1. A Cautionary Approach to the Precautionary Principle Bernard D. Goldstein, MD Dean University of Pittsburgh Graduate School of Public Health

3. Range of Expert Judgment XXXXXX

4. X X XX X X

5. CATNIP PRINCIPLE

6. CHEAPEST AVAILABLE TECHNOLOGY NOT INVOLVING PROSECUTION

7. Precautionary Principle Described in the Rio Declaration: Nations shall use the precautionary approach to protect the environment. Where there are threats of serious or irreversible damage, scientific uncertainty shall not be used to postpone cost-effective measures to prevent environmental degradation.

8. When an activity raises threat 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. Wingspread Statement

9. Differences between the Rio and Wingspread Definitions of Precautionary Principle Thrust of Statement –Rio: Negative: lack of certainty should not postpone measures –Wingspread: Positive: measures should be taken Extent of Harm –Rio: Serious and irreversible damage –Wingspread: Not specified Extent of Costs –Rio: Action should be cost effective –Wingspread: Not specified Areas of Relevance –Rio: Environment –Wingspread: Health and environment

10. Definition of the Precautionary Principle (Cynical American Version) The Precautionary Principle is a nebulous doctrine developed by Europeans as a means to erect a trade barrier against any item that can be produced more efficiently in the United States.

11. Risk Assessment and/or/vs the Precautionary Principle

12. Risk Assessment Is risk assessment antidemocratic?

13. “Those of us who support the Precautionary Principle do so in part because we perceive our democratic rights to a clean environment and health have been violated” “This technocratic process (risk assessment) purports to put the decisions into an objective framework but the process gives greater power to corporate interests and tends to violate individual and collective rights to health” Tickner and Ketelson, 2001

14. “Risk assessment obscures and removes the fundamental right to say ‘no’ to unnecessary poisoning of one’s body and environment” Mary O’Brien, Making Better Environmental Decisions, MIT Press, Cambridge, MA, 2000

15. RISK ASSESSMENT AND THE PRECAUTIONARY PRINCIPLE The Precautionary Principle is already incorporated in Risk Assessment

16. “Precautionary” aspects of risk assessment Factors of ten (“safety” factors) 95% upper confidence limits Models with prudent default assumptions (exposure; dose response; hazard identification) Inertia (regulatory prudence) Maximally exposed individual vs population based approaches

17. RISK ASSESSMENT AND THE PRECAUTIONARY PRINCIPLE The Precautionary Principle is already incorporated in Risk Assessment The Precautionary Principle should be incorporated into Risk Assessment

18. RISK ASSESSMENT AND THE PRECAUTIONARY PRINCIPLE The Precautionary Principle is already incorporated in Risk Assessment The Precautionary Principle should be incorporated into Risk Assessment The Precautionary Principle and Risk Assessment are completely antithetical

19. Control of Hazardous Air Pollutants in the United States BEFORE 1990AFTER 1990 Burden of proofTo list chemical, EPA must demonstrate that ambient levels of pollutant produce risk To remove chemical from list, industry must demonstrate that chemical does not produce risk Regulatory Control For Listed Pollutant Risk based application of control technology Maximum available control technology Role of Risk Assessment PrimarySecondary

20. Precautionary Principle Should invoking the precautionary principle automatically trigger research to determine if the precaution is needed?

21. Invoking the Precautionary Principle Requires Three Conditions to be Met: 1.Sufficient scientific information to raise the possibility of adverse impacts on humans or the environment.

22. Invoking the Precautionary Principle Requires Three Conditions to be Met: 1.Sufficient scientific information to raise the possibility of adverse impacts on humans or the environment. 2.Uncertainty as to the extent of the effects, with a possible worst case scenario of highly significant harm.

23. Invoking the Precautionary Principle Requires Three Conditions to be Met: 1.Sufficient scientific information to raise the possibility of adverse impacts on humans or the environment. 2.Uncertainty as to the extent of the effects, with a possible worst case scenario of highly significant harm. 3.The action advocated under the precautionary principle must have significant economic of societal costs.

24. The extent that a society lives by the precautionary principle can best be measured by the extent to which precautionary actions turn out to have been unnecessary.

25. Role of Surveillance as a Basis for Actions Under the Precautionary Principle Is it getting worse or is it getting better? –Global climate change vs POPS How would we know? –Indicators –Biological Markers: Exposure, Effect, Susceptibility

26. Public Health and Prevention Risk assessment is a more effective tool for secondary as compared to primary prevention. The precautionary principle is primary prevention The relative value of primary prevention as compared to treatment is 16:1

27. The Precautionary Principle Protection of Public Health and the Environment or Protection of Trade and National Interests

28. Example of a Public Health Loss Ascribable to the Precautionary Principle: Zambia Widespread hunger due to food shortages in Zambia in 2002 Cornmeal is base of standard Zambian diet 75% of food supplied to Zambia by UN World Food Program (WFP) donated by US Corn sent by US is routinely part of US diet

29. Example of a Public Health Loss Ascribable to the Precautionary Principle: Zambia Zambia has ruled that GMO corn is not safe and will not distribute it. Zambia is also concerned about losing any future export market to EU. In August 2002, 14,000 metric tons of US grain in storehouses and much more on way, but only 7000 tons of food, approx. 2 weeks worth, available for distribution to 2.5 million people in need

30. Example of a Public Health Loss Ascribable to the Precautionary Principle: Zambia Zambian President Levy Mwanawasa said “I’m not prepared to accept that we should use our people as guinea pigs”. Asked if he believes US grain is poisonous, Zambian Agriculture Minister Sikatana stated: “What else would you call an allergy caused by a substance? That substance that the person reacts to is poisonous” “Many Zambians … wonder why friends who received the American corn before the ban went into effect have not died” » Henri Cauvin, NY Times, 8/30/02; 9/4/02

31. Implications of Problems in European Agriculture Recent agriculture industry problems in EU countries include: – BSE (Mad Cow Disease) – Hoof and mouth disease – Dioxins in chicken feed These problems have led to public distrust and to support for the Precautionary Principle. The Precautionary Principle justifies exclusion of usual US food products, even though the US has had none of these agricultural problems –

32. Differential Implications of French HIV Hemophilia Scandal to EU and to US Many hemophiliacs died unnecessarily of AIDs Due to French government delaying approval of an assay developed by US company to detect HIV virus prior to transfusion of blood products. Goal of delay said to be to allow Pasteur Institute to develop its own HIV detection test Resultant scandal led to jail for head of blood bank in France and suggestions of cabinet involvement

33. Differential Implications of French HIV Hemophilia Scandal to EU and to US Implications to Europeans: Distrust in scientific institutions - and therefore the need for the Precautionary Principle Implications to Americans: Europeans can not be trusted to act fairly in trade matters even if it puts their own citizens at high risk - and the Precautionary Principle is just another European trade tactic

34. Role of Perception in Public Health Policy Decisions

37. The Precautionary Principle as a Place to Hide Behind Refuge from the need to understand science Simplistic shortcut to regulatory action Policy high ground (feel good approach) Avoidance of trade off decisions

38. Three Examples of Public Health Actions that Could Have Benefited From Application of the Precautionary Principle 1. Oxygenated fuels (United States) 2. Arsenic in water supplies (Bangladesh) 3. Hepatitis C (Egypt)