INNOVATION AND THE PRECAUTIONARY PRINCIPLE: ***

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INNOVATION AND THE PRECAUTIONARY PRINCIPLE

• Carolyn Raffensperger
• New York
• March 17, 2004

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Roadmap for this morningthree key ideas

• The precautionary principle
• Why
• What
• How
• The public trust doctrine
• What is government for?
• A public interest research agenda

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The central theme

• A key government role is to serve as the trustee
  of the common wealth for this and future
  generations. The precautionary principle enables
  government to carry out its responsibility.
  Public interest research adds to the common
  wealth. The precautionary principle helps decide
  what R D benefits or harms the common wealth.

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Jane Lubchencos questions

• How is our world changing?
• What are the implications of these changes for
  society?
• What is the role of science in meeting the
  challenges created by the changing world?
• How should scientists (government, business and
  citizens) respond to these challenges?

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Why we need the precautionary principle

• Humans have caused major global change  
• Some change has serious implications
• Hole in the ozone layer
• global climate change
• collapse of marine fisheries
• alteration of major biogeochemical cycles,
  including carbon, nitrogen, water, metals
• synthetic chemicals contaminate virtually all
  wildlife and humans
• The magnitude of human caused change is
  unprecedented
•  

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Why the precautionary principle? additional
perspectivesthe world is complex, interconnected
and dynamic

• Assessing cumulative, systems level or
  interactive effects is difficult.
• Surprises have occurred frequently ( Ex. CFCs and
  the hole in the ozone layer).
• Future generations have interests and needs that
  are difficult to protect with some
  decision-making strategies
• Many current choices have high decision stakes
  because of the scale at which they are made.
  (Global choices have global consequences.)

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An additional public health perspective

• Patterns of illness and disease are changing
  e.g., asthma, neurodevelopmental disorders,
  incidence of some malignancies and birth defects
  chronic, degenerative diseases.

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What is the precautionary principle?

• Wingspread Statement 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.

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Precautionary principle cont.

• Goal setting
• Shifting the burden of proof
• Examining a full range of alternatives and
  selecting the least harmful
• 4. Democratic decision-making

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The precautionary principle incorporates both
science and ethics

• Ethics and values
• Do no harm
• Science
• What we know
• How we know
• What we dont know

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Values underlying the precautionary principle

• 1) Respect - for the needs and rights of this and
  future generations as well as others who cannot
  speak for themselves
• 2) Humility - towards the natural world and our
  ability to understand it through science
• 3) Democracy - giving people a voice in matters
  that affect their lives
• 4) Responsibility
• - governments public trust responsibility to
  manage the commonwealth for this and future
  generations.
• - Individuals including industry, obligation
  to take responsibility for their actions in the
  world.

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Common elements of the precautionary principle in
international treaties

•  
• All formulations include
•  
• 1) Threat of harm
•  
• 2) Lack of scientific certainty
•  
• 3) Action to prevent harm

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Harm

• To whom or what?
• Environment
• Public Health
• Cultural, Social

• Magnitude and kind
• Serious
• Cumulative
• Irreversible
• Easily avoidable?

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Scientific uncertainty

• Uncertainty about cause or magnitude
• Uncertainty, indeterminacy, ignorance
• Value of more data
• Unpredictability of complex systems
• Asking the right questions
• (well come back to this in a minute)

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Precautionary Action

• Anticipatory and preventive
• Increases rather than decreases options
• Can be monitored and reversed
• Increases resilience, health, integrity of whole
  system
• Enhances diversity (one size does not fit all)

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Laws of Technology

• The bigger the technological solution, the
  greater the chance of extensive, unforeseen side
  effects. (Stephen Schneider, 1976)
• Scale matters
• The greater the rapidity of human-induced
  changes, the more likely they are to destabilize
  the complex systems of nature. (Leopold 1949)
• Speed matters

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Scientific responses to uncertainty

• Use multiple disciplines, not just toxicology or
  epidemiology. For instance, many endocrine
  disruptors act physiologically and
  pharmacologically.
• Use biological principles, not isolated, limited
  facts. For instance, bioaccumulation is a marker
  for potential harm even if the exact harm is not
  yet known.

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Hill criteria for causation in epidemiology

• Consistency of findings
• Strength of association
• Biological gradient (dose-response)
• Temporal sequence (cause before effect)
• Biologic plausibility (mechanism)
• Coherence with established facts
• Specificity of association

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Cigarettes and lung cancerevidence for causation

• 1945OchsnerIncidence rises together
• 1950Doll Hillcase-control study
• 1953Wyndertar causes cancer in mice
• 1954Follow up studies show association, and that
  greater exposure gt greater risk
• 1990sbiological mechanism(s) described (genetic
  factors mutations)

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Shifting the burden of proof

• Industry (or other proponent) has an obligation
• to test their product (ask the right questions
  and use the right scientific disciplines)
• heed early warnings
• seek safer alternatives
• publicly disclose information about harm.
• pay for damage and restoration.
• Shifting the burden of proof does NOT mean that
  industry has to prove absolute safety.
• Shifting the burden of proof does mean that the
  environment and public health get the benefit of
  the doubt.

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Implementing the precautionary principle when?

• People used to think the precautionary principle
  only meant bans (or moratoriums and sunsetting).
  This is too late in the game. It is costly and
  wasteful.
• This was a post-market strategy after research,
  after marketing and regulation. It was a
  whoops factor.

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Implementing the precautionary principle when?

• Using the precautionary principle earlier in the
  development of a product is a wiser use of
  resources and catches more potential harm.
• Public interest research agenda
• Pre-market testing

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Precaution as over-arching framework

• Public Interest Research Agenda
• Pre-market testing
• Regulation
• Monitoring
• Courts

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Government and business approaches to precaution
U.S.

• Policy framework
• San Francisco
• Systems to detect and respond to early warnings
• Minnesota Dept. of Health
• Verizon cell phone warning
• Identify and select alternatives to one or more
  harmful chemicals
• L.A. Unified School Districts pesticide policy.
• Guide the research agenda
• Bristol-Myers Squibbs research into drugs in H2O
• NYs legislation

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What is the Public Trust

• Part of the Common wealth
• Held in trust
• By government
• Managed for this and future generations
• The Public Trust Doctrine is a matter of common
  law or state constitutions in 48 states.

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The public trust doctrine provides a visionary
role for government. Government is the guardian
and manager of the common wealth.
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The Constitution of Hawaii says this For the
benefit of present and future generations, the
State and its political subdivisions shall
conserve and protect Hawaii's natural beauty and
all natural resources, including land, water,
air, minerals and energy sources, and shall
promote the development and utilization of these
resources in a manner consistent with their
conservation and in furtherance of the
self-sufficiency of the State. All public natural
resources are held in trust by the State for the
benefit of the people.
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The Public Trust and the Precautionary Principle

• In a legal challenge asking Hawaii to enforce its
  constitutional public trust responsibility the
  court said
• Where scientific evidence is preliminary and not
  yet conclusive it is prudent to adopt
  precautionary principles in protecting the
  resource. (Hawaii Supreme Court in Waiahole
  Ditch)

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The Commons and Public Interest Research

• Public Interest Research is one process or method
  for
• understanding
• protecting and
• adding to the common wealth

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Defining Public Interest Research

• Public interest research aims at developing
  knowledge and/or technology that increases the
  common wealth. (Peters, 1999)

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In President Kennedys words

• Scientists alone can establish the
  objectives of their research, but society, in
  extending support to science, must take account
  of its own needs