1. PP Res, Rat, Resp 03/07/06

2. Chair - Steven G. Gilbert, PhD, DABT Co-chair - Joel L. Mattsson, DVM, PhD The Precautionary Principle - Implications and Applications SOT – ELSI SS March 7, 2006

3. PP Res, Rat, Resp 03/07/06 Speakers  An Introduction to the Precautionary Principle Steven G. Gilbert, INND, Seattle, WA  Aspirations and Limitations of the Precautionary Principle Gary Marchant, Arizona State University College of Law, Tempe, AZ  Green Chemistry: Developing Sustainable Alternatives to Polluting Technologies Terry Collins, Carnegie Mellon University, Pittsburgh, PA  The Hazards of the Precautionary Principle Joel Mattsson, Dow AgroSciences, Indianapolis, IN  Discussion

4. PP Res, Rat, Resp 03/07/06 Steven G. Gilbert, PhD, DABT www.asmalldoseof.org The Precautionary Principle: Reasonable, Rational, and Responsible ( Evolutionary Not Revolutionary Approach)

5. PP Res, Rat, Resp 03/07/06 “When an activity raises threats of harm to human health or the environment, precautionary measures should be take even if some cause and effect relationships are not fully established scientifically.” Wingspread Conference, 1998. Precautionary Principle

6. PP Res, Rat, Resp 03/07/06 Setting goals (Health indicators) Taking preventive action in the face of uncertainty Shifting the burden of responsibility to the proponents of an activity (Who benefits?) Exploring a wide range of alternatives to possibly harmful actions (Is it necessary?) Increasing public participation in decision making (transparency of information & environmental justice) Central components

7. PP Res, Rat, Resp 03/07/06 Precautionary Principle  Reasonable  Rational  Responsible

8. PP Res, Rat, Resp 03/07/06 Reasonable Able to discourse or discuss matters; ready of tongue or speech; sensible; common sense; sound judgment

9. PP Res, Rat, Resp 03/07/06 Reasonable Able to discourse or discuss matters  Comprehensive and inclusive decision making approach  Brings stakeholders together  Emphasizes prevention rather than treatment  Encourages sharing of information  Considers future generations of humans and other species

10. PP Res, Rat, Resp 03/07/06 Risk & Precaution

11. PP Res, Rat, Resp 03/07/06 FDA & Precaution

12. PP Res, Rat, Resp 03/07/06 Benefits & Risk

13. PP Res, Rat, Resp 03/07/06 Rational Having the faculty of reasoning; endowed with reason; coherent; rational

14. PP Res, Rat, Resp 03/07/06 Rational Having the faculty of reasoning  Decisions based on scientific knowledge and experience  We have the knowledge and experience to prevent harm to future generations  Uncertainty is not a reason to delay action to ensure human and environmental health

15. PP Res, Rat, Resp 03/07/06 Lessons Learned  Thalidomide  Ethanol (Alcohol)  Methylmercury  Lead  PBDEs

16. PP Res, Rat, Resp 03/07/06 Thalidomide  Introduced in 1956 as sedative (sleeping pill) and to reduce nausea and vomiting during pregnancy  Withdrawn in 1961  Discovered to be a human teratogen causing absence of limbs or limb malformations in newborns  5000 to 7000 infants effected  Resulted in new drug testing rules

17. PP Res, Rat, Resp 03/07/06 What Is This? C H H HOHC H H (CH 3 -CH 2 - OH)

18. PP Res, Rat, Resp 03/07/06 FAS Child

19. PP Res, Rat, Resp 03/07/06 FAS & FAE Most common preventable cause of adverse CNS development Fetal Alcohol Syndrome (FAS) 4,000-12,000 infants per year in US Fetal Alcohol Effect (FAE) 7,000-36,000 infants per year in US 1 to 3 infants per 1,000 world wide??

20. PP Res, Rat, Resp 03/07/06 Mercury & Toxicology

21. PP Res, Rat, Resp 03/07/06 Fetal Effects of MeHg

22. PP Res, Rat, Resp 03/07/06 The Mercury Cycle

23. PP Res, Rat, Resp 03/07/06 Limit the amount of canned tuna you eat, based on your bodyweight. Guidelines are: Women of childbearing age should limit the amount of canned tuna they eat to about one can per week (six ounces.) A woman who weighs less than 135 pounds should eat less than one can of tuna per week. Children under six should eat less than one half a can of tuna (three ounces) per week. Specific weekly limits for children under six range from one ounce for a twenty pound child, to three ounces for a child weighing about sixty pounds. WA State Advisory http://www.doh.wa.gov/fish/FishAdvMercury.htm

24. PP Res, Rat, Resp 03/07/06 "Lead makes the mind give way." Ancient Awareness Greek Dioscerides - 2nd BC

25. PP Res, Rat, Resp 03/07/06 Lead In Homes

26. PP Res, Rat, Resp 03/07/06 Lead Health Effects  Children more vulnerable than adults Orally consumed lead absorbed in place of calcium CHILDREN absorb 30-50% of oral lead ADULTS absorb 5-10% of oral lead Increased absorption during pregnancy  Childhood effects Decreased intelligence (lower grades) Hyperactivity (higher school dropout rate) Growth retardation Effects at blood lead levels of >5 µq/dL

27. PP Res, Rat, Resp 03/07/06 Agency Blood Lead Levels

28. PP Res, Rat, Resp 03/07/06 Structure of PBDEs X & Y are number of Bromine atoms Common Penta, Octa, and Deca PolyBrominated Diphenyl Ether O Br x Br y

29. PP Res, Rat, Resp 03/07/06 PBDEs in House Dust (ppb) From EWG - Toxic Fire Retardants Contaminate American Homes - http://www.ewg.org/reports/inthedust/summary.php

30. PP Res, Rat, Resp 03/07/06 PBDEs in Breast Milk (ppb) From EWG - Toxic Fire Retardants in Breast Milk from American Mothers - http://www.ewg.org/reports/mothersmilk/es.php

31. PP Res, Rat, Resp 03/07/06 PBDEs In Milk Fat (adapted from Northwest Environmental Watch, 2004)

32. PP Res, Rat, Resp 03/07/06 Developmental Data 2863 above 1 Million pounds 78.2% no data 21.4% some data 12 or 0.4% good data www.preventingharm.org

33. PP Res, Rat, Resp 03/07/06  Nearly 12 million children (17%) under age 18 in the US suffer from one or more developmental disabilities  Learning disabilities – 5-10% of kids in public school  ADHD – 3-6% of all school kids, maybe higher The Consequences

34. PP Res, Rat, Resp 03/07/06 Estimated Costs - National Best Estimate Low EstimateHigh Estimate Lead Poisoning $43.4 Asthma $2.0$0.7$2.3 Cancer $0.3$0.2$0.7 Neurobehavioral Disorders $9.2$4.6 $18.4 TOTAL$54.9$48.8$64.8 Estimated Costs of Pediatric Disease of Environmental Origin, United States,1997 (billions) (From “Environmental Pollutants and Disease in American Children,” Landrigan, Schechter, et.al., 2002)

35. PP Res, Rat, Resp 03/07/06 Responsible Morally accountable for one's actions; capable of rational conduct; answerable

36. PP Res, Rat, Resp 03/07/06 Responsible Morally accountable for one's actions  Ethical responsibility and duty to prevent harm  Responsibility to promote human and environmental health  The proponents of an action are responsible for demonstrating safety  Duty and responsibility to future generations

37. PP Res, Rat, Resp 03/07/06 Child Health

38. PP Res, Rat, Resp 03/07/06 “Children can develop and mature in an environment that allows them to reach and maintain their full potential.” Vision for Child Health

39. PP Res, Rat, Resp 03/07/06 “Conditions that ensure that all living things have the best opportunity to reach and maintain their full genetic potential.” S. Gilbert (1999) Human & Environmental Health

40. PP Res, Rat, Resp 03/07/06 Socially responsible white guys?

41. PP Res, Rat, Resp 03/07/06 "A thing is right when it tends to preserve the integrity, stability, and beauty of the biotic community. It is wrong when it tends otherwise." - Aldo Leopold, 1949, A Sand County Almanac The First Bioethicist ---------- 1887 - 1948 ---------- Aldo Leopold

42. PP Res, Rat, Resp 03/07/06 “An ethic, ecologically, is a limitation on freedom of action in the struggle for existence” Aldo Leopold Limits on Freedom

43. PP Res, Rat, Resp 03/07/06 “The Commons” The Tragedy of the Commons By Garrett Hardin, Science, 1968

44. PP Res, Rat, Resp 03/07/06 Technical Solutions “It is our considered professional judgment that this dilemma has no technical solution.” The Tragedy of the Commons By Garrett Hardin, Science, 1968

45. PP Res, Rat, Resp 03/07/06 Problems – Solutions?  Lead and kids  Fetal alcohol syndrome  Nuclear disarmament  Bioterrorism  Ocean Fisheries  Persistent chemicals  The Commons

46. PP Res, Rat, Resp 03/07/06 The Precautionary Principle is part of the evolution in our thinking and decision making toward ensuring human and environmental health. Conclusion

47. PP Res, Rat, Resp 03/07/06 Precautionary Principle It is Reasonable, Rational, and Responsible to protect the potential of our children. We have a duty to the health of the environment and the health of future generations.

48. PP Res, Rat, Resp 03/07/06 A Seat Belt for the Brain Prevention

49. PP Res, Rat, Resp 03/07/06 The Potential of Children

50. PP Res, Rat, Resp 03/07/06 Additional Information  A Small Dose of Toxicology (www.asmalldoseof.org)  The Science and Environmental Health Network (SEHN) (www.sehn.org)  Late lessons from early warnings: the precautionary principle 1896-2000 – European Environment Agency  Ethical, legal, and social issues: our children's future. Steven G. Gilbert. Neurotoxicology, 26(4), pp 521-530, 2005.

51. PP Res, Rat, Resp 03/07/06 Questions or Comments? Download Presentation from www.asmalldoseof.org

52. PP Res, Rat, Resp 03/07/06 Authorship Information For Additional Information Contact Steven G. Gilbert, PhD, DABT E-mail: smdose@asmalldoseof.org Web: www.asmalldoseof.org This presentation is supplement to “A Small Dose of Toxicology”

53. PP Res, Rat, Resp 03/07/06 Socially Responsible

54. PP Res, Rat, Resp 03/07/06 A Small Dose of Toxicology See: www.asmalldoseof.org -- smdosesmdose

55. PP Res, Rat, Resp 03/07/06 NW Public Health See: http://healthlinks.washington.edu/nwcphp/nph/ nwph Public Health and the Precautionary Principle By Steven G. Gilbert

56. PP Res, Rat, Resp 03/07/06 Doubt / Uncertainty "Doubt is our product since it is the best means of competing with the 'body of fact' that exists in the mind of the general public.“ 1969 an executive at Brown & Williamson owned by R. J. Reynolds Tobacco Company (Doubt Is Their Product by David Michaels in Scientific American, June 15, 2005)

57. PP Res, Rat, Resp 03/07/06 NEW MEXICO CREATES A PRECAUTIONARY PRINCIPLE TASK FORCE In New Mexico, the state Environment Department and the state Department of Health have formed a joint task force to study the precautionary principle. The task force will advise the Governor and the Executive Branch on the potential and practice of implementing the principle in New Mexico. Findings and recommendations are due in October 2006 New Mexico & Precaution

58. PP Res, Rat, Resp 03/07/06  FDA regulations of Drugs (1938)  FDA regulations of Dietary Supplements (Dietary Supplement Health and Education Act of 1994 (DSHEA))  Ephedra present an unreasonable risk of illness or injury (Dec, 2003) Safety & Efficacy vs Harm

59. PP Res, Rat, Resp 03/07/06 Lessons Learned  Knowledge to policy  Disease is money  Externalize costs  How to make money from prevention?

60. PP Res, Rat, Resp 03/07/06 Vision of Child Health Knowledge of Reproductive and Developmental Toxicology Policy Approach within an ethical framework Social responsibilities No technical solutions Restriction of freedoms Precautionary Principle Convergence of Issues

61. PP Res, Rat, Resp 03/07/06 “When an activity raises threats of harm to human health or the environment, precautionary measures should be take even if some cause and effect relationships are not fully established scientifically.” Wingspread Conference, 1998. Precautionary Principle

62. PP Res, Rat, Resp 03/07/06 Setting goals (Health indicators) Taking preventive action in the face of uncertainty Shifting the burden of responsibility to the proponents of an activity (Who benefits?) Exploring a wide range of alternatives to possibly harmful actions (Is it necessary?) Increasing public participation in decision making (transparency of information & environmental justice) Central components

63. PP Res, Rat, Resp 03/07/06 Children have a right to a safe, fair and healthy environment Ethical Responsibility to share and use of knowledge Duty to promote health and well being of children Thoughtful public health advocate Knowledge - Responsibility

64. PP Res, Rat, Resp 03/07/06 Reasonable Able to discourse or discuss matters  Comprehensive and inclusive decision making approach  Brings stakeholders together  Emphasizes prevention rather than treatment  Encourages sharing of information  Considers future generations of humans and other species

65. PP Res, Rat, Resp 03/07/06 Rational Having the faculty of reasoning  Decisions based on scientific knowledge and experience  We have the knowledge and experience to prevent harm to future generations  Uncertainty is not a reason to delay action to ensure human and environmental health

66. PP Res, Rat, Resp 03/07/06 Responsible Morally accountable for one's actions  Ethical responsibility and duty to prevent harm  Responsibility to promote human and environmental health  The proponents of an action are responsible for demonstrating safety