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THE CITY OF ASPEN MEMORANDUM TO: Mayor and City Council FROM: Chris Everson, Affordable Housing Project Manager THRU: Barry Crook, Assistant City Manager DATE OF MEMO: September 23, 2011 MEETING DATE: September 27, 2011 RE: Presales for Burlingame Phase II REQUEST OF COUNCIL: Direction requested on Burlingame Pre Sales effort and potential for site work activity in 2012. PREVIOUS COUNCIL ACTION: On March 22, 2011, Council directed staff to proceed with the Reservation List part of the presales program for Burlingame Phase II. On July 18, 2011, the status of the presales effort was reported by staff to Council. BACKGROUND: On March 22, 2011, staff proposed a multi -part plan for presales, which is summarized below: LEVEL 1: RESERVATION LIST ✓ Buyer signs up on reservation list ✓ Buyer gets APCHA qualified, $40 fee LEVEL 2: RESERVATION AGREEMENT ✓ Buyer gets prequalification from bank ✓ Buyer pays $500 refundable deposit ✓ Buyer signs reservation agreement LEVEL 3: PRESALES AGREEMENT ✓ Buyer re- verifies loan prequalification ✓ Buyer pays $1,500 non - refundable deposit ✓ Buyer signs presales agreement, selects unit At that time, Council directed staff to go forward with Reservation List part of the plan only, take a "bare bones" approach, and minimize costs in doing so. On July 18, 2011, the status of the presales effort was reported by staff to Council as 167 total applicants, 58 of whom had been APCHA qualified by that date. DISCUSSION: Because Council wanted some expression of community interest in Burlingame before moving forward with construction, the presales program was launched. Staff suggested three levels of commitment in the program, with levels 2 and 3 requiring financial commitments and some kind of signed agreement. The first level of commitment was chosen to start the council's conversation with the community around Burlingame. Page 1 of 5 r THE CITY OF ASPEN Currently, the Burlingame Phase II presales list is up to 206 total applicants, 68 of whom have been thus far APCHA qualified. In an update to Council on July 18, 2011, staff indicated that 78% of applicants do not currently own deed restricted housing. Since July, APCHA staff has been accepting sign -ups and APCHA qualifications, but has not been advertising or pressing applicants to become APCHA qualified. Expenditures to date for presales total approximately $20,000. Questions in the community persist regarding demand for affordable housing in general as well as, in particular, for Burlingame Phase II. The housing office has been experiencing lower levels of bidding for turnover of existing affordable housing units than in years past, and there has been some difficulty finding buyers for units outside the UGB as well as some RO units within the UGB. We know that Pitkin County has experienced a loss of some 1700 jobs since the recession. The drop in free market housing prices has produced alternatives for workers that were not available before the recession began — particularly in those housing opportunities that are competitive with higher category deed restricted homes (hence the difficulty with RO sales), The presales effort for Burlingame Phase II was conceived to help Council verify demand for housing at Burlingame Phase II so that Council may make decisions regarding the potential construction of the project. Council members have indicated they might want to take another small step towards understanding potential buyers' ability to take on the purchase of a unit they have expressed interest in. Going forward from the current status, the presales program might logically include the following elements, each of which are further discussed below: A. Sign -Up and APCHA Qualification: Staff recommends that these program elements continue as has been done up now. Even though there are many applicants signed up to date, not all of them will become APCHA qualified, and not all of those who become APCHA qualified will prequalify for a mortgage, and not all of those who prequalify for a mortgage will necessarily be willing to place a deposit, thus it will be important to continue to fill the pipeline. B. Mortgage Prequalification: Some Council members have suggested that mortgage prequalification is a key step. Staff recommends that this element be incorporated into the program going forward, but staff feels that in order to get applicants to make the effort of getting prequalified for a mortgage, staff would need to provide some way of incentivizing applicants to take the necessary action. Potential incentives are discussed further below. C. Refundable Deposit and Reservation Agreement: In private developments, the main advantage of establishing deposits before construction begins is that buyers can purchase the unit for a lower price and developers can procure construction financing if they presell anywhere between 50 and 100 percent of the units. In the case of Burlingame Phase II, staff does not recommend soliciting for deposits until construction is under way because buyer expectations that come with deposits could conflict with Council's desire to gauge demand before starting construction of housing units. Page 2 of 5 THE CITY OF ASPEN Potential Incentives: It has been an ongoing challenge to get applicants who have signed up to become APCHA qualified. Potential buyers understood that Council wanted them to "sign up" and indicate their interest in buying at Burlingame and they have done that. Asking them to further extend themselves by spending money (even a sum as low as $40) or fill out laborious paperwork for a project that they understand Council "might, someday, if . . ." begin construction on has been problematic. While you might see that as a small step to take, buyers see it as superfluous at the moment. Parties have a "you go first" attitude — it becomes the "chicken and egg" situation. As it is, only 33% of total applicants have taken this step. Staff feels that a healthy program would entail that both the City and potential buyers take equitable steps toward the completion of the project. Staff has identified the potential incentives listed below as "tools" that will prompt further buyer action. In the absence of any concrete steps to begin construction activity on the site, creating a reason to "take the next step" beyond "council wants you to" might help you achieve the goal some of you are interested in — having expressed interest buyers who are both APCHA qualified and who have a sense of being able to obtain bank financing. Item# Incentive Estimated Maximum Cost 1 Subsidize APCHA qualification fees $40 x 82 / $3,280 total 2* Subsidize mortgage prequalification fees $30 x 82 / $2,460 total Subsidize a finish upgrade package for 15 of 3 the first 82 who become prequalified fora $2,000 x 15 / $30,000 total mortgage and later close on a unit (winners determined by lottery). Offer unit selection priority in the order in 4 which applicants become prequalified for a No cost mortgage Begin construction of site earthwork and Included in Construction Estimates. 5 * infrastructure in 2012 to demonstrate further Staff has GMP proposal in hand commitment to action on the project. No from Haselden Construction. decision on construction of housing units. Establish a threshold quantity or "magic 6* number" of applicants prequalified for a No cost mortgage where Council would be inclined to decide to begin construction of housing units * Further clarification for the starred item numbers has been provided below: 2. Subsidize mortgage prequalification fees: Bank charges for mortgage prequalification vary. Some banks do not charge while others charge only for the cost of a credit check. Additionally, staff is researching the possibility of offering buyers the opportunity to obtain mortgages through the Colorado Housing and Finance Authority (CHFA). While the City and /or APCHA cannot legally recommend a lender to potential buyers, this option could be offered as a mortgage option to potential buyers, which could create the opportunity for CHFA to source loans as they see fit, potentially providing the best loan options for buyers through sourcing efficiencies that CHFA could achieve. This option may create the opportunity for no -cost prequalifications and a high level of operational efficiency for APCHA. Staff is further researching this possibility. Page 3 of 5 411k THE CRY OF ASPEN 5. Begin Construction of Site Earthwork and Infrastructure in 2012: Staff has received a GMP proposal from the City's IPD precontractor, Haselden Construction, for this option. Costs for this approach are within the construction estimates that have been previously provided to Council. This option would demonstrate commitment on the part of the City by starting site work, but would stop short of a specific commitment on how many housing units would be constructed in the first construction mobilization. That decision could be made based on the outcome of further presales efforts. Staff believes that this effort would prompt a high level of action on the part of buyers and would ensure demand for housing unit purchases while containing costs within the estimates which have already been furnished to Council. In the "free market world" experience says that buyers do not begin to show real interest in a project until there is some activity on a development site. Until that point the proposal is simply some developer's idea on paper and no notion of when a buyer might really be able to plan a move in date exists. This lack of tangible evidence of a project in motion keeps potential buyers from moving towards real commitment. We believe that the onset of site work could allow the city to move to the 2 stage of buyer commitment where deposits are collected and further commitment to purchasing a unit at Burlingame can be secured. 6. "Magic Number ": If Council would like to establish a threshold or "magic number" of bank - qualified applicants that Council would like to see before beginning construction of housing units, staff suggests that the threshold be set at 52. This is enough to begin construction of the first five multifamily buildings. In the event that, once construction of the first five multifamily buildings in under way, the number of bank - qualified applicants increases to 82, staff would recommend that the construction of buildings six and seven be added to the scope of the construction work. This flexible approach would allow Council to conservatively gauge demand while remaining flexible enough to realize potential construction cost savings due to the efficiency of constructing seven buildings at one time instead of only five buildings at one time and then later re- mobilizing to construct buildings six and seven. The design team has estimated that this construction efficiency could produce as much a $3 million in savings. FINANCIALBUDGET IMPACTS: There is sufficient contingency in the Burlingame Phase II IPD design project budget in 2011 to be used in 2011 and 2012 for the program elements described herein. Staff anticipates that no additional allocation of funds will be needed. Operational costs for these presales elements can be contained through close partnership between City and APCHA staff. Direct costs for incentive items #1 and #2 would be realized during 2011 and 2012 and would be less than $6,000, but all other incentive items would be indirect expenses that do not require funding in 2011 and 2012. Page 4 of 5 THE CITY OF ASPEN RECOMMENDED ACTION: Staff recommends that: 1. The Level 1 presales program for Burlingame Phase II going forward should consist of applicant sign -up, APCHA- qualification and mortgage - prequalification until a time when enough applicants (52 is the "magic number" recommended) have been prequalified to this level of commitment. 2. When that threshold level is attained, Council may decide to approve the construction of the first 52 multifamily housing units at Burlingame Phase II. If additional prequalifications are achieved, Council may decide to expand that approval to include up to the first 82 multifamily housing units at Burlingame Phase II or may decide that 82 units should be built and allow staff to continue to sell up to that level of buyer commitment (taking advantage of the construction savings before buyers have all been found for every unit). Alternatively, you could decide to begin site work next year and allow us to move from Commitment Level 1 efforts to Commitment Level 2 efforts and use your "magic number" for Commitment Level 2 buyers as the trigger for vertical construction to commence. 3. We do recommend you begin site work next year. This will provide evidence that the project is "real" and moving forward. We can continue the revised Level 1 presales effort and begin to contemplate moving those participants into a Level 2 agreement. Staff would like your agreement to let us bring to you a supplementary budget proposal for the 2012 site earthwork and infrastructure construction start for council to consider during the upcoming 2012 budget development process on October 1 7th. Page 5 of 5 MEMORANDUM TO: Aspen Board of Health FROM: Lee Cassin, Public Health Agency Director Jannette Whitcomb, Senior Environmental Health Program Coordinator CJ Oliver, Senior Environmental Health Specialist DATE OF MEMO: August 17, 2011 MEETING DATE: September 27, 2011 RE: Third Quarterly Board of Health Meeting Please note the Electronic hazardous waste drop -off event being held on Friday Sept. 30 for businesses and Saturday Oct. 1 for residents. Also, thanks to the Aspen Police Department, residents may drop off unused medications at the Farmers' Market from 10 -1 on Saturday, Oct.1 and throughout the month of October at the Aspen Police Department. Health and Environmental Impact Assessment Update Background: State law requires us to do a health and environmental assessment every five years, and develop a plan to address priorities that come out of that assessment. We already routinely collect large amounts of health and environmental assessment data (ozone pollution, PM -10, greenhouse gas emissions, drinking water quality, radon levels, recycling and trash rates, cancer rates, etc.), and the state health department has advised that jurisdictions already have all the data they need to determine their priorities — so additional surveys and studies are not needed. In addition, Aspen has just (almost) completed the AACP process, which sets community goals for various health and environmental issues. In addition, each year the city surveys its citizens to determine their priorities and which issues they believe should receive more emphasis. Therefore, staff recommended, and the Board of Health agreed, that we should not undertake a new process, but should use the data and community processes we already have, to develop the assessment and formulate a future plan. The intent of the local public and environmental health improvement plan is not to address every possible area for improvement, but to focus on priorities set by Council. Page 1 of 13 We expect to share data with and from the assessments being done by Aspen Valley Hospital and Community Health Services to cover the public medical health status of the community, and data other entities such as the Police Department collect. Community Health Services is funded largely by Aspen residents through a countywide property tax, and is under the County's jurisdiction, but provides services to Aspen residents as well as Pitkin County and out -of- county residents. At the last Board of Health meeting the board approved this preliminary list of data we already have that we propose should constitute our health and environmental impact assessment. The board asked us to also include data on bicycle helmet use and related accidents, and current community efforts to make strides in this area. • Cancer rates by type, age- adjusted • Outdoor air quality (PM -10, ozone levels, asthma rates.) • Traffic levels, bus ridership • Indoor air quality (# of homes tested for radon, # of homes remediated, asbestos abatements, etc) • Drinking water quality • Surface water quality, stormwater runoff pollution • Pharmaceutical and electronic waste diversion • Recycling volumes by type /total trash volume • Greenhouse gas emissions — community and city government • City Chemical disposal • Hazardous air pollutant emissions • Pesticide use • Food safety analysis • Land use and development impacts • Child care capacity needs assessment • Crime rates by type • Accident rates and data connected with accidents, such as helmet use, age, etc. • Other health and environmental data we may be able to obtain At the next board of health meeting, Jannette Whitcomb will present information she has collected about cancer rates and risk factors in Aspen. Ozone As you know, breathing ozone can trigger a variety of health problems including chest pain, coughing, throat irritation, and congestion. It can worsen bronchitis, emphysema, and asthma. Ozone is a criteria air pollutant under the Clean Air Act. At this year's Aspen Ideas Festival, Administrator Lisa Jackson talked about the impact of natural gas production and hydraulic fracturing on rural air quality. (Ozone is not a localized air Page 2 of 13 pollutant, but is a regional one, thought to be due to natural gas drilling and production, regional traffic, and natural sources.) She was quoted by the Aspen Daily News on June 29 2011, "You are going to have huge smog problems where you never had them before... These are rural areas...There is a lot of activity around those wells and that has an impact on air quality...we already know it." EPA proposed a new ozone standard in the range of 60 -70 ppb, lower than the current 75 ppb, based on recommendations of its scientific advisory panel. In 2010, Aspen had 10 days with ozone levels above 60, with 14 days over 60 in 2011. The highest day so far has been a 70. The new standard has been repeatedly promised and delayed and Attachment A explains why. Areas in Colorado that have been monitoring ozone for enough years, and would not meet a standard of 65 ppb (to use the middle of the range) include Welby, Boulder, Denver, Chatfield, USAF Academy, Manitou, Arvada, Welch, Rocky Flats, NREL, Fort Collins, Palisade, Weld County, Ignacio, Bondad/Hwy 550, Rocky Mountain National Park, Mesa Verde National Park, Gothic, and the USFS site in Shamrock. Aspen does not yet have enough years of monitoring data, but would almost certainly not meet a standard of 65. Please see the maps included in Attachment A. Cottage Foods Bill State Senator Gail Schwartz introduced the Cottage Food Bill which would encourage the sale of locally grown foods, especially limited foods like produce, eggs, salsa, and spices at farmer's markets and roadside stands. It is likely that the bill will pass this year and there will be some impact on our workload. Environmental Health Department staff serves on the state committee working to draft a version of the bill that addresses some of the concerns raised by last year's bill. Pesticides (update) A worksession is scheduled for November 29, to discuss staff follow -up on a citizen request to Council to enact a strict pesticide law. A number of different pesticides have been associated with increased rates of certain cancers, Parkinson's disease, dementias, and respiratory symptoms. At the work session, staff will seek direction from Council about alternative ways to proceed. Core Public Health Services Rule (information item) The state board of health will be adopting a rule that defines "core public health services" at its meeting on October 19. Attachment B includes the proposed rule. Key elements include: • To the extent that financial resources allow, local public health agencies need to determine their highest priorities for health and environmental programs and either ensure that another entity can perform a given service, or perform services themselves. • Examples of services performed directly include environmental monitoring, restaurant inspections, sustainability programs, and complaint response Page 3 of 13 • Services provided by others include social services provided by non - profits, education provided by schools, and medical services provided by the hospital and non - profits • Services we contract with others to provide include vital records recording, done by Garfield County. • Core public health services includes assessment, planning, communication, statistics, disease prevention, health promotion, promoting sustainable environments, maximizing recycling, protecting air and water, emergency response, finance, and administration. Public Health Agency Director State law requires each local public health agency to appoint a director, who then selects staff and administers programs in the areas of food protection, air and water quality, and solid and hazardous waste. Since Lee Cassin, the current director, will be retiring in January of 2012, at that time the board will need to appoint a new director with a public or environmental health background. Page 4 of 13 Attachment A The Current 75 ppb Primary Standard _ �. CY.�_ fa �'�! �..�� Colorado Ozone Sites .n� '� " 4mNr Comparison to ■■ +» 2.a? ®p µ Federal Ozone Standard oll °-s ° - (0.075 ppm) g a — w r te— II 008 - 2010 z ;� .. Ozone standard: ,year average of lth maximum i - values must Ma0A75 ppm < tip s 7 • a .,.. ® _ ` Above level of swami Mena n1„. •Va mass -earn ..- j - s% years of data available) Oa,rdard hours i L • °�- C� A", 1 seed ones of Pima w•Y.bl - ( •' m's ` '% �� �P" • Below level of standard ra`<" S - � (used w m (]+ years of data available) ea. . - Id on ales toe arnot -rata :a _ - , --s — u Below lave, a standard r d a�� .-. ... T ( <a years or data available) 1 � M • Masson N • YIM tie NM Y• ovens) Nob inky le nr a n e r d r..drsnbn s � i ➢' M -.. �'-� - YlYbra0C0Rea a•dra,[W. 2ar-_ ® ® of . - �-... A Possible 65 ppb Primary Standard Colorado Ozone Sites mg 1 Bp911 , a l V - at Comparison to , � possible 0.085 ppm '*—'' � ' ` * o— Federal Ozone Standard ` r •r ' S2 =ai + -- 2008 -2010 -Ns II ll y, - ° I „ wee @ ® t F �`' • Above level of standard 'Its Pr ' I N'''''' � , ' 1 --- yM (3+ yeah of data available) sand `�. R yy e ,, 'ip yy sad one yr.ays MM Mee ee -fetoa i •e. • Above level of standard t4 m {,,�� t (<3 years of data available) � J (sass on .vy Groh low. M meat ma + r . ., .. • Below level of standard !• m 1 ,--'. ¶ W � (3+ years of data available) - ■ , owed on Syr. avg. MTh teak W20ae -2010) --:- ° �_. LL y s , , o1 • Below level of standard _' W T ' "- J p� , r ( <3 years of data available) siesta w I M "'+f r`7 . . ... �'� € -.. adon sdM mm availablavailable) yeas ..ble) I� 0, �s.i s ix w. ... a .- N _ F . - Nob: ONy Ww mMlna dll rpebm.nb : ID 1 • --- I . .. undere0CPR00 m dast.d Page 5 of 13 Attachment B DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT Colorado State Board of Health CORE PUBLIC HEALTH SERVICES - NEW RULE 6 CCR 1014 -7 Section 1— Purpose and Authority for Rules 1.1 These rules address the recognition that an effective public health system needs clearly defined core public health services. These core public health services are Tong -term programs, representing the minimum level of public health services that local public health agencies would provide in a modern public health system. Core public health services are intended to improve the health of individuals as well as the health of our communities. 1.2 These rules further recognize that county and district public health agencies are essential to the provision of quality and comprehensive public health services throughout the state and are critical partners with the Colorado Department of Public Health and Environment in maintaining a strong public health system. 1.3 This regulation is adopted pursuant to the authority in section 25 -1 -503 et seq., C.R.S. and is intended to be consistent with the requirements of the State Administrative Procedures Act, section 24 -4 -101 et seq. (the "APA "), C.R.S. Section 2 — Definitions 2.1 All definitions that appear in Section 25 -1 -502, C.R.S., shall apply to these rules. A. "Agency" means a county or district public health agency established pursuant to section 25 -1 -506. B. "Core public health" shall be defined by the state board and shall include, but need not be limited to, the assessment of health status and health risks, development of policies to protect and promote health, and the assurance of provision of the essential public health services. C. "Essential public health services" means to: Page 6 of 13 1. Monitor health status to identify and solve community health problems. 2. Investigate and diagnose health problems and health hazards in the community. 3. Inform, educate, and empower individuals about health issues. 4. Mobilize public and private collaboration and action to identify and solve health problems. 5. Develop policies, plans, and programs that support individual and community health efforts. 6. Enforce laws and regulations that protect health and promote safety. 7. Link people to needed personal health services and assure the provision of health care. 8. Encourage a competent public health workforce. 9. Evaluate effectiveness, accessibility, and quality of personal and population -based health services. 10. Contribute to research into insightful and innovative solutions to health problems. 2.2 IN ADDITION, THE DEFINITIONS LISTED BELOW SHALL APPLY TO THESE RULES. A. "ASSURE" MEANS TO: ADDRESS CURRENT AND EMERGING COMMUNITY HEALTH NEEDS THROUGH GOVERNMENTAL LEADERSHIP AND ACTION WITH PUBLIC HEALTH SYSTEM PARTNERS. TAKE REASONABLE AND NECESSARY ACTION THROUGH A COMMUNITY DEFINED MIX OF EDUCATION, SERVICES, REGULATIONS, AND ENFORCEMENT. B. "SUSTAINABLE DEVELOPMENT" REFERS TO FORMS OF PROGRESS OR DEVELOPMENT THAT MEETS THE NEEDS OF CURRENT GENERATIONS WITHOUT COMPROMISING THE ABILITY OF FUTURE GENERATIONS TO MEET THEIR NEEDS. Section 3 - General Statement of Duties: 3.1 Pursuant to Colorado Revised Statutes, part 5 of article 1 of title 25, in addition to all other powers and duties, a county or district public health agency has the following duties: A. To provide or arrange for the provision of quality core public health services as defined by the state board or deemed essential by the comprehensive statewide improvement plan (section 25 -1 -506 (3)(b)(iii), C.R.S.). Page 7 of 13 1. The county or district agency shall be deemed to have met this requirement if the agency can demonstrate to the county or district board that other providers offer core public health services that are sufficient to meet the local need as determined by a local public health IMPROVEMENT plan (Section 25 -1 -506 (3)(b)(iii), C.R.S.). B. Exemptions from the Provision of Core Services are further detailed in Section 5, below. Section 4 —The Provision of Core Public Health Services: 4.1 Public health core services in Colorado shall include, but need not be limited to the following: A. ASSESSMENT, PLANNING, AND COMMUNICATION Assessment and Planning. All county and district public health agencies are required to use assessment and planning methodologies to identify, evaluate and understand community health problems, priority populations, and potential threats to the public's health, and use this knowledge to determine what strategies are needed to engage partners and improve health. Furthermore, agencies are required to: 1. Participate in integrated state, local, and national surveillance system(s) that quantify public health and environmental problems and threats. 2. Complete a local public health improvement plan based on a comprehensive assessment of the community's health and environmental status at a minimum of every five years. 3. Use regional and county data, provided by CDPHE, on conditions of public health heath importance, including: chronic and communicable disease; environmental hazards; health disparities; determinants of health; and injury. 4. COMMUNICATE TO THE PUBLIC AND KEY STAKEHOLDERS THE RESULTS OF THE COMMUNITY HEALTH ASSESSMENT AND LOCAL PUBLIC HEALTH IMPROVEMENT PLAN, AS WELL AS OTHER PUBLIC HEALTH INFORMATION THAT IS IMPORTANT TO THE HEALTH OF RESIDENTS AND VISITORS. B. Vital Records and Statistics: All county and district public health agencies are required to record and report vital events (e.g., births and deaths) in compliance with Colorado statutes, Board of Health Regulations, and Office of the State Registrar of Vital Statistics policies. Page 8 of 13 1. County and district public health directors shall act as the local registrar of vital statistics or contract out the responsibility of registrar in the area over which the agency has jurisdiction. 2. The state registrar shall designate vital records offices and may establish or designate additional offices to aid in the efficient administration of the system of vital statistics. C. COMMUNICABLE DISEASE PREVENTION, INVESTIGATION, AND CONTROL igatc a d Control C ommunicp"'�o�.p X05: All county and district public health agencies are required to track the incidence and distribution of disease in the population and prevent and control vaccine - preventable diseases, zoonotic, vector, air - borne, water -borne and food -borne illnesses, and other diseases that are transmitted person -to- person. Furthermore, agencies are required to: 1. Collect and report disease information according to Colorado Board of Health Rules and Regulations. 2. Investigate cases of reportable diseases and suspected outbreaks according to standard protocols and guidance provided by CDPHE. 3. Assure immunizations using ESTABLISHED STANDARDSGt3ndOrd protocols, and, IN COLLABORATION WITH CDPHE, monitor community immunization levels. 4. Take appropriate measures to prevent disease transmission using methods specific to: infected persons (isolation, treatment, contact tracing /notification); contacts to infected persons (quarantine, prophylaxis); and the environment in which the communicable disease occurs (facility closure, disinfection). 5. Work closely with CDPHE in communicable disease investigation and control, particularly if the investigation crosses county lines or technical assistance is needed. D. Prevention and Population Health Promotion: All county and district public health agencies are required to develop, implement, and evaluate strategies (policies and programs) to enhance and promote healthy living, quality of life and wellbeing while reducing the incidence of preventable (chronic and communicable) diseases, injuries, disabilities and other poor health outcomes across the life -span. Furthermore, agencies are required to: 1. Promote physical (including oral) health, mental and behavioral health, and environmental health with emphasis on increasing health Page 9 of 13 equity among priority populations (e.g., children, elderly, racial or ethnic populations). 2. Address identified risk factors or behaviors (e.g., tobacco use, physical activity, nutrition, teen pregnancy, sexually- transmitted infections) based on community health assessment priorities. 3. Inform, educate, and engage the public and policymakers to build community consensus and capability to promote /support evidenced - based strategies that enable healthy BEHAVIORS AND ENVIRONMENTS FOR INDIVIDUALS, FAMILIES, ORGANIZATIONS, AND COMMUNITIES. personal 4. Assure strategies are delivered in a culturally and linguistically appropriate manner. 5. Coordinate efforts with governmental and community partners to link individuals to services such as primary care, maternal and child health care, oral health care, specialty care, and mental health care. 6. Develop community specific solutions to address prevention priorities. 7. Promote and participate in planning for sustainable environments that support healthy living. E. Emergency Preparedness and Response: All county and district public health agencies are required to prepare and respond to emergencies with a public health or environmental health implication in coordination with local, state and federal agencies and public and private sector partners. Furthermore, agencies are required to: 1. Participate in All- Hazards planning, training, exercises, and response activities within the local jurisdiction. 2. Serve as or support the "Emergency Support Function 8 - Public Health" lead for the county, region, or jurisdiction. 3. Implement an emergency communication strategy to inform the community and to activate emergency response personnel in the event of a public health crisis. 4. Coordinate with county Emergency Managers and other first responders. 5. PROMOTE COMMUNITY PREPAREDNESS BY COMMUNICATING STEPS THAT CAN BE TAKEN BEFORE, DURING, OR AFTER A DISASTER. F. Environmental Health: Recognizing that significant responsibility for environmental quality management and oversight lies with state and federal agencies, all county and district public health agencies are required Page l0 of 13 to participate in the protection and improvement of air, water, land, and food quality by identifying, investigating, and responding to community environmental health concerns, reducing current and emerging environmental health risks, preventing communicable diseases, and sustaining the environment. These activities shall be consistent with applicable laws and regulations, and coordinated with local, state and federal agencies, industry, and the public. Furthermore, agencies are required to: 1. Assure the prevention and control vector -borne (e.g. insects, rodents), air - borne, water- borne, food - borne, and other public health threats related to environmental hazards. 2. Assure the protection of surface water and groundwater, including recreational waters and drinking water sources, and assure appropriate local regulatory oversight of onsite waste water systems. 3. Assure the safety of food provided to the public at retail food establishments. 4. Assure sanitation of institutional facilities (e.g., child care facilities, local correctional facilities and schools). 5. Assure the proper storage, collection, treatment, and disposal of garbage, refuse, and solid and hazardous waste. 6. Promote programs to minimize the amount of solid and hazardous waste and maximize the amount of recycling and reuse. 7. Participate in land use planning and sustainable development to encourage decisions that promote positive public health outcomes (e.g., consideration of housing, urban development, recreational facilities and transport), and that protect and improve air quality, water quality and solid waste management. 8. Where appropriate and practicable, enter into contracts or other acceptable agreements with the state's environmental programs in order to perform local assessments, inspections, investigations, and monitoring programs. G. Administration and Governance: All county and district public health agencies are required to establish and maintain the necessary programs, personnel, facilities, information technology, and other resources to deliver public health services throughout the agency's jurisdiction. This may be done in collaboration with community and regional partners. Furthermore, agencies are required to: Page 11 of 13 1. Maintain competent, appropriate staffing and other resources to ensure capacity for delivery of core public health services. 2. Meet minimum quality standards in the delivery of public health services throughout the jurisdiction. 3. Implement public health laws, policies, and procedures regarding agency operations in coordination with state administrative rules and regulations. 4. ASSESS THE PROVISION OF Ass.k,tfeeva core public health services provided in the jurisdiction. 5. Establish procedures for working across jurisdictional boundaries and /or for requesting assistance in the delivery of public health services. 6. Demonstrate effective financial management systems and management of the public health fund in accordance with C.R.S. 25- 1 -511. 4.2 Delivery of the core services shall be performed in accordance with the 10 Essential Public Health Services as defined by section 25 -1 -502, C.R.S. Section 5 - Exemption from the Provision of Core Services: 5.1 When sufficient appropriations are absent, the county or district board may set priorities for fulfilling the duties described in paragraph (b), subsection (3) of section 25 -1 -506, C.R.S., and include the list of priorities in its county or district public health plan submitted pursuant to section 25 -1 -505, C.R.S. 5.2 The county or district board of health may choose to limit the scope of the core public health services provided if: A. There is limited need for the core public health services in the community, or B. Other providers provide this service sufficient to meet the local need. Section 6 —The Failure to Provide Core Public Health Services 6.1 Pursuant to section 25 -1 -510, C.R.S., the state department may: A. Reallocate state funds To OR from an agency that is not able to provide core public health services to another entity to deliver services in that agency's jurisdiction. B. IF A CORE SERVICE I5 NOT BEING PROVIDED WITHIN THE JURISDICTION, THE DEPARTMENT WILL WORK WITH THE LOCAL PUBLIC HEALTH AGENCY AND THE LOCAL BOARD OF HEALTH TO Page 12 of 13 ADDRESS HOW THE AGENCY HAS PRIORITIZED THE CORE PUBLIC HEALTH SERVICES IT WILL OFFER, AND ANY STATUTORY REQUIREMENTS TO PROVIDE THESE SERVICES. C. PRIOR TO THE REALLOCATION OF FUNDS, STAFF AND PROGRAMS WITHIN THE DEPARTMENT WILL WORK WITH A LOCAL PUBLIC HEALTH AGENCY THAT IS UNABLE TO PROVIDE CORE SERVICES, AGENCIES IN NEIGHBORING COUNTIES, LOCAL HEALTH PROVIDERS, AND OTHER ORGANIZATIONS TO DETERMINE HOW BEST TO PROVIDE OR ASSURE CORE SERVICES WITHIN THAT AGENCY'S JURISDICTION. Page 13 of 13 MEMORANDUM TO: Mayor and City Council FROM: Lee Cassin DATE OF MEMO: September 22, 2011 MEETING DATE: September 27, 2011 RE: Aspen Water Fluoridation Options REQUEST OF COUNCIL: Staff requests direction from Council about whether to discontinue adding fluoride to Aspen's water, add less fluoride (to the level of the new EPA/HHS recommended guideline), or continue to add fluoride at the current level. The issue this memo focuses on is not whether fluoride is "good or bad" (it has both benefits and risks) but whether the population already gets enough fluoride from a variety of sources to warrant allowing individuals a choice about their fluoride intake. PREVIOUS COUNCIL ACTION: Councils have discussed this issue at past worksessions and decided not to change fluoridation procedures. An advisory vote was held on fluoride in the 1980's with the result favoring continuing to fluoridate. When the new lowered water fluoridation recommended guidelines were released in January, council directed staff to return with as much scientific information as possible. BACKGROUND: In January of this year, the EPA and US Department of Health and Human Services (HHS) recommended that water districts lower the amount of fluoride they add to drinking water to the lowest amount expected to reduce the number of cavities. Their release stated that, "This updated recommendation is based on recent EPA and HHS scientific assessments to balance the benefits of preventing tooth decay while limiting any unwanted health effects." This information was presented to Council, which directed staff to bring back options at a worksession. Please see Attachment A for the release provided by EPA/HHS. DISCUSSION: Key issues are summarized here, with additional scientific and other background information included in the packet. This topic is an excellent example of an issue with significant tradeoffs and competing benefits and risks. The staff presentation will focus on the existing scientific studies and their limitations and will also include a list of entities supporting fluoridation, materials provided by the state health department, materials provided by concerned citizens, and information on what other areas are doing. Dr. Morris Cohen, Aspen's Medical Officer will speak after the staff presentation. Page 1 of 114 Science • It is crucial to rely on peer- reviewed studies, and to distinguish between studies whose methods have been evaluated by independent experts, and initial studies whose design cannot draw a scientific conclusion. • The National Research Council has reviewed the wealth of studies, evaluated which ones meet scientific standards, and listed the conclusions that can be drawn from those studies. Their charge was to evaluate whether the current maximum allowed level of fluoride naturally in water was strict enough, or whether high- fluoride water systems needed to do more to remove their fluoride. (They were asking whether natural levels of 4 ppm were too high, or whether the maximum should be lowered to 2 ppm. While they were not asked whether even lower levels still posed a risk, the scientific thinking is that if 10 x- rays a year increase your risk of cancer, five x -rays a year increases your risk, but by a lesser amount. So the risks, and benefits, they found, at 2 or 4 ppm would be expected to exist, but be smaller, at 0.7 ppm.) • Fluoride reduces the risk of dental cavities. This is considered to be a significant public health benefit. • Too much fluoride increases the risk of dental fluorosis and bone fractures. The NRC report stated that, "the majority of the committee concluded that the MCLG is not likely to be protective against bone fractures." (The MCLG is the 4 ppm that has been allowed in naturally high - fluoride water.) In more detail, the report noted, o "Bone Fractures o All members of the committee agreed that there is scientific evidence that under certain conditions fluoride can weaken bone and increase the risk of fractures... o The majority of the committee concluded that the MCLG is not likely to be protective against bone fractures... o Few studies have assessed fracture risk in populations exposed to fluoride at 2 mg/L in drinking water. The best available study was from Finland, which provided data that suggested an increased rate of hip fracture in populations exposed to fluoride at >1.5 mg/L. o Thus, the committee finds that the available epidemiologic data for assessing bone fracture risk in relation to fluoride exposure around 2 mg/L are inadequate for drawing firm conclusions about the risk or safety of exposures at that concentration. o More research is needed on bone concentrations of fluoride in people with altered renal function, as well as other potentially sensitive populations (e.g., the elderly, postmenopausal women, people with altered acid balance), to better understand the risks of musculoskeletal effects in these populations." Page 2 of 114 I • Ambiguous studies have raised the possibility, which is not confirmed or proven, that excess fluoride may increase the risk of rare bone cancers in some subpopulations. This is a perfect example of the difficulty of being able to draw firm conclusions, even from good peer- reviewed scientific studies. • Many claims of adverse effects from fluoride ranging from lowered IQ to cancers. A scientific hypothesis may be found to be valid in future studies but there is no support for these effects based on existing science. • Aspen's water has natural fluoride in levels that vary by season and by water source (well, surface, etc.) with the average level varying from .35 to .18 ppm. • Intake of fluoride has increased significantly in the decades since fluoridation was begun, from dietary changes, toothpastes, and dental treatments. Knowing how much fluoride people get from their diets is very challenging and it varies tremendously among people. • An unknown number of consumers of Aspen's water may not be able to afford adequate dental care and the amount of fluoride ingested in foods can vary widely. Inability to scientifically determine fluoride's effects • Studies that could answer the questions about whether fluoride at moderate levels causes various risks are either unethical, or are prohibitively expensive so have not been done. (This would involve exposing a large number of people to a given amount of fluoride, exposing others to none, and determining any differences in effects. Other variables would have to be kept constant.) • Studies that have tried to discern possible effects of moderate fluoride levels are confounded by numerous other variables, so in most cases, conclusions cannot be drawn either way — that fluoride causes no harmful effects, or that it does cause certain effects. (This includes looking for health effects in different towns with different fluoride levels and using a large enough sample that confounding variables can be accounted for.) • Animal studies are used often to assess health effects where humans cannot be subjects and have been widely used to find substances that cause cancer or other health effects. But everyone may not agree on how animal studies translate to human risks. • Studies are often funded by or performed by entities perceived by one group or another to be biased, from anti - fluoride groups to studies funded by dental associations. Sources of funding are limited and do not prove bias, which emphasizes the need to rely on peer - reviewed, double - blind, controlled studies. Endorsements by other groups: The Colorado Department of Public Health and Environment strongly supports adding fluoride to water, as does the Aspen to Parachute Dental Initiative. CDPHE's policy statement is, "Fluoridation of public water supplies is a safe, economical, and effective measure to prevent dental caries. Family physicians should know the fluoride content of local drinking water supplies, educate patients to prevent excessive fluoride intake, and be knowledgeable about the health risks and benefits associated with fluoride. Dietary fluoride supplements should be considered for children from ages 6 months through 16 years when drinking water levels are suboptimal. CDPHE strongly urges Aspen to continue adding fluoride to its water. Page 3 of 114 The Centers for Disease Control states, "For 65 years, community water fluoridation has been a safe and healthy way to effectively prevent tooth decay. CDC has recognized water fluoridation as one of 10 great public health achievements of the 20th century." Please see attachment F for documents provided by the CDPHE oral health director including a list of entities endorsing water fluoridation. What do other towns do? Please see Attachment E for details of the fluoridation status of water systems in Colorado. According to the Centers for Disease Control, most Colorado water districts do NOT add additional fluoride to their water, relying on natural fluoride levels or not wanting to add fluoride. However, more small districts do not add fluoride, compared to larger districts. In Europe, most countries do not add fluoride to their water, although many use fluoridated salt as an alternative that allows consumers to choose whether to increase or limit their fluoride intake, or to give extra fluoride to children without adding it to adults' diets. Natural Fluoride levels in Aspen's water: Here is historical data on AVERAGE fluoride levels by month in Aspen's water, provided by Treatment Manager Charlie Bailey. FLUORIDE LEVELS 2000 2005 2010 AVG JAN 0.37 0.30 0.30 0.32 FEB 0.29 0.36 0.27 0.31 MAR 0.37 0.37 0.29 0.34 APR 0.31 0.27 0.34 0.31 MAY 0.28 0.32 0.27 0.29 JUN 0.41 0.22 0.20 0.28 JUL 0.36 0.20 0.20 0.25 AUG 0.39 0.24 0.21 0.28 SEP 0.32 0.30 0.21 0.28 OCT 0.30 0.32 0.23 0.28 NOV 0.35 0.30 0.24 0.30 DEC 0.25 0.42 0.25 0.31 Page 4 of 114 FLUORIDE 0.40 0.35 0.30 0.25 0.20 - —FLUORIDE 0.15 0.10 0.05 0.00 ,. _ _ — JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC Miscellaneous • This memo does not address political aspects of the origins of fluoridation, but focuses on what is known and not known about the tradeoffs in water fluoridation. • This memo does not address sources of fluoride, although contamination of fluoride from China and other sources has been raised as an issue since fluoride from waste products may be used for fluoridation and other Chinese products have been adulterated. • This memo also does not address occupational exposure risks to employees who add fluoride to Aspen's water. If the benefits of fluoridation are deemed to outweigh the risks, employees accept this risk. If risks to the general population of too much fluoride are determined to be great enough to discontinue adding it to Aspen's water, this will not be an issue. Attachments • (A) (Page 7) Summary of recommendations from the US department of Health and Human Services and Environmental Protection Agency. This recommendation is to fluoridate to the lowest level in the range thought to reduce cavities, in order to reduce the risks of adverse effects from fluoride, considering increased dietary intake of fluoride. • (B) (Page 9) National Research Council summary of findings on fluoridation, excerpts. This independent scientific report was commissioned in response to studies suggesting that too much fluoride could cause adverse effects. The report is several hundred pages long so I have provided a link to the whole study as well as the summary. • (C) (Page 13) National Cancer Institute, "Childhood Cancer: Overview of Incidence Trends and Environmental Carcinogens" • (D) (Page 14) American Cancer Society, +Water Fluoridation and Cancer Risk" - http: / /www. cancer. org / Cancer / CancerCauses /OtherCarcinogens /AtHome /water- fluoridation- and - cancer -risk • (E) (Page 20) A summary of water fluoridation policies of towns in Colorado (provided by the CDC) and European cities and countries Page 5 of 114 • (F) (Page 24) Several pro - fluoridation documents provided by the state health department including list of entities endorsing fluoridation • (G) (Page 95) Listing of anti- fluoridation documents FINANCIALBUDGET IMPACTS: This issue is not driven by cost considerations. It costs the city a small amount of money to add fluoride to the water, including purchasing the material and staff time, training, and safety materials required for its addition. That amount of money could provide funding for dental sealants or tablets and treatments for low income people otherwise unable to afford dental care if Council chose or could be used to provide free fluoride - containing toothpaste. Such a step would be a cost - neutral way to allow people to choose to avoid excess fluoride exposure while providing fluoride to low- income residents. ENVIRONMENTAL IMPACTS: This is a public health, rather than an environmental issue. RECOMMENDED ACTION: Staff recommends that Council discontinue adding fluoride to Aspen's water, given the natural levels and additional sources of fluoride, and the small risks of too much fluoride. If Council feels there is a significant number of residents without access to enough fluoride in foods naturally in water, and via dental products, staff recommends using money not spent on adding fluoride to water to purchase and distribute fluoridated toothpaste or pay for fluoride pills. If council wishes to continue adding fluoride, staff recommends the level be immediately lowered to the levels recommended in the new HHS/EPA guidelines. ALTERNATIVES: Council could make no change, or could adopt the lower level recommended in the EPA/HHS guidelines. Council could also use the money saved by not adding fluoride to the water, to provide free fluoridated toothpaste to children whose teeth are developing, and/or could fund provision of free fluoride tablets to those who want additional fluoride for their children. PROPOSED MOTION: A motion is not required but staff requests direction from Council about how to proceed. CITY MANAGER COMMENTS: ATTACHMENTS: • Page 6 of 114 Attachment A News Release FOR IMMEDIATE RELEASE Contact: OASH ashmedia@hhs.gov 202-205 - January 7, 2011 0143 EPA isa.jalil @epa.gov or 202 -564 -3226 HHS and EPA announce new scientific assessments and actions on fluoride Agencies working together to maintain benefits of preventing tooth decay while preventing excessive exposure WASHINGTON – The U.S. Department of Health and Human Services (HHS) and the U.S. Environmental Protection Agency (EPA) today are announcing important steps to ensure that standards and guidelines on fluoride in drinking water continue to provide the maximum protection to the American people to support good dental health, especially in children. HHS is proposing that the recommended level of fluoride in drinking water can be set at the lowest end of the current optimal range to prevent tooth decay, and EPA is initiating review of the maximum amount of fluoride allowed in drinking water. These actions will maximize the health benefits of water fluoridation, an important tool in the prevention of tooth decay while reducing the possibility of children receiving too much fluoride. The Centers for Disease Control and Prevention named the fluoridation of drinking water one of the ten great public health achievements of the 20th century. "One of water fluoridation's biggest advantages is that it benefits all residents of a community— at home, work, school, or play," said HHS Assistant Secretary for Health Howard K. Koh, MD, MPH. "Today's announcement is part of our ongoing support of appropriate fluoridation for community water systems, and its effectiveness in preventing tooth decay throughout one's lifetime." "Today both HHS and EPA are making announcements on fluoride based on the most up to date scientific data," said EPA Assistant Administrator for the Office of Water, Peter Silva. "EPA's new analysis will help us make sure that people benefit from tooth decay prevention while at the same time avoiding the unwanted health effects from too much fluoride." HHS and EPA reached an understanding of the latest science on fluoride and its effect on tooth decay prevention and the development of dental fluorosis that may occur with excess fluoride consumption during the tooth forming years, age 8 and younger. Dental fluorosis in the United States appears mostly in the very mild or mild form – as barely visible lacy white markings or spots on the enamel. The severe form of dental fluorosis, with staining and pitting of the tooth surface, is rare in the United States. There are several reasons for the changes seen over time, including that Americans have access to more sources of fluoride than they did when water fluoridation was first introduced in the United States in the 1940s. Water is now one of several sources of fluoride. Other common Page 7 of 114 sources include dental products such as toothpaste and mouth rinses, prescription fluoride supplements, and fluoride applied by dental professionals. Water fluoridation and fluoride toothpaste are largely responsible for the significant decline in tooth decay in the U.S. over the past several decades. HHS' proposed recommendation of 0.7 milligrams of fluoride per liter of water replaces the current recommended range of 0.7 to 1.2 milligrams. This updated recommendation is based on recent EPA and HHS scientific assessments to balance the benefits of preventing tooth decay while limiting any unwanted health effects. These scientific assessments will also guide EPA in making a determination of whether to lower the maximum amount of fluoride allowed in drinking water, which is set to prevent adverse health effects. The new EPA assessments of fluoride were undertaken in response to findings of the National Academies of Science (NAS). At EPA's request, in 2006 NAS reviewed new data on fluoride and issued a report recommending that EPA update its health and exposure assessments to take into account bone and dental effects and to consider all sources of fluoride. In addition to EPA's new assessments and the NAS report, HHS also considered current levels of tooth decay and dental fluorosis and fluid consumption across the United States. UPDATE: The notice of the proposed recommendation published in the Federal Register on January 13 and HHS will accept comments from the public and stakeholders on the proposed recommendation for 30 days at CWFcomments @cdc.gov. HHS is expecting to publish final guidance for community water fluoridation by spring 2011. The proposed recommendation is available at http: / /frwebgate2.access.gpo. gov /cgi- bin/ TEXTgate. cgi? WAISdocID= WOYUwUO /1 /0 &WAISaction= retrieve. Comments regarding the EPA documents, Fluoride: Dose - Response Analysis For Non - cancer Effects and Fluoride: Exposure and Relative Source Contribution Analysis should be sent to EPA at FluorideScience@a,epa.gov. The documents can be found at http: // water.epa.gov/ action /advisories /drinking/fluoride index.cfm For more information about community water fluoridation, as well as information for health care providers and individuals on how to prevent tooth decay and reduce the chance of children developing dental fluorosis, visit http: / /www.cdc.gov /fluoridation. For information about the national drinking water regulations for fluoride, visit: http: // water.epa.gov/ drink / contaminants /basicinformation/fluoride.cf n Page 8 of 114 Attachment B Fluoride in Drinkinw Water: A Scientific Review of EPA's Standards (2006) National Academies of Science Below are excerpts from the 12 -page summary of the 531 -page document, as well as links to the whole document: http: / /www.nap.edu/openbook.php ?record id =11571 &page =6 "Summary Under the Safe Drinking Water Act, the U.S. Environmental Protection Agency (EPA) is required to establish exposure standards for contaminants in public drinking -water systems that might cause any adverse effects on human health.... Fluoride is one of the drinking -water contaminants regulated by EPA.... EPA's guidelines are maximum allowable concentrations in drinking water intended to prevent toxic or other adverse effects that could result from exposure to fluoride. In the early 1990s at the request of EPA, the National Research Council (NRC) independently reviewed the health effects of ingested fluoride and the scientific basis for EPA's Maximum Contaminant Level (MCL). It concluded that the MCL was an appropriate interim standard but that further research was needed to fill data gaps on total exposure to fluoride and its toxicity. Because new research on fluoride is now available and because the Safe Drinking Water Act requires periodic reassessment of regulations for drinking -water contaminants, EPA requested that the NRC again evaluate the adequacy of its MCLG and SMCL for fluoride to protect public health. COMMITTEE'S TASK In response to EPA's request, the NRC convened the Committee on Fluoride in Drinking Water, which prepared this report. The committee was charged to review toxicological, epidemiologic, and clinical data on fluoride— particularly data published since the NRC's previous (1993) report—and exposure data on orally ingested fluoride from drinking water and other sources.... The committee was asked to consider the relative contribution of various fluoride sources (e.g., drinking water, food, dental- hygiene products) to total exposure. The committee was also asked to identify data gaps and to make recommendations for future research. THE COMMITTEE'S EVALUATION ... The committee only considered adverse effects that might result from exposure to fluoride; it did not evaluate health risk from lack of exposure to fluoride or fluoride's efficacy in preventing dental caries. After reviewing the collective evidence, including studies conducted since the early 1990s, the committee concluded unanimously that the present Maximum Contaminant Level Goal of 4 mg/L for fluoride should be lowered. Exposure at the MCLG clearly puts children at risk of developing severe enamel fluorosis, a condition that is associated with enamel loss and pitting. In Page 9 of 114 addition, the majority of the committee concluded that the MCLG is not likely to be protective against bone fractures. The basis for these conclusions is expanded upon below. Exposure to Fluoride The major sources of exposure to fluoride are drinking water, food, dental products, and pesticides. The biggest contributor to exposure for most people in the United States is drinking water. Estimates from 1992 indicate that approximately 1.4 million people in the United States had drinking water with natural fluoride concentrations of 2.0 -3.9 mg/L, and just over 200,000 people had concentrations equal to or exceeding 4 mg/L (the presented MCL). In 2000, it was estimated that approximately 162 million people had artificially fluoridated water (0.7 -1.2 mg/L). Food sources contain various concentrations of fluoride and are the second largest contributor to exposure. Beverages contribute most to estimated fluoride intake, even when excluding contributions from local tap water. The greatest source of nondietary fluoride is dental products, primarily toothpastes. The public is also exposed to fluoride from background air and from certain pesticide residues. Other sources include certain pharmaceuticals and consumer products. Highly exposed subpopulations include individuals who have high concentrations of fluoride in drinking water, who drink unusually large volumes of water, or who are exposed to other important sources of fluoride. Some subpopulations consume much greater quantities of water than the 2 L per day that EPA assumes for adults, including outdoor workers, athletes, and people with certain medical conditions, such as diabetes insipidus. On a per- body- weight basis, infants and young children have approximately three to four times greater exposure than do adults. Dental-care products are also a special consideration for children, because many tend to use more toothpaste than is advised, their swallowing control is not as well developed as that of adults, and many children under the care of a dentist undergo fluoride treatments. Dental Effects Enamel fluorosis is a dose - related mottling of enamel that can range from mild discoloration of the tooth surface to severe staining and pitting. The condition is permanent after it develops in children during tooth formation, a period ranging from birth until about the age of 8. Whether to consider enamel fluorosis, particularly the moderate to severe forms, to be an adverse health effect or a cosmetic effect has been the subject of debate for decades. In previous assessments, all forms of enamel fluorosis, including the severest form, have been judged to be aesthetically displeasing but not adverse to health. This view has been based largely on the absence of direct evidence that severe enamel fluorosis results in tooth loss; loss of tooth function; or psychological, behavioral, or social problems. Severe enamel fluorosis is characterized by dark yellow to brown staining and discrete and confluent pitting, which constitutes enamel loss. The committee finds the rationale for considering severe enamel fluorosis only a cosmetic effect to be much weaker for discrete and confluent pitting than for staining. One of the functions of tooth enamel is to protect the dentin and, ultimately, the pulp from decay and infection. Severe enamel fluorosis compromises that health - protective function by causing structural damage to the tooth. The damage to teeth caused by severe enamel fluorosis is a toxic effect that is consistent with prevailing risk assessment Page 10 of 114 J • definitions of adverse health effects. This view is supported by the clinical practice of filling enamel pits in patients with severe enamel fluorosis and restoring the affected teeth. Moreover, the plausible hypothesis concerning elevated frequency of caries in persons with severe enamel fluorosis has been accepted by some authorities, and the available evidence is mixed but generally supportive. Musculoskeletal Effects Concerns about fluoride's effects on the musculoskeletal system historically have been and continue to be focused on skeletal fluorosis and bone fracture. Fluoride is readily incorporated into the crystalline structure of bone and will accumulate over time. Since the previous 1993 NRC review of fluoride, two pharmacokinetic models were developed to predict bone concentrations from chronic exposure to fluoride. Predictions based on these models were used in the committee's assessments below. Skeletal Fluorosis Skeletal fluorosis is a bone and joint condition associated with prolonged exposure to high concentrations of fluoride. Fluoride increases bone density and appears to exacerbate the growth of osteophytes present in the bone and joints, resulting in joint stiffness and pain. The condition is categorized into one of four stages: a preclinical stage and three clinical stages that increase in severity. The most severe stage (clinical stage III) historically has been referred to as the "crippling" stage. At stage II, mobility is not significantly affected, but it is characterized by chronic joint pain, arthritic symptoms, slight calcification of ligaments, and osteosclerosis of the cancellous bones. Whether EPA's MCLG of 4 mg/L protects against these precursors to more serious mobility problems is unclear. Few clinical cases of skeletal fluorosis in healthy U.S. populations have been reported in recent decades, and the committee did not find any recent studies to evaluate the prevalence of the condition in populations exposed to fluoride at the MCLG. Thus, to answer the question of whether EPA's MCLG protects the general public from stage II and stage III skeletal fluorosis, the committee compared pharmacokinetic model predictions of bone fluoride concentrations and historical data on iliac -crest bone fluoride concentrations associated with the different stages of skeletal fluorosis. The models estimated that bone fluoride concentrations resulting from lifetime exposure to fluoride in drinking water at 2 mg/L (4,000 to 5,000 mg/kg ash) or 4 mg/L (10,000 to 12,000 mg/kg ash) fall within or exceed the ranges historically associated with stage II and stage III skeletal fluorosis (4,300 to 9,200 mg/kg ash and 4,200 to 12,700 mg/kg ash, respectively). However, this comparison alone is insufficient for determining whether stage II or III skeletal fluorosis is a risk for populations exposed to fluoride at 4 mg/L, because bone fluoride concentrations and the levels at which skeletal fluorosis occurs vary widely. On the basis of the existing epidemiologic literature, stage III skeletal fluorosis appears to be a rare condition in the United Sates; furthermore, the committee could not determine whether stage II skeletal fluorosis is occurring in U.S. residents who drink water with fluoride at 4 mg/L. Thus, more research is needed to clarify the relationship between fluoride ingestion, fluoride concentrations in bone, and stage of skeletal fluorosis before any conclusions can be drawn. Page 11 of 114 Bone Fractures All members of the committee agreed that there is scientific evidence that under certain conditions fluoride can weaken bone and increase the risk of fractures... The majority of the committee concluded that the MCLG is not likely to be protective against bone fractures... Few studies have assessed fracture risk in populations exposed to fluoride at 2 mg/L in drinking water. The best available study was from Finland, which provided data that suggested an increased rate of hip fracture in populations exposed to fluoride at >1.5 mg/L. Thus, the committee finds that the available epidemiologic data for assessing bone fracture risk in relation to fluoride exposure around 2 mg/L are inadequate for drawing firm conclusions about the risk or safety of exposures at that concentration. More research is needed on bone concentrations of fluoride in people with altered renal function, as well as other potentially sensitive populations (e.g., the elderly, postmenopausal women, people with altered acid balance), to better understand the risks of musculoskeletal effects in these populations. Page 12 of 114 Attachment C Excerpts from "Childhood Cancer: Overview of Incidence Trends and Environmental Carcinogens ", National Cancer Institute "Some general environmental exposures via drinking water and air have been investigated with respect to childhood cancers. Possible carcinogenic effects related to fluoridation of municipal drinking water supplies have been evaluated thoroughly many times, most recently using 36 years of cancer mortality data and 15 years of cancer incidence data (132). Osteosarcoma was a cancer of particular interest because a 2 -year bioassay had reported a small number of osteosarcomas in male rats but not in female rats or mice of either gender (133). The human cancer incidence data revealed increases over time of osteosarcoma in young males under age 20 that were more prominent in fluoridated areas than in nonfluoridated areas. The increases were not related to the timing of fluoridation, however, so the authors concluded there was no Zink of cancer to fluoridation (134). This conclusion was consistent with several earlier expert evaluations of fluoride and cancer (135- 137)." 1 I 1 Page 13 of 114 , Attachment D Cancer THE OFFICIAL SPONSOR OF BIRTHDAYS! Society* PRINT ❑ ❑ ❑CLOSE ❑ • Learn About Cancer • What Causes Cancer? • Other Carcinogens • At Home Water Fluoridation and Cancer Risk More than 60 years after fluoride was first added to drinking water in some parts of the United States, there is still controversy about the possible health effects of drinking water fluoridation. Many people hold strong views either for or against water fluoridation. Their concerns are based on everything from legitimate scientific research, to freedom of choice issues, to government conspiracy theories. Here we will explore the possible link between fluoridation and cancer. We will not address in detail other possible health effects of water fluoridation (positive or negative). This is not intended as a position statement of the American Cancer Society. 'What is fluoride? Fluorides are compounds that combine the element fluorine with another substance, usually a metal. Examples include sodium fluoride, stannous fluoride, and fluoride monofluorophosphate (MFP fluoride). Once in the body, fluorides are absorbed into the blood through the digestive tract. They travel through the blood and tend to collect in areas high in calcium, such as the bones and teeth. Where is fluoride found? Some fluorides occur naturally in soil, air, or water, although the levels of fluoride can vary widely. Just about all water contains some level of fluoride. The major sources of fluoride for humans are water and other beverages, food, and fluoride- containing dental products (toothpastes, mouth rinses, etc.). Because dental products are generally not swallowed (except, perhaps, by younger children), they may be less of a concern with regard to possible health issues. Fluoride in drinking water Water fluoridation began in some parts of the United States in 1945, after scientists noted that people living in areas with higher water fluoride levels had fewer cavities. Page 14 of 114 • The United States Public Health Service (PHS) has, since 1962, recommended that public water supplies contain between 0.7 and 1.2 milligrams of fluoride per liter (mg/L) of drinking water to help prevent tooth decay. (Some natural water sources have fluoride levels within this range, or even higher.) Fluoride is now used in the public drinking water supplied to about 2 out of 3 Americans. The types of fluoride added to different water systems include fluorosilicic acid, sodium fluorosilicate, and sodium fluoride. The US Environmental Protection Agency (EPA) has set a maximum amount of fluoride allowable in drinking water of 4.0 mg/L. Long -term exposure to levels higher than this can cause a condition called skeletal fluorosis, in which fluoride accumulates in the bones. This can eventually result in joint stiffness and pain, and can lead to weak or brittle bones in older adults. The EPA also set a secondary standard of no more than 2.0 mg/L to help protect children (under the age of 9) from dental fluorosis. In this condition, fluoride collects in developing teeth, preventing tooth enamel from forming normally and resulting in permanent staining or pitting of teeth. Some states have maximum fluoride levels in drinking water that are lower than the national 4.0 mg/L standard. Does fluoride cause cancer? People have raised questions about the safety and effectiveness of water fluoridation since it first began. Over the years, many studies have looked at the possible link between fluoride and cancer. Some of the controversy concerning the possible link stems from a study of lab animals reported by the US National Toxicology Program in 1990. The researchers found "equivocal" (uncertain) evidence of cancer - causing potential of fluoridated drinking water in male rats, based on a higher than expected number of cases of osteosarcoma (a type of bone cancer). There was no evidence of cancer - causing potential in female rats or in male or female mice. Osteosarcoma seems to be the cancer about which the most concern has been raised. One theory on how fluoridation might affect the risk of osteosarcoma is based on the fact that fluoride tends to collect in parts of bones where they are growing. These areas, known as growth plates, are where osteosarcomas typically develop. The theory is that fluoride might somehow cause the cells in the growth plate to grow faster, which might make them more likely to eventually become cancerous. What have studies in humans found? More than 50 population -based studies looking at the potential link between water fluoride levels and cancer have been reported in the medical literature. Most of these have not found a strong link to cancer. Just about all of the studies have been retrospective (looking back in time). They have compared, for example, the rates of cancer in a community before and after water fluoridation, or compared cancer rates in communities with lower levels of fluoride in drinking Page 15 of 114 water to those with higher levels (either naturally or due to fluoridation). Some factors are hard to control for in these types of studies (that is, the groups being compared may be different in ways other than just the drinking water), so the conclusions reached by any single study must be looked at with caution. And there are other issues that make this topic hard to study. For example, if fluoridation is a risk factor, is the type of fluoride used important? Also, is there a specific level of fluoride above which the risk is increased? Osteosarcoma is a rare cancer. Only about 400 cases are diagnosed in children and teens each year in the United States. This means it can be hard to gather enough cases to do large studies. Smaller studies can usually detect big differences in cancer rates between 2 groups, but they may not be able to detect a smaller difference. If fluoride increased the risk only slightly, it might not be picked up by these types of studies. Small studies by themselves may not provide the answers, but taken as a whole they tend to have more weight. Several systematic reviews over the past 25 years have looked at all of the studies published on this subject. In its review published in 1987, the International Agency for Research on Cancer (IARC), part of the World Health Organization, labeled fluorides as "non- classifiable as to their carcinogenicity [ability to cause cancer] in humans." While they noted that the studies "have shown no consistent tendency for people living in areas with high concentrations of fluoride in the water to have higher cancer rates than those living in areas with low concentrations," they also noted that the evidence was inadequate to draw conclusions one way or the other. In 1991, the US Public Health Service issued a report on the benefits and risks of fluoride. When looking at a possible link with cancer, they first reviewed the results of studies done with lab animals. They concluded that the few studies available "fail[ed] to establish an association between fluoride and cancer." They also looked at population -based studies, including a large study conducted by the National Cancer Institute. They concluded: "Optimal fluoridation of drinking water does not pose a detectable cancer risk to humans as evidenced by extensive human epidemiological data available to date, including the new studies prepared for this report." The National Research Council (NRC), part of the National Academies, issued a report titled "Health Effects of Ingested Fluoride" in 1993. Its conclusion was that "the available laboratory data are insufficient to demonstrate a carcinogenic effect of fluoride in animals." They also concluded that "the weight of the evidence from the epidemiological [population -based] studies completed to date does not support the hypothesis of an association between fluoride exposure and increased cancer risk in humans." The report recommended that additional well- designed studies be done to look at the possible link to cancers, especially osteosarcomas. In the United Kingdom, the National Health Service (NHS) Centre for Reviews and Dissemination, University of York, published a systematic review of water fluoridation in the year 2000. After searching through the medical literature, they included 26 studies in their analysis, all of which were considered to be of "low" to "moderate" quality. They concluded, "Overall, no clear association between water fluoridation and incidence or mortality of bone Page 16 of 114 cancers, thyroid cancer, or all cancers was found." However, they also noted, "Given the level of interest surrounding the issue of public water fluoridation, it is surprising to find that little high quality research has been undertaken." The National Research Council issued an update of its 1993 review in early 2006. While the review included some new data, the results of this report were essentially the same: "On the basis of the committee's collective consideration of data from humans, genotoxicity assays, and studies of mechanisms of actions in cell systems, the evidence on the potential of fluoride to initiate or promote cancers, particularly of the bone, is tentative and mixed." The report also noted that an ongoing study from the Harvard School of Public Health would add important information to the current body of research. A partial report from the Harvard study, published in 2006, found that exposure to higher levels of fluoride in drinking water was linked to a higher risk of osteosarcoma in boys but not in girls. However, researchers linked to the study noted that early results from a second part of the study did not appear to match those of the report. They therefore advised caution in interpreting the report until the full results of the study become available. The full study has not yet been published. The US Centers for Disease Control and Prevention (CDC) has issued a statement on water fluoridation and osteosarcoma in response to the study, noting that "at this time, the weight of the scientific evidence, as assessed by independent committees of experts, comprehensive systematic reviews, and review of the findings of individual studies does not support an association between water fluoridated at levels optimal for oral health and the risk for cancer, including osteosarcoma." The statement also noted that further results from the Harvard study should "provide further information as to whether and to what extent an association may exist between osteosarcoma and exposure to fluoride." The general consensus among the reviews done to date is that there is no strong evidence of a link between water fluoridation and cancer. However, these reviews were all done before the partial results of the Harvard study were published in 2006. Several of the reviews noted that further studies, including the full results of the Harvard study, are needed to clarify the possible link. Can you reduce your fluoride exposure? Even without fluoridation, the natural levels of fluoride in water in some places can be even higher than 4 mg/L. Community water systems in such areas are required to lower the fluoride level below the acceptable standard. Private water sources, however, may still be higher. For people concerned that they or their families may be exposed to too much fluoride, there are some steps that can be taken to reduce exposure. First, people should know the level of fluoride in their drinking water. If your drinking water comes from a public source, you can find out about the levels of certain substances in your drinking water, including fluoride, by contacting your local community water system. Each system is also required to provide its customers with an annual report on water quality known as a Consumer Confidence Report. This report lists the levels of certain chemicals and other Page 17 of 114 substances in the water, including fluoride. You can also contact the EPA's Safe Drinking Water Hotline at 1- 800 - 426 -4791 for more general information about drinking water safety. Those who get their drinking water from a private source such as a well can consider having fluoride levels tested by a reputable laboratory. People who live in areas with high levels of fluoride in the water may consider using alternative sources of drinking water, such as bottled water. Most bottled water contains at least some fluoride, with natural spring waters tending to be the lowest. You may want to contact the bottler to find out about fluoride levels. (The US Food and Drug Administration (FDA) sets the standards for allowable levels of fluoride in bottled water.) There are also several methods to filter fluoride out of water, although these can be expensive. Parents with concerns should give small children only a pea -sized amount of toothpaste for brushing, and should do their best to ensure their children are not swallowing, as this can be a significant source of fluoride. Speak to your child's dentist before using toothpaste in children under 2 years of age. Low- and no- fluoride toothpastes and other dental products are also available. Additional resources More information from your American Cancer Society The following related information may also be helpful to you. These materials may be viewed on our Web site or ordered from our toll -free number, at 1- 800 - 227 -2345. Known and Probable Human Carcinogens National organizations and Web sites* In addition to the American Cancer Society, other sources of information include: Centers for Disease Control and Prevention (CDC) Toll -free number: 1 -800- CDC -INFO (1 800 - 232 - 4636) Web site: www.cdc.gov Community water fluoridation page: www.cdc.gov /fluoridation Environmental Protection Agency Toll -free number (Safe Drinking Water Hotline): 1 - 800 - 426 - 4791 Web site: www.epa.gov Ground water & drinking water page: www.epa.gov /safewater /index.html National Cancer Institute Toll -free number: 1- 800 -4- CANCER (1- 800 - 422 -6237) Web site: www.cancer.gov Fluoridated water page: www. cancer. gov/ cancertopics /factsheet/Risk/fluoridated -water Page 18 of 114 *Inclusion on this list does not imply endorsement by the American Cancer Society. No matter who you are, we can help. Contact us anytime, day or night, for information and support. Call us at 1- 800 - 227 -2345 or visit www.cancer.org. References Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention. ToxFAQs for Fluorine, Hydrogen Fluoride, and Fluorides. 2007. Accessed at www.atsdr.cdc.gov /tfacts11.html on December 30, 2009. Bassin EB, Wypij D, Davis RB, Mittleman MA. Age - specific fluoride exposure in drinking water and osteosarcoma (United States). Cancer Causes Control. 2006;17:421 -428. Centers for Disease Control and Prevention. CDC Statement on Water Fluoridation and Osteosarcoma. Accessed at www.cdc.gov/ fluoridation /safety /osteosarcoma.htm on December 29, 2009. Douglass CW, Joshipura K. Caution needed in fluoride and osteosarcoma study. Cancer Causes Control. 2006;17:481 -482. International Agency for Research on Cancer. Fluorides (Inorganic, Used in Drinking- water). 1987; Supp 7: 208 -210. Accessed at http:// monographs. iarc. fr/ENG/Monographs /suppl7 /Supp17- 83.pdf on December 30, 2009 McDonagh MS, Whiting PF, Wilson PM, et al. Systematic review of water fluoridation. BMJ. 2000;321:855 -859. (Full report available online at: www.york.ac.uk/inst/crd/CRDReports /crdreport18.pdf. Accessed December 30, 2009.) National Cancer Institute. Fluoridated Water: Questions and Answers. 2005. Accessed at www. cancer. gov/ cancertopics /factsheet/Risk/fluoridated -water on December 29, 2009. National Research Council. Fluoride in Drinking Water: A Scientific Review of EPA's Standards. 2006. Accessed at http:// books .nap.edu /catalog.php ?record_id =11571 on December 30, 2009. National Research Council. Health Effects of Ingested Fluoride. 1993. Accessed at http: / /www. nap .edu /catalog.php ?record _ id =2204 on December 30, 2009. National Toxicology Program. Toxicology and Carcinogenesis Studies of Sodium Fluoride (CAS No. 7681 -49 -4) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). 1990. Abstract accessed at http://ntp.niehs.nih.gov / index. cfm ?objectid= 0709411C- E355 -Al2E- DBB6666806CB8DB2 on December 30, 2009. United States Public Health Service. Review of Fluoride: Benefits and Risks. 1991. Accessed at www.health. gov / environment /ReviewofFluoride /default.htm on December 30, 2009. Last Medical Review: 11/03/2010 Last Revised: 11/03/2010 Page 19 of 114 Attachment E Here is a summary of what other water treatment systems in Colorado do, from the Centers for Disease Control registry of fluoridation status of all water systems. • 515 Colorado systems are listed in this database as "non- fluoridated ". This group is heavily weighted toward small systems, although it also includes large systems such as Thornton, Westminster, and Colorado Springs. This includes 23 systems in Pitkin County, 45 in Garfield County, and 21 in Eagle County. • 196 systems in Colorado are listed as "fluoridated" but by using the natural fluoride in their water. This includes towns like Woodland Park, La Junta, Salida, and Englewood and 3 water systems in Garfield County. • 50 water systems use natural fluoride but adjust levels to meet the standard. This includes such towns as Greeley, Breckenridge and Pueblo, two water systems in Pitkin County (Aspen and Snowmass), one in Garfield County and three in Eagle County. • 120 systems blend water from different sources with varying amounts of fluoride. The state health department's records provide different numbers, indicating that 73 systems adjust their fluoride levels (instead of the 50 listed by CDC) and notes that 11 of those systems have already adjusted their levels down to the new proposed EPA/HHS recommended guideline level of 0.7 ppm. Page 20 of 114 The following list from Wikipedia describes current water fluoridation programs. Europe [edit] Austria Austria has never implemented fluoridation. 12 [edit] Belgium Belgium does not fluoridate its water supply, although legislation permits it. 12 [edit] Czech Republic Czech Republic (Czechoslovakia respectively) started water fluoridation in 1958 in Tabor. After six years, 80% reduction of decay was asserted °" needed. This led to widespread introduction of fluoridation. In Prague, fluoridation started in 1975. It was stopped in 1988 there and subsequently in the whole country too. Currently (2008) no water is fluoridated. Fluoridated salt is available. 22 [edit] Croatia Croatia does not fluoridate its water. [edit] Denmark Denmark does not fluoridate its water, although the National Health Board is in favour. 12 [edit] Finland The Finnish government supports fluoridation, although only one community of 70 000 people was fluoridated, Kuopio. 12 Kuopio stopped fluoridation in 1992.E [edit] France France fluoridates salt. [edit] Germany Drinking water is not fluoridated in any part of Germany. The GDR used to fluoridate drinking water, but it was discontinued after the German reunification. [edit] Ireland In the Republic of Ireland the majority of drinking water is fluoridated; 71% of the population in 2002 resided in fluoridated communities. The fluoridation agent used is hydrofluosilicic acid (HFSA; H2SiF6). In a 2002 public survey, 45% of respondents expressed some concern about fluoridation. 27 Page 21 of 114 In 1957, the Department of Health established a Fluorine Consultative Council which recommended fluoridation at 1.0 ppm of public water supplies, then accessed by c.50% of the population. 2g This was felt to be a much cheaper way of improving the quality of children's teeth than employing more dentists. The ethical approval for this was given by the "Guild of Saints Luke, Cosmas and Damian", established by Catholic Archbishop of Dublin, John Charles McQuaid. This led to the Health (Fluoridation of Water Supplies) Act 1960, which mandated compulsory fluoridation by local authorities 12911301 The statutory instruments made in 1962 -65 under the 1960 Act were separate for each local authority, setting the level of fluoride in drinking water to 0.8 -1.0 ppm. 1313132 The current regulations date from 2007, and set the level to 0.6 -0.8 ppm, with a target value of 0.7 ppm. Implementation of fluoridation was held up by preliminary dental surveying and water testing, and a court case, Ryan v. Attorney General. In 1965, the Supreme Court rejected Gladys Ryan's claim that the Act violated the Constitution of Ireland's guarantee of the right to bodily integrity. By 1965, Greater Dublin's water was fluoridated; by 1973, other urban centres were.M Dental surveys of children from the 1950s to the 1990s showed marked reductions in cavities parallel to the spread of fluoridation.M [edit] Netherlands Water was fluoridated in large parts of the Netherlands from 1960 to 1973, when the High Council of The Netherlands declared fluoridation of drinking water unauthorized. Dutch authorities had no legal basis adding chemicals to drinking water if they will not improve the safety as such. Drinking water has not been fluoridated in any part of the Netherlands since 1973. edit] Spain Around 10% of the population receives fluoridated water. 40 [edit] Sweden In 1952, Norrkoping in Sweden became one of the first cities in Europe to fluoridate its water supply. 41 It was declared illegal by the Swedish Supreme Administrative Court in 1961, re- legalized in 1962 and finally prohibited by the parliament in 1971, after considerable debate. The parliament majority said that there were other and better ways of reducing tooth decay than water fluoridation. Four cities received permission to fluoridate tap water when it was legal.L -57 An official commission was formed, which published its final report in 1981. They recommended other ways of reducing tooth decay (improving food and oral hygiene habits) instead of fluoridating tap water. They also found that many people found fluoridation to impinge upon personal liberty/freedom of choice, and that the long -term effects of fluoridation were not sufficiently known. They also lacked a good study on the effects of fluoridation on formula -fed infants. 41 :29 [edit] Switzerland Page 22 of 114 In Switzerland since 1962 two fluoridation programmes had operated in tandem: water fluoridation in the City of Basel, and salt fluoridation in the rest of Switzerland (around 83% of domestic salt sold had fluoride added). However it became increasingly difficult to keep the two programmes separate. As a result some of the population of Basel were assumed to use both fluoridated salt and fluoridated water. In order to correct that situation, in April 2003 the State Parliament agreed to cease water fluoridation and officially expand salt fluoridation to Basel. )edit] United Kingdom Around 10% of the population of the United Kingdom receives fluoridated water about half a million people receive water that is naturally fluoridated with calcium fluoride which is different to sodium fluoride, and about 6 million total receive fluoridated water.li The All Party Parliamentary Group on Primary Care and Public Health recommended in April 2003 that fluoridation be introduced "as a legitimate and effective means of tackling dental health inequalities ". [citation needed] The Water Act 2003 required water suppliers to comply with requests from local health authorities to fluoridate their water. 4s The following UK water utility companies fluoridate their supply: • Anglian Water Services Ltd • Northumbrian Water Ltd • South Staffordshire Water plc • Severn Trent plc • United Utilities Water plc Earlier schemes were undertaken in the Health Authority areas of Bedfordshire, Hertfordshire, Birmingham, Black Country, Cheshire, Merseyside, County Durham, Tees Valley, Cumbria, Lancashire, North, East Yorkshire, Northern Lincolnshire, Northumberland, Tyne and Wear, Shropshire, Staffordshire, Trent and West Midlands South whereby fluoridation was introduced progressively in the years between 1964 and 1988. The South Central Strategic Health Authority carried out the first public consultation under the Water Act 2003, and in 2009 its board voted to fluoridate water supplies in the Southampton area to address the high incidence of tooth decay in children there. Surveys had found that the majority of surveyed Southampton residents opposed the plan, but the Southampton City Primary Care Trust decided that "public vote could not be the deciding factor ". A judicial review has been initiated. Fluoridation plans have been particularly controversial in the North West of England and have been delayed after a large increase on projected costs was revealled. 4a The water supply in Northern Ireland has never been artificially fluoridated except in two small localities where fluoride was added to the water for about 30 years. By 1999, fluoridation ceased in those two areas, as well. Scotland's parliament rejected proposals to fluoridate public drinking water following a public consultation.]`itation needed] Page 23 of 114 Appendix F 1) Osteosarcoma Study: http://jdr.sagepub.com/ Journal of Dental Research http: //j dr.sagepub.com/content/early /2011 /07/23/0022034511418828 The online version of this article can be found at: DOI: 10.1177/0022034511418828 J DENT RES published online 28 July 2011 F. M. Kim, C. Hayes, P. L. Williams, G. M. Whitford, K. J. Joshipura, R. N. Hoover and C. W. Douglass An Assessment of Bone Fluoride and Osteosarcoma Published by: http://www.sagepublications.com On behalf of: International and American Associations for Dental Research Additional services and information for Journal of Dental Research can be found at: Email Alerts: http://jdr.sagepub.com/cgi/alerts Subscriptions: http : / /jdr.sagepub.com/subscriptions Reprints: http:// www .sagepub.com/journalsReprints.nav Permissions: http:// www. sagepub .com/journalsPermissions.nav Downloaded from jdr.sagepub.com at International Association for Dental Research on September 6, 2011 For personal use only. No other uses without permission. © 2011 International and American Associations for Dental Research 1 DOI: 10.1177/0022034511418828 Received January 25, 2011; Last revision May 10, 2011; Accepted May 11, 2011 A supplemental appendix to this article is published electronically only at http: / /jdr.sagepub.com/supplemental. c International & American Associations for Dental Research F.M. Kiml, C. Hayes2, P.L. Williams3, G.M. Whitford4, K.J. Joshipura5, R.N. Hoover6, C.W. Douglass7,8 *, and the National Osteosarcoma Etiology Group9 lAt the time the research was conducted, affiliated with Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA, and Department of Oral Health Policy and Epidemiology, Harvard School of Dental Medicine, Boston, MA, USA; 2Frances Stern Nutrition Center, Tufts Medical Center, Boston, MA, USA; 3Department of Page 24 of 114 Biostatistics, Harvard School of Public Health, Boston, MA, USA; 4Department of Oral Biology Medical College of Georgia School of Dentistry, Augusta, GA, USA; 5Center for Clinical Research and Health Promotion, School of Dental Medicine, University of Puerto Rico, San Juan, PR; 6Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA; 7Department of Oral Health Policy and Epidemiology, Harvard School of Dental Medicine, Boston, MA, USA; 8Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA; and 9The National Osteosarcoma Etiology Group, represented by M.C. Gebhardt (Massachusetts General Hospital, Boston, MA, USA), M.T. Scarborough (Shands Medical Center, University of Florida, USA), S. Gitelis (Rush Presbyterian and St. Luke's Medical Center, USA), J.J. Eckardt (UCLA School of Medicine, USA), J.R. Neff (Nebraska Health System, USA), M.J. Joyce (Cleveland Clinic Foundation, USA), M. Malawer (Washington Cancer Institute, USA), M. McGuire (Creighton University, USA), and H.C. Anderson (University of Kansas Medical Center, USA); *corresponding author, Chester _douglass @hsdm.harvard.edu JDent Res X(X):xx -xx, XXXX Abstract The association between fluoride and risk for osteosarcoma is controversial. The purpose of this study was to determine if bone fluoride levels are higher in individuals with osteosarcoma. Incident cases of osteosarcoma (N = 137) and tumor controls (N = 51) were identified by orthopedic physicians, and segments of tumor - adjacent bone and iliac crest bone were analyzed for fluoride content. Logistic regression adjusted for age and sex and potential confounders of osteosarcoma was used to estimate odds ratios (OR) and 95% confidence intervals (CI). There was no significant difference in bone fluoride levels between cases and controls. The OR adjusted for age, gender, and a history of broken bones was 1.33 (95% CI: 0.56- 3.15). No significant association between bone fluoride levels and osteosarcoma risk was detected in our case - control study, based on controls with other tumor diagnoses. KEY WORDS: fluoride, osteosarcoma, case - control study, bone, oncology, epidemiology. Introduction Osteosarcoma, a rare, painful, primary malignant bone tumor, is more prevalent in males (Homa et al., 1991), in the long bones (Patel and Benjamin, 2005), and in individuals < 20 yrs old (Gurney et al., 1999). Chemicals and genetic factors have been suggested as risk factors of osteosarcoma (Miller et al., 1996), while ionizing radiation is the only documented Page 25 of 114 environmental risk factor for bone cancer (Steiner, 1965; Tucker et al., 1987). A National Toxicology Program (NTP) study concluded that there was "equivocal evidence" of carcinogenic activity of sodium fluoride in male rats that were given extremely high doses (100 ppm and 175 ppm) for 2 yrs (NTP, 1990). Other animal studies have not provided evidence of an association between fluoride and osteosarcoma (Maurer et al., 1990; NTP, 1992). Numerous descriptive studies, with self - reported or ecological level data used to determine fluoride exposure from drinking water, failed to demonstrate an association (Hoover et al., 1976; Doll and Kinlen, 1977, 1978; Newbrun, 1977; Hrudey et al., 1990; Mahoney et al., 1991; Freni and Gaylor, 1992). Similarly, case - control studies have not found any significant association between osteosarcoma risk and fluoridated drinking water (McGuire et al., 1991; Moss et al., 1995) or total lifetime fluoride (Gelberg et al., 1995). One exploratory analysis reported an increased risk among a subset of males exposed to fluoride in drinking water during childhood (Bassin et al., 2006). Fluoride has an affinity for calcified tissues, with 99% of fluoride in the body contained within the skeleton. Thus, bone fluoride levels can serve as a biomarker for chronic fluoride exposure, providing a more objective measure of fluoride exposure. The purpose of this study was to evaluate An Assessment of Bone Fluoride and Osteosarcoma Downloaded from jdr.sagepub.com at International Association for Dental Research on September 6, 2011 For personal use only. No other uses without permission. © 2011 International and American Associations for Dental Research 2 Kim et al. J Dent Res X(X) XXXX whether fluoride levels in bone are associated with the occurrence of osteosarcoma. Methods Study Population Patients were identified by physicians in the orthopedic departments from 9 hospitals across the US between 1993 and 2000. The study sample included incident cases of primary osteosarcoma, including osteoblastic, parosteal, and periosteal subtypes, and two control groups: tumor controls, patients with newly diagnosed malignant bone tumors; and orthopedic controls, surgical patients with benign tumors or non - neoplastic conditions. Since tumor controls were the only ones with available bone specimens for assay, they comprised the control series for this report. The study was approved by the Institutional Review Boards of the respective hospitals, Harvard Medical School, and the Medical College of Georgia. All eligible patients who consented to participate were interviewed in person during hospitalization, pre- admission, or postadmission. Medical information was requested for all living patients born in the US. Patients who completed at least 80% of Page 26 of 114 the questionnaire were considered to be enrolled in the study. Although the study protocol called for matching of cases and controls based on gender, age (❑ } 5 yrs), and distance from their medical center, this approach was abandoned early in the study, since it proved to be a barrier to recruiting controls. Thus, all available tumor patients were recruited, and the statistical analysis was adjusted for age and gender. Exposure and Outcome Assessment Cancer diagnoses were confirmed by pathology reports. Specimens of both the tumor and normal bone adjacent to the margins of tumor tissue, herein referred to as tumor- adjacent bone, were collected from cases and tumor controls during surgery. Given that bone at the tumor site was destroyed as a result of the tumor, tumor- adjacent bone was analyzed for fluoride content. In some centers, a segment of bone from the iliac crest was also requested for cases, to assess the correlation between fluoride in iliac crest bone and in tumor- adjacent bone. Methods used to measure fluoride concentration in the bone specimens have been described in detail elsewhere (Medina et al., 2006). A 4- to 6 -mg portion of bone was ashed, pulverized, and analyzed for fluoride concentrations (ash weight, mg F/kg, or ppm) according to a method developed by Taves (1968) and modified by Whitford (1996). With blinding to the case or control status of the bone specimens, each specimen was analyzed in duplicate; if measurements differed by more than 10 %, another specimen was analyzed. Deer bone specimens with known fluoride concentrations were included in each batch of specimens for quality control (Medina et al., 2006) and confirmed the validity of the bone fluoride assay procedure. Statistical Analysis We used Chi - square and Wilcoxon rank -sum tests to evaluate differences in patient characteristics and median fluoride concentrations between tumor- adjacent bone and iliac crest bone. We also evaluated all specimens of tumor - adjacent bone and iliac crest bone among the cases, taking into account the within- person correlation for those patients who had both types of bone specimens. We used Spearman's correlation to assess the correlation between fluoride iliac crest bone and fluoride in tumor - adjacent bone. In the subset of matched cases and controls, we used Wilcoxon's signed -rank test to evaluate if there were a difference in the median fluoride concentration in tumor - adjacent bone. Since this subset represented less than 25% of cases that provided bone, an unmatched analysis comparing median fluoride concentration in tumor - adjacent bone among all cases with Page 27 of 114 control bone was conducted by a Wilcoxon rank -sum test. We used both conditional and unconditional logistic regression to estimate the age- and sex - adjusted odds ratios (OR) and 95% confidence intervals (CI) to account for the initial matching. Fluoride measurements were transformed to a natural logarithmic scale to improve normality (Pagano and Gauvreau, 2000). Age- and sex - adjusted analysis was carried out for variables that were considered to be potential confounders of osteosarcoma: race /ethnicity; patient's, mother's, and father's education; combined household income; whether the patient ever lived in an urban area; and patient's past medical history (history of broken bones, other bone diseases, other cancers, receiving radiation for diagnosis or treatment prior to the present diagnosis); and variables with p value of < 0.25 in the demographicadjusted analysis were considered as potential confounders. The missing indicator method was used for patients missing information on household income and parents' level of education (Greenland and Finkle, 1995). Both manual and automated stepwise selection approaches were used to determine potential confounders to be included in the final risk - adjusted model. An exploratory analysis was also conducted among patients < 45 yrs old and < 20 yrs old. However, this study did not have sufficient power for a subgroup analysis among patients < 20 yrs old. Statistical analysis was carried out in SAS Version 9.1 (SAS Institute, Cary, NC, USA). Results In total, 314 patients were eligible for enrollment (200 cases; 114 controls), and 296 patients (94 %) completed the questionnaire (188 cases; 108 controls). Of these, 194 patients (142 cases; 52 controls) provided either tumor- adjacent or iliac crest bone for assay of fluoride content in bone. Eighteen patients were deceased, did not complete the questionnaire, or were otherwise lost to follow -up (12 cases; six controls). In total, 257 bone specimens were analyzed for fluoride content (200 tumoradjacent bone; 57 iliac crest bone). Bone from six patients (five cases; one control) had fluoride levels below 100 mg F /kg, and thus were considered to be tissue other than bone (G. Whitford, personal communication). Among patients who provided bone, there were no differences between cases and controls in enrollment site, race /ethnicity, patient's and mother's education level, combined household income, and whether they ever lived in an urban area. The median age of controls was higher than that of cases (p < 0.001); Downloaded from jdr.sagepub.com at International Association for Dental Research on September 6, 2011 For personal use only. No other uses without permission. Page 28 of 114 © 2011 International and American Associations for Dental Research JDent Res X(X) XXXX Bone Fluoride and Osteosarcoma Risk 3 gender- specific age differences were also significant, with controls being older, on average, than cases for both males (p < 0.001) and females (p = 0.02) (Table 1). There was a greater proportion of male cases than female cases (p = 0.03), and fathers of cases were significantly more likely to have higher education levels than those of controls (p = 0.02) (Table 1). Comparisons between all subjects who provided bone specimens versus those who did not are included in the Appendix Table 1. Among the 53 cases who provided both tumor- adjacent and iliac crest bone specimens, there was a significantly higher fluoride concentration in iliac crest bone than in tumor - adjacent bone (median = 697 vs. 558 mg F/kg bone ash, p < 0.001) (Fig., a). However, when all specimens of tumor- adjacent bone (N = 137) and iliac crest bone (N = 54) from cases were included, the median fluoride concentrations in iliac crest bone were not significantly higher than those in tumor - adjacent bone (median = 695 vs. 611 mg F/kg bone ash, p = 0.10) (Fig., b). In a validation study examining the fluoride content between iliac crest bone and tumor- adjacent bone among cases, the Spearman correlation was 0.61 (p < 0.001). There was no significant difference in the median fluoride concentration in bone between the matched osteosarcoma case and tumor control pairs (N = 32) (median = 804 vs. 714 mg F/ kg of bone ash, p = 0.63) (Fig., c). When bone specimens from all cases (N = 137) and controls (N = 51) were included in an unmatched analysis, the median bone fluoride concentration in tumor- adjacent bone was significantly higher in controls than in cases (median = 754 vs. 611 mg F/kg of bone ash, p = 0.01) (Fig., d). There were no differences in the results of the conditional and unconditional analyses; thus, the results of the unconditional analyses are reported given the increased power for detecting associations with bone fluoride. In the age- and sexadjusted analysis, OR = 1.22 for an increase in bone fluoride from the 25th percentile (463.5 ppm) to the 75th percentile (943.3 ppm), representing an OR = 1.32 (95% CI, 0.58 -3.03) for a 1 -unit increase in the natural log of fluoride (ppm). After adjustment for age and gender, history of broken bones, other bone diseases, other cancer diagnoses, and history of receiving radiation prior to illness were significant covariates (see Appendix Table 2). The OR for log bone fluoride adjusted for these predictors, age, and gender was 1.23 (95% CI, 0.51 -2.97) (Table 2). With a stepwise selection method to determine the final model Page 29 of 114 adjusted for age and gender, a history of broken bones remained as a significant predictor, and the final adjusted OR was 1.33 (95% CI: 0.56 -3.15) (Table 2). In an analysis restricted to patients < 45 yrs old (123 cases; 30 controls), history of broken bones was the only predictor of osteosarcoma risk at the p = 0.25 level, adjusted for age and gender. However, the final risk - adjusted model included only age and gender (OR = 1.23, 95% CI: 0.48 -3.16) (Table 2). Discussion The results of the present study are similar to results of several other case - control studies that included histories of fluoride exposure based on community water fluoride concentrations or from other fluoride sources, such as toothpaste and supplements (McGuire et al., 1991; Gelberg et al., 1995; Moss et al., 1995). The higher median fluoride concentration of controls compared with that of cases in this study is likely due to the fact that control patients tended to be older than the cases. In this study, fluoride content in bone in both cases and controls increased with age (moderate positive correlation, data not shown), which is similar to findings in studies that looked at the relationship between bone fluoride content and age (Parkins et al., 1974; Eble et al., 1992; Richards et al., 1994). Previous ecological and case - control studies that relied on historic residential information were limited in that they did not reflect the true exposure of fluoride at the individual level; thus, such studies are subject to the "ecological fallacy" (Aschengrau and Seage, 2003). They also did not take into account population mobility between fluoridated and non - fluoridated areas, or changes in population size and age (Freni and Gaylor, 1992), or potential confounders. In this study, cases were all recruited from academic referral centers for bone cancer and thus were not a random sample of osteosarcoma patients. Controls were also bone cancer patients recruited from these same centers, and thus likely reflect the same source population as the cases. Although there was a difference in participation rates in the bone donation component, with 76% of the cases and 48% of the controls participating, it is unlikely that any enthusiasm for participation was related to bone fluoride levels. Misclassification of exposure and /or outcome is always a concern in observational studies; however, given the laboratory measurement of fluoride exposure and the histologic confirmation of cases, misclassification bias is likely to be minimized in this study. The coefficient of variation for deer bone specimens, included in each batch of specimens as quality control, was Page 30 of 114 0.03, further decreasing the likelihood of substantial nonrandom misclassification bias. There are also some potential drawbacks to the use of bone fluoride measurements. For example, if risk is related to exposures at a specific time in life, rather than total accumulated dose, this metric would not be optimal. Also, it is possible that fluoride concentrations in bone may be influenced by the disease, or that concentrations in tumor tissue are not representative of predisease levels. For this reason, we chose normal tumor adjacent bone from the surgical specimens instead of the tumor tissue. It is possible that bone metabolism in the vicinity of the tumor could also be disrupted, however, we chose other bone tumors as controls. If such a circumstance prevailed, it would likely affect the controls in a manner similar to the cases. To address this concern, we compared fluoride levels in bone adjacent to the tumor with those in bone from a distant site (iliac crest) from the same patients. While the absolute levels were different, as anticipated from the different kinds of bone involved, there was a highly significant rank order correlation between the fluoride levels from these 2 locations, lending some confidence to the validity of the adjacent bone measures (data not shown). If fluoride levels were related to bone cancer in general, the current study design would be unable to detect this. There is no published evidence of such an association. Downloaded from jdr.sagepub.com at International Association for Dental Research on September 6, 2011 For personal use only. No other uses without permission. © 2011 International and American Associations for Dental Research 4 Kim et al. J Dent Res X(X) XXXX Table 1. Patient Characteristics of Osteosarcoma Cases (N = 137) and Tumor Controls (N = 51) Who Provided a Bone Specimena Cases ( %) Tumor Controls ( %) p Valuec (N = 137)b (N = 51)b (Chi - square) Site of enrollment MGH, Boston, MA 24 (17.5) 7 (13.7) 0.58d Creighton Univ. /St. Joseph's, Omaha, NE 3 (2.2) 4 (7.8) University of Nebraska, Omaha 12 (8.8) 1 (2.0) University of Chicago 37 (27.0) 20 (39.2) Rush Presbyterian, Chicago, IL 13 (9.5) 4 (7.8) University of Florida, Gainesville 21(15.3) 7 (13.7) University of California, Los Angeles 15 (11.0) 7 (13.7) Cleveland Clinic 10 (7.3) 1 (2.0) Children's Nat'l Med. Ctr., Washington, DC 2 (1.5) 0 (0) Gender Male 73 (53.3) 36 (70.6) 0.03 Female 64 (46.7) 15 (29.4) Page 31 of 114 Race /Ethnicity White, Non - Hispanic 112 (81.8) 41 (80.4) 0.83e Hispanic 12 (8.8) 1 (2.0) Black, Non - Hispanic 8 (5.8) 6 (11.8) Asian and Pacific Islander 3 (2.2) 0 (0) Other 2 (1.5) 3 (5.9) Patient's education Less than high school 74 (54.0) 18 (35.3) 0.07 HS /equivalent/post -HS training/ some college 43 (31.4) 22 (43.1) College or post -grad 20 (14.6) 11 (21.6) Missing 0 (0) 0 (0) Mother's education Less than high school 14 (10.2) 9 (17.7) 0.28f HS /equivalent/post -HS training/ some college 85 (62.0) 30 (58.8) College or post -grad 36 (26.3) 10 (19.6) Missing 2 (1.5) 2 (3.9) Father's education Less than high school 15 (11.0) 13 (25.5) 0.02 HS /equivalent/post -HS training/ some college 72 (52.6) 17 (33.3) College or post -grad 44 (32.1) 16 (31.4) Missing 6 (4.4) 5 (9.8) Combined household income < $40,000 $40,001 - $60,000 54 (37.2) 27 (19.7) 18 (35.3) 13 (25.5) 0.84 > $60,000 38 (27.7) 13 (25.5) Missing 18 (13.1) 7 (13.7) Urban Ever lived in urban area 119 (86.9) 47 (92.2) 0.32 Never lived in urban area 18 (13.1) 4 (7.8) Age (yrs) 0 - 14 37 (27.0) 9 (17.7) < 0.001 15 - 29 72 (52.6) 12 (23.5) 30 - 44 13 (9.5) 9 (17.7) 45 and older 15 (10.9) 21 (41.2) Median age (yrs) Overall 17.6 41.3 < 0.001g Males 17.0 42.0 < 0.00lg Females 17.0 39.0 0.02g aThere were 194 patients who provided tumor- adjacent bone specimens; however, fluoride concentrations from specimens (five cases and one Page 32 of 114 tumor control) were below < 100 mg F/kg bone ash and were not included in the analysis. In total, 188 patients were used in the analysis. bPercentages do not add up to 100 because of rounding. cChi - square testing differences between cases and tumor controls with bone specimens. dFor the comparisons, patients from MGH and Children's Nat'l Med. Ctr. were grouped together, since they are in the same region; patients from Creighton Univ. and the Univ. of Nebraska were grouped together, since they are in the same city; and patients from the Univ. of Chicago and Rush Presbyterian were grouped together, since they are in the same city. eComparing White, Non - Hispanics with all other racial /ethnic groups. fFisher's exact test. gWilcoxon rank sum. Downloaded from jdr.sagepub.com at International Association for Dental Research on September 6, 2011 For personal use only. No other uses without permission. © 2011 International and American Associations for Dental Research JDent Res X(X) XXXX Bone Fluoride and Osteosarcoma Risk 5 The major advantage of this study is the use of bone fluoride concentrations as the measure of fluoride exposure, rather than estimating fluoride exposure in drinking water (Bassin et al., 2006). Since 99% of the body burden of fluoride is located in calcified tissues, and fluoride concentration is dependent upon the amount and duration of exposure as well as the rate of bone turnover (Turner et al., 1993), if chronic fluoride intake was a risk factor for osteosarcoma, then it would be reasonable to expect that cases would have significantly higher bone fluoride concentrations than tumor controls. This study did not demonstrate an association between fluoride levels in bone and osteosarcoma. Acknowledgments The authors acknowledge the participation of the patients, hospitals, and surgeons in this study. This study was funded by the National Institute of Environmental Health Sciences, National Institutes of Health (NIH) grant 5R01ESO6000, National Institute of Dental and Craniofacial Research (NIH) grant T32DE07151, and National Cancer Institute (NIH). Data collection was conducted by Westat, Inc. This manuscript is based on a dissertation submitted to the faculty of the Harvard School of Public Health in partial fulfillment of the requirements for the degree of DrPH in the Department of Epidemiology (FMK). A portion was presented at the American Public Health Association 134th Annual Meeting and Exhibition, Boston, MA, 2006 (FMK). CWD has written reviews of the literature for several companies that sell, reimburse for, or do research on preventive dentistry products, most notably GlaxoSmithKline, Colgate - Palmolive, Dentsply, Quintile, Delta Dental Plans, and the United States Public Health Service (USPHS). CH has done Page 33 of 114 limited consulting with Procter & Gamble. All other authors have no conflict of interest to disclose. Figure. Box plots of interquartile range (IQR), range, and median fluoride concentrations (mg/kg bone ash). (A) Tumor- adjacent bone vs. iliac crest bone among cases that contributed both samples: IQR = 407.0 -746.5 vs. 538.0- 863.0; range = 121.0- 1859.5 vs. 318.5- 3732.5; median = 558.0 vs. 696.5 (p < 0.001, Wilcoxon signed -rank test). (B) Tumor - adjacent bone vs. iliac crest bone among all cases: IQR = 444.5 -853.0 vs. 527.0- 863.5; range = 121.0- 2939.0 vs. 318.5- 3732.5; median = 611.0 vs. 696.5 (p = 0.10, Wilcoxon rank -sum test). (C) Tumor- adjacent bone in matched cases vs. tumor controls: IQR = 474.8- 1419.5 vs. 501.0- 1176.5; range = 296.0- 1859.5 vs. 317.5- 2053.5; median = 803.8 vs. 714.3 (p = 0.63, Wilcoxon signed -rank test). (D) Tumor - adjacent bone among all cases vs. tumor controls: IQR = 451.5 -853.0 vs. 501.5- 1359.0; range = 121.0- 2939.0 vs. 317.5- 2885.0; median = 611.0 vs. 754.0 (p = 0.0008, Wilcoxon rank - sum test). Downloaded from jdr.sagepub.com at International Association for Dental Research on September 6, 2011 For personal use only. No other uses without permission. © 2011 International and American Associations for Dental Research 6 Kim et al. J Dent Res X(X) XXXX Refe rences Aschengrau A, Seage GR 3rd (2003). Essentials of epidemiology in public health. Sudbury, MA: Jones and Bartlett Publishers. Bassin EB, Wypij D, Davis RB, Mittleman MA (2006). Age - specific fluoride exposure in drinking water and osteosarcoma (United States). Cancer Causes Control 17:421 -428. Doll R, Kinlen L (1977). Fluoridation of water and cancer mortality in the U.S.A. Lancet 1:1300 -1302. Doll R, Kinlen L (1978). Cancer mortality and fluoridation. Lancet 1:150. Eble DM, Deaton TG, Wilson FC Jr, Bawden JW (1992). Fluoride concentrations in human and rat bone. JPublic Health Dent 52:288 -291. Freni SC, Gaylor DW (1992). International trends in the incidence of bone cancer are not related to drinking water fluoridation. Cancer 70: 611 -618. Gelberg KIT, Fitzgerald EF, Hwang SA, Dubrow R (1995). Fluoride exposure and childhood osteosarcoma: a case - control study. Am J Public Health 85:1678 -1683. Greenland S, Finkle WD (1995). A critical look at methods for handling missing covariates in epidemiologic regression analyses. Am J Epidemiol 142:1255-1264. Gurney JG, Swensen AR, Bulterys M (1999). Malignant bone tumors. In: Cancer incidence and survival among children and adolescents: United States SEER Program 1975 -1995, National Cancer Institute, SEER Program. Smith MAS, Ries LA, Gurney JG, Linet M, Tamra T, Young JL, et al., editors. Bethesda, MD: NIH Pub. No. 99 -4649, Page 34 of 114 pp. 99 -110. Homa DM, Sowers MR, Schwartz AG (1991). Incidence and survival rates of children and young adults with osteogenic sarcoma. Cancer 67:2219- 2223. Hoover RN, McKay FW, Fraumeni JF Jr (1976). Fluoridated drinking water and the occurrence of cancer. JNatl Cancer Inst 57:757 -768. Hrudey SE, Soskolne CL, Berkel J, Fincham S (1990). Drinking water fluoridation and osteosarcoma. Can J Public Health 81:415 -416. Mahoney MC, Nasca PC, Burnett WS, Melius JM (1991). Bone cancer incidence rates in New York State: time trends and fluoridated drinking water. Am JPublic Health 81:475 -479. Maurer JK, Cheng MC, Boysen BG, Anderson RL (1990). Two -year carcinogenicity study of sodium fluoride in rats. J Natl Cancer Inst 82: 1118 -1126. McGuire SM, Vanable ED, McGuire MH, Buckwalter JA, Douglass CW (1991). Is there a link between fluoridated water and osteosarcoma? JAm Dent Assoc 122:38 -45. Medina N, Douglass CW, Whitford GM, Hoover RN, Fears TR (2006). A reproducibility study for a fluoride assay in bone. Cancer Epidemiol Biomarkers Prev 15:1035 -1037. Miller RW, Boice JD Jr, Curtis RE (1996). Bone cancer. In: Cancer epidemiology and prevention. Schottenfeld D, Fraumeni JF Jr, editors. New York: Oxford University Press. pp. 946 -958. Moss ME, Kanarek MS, Anderson HA, Hanrahan LP, Remington PL (1995). Osteosarcoma, seasonality, and environmental factors in Wisconsin, 1979 -1989. Arch Environ Health 50:235 -241. Newbrun R (1977). The safety of water fluoridation. J Am Dent Assoc 94:301 -304. NTP (1990). National Toxicology Program Technical Report on the Toxicology and Carcinogenesis Studies of Sodium Fluoride (CAS No. 7681 -49 -4) in F344/N Rats and 136C3F1 Mice (Drinking Water Studies), Technical Report No. 393. Research Triangle Park, NC: NIH Publ. No. 91 -2848. National Institutes of Health, Public Health Service, U.S. Department of Health and Human Services. NTP (1992). National Toxicology Program Supplemental 2 -Year Study of Sodium Fluoride in Male F344 Rats (CAS No. 7681- 49 -4). Study No. C55221D. Research Triangle Park, NC: National Institutes of Environmental Health Sciences. Pagano M, Gauvreau K (2000). Principles of biostatistics. 2nd ed. Pacific Grove, CA: Duxbury Thomas Learning. Parkins FM, Tinanoff N, Moutinho M, Anstey MB, Waziri MH (1974). Relationships of human plasma fluoride and bone fluoride to age. CalcifTissue Res 16:335 -338. Patel SR, Benjamin RS (2005). Soft tissue and bone sarcomas and bone metastases. In: Harrison's principles of internal medicine. Kasper DL, Page 35 of 114 Braunwald E, Fauci AS, Hauser SL, Longo DL, Jameson JL, Isselbacher KJ, editors. New York: McGraw -Hill Co., Inc., pp. 610 -613. Richards A, Mosekilde L, Sogaard CH (1994). Normal age - related changes in fluoride content of vertebral trabecular bone — relation to bone quality. Bone 15:21 -26. Steiner GC (1965). Postradiation sarcoma of bone. Cancer 18:603 -612. Taves D (1968). Determination of submicromolar concentrations of fluoride in biological specimens. Talanta 15:1015 -1023. Tucker MA, D'Angio GJ, Boice JD Jr, Strong LC, Li FP, Stovall M, et al. (1987). Bone sarcomas linked to radiotherapy and chemotherapy in children. NEngl JMed 317:588 -593. Turner CH, Boivin G, Meunier PJ (1993). A mathematical model for fluoride uptake by the skeleton. Calcif Tissue Int 52:130 -138. Whitford GM (1996). Metabolism and toxicity of fluoride. 2nd ed. San Francisco, CA: S. Karger Publishers. Table 2. Odds Ratios and 95% CI for a 1 -unit Increase in Natural Log of Fluoride Concentration (ppm) in Bone and Risk of Osteosarcoma: (A) for All Osteosarcoma Cases and Tumor Controls and (B) among Patients under 45 Years of Age OR 95% CI p Value A. For all osteosarcoma cases and tumor controls Age- and sex - adjusted modela 1.32 (0.58, 3.03) 0.51 Fully adjusted modelb 1.23 (0.51, 2.97) 0.65 Risk - adjusted modelc 1.33 (0.56, 3.15) 0.58 B. Among patients younger than 45 yrs old Age- and sex - adjusted modela 1.23 (0.48, 3.16) 0.67 Fully adjusted modeld 1.27 (0.49, 3.35) 0.62 Risk- adjusted modele 1.23 (0.48, 3.16) 0.67 alncludes only age and gender. bincludes all variables that were significant at p < 0.25 in the age- and sex - adjusted analysis (history of broken bones, other cancers, other bone diagnosis, and received radiation prior to illness), plus age and gender. clncludes history of broken bones, plus age and gender. dlncludes history of broken bones (significant at p < 0.25 in the age- and sex - adjusted analysis), plus age and gender. elncludes age and gender and no other variables. Downloaded from jdr.sagepub.com at International Association for Dental Research on September 6, 2011 For personal use only. No other uses without permission. © 2011 International and American Associations for Dental Research Page 36 of 114 2) FAQ's on Fluoride, PEW Foundation Water Fluoridation Frequently Asked Questions The Pew Children's Dental Campaign supports water fluoridation because it's one of the most cost - effective strategies for states and communities to improve the oral health of their residents. Although a number of communities in the U.S. have been fluoridating their public water systems for more than 60 years, this strategy re- entered the spotlight in the wake of recent announcements from federal health officials about fluoride. This FAQ is meant to answer many key questions about the benefits of fluoridation and address the federal announcements. Q: What is fluoride and how does it benefit dental health? A: Fluoride is a mineral that exists naturally in nearly all water supplies. Research proves that at a certain level in drinking water, fluoride prevents tooth decay. This optimal level is reached when a public water system adjusts —either increasing or lowering —the level of fluoride. Q: I recently found the website of a group that opposes fluoridation. This group claims that the connection between fluoridation and cavity prevention isn't solid. Is that true? A: No, it is not true. There is solid, consistent evidence supporting fluoride's role in cavity prevention. Studies show that fluoridation reduces tooth decay by 18 to 40 percent. Two studies released in 2010 strengthened the already substantial evidence that fluoridated water prevents cavities. Q: Does fluoride in drinking water protect only the teeth of children or does it benefit everyone? A: People of all ages benefit from drinking water that is optimally fluoridated. Oral health is important throughout a person's life. In the 1950s, before water fluoridation was common, most people over the age of 65 had lost their teeth. Now, after decades of widespread fluoridation, more seniors are keeping most or all of their teeth. Between 1972 and 2001, the rate of edentulism— losing all of one's teeth — dropped 26 percent among lower - income seniors and fell 70 percent among upper- income seniors. Q: What do leading medical and health organizations say about drinking water that is optimally fluoridated? A: The American Academy of Pediatrics, the American Dental Association, the American Medical Association and many other respected medical or health organizations recognize the health benefits of fluoridation. The U.S. Centers for Disease Control and Prevention called water fluoridation "one of 10 great public health achievements of the 20th century." Page 37 of 114 Q: Federal health officials recently recommended that public water systems reduce the level of fluoride in drinking water. Exactly what was the recommendation and why was this new level set? A: In January 2011, the U.S. Department of Health and Human Services (HHS) recommended that the optimal level of fluoride in public water systems should be 0.7 milligrams per liter (mg/L) of water. This is a change from the previous recommendation that the optimal level would vary by a region's climate (average temperatures) within the range of 0.7 to 1.2 mg/L. This new recommendation by HHS recognizes these scientific findings: 1) Americans today are getting fluoride from more sources than they were when the original level was set, and 2) the water intake of children does not vary by climate or region. This new fluoride level demonstrates that federal health officials are periodically reviewing research and relying on the best science to update —if and when appropriate —their recommendations on fluoridated water. Q: Are many communities planning on completely removing fluoride from water because of the recent federal announcement on the fluoride level? A: Many communities are reviewing their fluoride levels and planning to adjust those levels to meet the new recommendation. There is no sign that many communities either want or plan to remove fluoride entirely. HHS and leading health experts do not support removing fluoride from water to a level below the recommended level because this would deprive people of cavity protection. In fact, the American Dental Association welcomed HHS' new fluoride level and said that water fluoridation remains "one of our most potent weapons in disease prevention." In Grand Rapids, Michigan —the first U.S. city that optimally fluoridated its water system the city's daily newspaper wrote an editorial noting that the new HHS recommendation "should not feed the flawed notion ... that fluoride must be removed entirely from drinking water. " Q. What impact will the new fluoride level have on Americans who are served by a public water system that's fluoridated? A: The new optimal fluoride level that federal health officials have recommended will have a positive impact. First, it will continue to protect teeth by helping to reduce tooth decay. Second, the new level will minimize the chances of fluorosis, a condition that typically causes a minor discoloration of teeth that is usually visible only to a dentist. The new HHS recommendation reflects the fact that Americans today receive fluoride from more sources (toothpaste, mouth rinses and other products) than they were getting several decades ago. Q: How many Americans receive water that is optimally fluoridated? A: Roughly 72 percent of Americans whose homes are connected to a community water system receive fluoride - adjusted water. Some communities have been doing so for over 60 years. Q: Water fluoridation helps to prevent tooth decay, but is that really a concern in the U.S. anymore? A: Yes, it remains a concern. Although dental health has improved for many Americans, tooth decay remains the most common chronic childhood disease —five times more prevalent than asthma. Tooth decay causes problems that often last long into adulthood, affecting kids' schooling and their ability to get jobs as adults. Page 38 of 114 Q: If I use fluoridated toothpaste, am I getting enough fluoride to protect against decay? A: No. The benefits from water fluoridation build on those from fluoride in toothpaste. Studies conducted in communities that fluoridated water in the years after fluoride toothpastes were widely used have shown a lower rate of tooth decay than communities without fluoridated water. The author of a 2010 study noted that research has confirmed "the most effective source of fluoride to be water fluoridation." Water fluoridation provides dental benefits to people of all ages and income groups without requiring them to spend extra money or change their daily routine. Q: Do any states have laws guaranteeing residents' access to fluoridated water? A: Twelve states and the District of Columbia have laws designed to ensure access to fluoridated water. Forty-three of the 50 Largest cities in the U.S. fluoridate their drinking water. Research shows that every $1 invested in water fluoridation saves $38 in unnecessary dental costs. Page 39 of 114 3) What Respected Organizations and Experts Say About Water Fluoridation Academy of General Dentistry: "Fluoride makes the entire tooth structure more resistant to decay and promotes remineralization, which aids in repairing early decay before damage is even visible. Studies have confirmed the most effective source of fluoride to be water fluoridation. "1 "Instead of drilling holes to fix cavities, dentists would rather educate the public on how to avoid developing tooth decay in the first place. Drinking tap water to receive fluoride is safe, and it's easier on your wallet than going to the dentist for a filling. "2 American Academy of Pediatrics: "Fluoride plays a very important role in the prevention of dental caries. Although the primary mechanism of action of fluoride in preventing dental caries is topical, systemic mechanisms are also important. "3 "Water fluoridation is a cost - effective means of preventing dental caries, with the lifetime cost per person equaling less than the cost of 1 dental restoration. In short, fluoridated water is the cheapest and most effective way to deliver anticaries benefits to communities. "4 American Academy of Pediatrics (New York State Chapter): "Community water fluoridation is safe, effective and necessary to prevent chronic dental disease in pediatric populations." "Dental decay is a common but preventable, chronic disease. It is our youngest children who are at the greatest risk for developing early dental disease while not having access to a dental care home.... Without community water fluoridation the incidence of this disease and its attendant complications will increase. "5 American Academy of Family Physicians: "Fluoridation of public water supplies is a safe, economical, and effective measure to prevent dental caries. "6 2 Page 40 of 114 American Academy of Physician Assistants: "Primary prevention keeps disease from occurring at all by removing its causes. Examples of primary prevention include ... giving immunizations for many communicable diseases, and counseling patients to adopt healthy lifestyles ... Examples include chlorination and fluoridation of the water supply ... "7 "Fluoride substantially decreases caries rates.... All children should receive fluoride through systemic water fluoridation or dietary supplements. "8 American Association for the Advancement of Science: "... fluoridation of community water supplies is repeatedly demonstrating that it is an effective public health measure for the mass partial control of dental cavities, and ... [AAAS is] on record as endorsing fluoridation of community water supplies as a method for advancing dental public health, as this 121st meeting of the AAAS. "9 American Association of Oral and Maxillofacial Surgeons: "Community water fluoridation, which adjusts the fluoride in water to a level sufficient for preventing and controlling tooth decay, reduces tooth decay by 30 -50 %. "Although great progress has been made, nearly 28% of public water systems do not have the capacity to deliver —and approximately 100 million Americans do not have access to— optimally fluoridated water. Many communities need support to upgrade or purchase new water systems and fluoridation equipment. "10 American Association of Public Health Dentistry: "... it has been shown that children with the greatest dental need and who are at highest risk for tooth decay benefit the most from water fluoridation." The resolution also stated: "The Association recommends that federal, state, and local agencies and organizations promote water fluoridation as the foundation for better oral health. "11 American Council on Science and Health: "Fluoride is harmless at the levels necessary for maximum (dental) benefits. Thousands of studies on fluorides and fluoridation have been completed in the last 50 years — more than 3,700 since 1970 alone. Over 50 peer- reviewed epidemiological studies have dealt with the claim that fluoridation increases cancer risk. None has substantiated the claim. "12 American Dental Association: "Studies conducted throughout the past 65 years have consistently shown that fluoridation of community water supplies is safe and effective in preventing dental decay in both children and adults. Simply by drinking water, children and adults can benefit from fluoridation's cavity protection whether they are at home, work or school. "13 3 Page 41 of 114 American Dental Education Association: "ADEA supports and encourages fluoridation of community water supplies and the use of topical fluoride. Community water fluoridation is safe, practical, and the most cost - effective measure for the prevention of dental caries. "14 American Dental Hygienists' Association: "Good scientific evidence supports the use of community water fluoridation and the use of fluoride dental products for preventing tooth decay for both children and adults. "Adjusting the level of fluoride in drinking water first used fluoride as a preventative for tooth decay in Grand Rapids, Michigan. Fluoridation of drinking water has been used successfully in the United States for more than 50 years. "15 American Dietetic Association: "The American Dietetic Association reaffirms that fluoride is an important element for all mineralized tissues in the body. Appropriate fluoride exposure and usage is beneficial to bone and tooth integrity and, as such, has an important, positive impact on health throughout life. "16 American Federation of Teachers: "The good news is that tooth decay and other oral diseases are preventable. The combination of dental sealants and fluoride has the potential to nearly eliminate tooth decay in school -age children. "17 American Medical Association: "The AMA urges state health departments to consider the value of required statewide fluoridation (preferably a comprehensive program of fluoridation of all public water supplies, where these are fluoride deficient), and to initiate such action as deemed appropriate. "18 AMA has also encouraged physicians to "become involved" in the fluoridation issue by determining "whether municipal water supplies are optimally fluoridated and ... working with public health agencies to take corrective action if suboptimal fluoridation is found. "19 American Osteopathic Association: "The American Osteopathic Association supports the fluoridation of fluoride - deficient public water supply. "20 American Public Health Association: "[The U.S. Department of Health and Human Services] announced proposed recommendations to simplify the recommended optimal level for community water systems to 0.7 mg /L fluoride ... APHA continues to support community water fluoridation as a sound public health preventive measure. APHA is supportive of the process of updating recommendations for optimal fluoride concentrations in water based on today's conditions."21 4 Page 42 of 114 American Society for Clinical Nutrition: "... the American Society for Clinical Nutrition agrees that fluoridation of community water supplies to an optimum level wherever the natural level is less than optimum is a safe, economical, and effective measure to improve dental health by improving nutrition. "22 American Water Works Association: '... community water fluoridation at optimal levels is beneficial for preventing tooth decay. "The goal of community water fluoridation is to achieve the desired oral health benefit while minimizing potential health risks. That is why water providers undergo thorough and extensive training to safely apply fluoride in the amount recommended by the world's most respected public health authorities. "23 Association of California Water Agencies: "ACWA is a diverse state wide organization representing nearly 450 public water agencies that collectively supply 90% of the water delivered in California for domestic, agricultural and industrial uses. California enjoys some of the highest water quality in the world. "... ACWA reaffirms its support for water fluoridation and strongly believes that its benefits need to be continued to communities served by centralized water systems. "24 Association of State & Territorial Dental Directors: "Community water fluoridation remains the cornerstone of dental caries prevention in the United States and has been demonstrated to be safe, cost - effective and beneficial through every stage of life and for all people, regardless of age, race, ethnicity or socio- economic status. "25 Audrey F. Manley, M.D., M.P.H., Surgeon General under President Bill Clinton: "Water fluoridation continues to be the cornerstone of community oral disease prevention. The benefits of fluoridation are available, on average, for little more than $0.50 per person per year, and even less, in large communities. "26 Australian Dental Association: "Drinking fluoridated water several times a day is the ideal way to give your teeth a quick fluoride treatment. "... Fluoride from fluoridated water is found in saliva and provides a wonderful, low concentration fluoride treatment for your teeth. "27 5 Page 43 of 114 The Bower Foundation: "The most inexpensive way to deliver the benefits of fluoride to all residents of a community is through water fluoridation. For most cities, every dollar invested in public water fluoridation saves $38 in dental treatment costs. "28 British Dental Association: "The BDA is pleased with [a program to expand fluoridation in southwest England] because it is likely to encourage consultation on similar schemes in other parts of the country where fluoride could help address the poor dental health of the population. "A recent European summary of the latest scientific evidence reiterated the view that water fluoridation is a safe and effective method of reducing oral health inequalities. "29 British Dental Health Foundation: "Fluoride was added to the Birmingham supply in 1964 and the difference in dental health compared to the neighbouring population in non- fluoridated Sandwell was stark. When Sandwell's water was fluoridated in 1987 it transformed levels of oral health, putting a poor borough amongst the top ten areas for dental health in the country. "30 British Medical Association: "The BMA remains committed to the fluoridation of mains water supplies, after appropriate public consultation, on the grounds of effectiveness, safety and equity. "31 Canadian Dental Association: "Fluoride is added to public drinking water to protect all members of the community from tooth decay. Community water fluoridation is a safe and effective way of preventing tooth decay at a low cost "32 Canadian Public Health Association "In 1945, Brantford, Ontario became the first Canadian community to test water fluoridation, thereby achieving a 54% reduction in decay experienced by 8- year - olds." "In Quebec, for instance, less than 7% of the population has access to fluoridated water. A study of the oral health of children between 1990 and 1999 found that kindergarten children in Quebec had 40% more cavities than children in Ontario and the United States, and that tooth decay affects 56% of Quebec children in Grade 2. "33 Centers for Disease Control and Prevention: The CDC named the "fluoridation of drinking water" as one of "10 great public health achievements" of the 20th century.34 6 Page 44 of 114 C. Everett Koop, M.D., Surgeon General under President Ronald Reagan: `... I encourage the dental profession in communities which do not enjoy the benefits of an optimally fluoridated drinking water supply to exercise effective leadership in bringing the concentration to within an optimum level. "35 Children's Dental Health Project: "Water fluoridation is particularly beneficial during childhood and in adolescence when cavity experience first begins. Not only do children who drink fluoridated water have fewer cavities but their cavities are smaller and less deep when they do occur. "36 Children's Hospital of Denver, Colorado: In 2008, this hospital was ranked in the top 10 children's hospitals in the U.S.37 "From a public health perspective, to improve the oral health of the people of Colorado the first important step is to fluoridate those public water systems that are as yet non - fluoridated." Council of State Governments: "... states need to reduce expenditures in Medicaid budgets and studies have proven that communities benefiting from fluoridated water use fewer Medicaid dollars to treat dental decay. "... simply by drinking water, everyone, especially those without access to regular dental care, can benefit from fluoridation's cavity protection whether they are at home, work or school. "38 David Satcher, M.D., Ph.D., Surgeon General under President Bill Clinton: "Other evidence of the benefits of fluoridation comes from studies of populations where fluoridation has ceased. Examples in the United States, Germany, and Scotland have shown that when fluoridation is withdrawn and there are few other fluoride exposures, the prevalence of caries increases. In Wick, Scotland, which began water fluoridation in 1969 but stopped it in 1979, the caries prevalence in 5- to 6- year -olds with limited exposure to other sources of fluoride increased by 27 percent between 1979 and 1984. This was despite a national decline in caries ... "39 Early Head Start National Resource Center: "Fluoride is the most effective agent to prevent tooth decay. It can be added to community water supplies, as needed, and occurs naturally in some areas." "... Early Head Start staff and parents should be aware that purchased bottled water usually does not contain enough fluoride to prevent tooth decay. "40 Ernie Mueller, Alaska's former Commissioner of Environmental Conservation: "I followed [the fluoridation issue] through my 35 -year career in water and wastewater research, supervision and management. ... What is disturbing is that the inflammatory and 7 Page 45 of 114 misleading rhetoric used by some of the opponents of fluoridation frightens many people who may not have personal knowledge of the issue. "41 Florida Public Health Institute: "Fluoride reduces the ability of bacteria to produce acid and promotes the remineralization of enamel, thereby preventing a cavity from continuing to form. Community water fluoridation is a proven cost - effective intervention that optimizes fluoride content in public water systems to promote oral health. Florida's Department of Health supports Community Water Fluoridation. "42 GreenFacts.org (international organization with a board of scientific advisers): "The numerous studies carried out in many countries on populations consuming fluoridated drinking water did not show any consistent evidence of an association between the consumption of controlled fluoridated drinking water and increased frequency of cancer. "43 Idaho Medical Association: "The IMA has historically taken a leadership role in public health and safety issues. Its proactive support for polio immunization, public water fluoridation, civil defense planning, cigarette warning labels, use of seat belts, child abuse reporting, motorcycle helmet use, day care licensing, cigarette taxes, minimum drinking age, and immunization of schoolchildren has positively impacted the quality of life and health of all Idahoans. "44 Indiana State Department of Health: "Despite the fact that thousands of studies, analyses, and experiments have shown fluoridation to be safe and effective, some insist that it cease until all doubts about its safety have been resolved. Of course, it is impossible to prove the absolute safety of anything. But in the case of fluoridation, opponents are constantly making new allegations, none of which are supported by science. "45 Indian Health Service (U.S. Dept. of Health and Human Services): "An effective community water fluoridation program should be the cornerstone of all public oral health programs. "46 "Recent studies have found a smaller difference in the caries prevalence between optimally fluoridated and fluoride - deficient communities. In American Indian /Alaska Native populations the expected reductions in disease may be even greater, given the high caries rates. "47 International Agency for Research on Cancer: "Fluoridation of drinking -water was introduced in the USA in 1950, and thus the studies in the USA encompass periods of observation of 20 years or more. ... The studies have shown no consistent tendency for people living in areas with high concentrations of fluoride in the water to have higher cancer rates than those living in areas with low concentrations or for cancer mortality rates to increase following fluoridation." 8 Page 46 of 114 "Since a large number of comparisons were made, some would be expected by chance alone to show differences. However, no consistent difference has been seen, and there have been as many significant negative associations between fluoridated water supplies and cancer incidence or mortality as there have been positive associations." "... Epidemiological studies have shown no association between the presence of fluorides in drinking -water and the incidence of Down's syndrome. "48 International Association of Dental Research: "The International Association for Dental Research (IADR), considering that dental caries (tooth decay) ranks among the most prevalent chronic diseases worldwide ... and taking into account that over 50 years of research have clearly demonstrated its efficacy and safety; and noting that numerous national and international health- related organizations endorse fluoridation of water supplies; fully endorses and strongly recommends the practice of water fluoridation for improving the oral health of nations. "49 Irish Forum on Fluoridation: Note: The Forum on Fluoridation was appointed by Ireland's government to study the impact of water fluoridation on the Irish people. The Forum published its report in September 2002. The very first conclusion of this report is below: "Water fluoridation has been very effective in improving the oral health of the Irish population, especially of children, but also of adults and the elderly. "50 Joseph Thompson, M.D., Surgeon General of the State of Arkansas: "Water fluoridation was trumpeted by the CDC as one of the most important health measures of the 20th century. Now that we are in the 21st century, every community and water system not currently providing this benefit to their residents and customers needs to step up and help their community and its residents. "51 Linus Pauling, winner of the Nobel Prize (1954) and National Medal of Science (1974): Note: Opponents of water fluoridation often label fluoride as "toxic" or "poison." Linus Pauling debunked this assertion in a 1967 article by writing: "In this respect, fluoride ion is similar to many other substances, such as vitamin D, that are harmful in large amounts but are required in small amounts for life and good health of human beings. "52 9 Page 47 of 114 Roughly 20 years before he died, Pauling cofounded the Linus Pauling Institute. The Institute has issued this statement on fluoride: "Although its role in the prevention of dental caries (tooth decay) is well established, fluoride is not generally considered an essential mineral element because humans do not require it for growth or to sustain life. However, if one considers the prevention of chronic disease (dental caries) an important criterion in determining essentiality, then fluoride might well be considered an essential trace element. "53 Massachusetts Dental Society: "...we also have come to realize that the issue of fluoride, to some, is less about science and more about emotion. The groups and individuals questioning the safety of fluoride tend to forget that many dentists are parents, too. Why would we advocate for water fluoridation if we believed that it would be compromising our own children's health in any way ? "54 Michigan Department of Community Health: "Community water fluoridation has proven to be safe through both practical experience and research. During the past 40 years, over 4,000 studies have measured and confirmed the safety of fluoride. Community water fluoridation has been studied more thoroughly than any other public health measure. "55 Michigan State Medical Society: "The Michigan State Medical Society, in cooperation with the Michigan Association of Public Health and Preventive Medicine Physicians, is urging citizens and public water facilities throughout the state not to misinterpret the new [federal] recommendations regarding the fluoridation of municipal water." '... the FDA believes that reducing the level of fluoride in municipal water will help reduce the occurrence of dental fluorosis, a harmless discoloration (mottling) that can occur with higher levels of exposure to fluoride. Fluoridation of water can decrease cavities by up to 40% if available to children during the first 7 years of their lives. The value of fluoridation has been thoroughly established as safe and effective. "56 Mississippi State Department of Health: "Water fluoridation is an effective, safe and inexpensive way to prevent tooth decay.... In Mississippi, the cost of water fluoridation is usually between one and two dollars per person per year and saves $16 -$19 per person per year in dental treatment costs. "57 National Consumers League; "Bottled water consumption has doubled over the past decade and as a result, the exposure to fluoride from tap water, which can not only prevent tooth decay, it can repair tooth decay, has been reduced as well." 10 Page 48 of 114 "Oral health is a critical component of overall health, and we need to spread the word about the importance of brushing with fluoridated toothpaste twice a day, drinking tap water wherever possible, and seeing the dentist twice a year. The benefits will pay off exponentially. "58 National Council Against Health Fraud: "Antifluoridationists who point out that fluoride can produce adverse effects deliberately fail to mention that the concentrations that produce adverse effects [are] higher than the concentration produced by properly maintained fluoridation systems." '... NCAHF believes that the factions that keep alive the antifluoridation movement are a major detriment to the health and well -being of the public. "59 National Dental Association: "As a result of water fluoridation half of all children ages 5 to 17 have never had a cavity in their permanent teeth. Despite the overwhelming evidence of the value of water fluoridation 34% of the population still does not have access to fluoridated water. Water fluoridation would save over $1.5 billion per year. "60 National Fluoride Information Centre (United Kingdom): Note: Many anti fluoridation activists tell the public that "Europe doesn't fluoridate." Although it is true that water fluoridation is not common in Europe, this argument is very misleading because there are other ways, such fluoridating salt and milk, that many European countries provide fluoride to their citizens: "Salt fluoridation was introduced in Switzerland in 1955 and it is now estimated that fluoridated salt is available to nearly 200 million people worldwide, including Europe, Central and South America and the Caribbean. It is the preferred method of fluoridation on mainland Europe and is widely available in France, Germany, Switzerland, Austria, Belgium, Spain, Czech Republic and Slovakia. "61 In addition, millions of Irish and English drink fluoridated water: "Five and a half million people in England drink artificially fluoridated water. In these areas the children have among the lowest levels of tooth decay in the country. Recent independent research at the University of York has confirmed the benefits of fluoridation. Fluoridation works best in large towns with a simple water supply and where the children have high amounts of dental decay. People living in Birmingham and Newcastle have been drinking fluoridated water for more than 30 years. "62 National Institute of Dental and Craniofacial Research: "Although dental caries remains a public health worry, it is no longer the unbridled problem it once was, thanks to fluoride. "63 11 Page 49 of 114 National PTA (Parent - Teacher Association): "PTA involvement laid the groundwork for cooperative partnerships with medical associations and health organizations in the decades to come.... [PTA also worked] to educate members about other immunizations and treating water with fluoride to prevent rampant dental problems. "64 Nevada State Medical Association: "... the NSMA and its component medical societies support legislative efforts to promote community water fluoridation at optimal levels to decrease the incidence of dental caries. "65 Oklahoma State Department of Health: "It is recommended that all public water systems in Oklahoma be fluoridated to provide this cost - effective oral disease prevention measure to residents throughout Oklahoma. "66 Oral Health America: "Oral Health America enthusiastically supports community water fluoridation. Fluoridated water supplies give Americans, especially those most vulnerable, equal access to one of the most celebrated public health measures of our time. Fluoridation brings healthy mouths to life. "67 Oregon Medical Association: "OMA recognizes the health benefits of fluoridation and has long stood in support of fluoridating public water supplies." "OMA reaffirms its support for fluoridation of all public water supply systems ... "68 Pew Center on the States: "Fluoride counteracts tooth decay and strengthens the teeth by fighting harmful acids and drawing calcium back into the teeth. Community water fluoridation can reduce tooth decay in children by up to 60 percent, and it costs as little as $1 per person, per year. "Research shows that community water fluoridation offers perhaps the greatest return -on- investment of any dental care strategy. The reduction in just the costs of filling and extracting diseased teeth (not counting reductions in lost work time and dental pain) more than makes up for the cost of fluoridation." Public Health Law Research (Temple University): "Fluoride is a mineral that has been proven effective at preventing tooth decay." 12 Page 50 of 114 "... In the judgment of a Community Guide expert panel, there is significant evidence to support water fluoridation as an effective public health intervention aimed at reducing tooth decay. "69 Richard H. Carmona, M.D., Surgeon General under President George W. Bush: "Water fluoridation is a powerful strategy in our efforts to eliminate differences in health among people and is consistent with my emphasis on the importance of prevention. "... Fluoridation is the single most effective public health measure to prevent tooth decay and improve oral health over a lifetime, for both children and adults. "70 Robert Wood Johnson University Hospital: "Fluoride, either applied topically to erupted teeth, or ingested orally (called systemic fluoride) during tooth development, helps to prevent tooth decay, strengthen tooth enamel, and reduce the harmful effects of plaque. "71 Tennessee Department of Health: "Fluoride is naturally occurring and present in all bodies of water (rivers, lakes, springs, and wells) to some degree. Water fluoridation is the adjustment of the natural level of fluoride to a level that is optimal for oral health. "... More than 60 years of research supports the fact that community water fluoridation is both safe and effective. "72 Texas Department of State Health Services: "The wide implementation of community water fluoridation in Texas has resulted in substantial savings in publicly financed dental care under the Texas Healthy Steps (EPSDT- Medicaid) program. Further savings may be made by implementing community water fluoridation in areas where it is lacking and feasible. "73 United Methodist Health Ministry Fund: "Since 1998, the Health Fund has offered grants to fund the start-up costs of community water fluoridation due to fluoridation's time - proven oral health benefits, safety, and practicality. Persons living in communities with fluoridated water enjoy 20 to 40% Tess tooth decay than those in areas without adequate fluoride. "74 U.S Task Force on Community Preventive Services: "The Task Force on Community Preventive Services recommends community water fluoridation based on strong evidence of effectiveness in reducing tooth decay. "75 13 Page 51 of 114 Utah Health Department: "The nationwide goal to prevent cavities through community water fluoridation is similar to previous public health efforts to prevent other common health problems. These include adding iodide to salt to prevent thyroid problems, adding iron to infant formula to prevent anemia, adding Vitamin D to milk to prevent rickets, adding niacin to flour and other foods to prevent pellagra, and adding folic acid to cereal grains products to prevent birth defects. "Each of these public health efforts represents situations where a nutritional additive is provided to everyone or to large target populations since it is impossible to individually identify and effectively treat the significant number of people who are at risk. "76 Vermont Medical Society: "... frequent exposure to small amounts of fluoride enhances developing enamel and encourages remineralization, replacing minerals that bacteria dissolve from the enamel surface of teeth." "... the Vermont Medical Society endorses fluoridation as an important community commitment to the oral health of its children and adults and it affirms the value of continuing fluoridation in community water systems. "77 Washington State Public Health Association: "... the benefits of fluoridation of water in the prevention of dental disease have been scientifically substantiated." "... the Washington State Public Health Association actively endorses and strongly supports fluoridation of the public water systems in the State of Washington. "78 WebMD.com: "Fluoride helps prevent tooth decay by making the tooth more resistant to acid attacks from plaque bacteria and sugars in the mouth. It also reverses early decay. In children under six years of age, fluoride becomes incorporated into the development of permanent teeth, making it difficult for acids to demineralize the teeth. Fluoride also helps speed remineralization as well as disrupts acid production in already erupted teeth of both children and adults. "79 Wisconsin Oral Health Coalition: "... community water fluoridation is a significant cost containment measure available for dental caries prevention in communities throughout Wisconsin, costing an average of approximately 50 cents per person per year while reducing the need for expensive treatment ... "80 World Health Organization: "Fluoride is being widely used on a global scale, with much benefit. Millions of people worldwide use fluoridated toothpaste. They benefit from fluoridated water, salt fluoridation or other forms of fluoride applications ... "81 14 Page 52 of 114 1 C.H. Chu, BDS, PhD, MAGD, ABGD, lead author of a 2010 study is quoted in: "Advocacy: Drinking Tap Water May Help You Avoid Dentist's Drill," Academy of General Dentistry, March 2010, accessed on February 11, 2011 at 1 http: / /www.agd.org /public /oralhealth /Default. asp ?IssID = 303 &Topic = F&ArtID= 7363 #bo dy. 2 Cynthia Sherwood, DDS, FAGD, a spokesperson for the Academy of General Dentistry is quoted at: "Advocacy: Drinking Tap Water May Help You Avoid Dentist's Drill," Academy of General Dentistry, March 2010, accessed on February 11, 2011 at http: / /www.agd.org /public /oralhealth/ Default. asp ?IssID = 303 &Topic = F&ArtID= 7363 #bo dy. 3 "Protecting All Children's Teeth (PACT)," a training module by the American Academy of Pediatrics, accessed on Jan. 20, 2011 at http: / /www.aap.org /oralhealth /pact /ch6_intro.cfm. 4 "Preventive Oral Health Intervention for Pediatricians," Pediatrics, Vol. 122, No. 6, December 2008, pp. 1387 -1394, accessed on Jan. 20, 2011 at http: / /aappolicy .aappublications.org /cgi/ content /full /pediatrics; 122 /6/1387. 5 Letter to New York City Councilman Peter Vallone from the New York State Chapter of the American Academy of Pediatrics, February 9, 2011. 6 "Fluoridation of Public Water Supplies," a policy statement of the American Academy of Family Physicians, accessed on January 24, 2011 at: http: / /www.aafp.org/ online /en/ home / clinical /clinicalrecs /guidelines /fluoridation.html. 7 "A Practical Approach to Prevention," American Academy of Physician Assistants, 2009, accessed on February 2, 2011 at http : / /web1.aapa.org /aapaconf2009/ syllabus /9144BergeisenPrevention .doc.pdf. 8 Wanda C. Gonsalves, M.D., "Incorporating Oral Health into Primary Care: The Role of the Physician Assistant," May 30, 2010, posted on the website of the American Academy of Physician Assistants, accessed on February 2, 2011 at http: / /web1. aapa. org/ 10ACSyllabi /1193OralHealthGonsalves.pdf. 9 "Fluoridation of Community Water Supplies," a resolution approved on December 30, 1954 by the AAAS Council, accessed on February 18, 2011 at http: / /archives.aaas. org /docs /resolutions.php ?doc_id =245. 10 Letter to Kathleen Sebelius, Secretary of the U.S. Department of Health and Human Services, June 3, 2010. (Note: The letter was signed by the American Association of Oral and Maxillofacial Surgeons and 13 other medical and health organizations.) The letter was accessed on February 18, 2011 at http: / /www.aaoms.org /docs / govt_ affairs /issue_letters /ppaca.pdf. 11 This resolution was adopted in March 2010 by the American Association of Public Health Dentistry, accessed on January 31, 2011 at http: / /www.aaphd.org /default. asp ?page= Resolution %20on %20Community %20Water %2 OFluoridation %20(CWF).html. 12 Dr. Michael W. Easley, "Fluoridation: A Triumph of Science Over Propaganda," American Council on Science and Health, October 1, 1996, accessed on January 21, 2011 at http: / /www.acsh.org /healthissues /newsid .724 /healthissue_detail.asp. 13 "Flouride & Fluoridation," American Dental Association, accessed on Jan. 12, 2011 at http: / /www.ada.org /fluoride.aspx. Page 53 of 114 14 "ADEA Policy Statements," approved by the 2010 ADEA House of Delegates, accessed on February 18, 2011 at http: / /www.adea.org/ about_ adea / governance /Pages /PolicyStatements.aspx. 15 "Fluoride Facts," American Dental Hygienists' Association, accessed on January 21, 2011 at http: / /www.adha.org /oralhealth /fluoride_facts.htm. 16 "Position of the American Dietetic Association: The Impact of Fluoride on Health," Journal of the American Dietetic Association (2005), Vol. 105. 17 "Linking Children's Health to Education," American Federation of Teachers, accessed on January 31, 2011 at http: / /www.aft.org /issues /childhealth /. 18 Submitted and approved as Resolution 9 by the AMA House of Delegates in 1986. The language was reaffirmed by AMA's House of Delegates in 1996 and 2006. Accessed on January 21, 2011 at http://www.ama- assn.org /ama /pub /physician- resources /clinical- practice- improvement /clinical - quality/ accreditation - collaboration /ada - council.shtml. 19 This statement on fluoridation was approved by the American Medical Association in 1991 and reaffirmed in 2001. Accessed on January 21, 2011 from the AMA website at http://www.ama- assn.org /ama /pub /physician- resources /clinical - practice- improvement /clinical - quality/ accreditation - collaboration /ada - council.shtml. 20 "Fluoridation," Resolution H268 -A, was approved in both 2004 and 2009 by the American Osteopathic Association's House of Delegates, accessed on February 18, 2011 at http://www.osteopathic.org / inside -aoa/ about / leadership /Documents /2010 - policy- compendium.pdf. 21 "APHA Reaffirms Its Support for Community Water Fluoridation," a press release by the American Public Health Association, January 11, 2011, accessed on January 18, 2011 at http: / /www.apha.org/ about / news /pressreleases /2011 /water +fluoridation +response.htm 22 "Resolution on fluoridation of drinking water," adopted by the American Society for Clinical Nutrition on May 2, 1985, published by the American Journal of Clinical Nutrition, accessed on March 11, 2011 at Sources: 15 Page 54 of 114 http: / /www.ajcn.org /content /43 /3 /480.full.pdf. (Note: In 2005, the American Society for Nutrition was created by the merger of the American Society for Clinical Nutrition, the American Society for Nutritional Science and the Society for International Nutrition.) 23 "AWWA backs best science on fluoridation," a statement by the American Water Works Association, January 7, 2011, accessed on February 10, 2011 at http: / /www.awwa.org/ publications / breakingnewsdetail .cfm ?itemnumber = 55972. 24 Letter from ACWA to the U.S. Centers for Disease Control and Prevention, February 11, 2011. 25 "ASTDD Statement in response to the recent Department of Health and Human Services and Environmental Protection Agency fluoridation announcements," Association of State & Territorial Dental Directors, accessed on January 13, 2011 at: http: / /www.astdd.org /. 26 "Surgeon General's Statement on Community Water Fluoridation, 1995," from the website of the U.S. Centers for Disease Control and Prevention, accessed on January 27, 2011 at: http: / /www.cdc.gov/ fluoridation /fact_sheets /sg95.htm. 27 "Fluoride FAQ's," Australian Dental Association, Inc., accessed on February 18, 2011 at http: / /www.ada.org.au/ oralhealth /fln /flfags.aspx #FLdismedcon. 28 "Mississippi Public Water Fluoridation Program Phases I - IV," The Bower Foundation, accessed on March 3, 2011 at http: / /www.bowerfoundation.org /htdocs/ case_ studies / investing /water_fluoridation.html 29 The comments of BDA's Scientific Adviser, professor Damien Walmsley are from: "BDA commends go -ahead for fluoridation," a press release by the British Dental Association, February 11, 2011, accessed on February 18, 2011 at http://www.bda.org/news- centre /press- releases / 30700 -bda- commends -go- ahead - for - fluoridation.aspx. 30 This quote by Dr. Nigel Carter, chief executive for the British Dental Health Foundation is from: "Foundation Urges More Water Fluoridation After High Court Ruling, UK," Medical News Today, February 15, 2011, accessed on March 2, 2011 at http: / /www.medicalnewstoday.com /articles /216530.php. 31 "Fluoridation of water," British Medical Association, January 12, 2010, accessed on February 18, 2011 at http: / /www.bma.org.uk/ health _promotion_ethics /environmental health /Fluoriwater.jsp. 32 "Your Oral Health," Canadian Dental Association, accessed on February 18, 2011 at http: / /www.cda- adc.ca /en /oral_health /fags_ resources /faqs /fluoride_fags.asp. 33 "Fighting the Good Fight: Fluoridation of Drinking Water," 12 Great Achievements, Canadian Public Health Association, (2010), accessed on March 12, 2011 at http://cpha100.ca/12- great- achievements / fighting -good- fight- fluoridation - drinking water. 34 "Ten Great Public Health Achievements - United States, 1900 - 1999," Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, April 2, 1999, Vol. 48, No. 12, 241 -243, accessed on January 25, 2011 at http: / /www.cdc.gov /mmwr /preview /mmwrhtml /00056796.htm. 35 Letter from C. Everett Koop, M.D., to John W. Hernandez, Jr., deputy administrator of the Environmental Protection Agency, July 30, 1982. 36 "Public Health Officials Reconfirm Value of Water Fluoridation While Adjusting Recommended Levels," press release by the Children's Dental Health Project, January 10, 2011, accessed on March 12, 2011 at Page 55 of 114 .- .a http: / /www.cdhp.org /press release /public_ health_ officials _reconfirm_value_water_fluorid ation_while_adj usting_recommended. 37 "US News Again Ranks The Children's Hospital in Top 10," The Children's Hospital of Denver, Colorado, accessed on March 11 at http: / /www.thechildrenshospital.org/ news /pr /2008news /USNews- 2008.aspx. 38 "The Council of State Governments Resolution on Community Water Fluoridation," adopted on May 10, 2006; accessed on February 17, 2011 at http: / /www.csg.org /knowledgecenter / docs /CommunityWaterFluoridation.pdf. 39 Oral Health in America: A Report of the Surgeon General, U.S. Department of Health and Human Services & U.S. Public Health Service, 2000, accessed on January 26, 2011 at http: // silk. nih. gov / public/ hck1ocv . @www.surgeon.fullrpt.pdf. 40 "Early Head Start Tip Sheet No. 18," Early Head Start National Resource Center (May 2004), accessed on March 12, 2011 at http: / /www.ehsnrc.org/ Publications / English% 20Tip %20Sheets /TIP_SHEET_18.PDF. 41 Ernie Mueller, "Some fluoride opponents are making misleading statements," Juneau Empire, April 6, 2004. 42 "Florida Oral Health Policy 101- Prevention," Florida Public Health Institute, accessed on March 9, 2011 at http: // floridaoralhealth. com /FloridaOralHealthPolicy101 /Prevention.aspx. 43 "5.1: Has Fluoride Exposure Caused Cancer ?" Scientific Facts on Fluoride, GreenFacts.org, (2005), accessed on February 11, 2011 at http: / /www.greenfacts.org /en/ fluoride / fluorides -2/05- effects- humans.htm# 1. 44 "IMA's History: A Legacy of Leadership," Idaho Medical Association, accessed on March 14, 2011 at http: / /www.idmed.org /d /history. 45 "Questions and Answers about Fluoridation," Indiana State Department of Health, accessed on March 11, 2011 at http : / /www.in.gov /isdh /24525.htm. 46 "Community Water Fluoridation," Oral Health Program Guide, Indian Health Service, 2007, accessed via http: / /www.ihs.gov /index.cfm. 47 ibid. 16 Page 56 of 114 48 "Fluorides," International Agency for Research on Cancer - Summaries & Evaluations, 1987, accessed on January 21, 2011 at http: / /www.inchem.org/ documents /iarc /suppl7 /fluorides.html. 49 "Fluoridation of Water Supplies," a policy statement adopted by the International Association for Dental Research, 1979, (statement updated in 1999). 50 Forum on Fluoridation 2002, a report to the Minister of Health and Children, September 2002, accessed on March 1 at http: / /www.dohc.ie/ publications/ pdf/ fluoridation_forum.pdf?direct =1. 51 "Fluoridation necessary," letter to the editor of the Arkansas Democrat - Gazette by Joseph W. 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Section= News_Releases &TEMPLATE = /CM /Con tentDisplay.cfm &CONTENTID= 17153. 57 "Mississippi Fact Sheet: Community Water Fluoridation and Oral Health," Mississippi State Department of Health, accessed on March 2, 2011 at http: / /msdh.ms.gov /msdhsite /_static /resources /3817.pdf. 58 Sally Greenberg, "Drink up! Tape water key to dental health," Savvy Consumer blog, National Consumers League, January 19, 2011, accessed on February 11, 2011 at http : / /savvyconsumer.wordpress.com /2 011/01/ 19/ drink -up- tap- water - key -to- dental- health/. 59 William T. Jarvis, Ph.D, "Fluoridation," National Council Against Health Fraud, (February 1, 2002), accessed Jan. 14, 2011 at http: / /www.ncahf.org /articles /e- i /fluoride.html. 60 "Position on Water Fluoridation," National Dental Association (2009), accessed on March 14, 2011 at http:/ /www.ndaonline.org /index.php? option =com_ content &view = article &id = 54:water- flouridation &catid= 34:position- statements &Itemid =59. 61 "Salt: The Facts," National Fluoride Information Centre, accessed on February 1, 2011 at http: / /www.fluorideinformation .com /guide_to_fluoride /salt. Page 57 of 114 62 "Water Fluoridation and Children," National Fluoride Information Centre, accessed on February 1, 2011 at http : / /www.fluorideinformation.com / images /leaflet_items /Binderl.pdf. 63 "The Story of Fluoridation," National Institute of Dental and Craniofacial Research, 2010, accessed on February 3, 2011 at http: / /www.nidcr.nih.gov /oralhealth/ topics/ fluoride /thestoryoffluoridation.htm. 64 Speaker Notes from "A Walk Through PTA History," July 16, 2010, accessed on January 31, 2011 at http: / /www.pta.org/ history _workshop_speaker_notes.pdf. 65 "Water Fluoridation," Resolution 1997 -28, adopted in 1997 by the Nevada State Medical Association. See: Nevada State Medical Association: Policy Compendium - 2008 -2009, accessed on March 9, 2011 at http: / /www.nsmadocs.org /PDF_08 /Compendium- 2009.pdf.(Note: This resolution was reaffirmed by NSMA in 2003.) 66 "Community Water Fluoridation Program," Oklahoma State Department of Health, accessed on February 18, 2011 at http: / /www.ok.gov/ health / Child_ and_ Family_ Health /Dental_Health_Service /Community_ Water_ Fluoridation _Program /index.html. 67 E -mail communication from Liz Rogers, Vice President of Oral Health America, sent to the Pew Center on the States at 3:00 pm on Monday, February 28, 2011. 68 Resolutions A -80 and A -91, adopted by the Oregon Medical Association, accessed on March 9, 2011 at http: / /www.theoma.org /Page.asp ?NavID =434. (Note: Resolution A -80 was reaffirmed by OMA's Resolution A -85.) 69 "Water Fluoridation," Public Health Law Research, November 14, 2009, accessed on February 22, 2011at http:// www.publichealthlawresearch.org /public - health- topics /oral- health / evidence - brief /water- fluoridation. 70 Statement of the United States Surgeon General, July 2004, accessed at http: / /www.nidcr.nih.gov /OralHealth/ Topics / Fluoride/ StatementWaterFluoridation.htm. 71 "Fluoride," Robert Wood Johnson University Hospital, accessed on March 9, 2011 at http: / /www.rwjuh.edu/ health_ information /adult_oralhlth_flouride.html. 72 "Fluoride Facts and Fiction," Tennessee Department of Health, accessed on February 2, 2011 at http: / /health. state. tn. us /oralhealth /facts_fiction.html. 17 Page 58 of 114 73 "Water Fluoridation Costs in Texas: Texas Healthy Steps (EPSDT- Medicaid)," Texas Department of Health (May 2000), a study authorized by House Concurrent Resolution 145 of the 75h Texas Legislature, accessed on January 25, 2011 at www.dshs.state.tx.us /idcu /health /dpn /issues /dpn62n04.pdf. 74 Health Fundamentals, an e- newsletter by the United Methodist Health Ministry Fund, September 3, 2004, accessed on March 3, 2011 at http: / /www.healthfund.org /newsletters /hfn09032004.php. 75 "Preventing Dental Caries: Community Water Fluoridation," a summary of the Task Force's recommendations, accessed on March 3, 2011 at http : / /www.thecommunityguide.org /oral /fluoridation.html. 76 "Statement on Community Water Fluoridation," Utah Department of Health (January 2007), accessed on March 10, 2011 at http: / /www. health. utah. gov/ oralhealth /pdf /Fluoridation07.pdf. 77 "Fluoridation in Community Water Systems," a resolution by the Vermont Medical Society, approved on February 2, 2006, http: / /www.vtmd.org/ sites / all / themes /vms/ documents /policies /2005 /dental.pdf, accessed on March 9, 2011. 78 "Fluoridation of Public Water Systems," Resolution 99 -04, Washington State Public Health Association, adopted on October 4, 1999, accessed on March 10, 2011 at http: / /www.wspha.org/ resources / Documents /Resolution %2099- 04.pdf. (Note: This resolution reaffirmed a 1968 resolution on fluoridation that was adopted by WSPHA.) 79 "Oral Health Guide," WebMD.com, accessed on January 27, 2011 at http: / /www.webmd.com/ oral - health /guide /fluoride- treatment. 80 "Resolution Regarding Community Water Fluoridation," Wisconsin Oral Health Coalition, adopted on September 23, 2004, accessed on March 12, 2011 at http://www.chawisconsin.org/documents/OH3resolution207.pdf. 81 "Oral Health: Risks to oral health and intervention," World Health Organization, accessed on January 21, 2011 at http: / /www.who.int /oral health /action /risks /en /indexl.html. Page 59 of 114 4) Costs and Savings Associated With Community Water Fluoridation Programs in Colorado ORIGINAL RESEARCH Suggested citation for this article: O'Connell JM, Brunson D, Anselmo T, Sullivan PW. Costs and savings associated with community water fluoridation programs in Colorado. Prev Chronic Dis [serial online] 2005 Nov [date cited]. Available from: URL: http: / /www.cdc.gov /pcd/issues /2005/ nov /05 0082.htm. PEER REVIEWED Abstract Introduction Local, state, and national health policy makers require information on the economic burden of oral disease and the cost - effectiveness of oral health programs to set policies and allocate resources. In this study, we estimate the cost savings associated with community water fluoridation programs (CWFPs) in Colorado and potential cost savings if Colorado communities without fluoridation programs or naturally high fluoride levels were to implement CWFPs. Methods We developed an economic model to compare the costs associated with CWFPs with treatment savings achieved through averted tooth decay. Treatment savings included those associated with direct medical costs and indirect nonmedical costs (i.e., patient time spent on dental visit). We estimated program costs and treatment savings for each water system in Colorado in 2003 dollars. We obtained parameter estimates from published studies, national surveys, and other sources. We calculated net costs for Colorado water systems with existing CWFPs and potential net costs for systems without CWFPs. The analysis includes data for 172 public water systems in Colorado that serve populations of 1000 individuals or more. We used second -order Monte Carlo simulations to evaluate the inherent uncertainty of the model assumptions on the results and report the 95% credible range from the simulation model. Results We estimated that Colorado CWFPs were associated with annual savings of $148.9 million (credible range, $115.1 million to $187.2 million) in 2003, or an average of $60.78 per person (credible range, $46.97 to $76.41). We Page 60 of 114 estimated that Colorado would save an additional $46.6 million (credible range, $36.0 to $58.6 million) annually if CWFPs were implemented in the 52 water systems without such programs and for which fluoridation is recommended. Conclusion Colorado realizes significant annual savings from CWFPs; additional savings and reductions in morbidity could be achieved if fluoridation programs were implemented in other areas. Introduction In 2000, the U.S. Department of Health and Human Services released the first national oral health report, Oral Health in America: A Report of the Surgeon General (1), which described a "'silent epidemic' of dental and oral diseases." Compared with other health conditions such as diabetes and depression (2,3), less is known about spending for oral disease in the United States because many spending estimates include only services provided in dental offices (4 -7; A. Martin, written communication, March The opinions expressed by authors contributing to this journal do not necessarily reflect the opinions of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above. www.cdc.gov /pcd /issues /2005 /nov /05_0082.htm • Centers for Disease Control and Prevention 1 Joan M. O'Connell, PhD, Diane Brunson, RDH, MPH, Theresa Anselmo, RDH, Patrick W. Sullivan, PhD VOLUME 2: SPECIAL ISSUE NOVEMBER 2005 2005). According to 2003 estimates (4,5, A. Martin, written communication, March 2005), spending for services provided in dental offices averaged $306 per capita in Colorado, with total annual spending for these services in Colorado estimated to be $1.3 billion. These estimates do not include dental services provided in other settings, such as hospitals, nor do they include services for other oral health conditions, such as oral cancer. Furthermore, the amount spent on oral disease may surpass the amount spent on medical services (both dental and other services) to treat such disease because of costs related to adverse health effects, productivity losses, and reduced quality of life. It is important for health policy makers, health education specialists, health care providers, and the news media to have state - specific quantitative information on the Page 61 of 114 impact of oral disease prevention strategies to maintain support for existing programs and promote implementation of new programs. Because of limited information on the economic burden associated with oral disease, the state of Colorado initiated a process to quantify the burden by building on data compiled for the state's Oral Health Surveillance System. The goal of the Oral Health Economic Burden Model is to quantify short-term and long -term medical and nonmedical costs associated with poor oral health to assist Colorado state and local policy makers in designing policies and optimizing allocation of health resources to improve oral health. The purpose of this article is to describe one component of the Oral Health Economic Burden Model; the component was used to estimate costs and savings associated with community water fluoridation programs (CWFPs). Community water fluoridation is defined as the adjustment of fluoride levels in public drinking water systems for the prevention of dental decay; it has been shown to be one of the most cost - effective public health strategies in the United States (8) and is recognized as one of the 10 great public health achievements of the 20th century (9). For most communities with CWFPs, the adjustment of fluoride levels requires the addition of fluoride compounds to increase the fluoride level to the recommended level; for a small percentage of communities, the adjustment requires the addition of water with lower concentrations of fluoride compounds to decrease the fluoride level to the recommended level. The nonfederal, independent Task Force on Community Preventive Services (Task Force) completed a systematic review of the evidence of effectiveness for CWFPs (8). Findings indicated a 29.1 % median decrease in dental caries among children aged 4 to 17 years in communities with CWFPs. This finding led the Task Force to strongly recommend that CWFPs be included as part of a comprehensive population -based strategy to prevent or control dental caries in communities. The systematic review by the Task Force on the cost - effectiveness of CWFPs found that among the five studies with sufficient data, CWFPs resulted in cost savings, with the savings in dental treatment costs exceeding fluoridation program costs for systems servicing populations of 20,000 or more (8). In 2001, Griffin et al conducted the most comprehensive data - driven economic evaluation of community water Page 62 of 114 fluoridation since the 1980s and reported on the net costs (program costs minus treatment savings) of CWFPs by community size (10). We adapted this model for use at the state level to estimate the net costs associated with existing CWFPs in Colorado and the potential net costs if communities without CWFPs, and for which such a program is recommended, were to implement fluoridation programs. In 2005, Colorado met the Healthy People 2010 objective (21 -9) of 75% or more of people using optimally fluoridated water through community water systems (11,12). The actual percentage in Colorado, however, was just above 75 %. Because communities with CWFPs face challenges in retaining water fluoridation programs, and communities without programs require information to make implementation decisions, it is important that data on CWFP costs and treatment savings be available at the state level. Methods Annual CWFP net costs in Colorado were estimated by comparing annual fluoridation program costs with treatment savings associated with averted tooth decay, where (1) Net Costswater system = Program Costswater system — Treatment Savingswater system. We assumed that the fluoride level of the water system was adjusted to the Centers for Disease Control and Prevention's (CDC's) recommended fluoride concentration level, based on the average temperature and altitude of the community. These levels range from 0.7 ppm to 1.2 ppm (13). If the difference between the CDC - recommended level and the natural fluoride level is 0.3 ppm or greater for a 2 Centers for Disease Control and Prevention • www.cdc.gov/pcd/issues/2005/nov/05_0082.htm The opinions expressed by authors contributing to this journal do not necessarily reflect the opinions of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above. water system, the CDC recommends the implementation of a CWFP (K. Duchon, PhD, written communication, January 2005). For example, if the CDC - recommended fluoride level for a water system was 1.0 ppm and the naturally occurring level was 0.4 ppm (a difference of 0.6 ppm), the water system was included in our list of systems for which fluoride was recommended. Our analysis included data from the Water Fluoride Reporting System for 172 public water systems in Colorado that served populations of 1000 or more in Page 63 of 114 2004 (11). The water systems include 61 water systems with CWFPs and 111 systems without CWFPs. Among the 111 systems without programs, CWFPs were recommended for 52, based on CDC recommendations. Among these systems, 32 systems had naturally occurring fluoride levels of less than 0.3 ppm, 9 had levels between 0.3 ppm and 0.5 ppm, and 11 had levels of more than 0.5 ppm. The remaining 59 systems had naturally occurring fluoride levels lower than the CDC - recommended level (yet within the 0.3 cutoff) or had levels equal to or greater than the recommended level. CWFPs were not recommended for these 59 water systems; we refer to these systems as having naturally high fluoride levels. Information on the size of populations served, according to the fluoride status of the water system, is provided in Table 1. Our analysis adhered to the recommendations of the Panel on Cost - Effectiveness in Health and Medicine (14,15). We reference the work of Griffin et al (10) in describing the methods we used to estimate CWFP net costs, noting modifications. When possible, we used state and local data sources such as the Water Fluoridation Reporting System (11) for information on fluoride levels of local water systems and Colorado Vital Statistics for population and mortality data (4). Other data sources included regional and national data, published studies, and expert opinion. CWFP costs and treatment savings were estimated from a societal perspective, with costs and savings provided in 2003 dollars using a discount rate of 3 %. The benefit from water fluoridation is primarily topical; fluoridation prevents decay in teeth after they have erupted (16). As such, we estimated program treatment savings for individuals aged 5 years and older and included costs for permanent teeth only. Costs associated with CWFPs CWFP cost estimates were based on data reported in a published study that included both one -time fixed costs and annual operating costs for communities in Florida that ranged in population from fewer than 5000 to more than 400,000 (17). These costs are the most complete costs reported in the literature. Even though these data are for the late 1980s, fluoridation technology has not changed in a way that would limit the usefulness of these data in our analysis. Page 64 of 114 We used data for 42 systems that fluoridated water with hydrofluosilicic acid, which is the most commonly used fluoridation compound. One -time fixed costs included general equipment, testing and safety equipment, installation, and engineering consultant fees. These costs were depreciated over a 15 -year period with no salvage value, using a 3% discount rate. The annual operating costs included fluoride compounds, labor, maintenance, and accessory supplies. These annual costs were adjusted for inflation to 2003. The Water, Sewage, and Maintenance cost component of the Consumer Price Index (18) was used to adjust chemical and labor costs. The Engineering News - Record Building Cost Index (19) was used to adjust capital costs. Operating and annual capital costs in 2003 dollars were summed to obtain total program costs and to calculate an annual mean CWFP per - person cost by water system size (Table 2). We estimated annual CWFP costs for each water system as follows: (2) Program Costswater system = Populationwater system x Program -Cost Per Personsize of water system. Treatment savings associated with CWFPs Annual treatment savings depend on both the averted decay attributable to CWFPs and the costs of treatment over the lifetime of the tooth that would have occurred without CWFPs: (3) Treatment Savingsper person = Averted Decayper person x Lifetime Treatment Costper person. VOLUME 2: SPECIAL ISSUE NOVEMBER 2005 www.cdc.gov /pcd /issues /2005 /nov /05_0082.htm • Centers for Disease Control and Prevention 3 The opinions expressed by authors contributing to this journal do not necessarily reflect the opinions of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above. VOLUME 2: SPECIAL ISSUE NOVEMBER 2005 1. Estimating annual averted decay attributable to CWFPs Averted decay is the product of the percentage reduction in tooth decay associated with CWFP (program effectiveness) and the annual per person decay increment in nonfluoridated areas: (4) Averted Decayper person = CWFP Effectiveness Page 65 of 114 X Decay Increment in Nonfluoridated Areasper person. Estimated age - specific annual decay increments (the number of new decayed tooth surfaces per year) for nonfluoridated communities were obtained from two sources. The decay increment in nonfluoridated areas for individuals aged younger than 45 years was derived by Griffin et al (10) from two national studies (20,21) that were conducted between 1985 and 1987 and that included information on community water fluoridation status. One study was of U.S. schoolchildren; the other study was of employed adults and seniors. The researchers estimated the annual decay increment (including root surfaces) to be 0.77 surfaces for individuals aged 6 to 17 years and 1.09 surfaces for individuals 18 to 44 years. Given the decline in decay increment since 1980 (22), we adjusted the annual decay increment for a secular trend (20.9 %) based on an analysis of data from the mid -1980s and a more recent survey (23). However, the decay increment for individuals aged 45 to 64 years in nonfluoridated areas was somewhat low, and no estimate was provided for individuals aged 65 and older. Consequently, we used findings from a recent meta - analysis of 11 studies conducted between 1983 and 1999 for individuals with and without exposure to fluoride to estimate the annual decay increment for individuals 45 years and older in nonfluoridated areas (24). In 2004, Griffin et al estimated the total (coronal and root) decay increment for individuals 45 years and older to be 1.31; we used this estimate for individuals aged 65 and older. Because of lower rates of root decay among individuals aged 45 to 64 years compared with individuals aged 65 years and older (24,25), we used an estimated total decay increment of 1.08 for individuals aged 45 to 64 years (S. Griffin, PhD, oral communication, June 2005). We did not adjust the more recent estimates for a secular trend; if the decay increment declined recently because of improvements in oral health, use of these estimates may positively bias results. On the other hand, use of a decay increment based on data for individuals with and without exposure to fluoride as estimates for nonfluoridated increments and exclusion of avoided caries in the primary dentition (i.e., baby teeth) from the model may negatively bias results. It was difficult to assess the directional impact of using these four age- specific estimates on CWFP treatment savings. We assumed that the population distribution of each water system was similar to the state's total population Page 66 of 114 and used the age - specific rates and the 2003 age distribution in Colorado (4) for individuals aged 5 years and older to derive an annual age - adjusted decay increment for Colorado nonfluoridated communities (0.78 surfaces per year per person) (Table 3). In addition, the age- specific rates were used to estimate the lifetime- treatment cost of applying and maintaining a restoration. Based on the findings of studies published in the 1990s (26 -28) and on national survey data (20), Griffin et al in 2001 estimated that CWFPs reduced the decay increment by approximately 25 %. This estimate of C WFP effectiveness is lower than earlier estimates because fluoride is now available from multiple sources (e.g., toothpaste, mouth rinses, professional applications, foods and beverages produced in areas with CWFPs) in addition to local drinking water (22). We multiplied the estimated annual decay increment for nonfluoridated communities (0.78 surfaces) by the percentage of reduction (25 %) estimated by Griffin et al to obtain the averted annual per - person decay increment attributable to CWFPs. This value, equal to 0.20 surfaces, was multiplied by the size of the population exposed to CWFPs to yield the total number of decayed surfaces averted due to 1 year of exposure to water fluoridation. 2. Lifetime cost of treatment: applying and maintaining a restoration A restoration requires maintenance over the time the tooth remains in the mouth. We derived the discounted lifetime cost of applying and maintaining a restoration using the approach employed by Griffin et al (10) with noted modifications. For each age group, we estimated the discounted lifetime - treatment cost from 1) the number of initial restorations averted because of fluoridation, 2) the number of averted replacement restorations expected over the course of a lifetime, 3) the types of restorations used for initial and replacement procedures, and 4) the costs of the associated dental visits. We combined the age - specific results with data on age distribution in Colorado to estimate an age - adjusted lifetime- treatment cost of applying and maintaining a restoration. 4 Centers for Disease Control and Prevention • www.cdc.gov/pcd/issues/2005/nov/05_0082.htm The opinions expressed by authors contributing to this journal do not necessarily reflect the opinions of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only Page 67 of 114 and does not imply endorsement by any of the groups named above. For each age group, the first step in estimating the lifetime - treatment cost was to derive the expected number of initial restorations, which we assumed to be the number of decayed surfaces averted because of 1 year of exposure to water fluoridation. We estimated the number of replacement restorations by using the midpoint of each age group listed in Table 3 and the expected life of the restorations. Based on published studies (29 -33), Griffin et al assumed that the expected life of a single amalgam restoration was 12 years (10). We used this value, and we assumed that multisurface amalgam and composite restorations have a similar expected life; the expected life of a crown was assumed to be 24 years. Consequently, an adolescent who has an initial restoration at age 12 may have three to four replacement restorations; a person who has an initial restoration at age 60 may have only one. For each age group, we estimated the total number of replacement restorations, given the mortality rate (4), the probability of having the tooth (25), and the probability of a tooth extraction resulting from tooth decay rather than other reasons (34). Next, we derived the cost of initial and replacement restorations using information on the types of materials used and the number of surfaces restored. The frequency of restoration procedures was obtained from age - specific restoration information calculated from private- sector administrative - claims data for 2002 from the largest dental insurer in Colorado (J.M.O., unpublished data, 2004). We recognized that privately insured individuals may obtain a different mix of services than that obtained by individuals without such coverage (7). For this analysis, we assumed services provided to individuals with private coverage represent practice standards and consumer expectations. We used these data as the best indicators of the value of maintaining a tooth; the data account for the longterm value of a tooth, including nutritional, other health, and quality -of -life considerations that are not quantified but well- recognized (1). We used data for five groups of restorations: single- surface amalgam, two -or- more - surfaces amalgam, single - surface composite, two -or- more - surfaces composite, and crowns. Over a lifetime, a restoration is often replaced with many restorations, resulting in an increased number of restored surfaces (35,36). For this reason, we used age as a proxy for Page 68 of 114 the types of restorations used for initial and replacement restorations. The distribution of initial restorations was assumed to be similar to restorations for individuals aged 6 to 17 years, excluding crowns. Crowns were excluded because most crowns for this age group may be associated with accidents rather than caries. Accordingly, 38% of initial restorations were assumed to be single - surface amalgam, 23% were two -or- more - surfaces amalgam, 24% were single- surface composite, and 15% were two -or- more - surfaces composite restorations. Likewise, restorations for individuals aged 18 to 29 years were assumed to be similar to the distribution for firstreplacement restorations; restorations for individuals aged 30 to 41 were assumed to be similar to the distribution for second - replacement restorations; restorations for individuals aged 42 to 53 were assumed to be similar to the distribution for third- replacement restorations; and restorations for individuals aged 54 to 64 were assumed to be similar to the distribution for fourth - replacement restorations. To control for the use of crowns for purposes other than decay, we assumed that the rate of such usage in older age groups would be similar to the rate for individuals aged 6 to 17 years; we adjusted the use of crowns for the older age groups accordingly. As such, second - replacement restorations were assumed to include 20% single - surface amalgam, 27% two -or- more - surfaces amalgam, 18% single - surface composite, 21% two -or- more - surfaces composite, and 13% crowns. This approach may be conservative because restorations for individuals at older ages include initial restorations as well as replacement restorations. Information on root canal treatments, bridges, and other restorative procedures were not included in our restoration calculations. We assumed dental fees approximated the cost of resources used to provide dental services, and we used the reported fees for amalgam restorations, composite restorations, five of the most frequently used crowns, and extractions from the 2003 Survey of Dental Fees (37) for the Mountain Region, which includes Colorado, for procedure cost estimates. We estimated the average cost of initial and first - through -fourth replacement restorations using the reported fees and distribution of restoration procedures by age group (Table 4). The cost of each dental visit included direct medical costs for the restoration and the nonmedical costs associated Page 69 of 114 with patient time spent for the dental visit, where (5) Dental Visit Costper visit = Direct Medical Cost for Restorationper visit + Patient Time Costper visit. VOLUME 2: SPECIAL ISSUE NOVEMBER 2005 www.cdc.gov /pcd /issues /2005 /nov /05_0082.htm • Centers for Disease Control and Prevention 5 The opinions expressed by authors contributing to this journal do not necessarily reflect the opinions of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above. VOLUME 2: SPECIAL ISSUE NOVEMBER 2005 The time spent receiving dental care and traveling to the dental office was estimated to be 1.6 hours per visit, based on published data on travel time, office -visit wait time, and actual treatment time in dental offices (38). The cost of a patient's time was quantified using a national estimate for the value of 1 hour of activity for men and women in 2000 (11), updated to 2003 dollars ($20.11) (39). This estimate was used to value time for all individuals, including individuals employed both inside and outside of the home. For each age group, we used estimates of the number of dental visits and related costs to calculate a discounted lifetime- treatment cost of applying and maintaining a restoration. For example, for an age group with three potential replacement restorations, the per - person discounted lifetime cost of applying and maintaining a restoration was calculated by using the following formula: (6) Lifetime - Treatment Costper person = (CRinitial/D) + (( {Ptooth x CRreplacel) + {Pextract x CE }] /D) + (( {Ptooth x CRreplace2) + {Pextract x CE}] /D) + (( {Ptooth x CRreplace3) + {Pextract x CE }] /D) where CR is the cost of restoration (including an initial dental visit [CRinitial] and three replacement dental visits [CRreplacel, CRreplace2, and CRreplace3]); D is the discount rate for the time period; Ptooth is the probability that the tooth exists; Pextract is the probability that the tooth will be extracted because of decay; and CE is the cost of a visit for an extraction. Using the per - person lifetime- treatment cost for each age group and the 2003 age distribution, we estimated the age- adjusted per - person discounted lifetimetreatment cost to be $290.27. We multiplied this value by the estimated per - person annual averted decay increment Page 70 of 114 attributable to fluoridation (0.20 surfaces) and arrived at a per - person annual treatment savings of $58.05. Similar to Griffin et al (10), we assumed that the adverse effects of exposure to water fluoridation were negligible (40) and did not adjust CWFP savings for such effects. CWFP annual treatment savings for a water system were estimated by multiplying the water system population by the per - person annual treatment savings: (7) Treatment Savingswater system = Populationwater system x Treatment Savingsper person. Analysis We first estimated total CWFP net costs for the existing 61 CWFPs in Colorado. Second, we used the same methodology to estimate total net program costs potentially associated with implementing CWFPs in 52 water systems recommended for fluoridation. The total CWFP net program costs represent the sum of net costs for each water system included in each estimate. We conducted sensitivity analyses to evaluate the inherent uncertainty of assumptions for the input variables on the model results. First, we employed univariate sensitivity analyses. Then we used second -order Monte Carlo probabilistic sensitivity analyses that allowed CWFP costs and effectiveness, decay increment, dental fees, and patienttime costs to vary simultaneously. The 10,000 Monte Carlo simulations were conducted using TreeAge Pro 2005 (TreeAge Software, Inc, Williamstown, Mass). The TreeAge Pro model was linked to a Microsoft Excel spreadsheet to estimate water - system — specific program costs and treatment savings. The Monte Carlo simulation is referred to as probabilistic sensitivity analysis because each inputparameter estimate that was not a fixed value was assigned a probability distribution that reflected beliefs about the feasible range of mean values. For each simulation, a value from each probability distribution was drawn for each parameter simultaneously. The CWFP costs and treatment savings were then calculated for each water system using these values as the input parameters. The simulation repeated this process 10,000 times to produce a range of possible values. We report the absolute value of CWFP net costs baseline estimates with a 95% credible range (the 2.5th to 97.5th percentiles of the 10,000 simulations) from the simulation model. Probability distributions were based on what was known about the parameter estimates: the age - specific decay rate Page 71 of 114 for nonfluoridated areas, the number of hours associated with a dental visit, and the dollar value of 1 hour of time were assumed to have normal distributions. The fluoride program effectiveness rate and the secular trend for the decay rate in nonfluoridated areas were represented as a distribution because they were expected to be normally distributed but restricted to values between 0 and 1. The CWFP program costs and restoration costs were characterized as distributions to ensure positive values. 6 Centers for Disease Control and Prevention • www.cdc.gov/pcd/issues/2005/nov/05_0082.htm The opinions expressed by authors contributing to this journal do not necessarily reflect the opinions of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above. In addition, we estimated net costs associated with CWFP implementation in the 52 water systems currently without fluoridation programs, using two alternative model specifications. In one model, we excluded from the analysis two water systems with populations greater than 90,000 and average natural fluoride levels of 0.6 ppm to 0.7 ppm. The difference between the CDC - recommended fluoride level and the natural fluoride level for the two systems was only slightly higher than 0.3 ppm. In the second model, we adjusted CWFP effectiveness by the natural fluoride level in the local communities using a linear model (22,41). We used the estimated effectiveness of a 25% decrease in decay for water systems with natural fluoride levels of 0.3 ppm or less. For systems with fluoride levels of 0.31 to 0.39 ppm, we used an effectiveness rate of 23 %; for levels of 0.40 to 0.49 ppm, a rate of 19 %; for levels of 0.50 to 0.59 ppm, a rate of 15 %; and for levels of 0.60 to 0.69 ppm, a rate of 10 %. Results Existing CWFPs in Colorado were associated with negative net annual costs (hereon referred to as net savings) of $148.9 million (credible range [CR], $115.1— $187.2 million) in 2003 or an average of $60.78 per person (CR, $46.97 — $76.41). When presented as a ratio of savings (benefits) to costs, the estimates ranged from $21.82 for small water systems to $135.00 for large systems. We varied the parameter estimates for the decay increments, program effectiveness, and program cost by +15% from the baseline value to assess which parameter estimates had the greatest Page 72 of 114 impact on program net savings (Figure). The results of the sensitivity analyses indicated that CWFP net savings were most sensitive to changes in the baseline estimates for CWFP effectiveness, as measured by the percentage of reduction in the decay increment and the decay increment in nonfluoridated areas for individuals aged 18 to 44 years. Using the baseline assumptions, we estimated that Colorado would save an additional $46.6 million (CR, $36.0 —$58.6 million) annually if CWFPs were implemented in the 52 nonfluoridated water systems for which fluoridation is recommended. Approximately 80% of these savings would be realized for the six Large water systems that serve populations greater than 20,000. However, two of the six water systems serve more than 90,000 individuals, and the difference between the CDC - recommended fluoride level and natural level was slightly more than 0.3 ppm. When these two systems were excluded from the analysis, potential savings in the other 50 water systems were estimated to total $34.4 million. We conducted one variation of the model by adjusting the CWFP effect on reducing decay for the presence of natural fluoride levels. Using lower rates of fluoride effectiveness for areas with fluoride levels greater than 0.3 ppm, net savings were estimated to be $39.0 million annually. Discussion Although Colorado realizes significant annual savings from existing CWFPs, additional savings and reductions in morbidity could be achieved if fluoridation programs were implemented in other areas. Approximately 80% of the additional savings would be realized if six large water systems that serve populations greater than 20,000 implemented fluoridation programs. There are limitations to our model and its assumptions that affect these estimates. First, CWFPs use different types of fluoride compounds. We based our model on the estimated cost of using hydrofluosilicic acid; we selected this compound because it is the most widely used fluoridation compound (11) and thought to be the most economical (17). Second, the fluoridation program cost estimates represent average costs by program size and include repairs and maintenance. These cost estimates, however, may not represent the actual costs for a particular water system during any one period. Third, the model includes VOLUME 2: SPECIAL ISSUE NOVEMBER 2005 • Page 73of114 www.cdc.gov /pcd /issues /2005 /nov /05_0082.htm • Centers for Disease Control and Prevention 7 The opinions expressed by authors contributing to this journal do not necessarily reflect the opinions of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above. Figure. Univariate sensitivity analysis of the variation in model parameter estimates on net savings in dental care costs resulting from community water fluoridation programs (CWFPs) in 61 water systems in Colorado. Model inputs were varied by ±15% from the baseline value to assess parameter estimates with the greatest impact on the variation in CWFP net savings. VOLUME 2: SPECIAL ISSUE NOVEMBER 2005 assumptions on decay increment, fluoride effectiveness, and use of restorations and extractions based on cross - sectional data. We were not able to identify data sources with longitudinal information. We used more than one data source to estimate the decay increment for the four age groups; we previously noted limitations of their use. The decay- increment estimates for individuals aged 45 to 64 years and 65 years and older were based on data for individuals with and without access to fluoride. Use of these estimates and exclusion of avoided caries in the primary dentition from the CWFP treatment savings negatively biased the results. A fourth limitation concerns the effectiveness of CWFPs at reducing the decay increment. The effectiveness of existing CWFPs may be underestimated because individuals living in nonfluoridated areas benefit from the diffusion of fluoride into their communities through foods and beverages produced in fluoridated areas; the effectiveness of new CWFPs may be overestimated because of diffusion. Furthermore, fluoride is now available from multiple sources such as toothpaste, mouth rinses, and professional applications; savings associated with CWFPs are reduced as use of these other fluoride sources increases. CWFP savings would also be reduced if recommended fluoride levels were lower. For example, the World Health Organization recommends a range of 0.5 ppm to 1.0 ppm; this range recognizes that variation in diet, temperature, culture, and exposure to other sources of fluoride must be taken into account (42). Fifth, the model accounts for time spent obtaining dental care, but the model does not account for the Toss in productivity f Page 74 of 114 due to morbidity. The inclusion of productivity losses would have increased CWFP treatment savings. Sixth, the model estimates the value of treating a tooth with decay using 1) patterns of use of dental services among individuals with private- sector dental coverage and 2) dental fees that assume competitive markets. Patterns of use of dental services among individuals without private coverage differ from individuals with such coverage; we assumed that private - sector patterns of use reflect the long -term value of maintaining a tooth for quality -of -life, nutritional, or other health considerations. We did not adjust for differences by insurance coverage or income level. Finally, the model included age - specific rates for estimates of dental- procedure use and for the probability of a tooth extraction. We did not include variability for other estimates because of the complexity of using age - specific rates for these two estimates. When possible, we used conservative assumptions in the model to negatively bias the net -cost estimates of CWFPs. However, as noted previously, it is difficult to assess the directional impact of other assumptions, and some may positively bias results. Health economic models are not designed to perfectly reflect all of the complexities of the real world (43). Given the limitations discussed, we believe this model, which accounts for some degree of uncertainty, provides useful information about the costs and savings associated with CWFPs. As new data and information become available, this model may be updated. Traditional messages on fluoridation have been, "it prevents caries," "it saves money," and "it's cost - effective." The model used in this analysis provides Colorado- specific estimates of CWFP savings and may be replicated for other states. Such information may be used by public health practitioners and policy makers at all levels to promote continued support for existing CWFPs and implementation of new programs. This study documents net costs of CWFPs for water systems serving populations of more than 1000. In addition to information on the costs and savings associated with CWFPs, it is important for communities to have information on decay increment and on all fluoride sources to be able to thoroughly evaluate the costs and benefits of CWFPs. It is also important to assess costs and savings of CWFPs and other fluoride delivery solutions, such as fluoride varnish, mouth rinse, and tablets, for populations in smaller communities. Finally, statewide cost estimates for Page 75 of 114 other oral health conditions and savings associated with other oral health programs are needed to further inform state policy and spending decisions to reduce rates of oral disease in Colorado. Acknowledgments We recognize the assistance provided by Susan Griffin, PhD, Health Economist, CDC; Kip Duchon, PE, National Fluoridation Engineer, CDC; and Dan Felzien, OHST, Fluoridation Specialist, Colorado Department of Public Health and the Environment. We thank Terrence S. Batliner, DDS, MBA, Vice President, Professional Affairs, Delta Dental Plan of Colorado for use of Colorado dental utilization data. This work was supported by CDC funding provided through State Cooperative Agreement U58/CCU819984- 01 -02. 8 Centers for Disease Control and Prevention • www.cdc.gov/pcd/issues/2005/nov/05_0082.htm The opinions expressed by authors contributing to this journal do not necessarily reflect the opinions of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above. Author Information Corresponding Author: Diane Brunson, RDH, MPH, Colorado Department of Public Health and the Environment, 4300 Cherry Creek Dr South, Denver, CO, 80246 -1530. Telephone: 303 - 692 -2428. Email: diane.brunson@ state.co.us. Author Affiliations: Joan M. O'Connell, PhD, University of Colorado at Denver and Health Science Center School of Medicine, Denver, Colo; Theresa Anselmo, RDH, Colorado Department of Public Health and the Environment, Denver, Colo; Patrick W. Sullivan, PhD, University of Colorado at Denver and Health Science Center School of Pharmacy, Denver, Colo. References 1. U.S. Department of Health and Human Services, National Institute of Dental and Craniofacial Research. Oral health in America: a report of the Surgeon General. Rockville (MD): U.S. Department of Health and Human Services; 2000. 2. Hogan P, Dall T, Nikolov P, American Diabetes Association. Economic costs of diabetes in the US in 2002. Diabetes Care 2003;26(3):917 -32. 3. Greenberg PE, Kessler RC, Birnbaum HG, Leong SA, Lowe SW, Berglund PA, et al. The economic burden of Page 76 of 114 depression in the United States: how did it change between 1990 and 2000? J Clin Psychiatry 2003;64(12):1465 -75. 4. Colorado Department of Public Health and Environment. Colorado vital statistics, Colorado births and deaths. Denver (CO): Colorado Department of Public Health and Environment; 2003. 5. U.S. Department of Health and Human Services, Center for Medicare and Medicaid Services. National health expenditures. Baltimore (MD): U.S. Department of Health and Human Services; 2003. 6. Brown E, Manski R. Dental services: use, expenses, and sources of payment, 1996 -2000. Rockville (MD): Agency for Healthcare Research and Quality; 2004. MEPS Research Findings No. 20 AHRQ Pub. No. 04- 0018. 7. Heffler S, Smith S, Keehan S, Borger C, Clemens M, Truffer C. U.S. health spending projections for 2004- 2014. Health Aff 2005 Feb 23. 8. Task Force on Community Preventive Services. The guide to community preventive services: what works to promote health? New York (NY): Oxford University Press; 2005. 9. From the Centers for Disease Control and Prevention. Achievements in public health, 1900 -1999: fluoridation of drinking water to prevent dental caries. JAMA 2000;283(10):1283 -6. 10. Griffin SO, Jones K, Tomar SL. An economic evaluation of community water fluoridation. J Public Health Dent 2001;61(2):78 -86. 11. Colorado Department of Public Health and Environment [Internet]. Water fluoride reporting system 2004 [cited 2005 Jan]. Available from: URL: http: / /www.cdphe .state.co.us /pp /oralhealth/ fluoridation.html. 12. U.S. Department of Health and Human Services. Healthy People 2010: understanding and improving health. 2nd ed. Washington (DC): U.S. Government Printing Office; 2000 Nov. 13. Centers for Disease Control and Prevention. Engineering and administrative recommendations for water fluoridation, 1995. MMWR Recomm Rep 1995;44(RR- 13):1 -40. 14. Gold M, Siegel J, Russell L, Weinstein M. Cost - effectiveness in health and medicine. New York (NY): Page 77 of 114 Oxford University Press; 1996. 15. Haddix A, Teutsch S, Corso P, editors. Prevention effectiveness: a guide to decision analysis and economic evaluation. 2nd ed. New York (NY): Oxford University Press; 2003. 16. Featherstone JD. Prevention and reversal of dental caries: role of low level fluoride. Community Dent Oral Epidemiol 1999;27(1):31 -40. 17. Ringelberg ML, Allen SJ, Brown LJ. Cost of fluoridation: 44 Florida communities. J Public Health Dent 1992;52(2):75 -80. 18. U.S. Department of Labor, Bureau of Labor Statistics. Consumer price index, water and sewerage maintenance. Washington (DC): U.S. Department of Labor [cited 2005 Feb]. Available from: URL: http://www.economagic.com. 19. Engineering News - Record [Internet]. Building Cost Index. Columbus (OH): The McGraw -Hill Companies, Inc [cited 2005 Feb]. Available from: URL: http: / /www.enr.com. 20. U.S. Department of Health and Human Services, National Institute of Dental and Craniofacial Research. Oral health of United States children. The national survey of oral health in US schoolchildren, VOLUME 2: SPECIAL ISSUE NOVEMBER 2005 www.cdc.gov /pcd /issues /2005 /nov /05_0082.htm • Centers for Disease Control and Prevention 9 The opinions expressed by authors contributing to this journal do not necessarily reflect the opinions of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above. VOLUME 2: SPECIAL ISSUE NOVEMBER 2005 1986 -1987. Bethesda (MD): U.S. Department of Health and Human Services; 1992. 21. U.S. Department of Health and Human Services, National Institute of Dental Research. Oral health of United States adults. The national survey of oral health in US employed adults and seniors, 1985 -1986. NIH 87 -2868. Washington (DC): U.S. Department of Health and Human Services; 1987. 22. Burt B, Eklund S. Dentistry, dental practice, and the community. 6th ed. St. Louis (MO): Elsevier, Inc; 2005. 23. Griffin SO, Griffin PM, Gooch BF, Barker LK. Page 78 of 114 Comparing the costs of three sealant delivery strategies. J Dent Res 2002;81(9):641 -5. 24. Griffin S, Griffin P, Swann J, Zlobin N. Estimating rates of new root caries in older adults. J Dent Res 2004;83(8):634 -8. 25. Winn D, Brunelle J, Selwitz R, Kaste L, Oldakowski R, Kingman A, et al. Coronal and root caries in the dentition of adults in the United States, 1988 -1991. J Dent Res 1996;75(Spec No):642 -51. 26. Grembowski D, Fiset L, Spadafora A. How fluoridation affects adult dental caries. J Am Dent Assoc 1992;123:49 -54. 27. Eklund S, Ismail A, Burt B, Calderone J. High- fluoride drinking water, fluorosis, and dental caries in adults. J Am Dent Assoc 1987;114:324 -8. 28. Brunelle J, Carlos J. Recent trends in dental caries in U.S. children and the effect of water fluoridation. J Dent Res 1990;69:723 -7. 29. Plasmans P, Creugers N, Mulder J. Long -term survival of extensive amalgam restorations. J Dent Res 1998;77:453 -60. 30. Bailit H, Chiriboga D, Grasso J, Willemain T, Damuth L. A new intermediate dental outcome measure: amalgam replacement rate. Med Care 1979;17(7):780 -6. 31. Roberts J. The fate and survival of amalgam and preformed crown molar restorations placed in a specialist pediatric dental practice. Br Dent J 1990;169:285 -91. 32. Rykke M. Dental materials for posterior restorations. Endod Dent Traumatol 1992;8:139-48. 33. Mjor A. The reasons for replacement and the age of failed restorations in general dental practice. Acta Odont Scand 1997;55:58 -63. 34. Agerholm D, Sidi A. Reasons given for extraction of permanent teeth by general dental practitioners in England and Wales. Br Dent J 1988;164(11):345 -8. 35. Brantley C, Bader J, Shugars D, Nesbit S. Does the cycle of rerestoration lead to larger restorations? J Am Dent Assoc 1995;126:1407 -13. 36. Worthington H, Mitropoulos C, Campbell- Wilson M. Selection of children for fissure sealing. Community Dental Health 1988;5(3):251 -254. 37. American Dental Association. 2003 survey of dental fees. Chicago (IL): American Dental Association; 2004. 38. American Dental Association. 2000 survey of dental practice. Chicago (IL): American Dental Association; Page 79 of 114 2002. 39. U.S. Department of Labor, Bureau of Labor Statistics [Internet]. Employer costs for employee compensation, Employment cost index. Washington (DC): U.S. Department of Labor [cited 2005 Apr]. Available from: URL: http: / /www.data.bls.gov. 40. U.S. Department of Health and Human Services, Public Health Service. Review of fluoride benefits and risks. Report of the ad hoc subcommittee on fluoride of the Committee to Coordinate Environmental Health and Related Programs. Washington (DC): U.S. Department of Health and Human Services; 1991. 41. Heller K, Eklund S, Burt B. Dental caries and dental fluorosis at varying water fluoride concentrations. J Public Health Dent 1997;57(3):136 -43. 42. World Health Organization. Fluorides and oral health. WHO technical report No. 846. Geneva, Switzerland: World Health Organization; 1994. 43. Weinstein M, Toy E, Sandberg E, Neumann P, Evans J, Kuntz K, et al. Modeling for health care and other policy decisions: uses, roles, and validity. Value Health 2001;4(5):348 -61. 10 Centers for Disease Control and Prevention • www.cdc.gov/pcd/issues/2005/nov/05_0082.htnn The opinions expressed by authors contributing to this journal do not necessarily reflect the opinions of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above. Tables Table 1. Public Water Systems by Population Size and Status of Community Water Fluoridation Program (CWFP), Colorado, 2004a >100,000 6 1,704,765 2 430,250 0 0 50,000- 99,999 4 290,996 1 90,700 0 0 20,000 - 49,999 6 183,929 3 91,357 5 174,968 10,000- 19,999 10 142,850 2 20,308 12 181,211 5000 -9999 7 54,376 10 70,370 8 56,723 1000 -4999 28 72,758 34 66,302 34 80,650 Total 61 2,449,674 52 769,287 59 493,552 aSource: Colorado Department of Public Health and Environment (11). Table 2. Estimated Mean Annual Cost per Person for Community Water Fluoridation Program by Size of Population Served by Water System, Colorado, 2004a 1000 -4999 2.66 0.40 5000 -9999 1.44 0.09 Page 80 of 114 • 10,000- 19,999 0.93 0.09 >20,000 0.43 0.05 aSources: Ringelberg ML, Allen SJ, Brown LJ (17); U.S. Department of Labor, Bureau of Labor Statistics (18); Engineering News Record (19). VOLUME 2: SPECIAL ISSUE NOVEMBER 2005 www.cdc.gov /pcd /issues /2005 /nov /05_0082.htm • Centers for Disease Control and Prevention 11 The opinions expressed by authors contributing to this journal do not necessarily reflect the opinions of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above. VOLUME 2: SPECIAL ISSUE NOVEMBER 2005 Table 3. Estimates of Annual Decay Increment by Age and the Age- adjusted Decay Increment in Nonfluoridated Areas, Colorado, 2004 5 -17 836,770 (20.0) 0.77d 0.61 0.12 18-44 1,871,371 (44.7) 1.09d 0.86 0.38 45 -64 1,054,858 (25.2) 1.08e 1.08 0.27 >65 428,027 (10.2) 1.31e 1.31 0.13 >5 4,191,026 (100.0) NCf NCf 0.78 aSource: Colorado Department of Public Health and Environment (4). bThe decay increments for ages 5 to 17 years and 18 to 44 years were adjusted for decay increment decreases that occurred since 1980 (22,23). cThe values in this column were calculated for each age group (5 -17 years, 18-44 years, 45 -64 years, and 665 years) by multiplying the percentage value Page 81 of 114 in the first column (2003 Colorado Population Age Distribution) and the value in the third column (Estimate of U.S. Average Annual Decay Increment in Nonfluoridated Areas, Adjusted for Secular Trend). dSource: Griffin et al (10). eSources: Griffin et al (24); S. Griffin, oral communication, June 2005. fNC indicates not calculated. Table 4. Dental Procedure Restoration Fees and Estimated Initial and Replacement Costs for Restorations, United States, 2003 D2140 Amalgam, 1 surface, primary or permanent 85 2.3 D2150 Amalgam, 2 surfaces, primary or permanent 108 3.2 D2160 Amalgam, 3 surfaces, primary or permanent 129 4.1 D2161 Amalgam, 4 or more surfaces, primary or permanent 154 4.4 D2330 Resin -based composite, 1 surface, anterior 105 2.5 D2331 Resin -based composite, 2 surfaces, anterior 132 3.3 D2332 Resin -based composite, 3 surfaces, anterior 162 4.0 D2335 Resin -based composite, 4 or more surfaces or involving incisal angle, anterior 200 5.3 D2391 Resin -based composite, 1 surface, posterior 113 2.6 12 Centers for Disease Control and Prevention • www.cdc.gov/pcd/issues/2005/nov/05_0082.htm The opinions expressed by authors contributing to this journal do not necessarily reflect the opinions of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above. aSource: American Dental Association (37). bStandard errors were estimated to be 10% of the baseline estimate. cSource: American Dental Association (38). dSources: Haddix et al (15); U.S. Department of Labor, Bureau of Labor Statistics (39). eThe medical costs for the initial and first through fourth replacement restoration costs were estimated using the reported dental procedure fees (37) and the age - specific distribution of restoration procedure types (J.M.O., unpublished data, 2004). (Continued on next page) D2392 Resin -based composite, 2 surfaces, posterior 150 3.6 D2393 Resin -based composite, 3 surfaces, posterior 185 4.6 D2394 Resin -based composite, 4 or more surfaces, posterior 210 6.3 Page 82 of 114 D2720 Crown, resin with high noble metal 708 28.2 D2750 Crown, porcelain fused to high noble metal 742 10.7 D2751 Crown, porcelain fused to predominantly based metal 684 11.9 D2752 Crown, porcelain fused to noble metal 714 9.9 D2790 Crown, full cast high noble metal 742 121.8 D7140 Extraction, erupted tooth or exposed root 96 2.0 No. hours spent obtaining dental treatmentc 1.6 0.16 Value of 1 hour of timed, $ 20.11 2.01 Initial restoration 141 14.1 First replacement restoration 174 17.4 Second replacement restoration 229 22.9 Third replacement restoration 286 28.6 Fourth replacement restoration 304 30.4 Extraction 128 12.8 aSource: American Dental Association (37). bStandard errors were estimated to be 10% of the baseline estimate. cSource: American Dental Association (38). dSources: Haddix et al (15); U.S. Department of Labor, Bureau of Labor Statistics (39). eThe medical costs for the initial and first - replacement through fourth- replacement restoration costs were estimated using the reported dental procedure fees (37) and the age- specific distribution of restoration procedure types (J.M.O., unpublished data, 2004). VOLUME 2: SPECIAL ISSUE NOVEMBER 2005 www.cdc.gov /pcd /issues /2005 /nov /05_0082.htm • Centers for Disease Control and Prevention 13 The opinions expressed by authors contributing to this journal do not necessarily reflect the opinions of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above. Table 4. (continued) Dental Procedure Restoration Fees and Estimated Initial and Replacement Costs for Restorations, United States, 2003 Page 83 of 114 5) Myths and Facts About Water Fluoridation (Updated March 17, 2011) Myths Facts 1. Adding fluoride to water is like forcing Fluoride occurs naturally in water. The term people to take medication. "fluoridated water" simply means that the fluoride level in a water system has been adjusted to a certain level —or optimal level —to prevent tooth decay. Most water systems in the U.S. are fluoride - deficient without this adjustment. Fluoride is not a medication. It is a mineral essential for human life based on its role in metabolism and other cell functions. Fluoride in drinking water has two beneficial effects: preventing tooth decay and contributing to healthy bones.i U.S. court decisions have rejected the argument that fluoride is a "medication" that should not be allowed in water. The American Journal of Public Health summarized one of these rulings, noting that "fluoride is not a medication, but rather a nutrient found naturally in some areas but deficient in others. "2 Adding fluoride to water is like any other treatment to improve the quality of drinking water. It is based on public officials making a decision that is informed by sound research — not driven by fear. Those who prefer not to drink from a public water system can do so. Maintaining an optimal amount of fluoride in water is based on the principle that decisions about public health should be based on what is healthy for the entire community, not based on the fears of a few individuals who have extreme opinions about their drinking water. Page 84 of 114 2. There is little difference in the dental There is a clear difference between the health of people in communities with health of communities that fluoridate their fluoridated water compared to those in drinking water and those that do not. communities without it. Fluoridation prevents tooth decay and improves dental health. Studies consistently show that water fluoridation reduces tooth decay by 18 to 40 percent.3 A study of two similar, adjacent communities in Arkansas showed that residents without access to fluoridated water had twice as many cavities as those with access to fluoridated water.4 Children on Medicaid in less fluoridated counties in New York State require 33 percent more treatments for tooth decay than those in counties where most water systems are optimally fluoridated.5 Texas saves $24 per child, per year in Medicaid expenditures for children because of the cavities averted by drinking fluoridated water.6 The benefits of fluoridation are long- lasting. A recent study of U.S. adults found that those born in counties with fluoridation lose fewer teeth than those born in fluoride - deficient counties.? International studies across the United States, Australia, Britain, Canada, Ireland, and New Zealand showed 15 to 40 percent less tooth decay in optimally fluoridated communities compared to fluoride - deficient communities.8 The Centers for Disease Control and Prevention named fluoridated water as one of "10 great public health achievements" of the 20th century. "9 4 Page 85 of 114 3. Fluoridation causes cancer and other Fluoridated water is safe. Claims that it serious health problems. causes cancer or other life- threatening illnesses are unproven. The National Cancer Institute has stated: "Many studies, in both humans and animals, have shown no association between fluoridated water and risk for cancer. "10 In 2006, a panel of the National Research Council —an arm of the National Academies of Science —found no convincing evidence of a causal link between fluoridation and cancer.ii A leading spokesperson for the Centers for Disease Control and Prevention notes that "60 years of research has shown that there's no persuasive evidence that points to any harm from community water fluoridation. "12 Fluoridation opponents cite an "exploratory" Harvard study in the mid -1990s associating fluoride with osteosarcoma, a rare bone cancer. The author herself described the study as having "limitations." In addition, the principal investigator of the study has stated that further analysis does not support this association.is The overwhelming evidence shows the benefits of water fluoridation far outweigh any perceived risk. A 2006 study by the Australian National Health and Medical Research Council examined 408 studies on fluoridation, and concluded that water fluoridation offers clear benefits without solid evidence of negative health effects.14 At least 100 million Americans have been drinking fluoridated water for many decades. 72 percent of the U.S. population served by community systems has fluoridated water.is Without fluoridated water, children face a much higher rate of tooth decay and the potential for related dental diseases can have lasting effects on their health, schooling and future. The risk we must avoid is that of allowing our children to grow up without water fluoridation. Page 86 of 114 4. There are better ways of delivering Water fluoridation provides dental benefits fluoride than adding it to water. to people of all age and income groups without requiring them to spend extra money or change their daily routine. The CDC notes that fluoride is most effective when provided in "the right amount in the right place at the right time, "16 and there's no better way to ensure that than fluoridated water. A 2003 study of fluoridation in Colorado concluded that "even in the current situation of widespread use of fluoride toothpaste," water fluoridation "remains effective and cost saving" at preventing cavities.17 Studies conducted in communities that fluoridated water in the years after fluoride toothpastes were widely used have shown a lower rate of tooth decay than communities without fluoridated water.18 For low- income individuals who are at higher risk of dental problems, fluoride rinses are a costly expense, which is why these products are not the "easy" answer that opponents of fluoridation claim they are. Water fluoridation is the least expensive and most effective solution. 1 1 Page 87 of 114 5. Fluoridated water isn't safe for babies. Fluoridated water is safe for babies and young children. The American Academy of Pediatrics and the American Medical Association support water fluoridation.19 Fluoridated water can be safely used to reconstitute infant formula. The only issue for parents of infants to consider is enamel fluorosis —a minor, cosmetic condition that produces faint white markings on permanent teeth as they are forming (from birth through age 8). The risk of dental fluorosis is low. Even when it occurs, fluorosis is barely noticeable — if noticed at aI1.2o Mothers who rely on reconstituted infant formula should consult with their pediatricians about options other than using fluoridated water. Some pediatricians may recommend alternatives to fluoridated water, while others may tell parents to continue using fluoridated water. The CDC concludes the vast majority of fluorosis cases are mild, and fluorosis can also occur in communities without fluoridated water.21 Fluoridated water has stood the test of time, serving U.S. communities since 1945.22 Today, over 195 million people (72 percent of Americans on public water supplies) drink fluoridated water.23 Tens of millions, many of whom are now parents themselves, were given formula reconstituted with fluoridated water when they were infants. Page 88 of 114 6. Tooth decay is no longer a problem in the Tooth decay is the most common childhood United States. disease, five times more prevalent than asthma. Tooth decay affects nearly 60 percent of children.24 Tooth decay causes problems that often last long into adulthood— affecting kids' schooling, access to healthcare, the ability to get jobs and even national security. o California children missed 874,000 school days in 2007 due to dental problems.25 o A study of seven Minneapolis -St. Paul hospitals showed that patients made over 10,000 trips to the emergency room because of dental health issues, costing more than $4.7 million.26 o An estimated 164 million hours of work are missed during a year because of dental problems or treatments.27 In addition, poor dental health worsens a person's future job prospects. A 2008 study confirmed a widely held but little- discussed prejudice: People who are missing front teeth are viewed as less intelligent, less desirable and less trustworthy than people without a gap in their smile.28 o In a 2008 study of the armed forces, 52 percent of new recruits were categorized as Class 3 in "dental readiness " — meaning they had oral health problems that needed urgent attention and would delay overseas deployment.29 Between 1994 and 2004, tooth decay increased by 15 percent among kids ages two to five.3o Page 89 of 114 7. Fluoridating water is an expensive Water fluoridation saves money. burden to communities or states in this time For most cities, every $1 spent on water of recession. fluoridation returns $38 in savings.31 The average cost for one dental filling is $120, compared to Less than $1 per person, per year to fluoridate water for a community of 20,000 residents or more.32 A study by the Texas Department of Health found that fluoridated water saved $24 per child, per year in state Medicaid costs.33 Researchers estimated that fluoridation saved Colorado nearly $149 million in 2003 by preventing unnecessary treatment costs. These savings averaged about $61 per person.34 A 1999 study compared Louisiana communities that were fluoridated with those that were not. The study found that low- income children in non - fluoridated communities were three times more likely than those in communities with fluoridated water to receive dental treatment in a hospital operating room.35 Like other public works, which continue to be funded even during economic downturns, fluoridation is an investment that provides huge economic returns to communities, once implemented, year after year. Page 90 of 114 8. Most countries in Western Europe don't Millions of people in Great Britain, Spain fluoridate their water so why should we? and Ireland drink fluoridated water. And millions of other Europeans receive fluoride through salt or milk. Whether the vehicle is water, salt or something else, millions of Europeans are receiving fluoride's protection to prevent tooth decay.36 In some Western European countries, the large number of separate water sources used for drinking water makes water fluoridation very difficult logistically.37 Several of these countries use salt fluoridation as an alternative, demonstrating that they recognize the public health value of fluoride.3s After the fall of communism in Czechoslovakia, school -based dental programs were discontinued and water fluoridation ended in most of the country. According to a study, "Subsequent surveys indicated an increasing [decay] prevalence after these changes. "39 In 2009, the European Archives of Paediatric Dentistry published an analysis of 59 studies and concluded that "water fluoridation is effective at reducing caries in children and adults. With the exception of dental fluorosis, no association between adverse effects and water fluoridation has been established. "4o An estimated 405 million people in 60 countries worldwide enjoy the benefits of fluoridated water.41 1 National Research Council. "Earth Materials and Health: Research Priorities for Earth Science and Public Health." National Academies Press. 2007. 2Readey v. St. Louis County Water Co., supranote 25 at 628, 631 for the court's statement that it could not assume that the addition of 0.5 parts per million of fluoride to water that already contained 0.5 parts per million would result in infringement of any constitutional rights; Roemer, Ruth. "Water Fluoridation PH Responsibility and the Democratic Process." American Journal of Public Health. Vol. 55 (9), 1965. (2) Chapman v. City of Shreveport, supra note 25 at 146. s Centers for Disease Control and Prevention. Public Health Service report on fluoride benefits and risks. Journal of the American Medical Association 1991; 266(8):1061 -1067. a Mouden, L. "Fluoride: The Natural State of Water." Arkansas Dentistry; Summer 2005; 77(2): 15 -16. s Kumar, J. "Geographic Variation in Medicaid Claims for Dental Procedures in New York State: Role of Fluoridation Under Contemporary Conditions ". Public Health Reports. Vol. 125, 2010. 6 Texas Department of Oral Health Website www.dshs.state.tx.us /dental /pdf /fluoridation.pdf Accessed August 1, 2010. 7M. Neidell, K Herzog, S Glied, "The Association Between Community Water Fluoridation and Adult Tooth Loss," American Journal of Public Health, in press. 8 U.S. Department of Health and Human Services (USDHHS). Review of fluoride benefits and risks: report of the Ad Hoc Subcommittee on Fluoride of the Committee to Coordinate Environmental Health and Related Programs. Washington: U.S. Department of Health and Human Services, Public Health Service; 1991. 9 "Ten Great Public Health Achievements — United States, 1900 - 1999," Centers for Disease Control and Prevention, April 2, 1999; accessed on July 13, 2010 at: http: / /www.cdc.gov /mmwr /preview /mmwrhtml /00056796.htm to National Cancer institute Website Water Fluoridation Fact Sheet. http: / /www. cancer. gov/ cancertopics /factsheetlRisk/fluoridated -water Accessed July 28, 2010. Page 91 of 114 7 ' ii National Research Council. Carcinogenicity of fluoride. In: Subcommittee on Health Effects of Ingested Fluoride, editor. Health Effects of Ingested Fluoride. Washington DC: National Academy Press, 1993. • 12 Dr. Bill Bailey, CDC Podcast 7/17/2008. http: / /www2c. cdc. gov/ podcasts /player.asp ?f= 9927#transcript 13 CDC Water Fluoridation Homepage. http:// www. cdc.gov /fluoridation/65_years.htm Accessed August 2, 2010. 14 National Health and Medical Research Council (Australia) (2007). "A systematic review of the efficacy and safety of fluoridation" (PDF). http: / /www.nhmrc. gov. au / PUBLICATIONS /synopses/ files/eh41.pdf. 15 CDC Water Fluoridation Homepage. http: / /www.cdc .gov /fluoridation/65years.htm. Accessed August 2, 2010. 16 CDC Fluoridation Website. http: / /www. cdc. gov /nunwr /preview /mmwrhtml /rr5014a1.htm Accessed August 10, 2010. l7 Report of the Fort Collins Fluoride Technical Study Group, (April 2003) 58. 18 ADA Fluoridation Facts, 2005, p., 10. http: / /www.ada.org/ sections / professionalResources /pdfs/fluoridation facts.pdf Accessed August 2, 2010. 19 ADA Website. www.ada.org/4052.aspx. Accessed August 2, 2010. 20 ADA Fluoridation Facts, 2005, p. 28. http:// www. ada. org/ sections /professionalResources /pdfs /fluoridation facts.pdf. Accessed August 2, 2010. 21 ADA Fluoridation Facts, 2005, p. 29. http: / /www.ada.org/ sections /professionalResources /pdfs /fluoridation facts.pdf. Accessed August 2, 2010. 22 ADA Fluoridation Facts, 2005, p. 1. http: / /www.ada.org/ sections / professionalResources /pdfs/fluoridation_facts.pdf 23 CDC. Water Fluoridation: Nature's Way to Prevent Tooth Decay. 2006, p. 2. www.cdc.gov/fluoridation/pdf/natures_way.pdf 24 Pew Center on the States. http: / /www.pewcenteronthestates.org/ initiatives _detail.aspx ?initiativeID =42360 25Nadereh Pourat and Gina Nicholson, "Unaffordable Dental Care Is Linked to Frequent School Absences," Health Policy Research Brief. (UCLA Center for Health Policy Research, Los Angeles, California) November 2009.6 p. 26 Advanced Dental Hygiene Practitioners Frequently Asked Questions. NNDHA Spring 2008, p. 8. http : / /www.nddha.org/DH %20FAQ.pdf 2a M. Willis, C. Esqueda, and R. Schact, "Social Perceptions of Individuals Missing Upper Front Teeth," Perceptual and Motor Skills, 106 (2008): 423 -435. 29 Thomas M. Leiendecker, Gary C. Martin et al., "2008 DOD Recruit Oral Health Survey: A Report on Clinical Findings and Treatment Need," Tri- Service Center for Oral Health Studies, (2008) 1 (accessed August 19, 2010). Sources: • • Page 92 of 114 3o B. Dye, et al., "Trends in Oral Health Status: United States, 1988 -1994 and 1999- 2004," Vital Health and Statistics Series 11, 248 (2007), Table 5, http: / /www. cdc .gov /nchs /data/series/sr /srl 1_248.pdf (accessed December 4, 2009). 31 Centers for Disease Control and Prevention, "Cost Savings of Community Water Fluoridation," August 9, 2007, http: / /www. cdc. gov / fluoridation /fact_sheets /cost.htm (accessed August 7, 2009). 32 National median fee for a two - surface amalgam (silver) filling among general dentists. (Procedure code D2150, amalgam, two surfaces, primary or permanent.) See American Dental Association, "2007 Survey of Dental Fees "; Centers for Disease Control and Prevention, Division of Oral Health, "Cost Savings of Community Water Fluoridation" (August 9, 2007), http: / /www. cdc. gov / fluoridation /fact_sheets /cost.htm (accessed August 7, 2009). 33 Texas Department of Health, "Water Fluoridation Costs in Texas: Texas Health Steps (EPSDT- Medicaid)," Report to Texas Legislature. May 2000, http: / /www.dshs. state .tx.us /dental/pdf/fluoridation.pdf (accessed August 2, 2010). 34 O'Connell J.M. et al., "Costs and savings associated with community water fluoridation programs in Colorado," Preventing Chronic Disease (November 2005), accessed on March 12, 2011 at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1459459/. 35 "Water Fluoridation and Costs of Medicaid Treatment for Dental Decay – Louisiana, 1995- 1996," Morbidity and Mortality Weekly Report, (U.S. Centers for Disease Control and Prevention), September 3, 1999, accessed on March 11, 2011 at http: / /www.cdc. gov /mmwr /preview /mmwrhtml/mm4834a2.htm. 36 T. Marthaler and G. Pollak, "Salt fluoridation in Central and Eastern Europe," Schweiz Monatsschr Zahnmed (August 2005), Vol. 115, http : / /www.zahnaerzte.ch /doc/doc_ download. cfm? uuid= 9553209DD9D9424C4C98A 160B35CD8DE & &IRACER_AUT OLINK && (accessed March 14, 2011); A.E. Villa, "Milk Fluoridation for the Prevention of Dental Caries," World Health Organization, 2009, pp. 93 -105, http: / /whglibdoc. who. int / publications /2009/9789241547758_eng.pdf (accessed on February 2, 2011). 37 ADA Fluoridation Facts, p. 54. http: / /www.ada.org/ sections/ professionalResources /pdfs/fluoridation_facts.pdf 38 ADA Fluoridation Facts, p. 19. http: / /www.ada.org/ sections / professionalResources /pdfs/fluoridation_facts.pdf 39 T. Marthaler and G. Pollak, pp. 671 -672. 40 Guidelines on the use of fluoride in children: An EAPD policy document. European Archives of Pediatric Dentistry, 10 (3), 2009, p. 130. 41 The British Fluoridation Society, The UK Public Health Association, The British Dental Association, The Faculty of Public Health of the Royal College of Physicians. "One in a million —the facts about water fluoridation." Manchester, England, 2004. Page 93 of 114 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Aq Office of the Surgeon General Rockville MD 20857 July 28, 2004 SURGEON GENERAL STATEMENT ON COMMUNITY WATER FLUORIDATION As noted in Oral Health in America: A Report of the Surgeon General, community water fluoridation continues to be the most cost - effective, equitable and safe means to provide protection from tooth decay in a community. Scientific studies have found that people living in communities with fluoridated water have fewer cavities than those living where the water is not fluoridated. For more than 50 years, small amounts of fluoride have been added to drinking water supplies in the United States where naturally- occurring fluoride levels are too low to protect teeth from decay. Over 8,000 communities are currently adjusting the fluoride in their community's water to a level that can protect the oral health of their citizens. Over 170 million people, or 67 percent of the United States population served by public water supplies, drink water with optimal fluoride levels for preventing decay. Of the 50 largest cities in the country, 43 are fluoridated. Although water fluoridation reaches some residents in every state, unfortunately, only 24 states are providing these benefits to 75% or more of their residents. A significant advantage of water fluoridation is that all residents of a community can enjoy its protective benefit —at home, work, school or play— simply by drinking fluoridated water or beverages and foods prepared with it. A person's income level or ability to receive routine dental care is not a barrier to receiving fluoridation's health benefits. Water fluoridation is a powerful strategy in our efforts to eliminate differences in health among people and is consistent with my emphasis on the importance of prevention. The U.S. Centers for Disease Control and Prevention has recognized the fluoridation of drinking water as one of ten great public health achievements of the twentieth century. Water fluoridation has helped improve the quality of life in the United States by reducing pain and suffering related to tooth decay, time lost from school and work, and money spent to restore, remove, or replace decayed teeth. An economic analysis has determined that in most communities, every $1 invested in fluoridation saves $38 or more in treatment costs. Fluoridation is the single most effective public health measure to prevent tooth decay and improve oral health over a lifetime, for both children and adults. While we can be pleased with what has already been accomplished, it is clear that there is much yet to be done. Policymakers, community leaders, private industry, health professionals, the media, and the public should affirm that oral health is essential to general health and well being and take action to make ourselves, our families, and our communities healthier. I join previous Surgeons General in acknowledging the continuing public health role for community water fluoridation in enhancing the oral health of all Americans. j 644.44.4ttiej ichard H. Carmona, M.D., M.P.H., F.A.C.S. VADM, USPHS United States Surgeon General Page 94 of 114 APPENDICES for The Case Against Fluoride The Case Against Fluoride How Hazardous Waste Ended Up in Our Drinking Water and the Bad Science and Powerful Politics That Keep It There By Paul Connett, James Beck and H.S. Micklem Published by Chelsea Green, 2010 See also: ENDNOTES APPENDIX 1 Fluoride and the Brain Twenty - three human studies that report an association of lowered IQ with fluoride exposure. veto ment of Children in High et al. "Research on the Intellectual De � Y. Chen,F.Han,Z.Z Development Areas," Fluoride 41, no. 2 (2008): 120 -24, (originally published in 1991 in Chinese Journal of Control of Endemic Diseases), http:// www. fluorideresearch .org/412 /files/FJ2008 v41 n2 p120- 124.pdf X. Guo, R. Wang, C. Cheng, et al., "A Preliminary Investigation of the IQs of 7 -13 Year Old Children from an Area with Coal Burning- Related Fluoride Poisoning," Fluoride 41, no. 2 (2008): 125 -28 (originally published in 1991 in Chinese Journal of Endemiology), http:// www. fluorideresearch .org/412 /files/FJ2008 v41 n2 p125- 128.pdf F. Hong, Y. Cao, D. Yang, and H. Wang, "Research on the Effects of Fluoride on Child Intellectual Development Under Different Environmental Conditions," Fluoride 41, no. 2 (2008): 156-60 (originally published in 2001 in Chinese Primary Health Care), http:// www. fluorideresearch .org/412 /files/FJ2008 v41 n2 p156- 160.pdf X. S. Li, J. L. Zhi, and R.O. Gao, "Effect of Fluoride Exposure on Intelligence in Children," Fluoride 28, no. 4 (1995): 189 -92, http: / /fluoridealert.org/scher /li- 1995.pdf Y. Li, X. Jing, D. Chen, L. Lin, and Z. Wang, "Effects of Endemic Fluoride Poisoning on the Intellectual Development of Children in Baotou," Fluoride 41, no. 2 (2008): 161 -64 (originally published in 2003 in Chinese Journal of Public Health Management), http:// www. fluorideresearch .org/412 /files/FJ2008 v41 n2 p161- 164.pdf F. F. Lin, Aihaiti, H. X. Zhao, et al., "The Relationship of a Low - Iodine and High - Fluoride Environment to Subclinical Cretinism in Xinjiang," Xinjiang Institute for Endemic Disease Control and Research; Office of Leading Group for Endemic Disease Control of Hetian Prefectural Committee of the Communist Party of China; and County Health and Epidemic Prevention Station, Yutian, Xinjiang, Iodine Deficiency Disorder Newsletter 7, (1991): 3, http: // fluoridealert.org /scher /lin- 1991.pdf -also see http : / /www.fluoridealert.org/IDD.htm Page 95 of 114 S. Liu, Y. Lu, Z. Sun, et al., "Report on the Intellectual Ability of Children Living in High - Fluoride Water Areas," Fluoride 41, no. 2 (2008): 144-47 (originally published in 2000 in Chinese Journal of Control of Endemic Diseases), http:// www. fluorideresearch .org/412 /files/FJ2008 v41 n2 p144- 147.pdf Y. Lu, Z. R. Sun, L. N. Wu, et al., "Effect of High- Fluoride Water on Intelligence in Children," Fluoride 33, no. 2 (2000): 74-78, http : / /www.fluorideresearch.org/332 /files /FJ2000 v33 n2 j74- 78.pdf L. Qin, S. Huo, R. Chen, et al., "Using the Raven's Standard Progressive Matrices to Determine the Effects of the Level of Fluoride in Drinking Water on the Intellectual Ability of School -Age Children," Fluoride 41, no. 2 (2008): 115 -19 (originally published in 1990 in Chinese Journal of the Control of Endemic Disease), http:// www. fluorideresearch .org/412 /files/FJ2008 v41 n2 p115- 119.pdf D. Ren, K. Li, and D. Liu, "A Study of the Intellectual Ability of 8 -14 Year -Old Children in High Fluoride, Low Iodine Areas," Fluoride 41, no. 4 (2008): 319 -20 (originally published in 1989 in Chinese Journal of Control of Endemic Diseases), http:// www. fluorideresearch .org/414 /files/FJ2008 v41 n4_p319- 320.pdf D. Rocha - Amador, M. E. Navarro, L. Carrizales, et al., "Decreased Intelligence in Children and Exposure to Fluoride and Arsenic in Drinking Water," Cadernos de Saude Piublica 23, suppl. 4 (2007): S579-87. B. Seraj, M. Shahrabi, M. Falahzade, et al., "Effect of High Fluoride Concentration in Drinking Water on Children's Intelligence," Journal of Dental Medicine 19, no. 2 (2007): 80-86. Note: English translation forwarded by lead author (B. Seraj, department of pediatric dentistry, faculty of dentistry, Tehran University of Medical Sciences), http://fluoridealert.org/scher/seraj- 2007.trans.pdf M. H. Trivedi, R. J. Verma, N. J. Chinoy, et al., "Effect of High Fluoride Water on Intelligence of School Children in India," Fluoride 40, no. 3 (2007): 178 -83, http:// www. fluorideresearch .org/403 /files/FJ2007 v40 n3 j178- 183.pdf G. Wang, D. Yang, F. Jia, and H. Wang, "A Study of the IQ Levels of Four- to Seven - Year -Old Children in High Fluoride Areas," Fluoride 41, no. 4 (2008): 340-43 (originally published in 1996 in Endemic Diseases Bulletin [China]), http:// www. fluorideresearch .org/414 /files/FJ2008 v41_n4 p340- 343.pdf S. Wang, H. Zhang, W. Fan, et al., "The Effects of Endemic Fluoride Poisoning Caused by Coal Burning on the Physical Development and Intelligence of Children," Fluoride 41, no. 4 (2008): 344-48 (originally published in 2005 in Journal of Applied Clinical Pediatrics [China]), http://www.fluorideresearch.org/414/files/FJ2008_v41 n4 p344- 348.pdf Page 96 of 114 S. X. Wang, Z. H. Wang, X. T. Cheng, et al., "Arsenic and Fluoride Exposure in Drinking Water: Children's IQ and Growth in Shanyin County, Shanxi Province, China," Environmental Health Perspectives 115, no. 4 (2007): 643 -47, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1852689/ Q. Xiang, Y. Liang, L. Chen, et al., "Effect of Fluoride in Drinking Water on Children's Intelligence," Fluoride 36, no. 2 (2003): 84-94, http:// www. fluorideresearch .org1362 /files/FJ2003 v36 n2 p84- 94.pdf - Also see Q. Xiang, Y. Liang, M. Zhou, and H. Zang, "Blood Lead of Children in Wamiao - Xinhuai Intelligence Study" (letter), Fluoride 36, no. 3 (2003): 198 -99, http:// www. fluorideresearch .org/363 /files/FJ2003 v36 n3 p198- 199.pdf L. B. Zhao, G. H. Liang, D. N. Zhang, and X. R. Wu, "Effect of High - Fluoride Water Supply on Children's Intelligence," Fluoride 29, no. 4 (1996): 190 -92, http:/ /fluoridealert.org /scher /zhao- 1996.pdf The following five Chinese I.Q. studies have not yet been translated: J. A. An, S. Z. Mei, A. P. Liu, et al., "Effect of High Level of Fluoride on Children's Intelligence" (article in Chinese), Zhong Guo Di Fang Bing Fang Zhi Za Zhi 7, no. 2 (1992): 93- 94. Z. X. Fan, H. X. Dai, A. M. Bai, et al., "Effect of High Fluoride Exposure on Children's Intelligence" (article in Chinese), Huan Jing Yu Jian Kang Za Zhi 24, no. 10 (2007): 802 -3. Y. L. Xu, C. S. Lu, and X. N. Zhang, "Effect of Fluoride on Children's Intelligence" (article in Chinese), Di Fang Bing Tong Bao 9 (1994): 83 -84. L. M. Yao, Y. Deng, S. Y. Yang, et al., "Comparison of Children's Health and Intelligence Between the Fluorosis Area with Altering Water Source and Those without Altering Water Source" (article in Chinese), Yu Fang Yi Xue Wen Xian Xin Xi 3, no. 1 (1997): 42 -43. J. W. Zhang, H. Yao, and Y. Chen, "Effect of High Level of Fluoride and Arsenium on Children's Intelligence" (article in Chinese), Zhong Guo Gong Gong Wei Sheng Xue Bao 17, no. 2 (1998): 119. Animal and biochemical studies in chronological order (This is a list of some of the studies that have been published.) 1941 S. Ochoa, "`Coupling' of Phosphorylation with Oxidation of Pyruvic Acid in Brain," The Journal of Biological Chemistry 138 (1941): 751 -73, http://www.jbc.org/content/138/2/751.full.pdf+html 1942 Page 97of E. Racker and H. Kabat, "The Metabolism of the Central Nervous System in Experimental Poliomyelitis," The Journal of Experimental Medicine 76, no. 6 (1942): 579 -85, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2135281/ 1943 D. Nachmansohn and A. L. Machado, "The Formation of Acetylcholine. A New Enzyme: `Choline Acetylase, "' Journal of Neurophysiology 6 (1943): 397 -403. 1966 G. Cimasoni, "Inhibition of Cholinesterases by Fluoride In Vitro," The Biochemical Journal 99, no. 1 (1966): 133 -37, http: / /www.ncbi.nlm.nih.gov /pmc /articles/PMC1264967/ 1971 J. P. Perkins and M. M. Moore, "Adenyl Cyclase of Rat Cerebral Cortex. Activation of Sodium Fluoride and Detergents," The Journal of Biological Chemistry 246, no. 1 (1971): 62-68, http://www.jbc.org/content/246/1/62.1ong 1973 R. A. Johnson and E. W. Sutherland, "Detergent- Dispersed Adenylate Cyclase from Rat Brain. Effects of Fluoride, Cations, and Chelators," The Journal of Biological Chemistry 248, no. 14 (1973): 5114 -21, http://www.jbc.org/content/248/14/5114.1ong S. Katz and A. Tenenhouse, "The Relation of Adenyl Cyclase to the Activity of Other ATP Utilizing Enzymes and Phosphodiesterase in Preparations of Rat Brain; Mechanism of Stimulation of Cyclic AMP Accumulation by NaF," British Journal of Pharmacology 48, no. 3 (1973): 505 -15, http: / /www.ncbi.nlm.nih.gov/ pmc / articles /PMC 1776132/pdf/bripharm00545- 0143.pdf 1974 K. Czechowicz, A. Osada, and B. Slesak, "Histochemical Studies on the Effect of Sodium Fluoride on Metabolism in Purkinje's Cells," Folia Histochemica et Cytochemica (Krakow) 12, no. 1 (1974): 37 -44. L. I. Popov, R. I. Filatova, and A. S. Shershever, "Aspects of Nervous System Affections in Occupational Fluorosis" (article in Russian), Gigiena Truda I Professional 'nye Zabolevaniia, no. 5 (1974): 25 -27. 1975 S. L. Manocha, H. Warner, and Z. L. Olkowski, "Cytochemical Response of Kidney, Liver and Nervous System to Fluoride Ions in Drinking Water," Histochemical Journal 7, no. 4 (1975): 343 -55. 1977 C. O. Brostrom, M. A. Brostrom, and D. J. Wolff, "Calcium- Dependent Adenylate Cyclase from Rat Cerebral Cortex. Reversible Activation by Sodium Fluoride," The Journal of Biological Page 98 of 114 Chemistry 252, no. 16 (1977): 5677 -85, http:// www. jbc .org/content /252/16/5677.1ong V. I. Tokar' and O. N. Savchenko, "Effect of Inorganic Fluorine Compounds on the Functional State of the Pituitary- Testis System" (article in Russian), Problemy E'ndokrinologii (Mosk) 23, no. 4 (1977): 104-7. 1978 M. Hebdon, H. Le Vine III, N. Sahyoun, et al., "Properties of the Interaction of Fluoride- and Guanylyl- 5'- Imidodiphosphate - Regulatory Proteins with Adenylate Cyclase," Proceedings of the National Academy of Sciences of the United States of America 75, no. 8 (1978): 3693 -97, http: / /www.ncbi .nlm.nih.gov /pmc /articles/PMC3 92852 /pdf /pnas00020- 0163.pdf 1980 C. F. Hongslo, J. K. Hongslo, and R. I. Holland, "Fluoride Sensitivity of Cells from Different Organs," Acta Pharmacologica et Toxicologica 46, no. 1 (1980): 73 -77. M. M. Rasenick and M. W. Bitensky, "Partial Purification and Characterization of a Enhances Fluoride Activation of Adenylate Proceedings of the en late C clase," Proceedin Macromolecule which Y Cyclase," g National Academy of Sciences of the United States of America 77, no. 8 (1980): 4628 -32, http://fluoridealert.org/re/rasenick-1980.pdf 1981 T. Nanba, M. Ando, Y. Nagata, et al., "Distribution and Different Activation of Adenylate Cyclase by NaF and of Guanylate Cyclase by NaN3 in Neuronal and Glial Cells Separated from Rat Cerebral Cortex," Brain Research 218, no. 1 -2 (1981): 267 -77. T. Tomomatsu, "Hygienic Study on Fluoride (4). Physiological Effects of Fluoride on Rat," J Tokyo Med Coll. 39, no. 3 (1981): 441 -60. 1984 G. Janiszewska, L. Lachowicz, and R. Wojtkowiak, "Effect of Certain Agents on Subcellular cAMP Level in Different Areas of Rat Brain," Acta Physiologica Polonica 35, no. 3 (1984): 199 -206. M. G. Soni, M. S. Kachole, and S. S. Pawar, "Alterations in Drug Metabolising Enzymes and Lipid Peroxidation in Different Rat Tissues by Fluoride," Toxicology Letters 21, no. 2 (1984): 167 -72. 1986 F. Geeraerts, G. Gijs, E. Finne, and R. Crokaert, "Kinetics of Fluoride Penetration in Liver and Brain," Fluoride 19, no. 3 (1986): 108 -12. Z. Z. Guan, "Morphology of the Brain of the Offspring of Rats with Chronic Fluorosis" (article in Chinese), Zhonghua Bing Li Xue Za Zhi 15, no. 4 (1986): 297 -99. Page 99 of 114 A. R. Kay, R. Miles, and R. K. Wong, "Intracellular Fluoride Alters the Kinetic Properties of Calcium Currents Facilitating the Investigation of Synaptic Events in Hippocampal Neurons," The Journal of Neuroscience 6, no. 10 (1986): 2915 -20, http://www.jneurosci.org/cgi/reprint/6/10/2915 1987 I. Litosch, "Guanine Nucleotide and NaF Stimulation of Phospholipase C Activity in Rat Cerebral- Cortical Membranes. Studies on Substrate Specificity," The Biochemical Journal 244, no. 1 (1987): 35-40, http: / /www. biochemj .org /bj/244/0035/2440035.pdf 1988 P. P. Godfrey and S. P. Watson, "Fluoride Inhibits Agonist- Induced Formation of lnositol Phosphates in Rat Cortex," Biochemical and Biophysical Research Communications 155, no. 2 (1988): 664 -69. R. S. Jope, "Modulation of Phosphoinositide Hydrolysis by NaF and Aluminum in Rat Cortical Slices," Journal of Neurochemistry 51, no. 6 (1988): 1731 -36. R. S. Jope and K. M. Lally, "Synaptosomal Calcium Influx is Activated by Sodium Fluoride," Biochemical and Biophysical Research Communications 151, no. 2 (1988): 774 -80. 1989 W. X. Liu, "Experimental Study of Behavior and Cerebral Morphology of Rat Pups Generated by Fluorotic Female Rat" (article in Chinese), Zhonghua Bing Li Xue Za Zhi 18, no. 4 (1989): 290- 92. H. Machida, "The Rabbit Thermo - Regulatory System. Effects of High Dose of Sodium Fluoride" (article in Japanese), Shikwa Gakuho 89, no. 3 (1989): 607 -26. 1990 E. Claro, M. A. Wallace, and J. N. Fain, "Dual Effect of Fluoride on Phosphoinositide Metabolism in Rat Brain Cortex. Stimulation of Phospholipase C and Inhibition of Polyphosphoinositide Synthesis," The Biochemical Journal 268, no. 3 (1990): 733 -37, http: / /www. biochemj .org /bi/268/0733/2680733.pdf I. M. Gardiner and J. de Belleroche, "Modulation of Gamma - Aminobutyric Acid Release in Cerebral Cortex by Fluoride, Phorbol Ester, and Phosphodiesterase Inhibitors: Differential Sensitivity of Acetylcholine Release to Fluoride and K+ Channel Blockers," Journal of Neurochemistry 54, no. 4 (1990): 1130 -35. P. P. Li, D. Sibony, and J. J. Warsh, "Guanosine 5'- O- Thiotriphosphate and Sodium Fluoride Activate Polyphosphoinositide Hydrolysis in Rat Cortical Membranes by Distinct Mechanisms," Journal of Neurochemistly 54, no. 4 (1990): 1426 -32. G. Tiger, P. E. Bjorklund, G. Brannstrom, and C. J. Fowler, "Multiple Actions of Fluoride Ions Page 100 of 114 Upon the Phosphoinositide Cycle in the Rat Brain," Brain Research 537, no. 1 -2 (1990): 93— ' 101. G. Tiger, P. E. Bjorklund, R. F. Cowburn, et al., "Effect of Monovalent Ions upon G Proteins Coupling Muscarinic Receptors to Phosphoinositide Hydrolysis in the Rat Cerebral Cortex," European Journal of Pharmacology 188, no. 1 (1990): 51-62. 1991 S. J. Publicover, "Brief Exposure to the G- Protein Activator NaF /A1C13 Induces Prolonged Enhancement of Synaptic Transmission in Area CAI of Rat Hippocampal Slices," Experimental Brain Research 84, no. 3 (1991): 680 -84. S. D. Yuan, K. Q. Song, Q. W. Xie, and F. Y. Lu, "An Experimental Study of Inhibition on Lactation in Fluorosis Rats" (article in Chinese), Sheng Li Xue Bao (Acta Physiologica Sinica) 43, no. 5 (1991): 512 -17. 1992 B. E. Hawes, J. E. Marzen, S. B. Waters, and P. M. Conn, "Sodium Fluoride Provokes Gonadotrope Desensitization to Gonadotropin- Releasing Hormone (GnRH) and Gonadotrope Sensitization to A23187: Evidence for Multiple G Proteins in GnRH Action," Endocrinology 130, no. 5 (1992): 2465-75. A. Shashi, "Studies on Alterations in Brain Lipid Metabolism Following Experimental Fluorosis," Fluoride 25, no. 2 (1992): 77 -84, http: / /fluoridealert.org/re /shashi- 1992.pdf 1993 T. J. Shafer, W. R. Mundy, and H. Tilson, "Aluminum Decreases Muscarinic, Adrenergic, and Metabotropic Receptor - Stimulated Phosphoinositide Hydrolysis in Hippocampal and Cortical Slices from Rat Brain," Brain Research 629, no. 1 (1993): 133 -40. B. M. Ross, M. McLaughlin, M. Roberts, et al., "Alterations in the Activity of Adenylate Cyclase and High Affinity GTPase in Alzheimer's Disease," Brain Research 622, no. 1 -2 (1993): 35-42. 1994 A. Shashi, J. P. Singh, and S. P. Thapar, "Effect of Long -Term Administration of Fluoride on Levels of Protein, Free Amino Acids and RNA in Rabbit Brain," Fluoride 27, no. 3 (1994): 155- 59, http: // fluoridealert.org /re /shashi- 1994.pdf X. L. Zhao, W. H. Gao, and Z. L. 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Note: sodium fluoride administered orally to adult male rats at a dose level of 4.5 ppm and 9.0 ppm for 75 days caused significant decrease in the body weight, brain index, and testicular index. 1996 X. Li, L. Song, and R. S. Jope, "Cholinergic Stimulation of AP -1 and NF Kappa B Transcription Factors Is Differentially Sensitive to Oxidative Stress in SH -SY5Y Neuroblastoma: Relationship to Phosphoinositide Hydrolysis," The Journal of Neuroscience 16, no. 19 (1996): 5914 -22. 1997 V. V. Frolkis, S. A. Tanin, and Y. N. Gorban, "Age- Related Changes in Axonal Transport," Experimental Gerontology 32, no. 4 (1997): 441 - 50. Z. Z. Guan, Y. Wang, and K. Xiao, "Influence of Experimental Fluorosis on Phospholipid Content and Fatty Acid Composition in Rat Brain" (article in Chinese), Zhonghua Yi Xue Za Zhi 77, no. 8 (1997): 592-96. R. L. Isaacson, J. A. Varner, and K. F. 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APPENDIX 2 Fluoride and Bone Clinical trials on the treatment of osteoporosis with sodium fluoride T. A. Bayley, J. E. Harrison, T. M. Murray, et al., "Fluoride- Induced Fractures: Relation to Osteogenic Effect," Journal of Bone and Mineral Research 5, suppl. 1 (1990): S217-22. M. A. Dambacher, J. Ittner, and P. Ruegsegger, "Long -Term Fluoride Therapy of Postmenopausal Osteoporosis," Bone 7, no. 3 (1986): 199 -205. J. C. Gerster, S. A. Charhon, P. Jaeger, et al., `Bilateral Fractures of Femoral Neck in Patients with Moderate Renal Failure Receiving Fluoride for Spinal Osteoporosis," British Medical Journal (Clinical Research Edition) 287, no. 6394 (1983): 723 -25. D. H. Gutteridge, R. I. Price, G. N. Kent, et al., "Spontaneous Hip Fractures in Fluoride- Treated Patients: Potential Causative Factors," Journal of Bone and Mineral Research 5, suppl. 1 (1990): 5205 -15. D. H. Gutteridge, G. O. Stewart, R. L. Prince, et al., "A Randomized Trial of Sodium Fluoride (60 mg) +1- Estrogen in Postmenopausal Osteoporotic Vertebral Fractures: Increased Vertebral Fractures and Peripheral Bone Loss with Sodium Fluoride; Concurrent Estrogen Prevents Peripheral Loss, but Not Vertebral Fractures," Osteoporosis International 13, no. 2 (2002): 158- 70. L. R. Hedlund and J. C. Gallagher, "Increased Incidence of Hip Fracture in Osteoporotic Women Treated with Sodium Fluoride," Journal of Bone and Mineral Research 4, no. 2 (1989): 223 -25. J. Inkovaara, R. Heikinheimo, K. Jarvinen, et al., "Prophylactic Fluoride Treatment and Aged Bones," British Medical Journal 3, no. 5975 (1975): 73-4. J. D. O'Duffy, H. W. Wahner, W. M. O'Fallon, et al., "Mechanism of Acute Lower Extremity Page 109 of 114 Pain Syndrome in Fluoride- Treated Osteoporotic Patients," American Journal of Medicine 80, no. 4 (1986): 561 -66. P. Orcel, M. C. de Vernejoul, A. Prier, et al., "Stress Fractures of the Lower Limbs in Osteoporotic Patients Treated with Fluoride," Journal of Bone and Mineral Research 5, suppl. 1 (1990): S191-94. B. L. Riggs, S. F. Hodgson, W. M. O'Fallon, et al., "Effect of Fluoride Treatment on the Fracture Rate in Post - Menopausal Women with Osteoporosis," New England Journal of Medicine 322, no. 12 (1990): 802 -9. C. M. Schnitzler, J. R. Wing, K. A. Gear, and H. J. Robson, "Bone Fragility of the Peripheral Skeleton during Fluoride Therapy for Osteoporosis," Clinical Orthopaedics no. 261 (1990): 268 - 75. Animal studies showing fluoride weakens bones D. F. Beary, "The Effects of Fluoride and Low Calcium on the Physical Properties of the Rat Femur," The Anatomical Record 164, no. 3 (1969): 305 -16. A. Bohatyrewicz, "Bone Fluoride in Proximal Femur Fractures," Fluoride 34, no. 4 (2001): 227- 35, http:// www. fluorideresearch .org/344 /files/FJ2001 v34 n4 p227- 235.pdf A. Bohatyrewicz, "Effects of Fluoride on Mechanical Properties of Femoral Bone in Growing Rats," Fluoride 32, no. 2 (1999): 47 -54, http:// fluoridealert.org /re/bohatyrewicz- 1999.pdf T. W. Burnell, E. R. Peo Jr., A. J. Lewis, and J. D. Crenshaw, "Effect of Dietary Fluorine on Growth, Blood and Bone Characteristics of Growing- Finishing Pigs," Journal of Animal Science 63, no. 6 (1986): 2053 -67. M. M. Chan, R. B. Rucker, F. Zeman, and R. S. Riggins, "Effect of Fluoride on Bone Formation and Strength in Japanese Quail," Journal of Nutrition 103, no. 10 (1973): 1431 -40. I. Gedalia, A. Frumkin, and H. Zukerman, "Effects of Estrogen on Bone Composition in Rats at Low and High Fluoride Intake," Endocrinology 75 (1964): 201 -5. M. H. Lafage, R. Balena, M. A. Battle, et al., "Comparison of Alendronate and Sodium Fluoride Effects on Cancellous and Cortical Bone in Minipigs. A One -Year Study," The Journal of Clinical Investigation 95, no. 5 (1995): 2127 -33. L. Mosekilde, J. Kragstrup, and A. Richards, "Compressive Strength, Ash Weight, and Volume of Vertebral Trabecular Bone in Experimental Fluorosis in Pigs," Calcified Tissue International 40, no. 6 (1987): 318 -22. R. S. Riggins, R. C. Rucker, M. M. Chan, et al., "The Effect of Fluoride Supplementation on the Strength of Osteopenic Bone," Clinical Orthopaedics, no. 114 (1976): 352 -57. Page 110 of 114 R. S. Riggins, F. Zeman, and D. Moon, "The Effects of Sodium Fluoride on Bone Breaking Strength," Calcified Tissue Research 14, no. 4 (1974): 283 -89. J. C. Robin, B. Schepart, H. Calkins, et al., "Studies on Osteoporosis III. Effect of Estrogens and Fluoride," Journal of Medicine 11, no. 1 (1980): 1 -14. H. Roeckert, "X -ray Absorption and X -ray Fluorescence Micro - Analyses of Mineralized Tissue of Rats Which Have Ingested Fluoridated Water," Acta Pathologica et Microbiologica Scandinavica 59 (1963): 32 -38. H. Roeckert and H. Sunzel, "Skeletal Lesions Following Ingestion of Fluoridated Water," Experientia 15 (1960): 155 -56. C. H. Sogaard, L. Mosekilde, W. Schwartz, et al., "Effects of Fluoride on Rat Vertebral Body Biomechanical Competence and Bone Mass," Bone 16, no. 1 (1995): 163 -9. C. H. Turner, M. P. Akhter, and R. P. Heaney, "The Effects of Fluoridated Water on Bone Strength," Journal of Orthopaedic Research 10, no. 4 (1992): 581 -87. C. H. Turner and A. J. Dunipace, "On Fluoride and Bone Strength" (letter), Calcified Tissue International 53, no. 4 (1993): 289 -90. C. H. Turner, L. P. Garetto, A. J. Dunipace, et al., "Fluoride Treatment Increased Serum IGF -1, Bone Turnover, and Bone Mass, But Not Bone Strength, in Rabbits," Calcified Tissue International 61, no. 1 (1997): 77 -83. C. H. Turner, K. Hasegawa, W. Zhang, et al., "Fluoride Reduces Bone Strength in Older Rats, Journal of Research 74, no. 8 (1995): 1475 -81, http://jdr.sagepub.cotn/cgi/reprint/74/8/1475 C. H. Turner, W. R. Hinckley, M. E. Wilson, et al., "Combined Effects of Diets with Reduced Calcium and Phosphate and Increased Fluoride Intake on Vertebral Bone Strength and Histology in Rats," Calcified Tissue International 69, no. 1 (2001): 51 -57. C. H. Tumer, I. Owan, E. J. Brizendine, et al., "High Fluoride Intakes Cause Osteomalacia and Diminished Bone Strength in Rats with Renal Deficiency," Bone 19, no. 6 (1996): 595 -601. B. Uslu, "Effect of Fluoride on Collagen Synthesis in the Rat," Research and Experimental Medicine 182, no. 1 (1983): 7 -12. I. Wolinsky, A. Simkin, and K. Guggenheim, "Effects of Fluoride on Metabolism and Mechanical Properties of Rat Bone," American Journal of Physiology 223, no. 1 (1972): 46 Nineteen studies on the possible association of hip fracture and fluoridated water published since 1990 Page 111 of 114 Studies reporting an association between fluoridated water (1 ppm fluoride) and trip fracture C. Cooper, C. Wickham, R. F. Lacey, and D. J. Barker, "Water Fluoride Concentration and Fracture of the Proximal Femur," Journal of Epidemiology and Community Health 44, no. 1 (1990): 17 -19; and C. Cooper, C. A. Wickham, D. J. Barker, and S. J. Jacobsen, "Water Fluoridation and Hip Fracture" (letter, a reanalysis of data presented in 1990 paper), Journal of the American Medical Association 266, no. 4 (1990): 513 -14. C. Danielson, J. L. Lyon, M. Egger, and G. K. Goodenough, "Hip Fractures and Fluoridation in Utah's Elderly Population," Journal of the American Medical Association 268, no. 6 (1992): 746 -48. K. T. Hegmann et al., "The Effects of Fluoridation on Degenerative Joint Disease (DJD) and Hip Fractures," abstract no. 71 of the 33rd Annual Meeting of the Society for Epidemiological Research, June 15 -17, 2000, published in a supplement of American Journal of Epidemiology (2000): P S18. S. J. Jacobsen, J. Goldberg, C. Cooper, and S. A. Lockwood, "The Association Between Water Fluoridation and Hip Fracture Among White Women and Men Aged 65 Years and Older. A National Ecologic Study," Annals of Epidemiology 2, no. 5 (1992): 617 -26. S. J. Jacobsen, J. Goldberg, T. P. Miles, et al., "Regional Variation in the Incidence of Hip Fracture. US White Women Aged 65 Years and Older," Journal of the American Medical Association 264, no. 4 (1990): 500 -502. H. Jacqmin - Gadda, D. Commenges, and J. F. Dartigues, "Fluorine Concentration in Drinking Water and Fractures in the Elderly" (letter), Journal of the American Medical Association 273, no. 10 (1995): 775 -76. H. Jacqmin - Gadda, A. Fourrier, D. Commenges, and J. F. Dartigues, "Risk Factors for Fractures in the Elderly," Epidemiology 9, no. 4 (1998): 417 -23. (An elaboration of the 1995 study referred to in the JAMA letter.) C. Keller, "Fluorides in Drinking Water" (unpublished results), discussed in S. L. Gordon and S. B. Corbin "Summary of Workshop on Drinking Water Fluoride Influence on Hip Fracture on Bone Health," Osteoporosis International 2 (1992): 109 -17. P. Kurttio, N. Gustaysson, T. Vartiainen, and J. Pekkanen, "Exposure to Natural Fluoride in Well Water and Hip Fracture: A Cohort Analysis in Finland," American Journal of Epidemiology 150, no. 8 (1999): 817 -24. D. S. May and M. G. Wilson, "Hip Fractures in Relation to Water Fluoridation: An Ecologic Analysis (unpublished data), discussed in S. L. Gordon and S. B. Corbin "Summary of Workshop Page 112 of 114 on Drinking Water Fluoride Influence on Hip Fracture on Bone Health," Osteoporosis International 2 (1992): 109 -17. Studies reporting an association between water fluoride levels higher than that of fluoridated water (4 ppm +) and hip fracture Y. Li, C. Liang, C. W. Slemenda, et al., "Effect of Long -Term Exposure to Fluoride in Drinking Water on Risks of Bone Fractures," Journal of Bone and Mineral Research 16, no. 5 (2001): 932 -39. M. F. Sowers, M. K. Clark, M. L. Jannausch, and R. B. Wallace, "A Prospective Study of Bone Mineral Content and Fracture in Communities with Differential Fluoride Exposure," American Journal of Epidemiology 133, no. 7 (1991): 649 -60. Studies reporting no association between water fluoride and hip fracture Note that in four of these eight studies, an association was found between fluoride and some other form of fracture —e.g. wrist fracture. See notes and quotes below. J. A. Cauley, P. A. Murphy, T. J. Riley, and A. M. Buhari, "Effects of Fluoridated Drinking Water on Bone Mass and Fractures: The Study of Osteoporotic Fractures," Journal of Bone and Mineral Research 10, no. 7 (1995): 1076 -86. D. Feskanich, W. Owusu, D. J. Hunter, et al., "Use of Toenail Fluoride Levels as an Indicator for the Risk of Hip and Forearm Fractures in Women," Epidemiology 9, no. 4 (1998): 412 -16. Note: While this study didn't find an association between water fluoride and hip fracture, it did fmd an association — albeit not statistically significant 1.6 (0.8 -3.1)— between fluoride exposure and elevated rates of forearm fracture. S. Hillier, C. Cooper, S. Kellingray, et al., "Fluoride in Drinking Water and Risk of Hip Fracture in the UK: A Case Control Study," The Lancet 335, no. 9200 (2000): 265 -69. S. J. Jacobsen, W. M. O'Fallon, and L. J. Melton III, "Hip Fracture Incidence Before and After the Fluoridation of the Public Water Supply, Rochester, Minnesota," American Journal of Public Health 83, no. 5 (1993): 743 -45, http:// ajph. aphapublications .org/cgi/reprint/83 /5 /743.pdf M. R. Karagas, J. A. Baron, J. A. Barrett, and S. J. Jacobsen, "Patterns of Fracture Among the United States Elderly: Geographic and Fluoride Effects," Annals of Epidemiology 6, no. 3 (1996): 209 -16. Note: As with Feskanich, et al. (1998), this study didn't find an association between fluoridation and hip fracture, but it did find an association between fluoridation and distal forearm fracture, as well as proximal humerus fracture. "Independent of geographic effects, men in fluoridated areas had modestly higher rates of fractures of the distal forearm and proximal humerus than did men in nonfluoridated areas." R. Lehmann, M. Wapniarz, B. Hofmann, et al., "Drinking Water Fluoridation: Bone Mineral Density and Hip Fracture Incidence," Bone 22, no. 3 (1998): 273 -78. Page 113 of 114 K. R. Phipps, E. S. Orwoll, J. D. Mason, and J. A Cauley, "Community Water Fluoridation, Bone Mineral Density and Fractures: Prospective Study of Effects in Older Women," British Medical Journal 321, no. 7265 (2000): 860 -64. Note: As with Feskanich, et al. (1998) and Karagas, et al. (1996), this study didn't find an association between water fluoride and hip fracture, but it did find an association between water fluoride and other types of fracture —in this case, wrist fracture. "There was a non - significant trend toward an increased risk of wrist fracture." M. E. Suarez- Almazor, G. Flowerdew, L. D. Saunders, et al., "The Fluoridation of Drinking Water and Hip Fracture Hospitalization Rates in Two Canadian Communities," American Journal of Public Health 83, no. 5 (1993): 689 -93, http: / /www.ncbi.nlm.nih.gov /pmc/ articles /PMC 1694711 /pdf/amiph00529- 0067.pdf -Note: While the authors of this study conclude that there is no association between fluoridation and hip fracture, their own data reveals a statistically significant increase in hip fracture for men living in the fluoridated area. According to the authors, "Although a statistically significant increase in the risk of hip fracture was observed among Edmonton men, this increase was relatively small (RR= 1.12)." See also: ENDNOTES Page 114 of 114