1. SOT – Fluoride - History – 01/31/10 HISTORICAL HIGHLIGHTS Fluoridation: Science Meets Policy ENV H 472 A - ENVIRONMENTAL RISK AND SOCIETY Class 9

2. SOT – Fluoride - History – 01/31/10 Mild fluorosis Issues Severe fluorosis  Should public water be fluoridated?  Benefits – reduced dental carries  Risks – dental fluorosis – bone disease  Dose - Response

3. SOT – Fluoride - History – 01/31/10 Fundamental Issue  Science meets Policy  Ethical, legal, social, political, scientific considerations  Engage Public?  Role of government agencies?  Local – National – International?

4. SOT – Fluoride - History – 01/31/10 History of Fluoride  1899 - Sodium Fluoride -- Herbert H Baldwin reported symptoms of acute toxicity (e.g. gastrointestinal upset) doses as low as 0.1-0.3 mg/kg.  1909 – “Colorado stain” (fluorosis) - Frederick McKay, observed children in the Pikes Peak region had of stain or mottling on their teeth but fewer cavities  1931 – G.V. Black (father of modern dentistry) and others concluded fluoride ion in the water was the cause

5. SOT – Fluoride - History – 01/31/10  1939 – Gerald J. Cox first publication recommending the addition of fluoride to drinking water to improve oral health at 1 ppm level  1945 - Grand Rapids, Michigan - first community in the world to add fluoride to its drinking water to benefit dental health  1940’s - several paired city studies conclude fluoride in drinking water is beneficial  1940’s Fluorine used in bomb making (University of Rochester – Harold Hodge) History of Fluoride

6. SOT – Fluoride - History – 01/31/10  1951, Joseph C. Muhler and Harry G. Day of Indiana University reported that stannous fluoride as a tooth decay preventive and the university first sold the technology to Procter & Gamble to use in Crest toothpaste. Stannous Fluoride

7. SOT – Fluoride - History – 01/31/10 CDC’s Recommendation “...fluoride prevents dental caries predominately after eruption of the tooth into the mouth, and its actions primarily are topical for both adults and children…” CDC (1999). Achievements in Public Health, 1900-1999: Fluoridation of Drinking Water to Prevent Dental Caries. MMWR, 48(41); 933-940, October 22. “Nature's Way to Prevent Tooth Decay”

8. SOT – Fluoride - History – 01/31/10 Dental Fluorosis with “Optimal” Fluoride 67% of US people exposed to fluoridated water – most large cities 1997 - 29.9% of US children living in fluoridated communities have dental fluorosis on (Heller et al, 1997). 2005 - CDC dental fluorosis effects 1 in 3 American kids - up 9% since 1986-87. 2006 - ADA & CDC offers interim guidance on infant formula and fluoride

9. SOT – Fluoride - History – 01/31/10 Ethical Issues Individual vs Public Health? Fluoridation of public water is "compulsory mass medication" Individual Consent? Legal – human rights – choice? Improves dental care for low-income people. Not mass medication because fluoride is natural. Similar to fortifying foods with vitamins

10. SOT – Fluoride - History – 01/31/10 MCLG-MCL MCLG – maximum contaminant level goal - level of a contaminant in drinking water below which there is no know or expected risk to health - non-enforceable public health goal MCL – maximum contaminant level - highest level of a contaminant allowed in drinking water - enforceable standard - set as close as feasible to the MCLG; technology and costs are considered

11. SOT – Fluoride - History – 01/31/10 SMCL SMCL – secondary maximum contaminant level - non-enforceable guideline for managing drinking water for aesthetic, cosmetic (e.g., tooth discoloration), or technical effects

12. SOT – Fluoride - History – 01/31/10 History 1986 –MCLG and MCL set at 4 mg/L to protect against “crippling” skeletal fluorosis –SMCL set at 2 mg/L to reduce occurrence and severity of “objectionable” enamel fluorosis. 1993 –MCL reviewed by NRC in 1993 –4 mg/L is appropriate as an interim MCL –More research needed on fluoride intake, enamel fluorosis, bone strength and fractures, and carcinogenicity.

13. SOT – Fluoride - History – 01/31/10 National Academy of Sciences - Tasks Review toxicologic, epidemiologic, and clinical data on fluoride, particularly data conducted since 1993 NRC report Review exposure data on orally ingested fluoride from drinking water and other sources (e.g., food, toothpaste) Evaluate the scientific basis of the MCLG and SMCL and their adequacy to protect children and others from adverse health effects. Consider relative contribution of various fluoride sources to total exposure. Identify data gaps and recommend research relevant to setting the MCLG and SMCL.

14. SOT – Fluoride - History – 01/31/10 Exposure Drinking Water Contribution to Total Exposure Drinking Water – Natural Sources - 2.0-3.9 mg/L (1.4 million people exposed) 57% - 90% for average individual 86% - 96% for high-water intake individual - ≥ 4mg/L (200,000 people exposed) 72% - 94% for average individual 92% - 98% for high-water intake individual Drinking Water – Artificial Sources - PHS recommends 0.7-1.2 mg/L (162 million people exposed) 41% - 83% for average individual 75% - 91% for high-water intake individual

15. SOT – Fluoride - History – 01/31/10 Enamel fluorosis Enamel fluorosis is a dose-related mottling of enamel ranging from mild discoloration to severe dark stains and pitting in children (0 to 8 years). Permanent condition. Historically, condition considered cosmetic because it is not associated with tooth loss, loss of tooth function, or psychological, behavioral, or social problems. Committee separated severe from moderate fluorosis. –Severe: mottling with enamel pitting and/or loss –Moderate: mottling but no enamel pitting or loss

16. SOT – Fluoride - History – 01/31/10 Severe Enamel Fluorosis

17. SOT – Fluoride - History – 01/31/10 Severe Enamel Fluorosis Severe Enamel Fluorosis in Children in the United States Source: Selwitz et al. (1995, 1998)

18. SOT – Fluoride - History – 01/31/10 Recommendations New risk assessment should be performed on fluoride. The assessment should include new data on health risks, better estimate of total exposure to fluoride, and updated approaches to risk assessment. Key end points for the risk assessment are severe enamel fluorosis, bone fracture, and stage II skeletal fluorosis. Committee’s conclusions about the adverse effects at the MCLG and SMCL do not address the lower concentrations of exposure that occur with water fluoridation.

19. SOT – Fluoride - History – 01/31/10 ADVERSE EFFECTS OF 4ppm FLUORIDE Enamel damage with severe fluorosis PROVEN Increased fractures in susceptible groups PROBABLE Skeletal fluorosis (stage II) POSSIBLE

20. SOT – Fluoride - History – 01/31/10 APPROPRIATE RESPONSE?? Precautionary principle (Wingspread, 1998) – 1. Take anticipatory action to prevent harm – 2. Burden of proof on proponents, not public – 3. Must examine all alternatives (do nothing) – 4. Process transparent & stakeholders involved Evidence based risk assessment (Guzelian, 2005) – 1. Research-based evidence vs expert opinion – 2. Strength of evidence vs weight of evidence – 3. Hazard, probability and causality. Hill criteria

21. SOT – Fluoride - History – 01/31/10 WHAT’S NEXT?? A comprehensive analysis of all the effects of fluoride (adverse, beneficial, incidence, severity, reversibility etc.) Move from “reasonable asurrance of no harm to a risk/benefit analysis (MOA and dose response).

22. SOT – Fluoride - History – 01/31/10 Effective versus Toxic Conc. Intake = 2L/day Safety factor=2.5X MCL=4ppm 0 1 2 4 ? ? 2.5ppm=“threshold” for severe dental fluorosis 1ppm=target level of water fluoridation LOAEL=20mg/day (crippling skeletal fluorosis) SCL=2ppm: 4-15% mod. dental fluorosis Prevalence (%) Severe Dental Fluorosis ppm in drinking water 2.5-4ppm IQ deficits in Chinese studies

23. SOT – Fluoride - History – 01/31/10 Effective versus Toxic Dose 4ppm (1L/d, 20 kg child) 0 0.05 0.10 0.20 4ppm (2L/d, 70kg adult) “Optimal” theraputic dose range EPA RfD Dose (mg/kg/day) 0.15 Average dietary intake Age 0-2 yrs Fluoride 0.7- 1.1 ppm 1ppm adult 1L/d 1ppm adult 2L/d 1ppm child 20 kg 1L/d 1ppm child 10kg 1L/d STANDARDSTHERAPUTIC/DIETARY RANGETOTAL INTAKES Crippling Skel. Flsis at 40 yr (NRC 77)

24. SOT – Fluoride - History – 01/31/10 Figure 2: Tooth Decay Trends for 12 Year Olds: Fluoridated Vs. Unfluoridated Countries. Data from World Health Organization. (Graph by Chris Neurath). Fluoridated vs. Unfluoridated

25. SOT – Fluoride - History – 01/31/10 More Findings from NAS The MCL should be lowered (EPA directed to do a new risk assessment). Bone fluoride concs from lifetime exposure at 2 ppm (SMCL) fall within or exceed levels associated with stage II (mod.) or stage III (sev.) skeletal fluorosis The SCML (2ppm) does not completely protect against moderate enamel fluorosis.(Moderate enamel fluorosis might have phychological or social effects.)

26. SOT – Fluoride - History – 01/31/10 More Findings from NAS The possibility has been raised by the studies conducted in China that fluoride can lower intellectual abilities. (2.5-4 ppm) Fluoride affects normal endocrine function or response; fluoride is an endocrine disruptor in the broad sense of altering normal endocrine function or response.

27. SOT – Fluoride - History – 01/31/10 More Information  Web Sites Toxipedia – Flioride http://www.toxipedia.org/display/toxipedia/Fluoride Wikipedia - http://en.wikipedia.org/wiki/Fluoride The Controversy - - http://en.wikipedia.org/wiki/Water_fluoridation_controversy Anti fluoridation groups -- Fluoride Action Network - http://www.fluoridealert.org/ - www.fluorideACTION.net/ Pro fluoridation -- CDC on Water Fluoridation http://www.cdc.gov/oralhealth/factsheets/index.htm#waterfluoridation American Dental Association Fluoridation Facts 2005 - http://www.ada.org/public/topics/fluoride/facts/fluoridation_facts.pdf