Proposed Guidance Regarding Operational Control Range Around Optimal Fluoride Concentration in Community Water Systems That Adjust Fluoride, 32666-32667 [2018-14968]

Download as PDF 32666 Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Notices received to both notices, as well as new literature, we revised the previous draft profile (including a revised Minimal Risk Level (MRL)); therefore, on June 21, 2018, ATSDR released a revised draft profile for public comment (83 FR 28849). Because the substantive revisions were limited to the MRLs Appendix, and given the public health demand for the updated toxicological profile, we opted for a 30 day comment period. ATSDR has received requests to extend the comment period for this profile. Accordingly, ATSDR is extending the comment period an additional 30 days. Comments must be submitted by August 20, 2018. Availability The Draft Toxicological Profiles are available online at https:// www.atsdr.cdc.gov/ToxProfiles and at www.regulations.gov, Docket No. ATSDR–2015–0004. Pamela I. Protzel Berman, Director, Office of Policy, Partnerships and Planning, Agency for Toxic Substances and Disease Registry. [FR Doc. 2018–15002 Filed 7–12–18; 8:45 am] BILLING CODE 4163–70–P 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 Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice; request for comment. AGENCY: 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 sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:47 Jul 12, 2018 Jkt 244001 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: https:// 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 https://regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to https://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: OPTOL2018@cdc.gov, 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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 E:\FR\FM\13JYN1.SGM 13JYN1 Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Notices 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-regulationsand-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? sradovich on DSK3GMQ082PROD with NOTICES 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-healthservice-recommendation-for-fluorideconcentration-in-drinking-water-forprevention-of. Accessed 5/11/2018. VerDate Sep<11>2014 16:47 Jul 12, 2018 Jkt 244001 Dated: July 9, 2018. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. 32667 Email: OIRA_submission@ omb.eop.gov To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in [FR Doc. 2018–14968 Filed 7–12–18; 8:45 am] this notice, you may make your request BILLING CODE 4163–18–P using one of following: 1. Access CMS’ website address at https://www.cms.hhs.gov/Paperwork DEPARTMENT OF HEALTH AND ReductionActof1995. HUMAN SERVICES 2. Email your request, including your address, phone number, OMB number, Centers for Medicare & Medicaid and CMS document identifier, to Services Paperwork@cms.hhs.gov. [Document Identifiers: CMS–10531, CMS– 3. Call the Reports Clearance Office at R–43, CMS–10102, CMS–10143, CMS–10261, (410) 786–1326. CMS–10500, and CMS–855I] FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– Agency Information Collection 1326. Activities: Submission for OMB Review; Comment Request SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) AGENCY: Centers for Medicare & (44 U.S.C. 3501–3520), federal agencies Medicaid Services, HHS. must obtain approval from the Office of ACTION: Notice. Management and Budget (OMB) for each collection of information they conduct SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is announcing or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. an opportunity for the public to 3502(3) and 5 CFR 1320.3(c) and comment on CMS’ intention to collect includes agency requests or information from the public. Under the requirements that members of the public Paperwork Reduction Act of 1995 submit reports, keep records, or provide (PRA), federal agencies are required to information to a third party. Section publish notice in the Federal Register 3506(c)(2)(A) of the PRA (44 U.S.C. concerning each proposed collection of 3506(c)(2)(A)) requires federal agencies information, including each proposed extension or reinstatement of an existing to publish a 30-day notice in the Federal Register concerning each collection of information, and to allow proposed collection of information, a second opportunity for public including each proposed extension or comment on the notice. Interested reinstatement of an existing collection persons are invited to send comments of information, before submitting the regarding the burden estimate or any collection to OMB for approval. To other aspect of this collection of information, including the necessity and comply with this requirement, CMS is publishing this notice that summarizes utility of the proposed information collection for the proper performance of the following proposed collection(s) of information for public comment: the agency’s functions, the accuracy of 1. Type of Information Collection the estimated burden, ways to enhance Request: Reinstatement with change of a the quality, utility, and clarity of the previously approved collection; Title of information to be collected and the use Information Collection: Transcatheter of automated collection techniques or other forms of information technology to Mitral Valve Repair (TMVR) National Coverage Decision (NCD); Use: The data minimize the information collection collection is required by the Centers for burden. Medicare and Medicaid Services (CMS) DATES: Comments on the collection(s) of National Coverage Determination (NCD) information must be received by the entitled, ‘‘Transcatheter Mitral Valve OMB desk officer by August 13, 2018. Repair (TMVR)’’. The TMVR device is only covered when specific conditions ADDRESSES: When commenting on the are met including that the heart team proposed information collections, please reference the document identifier and hospital are submitting data in a prospective, national, audited registry. or OMB control number. To be assured The data includes patient, practitioner consideration, comments and and facility level variables that predict recommendations must be received by outcomes such as all-cause mortality the OMB desk officer via one of the and quality of life. In order to remove following transmissions: the data collection requirement under OMB, Office of Information and this coverage with evidence Regulatory Affairs development (CED) NCD or make any Attention: CMS Desk Officer other changes to the existing policy, we Fax Number: (202) 395–5806 OR PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\13JYN1.SGM 13JYN1

Agencies

[Federal Register Volume 83, Number 135 (Friday, July 13, 2018)]
[Notices]
[Pages 32666-32667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14968]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: https://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 https://regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to https://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

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