Fluoride Action Network

EPA’s Six-Year Review of Fluoride: Public Comments requested.

Source: Federal Register | Proposed Rule 82 FR 3518 | January 11th, 2017 | U.S. Environmental Protection Agency
Industry type: Toothpaste

The U.S. Environmental Protection Agency (EPA) has released it’s Six-Year Review of Fluoride in the January 11, 2017, Federal Register, titled: National Primary Drinking Water Regulations; Announcement of the Results of EPA’s Review of Existing Drinking Water Standards and Request for Public Comment and/or Information on Related Issues.

Aside from Fluoride, the EPA is soliciting public comments on several other substances included in this proposed rule: Radionuclides, Disinfectants/Disinfection Byproducts, and Micorbial Contaminants,  which are due before or on March 13.

Some excerpts:

• … Some areas of the country have high levels of naturally occurring fluoride. EPA established the current NPDWR [National Primary Drinking Water Regulation] to reduce the public health risk associated with exposure to high levels of naturally occurring fluoride in drinking water sources.

• … The decision to fluoridate a community water supply is made by the state or local municipality, and is not mandated by EPA or any other federal entity.

• … EPA has reviewed the NPDWR for fluoride in previous Six-Year Review cycles. As a result of the first Six-Year Review (68 FR 42908, USEPA, 2003b), EPA requested that the National Research Council (NRC) of the National Academies of Sciences (NAS) conduct a review of the health and exposure data on orally ingested fluoride. In 2006, the NRC published the results of its review and concluded that severe dental fluorosis is an adverse health effect when it causes both a thinning and pitting of the enamel, a situation that compromises the function of the enamel in protecting against decay and infection (NRC, 2006a). The NRC recommended that EPA develop a dose-response assessment for severe dental fluorosis as the critical effect and update an assessment of fluoride exposure from all sources.

• During the Six-Year Review 2, the Agency was in the process of developing a dose-response assessment of the non-cancer impacts of fluoride on severe dental fluorosis and the skeletal system. In addition, EPA was in the process of updating its evaluation of the relative source contribution (RSC) of drinking water to total fluoride exposure considering the contributions from dental products, foods, pesticide residues, and other sources such as ambient air and medications. These assessments were not completed at the time of the Six-Year Review 2; thus, no action was taken under the Six-Year Review 2 (75 FR 15500, USEPA, 2010h).

• n 2010, EPA published fluoride health assessments. The “Dose Response Analysis for Non-Cancer Effects” (USEPA, 2010b) identified an oral RfD for fluoride of 0.08 milligrams per kilograms per day (mg/kg/day) based on studies of severe dental fluorosis among children in the six months to 14 year age group (USEPA, 2010b). The “Exposure and Relative Source Contribution Analysis” (USEPA, 2010c) concluded that the RSC values for drinking water range from 40 to 70 percent, with the higher values associated with infants fed with powdered formula or concentrate reconstituted with residential tap water (70%) and with adults (60%). The major contributors to total daily fluoride intakes for these age groups are drinking water, commercial beverages, solid foods and swallowed fluoride-containing toothpaste (USEPA, 2010c).

Note from FAN: The FAN team submitted two substantive responses to these documents in response to EPA’s solicitation for public comments, but EPA has not responded yet to FAN’s, or other, comments, and is treating these documents as if they were finalized, when in fact, they are still in draft form.

Summary of Review Results. The Agency has determined that a revision to the NPDWR for fluoride is not appropriate at this time. EPA acknowledges information regarding the exposure and health effects of fluoride (as discussed later in the “Health Effects” and “Occurrence and Exposure” sections)…

potential revision of the fluoride NPDWR is a lower priority that would divert significant resources from the higher priority candidates for revision that the Agency has identified, as well as other high priority work within the drinking water office.

• … While EPA has evaluated the available health effects and exposure information related to fluoride (as discussed later in the “Health Effects” and “Occurrence and Exposure” sections), the Agency also recognizes that new studies on fluoride are currently being performed. These include new studies that address health endpoints of concern other than dental fluorosis. Based on the NRC recommendations, EPA evaluated dental fluorosis for the purposes of this action. EPA will continue to monitor the evolving science, and, when appropriate, will reconsider the fluoride NPDWR’s relative priority for revision and take any other available and appropriate action to address fluoride risks under SDWA.