[Federal Register Volume 76, Number 9 (Thursday, January 13, 2011)]
[Notices]
[Pages 2383-2388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-637]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Proposed HHS Recommendation for Fluoride Concentration in
Drinking Water for Prevention of Dental Caries
AGENCY: Office of the Secretary, Department of Health and Human
Services.
ACTION: Notice.
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[[Page 2384]]
SUMMARY: The Department of Health and Human Services (HHS) seeks public
comment on proposed new guidance which will update and replace the 1962
U.S. Public Health Service Drinking Water Standards related to
recommendations for fluoride concentrations in drinking water. The U.S.
Public Health Service recommendations for optimal fluoride
concentrations were based on ambient air temperature of geographic
areas and ranged from 0.7-1.2 mg/L.
HHS proposes that community water systems adjust the amount of
fluoride to 0.7 mg/L to achieve an optimal fluoride level. For the
purpose of this guidance, the optimal concentration of fluoride in
drinking water is that concentration that provides the best balance of
protection from dental caries while limiting the risk of dental
fluorosis. Community water fluoridation is the adjusting and monitoring
of fluoride in drinking water to reach the optimal concentration
(Truman BI, et al, 2002).
This updated guidance is intended to apply to community water
systems that are currently fluoridating or will initiate
fluoridation.\1\ This guidance is based on several considerations that
include:
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\1\ Community water fluoridation of public drinking water
systems has been demonstrated to be effective in reducing caries and
producing cost-savings from a societal perspective. (Truman B et al,
2002). If local goals and resources permit, the use of this
intervention should be continued, initiated, or increased (CDC
2001a).
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Scientific evidence related to effectiveness of water
fluoridation on 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.
Current evidence on fluid intake in children across
various ambient air temperatures.
DATES: To receive consideration, comments on the proposed
recommendations for fluoride concentration in drinking water for the
prevention of dental caries should be received no later than February
14, 2011.
ADDRESSES: Comments are preferred electronically and may be addressed
to [email protected]. Written responses should be addressed to the
U.S. Department of Health and Human Services, Centers for Disease
Control and Prevention, CWF Comments, Division of Oral Health, National
Center for Chronic Disease Prevention and Health Promotion (NCCDPHP),
4770 Buford Highway, NE, MS F-10, Atlanta, GA 30341-3717.
FOR FURTHER INFORMATION CONTACT: Barbara F. Gooch, Associate Director
for Science (Acting), 770-488-6054, [email protected], Division of
Oral Health, National Center for Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for Disease Control and Prevention, 4770
Buford Highway, NE., MS F-10, Atlanta, GA 30341-3717.
SUPPLEMENTARY INFORMATION: The U.S. Public Health Service has provided
recommendations regarding optimal fluoride concentrations in drinking
water from community water systems (CWS) \2\ for the prevention of
dental caries (US DHEW, 1962). HHS proposes to update and replace these
recommendations because of new data that address changes in the
prevalence of dental fluorosis, fluid intake among children, and the
contribution of fluoride in drinking water to total fluoride exposure
in the United States. As of December 31, 2008, the Centers for Disease
Control and Prevention (CDC) estimated that 16,977 community water
systems provided fluoridated water to 196 million people. 95% of the
population receiving fluoridated water was served by community water
systems that added fluoride to water, or purchased water with added
fluoride from other systems. The remaining 5% were served by systems
with naturally occurring fluoride at or above the recommended level.
More statistics about water fluoridation in the United States are
available at http://www.cdc.gov/fluoridation/statistics/2008stats.htm.
Guidance for systems with naturally occurring fluoride levels above the
recommended level are beyond the scope of this document. Systems that
have fluoride levels greater than the national primary (4.0 mg/L) or
secondary (2.0 mg/L) drinking water standards established by EPA can
find more information at the following EPA Web site: http://water.epa.gov/drink/contaminants/basicinformation/fluoride.cfm. CDC's
Recommendations for Fluoride Use (CDC, 2001b), available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5014a1.htm, provides guidance on
community water fluoridation and use of other fluoride-containing
products.
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\2\ For purposes of this guidance, a water system is considered
a community water system if so designated by the State drinking
water administrator in accordance with the regulatory requirements
of the U.S. Environmental Protection Agency. In general, public
water systems provide water for human consumption through pipes or
other constructed conveyances to at least 15 service connections or
serves an average of at least 25 people for at least 60 days a year.
A community water system is a public water system that supplies
water to the same population year-round, http://water.epa.gov/infrastructure/drinkingwater/pws/factoids.cfm.
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Recommendation
HHS proposes that community water systems adjust their fluoride
content to 0.7 mg/L [parts per million (ppm)].
Rationale
Importance of community water fluoridation:
Community water fluoridation is a major factor responsible for the
decline of the prevalence and severity of dental caries (tooth decay)
during the second half of the 20th century. From the early 1970's to
the present, the prevalence of dental caries in at least one permanent
tooth (excluding third molars) among adolescents, aged 12-17 years,\3\
has decreased from 90% to 60% and the average number of teeth affected
by dental caries (i.e., decayed, missing and filled) from 6.2 to 2.6
(Kelly JE, 1975, Dye B, et al, 2007). Adults have also benefited from
community water fluoridation. Among adults, aged 35-44 years,\4\ the
average number of affected teeth decreased from 18 in the early 1960's
to 10 among adults, aged 35-49 years, in 1999-2004 (Kelly JE, et al,
1967; Dye B, et al, 2007). Although there have been notable declines in
tooth decay, it remains one of the most common chronic diseases of
childhood (USDHHS, 2000; Newacheck PW et al, 2000). Effective
population-based interventions to prevent and control dental caries,
such as community water fluoridation, are still needed (CDC, 2001a).
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\3\ There were slight differences in the age groups used in both
surveys. The 1971-1974 survey reported on adolescents aged 12-17
years (Kelly JE, 1975) while the 1999-2004 survey reported on
adolescents and youths aged 12-19 years (Dye B, et al., 2007).
Because the prevalence of dental caries increases with age, the
estimates for 12-17 year olds in the most recent survey (1999-2004)
should be slightly lower than those published for 12-19 year olds
(Dye B, et al, 2007).
\4\ There were slight differences in the age groups used in both
surveys. The 1962 survey reported on adults aged 35-44 years (Kelly
JE et al 1967) while the 1999-2004 survey reported on adults aged
35-49 years (Dye B, et al, 2007).
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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, Griffin SO,
et al, 2007). 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, Griffin SO, et al, 2007). When
analyses were limited to studies
[[Page 2385]]
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).
Fluoride works primarily to prevent dental caries through topical
remineralization of tooth surfaces when small amounts of fluoride,
specifically in saliva and accumulated plaque, are present frequently
in the mouth (Featherstone JDB, 1999). Consuming fluoridated water and
beverages and foods prepared or processed with fluoridated water
routinely introduces a low concentration of fluoride into the mouth.
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).
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 almost 50%
of the U.S. population by 1975 and 64% by 2008, http://www.cdc.gov/fluoridation/statistics/2008stats.htm; http://www.cdc.gov/fluoridation/pdf/statistics/1975.pdf. Toothpaste containing fluoride was first
marketed in the United States in 1955 (USDHEW, 1980) and by the 1990's
accounted for more than 90 percent of the toothpaste market (Burt BA
and Eklund SA, 2005). Other products that provide fluoride now include
mouthrinses, fluoride supplements, and professionally applied fluoride
compounds. More detailed explanations of these products are published
elsewhere (CDC, 2001b) (ADA, 2006) (USDHHS, 2010). More information on
all sources of fluoride and their relative contribution to total
fluoride exposure in the United States is presented in a report by EPA
(US EPA 2010a).
Dental Fluorosis
Fluoride ingestion while teeth are developing can result in a range
of visually detectable changes in the tooth enamel (Aoba T and
Fejerskov O, 2002). 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,\5\ extends from about birth through 8 years
of age when the preeruptive maturation of tooth enamel is complete
(CDC, 2001b; Massler M and Schour I, 1958). When communities first
began adding fluoride to their public water systems in 1945, drinking
water and foods and beverages prepared with fluoridated water were the
primary sources of fluoride for most children (McClure FJ, 1943). Since
the 1940's, other sources of ingested fluoride, such as fluoride
toothpaste (if swallowed) and fluoride supplements, have become
available. Fluoride intake from these products, in addition to water
and 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, Osuji OO et al, 1988, Pendrys DG et
al, 1994, Pendrys DG and Katz RV 1989, Pendrys DG, 1995). Both the 1962
USPHS recommendations and the current proposal for fluoride
concentrations in community drinking water were set to achieve a
reduction in dental caries while minimizing the risk of dental
fluorosis.
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\5\ Risk for the third molars (i.e., wisdom teeth) extends to
age 14 years (Massler M, 1958) . Third molars are much less likely
than other teeth to erupt fully into a functional position due to
space constraints in the dental arch and may be impacted, partially
erupted, or extracted. For these reasons third molars are not
assessed for dental caries or dental fluorosis in national surveys
in the U.S. In addition, based on their placement, these teeth are
unlikely to be of aesthetic concern.
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Results of two national surveys indicate that the prevalence of
dental fluorosis has increased since the 1980's, but mostly in the very
mild or mild forms. The most recent data on prevalence of dental
fluorosis come from the National Health and Nutrition Examination
Survey (NHANES), 1999-2004. NHANES assessed the prevalence and severity
of dental fluorosis among persons, aged 6 to 49 years. Twenty-three
percent had dental fluorosis of which the vast majority was very mild
or mild. Approximately 2% of persons had moderate dental fluorosis, and
less than 1% had severe. Prevalence was higher among younger persons
and ranged from 41% among adolescents aged 12-15 years to 9% among
adults, aged 40-49 years. The higher prevalence of dental fluorosis in
the younger persons probably reflects the increase in fluoride
exposures across the U.S. population through community water
fluoridation and increased use of fluoride toothpaste.
The prevalence and severity of dental fluorosis among 12-15 year
olds in 1999-2004 were compared to estimates from the Oral Health of
United States Children Survey, 1986-87, which was the first national
survey to include measures of dental fluorosis. Although these two
national surveys differed in sampling and representation
(schoolchildren versus household), findings support the hypothesis that
there has been an increase in dental fluorosis that was very mild or
greater between the two surveys. In 1986-87 and 1999-2004 the
prevalence of dental fluorosis was 23% and 41%, respectively, among
adolescents aged 12 to 15. (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%) have increased. The estimates for severe
fluorosis for adolescents in both surveys were statistically unreliable
because of too few cases in the samples.
More information on fluoride concentrations in drinking water and
the impact of severe dental fluorosis in children is presented in a
report by EPA (US EPA 2010 b).
Relationship between dental caries and fluorosis at varying water
fluoridation concentrations:
The 1986-87 Oral Health of United States Children Survey is the
only national survey that measured the child's water fluoride exposure
and can link that exposure to measures of caries and fluorosis (U.S.
DHHS, 1989). An additional analysis of data from this survey examined
the relationship between dental caries and fluorosis at varying water
fluoride concentrations for children aged 6 to 17 years (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 to 1.2 mg/L. In
contrast, the percentage of children with at least very mild dental
fluorosis increased with increasing fluoride concentrations in water.
The published report did not report standard errors.
In Hong Kong a small change of about 0.2 mg/L \6\ in the mean
fluoride concentration in drinking water in 1978 was associated with a
detectable reduction in fluorosis prevalence by the
[[Page 2386]]
mid 1980's \7\ (Evans R.W, Stamm JW., 1991). Across all age groups more
than 90% of fluorosis cases were very mild or mild. (Evans R.W, 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 those from the 1986-87 survey of U.S.
schoolchildren, suggest that risk of fluorosis can be reduced and
caries prevention maintained toward the lower end (i.e., 0.7 mg/L) of
the 1962 USPHS recommendations for fluoride concentrations for
community water systems.
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\6\ Fluoride concentrations in drinking water before and after
the 1978 reduction were 0.82 and 0.64 mg F/L, respectively.
\7\ Fluorosis prevalence ranged from 64% (SE = 4.1) to 47% (SE =
4.5) based on the upper right central incisor only.
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Relationship of fluid intake and ambient temperature among children
and adolescents in the United States:
The 1962 USPHS recommendations stated that community drinking water
should contain 0.7-1.2 mg/L [ppm] fluoride, depending on the ambient
air temperature of the area. These temperature-related guidelines were
based on studies conducted in two communities in California in the
early 1950's. Findings indicated that a lower fluoride concentration
was appropriate for communities in warmer climates because children
drank more tap 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 1950's, and thus, the assumption
that children living in warmer regions drink more tap water than
children in cooler regions may no longer be valid.
Studies conducted since 2001 suggest that fluid intake in children
does not increase with increases in ambient 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 1988 to 1994
did not find an association between fluid intake and ambient air
temperature (Sohn W, et al, 2001). A similar study using nationally
representative data from 1999 to 2004 also found no association between
fluid intake and ambient temperature among children or adolescents
(Beltr[aacute]n-Aguilar ED, et al, 2010b). These recent findings
demonstrating a lack of an association between fluid intake among
children and adolescents and ambient temperature support use of a
single target concentration for community water fluoridation in all
temperature zones of the United States.
Conclusions
HHS recommends an optimal fluoride concentration of 0.7 mg/L for
community water systems based on the following information:
Community water fluoridation is the most cost-effective
method of delivering fluoride for the prevention of tooth decay;
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;
Significant caries preventive benefits can be achieved and
risk of fluorosis reduced at 0.7 mg/L, the lowest concentration in the
range of the USPHS recommendation.
Recent data do not show a convincing relationship between
fluid intake and ambient air temperature. Thus, there is no need for
different recommendations for water fluoride concentrations in
different temperature zones.
Surveillance Activities
CDC and the National Institute of Dental and Craniofacial Research
(NIDCR), in coordination with other Federal agencies, will enhance
surveillance of dental caries, dental fluorosis, and fluoride intake
with a focus on younger populations at higher risk of fluorosis to
obtain the best available and most current information to support
effective efforts to improve oral health.
Process
The U.S. Department of Health and Human Services (HHS) convened a
Federal inter-departmental, inter-agency panel of scientists (Appendix
A) to review scientific evidence related to the 1962 USPHS Drinking
Water Standards related to recommendations for fluoride concentrations
in drinking water in the United States and to update these proposed
recommendations. Panelists included representatives from the Centers
for Disease Control and Prevention, the National Institutes of Health,
the Food and Drug Administration, the Agency for Healthcare Research
and Quality, the Office of the Assistant Secretary for Health, the U.S.
Environmental Protection Agency, and the U.S. Department of
Agriculture. The panelists evaluated existing recommendations for
fluoride in drinking water, systematic reviews of the risks and
benefits from fluoride in drinking water, the epidemiology of dental
caries and fluorosis in the U.S., and current data on fluid intake in
children, aged 0 to 10 years, across temperature gradients in the U.S.
Conclusions were reached and are summarized along with their rationale
in this proposed guidance document. This guidance will be advisory, not
regulatory, in nature. Guidance will be submitted to the Federal
Register and will undergo public and stakeholder comment for 30 days,
after which HHS will review comments and consider changes.
Dated: January 7, 2011.
Kathleen Sebelius,
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.
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.
Eugenio Beltr[aacute]n-Aguilar, DMD, MPH, DrPH, 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, Acting Director, Office of
Science and Communications, Office of the Surgeon General, U.S.
Department of Health and Human Services.
Linda Birnbaum, PhD, 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, PhD, 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, 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, PhD, Health Scientist, Health and Ecological
Criteria Division, Office of Science and Technology, Office of
Water, U.S. Environmental Protection Agency.
[[Page 2388]]
Elizabeth Doyle, PhD, 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, Acting Director, National Institute of
Dental and Craniofacial Research, National Institutes of Health,
U.S. Department of Health and Human Services.
Barbara Gooch, DMD, MPH, Acting 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, Chief Medical Officer, Office of the
Assistant Secretary for Health, U.S. Department of Health and Human
Services.
Susan O. Griffin, PhD, 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, PhD, 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, 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, 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.
William Kohn, DDS, Director, 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.
Richard Manski, DDS, MBA, PhD, Senior Scholar, Center for
Financing, Access and Cost Trends, Agency for Healthcare Research
and Quality, U.S. Department of Health and Human Services.
Benson Silverman, MD, 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, PhD, 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. 2011-637 Filed 1-12-11; 8:45 am]
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