[Federal Register Volume 76, Number 9 (Thursday, January 13, 2011)]
[Notices]
[Pages 2383-2388]
From the Federal Register Online via the Government Printing 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 CWFcomments@cdc.gov. 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, CWFcomments@cdc.gov, 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

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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.

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    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]
BILLING CODE P