is
disproportionate to the cost of considered
actions, including inaction. Sometimes a
screening process may be useful;
(ii) broadly defining problems to capture root
sources of risks, where appropriate;
(iii) considering and examining all available relevant
evidence on exposure, hazard and risk in an
interdisciplinary manner and taking account of
variability as well as relevant direct, indirect,
cumulative and interactive effects; this can
include conducting routine health and
environmental monitoring to provide a baseline
understanding of health and ecological impacts,
as well as health trends;
(iv) considering the application of simplifying rules
of thumb, safety factors, default values, or proxy
indicators of exposure and effects when
information is lacking;
(v) comprehensively examining uncertainty and
gaps in information, performing sensitivity
analyses and identifying research and other
ways to reduce uncertainties and gaps in
knowledge where appropriate;
(vi) examining a wide range of options to reduce
risks, as well as their trade-offs, advantages and
disadvantages;
(vii) determining an appropriate course of action
based on the scientific evidence, the examination
of alternatives, and public input. A wide variety
of policy tools to implement preventive or

25
WHO

protective actions should be considered, along

with their economic, technical and political
feasibility;
(viii) instituting post-implementation follow-up
measures, to ensure continuous risk reduction
and understand the positive and negative
impacts of interventions and possible
unintended consequences. This should include
an evaluation of measures taken and not taken,
so as to minimize unexpected adverse impacts
and to maximize learning.

19. Under this approach, there is no single recipe for taking

precaution. What is considered an “acceptable risk” or sufficient
evidence to act is a function not only of the level of risk and the
strength of evidence and uncertainty, but also of the magnitude,
reversibility and distribution of the risk, the availability of
opportunities to prevent risk, the public’s risk aversion, and
society’s culture and values. In the case of countries in
transition, this process can provide a tool for prioritization,
continuous improvement in human and ecosystem health, and
identification of cost-effective means for multi-risk reduction.
20. Decisions made using the proposed approach should be
based on the best available evidence, in addition to informed
judgment and common sense. Rigorous, high quality science,
which is explicit about its limitations and gaps, is critical in the
application of precaution to the protection of the health of
children and future generations. Scientific methods and tools
must be chosen to fit the nature and complexity of the problem.
Thus applying precaution does not exclude but rather advocates
for the need to improve the scientific basis for decisions,
including tools for assessing risks, improving surveillance of
health and interventions and evaluating alternative technologies
and activities.

Types of precautionary actions

21. Application of the precautionary principle to protection
of the health of children and future generations does not
necessarily mean stopping an activity. While always taken in
the face of acknowledged uncertainties, precautionary actions

26
 2. Dealing with uncertainty

can range from informing the public about risks and

uncertainties while further study is undertaken to characterize
them, to imposing restrictions on potentially harmful activities
and phasing out activities where evidence indicates that they
might be particularly problematic. One important aspect of
precautionary action entails placing responsibility and
incentives in ways that stimulate proponents of potentially
hazardous activities to understand the risks associated with
those activities and to take protective actions. The actions taken
in applying precaution can differ from country to country,
depending on capacities and the groups at risk, and other
economic, social and political factors. The types of precautionary
action should be multiple in nature and case-specific, depending
on:
x the nature of the risk, its level of uncertainty,
magnitude and reversibility;

x who is exposed (for example, disproportionately affected

or highly vulnerable communities);

x issues of technological and economic feasibility,

benefits, proportionality and non-discrimination;

x preventability of the risk;

x social values.

22. Precautionary actions ultimately aim at continuously

reducing and if possible removing exposures to potentially
harmful substances, activities and other conditions. If progress
is to be made in this direction the following goals should be
pursued: 1) encourage the substitution of dangerous substances
and activities by less dangerous substances or technologies
where suitable alternatives are available; 2) improve production
processes, products and human activities so as to minimize
significant adverse effects to health and the environment, for
example through the use of integrated pest management
strategies, land use planning, and life-cycle analysis; 3) establish
public health goals for protecting and restoring human and
ecosystem health; 4) provide information and education to
citizens to promote empowerment and accountability;

27
WHO

5) integrate precautionary considerations in the research agenda

to make possible rapid interventions to prevent damage to
health; and 6) minimize, so far as possible, unintended adverse
consequences that may be caused by precautionary actions.

Conclusions
23. In conclusion, applying precaution in the context of
protecting the health of children and future generations and
achieving sustainable development should be a continuous,
iterative process of seeking out sustainable ways of reducing the
adverse impacts of economic activity on public health. The
precautionary principle needs to remain an important risk
management tool, as defined by the European Commission, to
encourage protective actions when risks cannot be thoroughly
quantified on a scientific basis. The proposed approach builds on
the European Commission’s communication by incorporating
recent developments in application of the precautionary
principle, considering the needs of the entire WHO European
Region and focusing on establishing a set of considerations
designed to stimulate effective decision-making to protect the
health of children and future generations in the face of
uncertainty. Such an approach is also important for protecting
adults and ecosystems from the adverse effects of human
activities. It is an evolving approach, for which communication
between Member States in sharing research results, lessons
learned from applying the framework, and scientific and
technological best practices will ensure its improvement over
time. It requires institutional development to improve
transparency, apply new scientific tools and assess alternatives.
24. Implementing precautionary actions that are cost-
effective (i.e. least costly to achieve a particular goal) and that
have synergistic impacts (addressing several risks at once) can
often result in a “win-win” situation for the policy-maker and the
public at large. This requires incentives and support for
research, development and innovation in safer and cleaner
technologies and human activities that can help avoid risks in
the first place and restore health and ecosystems. A proactive
approach to precaution, directed towards creating the conditions
for sustainability and health rather than simply responding to
problems after they have occurred, is invaluable as we strive for

28
 2. Dealing with uncertainty

a world that protects children and future generations, as well as

adults and the ecosystems on which we depend, without
compromising science, economic development or innovation.

References
Commission of the European Communities, Communication from
the Commission on the precautionary principle. Brussels, 2000
(COM(2000) 1).

Late lessons from early warnings: the precautionary principle

1896–2000. Luxembourg, EEA, Office for Official Publications of
the European Communities, 2001 (Environmental issue report
No. 22).

Secretariat of the Convention on Biological Diversity, Cartagena

Protocol on Biosafety to the Convention on Biological Diversity.
Montreal, 2000.

UNEP, Stockholm Convention on Persistent Organic Pollutants.

Nairobi, 2001.

29
3. The precautionary principle: a legal and
policy history

Andrew Jordan & Timothy O’Riordan

Introduction
This chapter outlines the legal and policy history of the
precautionary principle and discusses its current status in
national and international (environmental) policy. We briefly
summarize the origins of the principle as it emerged in
Germany and then examine its metamorphosis into a legal
norm of European Union (EU) and international
environmental policy-making. We then analyse in more detail
the development of precautionary thinking in the EU
throughout the 1990s, focusing on the sharpening trade
conflicts with the United States. We pay particular attention
to a communication issued by the European Commission in
2000 to inform the EU’s discussions with its trading partners.
At the time of writing, this communication represents the
most succinct distillation of the EU’s thoughts on the practical
meaning of precaution.

Core elements of precautionary thinking

At the core of the precautionary principle lies the intuitively
simple idea that decision-makers should act in advance of
scientific certainty to protect the environment (and with it the
well-being interests of future generations) from incurring
harm. It demands that humans take care of themselves, their
descendants and the life-preserving processes that nurture
their existence. As was indicated in the 1990 Bergen
Conference on Sustainable Development, “it is better to be
roughly right in due time, bearing in mind the consequences of
being very wrong, than to be precisely right too late”
(Norwegian Research Council for Science and the Humanities
(NAVF), 1990).

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Several commonly occurring themes can be abstracted from

the complex, and at times confusing, debate on the meaning
and applicability of the precautionary principle. These are: a
willingness to take action in advance of formal justification of
proof; proportionality of response so that actions taken are
cost-effective; a preparedness to provide ecological space and
margins for error, given the great uncertainties surrounding
many environmental risks; a recognition of the well-being
interests of non-human entities; a shift in the onus of proof to
those who propose potentially harmful activities; and a greater
concern for intergenerational effects on future generations.

In particular, the precautionary principle and sustainable

development are closely connected, as evidenced by the
inclusion of the precautionary principle in the Bergen
Ministerial Declaration on Sustainable Development. The
application of precaution extends the scope of environmental
policy from certain and known problems that occur in the
present to future and more uncertain issues. Precaution urges
politicians to act with due care and diligence – to anticipate
and act against problems before they occur. Precautionary
actions could be considered as an investment (or insurance)
against unforeseen mishaps or the acceptance of higher costs
now to guard against dysgenic effects. But it also implies
committing current resources to investment for the future, the
benefits of which may be uncertain or at worse nonexistent.
Since conclusive scientific evidence of harm or excessive
damage in the future may not always be available to justify
the commitment of resources to precautionary investments,
other grounds for legitimacy may need to be present: moral,
political, ethical and legal. Democracy itself is poorly suited to
this time scale, with its heavy political biases in favour of
immediate gratification and gain today rather than tomorrow.
Here is an arena where the precautionary principle challenges
institutional performance and the sense of citizenship, which
primarily concentrates on the well-being of society today
rather than the state of the world in the future.

In the context of sustainable development, although the

principle of precaution does not state how various

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 3. The precautionary principle: a legal and policy history

environmental and economic factors should be traded off, it

strongly suggests that a strenuous search be conducted for
alternative modes of development that minimize discharges
and waste products, regardless of whether they are known to
have harmful effects, on the basis that prevention is often,
though not always, more cost-effective than cure. In general,
though, the closer controls are placed to the source of the
emission and the earlier environmental considerations are
factored into decision-making, the more precautionary the
overall trajectory of development will be.

Unfortunately, much of the debate about the precautionary

principle has become extremely technical in recent years.
Some of the early temporal (and hence intragenerational)
questions raised by the principle have since been crowded out
by the more technical debate about how to adapt risk
assessment in a way that is sympathetic to the precautionary
principle.

The precautionary principle: a brief history

Precaution emerged in the 1970s in the Federal Republic of
Germany. Other countries, such as the United States and
United Kingdom, had already incorporated elements of
precautionary thinking in their environmental policies at this
time, but it was the Federal Republic of Germany that
developed it into a broader environmental philosophy. At the
core of this early conception was the belief that regulatory
agencies and governments should move to minimize
environmental risks by anticipating possible danger and, if
possible, preventing it. In the 1980s, the Government of the
Federal Republic of Germany used the Vorsorgeprinzip
(foresight or precautionary principle) to justify the
implementation of vigorous policies to tackle acid rain, global
warming and pollution of the North Sea. In relation to these
problems, Vorsorge implied using the best available
technology to minimize pollution at the source.

Even at that time, there was no agreed statement about the

role or meaning of precaution. Albert Weale (1992) quotes one

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Jordan & O’Riordan

respected German commentator who had managed to identify

at least 11 separate meanings. In general, Vorsorge comes into
play when the risks of environmental damage “are not (yet)
identifiable, or even in the absence of risk” (Von Moltke, 1988:
61). In principle, Vorsorge implies that authorities should
move to minimize all risks, but in practice it tends to be
married to the concept of “proportionality”, which encompasses
issues such as the economic cost, technical and administrative
feasibility of a proposed measure (Von Moltke, 1988). For
Hajer (1995) and Weale (1992, 1993), Vorsorge was part of a
wider set of ideas or an ideology they label “ecological
modernization”. This formulation suggests that the
relationship between environmental protection and economic
development is not necessarily antagonistic, but can, with the
right mix of inducements, be mutually supportive. One might
argue that the precautionary principle was warmly received in
the Federal Republic of Germany precisely because it seemed
to legitimize “greener” forms of economic (and especially
technologically driven) growth.

Diffusion of the precautionary principle within the EU

Once strong environmental policies were in place, the Federal
Republic of Germany set about pressing the rest of the EU to
adopt similarly high standards, in part to prevent its own
industries from being placed at a competitive disadvantage.
The rationale for disseminating the precautionary principle
was therefore tied strongly to preserving economic
competitiveness as well as promoting forward-looking
environmental practices. This process of dissemination
occurred via both the formal structures of the EU (Jordan,
2001) and the overarching system of international
environmental law (see below). In 1990, all 12 EU Heads of
State or Government gave their formal, political blessing to
the principle, which was subsequently enshrined in the
Maastricht Treaty, the negotiation of which culminated in
1991.

In the United Kingdom, one of the least environmentally

progressive EU states in the mid-1980s, environmental values

34
 3. The precautionary principle: a legal and policy history

were not as prominent and “sound science” was regarded as

the best basis for policy. As in the Federal Republic of
Germany, the United Kingdom government also shaped the
meaning of the precaution to suit its short-term political
priorities, which at the time were resisting calls to reduce
acidic gases and the discharges of sewage and other heavy
metals into the North Sea (Jordan, 2002). The United
Kingdom therefore adopted a fairly “weak” interpretation of
precaution (Jordan & O’Riordan, 1995).

As the United Kingdom’s political priorities changed in the

1990s, becoming greener and more supportive of sustainable
development, the interpretation of precaution also began to
shift while retaining a core commitment to economic efficiency.
In 1999, the new Labour government suggested that
(Department of Environment, Transport and the Regions,
1999, para. 4.2):

The precautionary principle means that it is not

acceptable just to say “we can’t be sure that serious
damage will happen, so we’ll do nothing to prevent it”.
Precaution is not just relevant to environmental damage
– for example, chemicals which may affect wildlife may
also affect human health. At the same time,
precautionary action must be based on objective
assessments of the costs and benefits of action. The
principle does not mean that we only permit activities if
we are sure that serious harm will not arise, or there is
proof that the benefits outweigh all possible risks….
There are no hard and fast rules on when to taken
action: each case has to be considered carefully….
Transparency is essential…. Decisions should be
reviewed to reflect better of risk as more evidence
becomes available.

In contrast, the Netherlands did not adopt an item of national

legislation referring to precaution until as recently as 1998,
but the definition used is much stronger (Douma, 2001). To
summarize, precaution emerged in one sociocultural context
but has been reinterpreted as it has been integrated into
neighbouring jurisdictions, each with its own set of political,

35
Jordan & O’Riordan

economic and legal priorities. The precautionary principle,

therefore, has to be seen in the context in which it is used.

The diffusion of the precautionary principle in international

policy-making
In the 1980s and 1990s, interest in the precautionary principle
spread well beyond Europe at remarkable speed. Today, it
appears regularly in national legislation, in international
statements of policy and in the texts of international
conventions. It is also being continuously developed at
subnational levels of governance. Crucially, it appears in the
1992 Rio Declaration – a statement of principles and general
obligations to guide the international community towards
sustainable forms of development.

Although widely adopted, the precautionary principle has

neither a commonly agreed definition nor a set of criteria to
guide its implementation. One well-known legal commentator
(Fisher, 2002: 13) suggests that there are “countless different
legal and policy definitions … and endless examples of where
it has been explicitly put into operation”. Its advocates foresee
precaution developing into “the fundamental principle of
environmental protection policy at [all] scales” (Cameron &
Abouchar, 1991). Sceptics, in contrast, claim that: its
popularity derives from its vagueness; there is no single
principle but “droves of differing versions” (Stone, 2001); it
fails to bind anyone to anything; and it does not resolve any of
the deep dilemmas that characterize modern environmental
policy-making.

Some legal scholars believe that precaution is too blunt an

instrument to be a regulatory standard or principle of law.
Bodansky (1991) is highly suspicious because it “does not
specify how much caution should be taken” in a given situation
(see also: Bodansky, 1994). It does not, for example, define
what is an acceptable margin of error or what threshold of risk
warrants the application of precautionary action. Nor does the
precautionary principle determine when precautionary
measures should be taken or define the point at which

36
 3. The precautionary principle: a legal and policy history

abatement costs become socially or environmentally excessive.

In response, its advocates suggest that precaution is a
principle like proportionality or equality whose exact meaning
emerges through legal interpretation in different legal
cultures (Fisher, 2002).

Precaution: a continuum of definitions

As precaution has moved into new legal and political contexts,
it has taken on slightly different meanings, each giving a
slightly different emphasis to a particular aspect. Both
advocates and critics generally agree on one thing: that
precaution works along a continuum ranging from quite
“weak” formulations that are relatively protective of the status
quo to very “strong” formulations.

The weaker formulations tend to be restricted to the

substances or activities that are most toxic and threatening to
human life. They advocate a role for biased cost–benefit
analysis, incorporate some concern for technical feasibility and
economic efficiency arguments and emphasize the importance
of basing judgements on the dictates of “sound science”. The
United Kingdom advocates this type of formulation (HM
Government, 1990).

Where there are significant risks of damage to the

environment, [we] will be prepared to take
precautionary action to limit the use of potentially
dangerous materials or the spread of potentially
dangerous pollutants, even where scientific knowledge is
not conclusive, if the balance of likely costs and benefits
justifies it. The precautionary principle applies
particularly where there are good grounds for judging
either that action taken promptly at comparatively low
cost may avoid more costly damage later, or that
irreversible effects may follow if action is delayed.
[emphasis added]

In the same document, the United Kingdom government made

clear that environmental decision-makers must (HM
Government, 1990):

37
Jordan & O’Riordan

... look at all the facts and likely consequences of actions

on the basis of the best scientific evidence available.
Precipitate action on the basis of inadequate evidence is
the wrong response. [emphasis added]

If, as Cameron & Abouchar (1991) have pointed out,

precautionary measures must be justified by a scientifically
rigorous comparison of the resulting costs and benefits, then
these measures can only ever really be “preventive”; they are
not truly “precautionary”.

The Ministerial Declaration of the Third International

Conference on the Protection of the North Sea signed by
various North Sea states in 1990 offers one well-known
example of a strong formulation of precaution. It states that
governments should:

apply the precautionary principle, that is, to take action

to avoid potentially damaging impacts of [toxic]
substances ... even where there is no scientific evidence
to prove a causal link between emissions and effects.
[emphasis added]

On this conception, policy-makers undertake to go beyond

existing scientific knowledge to address known, but still
uncertain, threats to the environment. Not surprisingly, this
interpretation is both promoted by and finds support within
environmental pressure groups such as Greenpeace (Horsman,
1992).

The precautionary principle in EU law and policy

Precaution was introduced into the founding Treaties of the
European Union by the 1993 (Maastricht) Treaty on European
Union as a principle on which “Community policy on the
environment shall be based”. In practice, the heads of the
(then 12) Member States had actually given their political
blessing to the principle in June 1990 (the Dublin Declaration
of the European Council) (Haigh, 1994), but with its inclusion
in the Maastricht Treaty, it formally entered the acquis
communautaire: the “rights and obligations deriving from EU

38
 3. The precautionary principle: a legal and policy history

treaties, laws and regulations” (Dinan, 2000). These are, in

effect, the legal rules governing the membership of the EU.
Renumbered Article 174 by the 1999 Amsterdam Treaty, the
full reference is as follows:

[EU] policy on the environment shall aim at a high level

of protection taking into account the diversity of
situations in the various regions of the [EU]. It shall be
based on the precautionary principle and on the
principles that preventive action should be taken, that
environmental damage should, as a priority, be rectified
and that the polluter shall pay...

Interestingly, the Treaty mentions the precautionary principle

but does not offer an explicit definition. Lawyers, however,
consider it to be generally applicable to all risk regulation
activities in the EU (Fisher, 2002). Many directives, European
Court of Justice judgements and policy documents refer to
precaution, but rarely is the principle precisely defined. Haigh
(1994) observed that precaution applies when the EU
formulates future policies (that is, it does not apply
retrospectively) and does not apply to the parts of individual
Member States’ domestic policies that do not fall within the
legal competence of EU policy (that is, those that lie outside
the acquis comunautaire).

Legal flesh is gradually being added to the term by way of case

law stemming from rulings by the European Court of Justice.
For example in its judgement on the validity of the
Commission’s ban on the export of beef from the United
Kingdom, the Court (Cases C-157/96 and C-180/96, 5 May
1998) ruled that “[w]here there is uncertainty as to the
existence or extent of risks to human health, the institutions
may take protective measures without having to wait until the
reality and seriousness of those risks become fully apparent”.
Interestingly, although the case in question was primarily a
matter of human health, the Court based its ruling on the
environmental aspects of the Treaty (which at the time was
Article 130r(2)). In other words, it explicitly supported the

39
Jordan & O’Riordan

extension of precautionary-based measures to matters of

human health protection.

Of the 500 or so EU environmental statutes currently in

existence, many specifically adopt a precautionary approach.
One of the earliest examples of the EU behaving in a
precautionary manner was the 1979 directive on the testing of
new chemicals before they are marketed. This directive (which
is the sixth amendment of a much earlier directive) requires
authorities to assess the potential impact of new chemicals
before allowing them onto the market. Pressure for the
directive stemmed partly from the United States, which was
the primary pace-setter in environmental standard-setting at
the time (for details, see Haigh, 2000, section 7.3). The same
could be said of the policies adopted by the EU to combat ozone
depletion, which were also stimulated by regulatory pressures
from the United States (Jordan, 1998). In 1985, the EU
adopted another piece of precautionary legislation, the
Directive on Environmental Impact Assessment, this time
modelled on the 1969 National Environmental Protection Act
in the United States.

These three examples of early precautionary measures in the

EU testify to the leadership of the United States in
environmental policy-making in the 1960s, 1970s and 1980s.
However, the appearance of the precautionary principle in the
1990s marked a new and more self-confident stage in the
evolution of the EU’s environmental policy. Indeed, by the
early 1990s, roles had reversed and it was the United States
government that resisted precautionary-based controls in
areas such as climate change, whereas the EU surged ahead,
eager to put its ecological modernist philosophy to the test.

The 2000 European Commission guidance paper

In the 1990s, the EU cited the precautionary principle to
justify trade restrictions on the import of United States beef
treated with hormones and of genetically modified food
material. European regulators believed there was a risk of
adverse health effects but that the science involved was not

40
 3. The precautionary principle: a legal and policy history

sufficiently robust and used the precautionary principle to

justify the application of restrictions. The United States, in
contrast, claimed that the principle was ill-defined,
discriminatory and a barrier to free trade.

In an effort to find some agreement with the United States

and reflecting the growing influence of international trade
rules on environmental policy, the Member States requested
the Commission to produce a comprehensive policy guidance
statement on the meaning of precaution. Crucially, the
statement was to be produced by the whole Commission rather
than simply its environmental or consumer health
directorates, which had been the principal bodies concerned
with the legal development and policy implementation of
precaution up to that point. The need for the various parts of
the Commission to buy into the document raised the political
stakes significantly. Parts of the Commission that had never
paid much attention to precaution were suddenly forced to
adopt a position.

After much delay, in February 2000 the Commission published

a keenly awaited communication on precaution (European
Commission, 2000). As the “first major Community ventilation
of the principle” (Fisher, 2002), lawyers and policy analysts
eagerly read the communication. It has four main aims
(Fisher, 2002):

x to outline the Commission’s approach to using the

precautionary principle;

x to establish Commission guidelines for applying it;

x to build a common understanding of how to assess,

appraise, manage and communicate risks that science
is not yet able to evaluate fully; and

x to avoid unwarranted recourse to the precautionary

principle, which in certain cases could serve as a
justification for disguised protectionism.

41
Jordan & O’Riordan

The Commission is careful to point out that the

communication represents its own intentions with regard to
the implementation of the principle; it is “general guidance”
and “an input to the ongoing debate both at Community and
international level” (Fisher, 2002). Significantly, individual
Member States as well as other EU institutions (such as the
European Court of Justice and the Parliament) are not bound
by the Communication and, consistent with the definitional
differences noted above, are free to adopt their own
independent interpretations. The Court, however, has the final
word on the precise legal meaning of precaution in the EU.

The most important elements of the Communication are as

follows (Fisher, 2002).

x Precaution applies when “scientific information is

insufficient, inconclusive or uncertain or where there
are indications that the possible effects … may be
potentially dangerous and inconsistent with the chosen
level of protection”.

x Precaution is not simply an environmental principle

but applies equally to the protection of human health
and plant health.

x Precaution is a “fully fledged and general principle of

international law”, but development of international
guidelines on its meaning could avoid “unwarranted
recourse” to the precautionary principle.

x The precautionary principle belongs within rather

than outside the framework of risk analysis, and in
particular risk management.

x The precautionary principle is relevant “only in the

event of a potential risk … [but it] … can under no
circumstances be used to justify the adoption of
arbitrary decisions”.

42
 3. The precautionary principle: a legal and policy history

x Before it is invoked, there must be some scientific

investigation to identify gaps in the knowledge base.

x But the “absence of scientific proof of the existence of a

cause–effect relationship … should not be used to
justify inaction. Even if scientific advice is supported
by a minority fraction of the scientific community, due
account should be taken of their views, provided the
credibility and reputation of this fraction are
recognized”.

x Decision-making procedures should be as transparent

as possible.

x Reliance on the precautionary principle “is no excuse

for derogating from the general principles of risk
management”, namely proportionality of response,
non-discrimination, consistency of application,
examination of costs and benefits and the emergence of
new scientific developments.

x Precautionary-based measures should not seek to

achieve zero risk, “something which rarely exists”.

x The precautionary measures should be maintained “as

long as scientific data are inadequate, imprecise or
inconclusive and as long as the risk is considered too
high to be imposed on society”.

x The decision to apply the precautionary principle is

essentially political in nature: there is a “crucial …
distinction between the decision to act or not to act,
which is of an eminently political nature, and the
measures [used] … which must comply with the
general principles applicable to all risk management
measures”.

Environmental groups along with some academics and

government representatives felt that interdepartmental
battles within the Commission had whittled away the true

43
Jordan & O’Riordan

meaning of precaution. They were especially disappointed by

the emphasis placed on using precaution in risk analysis. This
point is firmly underlined in the concluding part of the
communication, which states that “every decision must be
preceded by an examination of all the available scientific data
and, if possible, a risk evaluation that is as objective and
comprehensive as possible” (Fisher, 2002). Greenpeace
challenged this assertion as well as the commitment to apply
precautionary measures only as a short-term response,
claiming that it “undermine[d] the very meaning and purpose”
of the precautionary principle (ENDS, 2000).

Environmental groups claimed that the Commission had been

swayed by the intensive lobbying efforts of industrial
representatives during the latter stages of the drafting
process. During that process, the EU Committee of the
American Chamber of Commerce had argued that the
precautionary principle was “not … a scientific principle, nor
is there a generally accepted definition of the term”. A risk
assessment stage should be the “cornerstone on which
fundamental scientific decisions are based” (ENDS, 1999). The
critical flaw in this line of argument is that precaution only
comes into play when, as the Commission correctly points out,
the scientific base is inconclusive or incomplete, that is, when
information is insufficient to undertake a formal risk
assessment.

The Commission’s shift towards a “risk-based” approach is an

indication of its desire to move closer to the United States’
interpretation of world trade rules. Thus, where science is
genuinely in contention, the communication states the
following.

x Full transparency should be in place when decisions

about whether to wait or not to wait for new scientific
findings are made.

x The absence of quantifiable probabilities should not be

a cause for inaction.

44
 3. The precautionary principle: a legal and policy history

x If only a minority of scientists demur over a proposed

cause of action, their views should be given due
account, in a transparent manner.

x All interested parties should be allowed to deliberate

on the available options once the assessment is
complete.

The Communication’s link between cost–benefit analysis and

the application of the precautionary principle continues to
upset some observers, although the Commission has indicated
that all relevant non-economic effects should be given due
weight, especially public health effects (including the
protection of health as a first priority). An important driver of
the Commission’s behaviour is the perceived need to give all
decisions a credible underpinning in case they are challenged
through the international trade dispute mechanism. Were this
to happen, the Commission would have to justify its reasoning
to the World Trade Organization using widely accepted
decision support tools such as risk and cost–benefit analysis.

Conclusion
This short history of the precautionary principle exemplifies
two important features of modern environmental policy-
making: a steady shift to more internationalized standard-
setting and the penetration of environmental principles into
previously “non”-environmental policy sectors such as trade,
industry and energy conversion. In the first phase of its rapid
dissemination, the concept of precautionary policy originated
in the Federal Republic of Germany during the 1970s. During
the second phase (the 1980s), it was gradually incorporated
into many national environmental policies in Europe before
being formally adopted as a guiding principle of EU
environmental policy in the 1993 Maastricht Treaty. During
the third phase, it gradually spread across the world, finding
expression in many international environmental agreements
such as the 1992 Rio Declaration. In the fourth stage, which
began in the late 1990s, precaution began to emerge as the
focus of dispute between the EU, the United States and other

45
Jordan & O’Riordan

large trading blocs. The conflicts over genetically modified

organisms, hormones in beef and other issues concern not only
environmental protection but also trade, health and consumer
safety, as well as raw politics.

The precautionary principle did not cause these disputes. Nor

have these disputes substantively altered the meaning of
precaution. But it has forced advocates such as the
Commission to issue clearer statements about how they wish
to apply precaution. These efforts may, in turn, trigger
international bodies such as the World Trade Organization to
develop similar guidance. Finally, the disputes have not really
made the task of applying precaution any easier. If anything
they have made it harder, by emphasizing to policy-makers
that they have less and less scope to act unilaterally against
important but uncertain risks.

Precaution is proving to be a potent source of conflict today

because it encapsulates the very different moral, ethical and
political standpoints from which the Europeans and the North
Americans currently view environmental risks. In a less
globalized world, these differences of attitude and approach
would not have impinged upon one another as much as they
are doing today. But for the moment they have succeeded in
pushing the precautionary principle centre stage in
international law, policy and politics.

References
Bodansky D (1991). Scientific uncertainty and the precautionary
principle. Environment, 33:4–5, 43–45.

Bodansky D (1994). The precautionary principle: the US

experience. In: O’Riordan T, Cameron J, eds. Interpreting the
precautionary principle. London, Earthscan.

Cameron J, Abouchar J (1991). The precautionary principle.

Boston College International and Comparative Law Review, 14:1–
27.

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Department of Environment, Transport and the Regions (1999). A

better quality of life. London, Department of Environment,
Transport and the Regions.

Dinan D (2000). Encyclopaedia of the European Union.

Basingstoke, Macmillan.

Douma W (2001). The precautionary principle in the Netherlands.

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precautionary principle. London, Cameron and May.

ENDS (1999). Environment on the agenda at international trade

talks. ENDS Daily, 295 (August).

ENDS (2000). Commission sets out guidelines on precautionary

principle. ENDS Daily, 301 (February).

European Commission (2000). Communication from the

Commission on the precautionary principle. Brussels, European
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Fisher E (2002). Precaution, precaution everywhere: developing a

“common understanding” of the precautionary principle in the
EC. Maastricht Journal of European and Comparative Law, 9:7–
28.

Haigh N (1994). The precautionary principle in British

environmental policy. In: O’Riordan T, Cameron J, ed.
Interpreting the precautionary principle. London, Earthscan.

Haigh N (2000). Manual of EC environmental policy and Britain.

London, Cartermill.

Hajer M (1995). The politics of environmental discourse. Oxford,

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environmental strategy. London, H.M. Stationery Office (Cmnd
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Horsman P (1992). Reduce it, don’t produce it: the real way
forward. In: O’Riordan T, Bowers V, ed. IPC: a practical guide for
managers. London, IBC Technical Services.

Jordan AJ (1998). The ozone endgame: the implementation of the

Montreal Protocol in the UK. Environmental Politics, 7(4):23–52.

Jordan AJ (2001). The Precautionary Principle in the European

Union. In: O’Riordan T, Cameron J, Jordan A, eds. Reinterpreting
the precautionary principle. London, Cameron and May.

Jordan AJ (2002). The Europeanization of British environmental

policy. Basingstoke, Palgrave.

Jordan AJ, O’Riordan T (1994). The precautionary principle in

UK environmental law and policy. In: Gray T, ed. UK
environmental policy in the 1990s. London. Macmillan:57–84.

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(NAVF) (1990). Sustainable development, science and policy: the
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Stone C (2001). Is there a precautionary principle? Environmental

Law Reporter, 7:107–190.

Von Moltke K (1988). The Vorsorgeprinzip in West German

environmental policy. In: Royal Commission on Environmental
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Weale A (1992). The new politics of pollution. London,

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European integration and environmental policy. London,
Belhaven Press.

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4. Public health and the precautionary
principle

Neil Pearce

Introduction
The primary goals of public health are preventing disease and
promoting health in populations. The concepts of precaution
and prevention have therefore always been at the heart of
public health practice. Although health is often regarded as a
result of individual lifestyle or individual susceptibility
(genetic or otherwise), every population has its own history,
culture and economic and social divisions that influence how
and why people are exposed to specific risk factors and how
they respond to such exposure. These societal influences are
becoming increasingly globalized, and adopting a global
approach to the practice of public health is therefore becoming
increasingly necessary. However, developing global solutions
requires changing scientific thinking (McMichael, 1993;
Pearce, 1996, 1999). Although continuing to identify, quantify
and reduce the health risks from specific, often local, exposure
is important, the health risks from macro-level socioeconomic
and environmental systems and processes must begin to be
anticipated. The precautionary principle, which states that
action should be taken to prevent harm even if some cause-
and-effect relationships have not been fully established
scientifically, will play a key role in this regard.

History, development and the health of populations

Three major revolutions can be identified, each of which has
had major consequences for human health. The agricultural
revolution involved major environmental changes from the
development of organized agriculture and the establishment of
settlements, whereas the industrial revolution involved major
environmental and social changes from the development of
machine tools and industrial production. The current
information technology revolution and the process of

49
Pearce

globalization will also have major health effects. However,

unlike previous revolutions, current changes have the
potential to endanger the sustainability of the biosphere’s
natural systems (Pearce & McMichael, 2001). I briefly discuss
these three revolutions before discussing the changing role of
public health and the relevance of the precautionary principle
to this changing role.

The agricultural revolution

Prior to about 10 000 years ago, all people on earth were
hunter–gatherers (Diamond, 1998). Since then, most parts of
the world have seen an agricultural revolution that has
profoundly affected human society and human health.
Although the fact that an agricultural existence is preferable
to that experienced by hunter–gatherers may now appear
obvious, this was probably not self-evident at the time.
Although population density rose faster than food production
and calorie intakes declined, the increased population both
needed and could produce more food, enabling neighbouring
hunter–gatherer populations to be displaced. Thus, the early
stages of the agricultural revolution in some instances saw a
paradoxical decrease in life expectancy accompanied by an
increase in population size, because the increase in birth rate
outweighed the accompanying increase in the death rate.
Rising population density was accompanied by the rise of the
major infectious diseases, which remained the major killers
until the 20th century (Diamond, 1998). The first evidence for
the occurrence of these epidemic diseases is often surprisingly
recent: 1600 BC for smallpox, 400 BC for mumps, 200 BC for
leprosy, 1840 for epidemic polio and 1959 for AIDS (Diamond,
1998). Hunter–gatherer populations did suffer from infectious
diseases, but the major epidemic infectious diseases (including
plague, measles, mumps, rubella, pertussis and smallpox)
require large populations and high population density and
cannot survive in hunter–gatherer populations. For example,
measles is likely to die out in any population fewer than half a
million people (Diamond, 1998). More importantly, these
diseases apparently did not exist in humans before
agrarianism but thrive in densely packed cities linked by
world trade routes. For example, bubonic plague appeared in

50
 4. Public health and the precautionary principle

Europe in the 6th century, but the plague epidemics hit

Europe in the 14th century following the establishment of the
relatively rapid overland trade route with China (Diamond,
1998). In fact, it was not until the beginning of the 20th
century that Europe’s major cities became self-sustaining.
Before then, constant migration from the countryside was
necessary to make up for deaths from epidemic diseases.

The industrial revolution

If the agricultural revolution can be considered to have
originated with the development of hand tools such as the
scythe and the plough, the industrial revolution can be
characterized by the development of machine tools, such as the
steam engine, the spinning jenny and Cort’s process in
metallurgy (Castells, 1996). The industrial revolution
conferred economic advantages on those who adopted the new
technology and the accompanying system of social relations,
which meant that the new technological and socioeconomic
paradigm eventually triumphed. However, these economic
advantages were often accompanied initially by social and
economic disadvantages for large sections of the population.
The industrial revolution in Europe initially involved
widespread social and economic disruption, unemployment,
homelessness, pollution and increased exposure to health
hazards both at work and at home. In the late 18th century,
the poorest 20% of people in England and France were
estimated to suffer such severe malnutrition that they were
unable to do labouring work (Fogel, 1994). As a result of such
conditions, the death rate in the United Kingdom and other
countries in the first half of the nineteenth century actually
increased, before it eventually began to decline in those born
after 1850 (McMichael, 2001). McKeown (1979) has argued
that the decline occurred largely prior to the introduction of
effective modern vaccines and treatments and was due mainly
to improvements in nutrition. However, specific public health
interventions on factors such as urban congestion probably
also played a major role (Szreter, 1988; Hardy, 1993). For
example, in France major gains in life expectancy emerged
first in Lyon (in the 1850s), then Paris (1860s to 1870s) and
then Marseille (in about 1890), in each instance following

51
Pearce

improvements in water supply and sanitation (McMichael,

2001).

During the later stages of the industrial revolution, sanitation

improved and “natural” infectious disease declined, but
“artificial” environmental hazards such as air pollution,
occupational hazards and food contamination also increased.
The spread of industry, and especially the automobile in the
20th century, has greatly increased the environmental burden
of exposure to human-made chemicals. However, it is
primarily in the latter third of the 20th century (Carson, 1962)
that concern has arisen concerning pervasive global
contamination from human-made chemicals that not only
affect human health directly but also the health of the overall
ecosystem.

The information technology revolution

The information technology revolution began in California in
the 1970s and is now transforming the world economic and
social order. The information technology revolution is
symbolized by the personal computer and the Internet, but
these are just symbols, albeit it influential ones, of the process
of global socioeconomic restructuring that occurred during the
1980s and 1990s (Castells, 1996). This is characterized by
economic globalization, especially the globalization of the
financial markets (Castells, 1996), reflected in the enormous
growth in trade and foreign capital flows (McMichael &
Beaglehole, 2000). From 1973 to 1995, global foreign exchange
turnover increased almost 100-fold and foreign direct
investment increased six-fold (United Nations Development
Programme, 1999). However, the gains in average gross
domestic product can mask major differences within and
between countries and a rapidly widening gap between rich
and poor (United Nations Development Programme, 1999).
Thus, the average incomes in 80 countries are lower today
than a decade ago, and the ratio of income between the richest
20% of people in the world and the poorest 20% increased from
30:1 in 1960 to 74:1 in 1997 (Lang, 1999).

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 4. Public health and the precautionary principle

These global economic and social changes have been

accompanied by global environmental changes (Acheson,
1992). These are not necessarily directly due to economic
globalization but reflect increasing population size (in part due
to economic growth) and especially increasing consumerism
(Smith, 1993; McMichael & Powles, 1999). These changes are
largely the legacy of the industrial revolution, but economic
globalization is making them more pervasive and severe, so
that humanity has the potential to damage the health of the
global ecosystem rather than just local ecosystems and
populations (Last, 1998). Human activities are changing the
gaseous composition of the lower and middle atmosphere,
reducing productive soils on all continents, depleting ocean
fisheries, overexploiting many of the great aquifers upon
which irrigated agriculture depends and resulting in an
unprecedented rate of loss of whole species and many local
populations. The demand for energy is growing and cannot be
met without new technologies, and the problem of waste
disposal is increasing (McMichael & Powles, 1999). Human
activities are even beginning to alter the Earth’s climate.
These unsustainable changes to Earth’s basic life-supporting
processes pose long-term risks to human population health –
although people remain largely uncertain, even ignorant, of
the long-term consequences (McMichael, 1993). The life-
support systems of human health are thus being perturbed or
depleted, and some of these environmental stressors are likely
to cause tensions between human communities, leading to
conflict and hence to damage to the population’s health. Thus,
the prospects of international conflict arising from
environmental decline, dwindling resources and ecological
disruption cast a long shadow over the prospects for human
health.

The role of public health

Human health and life expectancy are improving on average
(Sen & Bonita, 2000). However, this statement must be
qualified in two ways.

Firstly, a focus on averages may mask major negative effects

in specific populations. The agricultural and industrial

53
Pearce

revolutions both involved uneven development and an initial

fall in life expectancy before increases in population size and
productivity and, eventually, life expectancy. Globalization is
also producing major social and economic disruption, and the
health benefits and hazards are increasingly unevenly
distributed (Woodward et al., 2000). Thus, although average
life expectancy continues to increase globally, eastern Europe
suffered a sudden and dramatic fall in life expectancy in the
1990s (Men et al., 2003), and Africa struggles with the
problems of HIV/AIDS and the health effects of economic
stagnation and structural adjustment (Pearce et al., 1994).

Secondly, an increase in human health and life expectancy,

and the resulting increase in population size and
consumerism, can ultimately affect the health of the overall
ecosystem and paradoxically affect the survival of the human
race itself (McMichael, 1993). For the past two centuries,
environmental health concerns in the industrialized world
have focused very largely on toxic or microbial risks to health
from specific factors within the local environment, and there
has been considerable success in tacking these problems, at
least in industrialized countries. However, in the 21st century,
the scale of environmental health hazards is increasing in
range. The escalating impact of human economic activity has
begun to alter global biophysical systems (such as the climate
system) that underpin the sustainability of the health of
humans – and all other species (McMichael, 2000). There
appears to be a risk of incurring serious global ecological
deficit as, increasingly, people attempt to live beyond the
planet’s overall carrying capacity. It has been argued that
“society is locked in a struggle against time to … introduce
sustainable practices that will ensure the welfare of future
generations” (United Nations Environment Programme, 1999).

These are clearly global problems that require global solutions

(Pekkanen & Pearce, 2001). In fact, even for more traditional
public health issues such as tobacco smoking and occupational
exposure, a coordinated global public health approach had
long been needed. The limited success of legislative measures
in industrialized countries has led the tobacco industry to shift

54
 4. Public health and the precautionary principle

its promotional activities to developing countries so that more

people are exposed to tobacco smoke than ever before
(Tominaga, 1986; Barry, 1991). Similar shifts have occurred
for some occupational carcinogens; the worldwide production
of asbestos has not decreased but has merely changed location
(Pearce et al., 1994). Global public health strategies are even
more essential in tackling public health problems that
threaten the global ecosystem and environmental
sustainability. Thus, “epidemiology is in transition from a
science that identifies risk factors for disease to one that
analyses the systems that generate patterns of disease”
(Koopman, 1996). The analysis of such complex systems is
becoming increasingly important in many areas of research,
and the fact that some phenomena can be best understood at
the macro level is increasingly recognized (Pearce &
McMichael, 2001). These issues are of even more relevance to
the study of current changes in complex ecosystems that have
the potential to threaten the sustainability of human life itself.

The seminal document for the new public health movement is

the Ottawa Charter for Health Promotion (World Health
Organization, 1986), which builds on the work of the
Declaration of Alma-Ata (World Health Organization, 1978).
The Ottawa Charter argues that “the fundamental conditions
and resources for health are peace, shelter, education, food,
income, a stable eco-system, sustainable resources, social
justice and equity”. Under the Charter, health promotion
action means building healthy public policy, creating
supportive environments, strengthening community action,
providing information and education for health and enhancing
life skills, and reorienting health services towards health
promotion.

Although the Ottawa Charter recognizes and emphasizes the

importance of societal action, in practice public health
promotion has too often focused on individuals and
communities and has not tackled the major historical,
cultural, structural and macroeconomic determinants of
population health (Pearce & McKinlay, 1998). The focus has
been on persuading individuals to change their lifestyles,

55
Pearce

whereas persuading governments and industries to adopt

policies that protect and promote health has been regarded as
“too difficult”. However, the fundamental problem for health
ministers as well as public health researchers and policy-
makers is that the health services at most have a minor
influence on the health of a population (Pearce, 2002). What
the ministers responsible for finance, employment, social
welfare, education, housing, labour, environment and other
domains do inevitably has much greater influence on
population health than what the health minister does.

The traditional public health approach to this problem, in part

based on the Ottawa Charter, has been to attempt to “turn the
health services into public health services”. However, this
strategy is often ineffective. People working in the health
services are trained to treat illness in individuals, and they
often lack the time, the training and resources to deal with
larger issues of prevention in populations. Their
administrators also usually have more urgent priorities. As a
result, public health has continually lost out to the
“conventional” health services in battles for resources, and it
has had little influence on the major public health problems at
the population level (Pearce, 2002).

For these reasons, a number of new approaches have been

advocated and/or adopted in recent years to shift the focus of
public health back to the population level. One option that has
been advocated (but rarely adopted to date) has been to
establish ministries of public health (Pearce, 2002). Under this
approach, public health services for individuals (such as
immunization) would continue to be delivered through health
ministries, and attempts would continue to be made to
transform the health services towards public health as much
as possible. However, the ministries of public health would
tackle the real public health issues at the population level.
They would solely have a monitoring and advocacy role not
only with regard to routine monitoring of death rates, the
population burden of disease, etc., but also with regard to
monitoring and influencing the work of the other government
departments and ministries (including the health ministry).

56
 4. Public health and the precautionary principle

One way to do this is through health impact assessment of the

likely health effects of various public policies (Mindell, Ison &
Joffe, 2003). Under this approach, health should be an explicit
consideration when evaluating all public policies. However,
the limitations of health impact assessment should also be
recognized. In particular, Krieger et al. (2003) argue that
greater clarity is required regarding the criteria for initiating
and conducting health impact assessment and that “critical
debate over the promise, process, and pitfalls of health impact
assessment needs to be informed by multiple disciplines and
perspectives from diverse people and regions of the world”.

The precautionary principle

The concepts of precaution and prevention have thus always
been at the heart of public health practice. Public health is
inherently about identifying and avoiding risks to the health
of populations as well as in identifying and implementing
positive interventions to improve population health. However,
traditional public health interventions have generally focused
on removing hazards that have already been identified. In
contrast, the precautionary principle states that action should
be taken to prevent harm “even if some cause and effect
relationships are not fully established scientifically”
(Raffensperger & Tickner, 1999). The precautionary principle
therefore seeks to shift health and environmental policy from
a strategy of “reaction” to a strategy of “precaution” (Kriebel &
Tickner 2001). The central components of the precautionary
principle are all integral to public health: (1) taking preventive
action in the face of uncertainty; (2) shifting the burden of
proof to the proponents of an activity; (3) exploring a wide
range of alternatives to possibly harmful actions; and (4)
increasing public participation in decision-making (Kriebel &
Tickner, 2001; Kriebel et al., 2001 (reproduced as Chapter 9 of
this publication)).

Perhaps the most debatable component of the precautionary

principle is the one that shifts the burden of proof to the
proponents of an activity. In other words, the onus is on the
proponents to prove that an activity is safe rather than for its
opponents to prove that it is unsafe. The latter is usually very

57
Pearce

difficult, though not impossible, but can usually only be done

in a reactive manner after population exposure has already
occurred. In contrast, proving complete safety is usually
impossible. Some commentators have suggested that, if blindly
applied, shifting the burden of proof in this way would stifle
all innovation (Holm & Harris, 1999; Anonymous, 2000) and
create “false-positive” risks that waste resources and distract
from real problems (Graham & Weinder, 1995; Keeney & von
Winterfeldt, 2001). In fact, most public health decision-making
necessarily involves a “balance of evidence” approach rather
than an “innocent until proven guilty” or “guilty until proven
innocent” approach.

In response, proponents of the precautionary principle have

clarified this issue and emphasized that the precautionary
principle involves the “foresight” or “forecaring” principle,
which involves anticipatory, forward-looking action rather
than reactive impeding of progress (Tickner, Kriebel & Wright,
2003 (reproduced as Chapter 12 of this publication)). Thus,
“precaution does not mean only more sensitive tests; it also
means linking risk evaluation to alternatives assessments and
more democratic discussions of social needs and goals”
(Tickner, Kriebel & Wright, 2003). This formulation is
consistent with developments in health impact assessment,
and public health more generally. Thus, the precautionary
principle, together with related approaches such as health
impact assessment, provides a useful compass to guide public
health decisions under uncertainty, in a manner that
appropriately addresses the issues of power, ownership, equity
and dignity and the principles of “health by the people”
(Pearce, 2001).

Acknowledgement
Neil Pearce and the Centre for Public Health Research are
funded by the Health Research Council of New Zealand.

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5. Why is a precautionary approach needed?

Ted Schettler & Carolyn Raffensperger

Introduction
With the rapid growth of industrialization beginning in the
1850s, humans have increasingly dominated the earth’s
ecosystems in unprecedented ways. From the black smog of
Charles Dickens’ London to the massive damming projects in
China, the scale of change has expanded rapidly and
dramatically during the past 150 years. Population growth
and human activities such as resource extraction,
manufacturing, transport, agriculture and fishing have
escalated these changes and contributed to serious,
widespread and often avoidable harm to humans, wildlife and
ecosystems.

The planetary scope of these effects is apparent in climate

change; stratospheric ozone depletion; fundamental shifts in
the biogeochemical cycling of water, nitrogen and heavy
metals; air, soil and water pollution; worldwide degradation of
forests, coral reefs and fisheries; loss of biodiversity; and
contamination of virtually all organisms and ecosystems with
novel synthetic chemicals (Lubchenco, 1998; Johnson, Revenga
& Echeverria, 2001; McCally, 2002). A cascade of effects is also
apparent in changing patterns of acute and chronic diseases
and disabilities.

People do not experience the effects of these changes equally.

Children are uniquely susceptible to many types of
environmental exposure, nutritional deficit, infectious disease
and social upheaval, especially during specific periods of
development. Large populations in developing countries and
groups within industrialized countries are vulnerable when
inadequate resources, social and political institutions and
exploitation or marginalization limit their ability to respond to
changing circumstances. As a result, the risks and benefits of

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Schettler & Raffensperger

human enterprise are unequally and unjustly distributed.

This chapter discusses the precautionary principle as a tool to

help in decision-making when people face the uncertainty that
so often characterizes complex ecological systems. We describe
the new ecological reality that has emerged since the
industrial revolution and argue that the precautionary
principle is a key tool for managing health and environmental
well-being in this context.

Ecological realities
Decisions that people make about how to live in the world
have profound consequences for the functioning of ecological
systems. The dynamic of these systems is complex. Parts and
the whole influence each other; feedback loops may be
negative or positive. Changes in ecological systems may be
incremental and gradual or surprisingly large and sudden. For
example, scientists are increasingly concerned that
incremental climate warming could trigger an abrupt slowing
or reversal of ocean currents such as the relatively warm Gulf
Stream in the Atlantic Ocean. Were this to occur, the climate
of northern Europe would also abruptly change, with colder
temperatures much more like those in other northern regions
at similar latitudes. Such a change would result in marked
ecosystem changes, including the dislocation of large numbers
of people with severe economic and public health
consequences. When change is sufficient to cause a system to
cross a threshold, it operates within a new dynamic
equilibrium that has its own stability and does not change
easily. These new interactions become the norm and they call
for new institutions to address the new reality (Carpenter,
2003). Changing trends in human disease are evidence of just
such a shift. A long history of struggling with infectious
diseases and inadequate nutrition encouraged humans to
battle nature as an adversary and to focus attention on human
life expectancy and childhood mortality as measures of gains
against these scourges. To be sure, public health interventions
during the 20th century helped to prolong life and decrease

64
 5. Why is a precautionary approach needed?

childhood mortality in many parts of the world. At the same

time, important new disease patterns have emerged.

x The age-adjusted incidence of several kinds of cancer

has increased over the past 25 years (National Cancer
Institute, 1996).

x The incidence of some birth defects is increasing

(Paulozi, 1999).

x Developmental disabilities, including learning

disorders, attention deficit hyperactivity disorder and
autism, are increasingly common (Schettler et al.,
2000).

x Chronic diseases such as hypertension, heart disease,

diabetes and asthma are increasing throughout much
of the world.

x Obesity has become a major health problem, whereas

starvation persists in many parts of the world.

x Depression and other mental health disorders are new

public health threats in many parts of the world with
profound consequences for individuals, families and
communities.

These trends result from complex interactions among genetic,

nutritional, environmental and socioeconomic factors. Despite
extensive research efforts, the relative contributions and
interactions of these factors are uncertain. Nevertheless, a
shift has occurred that is not simply a result of people living
longer lives. Rather, the current pattern and those that will
follow are a result of choices people make and activities people
choose, individually and collectively – including how people
use technological capacity to fundamentally alter the function
and integrity of the world’s ecosystems and patterns of health
and disease in humans and wildlife.

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Schettler & Raffensperger

The precautionary principle as a guide to decision-

making
Given human capacity to cause change on an unprecedented
scale, how should people act when faced with pervasive,
inherent uncertainties? What values, along with scientific
understanding, should guide behaviour? Who should make key
decisions? How should people think about individual liberty
and the concept of “harm”?

The precautionary principle is a guide to public policy

decision-making under conditions of scientific uncertainty
(Raffensperger & Tickner, 1999; Schettler, Barrett &
Raffensperger, 2002). Recognizing the limits of science, the
precautionary principle is intended to enable and encourage
precautionary action that serves underlying values based on
what is known as well as what is not known. It encourages
close scrutiny of all aspects of science, from the research
agenda to the funding, design, interpretation and limits of
studies. According to the principle, when there are credible
threats of harm, precautionary action should be taken, even
when full understanding of the effects of a proposed activity is
lacking. In other words, the precautionary principle combines
the ethical notion of duty to prevent harm with the realities of
the limits of scientific understanding.

As with all guiding principles, the precautionary principle

carries its own values. The principle is based on recognizing
that people have a responsibility to prevent harm and to
preserve the natural foundations of life, now and into the
future. The needs of future generations of people and other
species and the integrity of ecosystems are recognized as being
worthy of care and respect. A precautionary approach asks
how much harm can be avoided rather than asking how much
is acceptable. It acknowledges that the world comprises
complex, interrelated systems that are vulnerable to harm
from human activities and resistant to full understanding.
Precaution gives priority to protecting these vulnerable
systems and requires gratitude, empathy, restraint, humility,
respect and compassion.

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 5. Why is a precautionary approach needed?

The precautionary principle is based on these underlying

values and three core elements: predicting, avoiding and
identifying harm; addressing scientific uncertainty; and taking
precautionary action. The following sections discuss each of
these elements.

The potential for harm

Precautionary action is appropriate when there is credible
evidence that a specific technology or activity might be
harmful, even if the nature of that harm is not fully
understood. This means that decision-makers must consider
hazards that have been identified or that are plausible based
on experience and what is known and/or predicted. Threats of
serious, irreversible, cumulative or widespread harm are of
more concern than trivial threats and demand precautionary
action commensurate with their nature. Most importantly, for
two reasons, “proof” of harm is not a requirement for
precautionary action. First, by definition, preventive measures
cannot be based on identifying harm that has already
occurred. Second, criteria for establishing the “proof” of a
cause-and-effect relationship are, by convention, rigorous and
difficult to fulfil. As a result, when “proof” of harm has been
established, considerable damage will already have occurred
that may have otherwise been avoidable.

Harm can occur at the level of the cell, individual organism,

population or ecosystem. The effects may be biological,
ecological, social, economic or cultural, and they may be
distributed equally or disproportionately among individuals,
populations or geographical areas, now or in the future.
Because systems are complex and outcomes are not always
predictable, it becomes extremely important for decision-
makers to specifically identify the parameters that are used to
assess the potential effects of a proposed activity. Moreover,
the standard against which an effect is measured must also be
defined. Asking whether a proposed agricultural or industrial
chemical is safer for use than another, for example, is very
different from asking whether either is necessary at all.
Alternatives analysis, further discussed below, can be used to

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Schettler & Raffensperger

identify the potential consequences associated with choices

among options in a given circumstance.

Scientific uncertainty
Recognition of scientific uncertainty is central to the
precautionary principle. Even when harm is unintended,
human activities often have effects that are difficult to predict
or even to recognize until damage is done. Complex systems
may react to change in non-linear ways that are sometimes far
removed in time and space. Sometimes a system crosses a
threshold and operates at a new state of relative equilibrium
from which there is no turning back. Cause-and-effect
relationships may be difficult or impossible to establish with
certainty. Nevertheless, failing to act – or continuing a
harmful action – until uncertainty is resolved is in itself a
form of action with consequences.

Understanding cause-and-effect relationships in complex

systems is limited by different kinds of uncertainty.
Uncertainty sometimes results from more than a simple lack
of data or inadequate models and is not easily reduced because
of the nature of the problem being studied. In these
circumstances, requiring absolute “proof” of harm before
action can be taken is either ideologically motivated or
deprived of a fundamental understanding of the limits of
science.

Most complex problems have a mixture of three general kinds

of uncertainty – statistical, model and fundamental – each of
which should be considered explicitly.

Statistical uncertainty
Statistical uncertainty is the easiest to reduce or to quantify
with some precision. It results from not knowing the value of a
specific variable at a point in time or space but knowing, or
being able to determine, the probability distribution of the
variable. An example is the intelligence quotient (IQ) or
quantitative intelligence estimate of an individual within a
given population. In this case, decisions can be based on

68
 5. Why is a precautionary approach needed?

knowing the likelihood of that variable having a particular

value.

Typically, however, real-world decisions are made in the

context of multiple, interactive variables. For example, the
incidence of cancer attributable to exposure to a carcinogen in
genetically and geographically diverse people is inherently
more difficult to determine than the incidence of cancer in a
group of genetically similar rodents exposed to the same
carcinogen living in controlled laboratory conditions. When
more than one variable is involved, a model is typically
constructed with certain assumptions and simplifications,
introducing a new kind of uncertainty – model uncertainty.

Model uncertainty
Model uncertainty is inherent in systems with multiple
variables interacting in complex ways. Even if the statistical
uncertainty surrounding the value of a single variable can be
defined or reduced, the nature of relationships among system
variables may remain difficult to understand. This is
especially problematic for any model of complex systems.
People may decide that the system will tend to behave in a
certain way, but the likelihood of that behaviour is difficult to
estimate.

Moreover, complex models can include only a finite number of

variables and interactions. The real world, however, is a
confluence of biological, ecological, social, cultural, economic
and political systems. No experimental model can fully
account for each of these and their interrelationships. Ongoing
research, monitoring and refining models may help to reduce
uncertainty, but imprecision is inevitable. Indeterminacy,
which increases when moving from statistical to model
uncertainty, is more correctly called ignorance at some point.

Fundamental uncertainty
Fundamental uncertainty encompasses this extension of
indeterminacy into ignorance. Ignorance that results from the
complexity or uniqueness of a system is of particular concern.

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This kind of uncertainty is inherent in novel or complex

systems in which existing models do not apply. Lack of valid
information about the likelihood of a specific outcome results
in fundamental uncertainty. It can also result from no
knowledge of what some of the outcomes may be. Here people
do not even know what they do not know. Chemical regulators,
for example, were unaware of the existence and functions of a
stratospheric ozone layer that would be damaged by
chlorofluorocarbons when they allowed them to be marketed
as safe for commercial use. Fundamental uncertainty is
extremely difficult to reduce or otherwise manage and
demands respect and humility.

Scientific uncertainty and scientific proof

Proof is a value-laden concept that integrates statistics,
empirical observation, inference, research design and research
agendas into a political and social context. This section
discusses the uses and misuses of some of the criteria
commonly used to establish proof. Strict criteria may be useful
for establishing “facts”, but by the time a fact or causal
relationship has been established by rigorous standards of
proof, considerable avoidable harm may already have
occurred. The effects of lead exposure on children’s brain
development or asbestos on lung cancer risk are examples. In
each case, people were damaged over many decades, long after
substantial evidence of serious health effects was established,
while lead and asbestos advocates contested epidemiological
“proof” of causation. Guided by the precautionary principle,
people are as concerned with the weight of the available
evidence as they are with establishing facts by rigorous
standards of proof. The weight of the evidence can guide
preventive action, whereas waiting for proof may allow
damage to occur.

By convention, a considerable amount of consistent evidence is

necessary to establish factual “proof” of a cause-and-effect
relationship. Traditionally, in a study of the relationship
between two variables, a correlation is said to be statistically
significant only if the results show the two to be linked,

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independent of other factors, with greater than 95% likelihood

that the positive results of the study did not occur by chance.
But correlation does not establish causation. In epidemiology,
a series of additional criteria, for example, those of Hill (1965),
are usually added before causation can be claimed. Hill
criteria include not only establishment of a statistically
significant correlation between two variables but also require
that the causal variable precede the effect, a dose–response
relationship, elimination of sources of bias and confounding,
coherence with other studies and understanding of a plausible
biological mechanism. Tobacco smoking, for example, was
known to be associated with lung cancer for more than 50
years before a plausible biological mechanism was finally
described. At that point, denying that tobacco “causes” cancer
became impossible.

People’s adherence to conventions or choices among criteria

expresses their willingness to make type I or type II errors. A
type I error is the mistake of concluding that an association or
phenomenon exists when, in truth, it does not. Conversely, a
type II error is the mistake of failing to recognize an
association or phenomenon when it does exist. Each kind of
error has consequences. Type II errors may, for example, lead
people to allow a harmful activity to go forward and are the
inevitable result of a consistent bias towards avoiding type I
errors. Type I errors will result in invalid concerns about a
product or activity and may lead to unnecessary restrictions.
Establishing type I and type II error rates is a choice that
reflects certain biases and is largely done by convention, often
without considering the consequences. For example, by
convention, interpretations of scientific data generally favour
type II over type I errors. People generally require strong
evidence that something is scientifically “true” before being
willing to say so.

An historical basis for error bias

A general theme that has gained currency in many countries
is that people are autonomous individuals who are free to live
as they wish and do as they want, provided that they do not

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cause harm to others. This concept has set up a tension

between the individual and society at large in terms of
establishing the limits of tolerance and defining harm. In On
Liberty, first published in 1859, John Stuart Mill (1978 (1859))
explored the nature and limits of power that can be
legitimately exercised by society over the individual. He
concluded that the only purpose for which power can be
rightfully exercised over any member of a civilized community,
against his or her will, is to prevent harm to others. Mill was
concerned that, in a democratic society, the majority would set
the limits to tolerance – that the majority would interfere with
the creative individual’s inclination to invent and develop and
to explore new frontiers. He also worried that the majority
would go so far as to define “harm”, using inappropriate
assertions of “harm” as a blockade to progress. In short, he
feared the “tyranny of the majority” and their inclination to
favour the status quo.

This tension is at the heart of many of today’s policy debates.

Not only must harm be defined but people also have to decide
how to act or how to legitimately exercise power when the
probability of harm (risk) is uncertain. Though decisions must
be based on what is known at the time, if “proof” of harm is
required before limiting an activity or choosing an alternative,
as Mill would have, there is a risk of failing to prevent harm.

Seeing how Mill’s fears are reflected in today’s policies in

many countries throughout the world is easy. In general, the
burden of proof of harm falls on the general public or
individuals who assert that another party has injured them.
High standards of “proof” add to this burden, even when the
weight of the evidence suggests that harm has occurred or is
likely. In other words, a bias towards type II errors –
established by convention in interpreting scientific data – has
also crept into social, political and judicial policy. Asking
whether such a bias is appropriate for preventing harm or for
choosing among optional human activities is fully legitimate.
Further, it may be legitimately ask how such a bias is likely to
influence the ways that human activities alter complex

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ecological systems that define the world to be left to future

generations – a consideration at the core of sustainability.

Children’s health, uncertainty, sustainability and

precaution
The various kinds of harm, proof and scientific uncertainty
become important in practice in children’s health. Focusing on
children’s health shows concern for the very young, their
future and future generations. Sustainability also implies
concern about the future, the integrity of ecosystems that
support life on earth and the kind of world that current
generations will leave to those who follow. Understanding
today’s patterns of children’s health and the current status of
global ecosystems is difficult because they reflect the
confluence of multiple interacting factors. Predicting future
patterns and making wise choices based on current
understanding of complex ecological relationships are even
more challenging. Our understanding and predictive capacity
are limited by statistical, model and fundamental uncertainty
that has several sources. This section briefly reviews some of
the factors that complicate decision-making for children’s
environment and health. The precautionary principle
encourages scientists and policy-makers to design research
and decision-making approaches that take these complicating
factors into account.

Long latency
Conditions with long latency periods between an action and an
outcome are difficult to study. Study design is necessarily
complex and implementation is expensive. Intervening
variables that must be considered in a comprehensive study
complicate the analysis. Subjects may also be lost to follow-up
during a prolonged study. For example, the effects of fetal
exposure to a chemical agent that disrupts the normal
development or functioning of the reproductive system may
not become apparent until an individual has reached
reproductive age or beyond. At that point, reconstructing the
circumstances that may have caused the adverse outcome is
extremely difficult, and studying a potentially causal

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relationship systematically in a population is even more

difficult.

Nonspecific or subtle endpoints

Adverse health outcomes or significant ecological changes are
often nonspecific as well as multifactorial in origin. Many
diseases, such as asthma or developmental disorders, for
example, are caused by complex interactions of many different
factors and are not easily linked to single variables. As a
result, determining causation precisely is difficult, if not
impossible, and some residual uncertainty will always remain.
The task of policy-makers or health care providers then
becomes to decide how to act in the face of uncertainty.

Investigative challenges are also increased when the health

outcome is subtle and detectable only by detailed, complex
testing. For example, subtle changes in functioning of the
immune system or brain may have significant practical
importance but be difficult to document easily.

Multiple and interacting variables

As noted earlier, predicting the impact of modifying single
variables is often difficult when multiple factors interact in
complex ways within a system. The nature, degree, timing and
place of even a single intervention in the system are each
important for determining the outcome. When systems exist
near a threshold, small perturbations at a critical point may
be sufficient to cause a shift to a new dynamic equilibrium or
more chaotic activity, whereas a more stable system may
easily be able to absorb such an intervention. Children’s
nervous system development is more vulnerable to the effects
of lead exposure among families living in stressful
socioeconomic conditions with suboptimal nutritional status
than among families living in more favourable circumstances
(National Research Council, 2000).

Circumstances are even more complicated when multiple

factors or mixtures of factors are changed. This guarantees
model and fundamental uncertainty, and “proof” of harm (or

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safety) is extraordinarily difficult to achieve. Nevertheless,

lack of “proof” of harm is often used to justify ongoing or
proposed activities when the weight of credible evidence
suggests that harm is plausible and perhaps even likely. Given
the limits of scientific inquiry in the world of complex systems,
establishing a high bar of proof as a prerequisite for taking
action is certain, in some instances, to result in unnecessary
and often irreversible harm (Beauchamp & Steinbock, 1999;
Kriebel et al., 2001 (reproduced as Chapter 9 of this
publication)).

Limits of current policy-making procedures: risk

assessment versus precaution
As noted previously, individual and collective human activities
have fundamentally altered the world’s ecosystems, including
patterns of disease. Current decision-making policies and
procedures do not demonstrate comprehensive understanding
or concern for the magnitude of change and their implications
for the future. Moreover, current policies are largely reactive
to individual problems and fail to incorporate mechanisms for
predicting harm, forestalling adverse outcomes and diverting
resources towards more sustainable activities.

A quantitative risk assessment approach to public policy

decision-making dominates in the United States and many
other parts of the world. With few exceptions, risk assessment
attempts to estimate the potential risks of proposed products
or activities on a case-by-case basis without considering the
complete context in which the activity will be carried out. Risk
assessment deals with incremental change caused by single
agents. Moreover, it rarely deals with any comparative
consideration of alternatives to the proposal (O’Brien, 2000).

Quantitative risk assessment usually responds to narrowly

framed questions and is often flawed by simplifying
assumptions that fail to address multicausal pathways and
complex interactions among variables. Risk assessment almost
always fails to consider a full range of biological, ecological,

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social, cultural and economic effects and how they are

distributed.

The relationship between the precautionary principle and

quantitative risk assessment highlights several differing
views, including how much is known, how much can be known,
how broadly questions should be framed, which questions
should be asked, who should frame the questions, the value of
non-human life, responsibility to future generations and how
humans plan for the future.

Advocates of a regulatory system dominated by quantitative

risk assessment sometimes argue that it is inherently
precautionary because it uses conservative assumptions and
safety factors. However, risk assessors often fail to distinguish
among various kinds of uncertainty and tend to misclassify
some model and fundamental uncertainty as statistical, to
which they apply “uncertainty” factors. When model and
fundamental uncertainty predominate in a system, this
approach becomes more likely to result in large errors in
estimates of risk, failure to predict adverse effects removed in
time and space and complete failure to predict surprises or
novel effects.

Risk assessors often claim that the precautionary principle is

“anti-science” or a tool to keep certain technologies from the
marketplace. In fact, a precautionary approach encourages
more science rather than less, acknowledging the need for
precautionary action while addressing the scientific
uncertainty that may be intractable using available tools. Not
only is research needed into the potential harm of existing
technologies and products, but the emerging fields of green
chemistry, green engineering and biomimicry offer exciting
new possibilities for technologies that do not damage the
planet or impair health.

Decision-making in the face of uncertainty is necessary and

frequently difficult and requires assessing relative risks.
Guided by an overarching commitment to precaution,
however, this assessment is not the exclusive domain of risk

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analysts, can be fully participatory and can fully consider a

range of alternatives.

Precautionary action
The precautionary principle prescribes precautionary action
under conditions of uncertainty. It does not prescribe what
this action should be in every case, but depending on
underlying values, the nature and plausibility of potential
harm and the degree and kind of uncertainty, the following
guides will be useful.

Protect resilience and diversity

Resilient and diverse systems are, in general, more resistant
to fundamental shifts than stressed systems operating near
thresholds.

Learn and adapt

Experiment on scales of space and time that are “safe to fail”.
Some ecologists have pointed out that experimentation and
precaution are compatible when the experiment is carried out
at a different scale than the scale at which precaution is a
primary necessity (Carpenter, 2003). For example, studying
the effects of neurotoxicants on rodents or in a test tube allows
learning without damaging the brains of an entire generation
of human children. Confined experiments that go awry are far
less problematic than those from which there is no return.
Under the precautionary approach, appropriate research and
monitoring are essential, especially after a decision to release
a technology or chemical into the world. Decisions must be
periodically re-examined based on new information. The
research agenda of private and public institutions should be
designed to reflect broad social goals that extend well beyond
developing marketable products. In this way the
precautionary approach is designed with feedback loops that
search for and take into account new information and the
unintended consequences of provisional decisions.

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Shift the burden of proof

Under the precautionary principle, the advocate of an activity
has the burden of proving the safety of the activity. The
precise nature of this burden may shift with the nature of the
harm and the scientific uncertainty. This approach suggests
that the burden of proof is better thought of as the burden of
persuasion and responsibility, which avoids the fruitless
assertion that absolute safety can never be “proven”. It
acknowledges that, as the potential for serious, irreversible
harm and scientific uncertainty increase, the proponent of an
activity has an increasing obligation to account for the
consequences of the activity and to take responsibility for the
adverse effects that may result from it. Then, more
comprehensive testing, monitoring and assumption of liability
shift the onus onto the proponent. This does not mean that
activities must cease until some unattainable, absolute level of
proof has been achieved. It does mean, however, that
advocates of an activity must make a persuasive case for what
they wish to do and must accept responsibility for it. Shifting
the burden of proof establishes a series of obligations. For
instance, under this burden shifting, proponents of potentially
damaging activities have an obligation to test their products or
technologies, publicly disclose information about potential for
harm and pay for damage and restoration should harm occur.
People should be able to make informed decisions about what
they choose to use and activities they undertake. This “right to
know” gains a new urgency on today’s planetary stage.

Set goals
Setting goals is particularly important for establishing
environmental and health policies. Goal setting requires
asking: “Where do we want to be at some future time? What
are we trying to accomplish?”. Starting with agreed goals and
then looking at the current situation can help in developing a
strategy for getting from here to there. Not all goals are
generally agreed upon or represent shared visions. But as
goals are made explicit, the values and assumptions
underlying decision-making processes will also become more

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 5. Why is a precautionary approach needed?

transparent and may result in processes for reconciling

differences.

Assess alternatives
A truly precautionary approach includes examining a range of
options for meeting policy goals. Currently, most settings have
few requirements for comprehensively assessing a range of
alternatives to proposed activities. For example, current
regulatory policies emphasize a risk assessment and risk
management framework. This approach attempts to estimate
the probability of harm (risk) from a proposed activity and
then asks whether that harm is acceptable. Risk management
techniques are intended to minimize the risks of the proposed
activity but not to question whether the activity is necessary
for achieving broader goals.

Alternatives assessment instead asks whether the harm is

necessary and whether there might be other ways to achieve
the agreed goals that would avoid harm altogether. When
alternatives assessment is applied earlier rather than later in
policy decision-making, innovative approaches that reflect
societal goals, ecological principles and the values that
underlie the precautionary principle are more likely to emerge.
Assessing alternatives can also lead to action that truly
respects the level of uncertainty in given circumstances.

Adopt transparent, inclusive and open processes

A precautionary approach requires open, inclusive and
transparent processes that are initiated early in decision-
making, beginning with goal-setting, when the health and
well-being of the public and environment are at stake. A
participatory approach is justified by a belief in the
fundamental fairness of democratic decision-making and by
the thought that a broad range of experience leads to better
science and decision-making. Transparency also helps to
ensure accountability among decision-makers.

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Schettler & Raffensperger

Analyse uncertainty
A precautionary approach requires explicitly recognizing the
scientific uncertainty inherent in understanding the potential
for harm from an ongoing or proposed activity.

Statistical uncertainty may be reduced by collecting more

data, but model and fundamental uncertainty is more difficult
to reduce. When model or fundamental uncertainty
predominates, requiring uncertainty to be resolved as a
prerequisite for decision-making shows a fundamental lack of
understanding of the limits of science or, alternatively, may be
nothing more than a tactic to maintain the status quo. For
example, the uncertainty inherent in predicting global
warming includes statistical, model and fundamental
uncertainty. Using the aggregate of these types of uncertainty
as a basis for rejecting action has no basis in an understanding
of the science.

Options for precautionary action

Choices among potential precautionary actions are made only
after potential harm and scientific uncertainty are fully
analysed. Precautionary action can take many directions. At
the level of regulation, when research and development of a
product or technology are complete and only regulatory
approval is needed for production and marketing, the options
are ordinarily limited to yes, no, with limits, with monitoring,
with labelling or with the posting of a performance bond.

At a pre-regulatory level, however, precautionary action might

include a closer look at problems that proposed technologies
are intended to solve. How was the problem defined and by
whom? Was the problem framed in the only or best way? Are
there alternatives to the proposed technology?

Evaluating a full range of possible precautionary measures

again requires a multidisciplinary, participatory approach to
elicit relevant knowledge and set priorities. Responses to
scientific uncertainty, as well as various kinds of harm,
legitimately vary among individuals, societies and cultures.

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 5. Why is a precautionary approach needed?

Considering alternatives, multiple sources of information and

priorities earlier in the process is easier than when a
developed product or technology is presented for regulatory
approval.

Conclusion
Although many measures of human health and circumstances
have improved in some parts of the world, human activity
during the 20th century caused both inexorable, incremental
degradation of ecological systems throughout the world and
fundamental shifts in ecosystem functioning on a planetary
scale. These changes, including their associated effects on
patterns of human health and disease, demand that old
approaches to public health be re-examined and new
institutions developed to respond to global problems. The
precautionary principle, based on the ethical notions of taking
care and preventing harm, is a new institution that will allow
people to respond in wise and innovative ways. It arises from
recognition of the extent to which scientific uncertainty and
inadequate evaluation of the full effects of human activities
have contributed to ecological degradation and harm to human
health. It can be used to help address these circumstances,
bringing together ethics and science and illuminating their
strengths, weaknesses, values or biases. The precautionary
principle encourages research, innovation and
interdisciplinary problem-solving. It serves as a guide for
considering the effects of human activities and provides a
framework for protecting young and old humans, other species
and life-sustaining ecological systems now and for future
generations.

References
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Boehmer-Christiansen S (1994). The precautionary principle in

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Carpenter S (2003). Regime shifts in lake ecosystems: pattern and

variation. Oldendorf/Luhe, Germany, International Ecology
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Hill AB (1965). The environment and disease: association or

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Johnson N, Revenga C, Echeverria J (2001). Managing water for

people and nature. Science, 292:1071–1072.

Kriebel D et al. (2001). The precautionary principle in

environmental science. Environmental Health Perspectives,
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Lubchenco J (1998). Entering the century of the environment: a

new social contract for science. Science, 279:491–497.

McCally M, ed. (2002). Life support: the environment and human

health. Cambridge, MA, MIT Press.

Mill JS (1978 (1859)). On liberty. Indianapolis, IN, Hackett

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National Cancer Institute (1996). SEER Cancer Statistics Review,

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neighborhoods. The science of early childhood development.
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O’Brien M (2000). Making better environmental decisions: an

alternative to risk assessment. Cambridge, MA, MIT Press.

Paulozi L (1999). International trends in rates of hypospadias and

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principle. In: McCally M, ed. (2002). Life support: the
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6. The precautionary principle in
decision-making: the ethical values

Pietro Comba, Marco Martuzzi & Caterina Botti

The precautionary principle implies adopting a set of rules

aimed at avoiding possible future harm associated with
suspected, but not ascertained, risk factors (Kourilsky &
Viney, 2000). When an adverse effect is ascertained, it is
avoided based on prevention and not on precaution. At the
other end of the spectrum, when little or nothing is known on
the health effects of a risk factor, precaution cannot be invoked
to stop technological development or ban a substance whose
future adverse effects can merely be hypothesized in the
absence of any evidence. The domain of precaution thus lies
between the domain of proper prevention and instances with
no indications of adverse health effects.

A WHO Regional Office for Europe (2002) workshop

extensively discussed a central issue in the implementation of
the precautionary principle: defining “a prudent approach to
risk”. It was stated, among other things, that adopting the
precautionary principle often implies some sort of immediate
action followed by a second stage of undertakings, including
scientific investigations and search for alternatives. Action
inspired by precaution is characterized by uncertainty, and the
policy framework should thus regularly be reviewed.

Uncertainty, however, characterizes much of contemporary

decision-making in environment and health. The relevance
and application of the precautionary principle has attracted
substantial attention because it encompasses many of the
underlying dimensions of decision-making under uncertainty
and provides a framework to support it. Several philosophical,
economic and societal questions contribute to the complexity of
this (Marchant, 2003; Sharp, 2003). The purpose of this
chapter is to discuss one of these components: the ethical
background and implications of decisions inspired by the

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Comba et al.

precautionary principle in environment and health.

A preliminary question that may be helpful to address is the

existence of two major philosophical approaches to decision-
making in uncertain settings: the Bayesian-utilitarian
approach and the “maximin” approach.

In the Bayesian-utilitarian approach, as elaborated by

Harsanyi (1979), which is largely used in public health,
choosing the course of action with the most favourable
outcome for all involved is rational. The outcome of an action
is measured using a utility function: a synthetic indicator of
the health and well-being of the population in question. Given
a certain action, the expected value of the utility function is
the weighted sum of all possible consequences of the action,
and the weights are given by the probabilities associated with
each consequence; probabilities are usually based on prior
knowledge, hence the Bayesian notion. Although the aim is
some form of “universal” welfare that takes into account all
individuals, the realistic objective is to maximize the utility
function, which in turn tends to be equivalent to an average.
Thus, the Bayesian-utilitarian approach, aiming towards the
most good for the most people, tends to favour the option that
maximizes the average utility and may overlook inequality in
the population distribution. Taking this approach to the
extreme, a choice that concentrates the adverse consequences
of an action in a small minority may have a higher utility than
an option in which all members of society have smaller
adverse effects. This paradox may apply to many
environmental risk factors with, for example, a linear, no-
threshold effect on morbidity or mortality.

Maximin, from maximum minimorum, is an alternative

principle in decision-making. Maximin is based on a rule
according to which, in decision-making, attention should be
paid to the worst outcome that could possibly occur in any
course of action, which should be taken into account in the
decision-making process (Rawls, 1971). Alternative policy
options are classified based on their worst possible result, and
the worst alternative consequences should be avoided even if

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highly improbable. The Bayesian-utilitarian approach is based

on maximizing the utility function, whereas the maximin
approach prescribes ranking policy options according to their
worst possible outcome, regardless of its likelihood, and
selecting the one with the least worst such outcome. Again,
this characterization is somewhat simplistic and refers to
literal application of the principle, but the maximin principle
tends to favour policy options inspired to precaution,
prescribing a “better safe than sorry” approach.

Both approaches are concerned with social welfare and aim at

protecting and enhancing a community’s overall health status,
but the Bayesian-utilitarian view identifies this as the
amelioration of the total or average well-being, whereas the
maximin approach is mainly concerned with the welfare of the
most disadvantaged population subgroups and results in
reducing the gap between those who are better off and those
who are worst off. Such a gap is not necessarily of concern in
Bayesian-utilitarian evaluation. Thus, the maximin strategy is
considered more adequate to deal with the problem of
distributive justice; inequality is allowed inasmuch as it
maximizes the long-term expectations of the worst-off part of
society, but a policy option that may produce marked
inequality is normally rejected. In fact, one society can be said
to be better than another if the worst-off members of the
former do better than the deprived members of the latter, even
if the overall utility may be lower.

Before these two approaches in decision-making in

environment and health are compared, note that risk
management strategies based on establishing a relevant
evidence base and applying cost–benefit analysis have
provided major contributions to public health (Vineis &
Soskolne, 1993). One of the crucial issues in applying the
Bayesian-utilitarian approach is how to address the dimension
of equity in the distribution of exposure between population
subgroups; this point requires some additional comments.

“Mainstream” environmental epidemiology, providing some of

the essential information for risk assessment exercises,

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Comba et al.

generally deals with diffuse types of exposure, often of limited

intensity, whose adverse health effects may consist of a
moderate increase in the risk of occurrence of a disease,
shared by a large number of people. Detecting and measuring
this kind of effect requires complex study designs (Steenland
& Savitz, 1997; Hertz-Picciotto, 1998). Although the risks
involved are typically small, the fact that large numbers of
people are affected results in sizeable effects on public health.
For example, slight differences in the choice of protective
standards or exposure limits might have important public
health implications. At the same time, reducing exposure or
imposing more restrictive limits for widespread types of
exposure normally has great costs for society. Balancing these
costs with the expected health benefits is therefore a crucial
exercise in these circumstances, and clearly formulating the
cost–benefit relationship is of great value. Adopting the
Bayesian-utilitarian approach is therefore natural to choose
the option that is expected to cause the greatest benefit to the
greatest number of people involved, maximizing health
returns for each unit of money spent.

A complementary approach may be pursued for relatively less

frequent situations, such as those involving limited numbers
of subjects exposed to relatively high levels of a specific
noxious agent. In these circumstances, measures of exposure
abatement aimed at the general population are likely to
produce limited benefits, resulting in ineffective health
returns per unit of money spent. Such measures tend thus to
be rejected based on cost–benefit considerations. However,
although the attributable risks may be very small among the
whole population, they can be substantial within the exposed
subgroups. Such subgroups, ultimately, are asked to carry
most of the burden of disease associated with the type of
exposure in question. Such an obvious equity problem is often
made worse by social disparity. For example, Bullard &
Wright (1993) investigated the non-random distribution of
locally unwanted land uses and health risks. Communities
with hazardous waste incinerators, for example, generally
have large ethnic-minority populations, low incomes and low
property values. Abandoned toxic-waste sites and wastewater

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 6. Precaution and the ethical values

pipes from polluting industries have been shown to cluster in

socioeconomically deprived districts, thus determining, among
else, contamination of groundwater. Some adverse health
effects associated with deprivation and with proximity to
hazardous waste sites, such as the risk of birth defects, may
coincide to some extent, thus justifying the urgent
requirement of adopting appropriate epidemiological study
designs aimed at appreciating both sets of risk factors and
their potential synergy effects.

The awareness of the existence of high-risk communities and

of the non-random distribution of environmental risks and
social deprivation has both triggered specific research projects
and developed public health action inspired by criteria of
environmental justice and distribution of exposure. In more
practical terms, these perspectives can be used as a basis for
policy-making on the ever-delicate issue of allocating finite
and normally scarce resources in protecting environment and
health. Sexton, Olden & Johnson (1993), for example,
recommend defining risk-base priority-setting for
environmental health problems. This procedure aims to ensure
that scarce resources are used to address the “worst” problems
first. Since environmental protection is a right for all
individuals, they suggested adopting a procedure by which
vulnerable subgroups are given priority, identified through
residence in certain geographical areas. In these areas or
neighbourhoods, environmental pollution coupled with
socioeconomic deprivation is more likely to damage human
health, through exposure that disproportionately affects the
people who are least capable of protecting themselves (Finkel
& Golding, 1993).

This strategy inherently represents a maximin approach,

which will lead to concentrating efforts to mitigate exposure
among the most affected population subgroups and pursuing
an equitable distribution of risks, whether natural or induced
by industrialization or technological development (Shrader-
Frechette, 1991). This may not be enough to ensure fairness of
outcome, but it will certainly contribute to the fairness of the
decision-making process.

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Comba et al.

For the sake of the debate around the precautionary principle,

explicitly addressing these dimensions is important. This
approach is consistent with several of the prescriptions of the
precautionary framework, for at least three reasons. Firstly,
the specific types of exposure under consideration (such as the
health effects of incinerators, waste-disposal sites,
groundwater pollution, airborne chemicals around industrial
sites and power-frequency electromagnetic fields) often
represent possible or suspected but not always ascertained
hazards, so that the uncertainty not only concerns the
magnitude of the risk but its very existence. Secondly,
remedial or cautionary action has to be taken despite such
uncertainty, and this process requires that all efforts be made
to maximize the use of available scientific information.
Finally, the precautionary framework requires that
involuntary exposure, especially if it may be viewed as
inequitable, should be a priority. The mere fact of making
these connections more explicit, it is hoped, can contribute to
more effective and equitable decision-making in environment
and health.

References
Bullard RD, Wright BH (1993). Environmental justice for all:
community perspectives on health and research needs. Toxicology
and Industrial Health, 9:821–841.

Finkel AM, Golding D (1993). Alternative paradigms: comparative

risk is not the only model. EPA Journal, 19:50–52.

Harsanyi JC (1979). Bayesian decision theory, rule utilitarianism

and Arrow’s impossibility theorem. Theory and Decision, 11:289–
317.

Hertz-Picciotto I (1998). Environmental epidemiology. In:

Rothman KJ, Greenland S, eds. Modern epidemiology. 2nd ed.
Philadelphia, Lippincott-Raven Publishers:555–583.

Kourilsky P, Viney G (2000). Le principe de précaution. Rapport

au Premier Ministre. Paris, Odile Jacob Editions.

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Marchant GE (2003). From general policy to legal rule:

aspirations and limitations of the precautionary principle.
Environmental Health Perspectives, 111:1799–1803.

Rawls J (1971). A theory of justice. Cambridge, MA, Harvard

University Press.

Sexton K, Olden K, Johnson BL (1993). “Environmental justice”:

the central role of research in establishing a credible scientific
foundation for informed decision making. Toxicology and
Industrial Health, 9:685–727.

Sharp RR (2003). Ethical issues in environmental health

research. Environmental Health Perspectives, 111:1786–1788.

Shrader-Frechette KS (1991). Uncertainty and the utilitarian

strategy. The case for a “maximin” account of risk and rationality.
In: Risk and rationality – philosophical foundations for populist
reforms. Berkeley, University of California Press:100–130.

Steenland K, Savitz D (1997). Topics in environmental

epidemiology. Oxford, Oxford University Press.

Vineis P, Soskolne CL (1993). Cancer risk assessment and

management. An ethical perspective. Journal of Occupational
Medicine, 35:902–908.

WHO Regional Office for Europe (2002). Precautionary policies

and health protection: principles and application: report on a
WHO workshop, Rome, Italy, 28–29 May 2001. Copenhagen,
WHO Regional Office for Europe: 1–21
(http://www.euro.who.int/document/e75313.pdf, accessed 24 May
2004).

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7. Late lessons from early warnings: improving
science and governance under uncertainty and
ignorance1

David Gee & Andrew Stirling

The European Environment Agency (EEA) is an independent

Agency of the European Community, which was founded in
1993. Its main task is to provide information to the policy-
making bodies of the European Union (EU) and its Member
States that can be of direct use for improving decision-making
and public participation in the fields of environment and
sustainable development. The main background against which
these activities are set is the growing scale and pace of
scientific and technological innovation, with the nature of the
consequences increasingly outstripping any social capacity for
prediction (WBGU, 2000). Decision-makers therefore often
need information in situations of scientific uncertainty and
ignorance. Herein lies the increasing relevance of the
precautionary principle, enshrined, along with the principles
of prevention and the polluter pays, in the Maastricht Treaty
on European Union (European Commission, 2000).

The precautionary principle is not just an issue for the

European Union: its potential impact on trade means that its
application can have global repercussions. There are currently
disputes both between and within the EU and the United
States on the use and application of precaution to hormones in
beef, genetically modified organisms (GMOs), and climate
change. In 2001 the EEA published “Late Lessons From Early
Warnings: The Precautionary Principle 1896-2000,” to
examine the use, or neglect, of information and precaution in
protecting both human and ecosystem health. The report was
based on an historical approach to scientific uncertainty (Gee,

1From Precaution, Environmental Science, and Preventive Public

Policy by Joel A. Tickner, ed. Copyright © 2003 Island Press.
Reproduced with permission of Island Press, Washington, D.C.

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Gee & Stirling

1997). Since discussions on precaution are sometimes

hampered by confusion about the meaning of terms used in
the debate, we felt it was important to analyze and learn from
past experiences in the use and non-use of precaution in
controlling hazardous technologies and to do so with a common
approach and terminology. Analysis of these histories
generated useful definitions of some of the key terms used in
debates on precaution and prevention (Box 1).

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 Box 1. Uncertainty and precaution – towards a clarification of terms
Situation State and dates of knowledge Examples of action
Risk ‘Known’ impacts; ‘known’ probabilities Prevention: action taken to reduce known
e.g. asbestos causing respiratory hazards
disease, lung and mesothelioma e.g. eliminate exposure to asbestos dust
cancer, 1965–present
Uncertainty ‘Known’ impacts; ‘unknown’ Precautionary prevention: action taken to
probabilities reduce potential risks
e.g. antibiotics in animal feed and e.g. reduce/eliminate human exposure to
associated human resistance to those antibiotics in animal feed
antibiotics, 1969–present
Ignorance ‘Unknown’ impacts and therefore Precaution: action taken to anticipate, identify
‘unknown’ probabilities and reduce the impact of ‘surprises’
e.g. the ‘surprises’ of e.g. use of properties of chemicals such as
chlorofluorocarbons (CFCs) and ozone persistence or bioaccumulation as ‘predictors’
layer damage prior to 1974; asbestos of potential harm; use of the broadest possible
mesothelioma cancer prior to 1959 sources of information and long term
monitoring

Source, EEA, 2001.

Gee &Stirling

Late lessons from early warnings: learning from

history
In trying to understand the reasons for inaction on early
evidence of harm, and the resulting costs, an examination of
historical cases such as that of asbestos (see Box 2) has rarely
been conducted. The Late Lessons report attempts to help fill
that gap.

Box 2
In 1898, Lucy Deane, a UK Factory Inspector, observed:
“The evil effects of asbestos dust have also instigated a
microscopic examination of the mineral dust by HM
Medical Inspector. Clearly revealed was the sharp glass-
like jagged nature of the particles, and where they are
allowed to rise and to remain suspended in the air of the
room in any quantity, the effects have been found to be
injurious as might have been expected.” (Deane, 1898)
One hundred years later, in 1998, the UK government
decided to ban “white” asbestos, a decision that was echoed
by the European Union (EU) the following year. The
current asbestos-induced death rate in the United
Kingdom is about 3 000 deaths per year, and some
250 000–400 000 asbestos cancers are expected in Western
Europe over the next 35 years, due to past exposures
(Peto, 1999).

Fourteen case studies were chosen from a range of hazards to

workers, the public and the environment, where enough was
known of their impacts for conclusions to be drawn about how
well they were dealt with by governments and civil society (see
Box 3). Obviously, there are other public health impacts and
environmental disasters that were not looked at, such as
thalidomide (James, 1965), lead (Millstone, 1997), and the Aral
Sea (Small, van der Meer J & Upshur REG, 2001). These
provide further lessons about unintended consequences, and
about the conflict between short and long term interests. The
authors of the case studies were asked to structure their
chapters around four key questions:

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 7. Late lessons from early warnings

x When was the first credible scientific “early warning”

of potential harm?

x When and what were the main actions or inactions on

risk reduction taken by regulatory authorities and
others?

x What were the resulting costs and benefits of the

actions or inactions, including their distribution
between groups and across time?

x What lessons can be drawn that may help future

decision-making?

Authors were also asked to base their conclusions on ‘the

information available at the time and not on the luxury of
hindsight.’ The objective was to see what could be learnt from
the histories which could help prevent, or at least minimize,
the impacts of current and future economic activities that may
turn out to be harmful, and to do so without stifling innovation
or compromising science.

Box 3. Late Lessons from Early Warnings: the Case

Studies Fisheries
Radiation
Benzene
Asbestos
Polychlorinated Biphenyls (PCBs)
Halocarbons and the ozone layer
Diethylstilbesterol (DES)
Antimicrobials as growth promoters
Sulphur dioxide
MTBE in petrol
Chemical contamination of the Great Lakes
Tributyltin (TBT) antifoulants
Hormones as growth promoters
“Mad cow disease” (BSE)

The case studies and authors were chosen with a transatlantic

audience in mind. Three chapters are focused either on a

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North American issue (pollution of the Great Lakes) or

primarily on the North American handling of issues that are
also directly relevant to Europe (benzene, and DES
administered in pregnancy) and are authored by scientists
from North America. Three chapters cover issues of some
conflict between North America and Europe (hormones as
growth promoters, asbestos, and MTBE in petrol); and all
other chapters are as relevant to the environments and public
health of North Americans as they are to Europeans. The case
study authors are not without their own views, being for the
most part active participants in the process of making the
histories summarized in each chapter. However, as respected
scientists in their fields, the authors attempted to adopt an
objective position in answering the four questions put to them.

The case studies are all about “false negatives” in the sense
that they are agents or activities that were regarded at one
time as harmless by governments and others, at prevailing
levels of exposure and “control,” until evidence about their
harmful effects emerged. While the editors wanted to include
some examples of “false positives,” where action was taken on
the basis of a precautionary approach, such examples were
difficult to find. Our attention was drawn to a US publication,
Facts versus fears (Lieberman & Kwon, 1998), which
attempted to provide some 25 examples of “false positives” but
on closer examination these turned out not to be robust
enough for those who recommended them to accept our
invitation to write case studies for this report. The challenge of
demonstrating “false positives” remains: possible candidates
that have been mentioned include the ban on dumping sewage
sludge in the North Sea, and the “Y2K millennium bug.”

An early use of the precautionary principle: London,

1854
The Introduction to the “Late Lessons” report illustrates an
early use of the precautionary principle in Europe: When in
the midst of a cholera outbreak in 1854 London, the physician
John Snow recommended removing the handle off the Broad
Street Pump, based on observation of patterns of the disease.

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The removal of the pump handle, despite the absence of strong

proof that polluted water was causing the cholera, or an
understanding of the etiology of the disease, helped control the
outbreak.

The story of John Snow and cholera contained several of the

key elements of precautionary policy-making:

x the long time lag between “knowing” about a hazard

and its likely causes and “understanding” the chemical
and other processes underlying the causal links;

x a focus on the potential costs of being wrong in acting,

or not acting;

x and the use of minority scientific opinions in policy-

making, as the majority of experts then thought that
polluted air caused cholera.

There are many differences between cholera, asbestos (which

came into use at about the time of Snow’s action), and the
other harmful agents in the case studies, not least being the
time lag between exposure to the harmful agent and the
health damage: hours in the case of cholera but decades in the
case of asbestos and most of the other agents studied. Had
governments adopted a similar approach to precautionary
prevention as Dr Snow, once the early warnings on asbestos
were published, much of the tragedy and the huge costs of
asbestos exposure could have been averted.

Politicians today are working in similar conditions of scientific

uncertainty and stress to Dr Snow, but now made more
difficult by the greater risks and uncertainties (economic,
health and ecological) of larger-scale activities (Beck, 1992)
and by greater pressure from the mass media (Smith, 2000).
They also work with more democratic institutions, and are
accountable to a better-educated and involved citizenry which
has greater access to information. Globalization and free trade
issues add further complications, as does the emerging science
of complexity, which adds to the need for greater humility and

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less hubris in science. It is in these circumstances of trying to

prevent potentially serious and irreversible effects, without
disproportionate costs, that the precautionary principle can be
useful.

Learning from history?

The European Scientific Technology Observatory (ESTO)
project on technological risk and the management of
uncertainty (Stirling, 1999) provided an initial framing for this
analysis. The ESTO project sets out a comprehensive structure
for the consideration of issues relating to precaution. The most
difficult question for the EEA case study authors to answer,
was “what were the resulting costs and benefits of the actions
or inactions?” This difficulty arose partly from the authors’
lack of an economic background, and partly because precise
characterization of counterfactual history is intrinsically
highly problematic. Also, the incommensurable nature of
different effects and their diverse social distributions militate
against any definitive assessment of the general pros and cons
of alternative courses of action.

In many of the EEA case studies, adequate information about

potential hazards was available well before decisive regulatory
advice was taken. However, the information was often either
not brought to the attention of the appropriate decision-
makers early enough, or was discounted by them and other
stakeholders.. It is also true that in some of the case studies,
early warnings – and even loud and late warnings – were
effectively ignored by decision-makers because of short-term
economic and political interactions (for example asbestos,
PCBs, the Great Lakes, and sulphur dioxide and acidification).
Many of the late lessons therefore relate to the type, quality,
processing and utilization of information within the context of
more participative and democratic processes. The scale and
scope of such integrated and comprehensive processes of
hazard and options appraisal needs to be related to the likely
scale of the potential consequences (environmental, health,
social, and economic) of the activity in question. For example,
the global and generational consequences of GMOs would

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merit a more comprehensive options appraisal than the local

consequences of a road by-pass.

Twelve late lessons from early warnings

The report authors generated twelve particular lessons for
improving science and governance about uncertain, complex
risks.

1. Respond to ignorance as well as uncertainty

A central lesson of the EEA report concerns the importance of
recognizing and fully understanding the nature and
limitations of our knowledge. What is often referred to as
“uncertainty” actually hides important distinctions. All of the
activities in the case studies were subjected to some form of
(formal or informal) assessment of risk. What remained
neglected, however, was the virtual certainty that there would
be factors that remained outside the scope of the risk
assessment. This is the domain of ignorance – the source of
inevitable surprises, or unpredicted effects (see Box 14.1).

Just as one basis for scientific research is the anticipation of

positive surprises – “discoveries” – so it can yield the
corresponding prospect of negative surprises. By their nature,
complex, cumulative, synergistic or indirect effects in
particular have traditionally been inadequately addressed in
regulatory appraisal. At first sight, responding to ignorance
may seem impossible. How can strategies be devised to
prevent outcomes, which, by definition are not known?
Analysis of the case studies suggest that it is possible to do, for
example:

x Use knowledge of the intrinsic properties of a

substance or activity when assessing possible impacts,
e.g.. a chemical substance that is persistent and
bioaccumulates carries a significant risk of a long-term
hazardous impact.

x Use a diversity of robust and adaptable technological

options to meet needs. This helps to limit technological

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“monopolies” such as that of asbestos, CFCs, PCBs and

thereby the scale of any “surprises.”

x Use a variety of scientific disciplines as well as “lay”

and “local” knowledge in risk assessments in order to
more effectively gather whatever information is
available in society.

x 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., PCBs and
asbestos).

x Reduce the general use of energy and materials via

greater eco-efficiencies, so as to reduce overall
environmental burdens, thereby limiting the scale of
future surprises.

x Use liability measures (e.g. legal duties and insurance

bonds) to compensate for potentially harmful impacts
and to provide an investment fund if no “surprise”
occurs.

x Use of prospective analyses and scenarios to help

foresee unintended consequences.

x Use more long-term environmental and health

monitoring to help detect “earlier warnings” of
surprises.

x Use more and better research, and its more effective

dissemination on “early warnings” so as to encourage
earlier action to reduce risks.

2. Research and monitor for “early warnings”

Well-planned research and long term monitoring are essential
to the systematic identification of areas of uncertainty and to
increase the prospect of timely alerts to problems arising out

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of ignorance. Awareness of uncertainty and ignorance helps in

posing appropriate research questions. The case studies
illustrate that even ‘critical path’ issues, identified at an early
stage, were not necessarily followed up in a timely or effective
fashion. For example, BSE was first identified as a new
disease in cattle in 1986, but research to verify its supposed
absence of maternal transmission – important to the early
position of the UK Ministry of Agriculture, Fisheries and Food
(MAFF) – was not initiated until 1989. Maternal transmission
did occur. Experiments concerning the transmissibility of
sheep scrapie to cattle (a favored hypothesis of the source of
the disease) were not begun until 1996. No surveys of the
number of infectious, but asymptomatic, cattle entering the
food chain were conducted. Yet reassurances on the part of the
UK government continued prominently to cite the absence of
evidence, when no evidence was actually being sought.

As human economic activities become geographically more

widespread and sometimes less reversible, the use of the
‘world as a laboratory’ (the only one we have) requires more
intelligently targeted, ecological and biological surveillance.
Research may reduce uncertainties and ignorance but this will
not necessarily be the case. There are examples where
research can compound uncertainty and reveal new sources of
ignorance. For example, a Canadian mathematical model of
the interactions between various fish species suggested that
these became more unpredictable as progressively more
biological data were incorporated into the model. Calls for
more research should be as specific as possible about the
scientific questions that need to be addressed; the time such
research may take; and the independence of the relevant
organization carrying it out.

3. Search out and address “blind spots” and gaps in scientific

knowledge
The confirmation of an Antarctic ‘ozone hole’ in 1985 was a by-
product of an experiment conducted for other purposes. A
dedicated satellite observation program to monitor
stratospheric ozone had earlier detected major depletion, but

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the results were considered suspect and set aside. Another

blind spot can occur where technological change is purported
to solve historic problems, even when the hazard is long term.
For example, successive claims were made that earlier health
impacts from asbestos were due to working conditions that
had been solved. Yet, even with improvements in working
conditions, disease was still identified and it took decades to
identify the risks at each successively lower level of exposure.
A more precautionary approach means systematically
searching out such blind spots using multiple disciplines and
other sources of knowledge which can help stimulate the
interactions between disciplines that are more likely to expose
uncertain assumptions and blind spots.

4. Identify and reduce interdisciplinary obstacles to learning

When hazardous impacts arise in a particular area (ie
veterinary health) this can lead to the regulatory appraisal
becoming unduly dominated by a particular discipline, such as
medicine in the asbestos case and veterinary science in the
antimicrobials case. This implicitly created a form of
institutional ignorance. The risk appraisal for MTBE was
based mainly on knowledge concerning engines, combustion
and air pollution. Water pollution aspects associated with
persistence and significant taste and odor problems were
essentially disregarded, though the information was available.
With regards to mad cow disease, UK veterinary officials
considered the possibility of BSE transmissibility to humans
as acceptably slight. This contrasts with the attitude in the
United States, where the possible link between sheep scrapie
and human Creutzfeldt-Jakob disease (CJD) had been
regarded as a possibility since the 1970s, when the entry of
infected animals into the food chain was banned.

5. Ensure that real world conditions are fully accounted for

Real world conditions can be very different from theoretical
assumptions, with serious consequences. In the real world,
bioaccumulated metabolites of PCBs were found to be more
toxic than indicated by experiments using original commercial
PCB formulations. It was also assumed that PCBs could be

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contained within ‘closed’ operating systems. This proved

impossible, resulting in releases into the food chain from
accidents and poorly maintained equipment, and illegal
disposal. Optimistic assumptions about the performance of
halocarbon containment equipment, and of the efficiency of
decommissioning, played a role in reducing the effectiveness of
control measures. Scientific advisory committees on growth
promoters only considered circumstances relating to
authorized use, and to assessments of individual growth
promoters, rather than in combination. It was many decades
after the early warnings of asbestos harm before authorities
acknowledged that asbestos users (or even local residents
around a factory), as well as asbestos manufacturing workers,
could be at risk from exposure to the dust.

6. Systematically scrutinize and justify the claimed pros and

cons
The regulatory appraisal process generally does not
systematically examine the claims made about the benefits of
a technology or product, including an identification and
assessment of the real world conditions under which the
claimed benefits could arise.

In the DES case study, the data from 1953 trials showed that
DES was ineffective as a means of reducing risks of
spontaneous abortion in certain groups of mothers. It was not
for another 20–30 years that use of this drug was actually
banned in some countries, due to the discovery in 1970 of an
increase in a rare cancer of the vagina in daughters of treated
women. Had greater critical attention been paid at the outset
to the claims of efficacy, then some of these second-generation
cancers might have been avoided.

The need to formally justify the claimed benefits of a

technology is rare. The ionizing radiation case study is a rare
example of such a “justification principle,” developed by the
International Committee on Radiological Protection in the
1950s. This was in response to the growth of a variety of
dubious or ineffective uses of radioactive materials, such as in

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fitting shoes for children, the cosmetic removal of hair, and the
treatment of mental disorders. Surveys of radiography
practices over the past decade or so have concluded that, while
radiation doses have reduced considerably, a large proportion
of medical X-rays are still of dubious clinical benefit.

Consideration of the full environmental and health costs and

benefits of various options is also important. The failure, in
cases like asbestos, halocarbons and PCBs, to include full
environmental and health costs in market prices gave these
products an unjustifiable advantage in the marketplace. This
in turn helped to keep technically superior substitutes off the
market for longer than necessary. Although the mechanisms
for the internalization of external environmental costs, and
the practical implementation of liability regimes, are
controversial, such measures are essential if both efficiency
and equity objectives are to be addressed effectively.

7. Evaluate alternatives and promote robust, diverse and

adaptable solutions
Even where the pros are scrutinized alongside the cons, if
attention is restricted simply to isolated technologies or
products then important practical insights may be missed.
One concern is that, once a technological commitment is made,
a host of institutional and market processes act to reinforce its
position, even if it is markedly inferior to potential
alternatives.

For example, while in principle the function of MTBE might be

substituted by alternative oxygenates such as bioethanol, by
improved engine technology, or by an increase in the octane
rating of the fuels themselves, little formal scrutiny of these
alternatives appeared to have been undertaken at the time of
the promotion of MTBE. The ozone-depleting properties of
second-generation CFC substitutes were perhaps also unduly
tolerated, because of their relatively low ozone impacts when
compared with the original substances. The existence of more
benign substitutes, with less global warming potential, was
not properly examined. Broader consideration of problems may

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give rise to more beneficial solutions than simple “chemical for

chemical” substitution.

The promotion and production of alternatives needs to take

place within a culture of eco-efficiency, clean production and
closed-loop material flows so as to minimize the size of any
future surprises in the use and impact of all technologies,
including those considered to be safer than those they are
replacing.

8. Use lay and local knowledge as well as all relevant

specialist expertise
Knowledgeable lay people may include industry workers, users
of the technology and people who live in the locality or, who
because of their lifestyle or consumption habits, are most
strongly affected. The value of involving lay people lies not in
assumptions that they are more knowledgeable, or
environmentally committed, but in the complementary value
of their perspectives that are often broader in scope, more
firmly grounded in real world conditions or more independent
than the narrow professional perspectives that can accompany
specialist expertise. The histories of asbestos and PCBs
provide examples of workers being aware of hazards well
before the regulators.

Another form of lay knowledge concerns remedial measures.

For example, although fishers can be less precautionary about
stock depletion than others, there are many examples where
fishers wish to act in a precautionary manner but are
prevented from doing so because of a systems failure. There is
an increasing emphasis in Canada and elsewhere on the need
to involve fishers in management, and take full account of
their knowledge and perspectives. Swedish farmers’
knowledge of alternative animal husbandry techniques
allowed them to promote animal health and growth without
the large-scale use of antimicrobials. Not only did they bring
valuable insights to the regulatory debate, but they were able
to undertake voluntary controls in advance of regulatory
requirements.

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Lay knowledge should also receive critical scrutiny, as lay

citizens are not immune to the pitfalls and difficulties noted in
these conclusions about specialist expertise. One example is
the “pensioners’ party fallacy” amongst asbestos workers who
pointed to the presence of healthy pensioners at the firm’s
Christmas party as evidence of the apparent harmlessness of
asbestos, overlooking that those who had been harmed would
of course not be able to attend a party.

9. Take account of wider social interests and values

Social and political conflicts can be aggravated by a regulatory
preoccupation with expert judgments and a lack of attention to
public perspectives and values. This is critical to the wider
assessment of the pros and cons. The implicit assumptions and
values of specialists and interest groups need to be aired and
shared. The Swedish farmers in the antimicrobials case study
show how lay views can help ensure that the regulatory
process reflects enlightened public and consumer values.

While expert institutions tend to focus on scientific analysis, a

public aversion to situations outside the bounds of normal
experience (“common sense”), or at least a desire to proceed
with caution, can be defended as a rational response to
scientific uncertainty. A key feature of the public reaction to
the emerging evidence of BSE was the surprised revulsion
that ruminants were being fed on offal and bodily wastes. It
seems likely that avoiding offal in ruminant feed would have
at least significantly limited the scale of the subsequent BSE
and CJD problems.

10.Maintain regulatory independence from economic and

political special interests
There is evidence in the case studies that interested parties
are often able to influence regulators unduly. As a result
decisions that might reasonably have been made on the basis
of the available evidence were not taken. Benzene was
demonstrated to be a powerful bone marrow poison in 1897;
the potential for acute respiratory effects of asbestos was first
identified in 1898; and the first cases of PCB-induced

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chloracne were documented in 1899, with effects on workers

known by the late 1930s. Yet it was not until the 1960s and
1970s that significant progress began to be made in restricting
the damage caused by these agents. Similarly, the temporary
lifting of the ban on DES as a growth promoter in the United
States in 1974 followed strong pressure from the farming
lobby, and occurred despite the availability of alternatives.

Independent information institutions are thus a key element

of authentic regulatory independence and robust governance
and appraisal. This is increasingly being recognized, for
example by the shifting of advisory committees from producer
directorates in the European Commission (for example,
agriculture) to the Health and Consumer Directorate. The
setting up of independent food agencies in some Member
States and at the EU level also reflects this concern for more
independent hazard appraisal institutions.

11. Identify and reduce institutional obstacles to learning and

action
The asbestos, benzene and PCB case studies provide examples
of how the short-term horizons of government and businesses
can militate against social welfare in the medium and long
term. However, institutional obstacles against timely
protection of health and the environment can take other forms
as well. The case studies illustrate three other areas: those
resulting from periods of transition (for example between
succeeding elected administrations), or from tensions between
different departments or levels of government and “their”
agencies, or from differing national approaches.

An official UK commission in 1979 recommended the setting of

minimum processing standards in the rendering industries. A
new administration later that year decided to withdraw the
resulting proposed regulations, finding them to be an
unnecessary burden on industry. It is not clear to what extent
such tighter standards might actually have inhibited the later
BSE outbreak, but it is notable that the implementation of

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standards of this sort featured prominently among that same

government’s later responses to the BSE crisis in 1996.

12. Avoid paralysis by analysis and apply precautionary

measures where there are reasonable grounds for concern
The general tenor of the lessons so far is to ‘know more’. But
how much information about potential hazards is deemed
enough to trigger risk reduction measures? There is a danger
of paralysis by analysis where either information overload, or
lack of political will, lead to a failure of timely hazard
reduction measures. One example is the anti-precautionary
straightjacket imposed upon U.S. benzene regulation by a
Supreme Court decision, which required layer upon layer of
additional information before regulatory action to reduce risks
was possible, resulting in a ten year delay in the occupational
benzene standard.

Experts have often argued at an early stage that we know

enough to take protective action. For antimicrobials the UK
Swann Committee in 1969 concluded: ‘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’. Other case studies, such as
asbestos and BSE, suggest that more, or better-targeted,
research, at an earlier stage, would have helped minimize
future costs. Similarly, for fisheries, the Ecosystems Principles
Advisory Panel to the US Congress concluded: “There will
always be unmeasured entities, random effects, and
substantial uncertainties, but these are not acceptable excuses
to delay implementing an ecosystem-based management
strategy.”

The level of proof (or strength of evidence) needed to justify

hazard reduction measures will vary with the size and nature
of the claimed benefits of the economic activity, its likely costs,
the significance of the uncertainties and types of ignorance
involved, and the availability of alternatives. The choice of

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which level of proof to use is a political choice based on values

and ethics as well as science.

The usual assumption in the case studies was that an activity

was harmless until proven harmful by the public authorities.
However, where activities are considered to be intrinsically
harmful, as with pesticides and pharmaceuticals, the burden
of demonstrating at least some evidence of harmlessness is
placed on the proponents of the activity. The Swedish
Chemicals Act of 1975 provides a clear illustration of both
different levels of proof and different locations of the burden of
proof in the same legislation. It requires the Public Authority
to take precautionary action on a chemical substance based on
a “scientific suspicion of risk” but then the burden of proof
passes to the producer of the substance, who has to show that
it is harmless “beyond all reasonable doubt.” This example
illustrates that a high level of proof is needed to show
harmlessness when there is already evidence of potential
hazard, whereas a lower level of proof is needed to
demonstrate potential harm when harmlessness is assumed.

Burdens of demonstrating harmlessness can involve

obligations to:

x justify the technology in relation to the benefits

claimed;

x show that alternative ways of meeting needs are likely

to be more hazardous or disproportionately costly.

x monitor the impacts of the technology; and

x investigate “early warnings.”

Conclusion
The EEA report provides a rich empirical history to underpin
the twelve “late lessons” with which it concludes. Taken
together, these lessons may help to minimize the future costs
of being wrong about environmental and health risks. In the

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past, conventional scientific method has been biased towards

avoiding the overstating of risks, sometimes at the expense of
public safety and the environment. As Underwood
(Underwood, 1999) concludes: ‘Typically there has been little
concern about Type II (a ‘false negative’) error. The chances of
erring in “favor” of the environment (a Type I error) is
deliberately kept small, whereas the chances of erring
“unfavorably” to environmental issues is not!” Participants at
a recent European workshop of policymakers concluded,
among other things, that “there should be a more efficient and
ethically acceptable balance between the generation of ‘false
positives’ and ‘false negatives’” (Swedish Environment
Ministry, 2001). If implemented, the EEA’s lessons should
contribute both to fewer ‘false negatives’ and to lower costs
from any “false positives” that may occur.

A further key finding of the EEA report is that we need to be

more precise and rigorous about what we mean by
‘uncertainty.’ Risk, uncertainty and ignorance each warrant
different treatment. More attention should be given to the
handling of complexity, indeterminacy, ambiguity, and
disagreement within or between technical disciplines (Wynne,
2001; Stirling 1999, 2003). In short, risk assessment should
become more reflective and humble. There is nothing scientific
about the ‘pretence at knowledge’ (von Hayek, 1978). As the
NRC (1996) and others in the United States (Omen et
al., 1997) and the United Kingdom (RECP, 1998) have
concluded, the prior framing of hazard appraisal requires open
public deliberation on issues such as the questions to be
addressed by science, the weighting of different risks and
benefits, the balance to strike between comprehensiveness and
specificity, and the interpretation of uncertainty, ambiguity
and ignorance.

As long as these issues remain neglected or implicit, the

‘pretence at knowledge’ in risk assessment has the effect of
undermining the authority and credibility of the associated
institutions, and even of science in general. As Stirling (1999,
2003) has pointed out, the precautionary principle has nothing
to do with anti-science. Indeed, it embodies a more rigorous

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and robust approach to scientific uncertainty and systems

complexity.

The tools for participatory approaches are in various stages of

development, and the challenges are far from trivial. But this
has to be set against traditional approaches, where the costs of
failure can also be high even for industry, as illustrated by the
European public rejection of irradiated foods and the
European response to many of the food applications of GMOs.

These considerations indicate the importance of

acknowledging the interpenetration of facts and values.
Popper pointed out long ago that is rationally impossible to
derive a proposal for a policy from facts alone (Popper, 1962).
Policies that unduly emphasize the factual basis of decisions,
without explicitly acknowledging, and engaging with, the
value judgments that frame and constitute the relevant facts,
are unlikely to lead to robust decisions, or to achieve public
acceptance (RMNO, 2000).

Critiques of the precautionary principle often cite its supposed

stifling of innovation. However, the implementation of the
EEA’s twelve late lessons would stimulate the application of
some emerging tools for the fostering of environmental
innovations. By maximizing the breadth of available
information and focusing on constructive solutions, approaches
like integrated environmental assessment (EFIEA, 2000;
Dowlatabadi & Rotmans, 2000), multi-criteria mapping
(Stirling & Mayer, 1999), constructive technology assessment
(Rip et al 1996), technology options analysis (Ashford 1991,
1984; Tickner, 2000), alternatives analysis (O’Brien, 2000),
and ‘what-if’ scenarios and participatory scenario development
techniques, can all assist in the management of ambiguities,
uncertainties and societal ignorance, while encouraging
technological, scientific, and social innovations.

Technological systems have a tendency to ‘lock’ into particular

configurations at a relatively early stage in their development,
thus foreclosing other options and raising the costs of shifting
to alternatives. The particular technologies that gain

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ascendancy in this way may do so for arbitrary reasons which

may have little to do with intrinsic qualities, and everything to
do with chance and “first-leader” advantage. A technology can
then virtually monopolize the meeting of some societal needs,
as the histories of asbestos, CFCs, benzene, and PCBs
illustrate. Application of the above ‘precautionary’ approaches
to technology appraisal early on in the innovation process can
often promote environmental innovations that are more cost
effective than when introduced after harmful technologies
have become ‘locked in’.

There is one final implication of the EEA’s lessons for risk

science and policy. Following episodes such as BSE in the
United Kingdom, dioxins in Belgium, and HIV-contaminated
blood in France, public trust in risk science is at a very low ebb
in Europe. Governments are increasingly aware of this and are
developing responses, such as the EU White Paper on
European Governance (July 2001). This includes
recommendations for improving public participation in
managing the inter-reactions between science, technologies
and society, issues which other public authorities outside
Europe are also promoting (eg Ministry of the Environment,
New Zealand, 2001, National Oceans Office, Australia, 2001).
The need for broader engagement in risk decision making,
highlighted in many of the EEA lessons, links directly with
these wider imperatives for the democratizing of scientific
expertise. The stakes are high, not just for public health and
the environment, but for how we go about choosing our future
technological pathways and for who has control.

Postscript
Since the European Environment Agency published Late
lessons from early warnings: the precautionary principle
1896–2000, there have been a number of criticisms of the
precautionary principle. Some have enriched the debate, but
many are based on misconceptions. The most common
misconceptions are identified and clarified below.

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 7. Late lessons from early warnings

x The precautionary principle is not a prediction – it is a

process that may or may not lead to measures to
reduce exposure.

x The precautionary principle is not the same as

“prevention”, which is concerned with “known” risks.
“Precaution” is concerned with uncertain and
unknown hazards and risks. For example, bans on
asbestos or tobacco smoking in the 1950s and 1960s
would have involved both precaution and prevention,
but bans in 2003 are simply prevention because the
risks are now well known.

x The precautionary principle is not based on zero risk

but aims to reduce lower and more acceptable risks
and hazards with lower overall costs, both quantifiable
and non-quantifiable.

x The precautionary principle does not ensure against

misuse or poor decision-making, as with any other
policy tool.

x The precautionary principle is not the same as risk

assessment. It is broader, deeper and supplementary
to risk assessment.

x The precautionary principle is not oblivious to costs of

all kinds and in both directions (that is, of acting or
not acting to reduce risks and hazards), including
secondary costs and benefits.

x The precautionary principle is not one-sided. It applies

to substitutes and alternatives as well.

x The precautionary principle is not based on anxiety

and emotion but rather uses the best of the systems
sciences of complex processes to make wiser decisions
in the face of uncertainty.

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x The precautionary principle does not guarantee

consistency or predictability between cases and
decisions. Each case is different and has different facts
and values.

x The precautionary principle does not brake but rather

stimulates innovation and can combat monopoly
technologies that might inhibit innovation such as
chlorofluorocarbons, asbestos and polychlorinated
biphenyls.

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8. Applying the precautionary principle in
environmental risk assessment to children

Philip J. Landrigan & Leonardo Trasande

Introduction
Infants and children are not little adults. They are
qualitatively different from mature humans in many aspects
of their behaviour and biology and thus are more vulnerable
than adults to many environmental toxicants. Lead, mercury,
pesticides, tobacco smoke, alcohol, dioxins and polychlorinated
biphenyls are among the chemicals that have been found to be
especially toxic to children (Harada, 1968; Amin-Zaki et al.,
1979; McConnochie & Roghmann, 1986; Bellinger et al., 1987;
Ogston, Florey & Walker, 1987; Haddow et al., 1988; Reed &
Lutz, 1988; Strachan, Jarvis & Feyerabend, 1989; Needleman
et al., 1990, 2002; Weitzman et al., 1990; Martinez, Cline &
Burrows, 1992; Chilmonczyk et al., 1993; Eskenazi, Prehn &
Christianson, 1995; Jacobson & Jacobson, 1996; Longnecker,
Rogan & Lucier, 1997; Eskenazi, Bradman & Castorina, 1999;
World Health Organization, 1999; Blanck et al., 2000;
Lanphear et al., 2000; National Academy of Sciences, 2000;
Weisglas-Kuperus et al., 2000). The Second national report on
human exposure to environmental chemicals of the United
States Centers for Disease Control and Prevention (2003) has
determined that children bear significantly heavier body
burdens than adults of many environmental chemicals. For
example, children have a two-fold higher urine level of the
pesticide chlorpyrifos and a nearly three-fold higher serum
level of cotinine, the principal metabolite of second-hand
cigarette smoke.

Risk assessment and risk management are the tools currently

used to protect populations against toxic environmental
hazards. These methods, as currently practised, have major
shortcomings: they consider only one chemical at a time; they
fail to account for the unique exposure and special
vulnerability of susceptible groups within the population, such

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as infants and children; and they presume, even in the

absence of toxicological testing data, that chemicals cause no
injury to health until injury is irrefutably proven. For these
reasons, traditional risk assessment fails to protect the health
of infants and children.

Evidence is increasing steadily that children's inadequately

controlled exposure to toxic chemicals is responsible for a
range of chronic diseases, including asthma, cancer, certain
birth defects, and neurodevelopmental disabilities. The
incidence rates of all of these diseases are rising. Chronic
diseases – asthma, developmental disabilities, cancer, autism
and obesity – are the predominant causes of sickness,
disability and death today among children in industrialized
countries. The rates of many of these diseases are on the rise.
These illnesses have been termed the new paediatric
morbidity (Haggerty & Rothman, 1975). Their increasing
incidence represents a failure of prevention and signals a need
for enhanced research into the causes and for change in
prevention policy.

This chapter describes the weaknesses of traditional risk

assessment that underlie its failure to protect children’s
health. We argue that the risk assessment paradigm must be
modified if human health is to be preserved, and especially to
protect infants and children. We argue that the precautionary
principle, when judiciously combined with traditional risk
assessment and risk management, will do a superior job of
protecting children from environmental hazards. We suggest
three specific applications of the precautionary principle
within the risk assessment paradigm.

x The worst chemicals must be banned outright, as has

happened intermittently in the past.

x The current practice of releasing untested and

potentially problematic chemicals to the environment
to learn only years or decades later of their hazards
must end; careful pre-market testing is needed.

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x Health-protective safety factors must be built into the

traditional risk assessment paradigm to protect
children's health when the available data are
insufficient to support a strictly mathematical
approach to the computation of risk.

We argue that children will continue to suffer disproportionate

health effects from environmental toxins until risk assessment
embraces and incorporates the precautionary principle.

Traditional risk assessment

Risk assessment and risk management are the core
components of the methods currently employed to protect
populations against environmental hazards (National
Academy of Sciences, 1983). These methods, as traditionally
practised, fail to protect the health of infants and children
(National Research Council, 1993). Traditional approaches to
risk assessment account for neither children’s unique
vulnerability nor their unique patterns of exposure to
environmental toxins. This failure contributes to the current
widespread failure of disease prevention.

Risk assessment is a mathematical approach to computing

risk and preventing diseases of toxic environmental origin that
is based on the proposition that there are quantitative dose–
response relationships between the level of exposure to a
chemical and the frequency and severity of disease. The
underlying hypothesis is that knowing the dose–response
relationship between a chemical and the disease or
dysfunction it has caused allows a scientifically based
standard to be developed that will protect human health.

Risk assessment appears straightforward, precise and logical.

For these reasons, it is extremely attractive and its application
has become widespread. However, as currently practised, both
risk assessment and risk management are deeply flawed. One
flaw is that risk assessment has traditionally studied only one
chemical at a time. This approach fails to recognize the reality
that people are exposed to hundreds of chemicals that

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probably have multiple interactions and synergistic effects on

human health. Risk assessment is not a sufficiently powerful
tool to address these complexities.

Another flaw inherent in risk assessment, as traditionally

practised, is that it has assumed that entire populations
consist of healthy adults – a “one size fits all” approach. This
overly simplistic assumption ignores the reality that
populations are highly heterogeneous. It fails to consider the
differential impact that environmental toxins may have on
infants, children and other vulnerable groups. It also ignores
the differing susceptibility and exposure people may have to
environmental toxins. The Human Genome Project is
beginning to elucidate the complexity of the gene–environment
interactions that affect individual susceptibility to
environmental chemicals (Kelada et al., 2003). One recent
study (Lammer et al., 2004), for example, found a fourfold
increased risk of orofacial clefts among infants with the NAT1
and NAT2 genetic polymorphisms born to mothers who
smoked. Further understanding of the role of genetic
polymorphisms and of their interaction with environmental
toxins will further undermine this basic premise of
homogeneity that lies at the core of risk assessment as
currently practised.

A final and perhaps most profound shortcoming of the

traditional risk assessment and risk management paradigm is
that it presumes that chemicals are innocent until proven
guilty. It assumed that a chemical is harmless until data have
been assembled that demonstrate with a minimum statistical
significance of 0.05 that a chemical can cause harm.
Unfortunately, most chemicals have not been assessed at even
the most basic level for their potential to cause toxicity in
animals or in humans. Even less information is available on
developmental toxicity and toxicity among children (EPA,
1998a). In the absence of such data, harm becomes impossible
to prove. Thus populations continue to be exposed to chemicals
in a potentially dangerous and uncontrolled natural
experiment.

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More than 80 000 new synthetic chemicals have been

developed and disseminated in the United States over the past
50 years. Children are at special risk of exposure to the 2 800
high-volume chemicals that are produced in quantities greater
than 450 000 kg per year and that are most widely dispersed
in air, water, food crops, communities, waste sites and homes
(EPA 1998a). Fewer than half of these high-volume chemicals
have been tested for their potential toxicity, and fewer still
have been tested for their possible developmental toxicity to
fetuses, infants and children (National Academy of Sciences,
1984; EPA, 1998b).

Why are children especially vulnerable to

environmental toxins?
In the past decade, researchers and policy-makers have
increasingly recognized that children have unique exposure
and special vulnerability to environmental chemicals and
therefore require special consideration in risk assessment
(National Research Council, 1993).

Children have disproportionately heavy exposure to many

environmental agents
Children drink more water, eat more food and breathe more
air per kilogram of body weight compared with adults. For
example, children in the first six months of life drink seven
times as much water, and children ages 1–5 years eat three to
four times as much food on a body-weight basis than the
average adult. The air intake of a resting infant is twice that
of an adult. The implication of these findings for health is that
children will have substantially greater exposure than adults
to any environmental contaminants present in water, food and
air (National Research Council, 1993). Two additional
characteristics of children further magnify their exposure:
their hand-to-mouth behaviour and their play close to the
ground.

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Children’s ability to metabolize, detoxify and excrete

environmental agents differs from that of adults
In some instances, children are better able than adults to deal
with environmental agents (Spielberg, 1992; National
Research Council, 1993) because they cannot create the active
metabolite required for toxicity. In other instances, children
are less able to deal with toxic chemicals and thus are more
vulnerable to them (Spielberg, 1992; National Research
Council, 1993). Metabolism also differs between prenatal and
postnatal life and may vary over the course of pregnancy. An
additional source of vulnerability in fetuses and young
children is that the blood–brain barrier is not fully developed,
and xenobiotics may therefore be more easily able to enter the
central nervous system (Rodier, 1995).

Developmental processes are easily disrupted during rapid

growth and development before and after birth
Rapid growth and development occur during embryonic and
fetal life as well as in the first years after birth. In the brain,
for example, billions of cells must form, move to their assigned
positions and establish precise connections with other cells
(Rodier, 1995). Development of the endocrine and reproductive
organs is guided by a complex and precisely timed sequence of
chemical messages. If cells in an infant’s brain are destroyed
by chemicals, if connections between neurons fail to form or if
false signals are sent to the developing reproductive organs by
endocrine disrupters, nervous system or reproductive
dysfunction may result (Bellinger et al., 1987; Needleman et
al., 1990; Jacobson & Jacobson, 1996). The effects can persist
throughout life.

Children have more years of future life and thus more time to
develop diseases initiated by early exposure
Because children have more future years of life than most
adults, they have more time to develop chronic diseases that
may be triggered by early exposure. Many diseases caused by
toxic agents in the environment require decades to develop.
Many of those diseases, including cancer and

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neurodegenerative diseases, are thought to arise through a

series of changes within cells that require many years to
evolve from initiation to actual manifestation of illness.
Exposure to environmental agents early in life, including
prenatal exposure, appears more likely to produce chronic
disease than similar exposure encountered later (Gray et al.,
1991; Ekbom et al., 1997; Landrigan et al., submitted). Thus,
there are likely to be critical windows of exposure, even for
these chronic diseases, that need to be further explored.

The incidence of several chronic diseases has been increasing

among children in the United States. This new paediatric
morbidity (Haggerty & Rothman, 1975) has become the main
cause of illness and death among children in the United
States. Increases in the rates of these diseases have raised the
urgency of applying the precautionary principle to protect
children from environmental toxins. Many diseases of great
importance to children in the United States today have been
shown, or at least suspected, to be caused or aggravated by
chemicals in the environment. Examples include asthma, for
which incidence and mortality have more than doubled in the
past decade (United States Centers for Disease Control and
Prevention, 1995a). These increases are particularly evident in
urban localities. In New York and in other major cities,
asthma has become the leading cause of admission of children
to hospitals and the leading cause of school absenteeism
(United States Centers for Disease Control and Prevention,
1995b). The increasing prevalence of asthma and the higher
asthma morbidity among children in the United States, albeit
still unexplained, suggest that, compared with adults, children
are more likely to develop asthma and asthma exacerbation
and/or be exposed to chemical or other factors that cause or
trigger asthma episodes.

The reported incidence of childhood cancer has also increased

substantially in the United States in the past two decades
(Devesa et al., 1995). Although death rates have declined as a
consequence of early detection and vastly improved treatment,
data from the National Cancer Institute show that the
reported incidence of acute lymphoblastic leukaemia increased

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by 27% from 1973 to 1990, from 2.8 cases per 100 000 children
to 3.5 per 100 000. Since 1990, the incidence of acute
lymphoblastic leukaemia has declined in boys but continues to
rise in girls (Robison et al., 1995). From 1973 to 1994, the
incidence of brain cancer increased by 40%, with nearly equal
increases in boys and girls (Schechter, 1999).

Neurodevelopmental disorders, including learning disabilities,

dyslexia, mental retardation, attention deficit disorder and
autism, are widespread and affect 5–10% of the 4 million
babies born in the United States each year. Some clinical
investigators have reported that prevalence is increasing, but
existing data are not of sufficient quality to either sustain or
refute that position (American Academy of Pediatrics, 2001). A
report from the National Research Council (2000) concluded
that 3% of developmental disabilities directly result from
neurotoxic environmental exposure and that another 25%
arise from the interplay of environmental factors and
individual genetic susceptibility (environment was defined
broadly in this report and included diet, alcohol, tobacco and
other lifestyle factors as well as toxic chemicals).

Although the causes of most of these chronic diseases are not

well understood, the lack of understanding has taken a
significant economic toll on United States society.
Environmental diseases among United States children now
account for at least US$ 54.9 billion per year or 2.8% of the
nationwide costs of illness. This estimate is probably
conservative, because it considered only the diseases for which
environmental links are best understood and did not account
for the pain, deterioration in quality of life and emotional
distress that children, families and relatives suffer from these
diseases (Landrigan et al., 2002).

Past success of the precautionary principle: the

National Research Council report on pesticides in
the diets of infants in children
The question of whether to regulate and at what level of
certainty is perennial in environmental health. Advocates of

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aggressive regulatory prevention point to John Snow’s

triumph in halting the London cholera epidemic by removing
the handle of the Broad Street pump more than three decades
before discovery of Vibrio cholerae, the epidemic’s causative
agent.

Over the past several decades, the United States has

intermittently been highly precautionary in regulating
chemicals and thus in protecting children’s health. The United
States banned the use of chlorofluorocarbons in aerosols in
1977, several years before several European countries
interceded. Manufacture of polychlorinated biphenyls was
banned in 1977 in the federal Toxic Substances Control Act.
Diethylstilbestrol was outlawed as a growth promoter in beef
as early as 1972, well before the European Union banned its
use in 1977 (Gee et al., 2002). And the National Research
Council (1993) report on Pesticides in the diets of infants and
children represents the most profound success of the
precautionary principle in protecting children from
environmental risks to date. Its publication was a critical
event in raising awareness about children’s unique exposure
and vulnerability and represents a paradigm for applying the
precautionary principle in protecting children from
environmental health hazards.

The National Research Council (1993) report recommended

that risk assessment move beyond consideration of “average”
exposure based primarily on adult characteristics to an
approach that accounted for the heterogeneity of exposure and
for potential differences in sensitivity at various life stages,
especially during prenatal development, infancy and
childhood. The report built on guidelines that the EPA (1986,
1991) had published for developmental toxicity risk
assessment in 1986 and revised in 1991. It also built on other
published documents such as Similarities and differences
between children and adults: implications for risk assessment
(Guzelian, Henry & Olin, 1992).

The National Research Council (1993) report noted that

“children are not little adults” and called for the development

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Landrigan & Trasande

of new risk assessment methods that would incorporate better

data on children’s exposure to pesticides during fetal
development, infancy and childhood. To “provide a more
complete characterization of risk”, the National Research
Council Committee on Pesticides in the Diets of Infants and
Children recommended the use of exposure distributions,
recognizing that levels of exposure could differ by several
orders of magnitude between children and adults. The report
also recommended that exposure assessment be expanded to
consider exposure to multiple chemicals with multiple routes
of exposure.

The National Research Council Committee also recommended

the development of pharmacokinetic models that could
incorporate the unique physiological features of young
developing humans. It recommended that bioassay protocols
incorporate the relative contributions of exposure at different
ages to lifetime risk. In addition, the Committee noted the lack
of “appropriate toxicological tests for perinatal and childhood
toxicity” that could be used to incorporate toxicity to these
populations in risk assessment models.

Given the admitted uncertainty about childhood exposure and

toxicity at different stages of development, the National
Research Council Committee concluded that, “in the absence
of data to the contrary, there should be a presumption of
greater risk to infants and children”. To validate this
presumption, the Committee recommended that “the
sensitivity of mature and immature individuals should be
studied systematically to expand the current limited database
as to relative sensitivity”. To provide enhanced protection to
children during vulnerable periods of early development, the
National Research Council Committee recommended that a
child-protective safety factor of up to 10-fold be considered in
risk assessment “when there is evidence of developmental
toxicity and when data from toxicity testing relative to
children are incomplete”.

The Committee noted that the EPA and United States Food
and Drug Administration had historically divided the no-

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observed-effect level obtained in animal test results by an

uncertainty factor of 100-fold in establishing a reference dose
for toxic effects other than cancer or heritable mutation. This
uncertainty factor incorporates a 10-fold uncertainty to
account for extrapolating data from animals to humans and a
second 10-fold uncertainty to accommodate variation within
the human population.

While the Committee acknowledged that the latter

uncertainty factor “generally provides adequate protection for
infants and children”, the Committee nevertheless
recommended consideration of a third, child-protective safety
factor in risk assessment. This safety factor was proposed to
account for the great gaps in developmental toxicity testing
data for many chemicals.

Following publication of the National Research Council report,

most of its recommendations were incorporated into the Food
Quality Protection Act of 1996, the principal federal statute on
pesticides in the United States, which was passed by
unanimous vote of both houses of the United States Congress.
It requires that standards for agricultural pesticides be set at
levels sufficiently strict to protect the health of infants and
children. It directs the EPA to use an additional tenfold safety
factor in assessing the risks to infants and children to take
into account the potential for pre- and postnatal toxicity,
particularly when the toxicology and exposure databases are
judged to be incomplete. The statute authorizes the EPA to
replace this default tenfold “Food Quality Protection Act safety
factor” with a different factor only if, based on reliable data,
the resulting margin would be adequate to protect infants and
children. This requirement was intended by Congress to
stimulate the generation of data on developmental toxicology
and on exposure in early life. As of July 30, 1999, the Food
Quality Protection Act child safety factor has been applied to
3 290 of 9 721 (34%) of pesticide tolerances evaluated by EPA
(EPA, 1999a). A review of current reference doses and
reference concentrations to which safety factors are applied to
pesticides suggests that some pesticides should actually

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receive a 30- to 50-fold child safety factor (Castorina &

Woodruff, 2003).

The Food Quality Protection Act has also led to outright bans
of certain uses of toxic pesticides that place children at risk. In
2000, after reviewing data on the fetal neurotoxicity of the
commonly used organophosphate pesticide chlorpyrifos, EPA
chose to ban residential use of this pesticide (EPA, 2000).
Similarly, on August 2, 1999, EPA Administrator Carol
Browner announced the voluntary cancellation of many of the
most significant food crop uses of methyl parathion, in large
part because of its developmental risk assessment under the
Food Quality Protection Act (EPA, 1999b).

Recent epidemiological studies indicate that applying the

precautionary principle is an effective intervention against
exposure to toxic substances. Children who ingest solely food
that is organically grown excrete one sixth as much urinary
organophosphate metabolites as children who ingest foods
grown with pesticides (Curl, Fenske & Elgethun, 2003).

A dangerous trend threatens to undermine the successful

application of the precautionary principle in United States
pesticide regulation. The industry has begun to conduct small
studies in humans to assess the health effects of pesticides.
The apparent motivation for these studies is to substitute for
rigorous, larger-scale studies that can assess subtle health
effects or health effects with a relatively long latency period.
However, these studies raise significant ethical concerns and
fail to meet the evidentiary standards approved for new
pharmaceuticals by the United States Food and Drug
Administration (Oleskey et al., 2004) Nevertheless, the United
States National Academy of Sciences (2004) recently
recommended that the EPA accept human testing studies
provided that they have been reviewed by an appropriate
review body, inform existing risk assessments and meet other
ethical and scientific requirements. Debate on the ethics of
human testing continues (Sass & Needleman, 2004).

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 8. Precautionary principle and children

Consequences of failure to apply the precautionary

principle
A devastating example of the failure to apply the
precautionary principle occurred in the regulation of benzene
in the late 1970s and early 1980s. In 1978, the United States
Occupational Safety and Health Administration reduced the
standard for permissible exposure for benzene from 10 parts
per million (ppm) to 1 ppm. Shortly thereafter, the Fifth
Circuit Court of Appeals blocked this ruling, and in 1980, the
Supreme Court overturned the regulation, citing insufficient
evidence of benefit. As a result, until 1997, when the standard
was lowered again, an estimated 9 600 United States workers
were exposed to benzene at levels between 1 and 10 ppm, and
an additional 370 were exposed at levels above 10 ppm.
Between 30 and 490 excess deaths from leukaemia are
anticipated to result from occupational exposure to benzene
exceeding 1 ppm between 1978 and 1987, and additional
deaths will likely occur from aplastic anaemia and lymphoma
(Nicholson & Landrigan, 1989).

Early disease outbreaks of environmental origin in children

have also failed to produce proactive response and regulation
to protect children. The history of lead use in the United
States provides a chilling reminder of the failure to use the
precautionary principle. Lead poisoning in young children was
first recognized in 1904 in Queensland, Australia, where a
clinical and epidemiological investigation traced the source of
an outbreak to the ingestion of lead-based paint by children
playing on verandas (Gibson, 1904). This led to the banning of
lead-based paint in many countries.

The removal of lead from gasoline has been indicated as a

successful application of the precautionary principle. The
argument is that this contributed dramatically to reducing the
mean childhood blood lead level by 90% from 1976 to 1999 and
produced economic benefits for each year’s cohort of 3.8 million
two-year-old children ranging from US$ 110 billion to US$ 319
billion (Grosse et al., 2002). However, although the success of
this initiative should not be overlooked, the primary rationale

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for removing lead from gasoline was to protect the catalytic

converters installed in many new cars in 1975 to reduce auto
air pollution emissions. Lead was not legally required to be
eliminated from all gasoline until 1985, more than 50 years
after the danger to children of tetraethyl lead in gasoline was
recognized (EPA, 1985).

Other current environmental threats to children remain

unheeded despite recognized public health epidemics that
could have resulted in prudent prevention. A report from
Minamata, Japan, in the 1960s described an epidemic of
cerebral palsy, mental retardation and convulsions among
children living in a fishing village on the Inland Sea. This
epidemic was traced to ingestion of fish and shellfish
contaminated with methylmercury. The source of this mercury
was found to be a plastics factory that had discharged metallic
mercury into the sediment on the floor of Minamata Bay. The
mercury was transformed by microorganisms into
methylmercury and then bioaccumulated as it moved up the
marine food chain, eventually reaching children who ate fish
and shellfish. The most devastating effects were seen among
children exposed in utero (Harada, 1978).

Despite this public health lesson, mercury emissions from

power plants also remain a significant environmental problem.
The 1999–2000 National Health and Nutrition Examination
Survey of the United States Centers for Disease Control and
Prevention found that 8% of women of childbearing age in the
United States had mercury levels in blood exceeding the EPA’s
reference dose of 5.8 µg/l (Schober et al., 2003). Clearly, the
evidence that supports the need for the precautionary
principle is only increasing, and preventable chronic diseases
in children will continue to increase in prevalence if it is not
applied.

Conclusion
Opponents of the precautionary principle argue that it will
stifle technological innovation and harm public health and the
environment by diverting attention from known to speculative

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 8. Precautionary principle and children

environmental hazards (Graham, 2004). This concern must be

addressed and resolute efforts to study the health effects of
environmental chemicals must continue so that people can act
with the most information possible.

Fundamentally, however, opponents’ concerns are misguided

and overstated. They miss the point that protecting the health
of vulnerable populations, especially children, is the core
mission of public health. They do not recognize that risk
assessment and risk management, as currently practised, fail
to provide this protection.

We argue that the current approach to risk assessment needs

to be modified by applying the precautionary principle to
protect children’s health. Chemicals need to be presumed
potentially toxic until proven safe; the current practice of
releasing untested and potentially problematic chemicals to
the environment to learn only years or decades later of their
hazards cannot continue. The worst chemicals need to be
replaced outright, as has happened intermittently in the past.
Safety factors need to be inserted into the traditional risk
assessment paradigm to protect children’s health when the
available data are insufficient to support a strictly
mathematical approach to computing risk.

The spirit of the precautionary principle is to react proactively

to significant environmental threats before they cause harm.
Children deserve especially proactive implementation of the
precautionary principle because of their unique vulnerability
and patterns of exposure to environmental toxins. Although
the United States has made significant strides in reducing the
prevalence of lead poisoning among children, the public is
learning ever more about the significant health effects of
newer chemicals such as phthalates that have already been
disseminated widely in the environment (Heindel et al., 1989;
Gray et al., 2000). The lead epidemic may pale in comparison
to the environmental epidemics of the future if regulators do
not prudently apply the precautionary principle to protect the
world’s most valuable resource – children.

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 9. The precautionary principle in environmental science

9. The precautionary principle in

environmental science2

David Kriebel, Joel A. Tickner, Paul Epstein, John Lemons,

Richard Levins, Edward L. Loechler, Margaret Quinn,
Ruthann Rudel, Ted Schettler & Michael Stoto

Introduction
There are few pressing social issues that depend as heavily on
scientific information as do environmental problems. Most
scientists and policy makers agree on the importance of
science in environmental policy debates, even when they can
agree on almost nothing else about the health of the
ecosphere. Thus, environmental scientists play a key role in
society’s responses to environmental problems, and many of
the studies performed by environmental scientists are
intended ultimately to affect policy. The precautionary
principle has been proposed as a new guideline in making
environmental policy (O’Riordan & Cameron, 1994; Freestone,
1996). In this paper we examine the implications of the
precautionary principle for environmental scientists. Specific
objectives are to define the precautionary principle and
illustrate it through three brief examples; identify aspects of
conventional science that may inhibit precautionary policies;
identify new directions for scientific research that would better
inform precautionary policies; and promote dialogue among
environmental scientists about the usefulness and potential
applications of the precautionary principle.

2Reproduced by permission of National Institute of Environmental

Health Sciences, USA, from Environmental Health Perspectives
2001;109: 871–876.

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Kriebel et al.

Definition of the precautionary principle

A 1998 consensus statement characterized the precautionary
principle this way: “when an activity raises threats of harm to
human health or the environment, precautionary measures
should be taken even if some cause and effect relationships are
not fully established scientifically” (Raffensperger & Tickner,
1999). The statement went on to list four central components
of the principle: taking preventive action in the face of
uncertainty; shifting the burden of proof to the proponents of
an activity; exploring a wide range of alternatives to possibly
harmful actions; and increasing public participation in
decision making. The term “precautionary principle” came into
English as a translation of the German word Vorsorgeprinzip.
An alternative translation might have been “foresight
principle,” which has the advantage of emphasizing
anticipatory action—a positive, active idea rather than
precaution, which to many sounds reactive and even negative.
Although the principle has its roots in German environmental
policy, over the past 20 years it has served as a central
element in international environmental treaties addressing
North Sea pollution, ozone-depleting chemicals, fisheries,
climate change, and sustainable development (Raffensperger
& Tickner, 1999). Precaution is one of the guiding principles of
environmental laws in the European Union.

The precautionary principle in practice

Historical links
The precautionary principle encourages policies that protect
human health and the environment in the face of uncertain
risks. In this broad sense it is not a new concept, and some
may object to giving it a new name, when similar ideas go by
different names in other disciplines. For example, public
health practitioners use the term primary prevention to mean
much the same thing. The physician’s obligation to first do no
harm is a precautionary approach to treating a sick person.
The governments of several Scandinavian countries have
made regulatory decisions about electromagnetic fields and
other hazards using a concept called prudent avoidance, which

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is also similar (WHO, 2001; Aasen et al., 1996). The term

precautionary principle has the advantage that it provides an
overarching framework that links environmental sciences and
public health.

Motivating factors
The precautionary principle has arisen because of the
perception that the pace of efforts to combat problems such as
climate change, ecosystem degradation, and resource depletion
is too slow and that environmental and health problems
continue to grow more rapidly than society’s ability to identify
and correct them. In addition, the potential for catastrophic
effects on global ecologic systems has weakened confidence in
the abilities of environmental science and policy to identify
and control hazards. There are also the apparent
contradictions of our regulatory process: if the laws governing
toxic chemical release are effective, then why are mercury
levels in freshwater fish so high that pregnant women should
not eat them (U.S. EPA, 1997; Schettler, 1997)? How is it
possible that human breast milk may not meet U.S. Food and
Drug Administration contaminant limits for baby food
(Abadin, Hibbs & Pohl, 1997; Pohl & Hibbs, 1996)? The great
complexity, uncertainty, and potential for catastrophe from
global climate change are among the strongest motivators for
those urging precaution in environmental policy. The earth
warmed over the twentieth century by an estimated 0.6°C
(Albritton et al., 2001). The trend was not uniform, though,
and warming is occurring faster during the winter and at
night (Easterling et al., 1997), and the winter warming is
occurring faster at high latitudes than near the tropics
(Houghton et al., 1996). For human populations, the rates of
change and wide swings in weather are of chief concern, as ice
core records indicate that increased climatic variability may be
associated with rapid climate change events and changes in
the ocean thermohaline circulation (Meyewski, personal
communication). Together, warming and more extreme
weather have begun to alter marine life and the weather
patterns that affect infectious diseases, their vectors, and
hosts. The unprecedented scale of this hazard justifies

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reexamination of environmental monitoring systems and

paradigms (Lubchenco, 1998).

Frustration with policy concerning toxic chemicals has also

stimulated interest in the precautionary principle. The risk
assessment process is perceived by a growing segment of the
population as antagonistic to strong environmental protection
and as excessively complex and full of hidden assumptions
that have the effect of disenfranchising all but the experts
from the decision-making process. Current U.S. environmental
policy often seems to be more reactionary than precautionary,
requiring a high degree of certainty of harm before preventive
action is taken, and emphasizing the management of risks
rather than their prevention. The precautionary principle, by
calling for preventive action even when there is uncertainty,
by placing the onus on those who create the hazard, and by
emphasizing alternatives and democracy, is viewed by
environmentalists as a way to shift the terms of the debate
and stimulate change.

Points of opposition
A lively debate is now underway about the usefulness of the
precautionary principle (Bishop, 2000; CEC, 2000; Holm &
Harris, 1999; Stirling, 2000; Danish Environmental Protection
Agency, 1998; Applegate, 2000). Perhaps the most frequently
voiced criticisms are a) current regulatory procedures are
already precautionary; for example, the safety factors used in
risk assessments insure precaution; b) the precautionary
principle is not scientifically sound because it advocates
making decisions without adequate scientific justification; and
c) if it were implemented, the precautionary principle would
stifle innovation by requiring proof of safety before new
technologies could be introduced. Each of these concerns has
been addressed by proponents of the principle (Wynne, 1993;
Ashford, 1999; Myers, 2000) and this article is not intended as
a comprehensive response to critics. The objective instead is to
discuss the implications of the precautionary principle for the
work of environmental scientists.

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Case illustrations
Cellular telephones in airplanes
When the flight attendant explains the safety procedures
before takeoff, there is an instruction not to use various
electronic devices during takeoff and landing and not to use
cellular telephones any time during flight. There is some very
limited (anecdotal) evidence that these devices may interfere
with the essential navigational and control systems of the
aircraft. In 1999, in response to inquiries about the necessity
of this ban, the U.S. Federal Aviation Administration (FAA)
commissioned a study to gather stronger evidence for or
against the hypothesis that consumer electronic devices
interfere with aircraft functions (McCarthy, McSweeny &
Watrous, 2000). The study failed to find any evidence of this
interference. Nevertheless, the FAA ruled that, in the absence
of strong evidence of safety, the ban would continue in effect.

Most people agree that the inconvenience of not being able to

talk on the phone in flight is offset by even a small risk of an
airplane crash. This illustrates the first component of the
principle: taking action in the face of uncertainty. The second
aspect of precaution deals with burdens of proof, and here, too,
there would probably be little controversy. Most would agree
that those who would change the rule on cellular telephone
use in flight should have the responsibility to show that the
change will not cause unreasonable risk. But suppose concerns
about portable electronic devices in airplanes had not been
raised initially, and so airline passengers were currently using
their cellular telephones in flight. Now suppose that a few
isolated malfunctions occurred in the navigational systems of
a small number of aircraft while cellular telephones were in
use, and concerns were raised. Should cell phone use be
banned? At that point there would be a quantifiable economic
loss from ending the practice. It seems quite likely that
implicitly or explicitly a cost–benefit analysis would be run,
and to do this, it would be necessary to estimate the risk—
something that would be, and is, very hard to do with any
confidence. Some might call this approach more “science
based,” but it would be a highly uncertain process, and one in

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which the risks being evaluated might be very small, but the
consequences potentially catastrophic. Fortunately, the way
events have actually unfolded, it is not necessary to estimate
the risk—precautionary action was taken. The availability of
an economically viable alternative (in-flight telephones) may
have made it easier to act in the absence of strong evidence,
which highlights the potential for the precautionary principle
to stimulate the search for safer technologies.

Pesticides in schools
Recently the Los Angeles Unified School District, the largest
public school system in the United States, announced a new
policy on the use of pesticides in schools (“Preferring the Least
Harmful Way”, 2000). The policy states unambiguously that
pesticides pose risks to the health of children and the
environment, that they shall be used only after nonchemical
methods have been considered, and that if there is a choice
among pest control methods, the least harmful one shall be
chosen. There is no mention of balancing risks and benefits,
nor a list of banned substances. The precautionary principle is
a long-term objective of the policy, according to its authors.

Critics worry that the precautionary principle will encourage

technology choices based on fear and emotions, rather than on
science. But another interpretation would be that the Los
Angeles Unified School District is saying that all pesticides
should be assumed to be hazardous, while acknowledging a
great deal of uncertainty about exactly how hazardous.

The intention to prefer nonchemical methods and to choose the

least toxic method encourages a search for alternatives, while
at the same time not preventing the use of a toxic chemical if
it is found to be necessary and irreplaceable. The new policy
also requires consideration of the service or function that a
pesticide provides. For example, a pesticide being used for
aesthetic purposes may be determined to be less important
than one that serves a hygienic function. The former may be
more readily eliminated than the latter, if no alternative can
be found.

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Polyvinyl chloride toys

Polyvinyl chloride (PVC) is an extremely versatile material,
made into thousands of products. By adding varying amounts
of a chemical called a plasticizer, the pliability of PVC can be
modified from hard and brittle to soft and almost spongy.
There is evidence that several of the plasticizers, members of
the phthalate chemical family, are reproductive toxicants in
animals. They may also cause reproductive toxicity in humans,
although this evidence is quite limited (Expert Panel Report,
2000; European Scientific Committee on Toxicity, Ecotoxicity,
and the Environment, 2001; Tickner et al., 2001). Until 1999,
many PVC plastic toys specifically designed to be sucked and
chewed contained the plasticizer diisononyl phthalate. Many
of the manufacturers of toys that formerly contained this
chemical have now voluntarily stopped using this plasticizer,
or in some instances completely phased out PVC in these toys,
in response to consumer and government concerns about toy
safety. But the evidence for human health risks is weak and
uncertain. Producers of PVC products have argued that there
is no evidence of harm from use of their products, given 40
years of use without apparent ill effects. There is a flaw in this
reasoning, however, because the absence of evidence of harm
is not the same thing as evidence of the absence of harm. Of
course, absolute safety can never be proven. But a lengthy and
costly risk assessment, followed by an equally lengthy and
acrimonious risk management process would be the likely
outcome of the present one-substance-at-a-time approach to
chemicals policy.

The precautionary principle seeks to minimize the limitations

of a risk assessment based regulatory policy by encouraging a
search for alternatives whenever a potentially hazardous
chemical is identified. If a clearly safer alternative exists, why
accept even a small, highly uncertain risk? The Danish
Environment Agency used just this logic in taking action to
eliminate phthalates from toys (Seedorf, personal
communication). They said, in essence, that there is exposure
to these compounds, there is animal toxicity data, the
exposure is to children who by definition are particularly

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susceptible to many toxic substances, there are alternatives,

and the product serves no necessary function. Considering all
these factors, they concluded that the plasticizer should not be
used in toys.

Limitations of conventional scientific methods

Environmental scientists study highly complex, poorly
understood systems. Often the most informative experiments
cannot be conducted for logistical or ethical reasons (there is
only one Atlantic Ocean to study; potential carcinogens cannot
be administered to humans in double-blind trials). At the
same time, this work is of great interest to those who seek to
balance economic growth and environmental protection. In
this complicated and contested terrain, it is useful to examine
the methodologies of science and to consider ways that,
without compromising integrity and objectivity, research can
be more or less helpful to those who would act with precaution.
It would, for example, be useful to policy makers if scientists
were more explicit about the limits of knowledge and about the
nature and amount of uncertainty in research findings.
Presented below are examples of the ways that science is
currently conducted that may make it more difficult to set
precautionary policies. There may be alternatives to these
methods, well within the bounds of good practice, that would
be more helpful to policy makers faced with high-stakes
decisions and great scientific uncertainty.

Hypothesis formulation
Einstein said that the theory decides what can be observed,
and at the more practical level, the formulation of specific
research hypotheses determines to a large degree the sorts of
results that can be found. Where does the particular
formulation of a hypothesis come from? Often the hypothesis is
formulated in a way that is feasible to test with the time and
resources available. There is also a tendency for researchers to
refine understanding of old problems rather than risk
investigating new ones (Kuller, 1999). Greater and greater
levels of detail are sought about well-defined problems, rather
than the higher stakes enterprise of searching for entirely new

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phenomena. For example, we refine understanding of the

mechanisms of toxicity of asbestos, lead, and polychlorinated
biphenyls, rather than evaluating effects of other, less well-
studied toxicants. Funding agencies and skeptical peer
reviewers reinforce this tendency by favoring tightly focused
proposals that repeat or incrementally build upon work in well
established areas.

Emphasis on independent effects, not interactions

There is a tendency to assume that the mechanisms
underlying the phenomena being studied are driven primarily
by the independent actions of a few causal factors. If they
interact, this is assumed to be of secondary importance. This
implicitly assumes that things are not connected and leads to
an atomized worldview. In reality, complex biological systems
such as ecosystems, human populations, or individual
physiology are composed of feedback loops and other
interactions which make cause–effect relationships far from
direct or linear. But many times the effects of hypothesized
causal factors are considered in research to be decomposable
into additive components that are measured individually. For
example, when studying a mixture of pollutants, the emphasis
is on identifying which component of the mixture is
problematic. Interactions are difficult to study, but this should
be seen as a challenge to develop more sensitive and complex
methods, rather than as an inherent limitation of science.

Narrow definition of uncertainty

The formal evaluation of error or uncertainty in many
environmental science papers is limited to a presentation of p-
values or confidence intervals for the main results. Beyond
this, there may be a qualitative examination of limitations of
the findings, which is relegated to the discussion section at the
end of the paper. The standard p-values and confidence
intervals indicate the magnitude of potential error in the
statistical parameter estimates due strictly to sampling
variability. But in observational studies of complex, poorly
understood systems, this may be the least important source of
uncertainty. Potentially more important are errors in the

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independent variables, errors arising from choice of the wrong

form for the model(s) used to analyze and interpret the data,
and biases from problems in the conduct of the study.

For example, a study of the effects of an environmental

contaminant on reproductive success in fish would typically
report the amount of sampling error around the final estimate
of the degree of association found between the contaminant
and the measure of reproductive behavior. But this would
typically not take into consideration the error in measuring
the levels of the contaminant in the fish or in the environment
and would not investigate the sensitivity of the findings to the
choice of statistical models used to link exposure with
reproductive outcome. It is sometimes argued that scientists
are trained to read papers critically and that they are able to
factor in these other sources of uncertainty in their evaluation
of a study. But applied scientists are also communicating to
nonscientists who may mistakenly take the limited
characterization of sampling error as the best estimate of all
the uncertainty.

Setting Type I and Type II error rates

Errors due to sampling variability are routinely quantified.
However, standard practice has led to a conservatism that
perhaps hinders precautionary action. When a scientific
investigation is designed to test a hypothesis, there are two
kinds of errors that one seeks to minimize. A Type I error is
the mistake of concluding that a phenomenon or association
exists when in truth it does not. (Technically, the Type I error
is rejecting the null hypothesis when it is really true. The
paraphrasing above, while valiantly railed against by
statistics teachers everywhere, is the way it is thought of in
everyday practice.) By convention, Type I (or alpha) errors are
guarded against by setting that error rate low, usually at 5%.
In other words, the finding must be so strong that there is less
than a 5% probability that this result would have been seen by
chance alone in a world in which no such phenomenon actually
exists. In this case the result is called statistically significant
(with the clear implication that one is supposed to believe it).

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The Type II error, failing to detect something that actually

does exist, is, by convention, often set at 20% (although
practical limitations of sample size often result in a
substantially higher or lower Type II error). Twenty percent of
the time, a real phenomenon will be missed because the data
were not strong enough to convincingly demonstrate its
existence. There is an implicit bias here: the test is set up to be
more cautious about falsely detecting something than about
failing to detect something. Should Type I and Type II error
rates be set explicitly and a priori, depending on the purposes
that the study is meant to serve? Bayesian statistical methods
promise a way out of these conundrums by shifting the focus
from formal testing to calculating the weight of evidence
provided by a particular study and the degree to which this
study should shift a priori beliefs. At present, Bayesian
methods are little used in practice, but research to make them
more accessible and practical is now under way (Malakoff,
1999; Carlin and Louis, 1996; Greenland & Poole, 1994).

Type III errors

A Type III error occurs when one provides an accurate answer
to the wrong problem (Schwartz & Carpenter, 1999). The
cliche about looking under the street light for the keys lost
down the block (because the light is better there) comes to
mind to illustrate this common problem. To some degree, this
is another aspect of hypothesis formulation discussed above.
Citizen groups who ask a scientist for help with a particular
environmental concern frequently experience the consequence
of Type III errors. The citizens have a broad concern about, for
example, potential health effects of a power plant in the
neighborhood. The scientist hears the concern, and translates
it into a problem that he or she is able to solve with the tools
at hand, such as, do the power plant emissions exceed current
health standards? This translation almost inevitably narrows
the focus to something manageable and solvable. But often the
citizens are frustrated with the results because scientists did
not adequately address the initial concerns. On the other
hand, the scientist is puzzled or, worse, concludes that the
citizens are “antiscience.”

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Disciplinary divisions
The citizens group’s concerns about the power plant would
probably be better addressed by an interdisciplinary
investigation, using a wide variety of different methods and
looking for an integrated understanding of the facility’s
impacts. Traditional boundaries between academic disciplines
make it difficult to bring together the broadest possible set of
research tools; combining for example quantitative and
qualitative methods.

Scientific methods to inform precautionary policy

As noted at the beginning of this paper, science plays a critical
role in environmental policy by providing insights into the
normal functioning of natural systems and the ways they are
disrupted by technologies and other human activities.
Environmental scientists use a wide variety of methods, and
these are to a large degree determined by the problem at hand.
In some fields, prediction is an essential part of scientific
proof. In others, it is useless or impractical. The simple
accumulation of confirming cases is of no use in fields that
hold to a high standard of mathematical proof, and in some
disciplines controlled experiments are essential. But in many
environmental sciences where observational studies are the
rule, experiments are often infeasible or unethical, and it is
impractical to wait to see if predictions are borne out. Other
types of evidence are used, and usually sufficient proof for
action comes from the accumulation of plausible inference
from independent lines of work. For instance, environmental
causes of cancer may be identified from the geographic
distributions of cancers; time trends in cancer frequency; the
occurrence of cancers in highly exposed working populations;
animal experiments; and experimental knowledge of chemical
pathways of cancer induction. And once it is demonstrated
that a particular molecule is carcinogenic, similar molecules
are at least suspect. Any one line of argument is imperfect,
and fault can be found with the details of most separate
methods. It is the preponderance of evidence that finally
prevails. It is never easy to determine the moment in this
process when there is sufficient evidence to act as if a causal

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connection exists, but scientists can and should play an

important role in this decision, as they are the ones who know
the data and the methods best. A shift to more precautionary
policies creates opportunities and challenges for scientists to
think differently about the way they conduct studies and
communicate results. The following paragraphs briefly
summarize some of the positive implications that such a policy
shift might have for the conduct of science.

What is studied
There is a great need for better methods to study whole
systems and the interactions of various causal factors. The
cumulative and interactive effects of multiple insults on an
organism or ecosystem are very difficult to study. There are
often many levels of a system (individuals, families,
communities, nations), and hazards often exert effects at
multiple levels. Current methods in many disciplines are not
well suited to such investigations. As noted above,
multidisciplinary teams will be more likely to find new ways to
frame hypotheses that lead to insights not possible from
narrow disciplinary viewpoints. The recent recognition of the
problem of endocrine disruption provides an example. A
review of many different types of evidence on the effects of
persistent pollutants on wildlife in the Great Lakes led to the
hypothesis that a common mechanism of action might be
causing a variety of reproductive and developmental effects
(Colborn & Clement, 1992; Krimsky, 1999). Because of the
fragmentation of scientific disciplines, no single researcher
was able to develop a coherent hypothesis. An
interdisciplinary conference (Colborn & Clement, 1992)
provided the opportunity for many different fields to meet and
share insights. The conference organizers summarized the
outcome (Colborn & Clement, 1992): “so shocking was this
revelation [about the widespread observation of endocrine
disruption in wildlife] that no scientist could have expressed
the idea using only the data from his or her discipline alone
without losing the respect of his or her peers.”

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Research methods
Uncertainty is a positive aspect of knowledge because it
clarifies what is known and unknown and thus stimulates
further investigation. But there is also a strong desire on the
part of scientists to be precise. This may result from a
confusion of uncertainty of information with quality of
information; but the two concepts are distinct (Funtowicz &
Ravetz, 1990). It is possible to produce high-quality
information about greatly uncertain phenomena. Most
scientists are aware that their p-values and confidence
intervals do not fully capture all of the likely error in their
results, but standard methods do not exist for characterizing
other aspects of uncertainty. There is a great need for research
to find ways to characterize, express, and communicate
uncertainty. Scientists develop intuition or professional
judgment about the strength of a particular result. The
Bayesian view of statistical inference, an increasingly popular
alternative to standard frequentist methods, acknowledges
that we have beliefs about the phenomena under study and
seeks to formalize the role these play in the way we view our
data (Carlin & Louis, 1996). The role of data, according to this
perspective, is to shift our a priori beliefs about the
phenomena under study. Strong results may shift beliefs a lot,
producing a posterior probability that may be far from the
prior probability that the researcher had assigned to the
hypothesis before conducting the research. But weak data will
have little impact, leaving posteriors close to priors.

There is increasing awareness that Bayesian statistical

methods correspond more closely to common approaches to
logical inference in everyday life. Methods development work
is still needed in most fields, however, before Bayesian
statistics can be routinely applied.

Uncertainties that derive from the choice of research methods

and mathematical models should also be more fully
investigated and discussed. Formal sensitivity analyses in
which the investigator assesses the degree to which results are
changed by using different assumptions or analytic methods

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should become standard practice (Greenland, 1996). Current

methods seldom encourage a search for patterns within noisy
data and “clusters of clusters” of similar effects in different
species.

Conservation medicine is a new academic initiative that links

human and animal health with ecosystem health and global
change (Tufts Center for Conservation Medicine, 1999). It
begins from the premise that the health of ecosystems is
directly related to the health of species, including humans.
The initiative arose from a growing understanding that
human impacts on ecosystems were multiple and integrated.
Conservation medicine uses interdisciplinary teams of
veterinary and medical health professionals to develop a
greater understanding of the ecological context of health and
advance biodiversity conservation and ecosystem health.

If society chooses to act with incomplete information, it must

be acknowledged that one kind of risk is being accepted to
avoid another. One risk being accepted is that the policy choice
may have been wrong. Fortunately, the effects of a policy can
often be evaluated for beneficial or detrimental unintended
consequences. Thus a strong environmental monitoring
program and formal evaluations of the interventions or
controls are essential parts of a policy of precaution (Goldstein,
1999). Despite the need for more and better systems research,
it remains true that much useful information is learned by
taking a system apart and testing its components. The
development of new approaches should supplement current
scientific methods, not replace them. There is also an
important role for those who can synthesize the results of the
work of many disparate disciplines to reach insights not
possible by the individual researchers. This has been called
“joining edge” research (as opposed to “cutting edge”).

Conclusions and recommendations

It is important to clearly distinguish between the development
of scientific information about an issue and the setting of
policy, but in practice, there is not always an unambiguous

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demarcation. Policy makers set agendas that determine the

questions asked of scientists; scientists formulate hypotheses
in ways limited by their tools and their imaginations; thus, the
information they provide to the policy makers is limited and to
a degree socially determined.

There is a complicated feedback relation between the

discoveries of science and the setting of policy. While
maintaining their objectivity and focus on understanding the
world, environmental scientists should be aware of the policy
uses of their work and of their social responsibility to do
science that protects human health and the environment
(Lubchenco, 1998). The precautionary principle highlights this
tight, problematic linkage between science and policy, which
can be summarized in the following seven points:

1. Scientific studies can tell us something about the costs,

risks, and benefits of a proposed action, but there will
always be value judgments that require political
decisions.
2. The scientific data used for making policy will nearly
always be limited by uncertainty. Even the best theory
and data will leave much that is not known about
estimates of risks, benefits, or costs.
3. In conducting their research, scientists must make
assumptions, choices, and inferences based on
professional judgment and standard practices, that if not
known by the public or policy makers, may make
scientific results appear to be more certain and less
value laden than is warranted.
4. Although there are some situations in which risks
clearly exceed benefits no matter whose values are being
considered, there is usually a large gray area in which
science alone cannot (and should not) be used to decide
policy.
5. In these gray areas, status quo activities that potentially
threaten human and environmental health are often
allowed to continue because the norms of traditional
science demand high confidence in order to reject null
hypotheses, and so detect harmful effects.

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6. This scientific conservatism is often interpreted as

favoring the promoters of a potentially harmful
technology or activity when the science does not produce
overwhelming evidence of harm.
7. The precautionary principle, then, is meant to ensure
that the public good is represented in all decisions made
under scientific uncertainty. When there is substantial
scientific uncertainty about the risks and benefits of a
proposed activity, policy decisions should be made in a
way that errs on the side of caution with respect to the
environment and the health of the public.
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10. The precautionary principle:
a central and eastern European perspective3

Janos Zlinszky

Introduction
The purpose of governments is to secure the free exercise of
people’s inalienable rights, such as the right to life, liberty and
the pursuit of happiness (such as enshrined in the Declaration
of Independence of the United States). Lengthy explanation is
not required to recognize that life is connected to health. So is
the pursuit of happiness, as soon as health is understood – as
it should be – as complete physical, mental and social well-
being in accordance with the WHO Constitution. In addition,
people and communities crippled by health problems will have
little freedom to actively pursue social or cultural betterment.
Risks to human health are risks to the common good.4

Governments exist to help communities and individuals to

avoid – or at best manage – threats to their common good and
to increase their chances of improving their lot. In this
endeavour, government has to navigate well-known straits: it
should seek options for solutions; it should assess the extent
and nature of risks associated with the options available for
directions and measures to be taken; it should make decisions

3 Paper based on the presentation, The Precautionary Principle: A

CEE Perspective. Presented at the WHO Meeting on Precautionary
Policies and Health, Paris France September 12-13, 2003.
Paper based on an address with the same title, given at the workshop
September 2003, Paris.
4An ecologist considers most of these risks environmental in the sense

that they originate from the environment of the individual. This is

especially true since the term environment can be defined as the
complete set of stimuli that will provoke physiological or
psychological reaction.

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and act (or refrain from action); and then it should monitor
and evaluate the consequences of its behaviour, thus
improving the chances of success for the next cycle. Intensive
communication with and active participation of those governed
is necessary throughout. The pursuit of sustainable
development lifts this process from a time scale of day-to-day
or year-to-year to the scale of whole generations.

In an optimum world, good governance ought to be based on a

solid knowledge of the context of decision-making: the
ecological, social and economic status quo, a vision for the
future and the framework conditions for change. Uncertainty
related to this necessary knowledge is a problem in its own
right in all aspects of governance. Changes at the personal or
community level – regarding both the composition of
governments and processes of governance – should (ideally) be
incremental: small steps. The evolution of personal and
community behaviour should be guided by two needs: the
advancing towards the goals, that is, the “ideal” position of the
community, while reacting to eventual changes in the
environment. In other words, governance has proactive and
reactive sides (I want to act, for I want a change; and I have to
act, for a change happened “to me”). Information and tools for
this evolution are provided by research and development
activities. Keeping the community of the decision-makers and
leaders up to date with knowledge is a necessary prerequisite
for proactive governance and is essential for preventive
management of problems.

In the life of any community, however, there can be cases,

situations and even periods of time in which knowledge on
which to base policy decisions is lacking. Facing new
technologies or situations, decision-makers may lack the usual
familiarity with the situation or the likely consequences of
their decisions. Time pressure, whether real or perceived,
often prevents policy-makers from carrying out the research
they would need to make a fully informed decision. Such
situations require a precautionary approach.

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 10. A central and eastern European perspective

This chapter discusses the needs and possibilities for applying

the precautionary principle in governance – permits, policy-
making, legislation and enforcement – in the countries in
transition in the eastern part of the European Region of WHO
at present and for the foreseeable future. These thoughts are
offered from the perspective of central and eastern Europe.5

The institutional experience of my points stems largely from

the experience of the Regional Environmental Center for
Central and Eastern Europe (REC) (http://www.rec.org,
accessed 17 May 2004). Since 1991, the REC has worked to
assist the economic and political transition in central and
eastern Europe. An independent international organization
supported by 27 governments and the European Commission,
the REC has been an international facilitator, mediator and
enabling institution for environmental stakeholders in and
beyond the 16 countries hosting REC offices, including the
latest one in Turkey. The institutional memory of the REC is
based on impressions and experiences from central Europe to
central Asia, from the Baltics to the Balkans, of colleagues
from literally dozens of different countries in eastern and
western Europe.

These experiences and observations demonstrate that the

precautionary principle is a tool of special importance for the
civil servants in the eastern part of the European Region of
WHO. In this rich yet fragile natural and cultural
environment, a socioeconomic experiment unprecedented in
scale and speed has been progressing since the early 1990s
and is likely to continue for some time. The many aspects of
this experiment called the transition together inevitably create
a great degree of uncertainty in decision-making. Responsible

5Thischapter defines central and eastern Europe as Albania, Bosnia

and Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia,
Hungary, Latvia, Lithuania, Poland, Romania, Serbia and
Montenegro, Slovakia, Slovenia and The former Yugoslav Republic of
Macedonia.

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Zlinszky

management of these changes is nearly impossible without a

precautionary approach to many of the risks involved.

Countries in transition: resources and vulnerabilities

Countries in transition are vulnerable: they have unique
social, cultural, historical and ecological treasures, and these
are fragile. The last intact wilderness ecosystems of the
European continent are in this region. Intact wilderness
means areas that measure hundreds of thousands of hectares,
have had little economic activity in the past century and would
therefore qualify as the “factories” of evolution in Europe and
the temperate and Arctic zone of the Northern Hemisphere in
general. In the European Union, the density and the economic
activity of the population ended such areas long ago. The
natural capital of central and eastern Europe includes many
other areas of special scientific interest or natural beauty as
well, or those harbouring many endangered species and
ecosystems – similar to some counterparts in western Europe
but altogether featuring a considerably higher quantity,
density and diversity of wildlife than those in the more
developed parts of Europe.

The natural and social capital of these countries is also still

rich. By European standards, the countries in transition have
many indigenous nations and communities – communities that
have lived in the same area for many centuries, even
millennia, still maintaining an extensive hunting and
gathering or agricultural way of life that is highly adapted to
their natural environment. Both intact nature and the
embedded intact human communities are at great risk from
economic development pressure and technical civilization.
Without decisive protection, their days are numbered.

Central and eastern Europe in particular, and the countries in

transition in general, also have a legacy of a unique and
diverse built environment. Buildings and townscapes –
including industrial monuments – of great architectural value
of the pre-communist period are still found everywhere: very
often derelict or in poor repair, but sometimes in good

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 10. A central and eastern European perspective

condition. These ailing areas awaiting repair could become

attraction centres for settlements and wider communities but
are currently threatened by the trend of the funds flowing into
greenfield investments (new industrial parks and residential
areas), leaving old buildings with the prospect of demolition
rather than rejuvenation.

Last but not least, many communities of central and eastern

Europe still retain aspects of a disappearing lifestyle, with
different consumption patterns, personal value systems and
networks of social ties from what are experienced in the
consumer society. Sustainability and health also requires
fulfilling people’s non-material needs, a reality the rich North
seems increasingly to forget. Changes in lifestyle and habits
may add to individual comfort at the expense of the quality of
the commons – such as changing the modality and/or
ownership of local and long-distance transport. In many
respects, the way of life of individuals and communities in
countries in transition is still more sustainable and sometimes
healthier than the new way of life that is being marketed to
them.

The challenges of rapid change

The transition of central and eastern Europe and the entire
eastern part of the WHO European Region must move on
several parallel tracks. The transition from oligarchy and
autocracy to democracy, transition from a centrally planned
economy to a free (and international) market economy, joining
global international policy coordination processes, and
embarking on sustainable development were processes
launched consecutively but must now be carried out
simultaneously. The international community previously had
the opportunity to witness countries embarking on one or
another of these transitions as a single issue (democratization,
establishment of a market, emerging from international
isolation, etc.). Patience and perseverance brought many
successes; other transitions such as that toward sustainable
development seem to be still a nut too hard to crack even for
the most industrialized countries. No doubt, the achievements

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Zlinszky

of multidimensional transition of the eastern part of the WHO

European Region in the past 14 years have been
unprecedented. So are the tasks still lying ahead – creating
the danger that policy-makers’ attention will be split among
too many competing agendas and dimensions.

Thus, the countries in transition are also vulnerable on

another account: their civil service, politicians and
communities face too many demands simultaneously at any
given time. Change has been rapid and has occurred in nearly
all aspects of life: the values for which to strive, the
institutions to which to turn, the ownership patterns to
respect, the rules to obey, the players, stakeholders and
partners with which to work, the processes to follow, the goods
available and social and employment status have all become
uncertain and prone to change. At this speed, change
management is next to impossible: there are simply too many
variables, too many unknown factors and too little time for
consideration. In such a decision-making environment,
calculating, modelling, simulating and planning for sound
decisions at any level is very difficult, be it personal,
community, national or international.

Environment and health in countries in transition

Mutatis, mutandis: what was true in the general, national
context about the multifaceted character of pressures and
demands is also true for individual policy fields such as
environment and health. Here, too, many needs, old and new,
have to be dealt with at the same time.

Many environmental problems inherited from the past still

present complex challenges. Environmental hot-spots, time
bombs of past pollution, are a particular problem in the
eastern part of the WHO European Region. Some of these
polluted sites are well known and labelled and priorities have
been set and queues made for pollution containment, if not yet
abatement. Sometimes whole towns or vast areas of the
countryside are thus affected. Other hot-spots are stumbled
upon by chance during building activities or demolition

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projects. Even without hidden, dangerous deposits, the mere

dismantling, dumping and disposing of old materials presents
health hazards. Sloppy record-keeping and poor law
enforcement, let alone inadequate building standards, all
contributed to a situation in which, more often than not, new
developers do not know which materials to prepare for at a
given site. Radioactive and hazardous waste can be expected
from energy, mining, industry, agriculture and even hospital
or office buildings. In this context, it is no wonder that
brownfield investing is problematic.

In addition to the problems from the past, the material

streams arising from new activities also pose dangers. The
import, production and release of new hazardous materials
requires strict monitoring and control. Both central and
eastern Europe and the Commonwealth of Independent States
countries find it difficult to avoid importing outdated
technologies and materials from some of the more developed
countries in the Organisation for Economic Co-operation and
Development. In addition to receiving materials and
technologies with known risks, the countries in transition are
also in danger of becoming an experimental area for new
technologies, from mobile telecommunication to genetically
modified organisms, from new chemicals to new waste-
disposal methods.

The new economic possibilities and the opening up of

resources in eastern Europe for the G7 industrial countries
and other trading partners often means unsustainable or
harmful pressures on ecosystems with renewable (such as
forests) or nonrenewable (such as oil and gas) reserves. Large
ecosystems are being destroyed at an alarming pace and scale,
which will have long-term effects on the environmental
commons such as water availability and quality, air quality,
climate and biodiversity (including soil availability and
fertility). Some of these risks can only be brought into the
decision-making process by allowing time and means for
complex analysis and would likely indicate effects on an
intergenerational time scale.

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Zlinszky

These considerations are but a reminder of well-known

pressures and risks, listed with the intention of illustrating
the complexity of problems faced by every area of government.

Resource limitations
Managing the social, health and environmental governance
aspects of a multidimensional transition process requires
adequate means and well-prepared human resources. But for
the countries in transition, the money, infrastructure and
human resources required to address these challenges are all
in short supply.

A great majority of these countries were left with heavy

foreign debts as they made the transition out of communism.
The incoming democratic governments had little if any ability
to alleviate this burden; the foreign debt of most of the
transition countries has grown rather than decreased in the
past 14 years. Generous bilateral and multilateral financial
and technical assistance programmes were launched and are
still in place in many countries. But this international
assistance is dwarfed by the scale of the problems to be
tackled. For example, of all the environment protection
investment undertaken during the transition in central and
eastern Europe, only about 5% was supported by international
donors;6 money for the rest had to be found at home.

After more than a decade of considerable effort and progress,

there are still substantial monetary needs. For example, the
infrastructure for both health care and environment protection
badly needs further repair, restoration, upgrading and
extension. At present, laboratories at universities and
government agencies are too few and often ill-equipped;

6International assistance has had some important side effects. In

particular, the strings attached to western funding (requirements
concerning application, evaluation, management and reporting
procedures) helped to create new skills and standards in the recipient
countries. Transparency and opportunities for public participation
are two notable areas in which this influence has been felt.

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underfunding usually prevents the available scientific

instruments from being fully used.

The most important resource for governance tasks is human

resources. The quality of human capital in central and eastern
Europe is enviable concerning science, engineering, philosophy
and art. The high quality of higher education in central and
eastern Europe is widely acknowledged. But most of the
government skills that are readily available in the
bureaucracy were originally geared for highly centralized
planning and management. Thus, those responsible for
managing the enormous changes occurring at every level of
society must simultaneously learn new skills themselves. They
must learn to change the most basic attitudes and instincts
that they learned under the previous system, and to pass on to
younger colleagues something they themselves were not
taught.

When facing their counterparts in other countries or the

technocrats of multinational firms, even the best civil servants
of the countries in transition are at a disadvantage. Coping
simultaneously with demands and advice to cut down the size
of the civil service, adopt and comply with new regulations,
learn new languages, inform and involve the public, become
faster and more accessible and participate in training is very
difficult. The civil service, if underpaid, understaffed, ill-
equipped and overloaded, will hardly be well positioned for
carrying out sound, balanced, informed, participatory (and
therefore time-consuming!) decision-making processes.

Addressing environment and health in countries in

transition: a rationale for precaution
Transition may be a suitable term to indicate most of the
aspects of the social, political and economic processes taking
place in central and eastern Europe; yet it can be misleading
when the situation and tasks of environment and health
authorities are contemplated. Transition would indicate that
something from the past is left behind, in exchange for
something new. Alas, nothing could be further from the truth

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concerning the demands on authorities responsible for public

health or environment protection. As indicated earlier, the
legacy of the past is all too present; it cannot be left behind but
presents urgent problems to solve. At the same time,
approaches to address the new realities – the very status to
which the transition should lead – have to be planned
(optimally) or simply tried.

Authorities are expected to discover and map problem areas,

be they in the area of pollution or disease; the pre-abatement
status quo has to be reliably established if progress in
alleviation and restoration programmes is to be measured
with any degree of accuracy. Risks such as harmful emissions
need to be reliably monitored, and the trends in any changes
need to be tracked. New (or simply hitherto uninvestigated)
materials, methods, standards must be tested. Linking
environment and health data and identifying coincidences and
causal links requires sophisticated data management and
statistical processing.

All these activities of monitoring, measurement, data analysis

and interpretation have to be carried out – in principle – with
substantial independence, accuracy and speed, achieving a
high level of efficiency while minimizing costs.

Such analysis and interpretation would establish the scientific

basis for the governance work of the environment and health
authorities. This is the basis on which policy-making, granting
permits, communication and enforcement is supposed to rest.
In these fields of governance, too, demands on and
expectations of decision-makers abound.

A full review of old policies is underway with regard to new

requirements (such as European Union approximation) and
framework conditions (such as democratic rules and new
institutional partners). New types of coordination have been
introduced before policies are finalized: international
coordination abroad and public participation at home, both of
which require a certain degree of transparency of policy
development. The main task of the new authorities has

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remained to reduce the level, number and diversity of health

risks posed by environmental conditions. The credibility of the
improved policies and the new, democratic authorities can only
be established through consistent, reliable enforcement; all
these must occur while focusing on the moving target of
improving standards and services as suggested by the west,
especially European Union countries.

All this is easier said than done: skills are mostly gained on
the job, and practice starts at the deep end. As discussed
above, the means and tools are modest and the time pressure
for quick decisions grows. Channels of communication for
policy development have yet to be established or widened in
relation to both the different sectors of government and the
different interest groups of society. Training for personnel of
public institutions as well as their partners in civil society is
an essential prerequisite for the necessary capacity-building.
Nevertheless, a vicious circle is common in which the available
number of civil servants is so low and pressure so high that
few or none can be freed to work on increasing staff capacity.
The continuing education of high-level, well-trained civil
servants with good language skills is especially problematic
because these people are not available for training. They are
simply too busy.

Besides the dwindling personnel of authorities, other human

factors drain the basis for sound decision-making. Old
attitudes such as the deep-rooted, instinctive mistrust
between the governing and the governed (“us and them”)
survive, especially because both sides are still used to public
authorities behaving in an authoritative rather than service-
oriented manner toward the public. When decisions are not
thoroughly and publicly justified and explained, they are
arrived at more quickly but are more likely to be opposed.
However authoritative the civil “service” may seem to be to the
public, in central and eastern Europe and beyond, they live in
a constant state of uncertainty because of the lack of job
security. Especially for the higher-ranking civil servants,
political polarization within the civil service has resulted in
sweeping replacements of staff after every change of

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government. In this climate, compliance with the expectations

of supervisors – or indeed powerful partners from the business
sector – would overrule the duty of conducting a well-based,
broad, investigative, cautious, participatory decision-making
process when, for example, permitting investment or imports.

Thus, a climate of uncertainty has been the rule rather than

the exception in political and administrative bodies in
countries in central and eastern Europe and other regions in
transition. The difficulty in achieving certainty when
evaluating policy alternatives – or facing up to the lack of
alternatives – is the cumulative result of many processes and
conditions that reinforce one another.

Yet these decisions incrementally determine the fate of

precious and often unique resources and the dignity, health
and well-being of communities. Harm to humans and their
natural and cultural environments is even more difficult to
heal than economic or technical damage. Ultimately, the
governance of the health and environmental aspects of the
transition process will reflect back – for better or worse – on
the political evaluation of the whole transition towards the
“western” model of democracy and market economy.7

Conclusion
In the countries of transition, the present “size” (workload)
and “weight” (level of risk involved) of tasks to be undertaken
are enormous, while the financial, technical, regulatory and
human means of the responsible institutions are limited. As a
result, these institutions cannot achieve the high degree of
certainty required for the common good of present and future
generations within the time frame given for decision-making

7The political history of the transition already clearly demonstrates

how the price paid by the individual citizen in exchange for
macroeconomic improvements contributes to the widening frustration
with political formations and processes that are perceived to advocate
for or require these changes.

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 10. A central and eastern European perspective

processes. Additional means are needed to break out of this

vicious circle. Introducing a clear policy and regulatory
framework for applying the precautionary principle in the face
of uncertainty is an important possibility that could and would
greatly improve the outcomes of the transition process in
Europe.

The civil service of the health and environment sector of the

transition countries can benefit particularly from this new tool
of governance. The availability of the precautionary approach
as an alternative process for decision-making would assist
public health efforts and favour a more cautious approach in
handling natural and cultural assets. As a result, both short-
term and long-term risks from trade and investment would
decrease, and sustainability would be enhanced.

The benefits of applying the precautionary principle widely

would be multidimensional, with many positive collateral
effects. When facing scientific uncertainty, the wide
implementation of the precautionary approach would
contribute to increasing the research and innovation capacity
of the eastern part of the WHO European Region. Part of the
investment supporting the increase of capacity would come
from the private sector, thus shifting away the financial
burden from the already overloaded taxpayer and the heavily
indebted state. The shift would support capacity-building
through education and training and create jobs in the
education, health and environment sectors.

Experience gained from the wide application of the

precautionary approach is likely to spill over and influence
similar situations of decision-making in which the uncertainty
is not directly derived from the lack of scientific proof.
Equipped with reliable audits and decision alternatives,
authorities would more readily engage in multi-stakeholder
dialogues for purposes of visioning, planning and decision-
making about changes, whether in the areas of granting
permits, investing or regulating. This, in turn, would increase
public confidence in the authorities and help avoid the delays
that result from simple distrust (a kind of “uncertainty” very

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Zlinszky

typical at present); it would also help to address the current

demand for more built-in checkpoints for public control.

Creating the room for precaution is simply evoking a very

basic European tradition, the ultimate standard for care and
responsibility – that of the bonus pater familias, the good
father of the family. At the personal level, we can admit that
we all know and apply this approach when our decisions affect
our loved ones, those for whom we are directly responsible.
The demand for a precautionary approach in politics has been
– in principle, on paper – a cornerstone of the environment
and health policy of many European countries for decades,
both inside and outside the European Union. From a central
and eastern European perspective, it would be wise and fair to
allow governments struggling with the present historical
transition to equip themselves with this tool, to use it for the
benefit of present and future generations. The sooner this
occurs, the better.

References
WHO. Preamble to the Constitution of the World Health
Organization as adopted by the International Health Conference,
New York, 19-22 June, 1946; signed on 22 July 1946 by the
representatives of 61 States (Official Records of the World Health
Organization, no. 2, p. 100) and entered into force on 7 April 1948.

180
11. Implementing precaution: assessment and
application tools for health and environmental
decision-making

Andrew Stirling & Joel A. Tickner

Current difficulties in the precaution debate

On both the national and the international stage, few current
policy issues are as topical in their profile, controversial in
their nature or pervasive in their implications as the
precautionary principle. Under these circumstances, it is
understandable that discussions should suffer from a certain
amount of expedient ambiguity and rhetorical smoke.
Nevertheless, amid the confusion, some substantive
difficulties are quite readily diagnosed and addressed.

Firstly, demarcating the scope and significance of the

precautionary principle is important. Much of the policy
discussion over application of the precautionary principle
centres around what threshold of information, assessment or
uncertainty must be met before the principle is invoked. This
discussion is based on the assumption that the precautionary
principle is primarily reactive rather than proactive. Although
the precautionary principle needs to be applied to effectively
identify and control potential harm, the value of precaution
can be seen in a broader context. Indeed, in its original
formulations, the Vorsorgeprinzip was a principle for taking
the future into account – a principle that would drive
comprehensive measures to forestall environmental harm and
stimulate innovation in environmental technologies and
economic development. This broader planning-focused notion
of precaution has been explicitly linked to the general
economic and environmental goals of the state (Boehmer-
Christiansen, 1994; Raffensperger & Tickner, 1999). Secondly,
taking a proactive and broader approach to precaution
requires developing tools for scientific assessment and the
appraisal of policy options.

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Stirling & Tickner

This chapter outlines the basic elements in a framework for

applying precaution and examples of decision-making and
regulatory frameworks and concrete tools for applying
precaution. We conclude that, without clear yet flexible
frameworks for applying the precautionary principle, the full
value of the principle will not be achieved in stimulating more
health-protective and forward-looking decisions under
uncertainty.

Elements of a precautionary decision-making

framework
Any effective approach to implementing precaution in
decision-making processes must satisfy several practical policy
criteria. At a minimum, these criteria might include: (i)
improving the scientific basis for decisions; (ii) enhancing the
quality of surveillance of health and interventions; (iii)
fostering greater transparency and inclusiveness in the
decision-making process; and (iv) promoting the development
of practical technology and policy alternatives. All this must
be achieved in a fashion that allows for proportionate, efficient
and timely decision-making (European Commission, 2000). To
these ends, a series of more detailed elements might be
considered important aspects of any practical framework for
implementing precaution, as we describe below.

Improving the scientific basis of decisions

Precaution is often defined as a risk management principle
invoked after scientific inquiry takes place (European
Commission, 2000). This scientific stage in the process is often
considered synonymous with risk assessment. Risk
assessment can be a powerful tool if uncertainties are familiar
and well understood, but precaution is essential, since many
uncertainties are much more challenging than this. It is far
from scientific to pretend otherwise. Likewise, risk assessment
can result in the adoption of a rather narrow perspective in
appraisal, often involving only a small subset of the relevant
scientific disciplines.

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Precaution encourages a more broadly based approach,

enhancing the ability of science to address complex
interactions in complex environmental systems and thus to
help detect and investigate early warnings. This may, in turn,
identify promising new options that might otherwise be
missed in risk management. In short, precaution helps to
improve the scientific basis for decision-making by prompting
greater rigour in the choice of methods and wider inclusion of
different scientific disciplines. This ensures that the most
salient information is gathered and the uncertainty is not
artificially understated (Wynne, 1992; Stirling & Calenbuhr,
1999).

Even when conventional risk assessment techniques are

considered sufficient, precaution has a further contribution to
make to the scientific basis for decision-making – before the
“risk management” stage. Conventional procedures for the
setting of levels and burdens of proof are not objective and
intrinsic to science but raise non-scientific questions over the
most appropriate values to apply. There are great questions,
for instance, related to who should bear the burden of
gathering the evidence and conducting the analysis. Should it
be the beneficiaries or those who are potentially at risk?

In many areas of scientific research, requiring high levels of

proof before accepting a new hypothesis is appropriate. This
approach gives privilege to well-established existing
understandings and thus helps to avoid the unproductive
pursuit of new hypotheses that may turn out to be false. For
risky new technologies (or even existing ones considered safe
until demonstrated harmful), however, this raises serious
questions. Is presuming that a risk is absent more scientific
than presuming that it is present? When the stakes include
public health or irreversible environmental harm, the
appropriateness of this same degree of conservatism can be
problematic. By downplaying the need for investigating
possible harm, a presumption of safety can actually serve to
inhibit scientific activity. By encouraging scientists to be more
critical and reflective over the adoption of hypotheses and the
setting of levels and burdens of proof, precaution actually

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serves to promote the conduct of science (Kriebel et al., 2001

(reproduced as Chapter 9 of this publication); Gee et al., 2002).

Precaution offers to improve the scientific basis for decision-

making in a third way. Precaution urges greater humility over
the definitive status of any particular body of scientific
findings. It involves recognizing that the answer science gives
to questions of safety and risk typically depends on the specific
question asked, how this is framed and the assumptions that
are made in developing a response (Jasanoff, 1990; Wynne,
1996). Science means about being rigorous not only about the
quantitative data but also about how these data are sensitive
to assumptions. Here, precaution prompts greater attention to
public participation and deliberation, but this attention to
participation is motivated by scientific and not political
reasons. It means being as rigorous in validating the questions
as in providing the answers. Valuing scepticism and dissent is
key to science. Rather than accepting a simple process in
which science delivers apparently definitive answers to policy-
making, precaution encourages a more dynamic, reflective and
critical relationship between policy-makers, scientific advisers
and wider stakeholders (Stirling, 2003).

Applying prevention
Precaution and public health prevention pursue similar goals
in identifying the causes of risks and reducing or preventing
them when possible at their source rather than seeking to
control proximate risk factors and to remedy damage after it is
done. Reducing risks, promoting healthy life: the world health
report 2002 (World Health Organization, 2002) notes that “in
order to protect and improve health around the world, much
more emphasis is needed on preventing the actual causes of
important diseases – the underlying risks to health …”.
Reducing and preventing risks is critical to promoting
sustainable development.

The terms precaution and prevention are often used

interchangeably, but a preventive decision need not be
precautionary – such as the decision to phase out lead in

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gasoline or action to prevent smoking. These were responses to

concrete scientific evidence of harm in which uncertainty
played very little role. But precautionary decisions should
always be preventive – they should not simply transfer risks
from humans to ecosystems, from workers to consumers and
so on. Ideally, implementing precaution involves shifting
attention upstream in the chain of determinants of health and
addressing – as a priority – additional questions about risk.

For example, before asking “What level of risk is acceptable?”

or “How much degradation can a human or ecosystem
assimilate?”, a proactive, truly preventive strategy would first
ask “How much contamination can we avoid while still
achieving our goals?” and “What are the alternatives or
opportunities for prevention?”. The goal of prevention is not to
eliminate technologies or activities that could have important
public health and development benefits but rather to
determine whether these benefits can be achieved more safely.
Far from impeding innovation, this kind of prevention actually
serves to encourage creativity and innovation (Tickner, 1999).

An integral part of prevention and precaution is seeking to

avoid creating new problems while solving existing ones. Well-
intended, precautionary public health interventions can
themselves result in serious adverse consequences (Goldstein,
1999). Indeed, almost any technology involves some hazards,
and changes undertaken to reduce exposure can sometimes
produce unintended consequences, including adverse ones.
Thus, ensuring that precaution is self-consistent requires
taking the same degree of care in appraising the likely
alternatives as in assessing the particular technology or policy
option under scrutiny (O’Brien, 2000; Tickner, 2002).

Public health has several types of prevention, all of which are

important in applying precaution. Primary prevention involves
intervening in systems to address the root factors of disease
before diagnosis; secondary prevention is early detection,
allowing minimal time lag time between identifying disease
and intervention (such as surveillance); and tertiary
prevention is control of damage and curative action once

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disease occurs (such as rapidly cleaning up and protecting

from the harmful effects of contaminated sites) (Leavell &
Clark, 1958). A fourth type of prevention could be termed
primordial prevention: action taken based on knowledge about
what might happen in the future, such as increases in
smoking and subsequent cardiovascular disease in developing
countries or increases in infectious disease caused by climate
change. These types of prevention can be applied at the
population level and used in an overlapping fashion.

Transparency, accountability and empowerment

Precaution conforms to the general principle that decisions on
environment and health should be informed by and consistent
with the available scientific evidence. In the broad sense of the
German Vorsorgeprinzip, it also upholds the wider imperative
that policy-making should pursue the technology and policy
options that are most favourable for society as a whole. This
means maximizing the economic and wider benefits and
minimizing the risks, costs and other adverse effects. In all
these areas – central to precaution – the crucial role played by
public values is increasingly being recognized. For these
reasons, effectively implementing precaution involves
particular attention to transparency, accountability and
empowerment.

As already noted, the answers science gives depend on the

questions asked. For instance, does regulation ask whether
technologies are tolerable, safe enough, safe, the safest
available or as safe as possible? The choice among these
questions depends on the values held, and the crucial role of
public values becomes even more important when attention
extends to appraising economic and wider benefits and
comparing different kinds of risk and cost. What weight
should be placed on present versus future risks? On risks to
workers versus risks to the general public? On risks to
children versus risks to adults? On injuries versus disease
versus death? On human health versus the environment?
There is no single definitive way to compare these apples and
oranges. Precaution recognizes that the only way to deal

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effectively with this dilemma is to ensure that everyone who

has an interest or who is likely to be affected is effectively
engaged in the decision-making process.

Interested stakeholders, local communities or members of the

public are not necessarily either well-informed or cautious
about risks. Indeed, the reverse may sometimes be the case.
However, the precautionary rationale for participation rests on
more subtle insights. Wider engagement is not an alternative
to expert knowledge but a complement. It is well established,
for instance, that, by thinking more broadly and escaping
disciplinary constraints, non-experts can sometimes see
problems, questions, issues, connections and solutions that
experts can miss (National Research Council, 1996; Omen et
al., 1997; Royal Commission on Environmental Pollution,
1998; United Kingdom House of Lords Select Committee on
Science and Technology, 2000; Gee et al., 2002). Including
outsiders helps to avoid uncritical group thinking. Non-
specialists have no interest in advancing particular
disciplines, exaggerating expertise or understating
uncertainty. As workers, consumers or local people, they may
sometimes have knowledge about real-world conditions of a
kind that might otherwise be missed or simplified in the
expert models. All these factors are important elements in
adopting a precautionary approach to appraisal.

Precautionary assessment
Precautionary assessment (Tickner, 2000, 2003) represents a
framework and set of procedural steps designed to embed
precaution in both the science and policy of environmental
decision-making. It incorporates broad framing of problems,
thorough examination of alternatives and an approach to
science that expands the considerations, disciplines and
constituencies involved in collecting and weighing scientific
evidence and in the ultimate process of decision-making.

Precautionary assessment incorporates a process flow that

emphasizes flexibility. This differs substantially from the more
rigid, formulaic four-step approach to risk assessment and

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management set forward by the National Research Council

(1983) in the United States but is consistent with approaches
to sound decision-making proposed in many business texts
(Hammond, Keeney & Raiffa, 1999). An iterative process flow
may be more useful than the prescriptive rules currently used
in environmental decision-making for several reasons.

x Each decision is different – with different types of

evidence, uncertainty, affected communities and
availability of alternatives.

x A more generalized approach permits a wider range of

information to be used in the decision-making process
and allows for more qualitative judgements in the face
of uncertainty and complexity.

x A process flow does not oversimplify or narrow the

decision-making process. Rather, it lays out a series of
procedural steps that should be considered in all sound
environmental and health decision-making processes.

Although the process of precautionary assessment (Box 1) may

appear cumbersome, it should be thought of as providing a
heuristic device and normative considerations to guide sound,
preventive environmental decision-making rather than an
inflexible set of steps that must be completed in a particular
way. Beginning with a holistic definition of the problem is
clearly important, as this affects each of the following steps.

Environment and health assessment

A centrepiece of precautionary assessment is environment and
health assessment, which weighs the science of hazards and
exposure. In this step, evidence of risk and uncertainty is
examined to determine the possibility (and plausibility) of a
significant health threat and the need for precautionary
action. As many environmental risks are complex and highly
uncertain, such an analysis must involve both the totality of
the evidence and individual pieces thereof to plausibly indicate
effects. The goal is to build a coherent picture of potential

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effects – a “story”. In precautionary assessment, this analysis

is completed using a research synthesis (Stoto, 2000) or weight
of the evidence approach (International Joint Commission,
1994).

The environment and health assessment should consider the

wide range of sources of information and plausible harms and
effects identified during the problem-scoping (the process of
defining the problem and potential effects). Evidence of
potential effects and uncertainty should be gathered from as
diverse an array of disciplines and constituencies as possible,
including: observational studies, worker case reports,
toxicological studies, studies of wildlife and domestic animals,
cellular studies, ecological assessment, community health
studies, modelling and monitoring. The effects examined in
the analysis should include effects on human health and
ecosystem health; acute and chronic effects; interactive and
cumulative effects; direct and indirect effects; and
socioeconomic, historical and aesthetic effects. Since the list of
plausible effects might be very large, setting priorities based
on the effects of greatest concern from the scientific and
political viewpoints is useful.

The four steps of environmental and health assessment are

hazard analysis, exposure analysis, magnitude analysis and
uncertainty analysis.

x Hazard analysis: the purpose of this step is to

understand the strength and quality of the evidence
that there is or could be a detrimental effect. Inherent
properties in the activity or substance that could lead
to adverse effects are considered.

x Exposure analysis: this step gathers evidence of actual

or potential exposure from various sources. The nature
(direct, dispersive, controlled or closed-system) and
intensity of exposure are analysed as well as when and
to whom exposure occurs, including the potential for
cumulative and interactive exposure.

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x Magnitude analysis: this step examines evidence on

the seriousness of potential effects, including: the
spatial and temporal scales of effects; potential
catastrophic effects; any susceptible subpopulations;
the reversibility of adverse effects; and the degree of
connectivity of effects. When the potential magnitude
of effects is large, weaker evidence provides a cause for
concern.

x Uncertainty analysis: this step assesses both

qualitative and quantitative gaps in knowledge.
Uncertainty should be analyzed broadly in terms of
type (parameter, model, systemic or ignorance),
sensitivity to changing assumptions and the feasibility
of reducing uncertainty.

Unpacking information on hazard, exposure, magnitude and

uncertainty rather than obtaining a single risk number
improves flexibility, understanding of the nature of potential
effects and opportunities for preventive interventions in
decision-making. The results of these subanalyses are
combined into a final environment and health assessment that
can be presented in a categorical fashion (such as significant
threat, minimal threat, etc.) with a concise, detailed narrative
outlining the rationale for the categories, the evidence on
which the determination was based and other quantitative
and qualitative considerations.

The environmental and health assessment narrative should be

clear about what is known, what is not known and what can
be known about the threat, the limitations of scientific studies
to understand the threat and gaps in information, including
research needs. It should also indicate the extent to which
uncertainty, and especially ignorance, can be reduced through
additional research. The plausibility and probability of various
outcomes should also be considered (the sensitivity of the
results). The analysis determines, based on the weight of the
evidence, whether an activity is associated with or may cause
harm and the potential severity of that harm.

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 11. Implementing precaution

Alternatives assessment
The other centerpiece of precautionary assessment is thorough
evaluation of any alternatives to prevent or minimize harm.
Alternatives assessment is the heart of the solutions-oriented
approach of the precautionary principle and is central to
sound, forward-looking environmental decision-making. This
focuses decision-making attention on opportunities rather
than simply the hazards associated with a narrow range of
options (O’Brien, 2000). The acceptability of a risk should be a
function not only of hazard and exposure but also of
uncertainty, the magnitude of the potential effects and the
availability of alternatives or preventive options. Availability
of a safer alternative can obviate the need for costly,
contentious and potentially misleading quantitative risk
assessment.

The goal of alternatives assessment is to identify and examine

opportunities to prevent an activity from adversely affecting
environment and health. A secondary goal is to drive
innovation towards more environmentally friendly and
sustainable technologies, products and practices. Thus,
alternatives assessment should consider not only existing,
easy and feasible options but also those that can be developed
– those that are on the horizon. Alternatives assessment often
has the greatest impact when undertaken early in a decision-
making process – in the development phase.

Nevertheless, alternatives assessment requires tools to

analyse comprehensively not only the risks but also the
feasibility of alternative technologies and products. Numerous
methods exist for these types of evaluations (Tickner, 2000).
Alternatives assessment should examine and understand the
effects and purpose of the activity; identify a wide range of
options; analyse alternatives comparatively; and select
alternatives.

x Examine and understand the effects and purpose of

the activity: the purpose of this step is to better
understand the service that the activity provides and

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Stirling & Tickner

whether it can be provided in a less damaging way;

how hazardous materials are used (materials
accounting); and the potential effects and benefits of
the activity.

x Identify a wide range of options: a diverse group of

stakeholders should brainstorm a wide range of
options that could lead to multiple opportunities to
reduce risk.

x Analyse alternatives comparatively: this aims to

thoroughly examine and compare the technical
feasibility and the economic, environmental, health
and safety effects and benefits of the existing or
proposed activity and identified alternatives.

x Select alternatives: the alternatives plan should

analyse the selected alternative, how it will be
implemented (including how barriers will be
addressed) and a plan for follow-up, continuous
improvement and monitoring for potential adverse
effects. Interim alternatives may be able to be
implemented while long-term alternatives with
greater environmental health benefits are being
developed.

Precautionary action analysis

The last part of precautionary assessment is to determine the
appropriate courses of action. This could be considered the
“risk management” phase of the decision-making process but
is fully integrated into all of the previous steps. Precautionary
action analysis involves weighing the information gathered
earlier to determine how much and what type of precaution
should be taken. Policy tools for implementing precautionary
action (see below), ranging from further study to banning the
activity, are chosen based on the severity of the risk,
uncertainty involved and availability of feasible alternatives.
Finally, a feedback and monitoring scheme is developed to
measure the benefits and provide early warning of potential

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problems. Action is determined not based on a specific

threshold for action but rather considering all the available
evidence to take the most health-protective, yet reasonable,
course of action. Precautionary assessment may also result in
a decision that an activity is unlikely to cause harm or that its
effects would be minimal – in which case instituting a
monitoring scheme may be the most appropriate action.
Decisions made under a precautionary assessment should not
be considered permanent but part of a continual process of
increasing understanding and reducing overall effects.
Regular follow-up can stimulate continual improvement in
environmental performance and technological innovation.

Box 1. The steps of precautionary assessment

The steps of precautionary assessment are described below. A
first step in the process is for authorities (and, when
appropriate, with stakeholders) to identify whether the threat
is of sufficient concern (either scientifically or in terms of
public perception or concern) to justify using public health
resources for further examination and analysis of alternatives.
For threats that are well established, proceeding directly to
examining alternatives and preventive interventions would be
reasonable.

Problem-scoping
• Broadly frame and define the problem.
• Outline the range and types of plausible effects (including
direct and indirect ones).
• Identify the populations affected and those that might be
disproportionately affected.
• Identify research and information needs about health effects
and alternatives.
• Identify who is responsible for studying the risk, providing
information or taking appropriate preventive action.
• Identify who should be involved in the decision-making
process and at what points during the process this
involvement should occur.

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Environment and health assessment

• Hazard analysis: weigh the strength of the evidence of
plausible effects. Broadly examine the evidence of hazards
from multiple sources and disciplines and set priorities
among the concerns. Consider the quality of the studies.
• Exposure analysis: examine the potential for exposure from
various sources. Consider the nature and intensity of
exposure and who is exposed (if one group may be exposed at
an especially sensitive time). Consider the potential for
cumulative and interactive exposure.
• Magnitude analysis: examine the magnitude and severity of
potential effects including the spatial and temporal scale,
susceptible subpopulations, reversibility and connectivity.
• Uncertainty analysis: examine the magnitude and type of
uncertainty and the feasibility of reducing uncertainty and
the potential effects on outcomes.
• Consider the weight of the evidence on association, exposure
and magnitude together to determine the potential threat to
health or the environment. Develop a narrative with a
rationale, the limitations in studies and the research
needed.

Alternatives assessment
• Examine and understand the effects and the purpose of the
activity.
• Identify a wide range of alternatives.
• Conduct detailed comparative analysis of the alternatives:
advantages and disadvantages, including economic,
technical, health and safety.
• Select the “best” alternative and institute implementation
and a follow-up plan.

Precautionary action analysis

• Determine the appropriate level of precaution needed based
on the level of threat of harm, uncertainty and the
availability of alternatives.
• Determine what other considerations must be included in
the decision, such as cost–effectiveness, the least
burdensome option, technical feasibility, political and
cultural feasibility or adaptiveness.

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 11. Implementing precaution

• Determine the types of interventions needed to ensure

adoption of the precautionary changes – such as technical
assistance, information or technology support.
• Determine a precautionary feedback regimen to minimize
unintended consequences and to ensure continual
improvement.

A precautionary framework for the general regulation

of risk
The previous section outlined a tool for applying precaution in
assessment processes. The question that results is how such
an assessment tool could be integrated into regulatory
decision-making processes. In an attempt to reconcile some of
the themes discussed so far with more conventional
approaches to risk regulation, an international team of
academics working in Europe has developed a proposal for a
novel general framework for the precautionary regulation of
risk, potentially addressing a range of different industrial
sectors and policy areas. The proposal was developed under
the auspices of the Precaupri Project financed by the European
Commission as a result of a series of collaborative workshops
involving chemical and biotechnology industry corporations,
nongovernmental environmental, consumer and public health
organizations, representatives of various national government
agencies and intergovernmental bodies and practicing
regulatory lawyers and legal scholars (Renn et al., 2003).

Among other things, the central aim of this new framework is

to focus directly on a series of challenging questions that are
often raised as criticisms of the precautionary principle. For
instance, what is the precise relationship between precaution
and established approaches to risk management based on risk
assessment? Exactly how does precaution relate to parallel
principles of good governance, such as openness, participation,
accountability, effectiveness and coherence? How can the
precautionary principle be harmonized with binding legal
commitments concerning non-discrimination, proportionality
and fundamental rights?

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Questions of this kind quickly demonstrate that neither

precaution nor conventional approaches to risk management
can usefully be seen simply as mechanical decision rules. For
instance, risk assessment is often considered a complete
operational tool for handling the absence of certainty. Risk
assessment results are typically presented in a precise and
apparently definitive fashion, as if they presented an
unambiguous basis for science-based policy-making. Ironically,
this is a rather unscientific perspective. In fact, in formal
scientific terms, risk assessment is applicable only under
limited special conditions – when all the possible outcomes can
be fully defined and their respective relative likelihoods
confidently determined. This leaves risk assessment
inherently incapable of addressing a range of important kinds
of incomplete knowledge. These include uncertainty in the
strict sense, in which the possible outcomes are known but not
their likelihood. It also includes ambiguity, in which the
possible outcomes themselves are unclear or subject to
different interpretations. Finally, there is the condition of
ignorance, under which not only the likelihood but even the
outcomes themselves are unknown. Here, scientists face the
prospect of surprise.

Although conventionally expressed with confidence and

precision, different (and equally reasonable) risk assessment
studies typically deliver radically different results under these
more intractable conditions (Stirling, 1994; Saltelli, 2001).
This state of affairs is not scientifically sound, nor does it offer
a practical basis for robust decision-making on risk. As an
operational decision rule to informing general decision-making
under uncertainty, then, the procedures of risk assessment are
seriously incomplete.

Rather than treating the precautionary principle simply as an

alternative decision rule substituting for risk assessment, the
proposed new framework sees precaution in regulatory
appraisal as a broader and deeper process of learning and
enquiry (Wynne, 1992; Stirling, 2003). Risk assessment
remains appropriate and applicable under the true
circumstances of risk – when probabilities can be determined

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and the complete range of possible outcomes measured.

Beyond this, however, the challenge is to ensure that the
process of regulatory appraisal can gather further salient
information in the most effective and efficient way.

Under the proposed general framework for regulating risk,

imperatives to non-discrimination and proportionality are
reconciled with the demands of addressing uncertainty,
ambiguity and ignorance by designing an initial screening
process to be implemented before the full appraisal of the
various types of threat. A series of clearly specified screening
criteria are developed to identify conditions of uncertainty,
ambiguity and complexity. These are then used to set
priorities in treating different types of threat and to decide on
the most efficient and effective approach to subsequent
regulatory appraisal.

One set of screening criteria is designed to identify threats

that are definitely serious, giving priority to immediate
attention to preventing unacceptable forms or levels of harm.
Another group of screening criteria seeks sociopolitical
ambiguity – for instance concerning the distribution of effects
across different groups or political, cultural, ethical or
religious issues. Such issues are then addressed through open-
ended participatory deliberation, using well-established
procedures such as consensus conferences and stakeholder
fora. With regard to precaution, a key set of screening criteria
is specifically designed to diagnose scientific uncertainty of a
kind that precludes the confident application of risk
assessment techniques. Under these conditions, the
subsequent regulatory appraisal process takes the form of
precautionary appraisal. This includes a broader and more
demanding array of elements than is usually explicitly
included in conventional risk assessment (see the discussion of
precautionary assessment above) (Stirling & Calenbuhr, 1999;
Tickner, 2000; Gee et al., 2002):

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x deliberately favouring those who stand to be harmed

(rather than those who benefit) in assigning
responsibility for the funding of analysis and gathering
of evidence and in setting the level of proof and burden
of persuasion (Tickner, 1999);

x placing greater weight on empirical field research and

scientific monitoring rather than relying heavily on
theoretical models or laboratory analyses (Jackson &
Taylor, 1992; Tickner, 1999; Gee et al., 2002);

x taking account of the comparative merits of alternative

options rather than restricting attention to the
acceptability of a single option (O’Brien, 2000);

x examining benefits and justifications as well as the

adverse effects of various technology or policy options
and weighing these together (Jackson & Taylor, 1992;
MacGarvin, 1995);

x considering technological and production systems as a

whole, including resource chains and life cycles, rather
than a single product or technology viewed in isolation
(Jackson & Taylor, 1992; MacGarvin, 1995; Tickner,
1999);

x looking at the general systemic properties displayed by

different portfolios of options, including diversity,
resilience, flexibility and adaptability (Collingridge,
1982; Holling, 1994; Stirling, 1994; Farber, 1995); and

x addressing the innovation process at the earliest

stages before firm financial and institutional
commitments are made (Rip, Misa & Schot, 1996;
Grove-White, Macnaghten & Wynne, 2000).

In this way, the proposed framework avoids the forced

standardized application of risk assessment techniques to
challenges of ambiguity or uncertainty that simply cannot be
met. On the other hand, the screening process helps ensure

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that much more straightforward cases of prevention, or simple

routine forms of risk, are not addressed using unduly
cumbersome, protracted and costly precautionary procedures.
The design and implementation both of the screening and of
the subsequent appraisal process is subject to continual,
inclusive and deliberative review. Accordingly – as a reflective
process rather than a threshold or decision rule – the
framework as a whole might be considered to be precautionary
without requiring that resources be devoted equally to all
cases irrespective of their uncertainty or potential seriousness.
This may reconcile the apparently conflicting imperatives of
precaution and proportionality in the regulatory appraisal of
risk.

Concluding thoughts: developing policy options and

tools for applying the precautionary principle
In addition to the importance of developing assessment and
regulatory frameworks for integrating precaution into
decision-making structures, tools for effecting precautionary
and preventive action should be outlined and developed. Such
tools (Annex) should be case-specific depending on the nature
of the risk and its preventability. They should help advance
precautionary goals such as action on early warnings and
seeking out a range of alternatives and should address, where
possible, multiple risks at once, as well as internalizing
precautionary thinking at the government, firm or societal
level. Feasibility and cost are important considerations, and
such tools must be politically and culturally appropriate.
Application of these tools should be combined with efforts to
eliminate institutional, financial and technical barriers to
implementing precaution and prevention.

The application of prevention and precaution represent

important steps towards achieving the long-term goal of
sustainable development. According to the World Commission
on Environment and Development (1987), rather than being a
static formula, sustainable development is a process of change
in which exploitation of resources, investment, technology and
institutional policies are made consistent with present as well

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as future needs. It is solution-oriented, emphasizing a long-

term view for improving the quality of life for everyone. It
focuses on equity, including ensuring the rights of poor people
and future generations. It stresses qualitative development
over quantitative growth. Like precaution and prevention, the
challenge of sustainable development requires systems
thinking – understanding the interactions between the
environment, economy and society so as to identify root causes
of degradation and focus on more sustainable patterns of
production and consumption that can leave a safer, cleaner
and more economically prosperous world for the future.

Annex
Tools for applying precaution and prevention in
practice
Cleaner production and preventing pollution
Cleaner production and preventing pollution involve changes
to production systems and products to reduce pollution at the
source (in the production process or during product
development). This includes reducing the raw material, energy
and natural resource inputs (dematerialization) as well as
reducing the quantity and harmful characteristics of toxic
substances (detoxification) used in production systems and
products (Jackson, 1993; Geiser, 2001). A central aspect of
cleaner production is understanding the service that a
production system or product provides and seeking out safer
alternatives to provide that same service (for example,
chlorinated solvents provide degreasing, and pesticides control
pests). Many countries – including many countries in
transition – have established cleaner production programmes,
which have demonstrated success in reducing industrial and
product-related pollution, while reducing costs and improving
productivity.

Cleaner production concepts can also be applied to the use of

pesticides (integrated pest management in agriculture and
housing, which uses a wide range of tools to control pests) and
to the design of cities, living spaces and building materials.
Environmentally sound building provides basic principles for

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more healthy and environmentally friendly design that

minimizes hazardous and non-hazardous materials; is energy
efficient but allows sufficient fresh air ventilation; minimizes
the build-up of allergens; and locates residential districts to
minimize adverse environmental effects and improve air
quality (such as designing cities to minimize air pollution from
transport and production facilities). Land-use planning can
help avoid problems of sprawl, poor transport infrastructure
and sedentary lifestyle that have been important risk factors
for disease.

Setting goals in environment and health

Goal-setting is a common practice in public health and is
important to achieving sustainability. It involves establishing
aggressive, preventive health goals (such as eradicating
childhood smoking or preventing sexually transmitted disease
or pollution) and developing policies and measures to achieve
these goals (and to reduce barriers to their implementation)
while minimizing social disruption (also known as backcasting
(Dreborg, 1996)). Goal-setting focuses not on what future
scenarios are likely to happen but on how desirable futures
can be obtained.

Environmental health indicators

An environmental health indicator is a “characteristic of the
environment that, when measured, characterizes the
magnitude of stress, habitat characteristics, degree of
exposure to a stressor, or degree of ecological response to the
exposure” (International Joint Commission, 1995). Indicators
(which can include human or ecosystem health aspects) have
several purposes, including: providing decision-makers with
information about the health status of a community or a
population and raising awareness and understanding about
environmental degradation by measuring progress towards
established environmental health goals. By tracking progress
and noting benchmarks, public health professionals and
politicians, as well as the general public, can assess the
efficacy of current practices, programmes and policies and find
ways to develop and implement more preventive approaches.

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For example, if a programme intended to reduce the incidence

of an environmentally mediated disease is found to be
ineffective in meeting its goal, then public officials and the
general public should implement alternative programmes that
have promise in meeting the intended goal of preventing the
disease in the future.

WHO has been collecting data on a wide range of indicators,

including: health status indicator data on mortality, hospital
admissions for home accidents and the incidence of childhood
cancer; exposure indicator information on indoor and outdoor
pollutants, such as environmental tobacco smoke, water
supply and water sanitation; and policy indicator data on
legislative, policy and programmatic interventions to improve
air quality, water supply and children’s nutritional and safety
needs.

Information dissemination and education

Information and education represent an important subset of
market-based mechanisms, especially for countries in
transition and developing countries, that are relatively low
cost and can have substantial influence in reducing the
adverse environmental effects of activities. Many institutions
are interested in implementing some precautionary measures
or undertaking research and development of a safer
technology but lack the capacity to do so. Information and
education can provide that important capacity and can inform
citizens about more environmentally friendly choices.
Information has several benefits, including: understanding the
risks of materials and activities and their alternatives;
identifying gaps in knowledge; identifying priority pollutants
or activities of concern; allowing comparison of hazards and
preventive actions across sectors, countries and companies;
and improving enforcement of environment and health
policies. Most important, information is critical to public
empowerment and accountability. If people know about risks
and options to prevent them, they can take personal action to
reduce them or hold government authorities or those who
create them accountable for prevention. Information can also

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serve to discourage risky behaviour by providing an incentive

for those creating risks to consider and internalize the effects
of their activities and seek alternatives.

In occupational health, hazard communication has provided

an important tool for workers to understand the potential
effects of chemicals used in the workplace and to demand safer
working conditions. Prior informed consent – in which a
county can deny access to a pesticide or hazardous chemical
restricted in other countries – is an important tool for
developing countries to understand in making decisions on
risks. Right-to-know laws in many countries have proven
useful in encouraging business managers to reduce their
pollution. Finally, labelling products – such as those produced
using organic methods, those that contain potentially
hazardous materials or those that are environmentally
friendly – can provide a tool for consumers to choose products
with the fewest adverse environmental effects for a particular
need.

An agenda for precautionary environment and health

research
Supporting precaution, the protection of children’s health and
sustainability requires developing a new paradigm of
environment and health research. It must be centred on the
needs and exposure of children and future generations as well
as on sustainability (Landrigan, 1999). Currently only a small
percentage of environmental research budgets focus on
children (who represent a major proportion of the population)
or prevention.

Environment and health research must form a central part of

any prevention strategy. A prevention-oriented research
agenda would include tools for rapidly identifying
environmental hazards as well as potential exposure. It would
develop tools to broaden understanding of the unique
susceptibility of some populations to environmentally related
illnesses. It would broaden the understanding of the complex
set of determinants of environmentally related disease,

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including proximate and more fundamental risk factors for

specific effects as well as the interactions between broad
categories of risks (chemical, physical, climate and social), the
cumulative effects of multiple risks. It would also project the
long-term implications of action today for future generations
(through, for example, integrated assessment methods). It
would examine and develop a range of preventive options to
reduce environmental risks while achieving good living
standards for everyone. It would also include measurement
and surveillance techniques (such as health indicators) to
measure progress towards reducing environmental risks and
achieving more sustainable forms of development as well as
identifying early warnings of adverse effects.

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Joel A. Tickner, David Kriebel & Sara Wright

Reproduced by permission of Oxford

University Press, Oxford, United Kingdom,
from International Journal of Epidemiology
2003; 32: 489-492.

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