[Federal Register Volume 80, Number 84 (Friday, May 1, 2015)]
[Notices]
[Pages 24936-24947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Public Health Service Recommendation for Fluoride Concentration 
in Drinking Water for Prevention of Dental Caries

AGENCY: Office of the Secretary, HHS.

SUMMARY: Through this final recommendation, the U.S. Public Health 
Service (PHS) updates and replaces its 1962 Drinking Water Standards 
related to community water fluoridation--the controlled addition of a 
fluoride compound to a community water supply to achieve a 
concentration optimal for dental caries prevention. For these community 
water systems that add fluoride, PHS now recommends an optimal fluoride 
concentration of 0.7 milligrams/liter (mg/L). In this guidance, the 
optimal concentration of fluoride in drinking water is the 
concentration that provides the best balance of protection from dental 
caries while limiting the risk of dental fluorosis. The earlier PHS 
recommendation for fluoride concentrations was based on outdoor air 
temperature of geographic areas and ranged from 0.7-1.2 mg/L. This 
updated guidance is intended to apply to community water systems that 
currently fluoridate or that will initiate fluoridation, and is based 
on considerations that include:
     Scientific evidence related to the effectiveness of water 
fluoridation in caries prevention and control across all age groups,
     Fluoride in drinking water as one of several available 
fluoride sources,
     Trends in the prevalence and severity of dental fluorosis, 
and
     Current evidence on fluid intake of children across 
various outdoor air temperatures.

FOR FURTHER INFORMATION CONTACT: Barbara F. Gooch, DMD, MPH, Centers 
for Disease Control and Prevention, National Center for Chronic Disease 
Prevention and Health Promotion, Division of Oral Health, 4770 Buford 
Highway NE., MS F-80, Atlanta, GA 30341-3717; tel. 770-488-6054; fax 
770-488-6080; email <[email protected]>.

SUPPLEMENTARY INFORMATION: Because fluoridation of public drinking 
water systems had been demonstrated as effective in reducing dental 
caries, the U.S. Public Health Service (PHS) provided recommendations 
regarding optimal fluoride concentrations in drinking water for 
community water systems in 1962 (U.S. DHEW, 1962). The U.S. Department 
of Health and Human Services (HHS) is releasing this updated PHS 
recommendation because of new data that address changes in the 
prevalence of dental fluorosis, the relationship between water intake 
and outdoor temperature in children, and the contribution of fluoride 
in drinking water to total fluoride exposure in the United States. 
Although PHS recommends community water fluoridation as an effective 
public health intervention, the decision to fluoridate water systems is 
made by state and local governments.
    As of December 31, 2012, the Centers for Disease Control and 
Prevention (CDC) estimated that approximately 200 million people in the 
United States were served by 12,341 community water systems that added 
fluoride to water or

[[Page 24937]]

purchased water with added fluoride from other systems. For many years, 
nearly all of these fluoridated systems used fluoride concentrations 
ranging from 0.8 to 1.2 mg/L; fewer than 1% of these systems used a 
fluoride concentration at 0.7 mg/L (Unpublished data, Water 
Fluoridation Reporting System, CDC, 2010). When water systems that add 
fluoride implement the new PHS recommendation (0.7 mg/L), the fluoride 
concentration in these systems will be reduced by 0.1 to 0.5 mg/L and 
fluoride intake from water will decline among most people served by 
these systems.
    It is expected that implementation of the new recommendation will 
lead to a reduction of approximately 25% (range: 12%-42%) in fluoride 
intake from drinking water alone and a reduction of approximately 14% 
(range: 5%-29%) in total fluoride intake. These estimates are based on 
intake among young children at the 90th percentile of drinking water 
intake for whom drinking water accounts for 40%-70% of total fluoride 
intake (U.S. EPA, 2010a). Furthermore, these estimates are based on a 
weighted mean fluoride concentration of 0.94 mg/L in systems that added 
fluoride (or purchased water from systems that added fluoride) in 2009 
(Unpublished data, Water Fluoridation Reporting System, CDC, 2009). 
Community water systems that contain naturally occurring fluoride at 
concentrations greater than 0.7 mg/L (estimated to serve about 11 
million people) will not be directly affected by the new PHS 
recommendation.
    Under the Safe Drinking Water Act, the U.S. Environmental 
Protection Agency (EPA) sets standards for drinking water quality (42 
U.S.C. 300f et seq. (1974)). EPA is in the process of reviewing the 
maximum amount of fluoride allowed in drinking water. Upon completion 
of its review, EPA will determine if it is appropriate to revise the 
drinking water standard for fluoride. Currently, the enforceable 
standard is set at 4.0 mg/L to protect against severe skeletal 
fluorosis, a rare condition in the United States (NRC, 2006; U.S. EPA, 
2010b). If the EPA determines that it is appropriate to revise the 
standard, any revisions could affect certain community water systems 
that have naturally occurring fluoride. More information about EPA's 
existing drinking water standards for fluoride can be found at: http://water.epa.gov/drink/contaminants/basicinformation/fluoride.cfm.

Recommendation

    For community water systems that add fluoride to their water, PHS 
recommends a fluoride concentration of 0.7 mg/L (parts per million 
[ppm]) to maintain caries prevention benefits and reduce the risk of 
dental fluorosis.

Rationale

Importance of Community Water Fluoridation

    Community water fluoridation is a major factor responsible for the 
decline in prevalence (occurrence) and severity of dental caries (tooth 
decay) during the second half of the 20th century (CDC, 1999). For 
adolescents, the prevalence of dental caries in at least one permanent 
tooth (excluding third molars) decreased from 90% among those aged 12-
17 years in the 1960's (Kelly JE, 1975) to 60% among those aged 12-19 
years in 1999-2004 (Dye B, et al., 2007); during that interval, the 
number of permanent teeth affected by dental caries (i.e., decayed, 
missing and filled) declined from 6.2 to 2.6, respectively. Adults also 
have benefited from community water fluoridation; the average number of 
affected teeth decreased from 18 among 35- to 44-year-old adults in the 
1960s to 10 among 35- to 49-year-old adults in 1999-2004 (Kelly JE, et 
al., 1973; Dye B, et al., 2007). Although data were not age-adjusted, 
age groups in the 1999-2004 survey used a higher upper age limit, and 
both caries prevalence and number of teeth affected increased with age; 
thus, these comparisons may underestimate caries decline over time.
    Although there have been notable declines in tooth decay, it 
remains one of the most common chronic diseases of childhood (U.S. 
DHHS, 2000; Newacheck PW et al., 2000). In 2009-2010, national survey 
data showed that untreated dental caries among children varied by race/
ethnicity and federal poverty level. About one in four children living 
below 100% of the federal poverty level had untreated decay (Dye BA et 
al., 2012). Untreated tooth decay can result in pain, school absences, 
and poorer school performance (Lewis C, et al., 2010; Detty AMR, et 
al., 2014; Jackson SL, et al., 2011; Seirawan H, et al., 2012).
    Systematic reviews of the scientific evidence related to fluoride 
have concluded that community water fluoridation is effective in 
decreasing dental caries prevalence and severity (McDonagh MS, et al., 
2000a; McDonagh MS, et al., 2000b; Truman BI, et al., 2002; ARCPOH 
2006; Griffin SO, et al., 2007; Yeung, 2008; CPSTF, 2013). Effects 
included significant increases in the proportion of children who were 
caries-free and significant reductions in the number of teeth or tooth 
surfaces with caries in both children and adults (McDonagh MS, et al., 
2000b; ARCPOH 2006; Griffin SO, et al., 2007; Yeung, 2008; CPSTF, 
2013). When analyses were limited to studies conducted after the 
introduction of other sources of fluoride, especially fluoride 
toothpaste, beneficial effects across the lifespan from community water 
fluoridation were still apparent (McDonagh MS, et al., 2000b; Griffin 
SO, et al., 2007; Slade, et al., 2013).
    Fluoride in saliva and dental plaque works to prevent dental caries 
primarily through topical remineralization of tooth surfaces 
(Koulourides T, 1990; Featherstone JDB, 1999). Consuming fluoridated 
water and beverages, and foods prepared or processed with fluoridated 
water, throughout the day maintains a low concentration of fluoride in 
saliva and plaque that enhances remineralization. Although other 
fluoride-containing products are available and contribute to the 
prevention and control of dental caries, community water fluoridation 
has been identified as the most cost-effective method of delivering 
fluoride to all members of the community regardless of age, educational 
attainment, or income level (CDC, 1999; Burt BA, 1989). Studies 
continue to find that community water fluoridation is cost-saving 
(Truman B, et al., 2002; O'Connell JM, et al., 2005; Campain AC, et 
al., 2010; Cobiac LJ and Vos T, 2012).

Trends in Availability of Fluoride Sources

    Community water fluoridation and fluoride toothpaste are the most 
common sources of non-dietary fluoride in the United States (CDC, 
2001b). Community water fluoridation began in 1945, reaching 49% of the 
U.S. population by 1975 and 67% by 2012 (http://www.cdc.gov/fluoridation/statistics/2012stats.htm; http://www.cdc.gov/nohss/FSGrowth_text.htm). Toothpaste containing fluoride was first marketed 
in the United States in 1955 (USDHEW, 1980). By 1983, more than 90% of 
children and adolescents 5-19 years of age, and almost 70% of young 
children 2-4 years of age, reportedly used fluoride toothpaste (Ismail 
AI, et al, 1987). By 1986, more than 90% of young children 2-4 years of 
age also were reported to use fluoride toothpaste (NCHS, 1988). And by 
the 1990s, fluoride toothpaste accounted for more than 90 percent of 
the toothpaste market (Burt BA and Eklund SA, 2005). Other products 
that provide fluoride now include mouth rinses, dietary fluoride 
supplements, and professionally applied fluoride compounds. More 
detailed explanations

[[Page 24938]]

of these products are published elsewhere. (CDC, 2001b; ADA, 2006; 
USDHHS, 2010)
    More information on major sources of ingested fluoride and their 
relative contributions to total fluoride exposure in the United States 
is presented in an EPA report (U.S. EPA 2010a). To protect the majority 
of the population, EPA uses the 90th percentile of drinking water 
intake for all age groups in calculating the relative contribution for 
each fluoride source. The EPA definition of ``drinking water'' includes 
tap water ingested alone or with beverages and certain foods 
reconstituted in the home. Among children aged 6 months to 14 years, 
drinking water accounts for 40%-70% of total fluoride intake; for 
adults, drinking water provides 60% of total fluoride intake. 
Toothpaste that has been swallowed inadvertently is estimated to 
account for about 20 percent of total fluoride intake in very young 
children (1-3 years of age) (U.S. EPA 2010a). Other major contributors 
to total daily fluoride intake are commercial beverages and solid 
foods.

Dental Fluorosis

    Fluoride ingestion while teeth are developing can result in a range 
of visually detectable changes in the tooth enamel called dental 
fluorosis. Changes range from barely visible lacy white markings in 
milder cases to pitting of the teeth in the rare, severe form. The 
period of possible risk for fluorosis in the permanent teeth, excluding 
the third molars, extends from birth through 8 years of age when the 
pre-eruptive maturation of tooth enamel is complete (CDC, 2001b; 
Massler M and Schour I, 1958; Avery, 1987). The risk for and severity 
of dental fluorosis depends on the amount, timing, frequency, and 
duration of the exposure (CDC, 2001b). When communities first began 
adding fluoride to their public water systems in 1945, drinking water 
and local foods and beverages prepared with fluoridated water were the 
primary sources of fluoride for most children (McClure FJ, 1943; U.S. 
EPA, 2010b). At that time, only a few systems fluoridated their water, 
minimizing the amount of fluoride contributed by processed water to 
commercial foods and beverages. Since the 1940s, other sources of 
ingested fluoride such as fluoride toothpaste (if swallowed) and 
dietary fluoride supplements have become available. Fluoride intake 
from these products, in addition to water, other beverages, and infant 
formula prepared with fluoridated water, have been associated with 
increased risk of dental fluorosis (Levy SL, et al., 2010; Wong MCM, et 
al., 2010; Ismail AI and Hasson H, 2008; Osuji OO et al., 1988; Pendrys 
DG et al., 1994; Pendrys DG and Katz RV 1989; Pendrys DG, 1995). Both 
the 1962 PHS recommendations and the current updated recommendation for 
fluoride concentration in community drinking water were set to achieve 
reduction in dental caries while minimizing the risk of dental 
fluorosis.
    Results of two national surveys indicate that the prevalence of 
dental fluorosis has increased since the 1980s, but mostly in very mild 
or mild forms. Data on prevalence of dental fluorosis come from the 
National Health and Nutrition Examination Survey (NHANES), 1999-2004 
(Beltr[aacute]n-Aguilar ED, et al., 2010a). NHANES assessed the 
prevalence and severity of dental fluorosis among people aged 6 to 49 
years. Twenty-three percent (95% confidence interval [CI]: 20.1, 26.1) 
had dental fluorosis, of which the vast majority was very mild or mild. 
Approximately 2% (95% CI: 1.5, 2.5) of people had moderate dental 
fluorosis, and less than 1% (95% CI: 0.1, 0.4) had severe fluorosis. 
Prevalence of dental fluorosis that was very mild or greater was higher 
among young people and ranged from 41% (95% CI: 36.3, 44.9) among 
adolescents aged 12-15 years to 9% (95% CI: 6.1, 11.4) among adults, 
aged 40-49 years.
    The prevalence and severity of dental fluorosis among 12- to 15-
year-olds in 1999-2004 also were compared with estimates from the Oral 
Health of United States Children survey, 1986-1987 (USDHHS, 1989), 
which was the first national survey to include measures of dental 
fluorosis. Although these two national surveys differed in sampling and 
representation (household vs. schoolchildren), findings support the 
hypothesis that there was an increase in dental fluorosis that was very 
mild or greater during the time between the two surveys. In 1986-1987 
and 1999-2004, the prevalence of dental fluorosis was 23% and 41%, 
respectively, among adolescents aged 12 to 15 years. (Beltr[aacute]n-
Aguilar ED, et al., 2010a). Similarly, the prevalence of very mild 
fluorosis (17.2% and 28.5%), mild fluorosis (4.1% and 8.6%), and 
moderate and severe fluorosis combined (1.3% and 3.6%) among 12- to 15-
year-old adolescents during 1986-1987 and 1999-2004, respectively, all 
showed increases. Estimates limited to severe fluorosis among 
adolescents in both surveys, however, were statistically unreliable 
because there were too few cases among survey participants examined. 
The higher prevalence of dental fluorosis in young people in 1999-2004 
may reflect increases in fluoride exposures (intake) across the U.S. 
population.
    Children are at risk for fluorosis in the permanent teeth from 
birth through 8 years of age. Adolescents who were 12-15 years of age 
when they participated in the national surveys of 1986-1987 and 1999-
2004 would have been at risk for dental fluorosis from 1971-1983 and 
from 1984-2000, respectively.
    By 1969, the percentage (number) of the U.S. population receiving 
fluoridated water was 44% (88,475,684). By 1985, this percentage 
(number) increased about 10 percentage points, reaching 55% 
(130,172,334). By 2000, this percentage (number) was 57% (161,924,080). 
Although the percentage point increases in more recent years appear 
small (2 percentage points from 1985 to 2000), it is important to note 
that the total size of the U.S. population also continued to expand 
during the time period. As a result, the 10-percentage-point increase 
from 1969 to 1985 reflects an increase of more than 40 million people 
receiving fluoridated water whereas the 2-percentage-point increase 
from 1985 to 2000 represents an increase of more than 30 million 
people.
    Available data do not support additional detailed examination of 
changes in the percentage of children and adolescents using fluoride 
toothpaste. As previously described in Trends in Availability of 
Fluoride Sources, by 1983, more than 90% of children and adolescents, 
5-19 years, and almost 70% of young children, 2-4 years of age, were 
reportedly using fluoride toothpaste (Ismail AI, et al., 1987); by 1986 
more than 90% of young children were also using fluoride toothpaste 
(NCHS, 1988). As mentioned, recent EPA estimates indicate that 
toothpaste swallowed inadvertently accounts for about 20 percent of 
total fluoride intake in very young children (U.S. EPA 2010a).
    More information on fluoride concentrations in drinking water and 
the risk of severe dental fluorosis in children is presented in a 
report by EPA (U.S. EPA 2010b). EPA's scientific assessments considered 
new data on dental fluorosis and updated exposure estimates to reflect 
current conditions. Based on original data from a study that predated 
widespread water fluoridation in the United States, EPA determined that 
the benchmark dose for a 0.5% prevalence of severe dental fluorosis was 
a drinking water fluoride concentration of 2.14 mg/L, with a lower 95% 
CI of 1.87 mg/L (U.S. EPA 2010b). Categorical regression modeling (U.S. 
EPA, 2011 presentation) also indicated that the concentration of

[[Page 24939]]

fluoride in water associated with a 1% prevalence of severe dental 
fluorosis decreased over time (1940-2000). These findings are 
consistent with an increase in exposures from other sources of fluoride 
and support the conclusion that a fluoride concentration in drinking 
water of 0.7 mg F/L would reduce the chance of dental fluorosis--
especially severe dental fluorosis--in the current context of multiple 
fluoride sources.
    The two EPA assessments of fluoride (U.S. EPA, 2010a; U.S. EPA, 
2010b) responded to earlier findings of the National Research Council 
(NRC) of the National Academies of Science (NRC, 2006). The NRC had 
reviewed new data on fluoride at EPA's request and in 2006 recommended 
that EPA update health and exposure assessments to consider all sources 
of fluoride and to take into account dental effects--specifically, 
pitting of teeth (i.e., severe dental fluorosis) in children. The NRC 
identified severe dental fluorosis as an adverse health effect, because 
pitting of the enamel compromises its protective function. The NRC's 
report focused on the potential for adverse effects from naturally 
occurring fluoride at 2-4 mg/L in drinking water; it did not examine 
benefits or risks that might occur at lower concentrations typically 
used for community water fluoridation (0.7 to 1.2 mg/L) (NRC, 2006). 
For this PHS recommendation, Panel scientists did review the balance of 
benefits and potential for unwanted effects of water fluoridation at 
those lower levels (U.S. EPA, 2010b).

Relationship Between Dental Caries and Fluorosis at Varying Water 
Fluoridation Concentrations

    The 1986-1987 Oral Health of United States Children survey has been 
the only national survey that assessed the child's water fluoride 
exposure, thus allowing linkage of that exposure to measures of caries 
and fluorosis (USDHHS, 1989). An additional analysis of data from this 
survey examined the relationship between dental caries and fluorosis at 
varying water fluoride concentrations for children and adolescents 
(Heller KE, et al., 1997). Findings indicate that there was a gradual 
decline in dental caries as fluoride content in water increased from 
negligible to 0.7 mg/L. Reductions plateaued at concentrations from 
0.7-1.2 mg/L. In contrast, the percentage of children with at least 
very mild dental fluorosis increased from 13.5% (standard error [SE] = 
1.9) to 41.4% (SE = 4.4) as fluoride concentrations in water increased 
from <0.3 mg/L to >1.2 mg/L.
    In Hong Kong, a small decrease of about 0.2 mg/L in the mean 
fluoride concentration in drinking water in 1978 (from 0.82 mg/L to 
0.64 mg/L) was associated with a detectable reduction in fluorosis 
prevalence by the mid-1980s, from 64% (SE = 4.1) to 47% (SE = 4.5), 
based on the upper right central incisor only. Across all age groups, 
more than 90 percent of fluorosis cases were very mild or mild (Evans 
RW and Stamm JW, 1991). The study did not include measures of fluoride 
intake. Concurrently, dental caries prevalence did not increase (Lo 
ECM, et al., 1990). Although not fully generalizable to the current 
U.S. context, these findings, along with findings from the 1986-1987 
survey of U.S. schoolchildren, suggest that the risk of fluorosis can 
be reduced and caries prevention maintained toward the lower end (i.e., 
0.7 mg/L) of the 1962 PHS recommendations for community water 
fluoridation.

Relationship of Water Intake and Outdoor Temperature Among Children and 
Adolescents in the United States

    The 1962 PHS recommendations stated that community drinking water 
should contain 0.7-1.2 mg/L (ppm) fluoride, depending on the outdoor 
air temperature of the area. These temperature-related guidelines were 
based on studies conducted in two communities in California in the 
early 1950s. Findings indicated that a lower fluoride concentration was 
appropriate for communities in warmer climates because children drank 
more water on warm days (Galagan DJ, 1953; Galagan DJ and Vermillion 
JR, 1957; Galagan DJ, et al., 1957). Social and environmental changes, 
including increased use of air conditioning and more sedentary 
lifestyles, have occurred since the 1950s--thus, the assumption that 
children living in warmer regions drink more tap water than children in 
cooler regions may no longer be valid (Heller, et al., 1999).
    Studies conducted since 2001 suggest that children's water intake 
does not increase with increases in outdoor air temperature (Sohn W, et 
al., 2001; Beltr[aacute]n-Aguilar ED, et al., 2010b). One study 
conducted among children using nationally representative data from 
NHANES 1988-1994 did not find an association between either total or 
plain water intake and outdoor air temperature (Sohn W, et al., 2001). 
Although a similar study using nationally representative data from 
NHANES 1999-2004 also found no association between total water intake 
and outdoor temperature among children or adolescents (Beltr[aacute]n-
Aguilar ED, et al., 2010b), additional analyses of these data detected 
a small but statistically significant association between plain water 
intake and outdoor temperature (Beltr[aacute]n-Aguilar ED, et al., 
manuscript for Public Health Reports). Temperature explained less than 
1% of the variation in plain water intake; thus, these findings support 
use of one target concentration for community water fluoridation in all 
temperature zones of the United States, a standard far simpler to 
implement than the 1962 temperature-based recommendations. In these 
analyses, ``plain water'' was defined as from the tap or bottled water 
and ``total water'' included water from or mixed with other beverages, 
such as juice, soda, sport drinks, and non-dairy milk, as well as water 
from or mixed with foods (Beltr[aacute]n-Aguilar ED, et al., manuscript 
for Public Health Reports).

Process

    HHS convened a federal inter-departmental, inter-agency panel of 
scientists (Appendix A) to review scientific evidence relevant to the 
1962 PHS Drinking Water Standards for fluoride concentrations in 
drinking water in the United States and to update these recommendations 
based on current science. Panelists included representatives from the 
CDC, the National Institutes of Health, the Food and Drug 
Administration (FDA), the Agency for Healthcare Research and Quality, 
the Office of the Assistant Secretary for Health, the EPA, and the U.S. 
Department of Agriculture. The Panel evaluated recent systematic 
reviews of the effectiveness of fluoride in drinking water to prevent 
dental caries, as well as published reports about the epidemiology of 
dental caries and fluorosis in the United States and the relationship 
of these conditions with varying water fluoridation concentrations. The 
Panel also reviewed existing recommendations for fluoride in drinking 
water and newer data on the relationship between water intake in 
children and outdoor air temperature in the United States--a 
relationship that had served as the basis for the 1962 recommendation.
    Recent systematic reviews of evidence on the effectiveness of 
community water fluoridation were from the Community Preventive 
Services Task Force (CPSTF), first published in 2001 and updated in 
2013, and the Australian National Health and Medical Research Council 
in 2007 (Truman BI, et al., 2002; CPSTF, 2013). Both reviews updated a 
comprehensive systematic review of water fluoridation completed by the 
National Health Service Centre for Reviews and Dissemination, 
University of York, in 2000 (McDonagh MS et al.,

[[Page 24940]]

2000a, McDonagh MS et al., 2000b). In these reviews, estimates of 
fluoridation effectiveness in preventing caries were limited to 
children and adolescents and based on comparative studies. Random 
assignment of individuals usually is not feasible for studies of water 
fluoridation, because the intervention occurs in the community water 
system. Another systematic review examined the effectiveness of water 
fluoridation in preventing dental caries in adults. Findings were based 
primarily on cross-sectional studies of lifelong residents of 
communities with fluoridated or non-fluoridated water (Griffin SO, et 
al, 2007). Studies in these systematic reviews were not limited to the 
United States.
    Panel scientists accepted an extensive review of fluoride in 
drinking water by the NRC (NRC, 2006) as the summary of hazard. The NRC 
review focused on potential adverse effects of naturally occurring 
fluoride at 2-4 mg/L in drinking water; it found no evidence 
substantial enough to support effects other than severe dental 
fluorosis at these levels. A majority of NRC Committee members also 
concluded that lifetime exposure to fluoride at a drinking water 
concentration of 4.0 mg/L (the enforceable standard established by EPA) 
is likely to increase bone fracture rates in the population, compared 
with exposures at 1.0 mg/L (NRC, 2006). Fluoride concentrations used 
for water fluoridation have been substantially lower than the 
enforceable standard EPA established to protect against severe skeletal 
fluorosis (USDHEW, 1962; NRC, 2006).
    Conclusions of the Panel were summarized, along with their 
rationale, in the Federal Register document (USDHHS, 2011). PHS 
guidance is advisory, not regulatory, in nature.
    Overview of Public Comments: The public comment period for the 
Proposed Recommendation for Fluoride Concentration in Drinking Water 
for the Prevention of Dental Caries lasted for 93 days; it began with 
publication of the Federal Register notice on January 13, 2011, and was 
extended from its original deadline of February 14, 2011, to April 15, 
2011 to allow adequate time for interested organizations and members of 
the public to respond. Duplicate comments (e.g., electronic and paper 
submissions from the same source) were counted as one comment. Although 
the 51 responses received electronically or postmarked after the 
deadline (midnight ET, April 15, 2011) were not reviewed, all other 
comments were considered carefully.
    Approximately 19,300 responses were received; of these responses, 
approximately 18,500 (96 percent) were nearly identical to a letter 
submitted by an organization opposing community water fluoridation, 
often originating from the Web site of that organization; hereafter, 
these responses are called ``standard letters.'' Of the remaining 746 
unique responses, 79 anecdotes described personal experiences, often 
citing potentially harmful effects, and 18 consisted of attachments 
only. Attachments to the unique submissions were examined to ensure 
that they addressed the recommendation, and to determine whether they 
supported it, opposed it as too low, or opposed it as too high. 
Although nearly all responses came from the general public, comments 
also were submitted by organizations, such as those representing 
dental, public health, or water supply professionals; those that 
advocate cessation of community water fluoridation; or commercial 
companies.
    Of the unique responses, most opposed the recommendation as still 
too high and presented multiple concerns. Four CDC scientists (who did 
not serve on the inter-agency Federal Panel) reviewed all unique 
responses and used an electronic list of descriptors to categorize 
their contents. Comments were summarized and reported to the full 
Federal Panel, along with examples reflecting a range of differing 
opinions regarding the new recommendation. The following sections 
summarize frequent comments and provide the Federal Panel's response, 
divided into three categories: Comments that opposed the recommendation 
as still too high, comments that opposed the recommendation as too low 
to achieve prevention of dental caries, and comments that supported the 
recommendation. Data on the approximate numbers of comments received in 
support of and opposed to the new recommendation are provided for 
informational purposes. Responses to these comments are based primarily 
on conclusions of evidence-based reviews and/or expert panels that 
reviewed and evaluated the best available science.

Comments That Opposed the Recommendation as Too High

    Nearly all submissions opposed community water fluoridation at any 
concentration; they stated that the new recommendation remains too 
high, and most asked that all fluoride be removed from drinking water. 
These submissions include the standard letters (~18,500) and unique 
responses (~700 said the new level was too high; of these ~500 
specifically asked for all fluoride to be removed). Nearly all of these 
submissions listed possible adverse health effects as concerns 
specifically, severe dental fluorosis, bone fractures, skeletal 
fluorosis, carcinogenicity, lowered IQ and other neurological effects, 
and endocrine disruption.
    In response to these concerns, PHS again reviewed the scientific 
information cited to support actions announced in January 2011 by the 
HHS (U.S. DHHS, 2011) and the EPA (U.S. EPA, 2010a; U.S. EPA, 2010b)--
and again considered carefully whether or not the proposed 
recommendations and standards on fluoride in drinking water continue to 
provide the health benefits of community water fluoridation while 
minimizing the chance of unwanted health effects from too much 
fluoride. After a thorough review of the comments opposing the 
recommendation, the Federal Panel did not identify compelling new 
information to alter its assessment that the recommended fluoride 
concentration (0.7 mg/L) provides the best balance of benefit to 
potential harm.

Dental Fluorosis

    The standard letters stated that the new recommendation would not 
eliminate dental fluorosis and cited its current prevalence among U.S. 
adolescents. In national surveys cited by the initial Federal Register 
notice, however, more than 90 percent of dental fluorosis in the United 
States is the very mild or mild form, most often appearing as barely 
visible lacy white markings or spots on the enamel (Beltr[aacute]n-
Aguilar, ED, at al., 2010a). EPA considers the severe form of dental 
fluorosis, with staining and pitting of the tooth surface, as the 
``adverse health effect'' to be prevented (U.S. EPA, 2010b). Severe 
dental fluorosis is rare in the United States, and its prevalence could 
not be estimated among adolescents in a national survey because there 
were too few cases among the survey participants examined to achieve 
statistical reliability (Beltr[aacute]n-Aguilar, ED, et al, 2010a). The 
NRC review noted that prevalence of severe dental fluorosis was near 
zero at fluoride concentrations below 2 mg/L (NRC, 2006, p. 10). In 
addition, the most recent review of community water fluoridation by the 
Community Preventive Services Task Force concluded that ``there is no 
evidence that community water fluoridation results in severe dental 
fluorosis'' (CPSTF, 2013).
    Standard letter submissions also expressed concern that infants fed 
formula reconstituted with fluoridated drinking water would receive too 
much fluoride. If an infant is consuming only

[[Page 24941]]

infant formula mixed with fluoridated water, there may be an increased 
chance for permanent teeth (when they erupt at ~ age 6) to have mild 
dental fluorosis (ADA, 2011). To lessen this chance, parents may choose 
to use low-fluoride bottled water some of the time to mix infant 
formula, e.g., bottled waters labeled as de-ionized, purified, 
demineralized, or distilled, and without any fluoride added after 
purification treatment (FDA requires the label to indicate when 
fluoride is added). Such guidance currently is found on the Web sites 
of both CDC (http://www.cdc.gov/fluoridation/safety/infant_formula.htm) 
and the American Dental Association (http://www.mouthhealthy.org/en/az-topics/f/fluorosis.aspx). The PHS recommendation to lower the fluoride 
concentration for community water fluoridation should decrease fluoride 
exposure during the time of enamel formation, from birth through 8 
years of age for most permanent teeth (CDC, 2001b; Avery, 1987; Massler 
M and Schour I, 1958), and further lessen the chance for children's 
teeth to have dental fluorosis, while keeping the decay prevention 
benefits of fluoridated water.

Bone Fractures and Skeletal Fluorosis

    Some unique comments (~100) cited fractures or other pathology of 
bone, while the standard letters expressed concern about skeletal 
fluorosis (i.e., a bone disease caused by excessive fluoride intake for 
a long period of time that in advanced stages can cause pain or damage 
to bones and joints) and suggested that symptoms of stage II skeletal 
fluorosis (i.e., a clinical stage associated with chronic pain) are 
identical to those of arthritis (i.e., sporadic pain and stiffness of 
the joints). The NRC review found no recent studies to evaluate the 
prevalence of skeletal fluorosis in U.S. populations exposed to 
fluoride at the current maximum level of 4.0 mg/L (NRC, 2006). On the 
basis of existing epidemiologic literature, the NRC concluded that 
stage III skeletal fluorosis (i.e., a clinical stage associated with 
significant bone or joint damage) ``appears to be a rare condition in 
the United States'' and stated that 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'' (NRC, 2006).
    The NRC also recommended that EPA consider additional long-term 
effects on bone in adults--stage II skeletal fluorosis and bone 
fractures--as well as the health endpoint that had been evaluated 
previously (i.e. stage III skeletal fluorosis) (NRC, 2006). In 
response, the EPA Dose-Response Analysis for Non-Cancer Effects noted 
that, although existing data were inadequate to model the relationship 
of fluoride exposure and its impact on bone strength, skeletal effects 
among adults are unlikely to occur at the fluoride intake level 
estimated to protect against severe dental fluorosis among children 
(U.S. EPA, 2010b). The EPA report concluded that exposure to 
concentrations of fluoride in drinking water of 4 mg/L and above 
appears to be positively associated with the increased relative risk of 
bone fractures in susceptible populations when compared with 
populations consuming fluoride concentrations of 1 mg/L (U.S. EPA, 
2010b). Recently, a large cohort study of older adults in Sweden 
reported no association between long-term exposure to drinking water 
with fluoride concentrations up to 2.7 mg/L and hip fracture 
(N[auml]sman P, et al., 2013).
    The fluoride intake estimated by EPA to protect against severe 
dental fluorosis among children during the critical period of enamel 
formation was determined to be ``likely also protective against 
fluoride-related adverse effects in adults, including skeletal 
fluorosis and an increased risk of bone fractures'' (U.S. EPA, 2010b). 
EPA compared its own risk assessments for skeletal effects with those 
made both by the NRC in 2006 and by the World Health Organization in 
2002. EPA concluded that its own dose recommendation is protective 
compared with each of these other benchmarks and, thus, is ``applicable 
to the entire population since it is also protective for the endpoints 
of severe fluorosis of primary teeth, skeletal fluorosis, and increased 
risk of bone fractures in adults'' (U.S. EPA, 2010b).

Carcinogenicity

    Some unique comments (~100) mentioned concerns regarding fluoride 
as a carcinogen, and the standard letters called attention to one study 
(Bassin, et al., 2006) that reported an association between 
osteosarcoma (i.e., a type of bone cancer) among young males and 
estimated fluoride exposure from drinking water, based on residence 
history. The study examined an initial set of cases from a hospital-
based case-control study of osteosarcoma and fluoride exposure. 
Findings from subsequent cases (Kim, et al., 2011) were published in 
2011. This later study assessed fluoride exposure using actual bone 
fluoride concentration--a more accurate and objective measure than 
previous estimates based on reported fluoride concentrations in 
drinking water at locations in the reported residence history. The 
later study showed no significant association between bone fluoride 
levels and osteosarcoma risk (Kim, et al., 2011). This finding is 
consistent with systematic reviews (McDonagh, 2000b; Parnell, 2009; 
ARCPOH, 2006, Yeung, 2008) and three recent ecological studies (Comber, 
et al., 2011; Levy and Leclerc, 2012; Blakey K, et al., 2014) that 
found no association between incidence of this rare cancer and the 
fluoride content of community water. Although study authors 
acknowledged the statistical and methodological limitations of 
ecological analyses, they also noted that their findings were 
consistent with the hypothesis that low concentrations of fluoride in 
water do not increase the risk of osteosarcoma development.
    A critical review of fluoride and fluoridating agents of drinking 
water, accepted by the European Commission's Scientific Committee on 
Health and Environmental Risks (SCHER) in 2010, used a weight-of-
evidence approach and concluded that epidemiological studies did not 
indicate a clear link between fluoride in drinking water and 
osteosarcoma or cancer in general. In addition, the committee found 
that the available data from animal studies, in combination with the 
epidemiology results, did not support classifying fluoride as a 
carcinogen (SCHER, 2010). Finally, the Proposition 65 Carcinogen 
Identification Committee, convened by the Office of Environmental 
Health Hazard Assessment, California Environmental Protection Agency, 
determined in 2011 that fluoride and its salts have not clearly been 
shown to cause cancer (OEHHA CA, 2011).

IQ and Other Neurological Effects

    The standard letters and approximately 100 unique responses 
expressed concern about fluoride's impact on the brain, specifically 
citing lower IQ in children. Several Chinese studies (Xiang, et al., 
2003; Lu, et al., 2000; Zhao, et al., 1996) considered in detail by the 
NRC review reported lower IQ among children exposed to fluoride in 
drinking water at mean concentrations of 2.5-4.1 mg/L--several times 
higher than concentrations recommended for community water 
fluoridation. The NRC found that ``the significance of these Chinese 
studies is uncertain'' because important procedural details were 
omitted, but also stated that findings warranted additional research on 
the effects of fluoride on intelligence (NRC, 2006).
    Based on animal studies, the NRC committee speculated about 
potential

[[Page 24942]]

mechanisms for nervous system changes and called for more research ``to 
clarify the effect of fluoride on brain chemistry and function'' (NRC, 
2006). These recommendations should be considered in the context of the 
NRC review, which limited its conclusions regarding adverse effects to 
water fluoride concentrations of 2-4 mg/L and did ``not address the 
lower exposures commonly experienced by most U.S. citizens'' (NRC, 
2006). A recent meta-analysis of studies conducted in rural China, 
including those considered by the NRC report, identified an association 
between high fluoride exposure (i.e., drinking water concentrations 
ranging up to 11.5 mg/L) and lower IQ scores; study authors noted the 
low quality of included studies and the inability to rule out other 
explanations (Choi, et al., 2012). A subsequent review cited this meta-
analysis to support its identification of ``raised fluoride 
concentrations'' in drinking water as a developmental neurotoxicant 
(Grandjean and Landrigan, 2014).
    A review by SCHER also considered the neurotoxicity of fluoride in 
water and determined that there was not enough evidence from well-
controlled studies to conclude if fluoride in drinking water at 
concentrations used for community fluoridation might impair the IQ of 
children (SCHER, 2010). The review also noted that ``a biological 
plausibility for the link between fluoridated water and IQ has not been 
established'' (SCHER, 2010). Findings of a recent prospective study of 
a birth cohort in New Zealand did not support an association between 
fluoride exposure, including residence in an area with fluoridated 
water during early childhood, and IQ measured repeatedly during 
childhood and at age 38 years (Broadbent, et al., 2014).

Endocrine Disruption

    All of the standard letters and some of the unique comments (~100) 
expressed concern that fluoride disrupts endocrine system function, 
especially for young children or for individuals with high water 
intake. The 2006 NRC review considered a potential association between 
fluoride exposure (2-4 mg/L) and changes in the thyroid, parathyroid, 
and pineal glands in experimental animals and humans (NRC, 2006). The 
report noted that available studies of the effects of fluoride exposure 
on endocrine function have limitations. For example, many studies did 
not measure actual hormone concentrations, and several studies did not 
report nutritional status or other factors likely to confound findings. 
The NRC called for better measurement of exposure to fluoride in 
epidemiological studies and for further research ``to characterize the 
direct and indirect mechanisms of fluoride's action on the endocrine 
system and factors that determine the response, if any, in a given 
individual'' (NRC, 2006). A review did not find evidence that consuming 
drinking water with fluoride at the level used in community water 
fluoridation presents health risks for people with chronic kidney 
disease (Ludlow, et al., 2007).

Effectiveness of Community Water Fluoridation in Caries Prevention

    In addition to citing potential adverse health effects, the 
standard letters stated that the benefits of community water 
fluoridation have never been documented in any randomized controlled 
trial. There are no randomized, double-blind, controlled trials of 
water fluoridation because its community-wide nature does not permit 
randomization of individuals to study and control groups or blinding of 
participants. However, community trials have been conducted, and these 
studies were included in systematic reviews of the effectiveness of 
community water fluoridation (McDonagh, et al., 2000b; Truman BI, et 
al., 2002; CPSTF, 2013). As noted, these reviews of the scientific 
evidence related to fluoride have concluded that community water 
fluoridation is effective in decreasing dental caries prevalence and 
severity.
    Standard letters also stated that African-American and low-income 
children would not be protected by the recommendation, as they have 
experienced more tooth decay than other racial/ethnic groups, despite 
exposure to fluoride through drinking water and other sources. Data 
from the NHANES (Dye B, et al., 2007) do not support this statement 
and, instead, document a decline in the prevalence and severity of 
dental caries (tooth decay) across racial/ethnic groups. For example, 
in 1999-2004, compared with 1988-1994, the percentage of adolescents 
aged 12-19 years who had experienced dental caries in their permanent 
teeth, by race/ethnicity, was 54% in African-American (down from 63%), 
58% in non-Hispanic white (down from 68%), and 64% in Mexican-American 
(down from 69%) adolescents (Dye B, et al., 2007). For adolescents 
whose family income was less than 100% of the federal poverty level, a 
similar decline occurred: 66% had experienced dental caries in 1999-
2004, down from 72% in 1988-1994. Although disparities in caries 
prevalence among these adolescent groups remain, the prevalence for 
each group was lower in 1999-2004 than in 1988-1994. Concurrent with 
these reductions in the prevalence of dental caries, the percentage 
(number) of the U.S. population receiving fluoridated water increased 
from 56% (144,217,476) in 1992 to 62% (180,632,481) in 2004 (http://www.cdc.gov/nohss/fsgrowth.htm). This change represented an increase of 
more than 36 million people.

Cost-Effectiveness of Community Water Fluoridation

    Some unique comments (~200) called attention to the cost of water 
fluoridation or stated that it was unnecessary or inefficient given the 
availability of other fluoride modalities and the amount of water used 
for purposes other than drinking. Cost-effectiveness studies that 
included costs incurred in treating all community water with fluoride 
additives still found fluoridation to be cost-saving (Truman, et al., 
2002, Griffin, et al., 2001). Although the annual per-person cost 
varies by size of the water system (from $0.50 in communities of 20,000 
or more to $3.70 for communities of 5,000 or fewer, updated to 2010 
dollars using the Consumer Price Index [CPI]), it remains only a 
fraction of the cost of one dental filling. The annual per person cost 
savings for those aged 6 to 65 years ranged from $35.90 to $28.70 for 
larger and smaller communities, respectively (Griffin, et al., 2001, 
updated to 2010 dollars using CPI-dental services). Studies in the 
United States and Australia also have documented the cost-effectiveness 
of community water fluoridation (Truman BI, et al., 2002; O'Connell JM 
et al., 2005; Campain AC et al., 2010; Cobiac LJ and Vos T, 2012).

Safety of Fluoride Additives

    Unique comments (~300) expressed concern that fluoride is poison 
and an industrial waste product; standard letters noted the lack of 
specific data on the safety of silicofluoride compounds used by many 
water systems for community water fluoridation. All additives used to 
treat water, including those used for community water fluoridation, are 
subject to a system of standards, testing, and certification involving 
participation of the American Water Works Association, NSF 
International, and the American National Standards Institute (ANSI)--
entities that are nonprofit, nongovernmental organizations. Most states 
require that water utilities use products that have been certified 
against ANSI/NSF Standard 60: Drinking Water Treatment Chemicals--
Health Effects

[[Page 24943]]

(hereinafter, Standard 60) by an ANSI-accredited laboratory (U.S. EPA, 
2000). All fluoride products evaluated against Standard 60 are tested 
to ensure that the levels of regulated impurities present in the 
product will not contribute to the treated drinking water more than 10% 
of the corresponding Maximum Contaminant Level (MCL) established by EPA 
for that contaminant (U.S. EPA, 2000). Results from 2000-2011, reported 
on the NSF International Web site (http://www.nsf.org/newsroom_pdf/NSF_Fact_Sheet_on_Fluoridation.pdf) found that no contaminants exceeded 
the concentration allowed by Standard 60.
    Although commenters expressed concerns about silicofluorides, 
studies have shown that these compounds achieve virtually complete 
dissolution and ionic disassociation at concentrations added to 
drinking water and thus, are comparable to the fluoride ion produced by 
other additives, such as sodium fluoride (Crosby, 1969; Finney, et al;, 
2006, U.S. EPA, 2000). At the pH of drinking water, usually 6.5-8.5, 
and at a fluoride concentration of 1 mg/L, the degree of hydrolysis of 
hexafluorosilicic acid has been described as ``essentially 100%'' (U.S. 
EPA, 2000). Standard 60 provides criteria to develop an allowable 
concentration when no MCL has been established by the EPA. Using this 
protocol, NSF International calculations showed that a sodium 
fluorosilicate concentration needed to achieve 1.2 mg F/L would result 
in 0.8 mg/L of silicate, or about 5% of the allowable concentration 
calculated by NSF International. (http://www.nsf.org/newsroom_pdf/NSF_Fact_Sheet_on_Fluoridation.pdf).
    SCHER also considered health and environmental risks associated 
with the use of silicofluoride compounds in community water 
fluoridation and concurred that in water they are rapidly hydrolyzed to 
fluoride, and that concentrations of contaminants in drinking water are 
well below guideline values established by the World Health 
Organization (SCHER, 2010).

Ethics of Community Water Fluoridation

    All standard letters and some unique comments (~200) stated that 
water fluoridation is unethical mass medication of the population. To 
determine if a public health action that may encroach on individual 
preferences is ethical, a careful analysis of its benefits and risks 
must occur. In the case of water fluoridation, the literature offers 
clear evidence of its benefits in reducing dental decay (McDonagh MS, 
et al., 2000a; McDonagh MS, et al., 2000b; Truman BI, et al., 2002; 
ARCPOH, 2006; Griffin SO, et al., 2007; Yeung, 2008; CPSTF, 2013), with 
documented risk limited to dental fluorosis (U.S. EPA, 2010a; U.S. EPA, 
2010b; McDonagh MS, et al., 2000a; ARCPOH, 2006; CPSTF, 2013).
    Several aspects of decision-making related to water fluoridation 
reflect careful analysis and lend support to viewing the measure as a 
sound public health intervention. State and local governments decide 
whether or not to implement water fluoridation, after considering 
evidence regarding its benefits and risks. Often, voters themselves 
make the final decision to adopt or retain community water 
fluoridation. Although technical support is available from HHS, federal 
agencies do not initiate efforts to fluoridate individual water 
systems. In addition, court systems in the United States have 
thoroughly reviewed legal challenges to community water fluoridation, 
and have viewed it as a proper means of furthering public health and 
welfare (http://fluidlaw.org).

Comments That Opposed the Recommendation as Too Low

    Several unique comments said that 0.7mg/L is too low to offer 
adequate protection against tooth decay. Evidence, however, does 
suggest that 0.7 mg/L will maintain caries preventive benefits. 
Analysis of data from the 1986-1987 Oral Health of United States 
Children survey found that reductions in dental caries plateaued 
between 0.7-1.2 mg/L of fluoride (Heller KE et al., 1997). In addition, 
fluoride in drinking water is only one of several available fluoride 
sources, such as toothpaste, mouth rinses, and professionally applied 
fluoride compounds.

Comments That Supported the Recommendation

    Some submissions specifically endorsed lowering the concentration 
of fluoride in drinking water for the prevention of dental caries. 
Other commenters asked for guidance on the operational range for 
implementing the recommended concentration of 0.7 mg/L and on 
consistent messaging regarding the recommended change. Currently, CDC 
is reviewing available data and collaborating with organizations of 
water supply professionals to update operational guidance. In addition, 
CDC continues to support local and state infrastructure needed to 
implement and monitor the recommendation. Examples of this support 
include maintenance of the Water Fluoridation Reporting System; 
provision of training opportunities for water supply professionals; 
assisting state and local health agencies with health promotion and 
public education related to water fluoridation; and funding (in 
coordination with other Federal agencies, including the National 
Institute of Dental and Craniofacial Research) for research and 
surveillance activities related to dental caries, dental fluorosis, and 
fluoride intake.

Monitoring Implementation of the New Recommendation

    Unpublished data from the Water Fluoridation Reporting System show 
how rapidly the proposed change in recommended concentration has gained 
acceptance. In December 2010, about 63% of the population on water 
systems adjusting fluoride (or buying water from such systems) was at 
1.0 mg/L or greater and fewer than 1% at 0.7 mg/L. By summer 2011, only 
6 months after publication of the draft notice, 68% of that population 
was at 0.7 mg/L and about 28% was at 1.0 mg/L or greater.
    Following broad implementation of the new recommendation, enhanced 
surveillance during the next decade will detect changes in the 
prevalence and severity of dental caries and of dental fluorosis that 
is very mild or greater, nationally and for selected socio-demographic 
groups. For example, the 2011-2012 NHANES included clinical examination 
of children and adolescents by dentists to assess decayed, missing and 
filled teeth; presence of dental sealants; and dental fluorosis. The 
2013-2014 examination added fluoride content of home water (assessed 
using water taken from a faucet in the home), residence history (needed 
to estimate fluoride content of home tap water for each child since 
birth), and questions on use of other fluoride modalities (e.g., 
toothpaste, prescription drops, and tablets). As findings from these 
and future examinations become available, they can be accessed through 
the CDC Web site (http://www.cdc.gov/nchs/nhanes/nhanes_products.htm).
    Definitive evaluation of changes in dental fluorosis prevalence or 
severity, associated with reduction in fluoride concentration in 
drinking water, cannot occur until permanent teeth erupt in the mouths 
of children who drank that water during the period of tooth 
development. HHS agencies continue to give priority to the development 
of valid and reliable measures of fluorosis, as well as technologies 
that could assess individual fluoride exposure precisely. A recent 
study documented the validity of fingernail fluoride concentrations at 
age 2-7 years as a biomarker for dental fluorosis of the permanent 
teeth at age 10-15 years (Buzalaf MA, et al., 2012).

[[Page 24944]]

Summary and Conclusions

    PHS acknowledges the concerns of commenters and appreciates the 
efforts of all who submitted responses to the Federal Register notice 
describing its recommendation to lower the fluoride concentration in 
drinking water for the prevention of dental caries. The full Federal 
Panel considered these responses in the context of best available 
science but did not alter its recommendation that the optimal fluoride 
concentration in drinking water for prevention of dental caries in the 
United States should be reduced to 0.7 mg/L, from the previous range of 
0.7-1.2 mg/L, based on the following information:
     Community water fluoridation remains an effective public 
health strategy for delivering fluoride to prevent tooth decay and is 
the most feasible and cost-effective strategy for reaching entire 
communities.
     In addition to drinking water, other sources of fluoride 
exposure have contributed to the prevention of dental caries and an 
increase in dental fluorosis prevalence.
     Caries preventive benefits can be achieved and the risk of 
dental fluorosis reduced at a fluoride concentration of 0.7 mg/L.
     Recent data do not show a convincing relationship between 
water intake and outdoor air temperature. Thus, recommendations for 
water fluoride concentrations that differ based on outdoor temperature 
are unnecessary.
    Surveillance of dental caries, dental fluorosis, and fluoride 
intake will monitor changes that might occur, following implementation 
of the recommendation.

     Dated: April 24, 2015.
Sylvia M. Burwell,
Secretary.

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Appendix A--HHS Federal Panel on Community Water Fluoridation

Peter Briss, MD, MPH--Panel Chair, Medical Director, National Center 
for Chronic Disease Prevention and Health Promotion, Centers for 
Disease Control and Prevention, U.S. Department of Health and Human 
Services
William Bailey, DDS, MPH (former Panel member), Acting Director 
(2011-2013), Division of Oral Health, National Center for Chronic 
Disease Prevention and Health Promotion, Centers for Disease Control 
and Prevention, U.S. Department of Health and Human Services
Laurie K. Barker, MSPH, Statistician, Division of Oral Health, 
National Center for Chronic Disease Prevention and Health Promotion, 
Centers for Disease Control and Prevention, U.S. Department of 
Health and Human Services
Leila T. Beker, Ph.D., RD, Interdisciplinary Scientist, Infant 
Formula and Medical Foods Review Team, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, U.S. Department of 
Health and Human Services
Eugenio Beltr[aacute]n-Aguilar, DMD, MPH, DrPH (former Panel 
member), Senior Epidemiologist, Division of Oral Health, National 
Center for Chronic Disease Prevention and Health Promotion, Centers 
for Disease Control and Prevention, U.S. Department of Health and 
Human Services
Mary Beth Bigley, DrPH, MSN, ANP (former Panel member), Acting 
Director, Office of Science and Communications, Office of the 
Surgeon General, U.S. Department of Health and Human Services
Linda Birnbaum, Ph.D., DABT, ATS, Director, National Institute of 
Environmental Health Sciences and National Toxicology Program, 
National Institutes of Health, U.S. Department of Health and Human 
Services
John Bucher, Ph.D., Associate Director, National Toxicology Program, 
National Institute of Environmental Health Sciences, National 
Institutes of Health, U.S. Department of Health and Human Services
Amit Chattopadhyay, PhD. (former Panel member), Epidemiologist, 
Office of Science and Policy Analysis, National Institute of Dental 
and Craniofacial Research, National Institutes of Health, U.S. 
Department of Health and Human Services
Joyce Donohue, Ph.D., Health Scientist, Health and Ecological 
Criteria Division, Office of Science and Technology, Office of 
Water, U.S. Environmental Protection Agency
Elizabeth Doyle, Ph.D., Chief, Human Health Risk Assessment Branch, 
Health and Ecological Criteria Division, Office of Science and 
Technology, Office of Water, U.S. Environmental Protection Agency
Isabel Garcia, DDS, MPH, Deputy Director, National Institute of 
Dental and Craniofacial Research, National Institutes of Health, 
U.S. Department of Health and Human Services
Barbara Gooch, DMD, MPH, Associate Director for Science, Division of 
Oral Health, National Center for Chronic Disease Prevention and 
Health Promotion, Centers for Disease Control and Prevention, U.S. 
Department of Health and Human Services
Jesse Goodman, MD, MPH, Chief Scientist and Deputy Commissioner for 
Science and Public Health, Food and Drug Administration, U.S. 
Department of Health and Human Services
J. Nadine Gracia, MD, MSCE (former Panel member), Chief Medical 
Officer (2009-2011), Office of the Assistant Secretary for Health, 
U.S. Department of Health and Human Services
Susan O. Griffin, Ph.D., Health Economist, Division of Oral Health, 
National Center for Chronic Disease Prevention and Health Promotion, 
Centers for Disease Control and Prevention, U.S. Department of 
Health and Human Services
Laurence Grummer-Strawn, Ph.D., Chief, Maternal and Child Nutrition 
Branch, Division of Nutrition, Physical Activity, and Obesity, 
National Center for Chronic Disease Prevention and Health Promotion, 
Centers for Disease Control and Prevention, U.S. Department of 
Health and Human Services
Jay Hirschman, MPH, CNS, Director, Special Nutrition Staff, Office 
of Research and Analysis, Food and Nutrition Service, U.S. 
Department of Agriculture
Frederick Hyman, DDS, MPH, Dental Officer, Division of Dermatology 
and Dental Products, Center for Drug Evaluation and Research, Food 
and Drug Administration, U.S. Department of Health and Human 
Services
Timothy Iafolla, DMD, MPH, Supervisory Science Policy Analyst, 
Office of Science and Policy Analysis, National Institute of Dental 
and Craniofacial Research, National Institutes of Health, U.S. 
Department of Health and Human Services

[[Page 24947]]

William Kohn, DDS (former Panel member), Director (2010-11), 
Division of Oral Health, National Center for Chronic Disease 
Prevention and Health Promotion, Centers for Disease Control and 
Prevention, U.S. Department of Health and Human Services
Arlene M. Lester, DDS, MPH, CAPT, United States Public Health 
Service, Regional Minority Health Consultant, Office of the 
Secretary, US Department of Health and Human Services
Nicholas S. Makrides, DMD, MA, MPH, Assistant Surgeon General, Chief 
Dental Officer, United States Public Health Service, Chief Dentist, 
Federal Bureau of Prisons, U.S. Department of Justice
Richard Manski, DDS, MBA, Ph.D., Senior Scholar, Center for 
Financing, Access and Cost Trends, Agency for Healthcare Research 
and Quality, U.S. Department of Health and Human Services
Ana Maria Osorio, MD, MPH, Senior Advisor for the Public Health 
Service, Office of the Assistant Secretary for Health, U.S. 
Department of Health and Human Services
Benson Silverman, MD (former panel member, deceased), Staff 
Director, Infant Formula and Medical Foods, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, U.S. Department 
of Health and Human Services
Thomas Sinks, Ph.D., Deputy Director, National Center for 
Environmental Health/Agency for Toxic Substances and Disease 
Registry, Centers for Disease Control and Prevention, U.S. 
Department of Health and Human Services


[FR Doc. 2015-10201 Filed 4-30-15; 8:45 am]
 BILLING CODE 4163-18-P