83 FR 32666 - Proposed Guidance Regarding Operational Control Range Around Optimal Fluoride Concentration in Community Water Systems That Adjust Fluoride

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 135 (July 13, 2018)

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces in this Federal Register Notice a proposed operational control range around optimal fluoride concentration in community water systems that adjust fluoride, and monthly adherence to that range. The proposal is based on analysis of available data, provided in the Background document. CDC is opening a docket to obtain comment on the existence of evidence-based concerns about the appropriateness of the proposed operational control range and criteria for adherence based on measurement capacity or feasibility of maintaining a target level. The operational control range specifies upper and lower limits of variation around a target concentration of fluoride. Managers of adjusted water systems at state and local levels need this updated operational control range to ensure the maintenance of consistent monthly averages in fluoride concentration that maximize prevention of tooth decay and minimize the possibility of dental fluorosis. The proposed operational control range is 0.6 mg/L to 1.0 mg/L. CDC bases this guidance on the following considerations: (1) Concentration of fluoride in water shown to prevent tooth decay and (2) Ability of water systems to control variation in fluoride concentration.

[Federal Register Volume 83, Number 135 (Friday, July 13, 2018)]
[Notices]
[Pages 32666-32667]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-14968]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2018-0064]


Proposed Guidance Regarding Operational Control Range Around 
Optimal Fluoride Concentration in Community Water Systems That Adjust 
Fluoride

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice; request for comment.

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SUMMARY: The Centers for Disease Control and Prevention (CDC) in the 
Department of Health and Human Services (HHS) announces in this Federal 
Register Notice a proposed operational control range around optimal 
fluoride concentration in community water systems that adjust fluoride, 
and monthly adherence to that range. The proposal is based on analysis 
of available data, provided in the Background document. CDC is opening 
a docket to obtain comment on the existence of evidence-based concerns 
about the appropriateness of the proposed operational control range and 
criteria for adherence based on measurement capacity or feasibility of 
maintaining a target level. The operational control range specifies 
upper and lower limits of variation around a target concentration of 
fluoride. Managers of adjusted water systems at state and local levels 
need this updated operational control range to ensure the maintenance 
of consistent monthly averages in fluoride concentration that maximize 
prevention of tooth decay and minimize the possibility of dental 
fluorosis. The proposed operational control range is 0.6 mg/L to 1.0 
mg/L. CDC bases this guidance on the following considerations: (1) 
Concentration of fluoride in water shown to prevent tooth decay and (2) 
Ability of water systems to control variation in fluoride 
concentration.

DATES: Written comments must be received on or before October 11, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0064 by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Division of Oral Health, Centers for Disease Control 
and Prevention, 4770 Buford Highway, MS S107-8, Atlanta, Georgia 30341. 
Attn: Docket Number: CDC-2018-0064.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to http://regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Valerie Robison, D.D.S., M.P.H., 
Ph.D., Dental Officer, Division of Oral Health, Centers for Disease 
Control and Prevention, 4770 Buford Highway, MS S107-8, Atlanta, GA 
30341. Email: [email protected], telephone: (770) 488-6054.

SUPPLEMENTARY INFORMATION: In 2015, the U.S. Public Health Service 
(PHS) recommended that community water systems maintain a concentration 
of 0.7 mg/L to achieve a beneficial fluoride level.\1\ This 
recommendation, which updated and replaced the 1962 Drinking Water 
Standards related to community water fluoridation, did not include an 
operational control range associated with the recommended level of 0.7 
mg/L.\1\ \2\
    After the 2015 PHS recommendation was issued, several state water 
fluoridation and drinking water programs contacted the Centers for 
Disease Control and Prevention (CDC) to request development of revised 
operational control range guidance around the 0.7 mg/L target level. As 
part of the range-setting process, these programs requested that CDC 
consider how consistently water treatment systems can stay within an 
operational control range on a daily basis. A detailed summary of the 
information CDC considered in developing a proposed operational control 
range recommendation is available in the Background document found in 
the Supplement Material tab of the docket.

Recommended Operational Control Range

    Since water systems tend to favor an operating strategy that has a 
lower feed rate, or the rate at which product is added, CDC recommends 
an asymmetrical operational control range of 0.6 mg/L to 1.0 mg/L in 
order for public water systems to consistently meet the recommended 
concentration of 0.7 mg/L.\3\
    The lowest concentration of 0.6 mg/L (-0.1 mg/L below the target 
level of 0.7 mg/L) will allow public water systems to maintain the oral 
health benefits of water fluoridation. A lowest concentration of 0.6 
mg/L in an operational control range has been in effect since 1962 and 
water systems have demonstrated experience in meeting it in normal 
operations.\2\ \3\
    The highest concentration of 1.0 mg/L (+0.3 mg/L above the target 
level of 0.7 mg/L) will reduce the possibility of dental fluorosis.\4\ 
\5\
    An operational control range of 0.4 mg/L (-0.1 mg/L to +0.3 mg/L) 
[actual values (0.6 mg/L to 1.0 mg/l)] will provide operational 
flexibility. This is based on data demonstrating the ability of water 
systems to stay successfully within a particular operational control 
range.\4\ \6\ \7\ A detailed summary of these findings is available in 
the Background document.
    CDC has received requests for criteria that demonstrate compliance 
with the operational control range. Published studies have shown that 
water systems are able to maintain at least 80% of daily measurements 
during the month within the proposed operational control range.\6\ \7\ 
Based on these findings, CDC recommends the following operational 
criteria; the monthly average fluoride level is maintained within the 
proposed operational control range, and 80% of daily measurements of 
fluoride are maintained within the proposed operational control range.
    In this docket, we are only concerned with the operational control 
range for water systems that adjust the fluoride level in the water. 
This request does not apply to water systems that have natural fluoride 
levels that exceed this

[[Page 32667]]

recommended level. Further, the issues of whether or not to adjust 
fluoride in drinking water, as well as the recommended level to which 
fluoride should be adjusted, have previously been addressed in the 
Federal Register and are not part of this request.\8\
    Note: Public water systems must continue to comply with 
Environmental Protection Agency (EPA) requirements for a special notice 
for exceedance of the secondary standard of 2 mg/L (40 CFR 141.208) 
(https://www.epa.gov/dwregdev/drinking-water-regulations-and-contaminants).
    CDC is seeking public comment on the following:
    1. Are there any evidence-based concerns about the appropriateness 
of the proposed operational control range and criteria for adherence 
based on measurement capacity or feasibility of maintaining the target 
level?

References

1. U.S. Public Health Service Recommendations for Fluoride 
Concentration in Drinking Water for the Prevention of Dental Caries. 
Public Health Reports. 2015 July-Aug;130(4):318-331.
2. Department of Health, Education and Welfare (US) Public Health 
Service drinking water standards, revised 1962. Washington: Public 
Health Service (US); 1962. PHS Publication No. 956.
3. Barker LK, Duchon KK, Lesaja S, et al. Adjusted Fluoride 
Concentrations in 34 States: 2006-2010 and 2015. Journal AWWA. 
2017;109(8):2-17.
4. Engineering and Administrative Recommendations for Water 
Fluoridation, MMWR Sept 29,1995/44(RR-13:1-40. Fluoride 
Recommendations Work Group. Recommendations for using fluoride to 
prevent and control dental caries in the United States. MMWR Recomm 
Rep. 2001;50(RR-14):1-42.
5. Heller KE, Eklund SA, Burt BA. Dental caries and dental fluorosis 
at varying water fluoride concentrations. J Public Health Dent. 
1997;57:136-43.
6. Brown R, McTigue N, Graf K. Monitoring fluoride: how closely do 
utilities match target versus actual levels? Opflow, 40;7:10. 
https://doi.org/10.5991/OPF.2014.40.0042.
7. Teefy S. Managing fluoridation within a stringent regulatory 
framework. Proc 2013 AWWA Water Quality Technology Conference, 
Oakland, Calif.
8. Public Health Service Recommendation for Fluoride Concentration 
in Drinking Water for the Prevention of Dental Caries. Fed Regist. 
2015;80(84):24936-24947. Available at: https://www.federalregister.gov/documents/2015/05/01/2015-10201/public-health-service-recommendation-for-fluoride-concentration-in-drinking-water-for-prevention-of. Accessed 5/11/2018.

    Dated: July 9, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2018-14968 Filed 7-12-18; 8:45 am]
 BILLING CODE 4163-18-P