83_FR_32801 83 FR 32666 - Proposed Guidance Regarding Operational Control Range Around Optimal Fluoride Concentration in Community Water Systems That Adjust Fluoride

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)

Page Range32666-32667
FR Document2018-14968

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 Issue 135 (Friday, July 13, 2018) 
[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

32666 Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Notices received to both notices, as well as new operational control range specifies around the 0.7 mg/L target level. As part literature, we revised the previous draft upper and lower limits of variation of the range-setting process, these profile (including a revised Minimal around a target concentration of programs requested that CDC consider Risk Level (MRL)); therefore, on June 21, fluoride. Managers of adjusted water how consistently water treatment 2018, ATSDR released a revised draft systems at state and local levels need systems can stay within an operational profile for public comment (83 FR this updated operational control range control range on a daily basis. A 28849). Because the substantive to ensure the maintenance of consistent detailed summary of the information revisions were limited to the MRLs monthly averages in fluoride CDC considered in developing a Appendix, and given the public health concentration that maximize prevention proposed operational control range demand for the updated toxicological of tooth decay and minimize the recommendation is available in the profile, we opted for a 30 day comment possibility of dental fluorosis. The Background document found in the period. ATSDR has received requests to proposed operational control range is Supplement Material tab of the docket. extend the comment period for this 0.6 mg/L to 1.0 mg/L. CDC bases this Recommended Operational Control profile. Accordingly, ATSDR is guidance on the following Range extending the comment period an considerations: (1) Concentration of additional 30 days. Comments must be fluoride in water shown to prevent tooth Since water systems tend to favor an submitted by August 20, 2018. decay and (2) Ability of water systems operating strategy that has a lower feed to control variation in fluoride rate, or the rate at which product is Availability added, CDC recommends an concentration. The Draft Toxicological Profiles are asymmetrical operational control range DATES: Written comments must be available online at http:// of 0.6 mg/L to 1.0 mg/L in order for received on or before October 11, 2018. www.atsdr.cdc.gov/ToxProfiles and at public water systems to consistently www.regulations.gov, Docket No. ADDRESSES: You may submit comments, meet the recommended concentration of ATSDR–2015–0004. identified by Docket No. CDC–2018– 0.7 mg/L.3 0064 by any of the following methods: The lowest concentration of 0.6 mg/L Pamela I. Protzel Berman, • Federal eRulemaking Portal: http:// (¥0.1 mg/L below the target level of 0.7 Director, Office of Policy, Partnerships and www.regulations.gov. Follow the mg/L) will allow public water systems Planning, Agency for Toxic Substances and instructions for submitting comments. to maintain the oral health benefits of Disease Registry. • Mail: Division of Oral Health, water fluoridation. A lowest [FR Doc. 2018–15002 Filed 7–12–18; 8:45 am] Centers for Disease Control and concentration of 0.6 mg/L in an BILLING CODE 4163–70–P Prevention, 4770 Buford Highway, MS operational control range has been in S107–8, Atlanta, Georgia 30341. Attn: effect since 1962 and water systems Docket Number: CDC–2018–0064. have demonstrated experience in DEPARTMENT OF HEALTH AND Instructions: All submissions received HUMAN SERVICES meeting it in normal operations.2 3 must include the agency name and The highest concentration of 1.0 mg/ Docket Number. All relevant comments L (+0.3 mg/L above the target level of Centers for Disease Control and received will be posted without change Prevention 0.7 mg/L) will reduce the possibility of to http://regulations.gov, including any dental fluorosis.4 5 [Docket No. CDC–2018–0064] personal information provided. For An operational control range of 0.4 access to the docket to read background mg/L (¥0.1 mg/L to +0.3 mg/L) [actual Proposed Guidance Regarding documents or comments received, go to values (0.6 mg/L to 1.0 mg/l)] will Operational Control Range Around http://www.regulations.gov. provide operational flexibility. This is Optimal Fluoride Concentration in FOR FURTHER INFORMATION CONTACT: based on data demonstrating the ability Community Water Systems That Valerie Robison, D.D.S., M.P.H., Ph.D., of water systems to stay successfully Adjust Fluoride Dental Officer, Division of Oral Health, within a particular operational control AGENCY: Centers for Disease Control and Centers for Disease Control and range.4 6 7 A detailed summary of these Prevention (CDC), Department of Health Prevention, 4770 Buford Highway, MS findings is available in the Background and Human Services (HHS). S107–8, Atlanta, GA 30341. Email: document. ACTION: Notice; request for comment. OPTOL2018@cdc.gov, telephone: (770) CDC has received requests for criteria 488–6054. that demonstrate compliance with the SUMMARY: The Centers for Disease SUPPLEMENTARY INFORMATION: In 2015, operational control range. Published Control and Prevention (CDC) in the the U.S. Public Health Service (PHS) studies have shown that water systems Department of Health and Human recommended that community water are able to maintain at least 80% of Services (HHS) announces in this systems maintain a concentration of 0.7 daily measurements during the month Federal Register Notice a proposed mg/L to achieve a beneficial fluoride within the proposed operational control operational control range around level.1 This recommendation, which range.6 7 Based on these findings, CDC optimal fluoride concentration in updated and replaced the 1962 Drinking recommends the following operational community water systems that adjust Water Standards related to community criteria; the monthly average fluoride fluoride, and monthly adherence to that water fluoridation, did not include an level is maintained within the proposed range. The proposal is based on analysis operational control range associated operational control range, and 80% of of available data, provided in the with the recommended level of 0.7 mg/ daily measurements of fluoride are Background document. CDC is opening sradovich on DSK3GMQ082PROD with NOTICES L.1 2 maintained within the proposed a docket to obtain comment on the After the 2015 PHS recommendation operational control range. existence of evidence-based concerns was issued, several state water In this docket, we are only concerned about the appropriateness of the fluoridation and drinking water with the operational control range for proposed operational control range and programs contacted the Centers for water systems that adjust the fluoride criteria for adherence based on Disease Control and Prevention (CDC) to level in the water. This request does not measurement capacity or feasibility of request development of revised apply to water systems that have natural maintaining a target level. The operational control range guidance fluoride levels that exceed this VerDate Sep<11>2014 16:47 Jul 12, 2018 Jkt 244001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\13JYN1.SGM 13JYN1

Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Notices 32667 recommended level. Further, the issues Dated: July 9, 2018. Email: OIRA_submission@ of whether or not to adjust fluoride in Sandra Cashman, omb.eop.gov drinking water, as well as the Executive Secretary, Centers for Disease To obtain copies of a supporting recommended level to which fluoride Control and Prevention. statement and any related forms for the should be adjusted, have previously [FR Doc. 2018–14968 Filed 7–12–18; 8:45 am] proposed collection(s) summarized in been addressed in the Federal Register BILLING CODE 4163–18–P this notice, you may make your request and are not part of this request.8 using one of following: Note: Public water systems must 1. Access CMS’ website address at continue to comply with Environmental DEPARTMENT OF HEALTH AND http://www.cms.hhs.gov/Paperwork Protection Agency (EPA) requirements HUMAN SERVICES ReductionActof1995. 2. Email your request, including your for a special notice for exceedance of the Centers for Medicare & Medicaid address, phone number, OMB number, secondary standard of 2 mg/L (40 CFR Services and CMS document identifier, to 141.208) (https://www.epa.gov/ Paperwork@cms.hhs.gov. dwregdev/drinking-water-regulations- [Document Identifiers: CMS–10531, CMS– 3. Call the Reports Clearance Office at and-contaminants). R–43, CMS–10102, CMS–10143, CMS–10261, (410) 786–1326. CDC is seeking public comment on CMS–10500, and CMS–855I] FOR FURTHER INFORMATION CONTACT: the following: Reports Clearance Office at (410) 786– Agency Information Collection 1. Are there any evidence-based Activities: Submission for OMB 1326. concerns about the appropriateness of Review; Comment Request SUPPLEMENTARY INFORMATION: Under the the proposed operational control range Paperwork Reduction Act of 1995 (PRA) and criteria for adherence based on AGENCY: Centers for Medicare & Medicaid Services, HHS. (44 U.S.C. 3501–3520), federal agencies measurement capacity or feasibility of must obtain approval from the Office of maintaining the target level? ACTION: Notice. Management and Budget (OMB) for each References SUMMARY: The Centers for Medicare & collection of information they conduct 1. U.S. Public Health Service Medicaid Services (CMS) is announcing or sponsor. The term ‘‘collection of an opportunity for the public to information’’ is defined in 44 U.S.C. Recommendations for Fluoride Concentration in Drinking Water for the comment on CMS’ intention to collect 3502(3) and 5 CFR 1320.3(c) and Prevention of Dental Caries. Public information from the public. Under the includes agency requests or Health Reports. 2015 July– Paperwork Reduction Act of 1995 requirements that members of the public Aug;130(4):318–331. (PRA), federal agencies are required to submit reports, keep records, or provide 2. Department of Health, Education and publish notice in the Federal Register information to a third party. Section Welfare (US) Public Health Service 3506(c)(2)(A) of the PRA (44 U.S.C. drinking water standards, revised 1962. concerning each proposed collection of information, including each proposed 3506(c)(2)(A)) requires federal agencies Washington: Public Health Service (US); 1962. PHS Publication No. 956. extension or reinstatement of an existing to publish a 30-day notice in the collection of information, and to allow Federal Register concerning each 3. Barker LK, Duchon KK, Lesaja S, et al. Adjusted Fluoride Concentrations in 34 a second opportunity for public proposed collection of information, States: 2006–2010 and 2015. Journal comment on the notice. Interested including each proposed extension or AWWA. 2017;109(8):2–17. persons are invited to send comments reinstatement of an existing collection 4. Engineering and Administrative regarding the burden estimate or any of information, before submitting the Recommendations for Water other aspect of this collection of collection to OMB for approval. To Fluoridation, MMWR Sept 29,1995/ 44(RR–13:1–40. Fluoride information, including the necessity and comply with this requirement, CMS is utility of the proposed information publishing this notice that summarizes Recommendations Work Group. Recommendations for using fluoride to collection for the proper performance of the following proposed collection(s) of the agency’s functions, the accuracy of information for public comment: prevent and control dental caries in the United States. MMWR Recomm Rep. the estimated burden, ways to enhance 1. Type of Information Collection 2001;50(RR–14):1–42. the quality, utility, and clarity of the Request: Reinstatement with change of a 5. Heller KE, Eklund SA, Burt BA. Dental information to be collected and the use previously approved collection; Title of caries and dental fluorosis at varying of automated collection techniques or Information Collection: Transcatheter water fluoride concentrations. J Public other forms of information technology to Mitral Valve Repair (TMVR) National Health Dent. 1997;57:136–43. Coverage Decision (NCD); Use: The data 6. Brown R, McTigue N, Graf K. Monitoring minimize the information collection burden. collection is required by the Centers for fluoride: how closely do utilities match Medicare and Medicaid Services (CMS) target versus actual levels? Opflow, DATES: Comments on the collection(s) of National Coverage Determination (NCD) 40;7:10. https://doi.org/10.5991/ information must be received by the OPF.2014.40.0042. entitled, ‘‘Transcatheter Mitral Valve OMB desk officer by August 13, 2018. Repair (TMVR)’’. The TMVR device is 7. Teefy S. Managing fluoridation within a stringent regulatory framework. Proc ADDRESSES: When commenting on the only covered when specific conditions 2013 AWWA Water Quality Technology proposed information collections, are met including that the heart team Conference, Oakland, Calif. please reference the document identifier and hospital are submitting data in a 8. Public Health Service Recommendation for or OMB control number. To be assured prospective, national, audited registry. Fluoride Concentration in Drinking consideration, comments and The data includes patient, practitioner sradovich on DSK3GMQ082PROD with NOTICES Water for the Prevention of Dental recommendations must be received by and facility level variables that predict Caries. Fed Regist. 2015;80(84):24936– the OMB desk officer via one of the outcomes such as all-cause mortality 24947. Available at: https:// www.federalregister.gov/documents/ following transmissions: and quality of life. In order to remove 2015/05/01/2015-10201/public-health- OMB, Office of Information and the data collection requirement under service-recommendation-for-fluoride- Regulatory Affairs this coverage with evidence concentration-in-drinking-water-for- Attention: CMS Desk Officer development (CED) NCD or make any prevention-of. Accessed 5/11/2018. Fax Number: (202) 395–5806 OR other changes to the existing policy, we VerDate Sep<11>2014 16:47 Jul 12, 2018 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\13JYN1.SGM 13JYN1


Document Created: 2018-07-13 01:04:13
Document Modified: 2018-07-13 01:04:13
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; request for comment.
DatesWritten comments must be received on or before October 11, 2018.
ContactValerie 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.
FR Citation83 FR 32666 
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