[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.,
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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