1. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Advocacy, Ethics, & PP Advocacy, Ethics, and the Precautionary Principle NAHMMA's 2005 Conference September 18-23, 2005 Tacoma, Washington Steven G. Gilbert, PhD, DABT www.asmalldoseof.org LINKLINK

2. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 NW Public Health See: http://healthlinks.washington.edu/nwcphp/nph/ nwph Public Health and the Precautionary Principle By Steven G. Gilbert

3. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Child Health

4. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 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)

5. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 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

6. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 American Academy of Pediatrics Mission and vision To attain optimal physical, mental and social health and well-being for all infants, children, adolescents and young adults. http://www.aap.org/member/memcore.htm

7. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 American Academy of Pediatrics The APA goes on to state: “To this purpose, the AAP and its members dedicate their efforts and resources. The vision: 1) to advocate for infants, children, adolescents, and young adults and provide for their care; 2) to collaborate with others to assure child health; and …. http://www.aap.org/member/memcore.htm

8. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 “Conditions that ensure that all living things have the best opportunity to reach and maintain their full genetic potential.” S. Gilbert (1999) Environmental & Human Health

9. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 The challenge To develop an individual and societal ethical framework for decision making that supports the long term maintenance of a globally sustainable ecology Ecological Bioethics

10. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Socially responsible white guys?

11. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 "All scientific work is incomplete - whether it be observational or experimental. All scientific work is liable to be upset or modified by advancing knowledge. That does not confer upon us a freedom to ignore the knowledge we already have or postpone the action that it appears to demand at a given time. " Sir Austin Bradford Hill (1965) Sir Austin Bradford Hill

12. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 1.Strength of association 2.Consistency of findings 3.Biological gradient 4.Temporal sequence 5.Biologic or theoretical plausibility 6.Coherence with established knowledge 7.Specificity of association Sir Austin Bradford Hill (1965) Determining Causation

13. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Statistical Model Fundamental Types of Uncertainty

14. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Easiest to examine & reduce Not knowing the exact value of a variable (inter and intra subject variance) Sample size Statistical Uncertainty Reducing Variability

15. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Not fully understanding the relations between variables (mechanism of action) Which variables are most important (high dose vs low dose) Model or System Uncertainty

16. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Not knowing the right questions to ask Most sensitive end point “we don’t know what we don’t know” Fundamental Uncertainty

17. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead In Homes

18. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead in Families

19. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 "Lead makes the mind give way." Ancient Awareness Greek Dioscerides - 2nd BC

20. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead Based Paint Products

21. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead Based Paint 1887 - US medical authorities diagnose childhood lead poisoning 1904 - Child lead poisoning linked to lead-based paints 1909 - France, Belgium and Austria ban white-lead interior paint 1914- Pediatric lead-paint poisoning death from eating crib paint is described 1921 - National Lead Company admits lead is a poison 1922 - League of Nations bans white-lead interior paint; US declines to adopt 1943- Report concludes eating lead paint chips causes physical and neurological disorders, behavior, learning and intelligence problems in children 1971- Lead-Based Paint Poisoning Prevention Act passed

22. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead Industry Advertisements http://www.cincinnatichildrens.org/research/project/enviro/hazard/lead/lead-advertising/default.htmhttp://www.cincinnatichildrens.org/research/project/enviro/hazard/lead/lead-advertising/default.htm History of Lead Industry Advertisements (LINK)LINK http://www.cincinnatichildrens.org/research/project/enviro/hazard/lead/lead-advertising/default.htm

23. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Agency Blood Lead Levels

24. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 California Suing Major Retailers Over Lead in Jewelry Allegations California is suing 13 major retailers alleging they broke state law by not warning customers that some of their jewelry contains lead. Private lawsuits containing similar allegations have been filed against a further 11 retailers. Named in the state's suit were Macy's, Target, Wal- Mart, Kmart, J.C. Penney, Mervyn's, Nordstrom, Ross, Sears, Express, Claire's, Toys "R" Us and Burlington Coat Factory, along with some of their affiliates and parent companies, according to The San Jose Mercury News. (June 24, 2004) Lead in Jewelry

25. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead in Jewelry http://www.leadinspector.com/

26. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Children & Candy & Lead Data from WA DOH (http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/candy.htm)

27. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 WA State Guidelines The Washington State Department of Health advises consumers not to eat candy from Mexico or southeast Asia that contains tamarind or chili powder. (http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/candy.htm) California also has documented lead in candy. See the Orange County Register series on lead in candy: http://www.ocregister.com/investigations/2004/lead/index.shtml

28. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead in WA Candy Data from WA DOH (http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/candy.htm)

29. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead in Pottery – Action Levels US Food and Drug Administration (FDA) action levels for the lead content of the leachate: Cups, mugs, and pitchers: 0.5 ppm Large hollowware (serving dishes): 1 ppm Small hollowware (bowls): 2 ppm Plates, saucers, and other flatware: 3 ppm

30. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead in WA Pottery Data from WA DOH (http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/pottery.htm)

31. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Pottery with Lead Data from WA DOH (http://www.doh.wa.gov/EHSPHL/Epidemiology/NICE/Lead/pottery.htm)

32. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead & Lunchboxes The Center for Environmental Health (CEH) http://www.cehca.org/lunchboxes.htm

33. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead In Ethnic Remedies RemedyUseLead Content Azarcon (Mexico) Digestive problems 76-86% Greta (Mexico) Digestive problems 4-90% Surma (India) Cosmetic to improve eye sight 23-26% Tibet Improve slow development 1-3%

34. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Policy Implications Drinking water in Seattle Schools

35. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Children in WA State Blood Lead No.% (mcg/dL) 0-19,56955.3 2-46,43137.2 5-91,103 6.4 10-19 167 1.0 20+ 26 0.15 Children 0-6 tested in 2002-2004 WA State DOH

36. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Children with >10 mcg/dL In 1999 and 2000, 2.2% of children 1-5 year age had lead levels that were above 10 mcg/dL. Approximately 20 million children under age 5, thus about 440,000 children in the US have blood lead levels above 10 mcg/dL. From CDC

37. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 A Small Dose of …. Health Effects (< 10 mcg/dL)

38. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Needleman, NEJM, 1979

39. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Consequences for Society (Slide from B. Weiss)

40. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead-associated Reading Deficits in U.S. Children Blood lead levels (  g/dl) Reading Score Lanphear BP, et al. Public Health Reports 2000;115:521-529. (BL’s slide)

41. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Canfield R, et al. NEJM 2003;348:1517-1526 IQ and Blood Lead Life time overall Increase in 1 mcg/dl = 0.87 IQ drop Covariates - 1 mcg/dl = 0.46 IQ drop 1 to 10 mcg/dl (bigger drop) Increase in 1 mcg/dl = 1.37 IQ drop Non-linear - 1 mcg/dl = 7.4 IQ drop

42. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Canfield R, et al. NEJM 2003;348:1517-1526. (slide from BL) IQ and Blood Lead

43. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 The challenge “the knowledge of how to use knowledge for the social good” Knowledgeable Bioethics

44. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 “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

45. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05  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

46. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Taking preventive action in the face of uncertainty Shifting the burden of proof/responsibility to the proponents of an activity Exploring a wide range of alternatives to possibly harmful actions Increasing public participation in decision making (environmental justice) Wingspread Conference, 1998. Central components

47. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 City Comprehensive Plans Every citizen of Seattle has an equal right to a healthy and safe environment. Seattle sees the Precautionary Principle approach as its policy framework to develop laws for a healthier and more just Seattle. Seattle PP working group Seattle Initiative

48. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Seattle Precautionary Principle White Paper (www.asmalldoseof.org) Inclusion of PP in Comp Plan Environment Element (http://www.seattle.gov/dpd/Planning/Seattle's_Compr ehensive_Plan/DPD_001178.asp) LinkLink Result of Effort

49. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 “Protecting Public Health by Adopting the Precautionary Principle as an Approach to Decision Making” Resolution Submitted to Washington State Public Health Association WSPHA Resolution

50. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05  California San Francisco Precautionary Purchasing Ordinance - June 2005 Resolution of the Marin county board of supervisors “A resolution to continue to incorporate the precautionary principle in county operations.” Oct 2004  Oregon Multnomah County, OR Resolution - September 2004  New York State Legislation - April 2005  Bill A07256 “To protect public health and the environment by establishing a precautionary policy for state and local governments in New York State.”  Bill A07257 “To establish a preference for the purchase of commodities, services, and technologies by the State of New York that minimize potential adverse impacts on public health and the environment.” States in the US

51. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Agreement Respecting Canada-wide Standards for Dioxins and Furans: Steel Manufacturing Electric Arc Furnaces Pollution Prevention Strategy “In keeping with the Precautionary Principle as set out as guidance in the Canada-wide Standards Sub-agreement, and in consideration of the CWS principles of sound science, technical feasibility and socio-economic impacts, …..” http://www.ec.gc.ca/CEPARegistry/notices/NoticeText.cfm?intNotice=159&intDocument=939 Canada and PP

52. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 REACH -- Registration, Evaluation and Authorization of Chemicals  The two most important aims are to improve protection of human health and the environment from the hazards of chemicals and enhance the competitiveness of the EU chemicals industry.  The Commission’s White Paper on the Strategy for a future Chemicals Policy was adopted in on 13 February 2001.  A Precautionary approach REACH-European Union

53. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 REACH -- Registration, Evaluation and Authorization of Chemicals  Initially regulate High Production Volume (HPV) chemicals - produced or imported above 1,000 metric tons.  Total world wide production of chemicals 400 million metric tons per year or $1.6 Trillion  To be introduced into European Parliament late this year. REACH

54. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 The citizen toxicologist is a thoughtful advocate for human and environmental health, who strives to share their scientific knowledge with the public, speaking to public interests rather than private or special interests. Citizen Toxicologist Socially Responsible Toxicologist

55. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Testifying Writing review papers K-12 class room teaching Adding expertise to community groups Education Mentoring Speakers Bureau Socially Responsible Actions

56. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Forum in which to discuss the ethical implications of results from our science as well as the resulting legal and social implications. 2005 SOT meeting – workshop on Conflict of Interest SOT - ELSI Specialty Section http://www.toxicology.org/memberservices/specsection/specsection.html

57. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 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

58. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Additional Information  The Science and Environmental Health Network (SEHN) (www.sehn.org)  Late lessons from early warnings: the precautionary principle 1896-2000 – European Environment Agency (free)  Garrett Hardin - The Tragedy of the Commons (Science, 1968)  Ethics and Environmental Health – Mini Monograph - Environmental Health Perspectives (November 2003)  Ethical, legal, and social issues: our children's future. Steven G. Gilbert. Neurotoxicology, 26/4 pp 521-530, 2005.  Public Health and the Precautionary Principle. Steven G. Gilbert. NW Public Health, Spring 2005. http://healthlinks.washington.edu/nwcphp/nph/

59. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Scientific Process Variability Uncertainty

60. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Statistical Model Fundamental Types of Uncertainty

61. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Easiest to examine & reduce Not knowing the exact value of a variable (inter and intra subject variance) Sample size Statistical Uncertainty Reducing Variability

62. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Not fully understanding the relations between variables (mechanism of action) Which variables are most important (high dose vs low dose) Model or System Uncertainty

63. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Not knowing the right questions to ask Most sensitive end point “we don’t know what we don’t know” Fundamental Uncertainty

64. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Dose Response Issues Higher metabolic rate Different nutritional requirements Rapidly dividing & migrating cells Immature organs Susceptibility of Children

65. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Ethics and the Precautionary Principle Questions or Comments? Download Presentation from www.asmalldoseof.org

66. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 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”

67. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Socially Responsible

68. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Recycling Lead

69. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 “Conclusions: Blood lead concentrations, even those below 10 mgc/dL, are inversely associated with children’s IQ scores at three and five years of age, and associated declines in IQ are greater at these concentrations than at higher concentrations. These findings suggest that more U.S. children may be adversely affected by environmental lead than previously estimated.” Canfield et al. 2003, NEJM, 384 Canfield et al…, 2003

70. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Agency Blood Lead Levels

71. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Environmental Pollutants and Disease in American Children: Estimates of Morbidity, and Costs for Lead Poisoning, Asthma, Cancer, and Developmental Disabilities, by Landrigan, P. et al. EHP, 110, July 2002, 721-728. Cost of Childhood Lead Assumptions in calculating costs All lead is harmful and from environment Blood lead of children age 5 – 2.7 ug/dl (CDC) 5-year old boys (1,960,200) and girls (1,869,800) 1 ug/dl of lead = 0.25 IQ point reduction Cost – boys $27.8 and girls $15.6 Billion Total Costs $43.4 Billion

72. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Stephen J. Rothenberg and Jesse C. Rothenberg, Testing the Dose-Response Specification in Epidemiology: Public Health and Policy Consequences for Lead Environ Health Perspect 113:1190-1195 (2005) Policy Consequences of Lead “The Centers for Disease Control and Prevention action limit of 10 µg/dL for children fails to protect against most damage and economic cost attributable to lead exposure.”

73. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 A Small Dose of …. Regulation (CDC Guidelines)

74. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Current CDC Policy Blood lead level µg/dL) b Actions Time frame for beginning intervention 10-14Provide caregiver lead education. Provide follow-up testing. Refer the child for social services if necessary. Within 30 days 15-19Above actions, plus: If BLLs persist (i.e., 2 venous BLLs in this range at least 3 months apart) or increase, proceed according to actions for BLLs 20-44. Within 2 weeks 20-44Above actions, plus: Provide coordination of care (case management). Provide clinical evaluation and care. c Provide environmental investigation and control current lead hazards. Within 1 week 45-70Above actions.Within 48 hours 70 or higherAbove actions, plus hospitalize child for chelation therapy immediately. Within 24 hours

75. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Proposed CDC Policy Blood lead level (µg/dL) ActionsTime frame for beginning intervention <2No action 2-5Provide caregiver lead education. Provide follow-up testing. Refer the child for social services to investigate possible sources of lead exposure. Within 30 days 5-10Above actions, plus:If BLLs persist (i.e., 2 venous BLLs in this range at least 3 months apart) or increase, proceed according to actions for BLLs 10-20. Within 2 weeks 10-20Above actions, plus: Provide coordination of care (case management). Provide clinical evaluation and care. Provide environmental investigation and control current lead hazards. Within 1 week 20-70Above actions.Within 24 hours 70 or higherAbove actions, plus hospitalize child for chelation therapy immediately. Within 24 hours

76. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Policy Implications An Ethical and Precautionary Approach to Protecting Our Children Drinking water in Seattle Schools

77. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Agency Blood Lead Levels

78. A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead 10 to 2 Campaign Steven G. Gilbert www.asmalldoseof.org sgilbert@innd.org