1. INNOVATION AND THE PRECAUTIONARY PRINCIPLE: *** Carolyn Raffensperger New York March 17, 2004

2. Roadmap for this morning: three key ideas The precautionary principle Why What How The public trust doctrine What is government for? A public interest research agenda

3. 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.

4. Jane Lubchenco’s 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?

5. 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

6. Why the precautionary principle?: additional perspectives the 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.)

7. 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.

8. 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.”

9. Precautionary principle cont. 1.Goal setting 2.Shifting the burden of proof 3.Examining a full range of alternatives and selecting the least harmful 4. Democratic decision-making

10. The precautionary principle incorporates both science and ethics –Ethics and values Do no harm –Science What we know How we know What we don’t know

11. 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 - government’s 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.

12. 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

13. Harm To whom or what? –Environment –Public Health –Cultural, Social Magnitude and kind –Serious –Cumulative –Irreversible –Easily avoidable?

14. Scientific uncertainty Uncertainty about cause or magnitude Uncertainty, indeterminacy, ignorance –Value of more data –Unpredictability of complex systems –Asking the right questions (we’ll come back to this in a minute)

15. 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)

16. 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

17. 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.

18. 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

19. Cigarettes and lung cancer— evidence for causation 1945—Ochsner—Incidence rises together 1950—Doll & Hill—case-control study 1953—Wynder—tar causes cancer in mice 1954—Follow up studies show association, and that greater exposure > greater risk 1990s—biological mechanism(s) described (genetic factors; mutations)

20. 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.

21. 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.

22. 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

23. Precaution as over-arching framework Public Interest Research Agenda Pre-market testing Regulation Monitoring Courts

24. 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 District’s pesticide policy. Guide the research agenda –Bristol-Myers Squibb’s research into drugs in H2O –NY’s legislation

25. 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.

26. The public trust doctrine provides a visionary role for government. Government is the guardian and manager of the common wealth.

27. 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.”

28. 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)

29. The Commons and Public Interest Research Public Interest Research is one process or method for –understanding –protecting and –adding to the common wealth

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

31. In President Kennedy’s words “Scientists alone can establish the objectives of their research, but society, in extending support to science, must take account of its own needs”