82 FR 11878 - Fluoride Chemicals in Drinking Water; TSCA Section 21 Petition; Reasons for Agency Response
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 37 (February 27, 2017)
Federal Register Volume 82, Issue 37 (February 27, 2017)
| Page Range | 11878-11890 | |
| FR Document | 2017-03829 |
[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)] [Proposed Rules] [Pages 11878-11890] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-03829] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Chapter I [EPA-HQ-OPPT-2016-0763; FRL-9959-74] Fluoride Chemicals in Drinking Water; TSCA Section 21 Petition; Reasons for Agency Response AGENCY: Environmental Protection Agency (EPA). ACTION: Petition; reasons for Agency response. ----------------------------------------------------------------------- SUMMARY: This document announces the availability of EPA's response to a petition it received on November 23, 2016, under section 21 of the Toxic Substances Control Act (TSCA). The TSCA section 21 petition was received from the Fluoride Action Network, Food & Water Watch, Organic Consumers Association, the American Academy of Environmental Medicine, the International Academy of Oral Medicine and Toxicology, and other individual petitioners. The TSCA section 21 petition requested that EPA exercise its authority under TSCA section 6 to ``prohibit the purposeful addition of fluoridation chemicals to U.S. water supplies.'' After careful consideration, [[Page 11879]] EPA has denied the TSCA section 21 petition for the reasons discussed in this document. DATES: EPA's response to this TSCA section 21 petition was signed February 17, 2017. FOR FURTHER INFORMATION CONTACT: For technical information contact: Darlene Leonard, National Program Chemicals Division (7404T), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 566-0516; fax number: (202) 566-0470; email address: [email protected]. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? This action is directed to the public in general. This action may, however, be of interest to individuals or organizations interested in drinking water and drinking water additives, including fluoride. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. B. How can I access information about this petition? The docket for this TSCA section 21 petition, identified by docket identification (ID) number EPA-HQ-OPPT-2016-0763, is available online at http://www.regulations.gov or in person at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. Six binders containing copies of references were submitted along with the petition (Ref. 1). Those binders are not available electronically in the docket but may be reviewed in the Public Reading Room. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566- 0280. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. II. TSCA Section 21 A. What is a TSCA section 21 petition? Under TSCA section 21 (15 U.S.C. 2620), any person can petition EPA to initiate a rulemaking proceeding for the issuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 8 or an order under TSCA sections 4, 5(e), or 5(f). A TSCA section 21 petition must set forth the facts that are claimed to establish the necessity for the action requested. EPA is required to grant or deny the petition within 90 days of its filing. If EPA grants the petition, the Agency must promptly commence an appropriate proceeding that is ``in accordance'' with the underlying TSCA authority. If EPA denies the petition, the Agency must publish its reasons for the denial in the Federal Register. 15 U.S.C. 2620(b)(3). A petitioner may commence a civil action in a U.S. district court to compel initiation of the requested rulemaking proceeding within 60 days of either a denial or the expiration of the 90-day period. 15 U.S.C. 2620(b)(4). B. What criteria apply to a decision on a TSCA section 21 petition? TSCA section 21(b)(1) requires that the petition ``set forth the facts which it is claimed establish that it is necessary'' to issue the rule or order requested. 15 U.S.C. 2620(b)(1). Thus, TSCA section 21 implicitly incorporates the statutory standards that apply to the requested action. In addition, TSCA section 21 establishes standards a court must use to decide whether to order EPA to initiate rulemaking in the event of a lawsuit filed by the petitioner after denial of a TSCA section 21 petition. 15 U.S.C. 2620(b)(4)(B). Accordingly, EPA has relied on the standards in TSCA section 21 (and those in the provisions under which action has been requested) to evaluate this TSCA section 21 petition. III. TSCA Section 6 Of particular relevance to this TSCA section 21 petition are the legal standards regarding TSCA section 6(a) rules. These standards were significantly altered in 2016 by the ``Frank R. Lautenberg Chemical Safety for the 21st Century Act,'' Public Law 114-182 (2016), which amended TSCA. One of the key features of the new law is the requirement that EPA now systematically prioritize and assess existing chemicals, and manage identified risks. Through a combination of new authorities, a risk-based safety standard, mandatory deadlines for action, and minimum throughput requirements, TSCA effectively creates a ``pipeline'' by which EPA will conduct review and management of existing chemicals. This new pipeline--from prioritization to risk evaluation to risk management (when warranted)--is intended to drive forward steady progress on the backlog of existing chemical substances left largely unaddressed by the original law. (Ref. 2). In the initial phase of the review pipeline, EPA is to screen a chemical substance for its priority status, propose a designation as either high or low priority, and then issue a final priority designation within one year of starting the screening process. 15 U.S.C. 2605(b)(1)(C). If the substance is high priority, EPA must initiate a risk evaluation for that substance. 15 U.S.C. 2605(b)(4)(C). EPA must define the scope of the risk evaluation within six months of starting, 15 U.S.C. 2605(b)(4)(D), and complete the risk evaluation within 3 to 3.5 years. 15 U.S.C. 2605(b)(4)(G). If EPA concludes that a chemical substance presents an unreasonable risk, EPA must propose a risk management rule under TSCA section 6(a) within one year and finalize that rule after another year, with limited provision for extension. 15 U.S.C. 2605(c). As EPA completes risk evaluations, EPA is to designate replacement high-priority substances, on a continuing basis. 15 U.S.C. 2605(b)(2)(C) and (b)(3)(C). In general, to promulgate a rule under TSCA section 6(a), EPA must first determine ``in accordance with section 6(b)(4)(A) that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture . . . presents an unreasonable risk.'' 15 U.S.C. 2605(a). TSCA section (b)(4)(A) is part of the risk evaluation process whereby EPA must determine ``whether a chemical substance presents an unreasonable risk of injury to health or the environment,'' and thus, whether a rule under TSCA section 6(a) is necessary. 15 U.S.C. 2605(b)(4)(A). In particular, EPA must conduct this evaluation ``without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use.'' Id. Unless EPA establishes an exemption under TSCA section 6(g) (whereby certain unreasonable risks may be allowed to persist for a limited period) or EPA is addressing a persistent, bioaccumulative, and toxic substance as set forth in TSCA section 6(h), the standard for an adequate rule under TSCA section 6(a) is that it regulates ``so that the chemical [[Page 11880]] substance or mixture no longer presents'' unreasonable risks under the conditions of use. 15 U.S.C. 2605(a). Prior to the 2016 amendment of TSCA, EPA completed risk assessments that were limited to selected uses of chemical substances. The amended TSCA authorizes EPA to issue TSCA section 6 rules that are not comprehensive of the conditions of use, so long as they are consistent with the scope of such pre-amendment risk assessments. 15 U.S.C. 2625(l)(4). But EPA has interpreted the amended TSCA as requiring that forthcoming risk evaluations encompass all manufacture, processing, distribution in commerce, use, and disposal activities that the Administrator determines are intended, known or reasonably foreseen. (Ref. 2, p. 7565). EPA interprets the scope of post-risk-evaluation rulemaking under TSCA section 6(a) in a parallel fashion: While risk management rules for a certain subset of the conditions of use may be promulgated ahead of rulemaking for the remaining conditions of use, rules covering the complete set of conditions of use must be promulgated by the deadlines specified in TSCA section 6(c). 15 U.S.C. 2605(c). While EPA has authority under TSCA section 6(a) to establish requirements that apply only to ``a particular use,'' the restriction of just one particular use would not constitute an adequate risk management rule unless that particular use were the only reason that the chemical substance presented an unreasonable risk. TSCA section 21(b)(4)(B) provides the standard for judicial review should EPA deny a request for rulemaking under TSCA section 6(a): ``If the petitioner demonstrates to the satisfaction of the court by a preponderance of the evidence that . . . the chemical substance or mixture to be subject to such rule . . . presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use,'' the court shall order the EPA Administrator to initiate the requested action. 15 U.S.C. 2620(b)(4)(B). EPA notes that bills preceding the final amendment to TSCA retained language in section 21 that resembled the pre-amendment criteria for rulemaking under section 6. Compare 15 U.S.C. 2620(b)(4)(B)(ii) (2015) (amended 2016), 15 U.S.C. 2605(a) (2015) (amended 2016), S. Rep. 114-67 at 135 (Ref. 3), and H.R. Rep. No. 114-176 at 81 (Ref. 4). But the effect of the revision in the final bill is to align the standard for judicial review of a TSCA section 21 petition with the standard for EPA's preparation of risk evaluation under TSCA section 6(b)(4)(A). Consistent with these revisions, EPA concludes that Congress intended for a petition to set forth facts that would enable EPA to complete a risk evaluation under TSCA section 6(b). In light of this, EPA interprets TSCA section 21 as requiring the petition to present a scientific basis for action that is reasonably comparable, in its quality and scope, to a risk evaluation under TSCA section 6(b). This requirement includes addressing the full set of conditions of use for a chemical substance and thereby describing an adequate rule under TSCA section 6(a)--one that would reduce the risks of the chemical substance ``so that the chemical substance or mixture no longer presents'' unreasonable risks under all conditions of use. 15 U.S.C. 2605(a). Specifically, EPA interprets section 21(a)--which authorizes petitions ``to initiate a proceeding for the issuance . . . of a rule under . . . section 6''--as authorizing petitions for rules that would comply with the requirements of sections 6(a) and 6(c). EPA recognizes that information on a single condition of use could, in certain instances, suffice to demonstrate that a chemical substance, as a whole, presents an unreasonable risk. Nonetheless, EPA concludes that such information does not fulfill a petitioner's burden to justify ``a rule under [TSCA section 6],'' under TSCA section 21, since the information would merely justify a subset of an adequate rule. To issue an adequate rule under section 6, EPA would need to conduct a catch-up risk evaluation addressing all the conditions of use not addressed by the petition, and either determine that those conditions do not contribute to the unreasonable risk or enlarge the scope of the rule to address those further conditions of use. See 15 U.S.C. 2605(a). To issue this rule within the time required by section 6(c), EPA would have to proceed without the benefit of the combined 4 to 4.5-year period that TSCA section 6(b) would ordinarily afford EPA (i.e., time to prioritize a chemical substance, conduct a careful review of all of its conditions of use, and receive the benefit of concurrent public comment). Additionally, before even initiating the prioritization process for a chemical substance, EPA would generally screen the chemical substance to determine whether the available hazard and exposure-related information are sufficient to allow EPA to complete both the prioritization and the risk evaluation processes. (Ref. 5). EPA's interpretation is most consonant with the review pipeline established in TSCA section 6. In particular, the prioritization process established in section 6(b) recognizes that a number of chemical substances may present an unreasonable risk of injury to health or the environment and charges EPA with prioritizing those that should be addressed first. EPA is required to have 10 chemical substances undergoing risk evaluation as of December 19, 2016, and must have a steady state of at least 20 high-priority substances undergoing risk evaluation by December 2019 (and as many as 10 substances nominated for risk evaluation by manufacturers). 15 U.S.C. 2605(b)(2)(A), (B), 2605(b)(4)(E)(i). EPA is obligated to complete rulemakings to address any unreasonable risks identified in these risk evaluations within prescribed timeframes. 15 U.S.C. 2605(c)(1). These required activities will place considerable demands on EPA resources. Indeed, Congress carefully tailored the mandatory throughput requirements of TSCA section 6, based on its recognition of the limitations of EPA's capacity and resources, notwithstanding the sizeable number of chemical substances that will ultimately require review. Under this scheme, EPA does not believe that Congress intended to empower petitioners to promote chemicals of particular concern to them above other chemicals that may well present greater overall risk, and force completion of expedited risk evaluations and rulemakings on those chemicals, based on risks arising from individual uses. EPA recognizes that some members of the public may have safety concerns that are limited to a single condition of use for a chemical substance. But EPA's interpretation of TSCA section 21 does not deprive such persons of a meaningful opportunity to request that the Administrator proceed on their concerns. For example, such persons may submit a petition under the Administrative Procedure Act, requesting EPA to commence a ``risk-based screening'' of the chemical substance under TSCA section 6(b)(1)(A), motivated by their concern about a single condition of use. IV. Summary of the TSCA Section 21 Petition A. What action was requested? On November 23, 2016, a TSCA section 21 petition was submitted by the Fluoride Action Network, Food & Water Watch, Organic Consumers Association, the American Academy of Environmental Medicine, the [[Page 11881]] International Academy of Oral Medicine and Toxicology, Moms Against Fluoridation, and the following individuals signing on behalf of themselves and their children: Audrey Adams of Renton, Washington, Jacqueline Denton of Asheville, North Carolina, Valerie Green of Silver Spring, Maryland, Kristin Lavelle of Berkeley, California, and Brenda Staudenmaier of Green Bay, Wisconsin (Ref. 1). The general object of the petition is to urge EPA ``to protect the public and susceptible subpopulations from the neurotoxic risks of fluoride by banning the addition of fluoridation chemicals to water'' (Ref. 1). The specific action sought is a rule, under TSCA section 6(a)(2), to ``prohibit the purposeful addition of fluoridation chemicals to U.S. water supplies.'' However, such a restriction on the allowable use of fluoridation chemicals would actually be based on a rule under TSCA section 6(a)(5), not a rule under TSCA section 6(a)(2). In light of the discrepancy between the description of the rule sought and the cited authority, EPA interprets the petition as requesting both a TSCA section 6(a)(5) rule whereby the purposeful addition of any fluoridation chemical to a drinking water supply would be prohibited and a TSCA section 6(a)(2) rule whereby the manufacture, processing, or distribution in commerce of any fluoridation chemical for such use would be prohibited. B. What support does the petition offer? The petition is focused on the potential for fluoride to have neurotoxic effects on humans; it cites numerous studies bearing on this issue. The petition contends that the purposeful fluoridation of drinking water presents an unreasonable risk to human health from neurotoxicity, and that a ban on this use of fluoridation chemicals is necessary to curtail this unreasonable risk. The following is a summary of the primary support given in the petition for this view: 1. Fluoride neurotoxicity at levels relevant to U.S. population. The petition claims that fluoride poses neurotoxic risks to the U.S. population. The petition claims that the cited studies of fluoride- exposed human populations have consistently found neurotoxic effects (lower-than-average IQs) at water fluoride levels below the current Maximum Contaminant Level Goal of 4 mg/L set by EPA's Office of Water. The petition argues that the difference between the fluoride levels in the United States and the greater levels in rural China (where most of the cited IQ studies were conducted) is ``lessen[ed]'' by the abundance of fluoridated toothpaste in the U.S. 2. Recent epidemiological studies corroborate neurotoxic risk in Western populations. The petition cites two studies from Western populations to attempt to corroborate the assertion that exposure to fluoride in drinking water presents unreasonable risks for neurotoxicity (Refs. 6 and 7). 3. Neurotoxic risks supported by animal and cell studies. The petition argues that studies on both experimental animals and cell cultures are consistent with cited human research linking fluoride exposure with neurotoxic effects in humans. 4. Susceptible subpopulations are at heightened risk. The petition argues that certain subpopulations (e.g., infants, the elderly, and persons with nutritional deficiencies, kidney disease or certain genetic predispositions) are more susceptible to fluoride neurotoxicity. 5. RfD/RfC derivation and uncertainty factor application. The petition argues that EPA's 1998 Guidelines for Neurotoxicity Risk Assessment support the need to apply a 10-fold uncertainty factor in deriving an oral Reference Dose (RfD) or inhalation Reference Concentration (RfC). 6. Benefits to public health. The petition bases, in part, its claim of unreasonable risk on the assertion that the fluoridation of drinking water confers little benefit to public health, relative to the alleged neurotoxic risks. The petition argues that since fluoride's primary benefit comes from topical contact with the teeth, there is little benefit from swallowing fluoride, in water or any other product. The petition argues that there is therefore ``little justification'' in exposing the public to ``any risk'' of fluoride neurotoxicity. 7. Extent and magnitude of risk from fluoridation chemicals. The petition bases, in part, its claim of unreasonable risk on estimates of the extent and magnitude of risk posed to portions of the U.S. population living in areas where artificial fluoridation occurs. 8. Consequences of eliminating use of fluoridation chemicals. The petition argues that the risks of fluoride exposure from fluoridated drinking water are unreasonable, in part, because they could be easily and cheaply eliminated, and because alternative products containing topical fluoride are widely available. 9. Link to elevated blood lead levels. The petition argues that artificial fluoridation chemicals are linked with pipe corrosion and elevated blood lead levels. The petition interprets data in several studies as demonstrating an association between fluoridation chemicals and elevated blood lead levels. In addition to supplying the petition, on January 30, 2017, the petitioners also delivered an in-person oral presentation of their views (Ref. 8). At their oral presentation, petitioners reiterated the information already supplied in writing, and requested that EPA also consider an additional study that was not part of the petition (Ref. 9). EPA has discretion (but not an obligation) to consider extra- petition materials when evaluating a petition submitted under TSCA section 21. In cases where the petitioners themselves attempt to enlarge the scope of materials under review while EPA's petition review is pending, EPA exercises its discretion to consider or not consider the additional material based on whether the material was submitted early enough in EPA's petition review process to allow adequate evaluation of the study prior to the petition deadline, the relation of the late materials to materials already submitted. Given the particularly late submittal of the additional study, EPA conducted an abbreviated review of the study and found that the health concerns covered were substantially the same as those covered in other studies submitted with the petition. Based on this abbreviated review, EPA does not believe that the new study provided any new scientific grounds for granting the petition. V. Disposition of TSCA Section 21 Petition A. What was EPA's response? After careful consideration, EPA denied the TSCA section 21 petition, primarily because EPA concluded that the petition has not set forth a scientifically defensible basis to conclude that any persons have suffered neurotoxic harm as a result of exposure to fluoride in the U.S. through the purposeful addition of fluoridation chemicals to drinking water or otherwise from fluoride exposure in the U.S. In judging the sufficiency of the petition, EPA considered whether the petition set forth facts that would enable EPA to complete a risk evaluation under TSCA section 6(b). EPA also denied the petition on the independent grounds that the petition neither justified the regulation of fluoridation chemicals as a category, nor identified an adequate section 6 rule as the action sought. Rather than comprehensively addressing the conditions of use that apply to a particular chemical substance, the petition requests EPA to take action on a single condition of use (water [[Page 11882]] fluoridation) that cuts across a category of chemical substances (fluoridation chemicals). A copy of the Agency's response, which consists of a letter to the petitioners, is available in the docket for this TSCA section 21 petition. B. What were EPA's reasons for this response? To take the actions under TSCA section 6 requested by the petitioners, EPA would need to make a determination of whether a chemical substance or substances present an unreasonable risk to human health or the environment. This section describes why the petitioners have not provided adequate and sufficient scientific information to make such a determination. 1. Fluoride neurotoxicity at levels relevant to U.S. population. The petition ignores a number of basic data quality issues associated with the human studies it relies upon. Many of the human studies cited in the petition are cross-sectional in design, and are affected by antecedent-consequent bias. The antecedent-consequent bias means it cannot be determined whether the exposure came before or after the health effects, since both are evaluated at the same time. Cross- sectional studies are most useful for developing hypotheses about possible causal relationships between an exposure and a health effect, but are rarely suitable for the development of a dose-response relationship for risk assessment. These studies are most useful in supporting more robust epidemiological studies in which defined exposures can be linked quantitatively to an adverse outcome. The petition also does not properly account for the relatively poor quality of the exposure and effects data in the cited human studies (e.g., it appears to give all studies equivalent weight, regardless of their quality). When an association is suggested between an exposure and a disease outcome, the studies need to be assessed to determine whether the effect is truly because of exposure or if alternate explanations are possible. The way to do that is to adjust for potential confounders, such as diet, behavior, and socioeconomic status, in order to appropriately assess the real relationship between the exposures to a specific substance and health effects. In other words, when these confounding factors are potentially present, but not recognized or controlled for, it is not possible to attribute effects to the contaminant of concern (fluoride) as opposed to other factors or exposures. The evidence presented did not enable EPA to determine whether various confounding factors (e.g., nutritional deficiencies) were indeed placing particular subpopulations at a ``heightened risk of fluoride neurotoxicity,'' as alleged, because the evidence did not adequately account for the possibility that the confounding factors themselves, rather than concurrent fluoride exposure, were partly or wholly responsible for the health effects observed. Specific confounding factors or variables were noted by the National Research Council (NRC) (Ref. 10). They may include climate, drinking water intake, excessive dietary fluoride, low calcium intake, drinking water sources with fluctuating fluoride levels, and industrial pollution such as use of coal for domestic heating. These factors have the potential to confound efforts to identify a causal relationship between drinking water fluoride exposure and particular health effects, either by introducing additional, unaccounted for sources of fluoride exposure, by being associated with the pertinent health endpoint through some mechanism other than fluoride toxicity, or by directly affecting the health endpoint. The petition relies heavily on two meta-analyses which include human cross-sectional (Ref. 11) and case control (Ref. 19) studies. All of the studies listed in Table 1 of the petition were examined in detail by the 2012 Choi et al. study (Ref. 11) as part of their systematic review and meta-analysis to investigate the possibility that fluoride exposure delays neurodevelopment in children. The Choi et al. analysis analyzes studies in which IQ was measured using various IQ tests, compares children of various fluoride exposure ranges without accounting for differences in susceptibility to fluoride by age, and used different exposure measures which only delineated between high and low exposure groups. A variety of measures of fluoride exposure were present across studies included in the Choi et al. study, including levels of fluoride in drinking water, observed dental fluorosis, coal burning in houses (i.e., air fluoride levels), and urine fluoride. Despite this disparate collection of types of measurements, all exposure measures were treated equally in the analysis (Ref. 11, Table 1). The authors of the analysis identified a variety of data quality issues associated with this collection of studies. For example, they recognized that several of the populations studied had fluoride exposures from sources other than drinking water (e.g., coal burning; Refs. 13-15); they therefore controlled for this confounding factor by excluding such studies from their analysis. Co-exposures to other potentially neurotoxic chemicals (e.g., iodine) (Refs. 16-18) and arsenic (Refs. 19-22) were also recognized and accounted for in the Choi et al. analysis to understand confounding by these factors. Yet the petitioners include such studies in making their assertion that fluoride is neurotoxic, but have not indicated any attempts to control for the confounding factors. Choi et al. also noted that basic information such as the study subjects' sex and parental education was missing in 80 percent of the studies and household income was missing in 93 percent of studies; they stated that they could not therefore control for these co-variables in their analysis. Consideration of these confounding factors and their impact on the applicability of these studies in a risk assessment context is evident in the authors' discussion. The authors caution readers that ``our review cannot be used to derive an exposure limit, because the actual exposures of the individual children are not known'' and they are measured in their conclusions (i.e., ``our results support the possibility of adverse effects of fluoride exposures on children's neurodevelopment'') (Ref. 11). The authors indicate that ``further research should formally evaluate dose-response relationships based on individual-level measures of exposure over time, including more precise prenatal exposure assessment and more extensive standardized measures of neurobehavioral performance, in addition to improving assessment and control of potential confounders'' (Ref. 11). EPA agrees with the conclusions by Choi et al. (Ref. 11) that the studies included in Table 1 of the petition are unsuitable for evaluating levels of fluoride associated with neurotoxic effects and for deriving dose-response relationships necessary for risk assessment. The petition also cites an article by Grandjean and Landrigan (Ref. 23), for the proposition that fluoride is ``known'' to cause developmental neurotoxicity in humans. Grandjean and Landrigan refer only to the study of Choi et al. (2012), of which Grandjean is a co- author, in discussing fluoride. EPA's observations about the limitations of Choi et al. (2012) thus apply with equal force to the cited statement from Grandjean and Landrigan. Grandjean and Landrigan summarize that Choi et al. (2012) ``suggests an average IQ decrement of about seven points in children exposed to raised fluoride concentrations.'' (Ref. 23). But Grandjean and Landrigan do not opine on whether fluoride exposures, arising from the purposeful addition of fluoridation chemicals to [[Page 11883]] U.S. water supplies, are in fact causing developmental neurotoxic effects to persons in the U.S. The petition itself concedes that the actual existence of such effects is unestablished, in urging EPA to conduct ``a diligent risk assessment, per EPA's Guidelines, to ensure that the general public, and sensitive subpopulations, are not ingesting neurotoxic levels'' (Ref 1, p. 3). The other meta-analysis cited in the petition (Ref. 12) showed that, based on 16 case-control studies in China, children living in an area with endemic fluorosis are more likely to have low IQ compared to children living in an area with slight fluorosis or no fluorosis. While this analysis may suggest an association between fluorosis and lowered IQ (both of which are possible effects of fluoride exposure at certain levels) any fluoride concentration-to-IQ effect relationship (i.e., dose-response relationship) is only inferred because actual fluoride exposures were not measured. Further, the two effects (fluorosis and lower IQ) both occur at fluoride exposures well above those found in fluoridated U.S. drinking water, such that any inference would only apply at fluoride concentrations not relevant to exposures in the U.S. The studies in the Tang et al. review (Ref. 12) correlate one effect (fluorosis) to another effect (neurotoxicity), but do not establish a dose-response relationship between fluoride exposure and neurotoxicity. This lack of a dose-dependent increase in effect with increasing exposure is a critical limitation of these data. Establishing a dose- response relationship between exposure to a toxicant and an effect ``is the most fundamental and pervasive concept in toxicology. Indeed, an understanding of this relationship is essential for the study of toxic materials'' (Ref. 12). Likewise, the IQ changes noted in Table 1 (Ref. 1) do not increase with increasing water fluoride concentration (e.g., dose) (Ref. 1). The petition suggested that a dose-response relationship between urinary fluoride and IQ is seen in several studies (Refs. 24-26) shown in Figures 1-5 of the petition (Ref. 1). Assuming, as the petitioners claim, that all children were malnourished in the Das and Mondal (Ref. 26) study, it is not possible to determine whether effects on IQ were due to fluoride or to malnutrition (i.e., nutritional status may be an uncontrolled confounding factor). The study authors caution that ``it is difficult to determine with any degree of accuracy whether the difference of children's IQ scores solely depends on the exposure dose because many social and natural factors like economic condition, culture and geological environments are also responsible'' (Ref. 26). Hence, extrapolating relationships from this study population to other populations is not scientifically defensible. Choi et al. (2015) (Ref. 27) report that moderate and severe dental fluorosis was significantly associated with lower cognitive functions. However, associations between drinking water and urine fluoride and the same cognitive functions were not found to be significantly associated. They reached this conclusion from a study of 51 children in China and a comparison group of eight with dental fluorosis (Table 4 in Choi et al., 2015). The authors discuss potential problems associated with using these biomarkers of exposure to fluoride. For example, water samples may be imprecise because internal dose of fluoride depends on total water intake, and urine samples may be affected by the amount of water the subject drank prior to sampling. With regard to fluorosis, the degree of dental fluorosis is dependent not only on the total fluoride dose but also on the timing and duration of fluoride exposure. A person's individual response to fluoride exposure depends on factors such as body weight, activity level, nutritional factors, and the rate of skeletal growth and remodeling. These variables, along with inter- individual variability in response to similar doses of fluoride, indicate that enamel fluorosis cannot be used as a biological marker of the level of fluoride exposure for an individual (Ref. 28). Hence, the petitioner's use of fluorosis levels as a surrogate for evidence of neurotoxic harm to the U.S. population is inappropriate evidence to support an assertion of unreasonable risk to humans from fluoridation of drinking water. The petition also cites four studies (Refs. 24, 29-31) that rely on human urine or serum fluoride concentrations as biomarkers of exposure but does not discuss the limitations associated with the biomarkers used in the studies. In their report, Human Biomonitoring for Environmental Chemicals, NRC defines properties of biomarkers and created a framework for grouping biomarkers of exposure (Ref. 32). Figure 3-1 in the NRC report illustrates the relationship between external dose (e.g., water), internal dose (e.g., fluoride concentration) and biological effects, and indicates that internal dose is measured through biomonitoring (e.g., fluoride concentrations measured in urine or serum). NRC grouped the quality of biomarkers based on the robustness of these relationships. NRC designated biomarkers for substances that have been observed in bodily fluids, but that lack established relationships between external dose (e.g., water), internal dose (e.g., urine or serum) and biological effects (e.g., neurotoxicity) as ``Group I'' biomarkers. Although many human studies have been collated and reviewed in the petition, for the reasons outlined previously--particularly study design and confounding factors--relationships between urine and serum fluoride (internal doses), water fluoride concentration (external dose), and neurotoxic effects in humans have not been established. Further, serum and urine biomarkers for fluoride reflect only recent exposures, not long-term exposures, and may be different from the exposures during the specific time when developmental effects can occur. A lack of established sampling protocols and analytical methods are also hallmarks of ``Group I'' biomarkers. The main studies cited in the petition which attempt to relate urine or serum levels to possible neurotoxic effects suffer from either lack of good sampling protocols or absence of documenting the sampling protocols. Important issues such as the timing and methods of sample collection were also often not reported in the studies. Using the NRC Framework, urine and serum fluoride levels would be at best ``Group I'' biomarkers for fluoride-related neurotoxicity. The NRC Framework states ``[b]iomarkers in this category may be considered useless'' for risk assessment purposes (Ref. 32, p. 78). 2. Recent epidemiological studies corroborate neurotoxic risk in Western populations. The petition cites two studies from Western populations to attempt to corroborate the assertion that exposure to fluoridated water presents unreasonable risks for neurotoxicity. Two population-level studies were cited which link fluoridated water to attention-deficit/hyperactivity disorder (ADHD) prevalence in the U.S. (Ref. 6) and drinking water exposures and hypothyroidism prevalence in England (Ref. 7). These studies use cross-sectional population-level data to examine the association between ADHD and hypothyroidism and fluoridated water levels. The studies make reasonable use the population-level data available, but causal inference cannot be made from these studies (Ref. 3). As stated in the conclusion of Malin and Till, an association has been reported, but ``[p]opulation studies designed to examine possible mechanisms, patterns and levels of exposure, covariates and moderators of [[Page 11884]] this relationship are warranted'' (Ref. 6, p. 8). In epidemiology, studies using cross-sectional data are most often used to generate hypotheses that need to be further studied to determine whether a ``true'' association is present. Ideally, the study designs and methods are improved by each study that is undertaken, such as, among other things, identifying additional potential confounders, considering timing issues or resolving ambiguity in collection of samples and disease outcome, improving upon the exposure analysis, and evaluating the magnitude and consistency of the results, so that the evaluation can adequately assess the association (Ref. 34). For example, the authors assert that there are design issues with their study, especially related to the exposure categories, and they suggest how to address these issues in future studies. Although it is possible that there may be biological plausibility for the hypothesis that water fluoridation may be associated with ADHD, this single epidemiological study is not sufficient to ``corroborate'' neurotoxic health effects, as stated in the petition. More study would be needed to develop a body of information adequate to make a scientifically defensible unreasonable risk determination under TSCA. The Peckham et al. study (Ref. 7) suffers from similar issues noted in Malin and Till (Ref. 6). Adjustment for some confounders was considered, including sex and age, but other potential confounders (such as iodine intake) were not assessed. Fluoride from other sources and other factors associated with hypothyroidism were not assessed in this study. Exposure misclassification, in which populations are placed in the wrong exposure categories based on the water fluoridation status, is very possible in either of the studies presented and is a limitation of the study designs. 3. Neurotoxic risks supported by animal and cell studies. The National Toxicology Program (NTP) conducted a systematic review of animal and cell studies on the effects of fluoride on learning and memory available up to January 2016 (Ref. 35). Almost all (159 out of 171) of the animal and cell culture studies cited in the petition in Appendix D-E were included in the NTP systematic review. From among 4,656 studies identified in the NTP database search, 4,552 were excluded during title and abstract screening, 104 were reviewed at the full-text level and 68 studies were considered relevant and were included in the analysis. NTP assessed each study for bias, meaning a systematic error in the study that can over or underestimate the true effect and further excluded any studies with a high risk of bias. Of the 68 studies, including studies provided by the Fluoride Action Network, 19 were considered to pose a very serious overall risk of bias, primarily based on concern for at least three of the following factors: Lack of randomization, lack of blinding at outcome assessment in conjunction with not using automated tools to collect information, lack of reporting on what was administered to animals (source, purity, chemical form of fluoride), lack of control for litter effects, lack of expected response in control animals, and lack of reporting of key study information such as the number or sex of animals treated. Of the studies cited in Table 4 in the petition, two were excluded from the NTP analysis because of serious concerns for study bias (Refs. 36 and 37). Based on its review of animal and cell studies, NTP concluded that ``[t]he evidence is strongest (moderate level-of-evidence) in animals exposed as adults tested in the Morris water maze and weaker (low level-of-evidence) in animals exposed during development'' and ``[v]ery few studies assessed learning and memory effects at exposure levels near 0.7 parts per million, the recommended level for community water fluoridation in the United States.'' The animal studies cited in the petition (Ref. 1, p. 14, Table 4) reflect these high drinking water exposures ranging from 2.3 mg/L to 13.6 mg/L, equivalent to 3-20 times the levels to which drinking water is fluoridated in the U.S. Overall, NTP concluded that, ``[r]esults show low-to-moderate level-of-evidence in developmental and adult exposure studies for a pattern of findings suggestive of an effect on learning and memory'' (Ref. 35, p. 52). Based on this review of available evidence, and the identified limitations in the database, NTP is currently pursuing experimental studies in rats to address key data gaps, starting with pilot studies that address limitations of the current literature with respect to study design (e.g., randomization, blinding, control for litter effects), and assessment of motor and sensory function to assess the degree to which impairment of movement may impact performance in learning and memory tests. If justified, follow-up studies would address potential developmental effects using lower dose levels more applicable to human intakes. Two studies included in Table 4 (Ref. 1) were not included in the NTP review, but do not show neurotoxicity effects at doses relevant to U.S. populations. One study aimed to establish vitamin A as a marker for fluoride neurotoxicity (Ref. 38), but changes in vitamin A were measured only at an excessive fluoride dose of 20 mg/L. The other study dosed rats with fluoride in drinking water (Ref. 39) and showed effects on behavior and brain neurotransmitters at a dose of 5 mg/L, a level well above the 0.7 parts per million level recommended for community water fluoridation in the United States. Other studies in Table 4, which, according to the title of the table, are indicative of ``Water Fluoride Levels Associated with Neurotoxic Effects in Rodents,'' erroneously report effect levels not supported by the studies themselves. In Wu et al. (Ref. 36), which NTP excluded based on high bias, no adverse effects were seen at a dose of 1 mg/kg-day as claimed in the petition. In fact, the behavioral effects occurred only at doses of 5 and 25 mg/L. In Chouhan et al. (Ref. 40), which NTP excluded in the initial screen for relevancy, no significant neurotoxicity was seen at 1 mg/L fluoride, in contrast to what the petition claims. In addition, the petition's statement that ``rats require 5 times more fluoride in their water to achieve the same level of fluoride in their blood as humans'' (Ref. 1) as a rationale for why higher exposure levels in animals are relevant to lower levels in humans is not supported by the NTP review in the petition. The NTP review indicates that ``assuming approximate equivalence [of drinking water concentrations in rodents and humans] is not unreasonable'' (Ref. 35, p. 58). These several erroneously reported studies do not change EPA's agreement with the conclusions of the NTP report that their ``[r]esults show low-to-moderate level-of-evidence in developmental and adult exposure studies for a pattern of findings suggestive of an effect on learning and memory'' (Ref. 35, p. 52). In cell studies cited in the petition, two studies demonstrated effects following exposure of artificial brain cells to fluoride at concentrations in the range purported to be in the bloodstream of humans. However, relevance of cell assays to humans is limited because the concentrations of fluoride experienced by cells by themselves in culture are not directly comparable to an animal or human exposure due to lack of metabolism, interactions between cells, and the ability to measure chronic (long-term) effects (Ref. 41). Extrapolation from concentrations in cell cultures to human exposures is not straightforward. Pharmacokinetic modeling is necessary to convert the concentrations to a [[Page 11885]] human equivalent dose relevant to risk assessment (Ref. 42), but the petition did not address whether data are available or lacking to complete such an analysis. 4. Susceptible subpopulations are at heightened risk. The data and information provided in the petition do not support the claims that ``nutritional status, age, genetics and disease are known to influence an individual's susceptibility to chronic fluoride toxicity.'' The only reference the petition presents that specifically addresses the claim that nutrient deficiencies (i.e., deficiencies in iodine and calcium) can ``amplify fluoride's neurotoxicity'' is the study by Das and Mondal (Ref. 26). However, the study did not measure any nutrients in their test subjects. Rather, they measured Body Mass Index (BMI), acknowledging that ``BMI is the most commonly used measure for monitoring the prevalence of overweight and obesity at population level'' and ``it is only a proxy measure of the underlying problem of excess body fat or underweight cases.'' Not only is the BMI an indirect proxy for the iodine and calcium deficiencies supposed in the petition, the BMI results presented in this study are themselves equivocal, as they show that BMIs ranged from underweight to overweight to obesity depending on the sex and age of the study subjects. Furthermore, the petition concedes that the Das and Mondal study data are only ``suggestive'' of an area with chronic malnutrition. A few human studies cited provide only suggestive evidence that low levels of iodine may increase the effects of high levels of fluoride in children, but these studies suffer from study design and confounding issues already described previously. Other cited studies describe the effects of iodine or calcium on rats or rat brain cells in addition to irrelevantly high fluoride levels. The petition also claims that a certain ``COMT gene polymorphism greatly influences the extent of IQ loss resulting from fluoride exposure,'' citing a study by Zhang et al. (Ref. 29) as support. The COMT gene encodes for the enzyme, catechol-O- methyltransferase, which is responsible for control of dopamine levels in the brain. Zhang et al. concludes that, ``[t]he present study has several limitations. First, the cross-sectional observational design does not allow us to determine temporal or causal associations between fluoride and cognition. Second, the study has a relatively small sample size, which limits the power to assess effects of gene-environmental interactions on children's IQ'' (Ref. 29). Zhang et al. continues ``[d]espite the study limitations, this is the first gene-environment study investigating the potential impact of COMT single-nucleotide polymorphism (SNP) on the relationship between children's cognitive performance and exposure to elemental fluoride'' (Ref. 29). Several studies are cited in the petition to support the assertion that infants, the elderly and individuals with deficient nutritional intake and kidney disease are more susceptible to fluoride neurotoxicity. However, the level of supporting evidence from these studies (i.e., to specify the potentially greater susceptibility of any particular subpopulation) is insufficient to overcome the petition's broader failure to set forth sufficient facts to establish that fluoridation chemicals present an unreasonable risk to the general population, to allow EPA to reach a risk evaluation. 5. RfD/RfC derivation and uncertainty factor application. An oral Reference Dose or inhalation Reference Concentration is a daily exposure to the human population, including sensitive subgroups, that is likely to be without an appreciable risk of deleterious effects during a lifetime (Ref. 43). The petition cites EPA's 1998 guidance document, Guidelines for Neurotoxicity Risk Assessment (Ref. 44), purporting that it demonstrates the necessity of applying an uncertainty factor of at least 10. It appears that the petition has selected the eight studies presented in Table 5 (Ref. 1, p. 19) as candidates for deriving a Reference Dose (RfD) or Reference Concentration (RfC). The petition asserts that these dose or concentration values are relevant oral reference values for neurotoxic effects. However, the petition fails to recognize that the question of applying an uncertainty factor does not even arise until one has first appropriately performed a hazard characterization for all health endpoints of concern (Ref. 30, Section 3.1). As outlined in EPA's document, A Review of the Reference Dose and Reference Concentration Processes (Ref. 43), the first step in deriving an RfD or RfC is to evaluate the available database. The petition does not set forth the strengths and limitations of each of the studies in the overall database of available studies nor any criteria or rationale for selecting the eight particular studies from which to derive an RfD or RfC. Without setting forth the strengths and limitations associated with each study and the weight of evidence provided by the available database, a necessary step in any assessment, it is not possible to determine whether uncertainty factors are necessary. Following hazard characterization and identification of suitable studies for an RfD or RfC, uncertainty factors are generally applied to a lower limit dose or concentration on the continuum of observed effects (dose-response curve) in an individual study (e.g., NOAEL, LOAEL, Benchmark Dose, etc.). The selection of uncertainty factors and their magnitude should be based on the quality of the data, extent of the database and sound scientific judgment and consider the impact of having adverse effects from an inadequate exposure as well as an excess exposure. Uncertainty factor values may be considered appropriate to account for uncertainties associated with extrapolating from (1) a dose producing effects in animals to a dose producing no effects, (2) subchronic to chronic exposure in animals, (3) animal toxicological data to humans (interspecies), (4) sensitivities among the members of the human population (intraspecies), and (5) deficiencies in the database for duration or key effects (Ref. 43). Conflicting statements in the petition indicate that there is both a robust and certain dose- response relationship between fluoride exposure and IQ including for sensitive subpopulations. However, the petition does not clearly identify which sources/types of uncertainty in the data exist, nor which of the aforementioned uncertainty factors should be applied based on the review of the selected studies. 6. Benefits to public health. The petition asserts that the fluoridation of drinking water confers little benefit to public health, claiming that the primary benefit of fluoride comes from topical fluoride contact with the teeth and that there is thus little benefit from ingesting fluoride in water or any other product. The petition claims there are no randomized controlled trials on the effectiveness of fluoridation, and that few studies adequately account for potential confounding factors. In addition, the petition states that modern studies of fluoridation and tooth decay have found small, inconsistent and often non-existent differences in cavity rates between fluoridated and non-fluoridated areas. Further, the petition questions the cost- effectiveness of fluoridation relative to costs associated with what have been asserted to be fluoridation-related drops in IQ. The petition argues, then, that there is ``little justification'' in exposing the public to ``any risk'' of fluoride neurotoxicity (Ref. 1). [[Page 11886]] EPA does not believe that the petition has presented a well-founded basis to doubt the health benefits of fluoridating drinking water. The petition's argument about fluoridation benefits (i.e., that the risks of neurotoxic health effects from fluoridation are unreasonable in part because they outweigh the expected health benefits arising from exposure to fluoride) depends on first setting forth sufficient facts to establish the purported neurotoxic risks, to which the countervailing health benefits from fluoridation could be compared. But as noted earlier, EPA and other authoritative bodies have previously reviewed many of the studies cited as evidence of neurotoxic effects of fluoride in humans and found significant limitations in using them to draw conclusions on whether neurotoxicity is associated with fluoridation of drinking water. Irrespective of the conclusions one draws about the health benefits of drinking water fluoridation, the petition did not set forth sufficient facts to justify its primary claims about purported neurotoxic effect from drinking fluoridated water. The petition cites several studies as evidence that water fluoridation does not have any demonstrable benefit to the prevention of tooth decay (Refs. 45-49). However, EPA has found substantial concerns with the designs of each of these studies including small sample size and uncontrolled confounders, such as recall bias and socioeconomic status. Additionally, in Bratthall et al. (Ref. 45), for example, the appropriate interpretation of the responses of the 55 dental care professionals surveyed, based on the data provided in the paper, is that in places where water is fluoridated, the fluoridation is the primary reason for the reduction in dental caries. Diesendorf (Ref. 49) cites only anecdotal evidence and Cheng et al. (Ref. 46) is commentary only, with no supporting data. EPA is mindful of the public health significance of reducing the incidence of dental caries in the U.S. population. Dental caries is one of the most common childhood diseases and continues to be problematic in all age groups. Historically, the addition of fluoride to drinking water has been credited with significant reductions of dental caries in the U.S. population. In 2000, the then-Surgeon General noted that ``community water fluoridation remains one of the great achievements of public health in the twentieth century--an inexpensive means of improving oral health that benefits all residents of a community, young and old, rich and poor alike.'' The U.S. Surgeon General went on to note, ``it [is] abundantly clear that there are profound and consequential disparities in the oral health of our citizens. Indeed, what amounts to a silent epidemic of dental and oral diseases is affecting some population groups.'' (Ref. 50). At that time, among 5- to 17-year-olds, dental caries was more than five times as common as a reported history of asthma and seven times as common as hay fever. Prevalence increases with age. The majority (51.6 percent) of children aged 5 to 9 years had at least one carious lesion or filling in the coronal portion of either a primary or a permanent tooth. This proportion increased to 77.9 percent for 17-year-olds and 84.7 percent for adults 18 or older. Additionally, 49.7 percent of people 75 years or older had root caries affecting at least one tooth (Ref. 50). More recently, from the National Health and Nutrition Examination Survey (NHANES) for 2011-2012, approximately 23% of children aged 2-5 years had dental caries in primary teeth. Untreated tooth decay in primary teeth among children aged 2-8 was twice as high for Hispanic and non-Hispanic black children compared with non-Hispanic white children. Among those aged 6-11, 27% of Hispanic children had any dental caries in permanent teeth compared with nearly 18% of non- Hispanic white and Asian children. About three in five adolescents aged 12-19 years had experienced dental caries in permanent teeth, and 15% had untreated tooth decay (Refs. 51). Further, in 2011-2012, 17.5 percent of Americans ages 5-19 years were reported to have untreated dental caries, while 27.4 percent of those aged 20-44 years had untreated caries (Ref. 52). For those living below the poverty line, 24.6 percent of those aged 5-19 years and 40.2 percent of those aged 20-44 years had untreated dental caries (Ref. 52). Untreated tooth decay can lead to abscess (a severe infection) under the gums which can spread to other parts of the body and have serious, and in rare cases fatal, results (Ref. 53). Untreated decay can cause pain, school absences, difficulty concentrating, and poor appearance, all contributing to decreased quality of life and ability to succeed (Ref. 54). These data continue to suggest dental caries remains a public health problem affecting many people. Fluoride has been proven to protect teeth from decay by helping to rebuild and strengthen the tooth's surface or enamel. According to the Centers for Disease Control and Prevention and the American Dental Association, water fluoridation prevents tooth decay by providing frequent and consistent contact with low levels of fluoride (Refs. 55 and 56). Thus, the health benefits of fluoride include having fewer cavities, less severe cavities, less need for fillings and removing teeth, and less pain and suffering due to tooth decay (Ref. 55). Fluoride protects teeth in two ways--systemically and topically (Ref. 57). Topical fluorides include toothpastes, some mouth rinse products and professionally applied products to treat tooth surfaces. Topical fluorides strengthen teeth already in the mouth by becoming incorporated into the enamel tooth surfaces, making them more resistant to decay. Systemic fluorides are those ingested into the body. Fluoridated water and fluoride present in the diet are sources of systemic fluoride. As teeth are developing (pre-eruptive), regular ingestion of fluoride protects the tooth surface by depositing fluorides throughout the entire tooth surface (Ref. 56). Systemic fluorides also provide topical protection as ingested fluoride is present in saliva which continually bathes the teeth (Ref. 56). Water fluoridation provides both systemic and topical exposure which together provide for maximum reduction in dental decay (Ref. 56). The Surgeon General, the Public Health Service and the Centers for Disease Control and Prevention reaffirmed in 2015 the importance of community water fluoridation for the prevention of dental caries and its demonstrated effectiveness (Refs. 54 and 58). In the Public Health Service's 2015 Recommendation for Fluoride Concentration in Drinking Water, they note ``there are no randomized, double-blind, controlled trials of water fluoridation because its community-wide nature does not permit randomization of individuals to study and control groups or blinding of participants. However, community trials have been conducted, and these studies were included in systematic reviews of the effectiveness of community water fluoridation. As noted, these reviews of the scientific evidence related to fluoride have concluded that community water fluoridation is effective in decreasing dental caries prevalence and severity'' (Ref. 59). 7. Extent and magnitude of risk from fluoridation chemicals. The petition argues that the purported risks of drinking water fluoridation are unreasonable in part because they are borne by a large population. The petition (in its discussion of the extent and magnitude of risk posed) cites the total U.S. population and estimates the [[Page 11887]] number of U.S. children under the age of 18 years who live in areas where artificial fluoridation occurs. That estimate is then multiplied by an estimate of the average decrease in lifetime earnings associated with IQ point loss to calculate the overall potential IQ point loss and associated decrease in lifetime earnings for the segment of the U.S. population under the age of 18 years potentially exposed to artificially fluoridated water. The petition concludes, based on the potential extent and magnitude of exposure to fluoridation chemicals, that fluoridation would have caused ``a loss of between 62.5 to 125 million IQ points'' (Ref. 1, p. 24). The petition has not set forth a scientifically defensible basis to conclude that any persons have suffered neurotoxic harm as a result of exposure to fluoride in the U.S. through the purposeful addition of fluoridation chemicals to drinking water or otherwise from fluoride exposure in the U.S. Still less has the petition set forth a scientifically defensible basis to estimate an aggregate loss of IQ points in the U.S., attributable to this use of fluoridation chemicals. As noted previously, EPA has determined the petition did not establish that fluoridation chemicals present an unreasonable risk of injury to health or the environment, arising from these chemical substances' use to fluoridate drinking water. The fact that a purported risk relates to a large population is not a basis to relax otherwise applicable scientific standards in evaluating the evidence of that purported risk. EPA and other authoritative bodies have previously reviewed many of the studies cited as evidence of neurotoxic effects of fluoride in humans and found significant limitations in using them to draw conclusions on whether neurotoxicity is associated with fluoridation of drinking water. In contrast, the benefits of community water fluoridation have been demonstrated to reduce dental caries, which is one of the most common childhood diseases and continues to be problematic in all age groups. Left untreated, decay can cause pain, school absences, difficulty concentrating, and poor appearance, all contributing to decreased quality of life and ability to succeed (Ref. 54). 8. Consequences of eliminating use of fluoridation chemicals. Apparently citing to a repealed provision of TSCA (15 U.S.C. 2605(c)[1](A) (2015)) and guidance issued with respect to that statutory provision, the petition argues that the following factors are germane to determining whether the alleged neurotoxic risks presented by fluoridation chemicals are unreasonable: ``the societal consequences of removing or restricting use of products; availability and potential hazards of substitutes, and impacts on industry, employment, and international trade.'' Along these lines, the petition includes claims such as the following: That any risks of fluoridation chemicals could be easily reduced by discontinuing purposeful fluoridation practices; that alternative topical fluoride products have widespread availability; and that the impacts on the requested rule on industry, employment, and international trade would be little, if any. In short, the petition urges EPA to conclude that the risks of fluoridation chemicals are unreasonable, in part because if EPA found that the risks were unreasonable, the cost and non-risk factors that EPA would need to address in ensuing risk management rulemaking could be readily addressed. But this sort of ends-driven reasoning is forbidden by the texts of section 6(b)(4)(A) and 21(b)(4)(B)(ii) of the amended TSCA, which exclude ``costs or other non-risk factors'' from the unreasonable risk determination. It is also plainly inconsistent with Congress' intent, in amending TSCA, to ``de-couple'' the unreasonable risk decision from the broader set of issues (e.g., chemical alternatives and regulatory cost-effectiveness) that may factor into how best to manage unreasonable risks, once particular risks have been determined to be unreasonable. See S. Rep. 114-67 at 17 (Ref. 3); H.R. Rep. 114- 176 at 23 (Ref. 4); and 162 Cong. Rec. S3516 (Ref. 60). 9. Link to elevated blood lead levels. To support the contention that TSCA (and not the Safe Drinking Water Act [SDWA]) is the appropriate regulatory authority, the petition asserts an association between fluoridation chemicals and elevated blood lead levels and claims that there is laboratory and epidemiological research linking artificial fluoridation chemicals with pipe corrosion. The petition then argues that issuing a rule under TSCA section 6 rather than SDWA would allow EPA to specifically target and prohibit the addition of fluoridation chemicals to drinking water. The petition argues that SDWA would not allow EPA to distinguish between intentionally-added, artificial and naturally-occurring fluoride. It is in the public interest, says the petition, to opt for the regulatory option that is less expensive and can be more narrowly tailored. Regarding the claims about the relative extent of legal authorities under TSCA and SDWA, EPA notes that the petition has not set forth any specific legal basis for its views on the purported limitations of SDWA. For this reason, and because the petition has not set forth facts sufficient to show that the fluoridation of drinking water presents an unreasonable risk under TSCA, the Agency need not resolve such legal questions in order to adjudicate this petition. EPA has further observations about the petition's claims that drinking water fluoridation is linked to lead hazards. The Centers for Disease Control and Prevention (CDC) studied the relationship between fluoridation additives and blood lead levels in children in the United States (Ref. 61). More than 9,000 children between the ages of 1-16 years were included in the study's nationally representative sample. The petition argues that the study, and Table 4 in particular, shows that fluorosilicic acid was associated with increased risk of high blood lead levels. In fact, Macek et al. concluded that their detailed analyses did not support concerns that silicofluorides in community water systems cause high lead concentrations in children. The petition also points to another study (Ref. 62) which re-analyzed CDC's data and concluded that children exposed to ``silicofluoridated'' water had an elevated risk of having high blood lead levels. Coplan et al. (Ref. 62) criticized the Macek et al. approach as flawed and reevaluated the NHANES data comparing systems that used silicofluorides to all systems (e.g., a combination of fluoridated, nonfluoridated and naturally fluoridated) and found a small difference between the number of children in each group with blood lead levels >5 [micro]g/dL; the results were not evaluated to see if the difference was statistically significant. A number of other chemical characteristics are known to increase lead release into water sources such as pH, natural organic matter, water hardness, oxidant levels, and type of piping, age of housing; the Coplan et al. study did not evaluate these factors. In any event, the Agency is not persuaded that the examination of the relationship between fluoridation chemicals, pipe corrosion, and elevated blood lead levels nor their bearing on the comparative efficacy of TSCA or SDWA is germane to the disposition of the petition. Under TSCA, where the EPA Administrator determines ``that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture . . . presents an unreasonable risk of injury [[Page 11888]] to health or the environment, the Administrator shall by rule [regulate a] . . . substance or mixture to the extent necessary so that the chemical substance or mixture no longer presents such risk'' 15 U.S.C. 2605(a). As previously discussed, the petition does not demonstrate that purposeful addition of fluoridation chemicals to U.S. water supplies presents such unreasonable risk. 10. Regulation of fluoridation chemicals as a category. EPA has broad discretion to determine whether to regulate by category under TSCA section 26(c) rather than by individual chemical substances. In a prior evaluation of a section 21 petition seeking the regulation of a category of chemical substances, EPA explained that it does so in light of Congress' purpose in establishing the category authority: To ``facilitate the efficient and effective administration'' of TSCA. See 72 FR 72886 (Ref. 63) (citing Senate Report No. 94-698 at 31). It is of course self-evident that various chemical substances constituting ``fluoridation chemicals'' would have in common their use to fluoridate drinking water. But as discussed in Unit III., the inquiry does not end there. If EPA were to grant the petitioner's request, the Agency would become obligated to address all conditions of use of the category. If certain chemical substances comprising the category present conditions of use that other members do not, and any of those conditions of use would be significant to whether the category as a whole presents an unreasonable risk to human health or the environment, then the overall approach of regulating by category is less suited to the efficient and effective administration of TSCA. But the petition does not set forth facts that would enable the Agency to reasonably evaluate whether a category approach on fluoridation chemicals would be consistent with the efficient and effective administration of TSCA. Nor does the petition set forth the specific chemical substances that should comprise the category of fluoridation chemicals. 11. Specification of an adequate rule under TSCA section 6(a). As discussed earlier, the petition does not set forth facts that satisfactorily demonstrate to the Agency that fluoridation chemicals present an unreasonable risk to human health, specifically arising from these chemical substances' use to fluoridate drinking water. But even if the petition had done so, it would still be inadequate as a basis to compel the commencement of section 6(a) rulemaking proceeding under TSCA section 21. This is because the petition does not address whether fluoridation chemicals would still present an unreasonable risk, even after implementing the requested relief, arising from other conditions of use. As discussed earlier in Unit III., EPA interprets TSCA section 21 as requiring a petition to address the full set of conditions of use for a chemical substance and thereby describe an adequate rule under TSCA section 6(a), as opposed to a rule that would merely address a particular subset of uses of special interest. The petition at issue pays little or no attention to the other conditions of use of the various fluoridation chemicals (i.e., uses other than the eponymous use to treat drinking water) and makes no claim for any of these chemical substances that the risks to be addressed by curtailing drinking water fluoridation would be the only unreasonable risks or even the most significant unreasonable risks. This problem is compounded by the petition's lack of specificity as to which chemical substances are being construed as ``fluoridation chemicals.'' EPA acknowledges that its interpretation of the requirements of TSCA section 21, for petitions seeking action under TSCA section 6, was not available to petitioners at the time they prepared this petition. EPA has issued general guidance for preparing citizen's petitions, 50 FR 56825 (1985), but that guidance does not account for the 2016 amendments to TSCA. Particularly relevant under these circumstances, the Agency wishes to emphasize that its denial does not preclude petitioners from obtaining further substantive administrative consideration, under TSCA section 21, of a substantively revised petition under TSCA section 21 that clearly identifies the chemical substances at issue, discusses the full conditions of use for those substances, and sets forth facts that would enable EPA to complete a risk evaluation under TSCA section 6(b) for those substances. VI. References As indicated under ADDRESSES, a docket has been established for this document under docket ID number EPA-HQ-OPPT-2016-0763. The following is a listing of documents that are specifically referenced in this notice. The docket itself includes both these referenced documents and further documents considered by EPA. The docket also includes supporting documents provided by the petitioner and cited in the petition, which are not available in the electronic version of the docket. For assistance in locating these printed documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT. 1. Fluoride Action Network. Citizen Petition Under Section 21 of TSCA. November 2016. 2. EPA. Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act; Notice. Federal Register (82 FR 7562, January 19, 2017). 3. Senate Report 114-67. June 18, 2015. Available at https://www.congress.gov/114/crpt/srpt67/CRPT-114srpt67.pdf. 4. House Report 114-176. June 23, 2015. Available at https://www.congress.gov/114/crpt/hrpt176/CRPT-114hrpt176.pdf. 5. EPA. Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substance Control Act; Notice. Federal Register (82 FR 4831, January 17, 2017). 6. Malin, A.J. and Till, C. Exposure to fluoridated water and attention deficit hyperactivity disorder prevalence among children and adolescents in the United States: An ecological association. Environmental Health. Vol. 14, pp. 1-10. 2015. 7. Peckham, S.; Lowery, D. and Spencer, S. Are fluoride levels in drinking water associated with hypothyroidism prevalence in England? A large observational study of GP practice data and fluoride levels in drinking water. Journal of Epidemiology and Community Health. Vol. 69, pp. 619-624. 2015. 8. Connett, M. Fluoridation & neurotoxicity: An unreasonable risk. [PowerPoint presentation]. Presented on January 30, 2017. 9. Hirzy, W.; Connett, P.; Xiang, Q.; Spittle, B.J. and Kennedy, D.C. Developmental neurotoxicity of fluoride: A quantitative risk analysis towards establishing a safe daily dose of fluoride for children. Fluoride. Vol. 49, pp. 379-400. 2016. 10. National Research Council. Fluoride in drinking water: A scientific review of EPA's standards. The National Academies Press. Washington, DC 2006. 11. Choi, A.L.; Sun, G.; Zhang, Y. and Grandjean, P. Developmental fluoride neurotoxicity; a systematic review and meta-analysis. Environmental Health Perspectives. Volume 120, pp. 1362-1368. 2012. 12. Tang, Q.; Du, J.; Ma, H.H.; Jiang, S.J. and Zhou, S.J. Fluoride and children's intelligence: A meta-analysis. Biological Trace Element Research. Vol. 126, pp. 115-120. 2008. 13. Li, F.; Chen, X.; Huang, R. and Xie, Y. The impact of endemic fluorosis caused by the burning of coal on the development of intelligence in children. Journal of Environment and Health. Vol. 26, pp. 838-840. 2009. 14. Guo, X.; Wang, R.; Cheng, C.; Wei, W.; Tang, L.; et al. A preliminary investigation of the IQs of 7-13 year-old children from an area with coal burning-related fluoride poisoning. Fluoride. Vol. 41, pp. 125-128. 2008. 15. Li, Y.; Li, X. and Wei, S. Effects of high fluoride intake on child mental work capacity: Preliminary investigation into [[Page 11889]] the mechanisms involved. Fluoride. Vol. 41, pp. 331-335. 2008. 16. Hong, F.; Cao, Y.; Yang, D. and Wang, H. Research on the effects of fluoride on child intellectual development under different environmental conditions. Fluoride. Vol 41, pp. 156-160. 2008. 17. Lin, F.F.; Aihaiti; Zhao, H.X.; Lin, J.; et al. The relationship of a low-iodine and high-fluoride environment to subclinical cretinism in Xinjiang. Endemic Disease Bulletin. Vol. 6, pp. 62-67. 1991. (republished in Iodine Deficiency Disorder Newsletter. Vol 7, pp. 24-25. 1991) Available at http://www.fluoridealert.org/wp-content/uploads/lin-1991.pdf. 18. Wang, X.-H.; Wang, L.-F.; Hu, P.-Y; Guo, X.-W. and Luo, X.-H. Effects of high iodine and high fluorine on children's intelligence and thyroid function. Chinese Journal of Endemiology. Vol. 20, pp. 288-290. 2001. (Translated from Chinese into English by Fluoride Action Network in 2001) Available at http://www.fluoridealert.org/wp-content/uploads/wang-2001.pdf. 19. Wang, S.-X.; Wang, Z.-H.; Cheng, X.-T.; Li, J.; et al. Arsenic and fluoride exposure in drinking water: Children's IQ and growth in Shanyin county, Shanxi province, China. Environmental Health Perspectives. Vol. 115, pp. 643-647. 2007. 20. Xiang, Q.; Liang, Y.; Chen, C.; Wang, C.; et al. Effect of fluoride in drinking water on children's intelligence Fluoride. Vol. 36, pp. 84-94. 2003. 21. Zhao, L.B.; Liang, G.H.; Zhang, D.N. and Wu, X.R. Effect of a high fluoride water supply on children's intelligence. Fluoride. Vol. 29, pp. 190-192. 1996. 22. Zhang, J.; Yao, H. and Chen, Y. The effect of high levels of arsenic and fluoride on the development of children's intelligence. Chinese Journal of Public Health. Vol. 17, p. 119. 1998. (Translated from Chinese into English by Fluoride Action Network in 2012). Available at http://www.fluoridealert.org/wp-content/uploads/zhang-1998.pdf. 23. Grandjean, P. and Landrigan, P. Neurobehavioral effects of developmental toxicity. Lancet Neural. Vol. 13, pp. 330-338. 2014. 24. Ding, Y.; Yanhui, G.; Sun, H.; Han, H.; et al. The relationships between low levels of urine fluoride on children's intelligence, dental fluorosis in endemic fluorosis areas in Hulunbuir, Inner Mongolia, China. Journal of Hazardous Materials. Vol. 186, pp. 1942- 1946. 2011. 25. Wang, Q.-J.; Gao, M.-X.; Zhang, M.-F.; Yang, M.-L. and Xiang, Q.-Y. Study on the correlation between daily total fluoride intake and children's intelligence quotient. Journal of Southeast University. Vol. 31, pp. 743-46. 2012. (Translated from Chinese into English by Fluoride Action Network in 2016.) 26. Das, K. and Mondal, N.K.; Dental fluorosis and urinary fluoride concentration as a reflection of fluoride exposure and its impact on IQ level and BMI of children of Laxmisagar, Simlapal Block of Bankura District, W.B., India. Environmental Monitoring & Assessment. Vol. 188, pp. 218. 2016. 27. Choi, A.L.; Zhang, Y.; Sun, G. and Bellinger, D.C. Association of lifetime exposure to fluoride and cognitive functions in Chinese children: A pilot study. Neurotoxicology and Teratology. Vol. 47, pp. 96-101. 2015. 28. Agali, R.C. and Shintre, S. B. Biological markers of fluoride exposure: A review. IJSS Case Reports & Reviews. Vol. 2, pp. 49-52. 2016. 29. Zhang, S.; Zhang, X.; Liu, H.; Qu, W.; et al. Modifying effect of COMT gene polymorphism and a predictive role for proteomics analysis in children's intelligence in endemic fluorosis area in Tianjin, China. Toxicological Sciences. Vol. 144, pp. 238-245. 2015. 30. Li, M.; Gao, Y.; Ciu J.; Li, Y.; et al. Cognitive impairment and risk factors in elderly people living in fluorosis areas in China. Biological Trace Element Research. Vol. 172, pp. 53-60. 2016. 31. Xiang, Q.; Liang, Y.; Chen, B. and Chen, L. Analysis of children's serum fluid levels in relation to intelligence scores in a high and low fluoride water village in China. Fluoride. Vol. 44, pp. 191-194. 2011. 32. National Research Council. Human Biomonitoring for Environmental Chemicals. The National Academies Press. Washington, DC 2006. 33. Morgenstern, H. Ecologic Studies in Epidemiology: Concepts, Principles, and Methods. Annual Review of Public Health. Vol. 16, pp. 1-81. 1995. 34. EPA. Guidelines for Carcinogen Risk Assessment. March 2005. Available at https://www.epa.gov/sites/production/files/2013-09/documents/cancer_guidelines_final_3-25-05.pdf. 35. National Toxicology Program (NTP). Systematic literature review on the effects of fluoride on learning and memory in animal studies. NTP Research Report 1. Research Triangle Park, NC. 2016. Available at https://ntp.niehs.nih.gov/ntp/ohat/pubs/ntp_rr/01fluoride_508.pdf. 36. Wu, N.; Zhao, Z.; Gao, W. and Li, X.; Behavioral teratology in rats exposed to fluoride. Fluoride. Vol. 41, pp. 129-133. 2008. (Originally published in Chinese in the Chinese Journal of Control of Endemic Diseases. Vol. 14, pp. 271. 1995. 37. Han, H.; Du, W.; Zhou, B.; Zhang, W.; et al. Effects of chronic fluoride exposure on object recognition memory and mRNA expression of SNARE complex in hippocampus of male mice. Biological Trace Element Research. Vol. 158, pp. 58-64. 2014. 38. Banala, R.R. and Karnati, P.R. Vitamin A deficiency: An oxidative stress marker in sodium fluoride (NaF) induced oxidative damage in developing rat brain. International Journal of Developmental Neuroscience. Vol. 47, pp. 298-303. 2015. 39. Sandeep, B.; Kavitha, N.; Praveena, M.; Sekhar, P.R. and Rao, K.J. Effect of NaF on albino female mice with special reference to behavioral studies and ACh and AChE levels. International Journal of Pharmacy & Life Sciences. Vol. 4, pp. 2751-2755. 2013. 40. Chouhan, S.; Lomash, V. and Flora, S.J. Fluoride-induced changes in haem biosynthesis pathway, neurological variables and tissue histopathology of rats. Journal of Applied Toxicology. Vol. 30, pp. 63-73. 2010. 41. Tice, R.R.; Austin, C.P.; Kavlock, R.J. and Bucher, J.R. Improving the Human Hazard Characterization of Chemicals: A Tox21 Update. Environmental Health Perspectives. Vol. 121, pp. 756-765. 2013. 42. Yoon, M.; Campbell, J.L.; Andersen, M.E.; and Clewell, H.J. Quantitative in vitro to in vivo extrapolation of cell-based toxicity assay results. Critical Reviews in Toxicology. Vol 42, pp. 633-652. 2012. 43. EPA. A Review of the Reference Dose and Reference Concentration Processes. December 2002. Available at https://www.epa.gov/sites/production/files/2014-12/documents/rfd-final.pdf. 44. EPA. Guidelines for Neurotoxicity Risk Assessment; Notice. Federal Register (63 FR 26926, May 14, 1998). 45. Bratthall, D.; Hansel-Petersson, G. and Sundberg, H. Reasons for the caries decline: What do the experts believe? European Journal of Oral Science. Vol. 104, pp. 416-422. 1996. 46. Cheng, K.K.; Chalmers, I. and Sheldon, T.A. Adding fluoride to water supplies. The BMJ. Vol. 335, pp. 699-702. 2007. 47. Pizzo, G.; Piscopo, M.R.; Pizzo, I. and Giuliana, G. Community water fluoridation and caries prevention: A critical review. Clinical Oral Investigations. Vol. 11, pp. 189-193. 2007. 48. Neurath, C. Tooth decay trends for 12 year olds in nonfluoridated and fluoridated countries. Fluoride. Vol. 38, pp 324- 325. 2005. 49. Diesendorf, M. The mystery of declining tooth decay. Nature. Vol. 322, pp. 125-129. 1986. 50. U.S. Department of Health and Human Services. Oral Health in America: A Report of the Surgeon General. 2000. Available at https://profiles.nlm.nih.gov/ps/access/NNBBJT.pdf. 51. Dye B.A.; Thornton-Evans G.; Li X. and Iafolla, T.J. Dental caries and sealant prevalence in children and adolescents in the United States, 2011-2012. NCHS Data Brief, No. 191. Hyattsville, MD: National Center for Health Statistics. 2015. 52. U.S. Department of Health and Human Services. Health, United States, 2015: With Special Feature on Racial and Ethnic Health Disparities. 2016. Available at https://www.cdc.gov/nchs/data/hus/hus15.pdf. 53. U.S. Department of Health and Human Services. Oral Health Conditions. Retrieved February 1, 2017 from https://www.cdc.gov/oralhealth/conditions/index.html. 54. U.S. Department of Health and Human Services. Statement on the Evidence [[Page 11890]] Supporting the Safety and Effectiveness of Community Water Fluoridation. January 30, 2017. Available at https://www.cdc.gov/fluoridation/pdf/cdc-statement.pdf. 55. U.S. Department of Health and Human Services. Water Fluoridation Basics. Retrieved February 1, 2017 from https://www.cdc.gov/fluoridation/basics/index.htm. 56. American Dental Association. Fluoridation Facts. 2005. Available at http://www.ada.org/~/media/ADA/Member%20Center/FIles/ fluoridation_facts.ashx. 57. Buzalaf, M.A.R.; Pessan, J.P.; Honorio, H.M. and ten Cate, J.M. Mechanisms of action of fluoride for caries control. Monographs in Oral Science: Fluoride and the Oral Environment. Vol. 22, pp. 97- 114. 2011. 58. Murthy, V.H. Surgeon General's Perspectives: Community water fluoridation: One of CDC's ``10 great public health achievements of the 20th century''. Public Health Reports. Vol. 130, pp. 296-298. 2015. 59. U.S. Department of Health and Human Services. U.S. Public Health Service recommendation for fluoride concentration in drinking water for the prevention of dental caries. Public Health Reports. Vol. 130, pp. 318-331. 2015. 60. Congressional Record S3516. June 7, 2016. Available at https://www.congress.gov/crec/2016/06/07/CREC-2016-06-07-pt1-PgS3511.pdf. 61. Macek, M.D.; Matte, T.D.; Sinks, T. and Malvitz, D.M. Blood lead concentrations in children and method of water fluoridation in the United States, 1988-1994. Environmental Health Perspectives. Vol. 114, pp. 130-134. 2006. 62. Coplan, M.J.; Patch, S.C.; Masters, R.D. and Bachman, M.S. Confirmation of and explanations for elevated blood lead and other disorders in children exposed to water disinfection and fluoridation chemicals. NeuroToxicology. Vol. 28, pp. 1032-1042. 2007. 63. EPA. Air Fresheners; TSC Section 21 Petition; Notice. Federal Register (72 FR 72886, December 21, 2007). List of Subjects Environmental protection, Fluoridation chemicals, Drinking water, Toxic Substances Control Act (TSCA). Dated: February 17, 2017. Wendy Cleland-Hamnett, Acting Assistant Administrator, Office of Chemical Safety and Pollution Prevention. [FR Doc. 2017-03829 Filed 2-24-17; 8:45 am] BILLING CODE 6560-50-P
![11878 Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Proposed Rules
cards, letters, and flats; USPS Marketing 600 Basic Mailing Standards for All Service in a calendar month would
Mail automation letters and flats; USPS Mailing Services receive electronic address correction
Marketing Mail Carrier Route, High * * * * * notices for their qualifying Basic
Density, and Saturation letters; automation and non-automation First-
Periodicals Outside County barcoded or 602 Addressing Class Mail and USPS Marketing
Carrier Route letters and flats; * * * * * mailpieces charged at the applicable
Periodicals In-County automation or Full-Service address correction fee for
Carrier Route letters and flats; and 5.0 Move Update Standards future billing cycles. The Basic
Bound Printed Matter Presorted, non- * * * * * automation and non-automation First-
DDU barcoded flats. Mailers who [Revise 602.5.3 by deleting former Class Mail and USPS Marketing Mail
present at least 95 percent of their contents and replacing with new title mailpieces must:
eligible First-Class Mail and USPS and contents as follows:] 1. Bear a unique IMb printed on the
Marketing Mail volume as Full-Service mailpiece.
in a calendar month would receive 5.3 Move Update Verification 2. Include a Full-Service or OneCode
electronic address correction notices for Mailers who submit any Full-Service ACS STID in the IMb.
their qualifying Basic automation and volume in a calendar month will be 3. Include the unique IMb in eDoc.
non-automation First-Class Mail and verified pursuant to the Address Quality 4. Be sent by an eDoc submitter
USPS Marketing Mail pieces, at the Census Measurement and Assessment providing accurate Mail Owner
address correction fee for pieces eligible Process beginning in the next calendar identification in eDoc.
for the Full-Service Intelligent Mail month. First-Class Mail and USPS 5. Be sent by an eDoc submitter
option as described in DMM 705.23.0 Marketing Mail letter and flat-size maintaining 95 percent Full-Service
for future billing cycles. The Basic First- mailpieces with addresses that have not compliance to remain eligible for this
Class Mail and USPS Marketing Mail been updated in accordance with the service and undergo periodic USPS re-
mailpieces must: Move Update Standard will be subject evaluation.
1. Bear a unique IMb printed on the to the Move Update assessment charge, * * * * *
mailpiece; if submitted via eDoc with unique Basic We will publish an appropriate
2. Include a Full-Service or OneCode or Full-Service IMbs. Supporting details amendment to 39 CFR part 111 to reflect
ACS STID in the IMb; are described in Publication 6850, these changes, if our proposal is
3. Include the unique IMb in eDoc; Publication for Streamlined Mail adopted.
4. Be sent by an eDoc submitter
Acceptance for Letters and Flats,
providing accurate Mail Owner Stanley F. Mires,
available at www.postalpro.usps.com.
identification in eDoc, and; [Revise 602.5.4 as follows:] Attorney, Federal Compliance.
5. Be sent by an eDoc submitter [FR Doc. 2017–03723 Filed 2–24–17; 8:45 am]
maintaining 95 percent Full-Service 5.4 Mailer Certification BILLING CODE 7710–12–P
compliance to remain eligible for this The mailer’s signature on the postage
service and undergo periodic Postal statement or electronic confirmation
Service re-evaluation. during eDoc submission certifies that ENVIRONMENTAL PROTECTION
* * * * * the Move Update standard has been met AGENCY
4.2.8 Address Correction Service Fee for the address records including each
address in the corresponding mailing 40 CFR Chapter I
[Revise 507.4.2.8 by deleting the old presented to the USPS.
language and replacing with new [EPA–HQ–OPPT–2016–0763; FRL–9959–74]
* * * * *
language as follows:]
ACS fees would be assessed as Fluoride Chemicals in Drinking Water;
700 Special Standards
follows: TSCA Section 21 Petition; Reasons for
a. The applicable fee for address * * * * * Agency Response
correction is charged for each separate 705 Advanced Preparation and AGENCY: Environmental Protection
notification of address correction or the Special Postage Payment Systems Agency (EPA).
reason for nondelivery provided, unless ACTION: Petition; reasons for Agency
* * * * *
an exception applies. response.
b. Once the ACS fee charges have 23.0 Full-Service Automation Option
been invoiced, any unpaid fees for the SUMMARY: This document announces the
* * * * *
prior invoice cycle (month) would be availability of EPA’s response to a
assessed an annual administrative fee of 23.5 Additional Standards petition it received on November 23,
10 percent for the overdue amount. * * * * * 2016, under section 21 of the Toxic
c. Mailers who present at least 95 Substances Control Act (TSCA). The
percent of their eligible First-Class Mail 23.5.2 Address Correction Notices TSCA section 21 petition was received
and USPS Marketing Mail volume as * * * * * from the Fluoride Action Network, Food
Full-Service in a calendar month would [Revise 705.23.5.2a as follows:] & Water Watch, Organic Consumers
receive electronic address correction a. Address correction notices would Association, the American Academy of
notices for their qualifying Basic be provided at the applicable Full- Environmental Medicine, the
jstallworth on DSK7TPTVN1PROD with PROPOSALS
automation and non-automation First- Service address correction fee for letters International Academy of Oral Medicine
Class Mail and USPS Marketing Mail and flats eligible for the Full-Service and Toxicology, and other individual
mailpieces, as specified in 4.2.2. The option, except for USPS Marketing Mail petitioners. The TSCA section 21
electronic address correction notices are ECR flats, BPM flats dropshipped to petition requested that EPA exercise its
charged at the applicable Full-Service DDUs, or BPM carrier route flats. authority under TSCA section 6 to
address correction fee for all future Mailers who present at least 95 percent ‘‘prohibit the purposeful addition of
billing cycles. of their eligible First-Class Mail and fluoridation chemicals to U.S. water
* * * * * USPS Marketing Mail volume as Full- supplies.’’ After careful consideration,
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![11880 Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Proposed Rules
substance or mixture no longer standard for EPA’s preparation of risk EPA’s interpretation is most
presents’’ unreasonable risks under the evaluation under TSCA section consonant with the review pipeline
conditions of use. 15 U.S.C. 2605(a). 6(b)(4)(A). Consistent with these established in TSCA section 6. In
Prior to the 2016 amendment of revisions, EPA concludes that Congress particular, the prioritization process
TSCA, EPA completed risk assessments intended for a petition to set forth facts established in section 6(b) recognizes
that were limited to selected uses of that would enable EPA to complete a that a number of chemical substances
chemical substances. The amended risk evaluation under TSCA section may present an unreasonable risk of
TSCA authorizes EPA to issue TSCA 6(b). injury to health or the environment and
section 6 rules that are not In light of this, EPA interprets TSCA charges EPA with prioritizing those that
comprehensive of the conditions of use, section 21 as requiring the petition to should be addressed first. EPA is
so long as they are consistent with the present a scientific basis for action that required to have 10 chemical substances
scope of such pre-amendment risk is reasonably comparable, in its quality undergoing risk evaluation as of
assessments. 15 U.S.C. 2625(l)(4). But and scope, to a risk evaluation under December 19, 2016, and must have a
EPA has interpreted the amended TSCA TSCA section 6(b). This requirement steady state of at least 20 high-priority
as requiring that forthcoming risk includes addressing the full set of substances undergoing risk evaluation
evaluations encompass all manufacture, conditions of use for a chemical by December 2019 (and as many as 10
processing, distribution in commerce, substance and thereby describing an substances nominated for risk
use, and disposal activities that the adequate rule under TSCA section evaluation by manufacturers). 15 U.S.C.
Administrator determines are intended, 6(a)—one that would reduce the risks of 2605(b)(2)(A), (B), 2605(b)(4)(E)(i). EPA
known or reasonably foreseen. (Ref. 2, p. the chemical substance ‘‘so that the is obligated to complete rulemakings to
7565). EPA interprets the scope of post- chemical substance or mixture no longer address any unreasonable risks
risk-evaluation rulemaking under TSCA presents’’ unreasonable risks under all identified in these risk evaluations
section 6(a) in a parallel fashion: While conditions of use. 15 U.S.C. 2605(a). within prescribed timeframes. 15 U.S.C.
risk management rules for a certain Specifically, EPA interprets section 2605(c)(1). These required activities will
subset of the conditions of use may be 21(a)—which authorizes petitions ‘‘to place considerable demands on EPA
promulgated ahead of rulemaking for initiate a proceeding for the issuance resources. Indeed, Congress carefully
the remaining conditions of use, rules . . . of a rule under . . . section 6’’— tailored the mandatory throughput
covering the complete set of conditions as authorizing petitions for rules that requirements of TSCA section 6, based
of use must be promulgated by the would comply with the requirements of on its recognition of the limitations of
deadlines specified in TSCA section sections 6(a) and 6(c). EPA’s capacity and resources,
6(c). 15 U.S.C. 2605(c). While EPA has EPA recognizes that information on a notwithstanding the sizeable number of
authority under TSCA section 6(a) to single condition of use could, in certain chemical substances that will ultimately
establish requirements that apply only instances, suffice to demonstrate that a
require review. Under this scheme, EPA
to ‘‘a particular use,’’ the restriction of chemical substance, as a whole,
does not believe that Congress intended
just one particular use would not presents an unreasonable risk.
to empower petitioners to promote
constitute an adequate risk management Nonetheless, EPA concludes that such
chemicals of particular concern to them
rule unless that particular use were the information does not fulfill a
above other chemicals that may well
only reason that the chemical substance petitioner’s burden to justify ‘‘a rule
present greater overall risk, and force
presented an unreasonable risk. under [TSCA section 6],’’ under TSCA
completion of expedited risk
TSCA section 21(b)(4)(B) provides the section 21, since the information would
evaluations and rulemakings on those
standard for judicial review should EPA merely justify a subset of an adequate
chemicals, based on risks arising from
deny a request for rulemaking under rule. To issue an adequate rule under
TSCA section 6(a): ‘‘If the petitioner section 6, EPA would need to conduct individual uses.
EPA recognizes that some members of
demonstrates to the satisfaction of the a catch-up risk evaluation addressing all
the public may have safety concerns
court by a preponderance of the the conditions of use not addressed by
that are limited to a single condition of
evidence that . . . the chemical the petition, and either determine that
use for a chemical substance. But EPA’s
substance or mixture to be subject to those conditions do not contribute to
interpretation of TSCA section 21 does
such rule . . . presents an unreasonable the unreasonable risk or enlarge the
not deprive such persons of a
risk of injury to health or the scope of the rule to address those
meaningful opportunity to request that
environment, without consideration of further conditions of use. See 15 U.S.C.
costs or other non-risk factors, including 2605(a). To issue this rule within the the Administrator proceed on their
an unreasonable risk to a potentially time required by section 6(c), EPA concerns. For example, such persons
exposed or susceptible subpopulation, would have to proceed without the may submit a petition under the
under the conditions of use,’’ the court benefit of the combined 4 to 4.5-year Administrative Procedure Act,
shall order the EPA Administrator to period that TSCA section 6(b) would requesting EPA to commence a ‘‘risk-
initiate the requested action. 15 U.S.C. ordinarily afford EPA (i.e., time to based screening’’ of the chemical
2620(b)(4)(B). EPA notes that bills prioritize a chemical substance, conduct substance under TSCA section
preceding the final amendment to TSCA a careful review of all of its conditions 6(b)(1)(A), motivated by their concern
retained language in section 21 that of use, and receive the benefit of about a single condition of use.
resembled the pre-amendment criteria concurrent public comment). IV. Summary of the TSCA Section 21
for rulemaking under section 6. Additionally, before even initiating the Petition
jstallworth on DSK7TPTVN1PROD with PROPOSALS
Compare 15 U.S.C. 2620(b)(4)(B)(ii) prioritization process for a chemical
(2015) (amended 2016), 15 U.S.C. substance, EPA would generally screen A. What action was requested?
2605(a) (2015) (amended 2016), S. Rep. the chemical substance to determine On November 23, 2016, a TSCA
114–67 at 135 (Ref. 3), and H.R. Rep. whether the available hazard and section 21 petition was submitted by the
No. 114–176 at 81 (Ref. 4). But the effect exposure-related information are Fluoride Action Network, Food & Water
of the revision in the final bill is to align sufficient to allow EPA to complete both Watch, Organic Consumers Association,
the standard for judicial review of a the prioritization and the risk evaluation the American Academy of
TSCA section 21 petition with the processes. (Ref. 5). Environmental Medicine, the
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![Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Proposed Rules 11881
International Academy of Oral Medicine by the abundance of fluoridated chemicals and elevated blood lead
and Toxicology, Moms Against toothpaste in the U.S. levels.
Fluoridation, and the following 2. Recent epidemiological studies In addition to supplying the petition,
individuals signing on behalf of corroborate neurotoxic risk in Western on January 30, 2017, the petitioners also
themselves and their children: Audrey populations. The petition cites two delivered an in-person oral presentation
Adams of Renton, Washington, studies from Western populations to of their views (Ref. 8). At their oral
Jacqueline Denton of Asheville, North attempt to corroborate the assertion that presentation, petitioners reiterated the
Carolina, Valerie Green of Silver Spring, exposure to fluoride in drinking water information already supplied in writing,
Maryland, Kristin Lavelle of Berkeley, presents unreasonable risks for and requested that EPA also consider an
California, and Brenda Staudenmaier of neurotoxicity (Refs. 6 and 7). additional study that was not part of the
Green Bay, Wisconsin (Ref. 1). The 3. Neurotoxic risks supported by petition (Ref. 9). EPA has discretion (but
general object of the petition is to urge animal and cell studies. The petition not an obligation) to consider extra-
EPA ‘‘to protect the public and argues that studies on both experimental petition materials when evaluating a
susceptible subpopulations from the animals and cell cultures are consistent petition submitted under TSCA section
neurotoxic risks of fluoride by banning with cited human research linking 21. In cases where the petitioners
the addition of fluoridation chemicals to fluoride exposure with neurotoxic themselves attempt to enlarge the scope
water’’ (Ref. 1). The specific action effects in humans. of materials under review while EPA’s
sought is a rule, under TSCA section 4. Susceptible subpopulations are at petition review is pending, EPA
6(a)(2), to ‘‘prohibit the purposeful heightened risk. The petition argues that exercises its discretion to consider or
addition of fluoridation chemicals to certain subpopulations (e.g., infants, the not consider the additional material
U.S. water supplies.’’ However, such a elderly, and persons with nutritional based on whether the material was
restriction on the allowable use of deficiencies, kidney disease or certain submitted early enough in EPA’s
fluoridation chemicals would actually genetic predispositions) are more petition review process to allow
be based on a rule under TSCA section susceptible to fluoride neurotoxicity. adequate evaluation of the study prior to
6(a)(5), not a rule under TSCA section 5. RfD/RfC derivation and uncertainty the petition deadline, the relation of the
6(a)(2). In light of the discrepancy factor application. The petition argues late materials to materials already
between the description of the rule that EPA’s 1998 Guidelines for submitted. Given the particularly late
sought and the cited authority, EPA Neurotoxicity Risk Assessment support submittal of the additional study, EPA
interprets the petition as requesting both the need to apply a 10-fold uncertainty conducted an abbreviated review of the
a TSCA section 6(a)(5) rule whereby the factor in deriving an oral Reference Dose study and found that the health
purposeful addition of any fluoridation (RfD) or inhalation Reference concerns covered were substantially the
chemical to a drinking water supply Concentration (RfC). same as those covered in other studies
would be prohibited and a TSCA 6. Benefits to public health. The
submitted with the petition. Based on
section 6(a)(2) rule whereby the petition bases, in part, its claim of
this abbreviated review, EPA does not
manufacture, processing, or distribution unreasonable risk on the assertion that
believe that the new study provided any
in commerce of any fluoridation the fluoridation of drinking water
new scientific grounds for granting the
chemical for such use would be confers little benefit to public health,
petition.
prohibited. relative to the alleged neurotoxic risks.
The petition argues that since fluoride’s V. Disposition of TSCA Section 21
B. What support does the petition offer? primary benefit comes from topical Petition
The petition is focused on the contact with the teeth, there is little
A. What was EPA’s response?
potential for fluoride to have neurotoxic benefit from swallowing fluoride, in
effects on humans; it cites numerous water or any other product. The petition After careful consideration, EPA
studies bearing on this issue. The argues that there is therefore ‘‘little denied the TSCA section 21 petition,
petition contends that the purposeful justification’’ in exposing the public to primarily because EPA concluded that
fluoridation of drinking water presents ‘‘any risk’’ of fluoride neurotoxicity. the petition has not set forth a
an unreasonable risk to human health 7. Extent and magnitude of risk from scientifically defensible basis to
from neurotoxicity, and that a ban on fluoridation chemicals. The petition conclude that any persons have suffered
this use of fluoridation chemicals is bases, in part, its claim of unreasonable neurotoxic harm as a result of exposure
necessary to curtail this unreasonable risk on estimates of the extent and to fluoride in the U.S. through the
risk. The following is a summary of the magnitude of risk posed to portions of purposeful addition of fluoridation
primary support given in the petition for the U.S. population living in areas chemicals to drinking water or
this view: where artificial fluoridation occurs. otherwise from fluoride exposure in the
1. Fluoride neurotoxicity at levels 8. Consequences of eliminating use of U.S. In judging the sufficiency of the
relevant to U.S. population. The petition fluoridation chemicals. The petition petition, EPA considered whether the
claims that fluoride poses neurotoxic argues that the risks of fluoride petition set forth facts that would enable
risks to the U.S. population. The exposure from fluoridated drinking EPA to complete a risk evaluation under
petition claims that the cited studies of water are unreasonable, in part, because TSCA section 6(b).
fluoride-exposed human populations they could be easily and cheaply EPA also denied the petition on the
have consistently found neurotoxic eliminated, and because alternative independent grounds that the petition
effects (lower-than-average IQs) at water products containing topical fluoride are neither justified the regulation of
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fluoride levels below the current widely available. fluoridation chemicals as a category, nor
Maximum Contaminant Level Goal of 4 9. Link to elevated blood lead levels. identified an adequate section 6 rule as
mg/L set by EPA’s Office of Water. The The petition argues that artificial the action sought. Rather than
petition argues that the difference fluoridation chemicals are linked with comprehensively addressing the
between the fluoride levels in the pipe corrosion and elevated blood lead conditions of use that apply to a
United States and the greater levels in levels. The petition interprets data in particular chemical substance, the
rural China (where most of the cited IQ several studies as demonstrating an petition requests EPA to take action on
studies were conducted) is ‘‘lessen[ed]’’ association between fluoridation a single condition of use (water
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U.S. water supplies, are in fact causing and natural factors like economic robustness of these relationships. NRC
developmental neurotoxic effects to condition, culture and geological designated biomarkers for substances
persons in the U.S. The petition itself environments are also responsible’’ (Ref. that have been observed in bodily
concedes that the actual existence of 26). Hence, extrapolating relationships fluids, but that lack established
such effects is unestablished, in urging from this study population to other relationships between external dose
EPA to conduct ‘‘a diligent risk populations is not scientifically (e.g., water), internal dose (e.g., urine or
assessment, per EPA’s Guidelines, to defensible. serum) and biological effects (e.g.,
ensure that the general public, and Choi et al. (2015) (Ref. 27) report that neurotoxicity) as ‘‘Group I’’ biomarkers.
sensitive subpopulations, are not moderate and severe dental fluorosis Although many human studies have
ingesting neurotoxic levels’’ (Ref 1, p. was significantly associated with lower been collated and reviewed in the
3). cognitive functions. However, petition, for the reasons outlined
The other meta-analysis cited in the associations between drinking water previously—particularly study design
petition (Ref. 12) showed that, based on and urine fluoride and the same and confounding factors—relationships
16 case-control studies in China, cognitive functions were not found to be between urine and serum fluoride
children living in an area with endemic significantly associated. They reached (internal doses), water fluoride
fluorosis are more likely to have low IQ this conclusion from a study of 51 concentration (external dose), and
compared to children living in an area children in China and a comparison neurotoxic effects in humans have not
with slight fluorosis or no fluorosis. group of eight with dental fluorosis been established. Further, serum and
While this analysis may suggest an (Table 4 in Choi et al., 2015). The urine biomarkers for fluoride reflect
association between fluorosis and authors discuss potential problems only recent exposures, not long-term
lowered IQ (both of which are possible associated with using these biomarkers exposures, and may be different from
effects of fluoride exposure at certain of exposure to fluoride. For example, the exposures during the specific time
levels) any fluoride concentration-to-IQ water samples may be imprecise when developmental effects can occur.
effect relationship (i.e., dose-response because internal dose of fluoride A lack of established sampling protocols
relationship) is only inferred because depends on total water intake, and urine and analytical methods are also
actual fluoride exposures were not samples may be affected by the amount hallmarks of ‘‘Group I’’ biomarkers. The
measured. Further, the two effects of water the subject drank prior to main studies cited in the petition which
(fluorosis and lower IQ) both occur at sampling. With regard to fluorosis, the attempt to relate urine or serum levels
fluoride exposures well above those degree of dental fluorosis is dependent to possible neurotoxic effects suffer
found in fluoridated U.S. drinking not only on the total fluoride dose but from either lack of good sampling
water, such that any inference would also on the timing and duration of protocols or absence of documenting the
only apply at fluoride concentrations fluoride exposure. A person’s individual sampling protocols. Important issues
not relevant to exposures in the U.S. response to fluoride exposure depends such as the timing and methods of
The studies in the Tang et al. review on factors such as body weight, activity sample collection were also often not
(Ref. 12) correlate one effect (fluorosis) level, nutritional factors, and the rate of reported in the studies. Using the NRC
to another effect (neurotoxicity), but do skeletal growth and remodeling. These Framework, urine and serum fluoride
not establish a dose-response variables, along with inter-individual levels would be at best ‘‘Group I’’
relationship between fluoride exposure variability in response to similar doses biomarkers for fluoride-related
and neurotoxicity. This lack of a dose- of fluoride, indicate that enamel neurotoxicity. The NRC Framework
dependent increase in effect with fluorosis cannot be used as a biological states ‘‘[b]iomarkers in this category
increasing exposure is a critical marker of the level of fluoride exposure may be considered useless’’ for risk
limitation of these data. Establishing a for an individual (Ref. 28). Hence, the assessment purposes (Ref. 32, p. 78).
dose-response relationship between petitioner’s use of fluorosis levels as a 2. Recent epidemiological studies
exposure to a toxicant and an effect ‘‘is surrogate for evidence of neurotoxic corroborate neurotoxic risk in Western
the most fundamental and pervasive harm to the U.S. population is populations. The petition cites two
concept in toxicology. Indeed, an inappropriate evidence to support an studies from Western populations to
understanding of this relationship is assertion of unreasonable risk to attempt to corroborate the assertion that
essential for the study of toxic humans from fluoridation of drinking exposure to fluoridated water presents
materials’’ (Ref. 12). Likewise, the IQ water. unreasonable risks for neurotoxicity.
changes noted in Table 1 (Ref. 1) do not The petition also cites four studies Two population-level studies were cited
increase with increasing water fluoride (Refs. 24, 29–31) that rely on human which link fluoridated water to
concentration (e.g., dose) (Ref. 1). urine or serum fluoride concentrations attention-deficit/hyperactivity disorder
The petition suggested that a dose- as biomarkers of exposure but does not (ADHD) prevalence in the U.S. (Ref. 6)
response relationship between urinary discuss the limitations associated with and drinking water exposures and
fluoride and IQ is seen in several the biomarkers used in the studies. In hypothyroidism prevalence in England
studies (Refs. 24–26) shown in Figures their report, Human Biomonitoring for (Ref. 7). These studies use cross-
1–5 of the petition (Ref. 1). Assuming, Environmental Chemicals, NRC defines sectional population-level data to
as the petitioners claim, that all children properties of biomarkers and created a examine the association between ADHD
were malnourished in the Das and framework for grouping biomarkers of and hypothyroidism and fluoridated
Mondal (Ref. 26) study, it is not possible exposure (Ref. 32). Figure 3–1 in the water levels. The studies make
to determine whether effects on IQ were NRC report illustrates the relationship reasonable use the population-level data
jstallworth on DSK7TPTVN1PROD with PROPOSALS
due to fluoride or to malnutrition (i.e., between external dose (e.g., water), available, but causal inference cannot be
nutritional status may be an internal dose (e.g., fluoride made from these studies (Ref. 3).
uncontrolled confounding factor). The concentration) and biological effects, As stated in the conclusion of Malin
study authors caution that ‘‘it is difficult and indicates that internal dose is and Till, an association has been
to determine with any degree of measured through biomonitoring (e.g., reported, but ‘‘[p]opulation studies
accuracy whether the difference of fluoride concentrations measured in designed to examine possible
children’s IQ scores solely depends on urine or serum). NRC grouped the mechanisms, patterns and levels of
the exposure dose because many social quality of biomarkers based on the exposure, covariates and moderators of
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this relationship are warranted’’ (Ref. 6, over or underestimate the true effect and study aimed to establish vitamin A as a
p. 8). In epidemiology, studies using further excluded any studies with a high marker for fluoride neurotoxicity (Ref.
cross-sectional data are most often used risk of bias. Of the 68 studies, including 38), but changes in vitamin A were
to generate hypotheses that need to be studies provided by the Fluoride Action measured only at an excessive fluoride
further studied to determine whether a Network, 19 were considered to pose a dose of 20 mg/L. The other study dosed
‘‘true’’ association is present. Ideally, very serious overall risk of bias, rats with fluoride in drinking water (Ref.
the study designs and methods are primarily based on concern for at least 39) and showed effects on behavior and
improved by each study that is three of the following factors: Lack of brain neurotransmitters at a dose of 5
undertaken, such as, among other randomization, lack of blinding at mg/L, a level well above the 0.7 parts
things, identifying additional potential outcome assessment in conjunction per million level recommended for
confounders, considering timing issues with not using automated tools to community water fluoridation in the
or resolving ambiguity in collection of collect information, lack of reporting on United States. Other studies in Table 4,
samples and disease outcome, what was administered to animals which, according to the title of the table,
improving upon the exposure analysis, (source, purity, chemical form of are indicative of ‘‘Water Fluoride Levels
and evaluating the magnitude and fluoride), lack of control for litter Associated with Neurotoxic Effects in
consistency of the results, so that the effects, lack of expected response in Rodents,’’ erroneously report effect
evaluation can adequately assess the control animals, and lack of reporting of levels not supported by the studies
association (Ref. 34). For example, the key study information such as the themselves. In Wu et al. (Ref. 36), which
authors assert that there are design number or sex of animals treated. Of the NTP excluded based on high bias, no
issues with their study, especially studies cited in Table 4 in the petition, adverse effects were seen at a dose of 1
related to the exposure categories, and two were excluded from the NTP mg/kg-day as claimed in the petition. In
they suggest how to address these issues analysis because of serious concerns for fact, the behavioral effects occurred only
in future studies. Although it is possible study bias (Refs. 36 and 37). Based on at doses of 5 and 25 mg/L. In Chouhan
that there may be biological plausibility its review of animal and cell studies, et al. (Ref. 40), which NTP excluded in
for the hypothesis that water NTP concluded that ‘‘[t]he evidence is the initial screen for relevancy, no
fluoridation may be associated with strongest (moderate level-of-evidence) significant neurotoxicity was seen at 1
ADHD, this single epidemiological in animals exposed as adults tested in mg/L fluoride, in contrast to what the
study is not sufficient to ‘‘corroborate’’ the Morris water maze and weaker (low petition claims. In addition, the
neurotoxic health effects, as stated in level-of-evidence) in animals exposed petition’s statement that ‘‘rats require 5
the petition. More study would be during development’’ and ‘‘[v]ery few times more fluoride in their water to
needed to develop a body of information studies assessed learning and memory achieve the same level of fluoride in
adequate to make a scientifically effects at exposure levels near 0.7 parts their blood as humans’’ (Ref. 1) as a
defensible unreasonable risk per million, the recommended level for rationale for why higher exposure levels
determination under TSCA. community water fluoridation in the in animals are relevant to lower levels
The Peckham et al. study (Ref. 7) United States.’’ The animal studies cited in humans is not supported by the NTP
suffers from similar issues noted in in the petition (Ref. 1, p. 14, Table 4) review in the petition. The NTP review
Malin and Till (Ref. 6). Adjustment for reflect these high drinking water indicates that ‘‘assuming approximate
some confounders was considered, exposures ranging from 2.3 mg/L to 13.6 equivalence [of drinking water
including sex and age, but other mg/L, equivalent to 3–20 times the concentrations in rodents and humans]
potential confounders (such as iodine is not unreasonable’’ (Ref. 35, p. 58).
levels to which drinking water is
intake) were not assessed. Fluoride from
fluoridated in the U.S. Overall, NTP These several erroneously reported
other sources and other factors
concluded that, ‘‘[r]esults show low-to- studies do not change EPA’s agreement
associated with hypothyroidism were
moderate level-of-evidence in with the conclusions of the NTP report
not assessed in this study. Exposure
developmental and adult exposure that their ‘‘[r]esults show low-to-
misclassification, in which populations
studies for a pattern of findings moderate level-of-evidence in
are placed in the wrong exposure
suggestive of an effect on learning and developmental and adult exposure
categories based on the water
memory’’ (Ref. 35, p. 52). Based on this studies for a pattern of findings
fluoridation status, is very possible in
review of available evidence, and the suggestive of an effect on learning and
either of the studies presented and is a
identified limitations in the database, memory’’ (Ref. 35, p. 52).
limitation of the study designs.
3. Neurotoxic risks supported by NTP is currently pursuing experimental In cell studies cited in the petition,
animal and cell studies. The National studies in rats to address key data gaps, two studies demonstrated effects
Toxicology Program (NTP) conducted a starting with pilot studies that address following exposure of artificial brain
systematic review of animal and cell limitations of the current literature with cells to fluoride at concentrations in the
studies on the effects of fluoride on respect to study design (e.g., range purported to be in the
learning and memory available up to randomization, blinding, control for bloodstream of humans. However,
January 2016 (Ref. 35). Almost all (159 litter effects), and assessment of motor relevance of cell assays to humans is
out of 171) of the animal and cell and sensory function to assess the limited because the concentrations of
culture studies cited in the petition in degree to which impairment of fluoride experienced by cells by
Appendix D–E were included in the movement may impact performance in themselves in culture are not directly
NTP systematic review. From among learning and memory tests. If justified, comparable to an animal or human
jstallworth on DSK7TPTVN1PROD with PROPOSALS
4,656 studies identified in the NTP follow-up studies would address exposure due to lack of metabolism,
database search, 4,552 were excluded potential developmental effects using interactions between cells, and the
during title and abstract screening, 104 lower dose levels more applicable to ability to measure chronic (long-term)
were reviewed at the full-text level and human intakes. effects (Ref. 41). Extrapolation from
68 studies were considered relevant and Two studies included in Table 4 (Ref. concentrations in cell cultures to human
were included in the analysis. NTP 1) were not included in the NTP review, exposures is not straightforward.
assessed each study for bias, meaning a but do not show neurotoxicity effects at Pharmacokinetic modeling is necessary
systematic error in the study that can doses relevant to U.S. populations. One to convert the concentrations to a
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human equivalent dose relevant to risk continues ‘‘[d]espite the study determine whether uncertainty factors
assessment (Ref. 42), but the petition limitations, this is the first gene- are necessary.
did not address whether data are environment study investigating the Following hazard characterization
available or lacking to complete such an potential impact of COMT single- and identification of suitable studies for
analysis. nucleotide polymorphism (SNP) on the an RfD or RfC, uncertainty factors are
4. Susceptible subpopulations are at relationship between children’s generally applied to a lower limit dose
heightened risk. The data and cognitive performance and exposure to or concentration on the continuum of
information provided in the petition do elemental fluoride’’ (Ref. 29). Several observed effects (dose-response curve)
not support the claims that ‘‘nutritional studies are cited in the petition to in an individual study (e.g., NOAEL,
status, age, genetics and disease are support the assertion that infants, the LOAEL, Benchmark Dose, etc.). The
known to influence an individual’s elderly and individuals with deficient selection of uncertainty factors and their
susceptibility to chronic fluoride nutritional intake and kidney disease magnitude should be based on the
toxicity.’’ The only reference the are more susceptible to fluoride quality of the data, extent of the
petition presents that specifically neurotoxicity. However, the level of database and sound scientific judgment
addresses the claim that nutrient supporting evidence from these studies and consider the impact of having
deficiencies (i.e., deficiencies in iodine (i.e., to specify the potentially greater adverse effects from an inadequate
and calcium) can ‘‘amplify fluoride’s susceptibility of any particular exposure as well as an excess exposure.
neurotoxicity’’ is the study by Das and subpopulation) is insufficient to Uncertainty factor values may be
Mondal (Ref. 26). However, the study overcome the petition’s broader failure considered appropriate to account for
did not measure any nutrients in their to set forth sufficient facts to establish uncertainties associated with
test subjects. Rather, they measured that fluoridation chemicals present an extrapolating from (1) a dose producing
Body Mass Index (BMI), acknowledging unreasonable risk to the general effects in animals to a dose producing
that ‘‘BMI is the most commonly used population, to allow EPA to reach a risk no effects, (2) subchronic to chronic
measure for monitoring the prevalence evaluation. exposure in animals, (3) animal
of overweight and obesity at population toxicological data to humans
level’’ and ‘‘it is only a proxy measure 5. RfD/RfC derivation and uncertainty (interspecies), (4) sensitivities among
of the underlying problem of excess factor application. An oral Reference the members of the human population
body fat or underweight cases.’’ Not Dose or inhalation Reference (intraspecies), and (5) deficiencies in the
only is the BMI an indirect proxy for the Concentration is a daily exposure to the database for duration or key effects (Ref.
iodine and calcium deficiencies human population, including sensitive 43). Conflicting statements in the
supposed in the petition, the BMI subgroups, that is likely to be without petition indicate that there is both a
results presented in this study are an appreciable risk of deleterious effects robust and certain dose-response
themselves equivocal, as they show that during a lifetime (Ref. 43). The petition relationship between fluoride exposure
BMIs ranged from underweight to cites EPA’s 1998 guidance document, and IQ including for sensitive
overweight to obesity depending on the Guidelines for Neurotoxicity Risk subpopulations. However, the petition
sex and age of the study subjects. Assessment (Ref. 44), purporting that it does not clearly identify which sources/
Furthermore, the petition concedes that demonstrates the necessity of applying types of uncertainty in the data exist,
the Das and Mondal study data are only an uncertainty factor of at least 10. It nor which of the aforementioned
‘‘suggestive’’ of an area with chronic appears that the petition has selected uncertainty factors should be applied
malnutrition. A few human studies the eight studies presented in Table 5 based on the review of the selected
cited provide only suggestive evidence (Ref. 1, p. 19) as candidates for deriving studies.
that low levels of iodine may increase a Reference Dose (RfD) or Reference 6. Benefits to public health. The
the effects of high levels of fluoride in Concentration (RfC). The petition asserts petition asserts that the fluoridation of
children, but these studies suffer from that these dose or concentration values drinking water confers little benefit to
study design and confounding issues are relevant oral reference values for public health, claiming that the primary
already described previously. Other neurotoxic effects. However, the benefit of fluoride comes from topical
cited studies describe the effects of petition fails to recognize that the fluoride contact with the teeth and that
iodine or calcium on rats or rat brain question of applying an uncertainty there is thus little benefit from ingesting
cells in addition to irrelevantly high factor does not even arise until one has fluoride in water or any other product.
fluoride levels. The petition also claims first appropriately performed a hazard The petition claims there are no
that a certain ‘‘COMT gene characterization for all health endpoints randomized controlled trials on the
polymorphism greatly influences the of concern (Ref. 30, Section 3.1). As effectiveness of fluoridation, and that
extent of IQ loss resulting from fluoride outlined in EPA’s document, A Review few studies adequately account for
exposure,’’ citing a study by Zhang et al. of the Reference Dose and Reference potential confounding factors. In
(Ref. 29) as support. The COMT gene Concentration Processes (Ref. 43), the addition, the petition states that modern
encodes for the enzyme, catechol-O- first step in deriving an RfD or RfC is to studies of fluoridation and tooth decay
methyltransferase, which is responsible evaluate the available database. The have found small, inconsistent and
for control of dopamine levels in the petition does not set forth the strengths often non-existent differences in cavity
brain. Zhang et al. concludes that, ‘‘[t]he and limitations of each of the studies in rates between fluoridated and non-
present study has several limitations. the overall database of available studies fluoridated areas. Further, the petition
jstallworth on DSK7TPTVN1PROD with PROPOSALS
First, the cross-sectional observational nor any criteria or rationale for selecting questions the cost-effectiveness of
design does not allow us to determine the eight particular studies from which fluoridation relative to costs associated
temporal or causal associations between to derive an RfD or RfC. Without setting with what have been asserted to be
fluoride and cognition. Second, the forth the strengths and limitations fluoridation-related drops in IQ. The
study has a relatively small sample size, associated with each study and the petition argues, then, that there is ‘‘little
which limits the power to assess effects weight of evidence provided by the justification’’ in exposing the public to
of gene-environmental interactions on available database, a necessary step in ‘‘any risk’’ of fluoride neurotoxicity
children’s IQ’’ (Ref. 29). Zhang et al. any assessment, it is not possible to (Ref. 1).
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EPA does not believe that the petition The U.S. Surgeon General went on to Association, water fluoridation prevents
has presented a well-founded basis to note, ‘‘it [is] abundantly clear that there tooth decay by providing frequent and
doubt the health benefits of fluoridating are profound and consequential consistent contact with low levels of
drinking water. The petition’s argument disparities in the oral health of our fluoride (Refs. 55 and 56). Thus, the
about fluoridation benefits (i.e., that the citizens. Indeed, what amounts to a health benefits of fluoride include
risks of neurotoxic health effects from silent epidemic of dental and oral having fewer cavities, less severe
fluoridation are unreasonable in part diseases is affecting some population cavities, less need for fillings and
because they outweigh the expected groups.’’ (Ref. 50). removing teeth, and less pain and
health benefits arising from exposure to At that time, among 5- to 17-year-olds, suffering due to tooth decay (Ref. 55).
fluoride) depends on first setting forth dental caries was more than five times Fluoride protects teeth in two ways—
sufficient facts to establish the as common as a reported history of systemically and topically (Ref. 57).
purported neurotoxic risks, to which the asthma and seven times as common as Topical fluorides include toothpastes,
countervailing health benefits from hay fever. Prevalence increases with some mouth rinse products and
fluoridation could be compared. But as age. The majority (51.6 percent) of professionally applied products to treat
noted earlier, EPA and other children aged 5 to 9 years had at least tooth surfaces. Topical fluorides
authoritative bodies have previously one carious lesion or filling in the strengthen teeth already in the mouth by
reviewed many of the studies cited as coronal portion of either a primary or a becoming incorporated into the enamel
evidence of neurotoxic effects of permanent tooth. This proportion tooth surfaces, making them more
fluoride in humans and found increased to 77.9 percent for 17-year- resistant to decay. Systemic fluorides
significant limitations in using them to olds and 84.7 percent for adults 18 or are those ingested into the body.
draw conclusions on whether older. Additionally, 49.7 percent of Fluoridated water and fluoride present
neurotoxicity is associated with people 75 years or older had root caries in the diet are sources of systemic
fluoridation of drinking water. affecting at least one tooth (Ref. 50). fluoride. As teeth are developing (pre-
Irrespective of the conclusions one More recently, from the National eruptive), regular ingestion of fluoride
draws about the health benefits of Health and Nutrition Examination protects the tooth surface by depositing
drinking water fluoridation, the petition Survey (NHANES) for 2011–2012, fluorides throughout the entire tooth
did not set forth sufficient facts to approximately 23% of children aged 2– surface (Ref. 56). Systemic fluorides also
justify its primary claims about 5 years had dental caries in primary provide topical protection as ingested
purported neurotoxic effect from teeth. Untreated tooth decay in primary fluoride is present in saliva which
drinking fluoridated water. teeth among children aged 2–8 was continually bathes the teeth (Ref. 56).
The petition cites several studies as twice as high for Hispanic and non- Water fluoridation provides both
evidence that water fluoridation does Hispanic black children compared with systemic and topical exposure which
not have any demonstrable benefit to non-Hispanic white children. Among together provide for maximum
the prevention of tooth decay (Refs. 45– those aged 6–11, 27% of Hispanic reduction in dental decay (Ref. 56).
49). However, EPA has found children had any dental caries in The Surgeon General, the Public
substantial concerns with the designs of permanent teeth compared with nearly Health Service and the Centers for
each of these studies including small 18% of non-Hispanic white and Asian Disease Control and Prevention
sample size and uncontrolled children. About three in five reaffirmed in 2015 the importance of
confounders, such as recall bias and adolescents aged 12–19 years had community water fluoridation for the
socioeconomic status. Additionally, in experienced dental caries in permanent prevention of dental caries and its
Bratthall et al. (Ref. 45), for example, the teeth, and 15% had untreated tooth demonstrated effectiveness (Refs. 54 and
appropriate interpretation of the decay (Refs. 51). 58). In the Public Health Service’s 2015
responses of the 55 dental care Further, in 2011–2012, 17.5 percent of Recommendation for Fluoride
professionals surveyed, based on the Americans ages 5–19 years were Concentration in Drinking Water, they
data provided in the paper, is that in reported to have untreated dental caries, note ‘‘there are no randomized, double-
places where water is fluoridated, the while 27.4 percent of those aged 20–44 blind, controlled trials of water
fluoridation is the primary reason for years had untreated caries (Ref. 52). For fluoridation because its community-
the reduction in dental caries. those living below the poverty line, 24.6 wide nature does not permit
Diesendorf (Ref. 49) cites only anecdotal percent of those aged 5–19 years and randomization of individuals to study
evidence and Cheng et al. (Ref. 46) is 40.2 percent of those aged 20–44 years and control groups or blinding of
commentary only, with no supporting had untreated dental caries (Ref. 52). participants. However, community trials
data. Untreated tooth decay can lead to have been conducted, and these studies
EPA is mindful of the public health abscess (a severe infection) under the were included in systematic reviews of
significance of reducing the incidence of gums which can spread to other parts of the effectiveness of community water
dental caries in the U.S. population. the body and have serious, and in rare fluoridation. As noted, these reviews of
Dental caries is one of the most common cases fatal, results (Ref. 53). Untreated the scientific evidence related to
childhood diseases and continues to be decay can cause pain, school absences, fluoride have concluded that
problematic in all age groups. difficulty concentrating, and poor community water fluoridation is
Historically, the addition of fluoride to appearance, all contributing to effective in decreasing dental caries
drinking water has been credited with decreased quality of life and ability to prevalence and severity’’ (Ref. 59).
significant reductions of dental caries in succeed (Ref. 54). 7. Extent and magnitude of risk from
jstallworth on DSK7TPTVN1PROD with PROPOSALS
the U.S. population. In 2000, the then- These data continue to suggest dental fluoridation chemicals. The petition
Surgeon General noted that ‘‘community caries remains a public health problem argues that the purported risks of
water fluoridation remains one of the affecting many people. Fluoride has drinking water fluoridation are
great achievements of public health in been proven to protect teeth from decay unreasonable in part because they are
the twentieth century—an inexpensive by helping to rebuild and strengthen the borne by a large population. The
means of improving oral health that tooth’s surface or enamel. According to petition (in its discussion of the extent
benefits all residents of a community, the Centers for Disease Control and and magnitude of risk posed) cites the
young and old, rich and poor alike.’’ Prevention and the American Dental total U.S. population and estimates the
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number of U.S. children under the age determining whether the alleged TSCA and SDWA, EPA notes that the
of 18 years who live in areas where neurotoxic risks presented by petition has not set forth any specific
artificial fluoridation occurs. That fluoridation chemicals are legal basis for its views on the purported
estimate is then multiplied by an unreasonable: ‘‘the societal limitations of SDWA. For this reason,
estimate of the average decrease in consequences of removing or restricting and because the petition has not set
lifetime earnings associated with IQ use of products; availability and forth facts sufficient to show that the
point loss to calculate the overall potential hazards of substitutes, and fluoridation of drinking water presents
potential IQ point loss and associated impacts on industry, employment, and an unreasonable risk under TSCA, the
decrease in lifetime earnings for the international trade.’’ Along these lines, Agency need not resolve such legal
segment of the U.S. population under the petition includes claims such as the questions in order to adjudicate this
the age of 18 years potentially exposed following: That any risks of fluoridation petition.
to artificially fluoridated water. The chemicals could be easily reduced by EPA has further observations about
petition concludes, based on the discontinuing purposeful fluoridation the petition’s claims that drinking water
potential extent and magnitude of practices; that alternative topical fluoridation is linked to lead hazards.
exposure to fluoridation chemicals, that fluoride products have widespread The Centers for Disease Control and
fluoridation would have caused ‘‘a loss availability; and that the impacts on the Prevention (CDC) studied the
of between 62.5 to 125 million IQ requested rule on industry, relationship between fluoridation
points’’ (Ref. 1, p. 24). employment, and international trade additives and blood lead levels in
The petition has not set forth a would be little, if any. In short, the children in the United States (Ref. 61).
scientifically defensible basis to petition urges EPA to conclude that the More than 9,000 children between the
conclude that any persons have suffered risks of fluoridation chemicals are ages of 1–16 years were included in the
neurotoxic harm as a result of exposure unreasonable, in part because if EPA study’s nationally representative
to fluoride in the U.S. through the found that the risks were unreasonable, sample. The petition argues that the
purposeful addition of fluoridation the cost and non-risk factors that EPA study, and Table 4 in particular, shows
chemicals to drinking water or would need to address in ensuing risk that fluorosilicic acid was associated
otherwise from fluoride exposure in the management rulemaking could be with increased risk of high blood lead
U.S. Still less has the petition set forth readily addressed. But this sort of ends- levels. In fact, Macek et al. concluded
a scientifically defensible basis to driven reasoning is forbidden by the that their detailed analyses did not
estimate an aggregate loss of IQ points texts of section 6(b)(4)(A) and support concerns that silicofluorides in
in the U.S., attributable to this use of 21(b)(4)(B)(ii) of the amended TSCA, community water systems cause high
fluoridation chemicals. As noted which exclude ‘‘costs or other non-risk lead concentrations in children. The
previously, EPA has determined the factors’’ from the unreasonable risk petition also points to another study
petition did not establish that determination. It is also plainly (Ref. 62) which re-analyzed CDC’s data
fluoridation chemicals present an inconsistent with Congress’ intent, in and concluded that children exposed to
unreasonable risk of injury to health or amending TSCA, to ‘‘de-couple’’ the ‘‘silicofluoridated’’ water had an
the environment, arising from these unreasonable risk decision from the elevated risk of having high blood lead
chemical substances’ use to fluoridate broader set of issues (e.g., chemical levels. Coplan et al. (Ref. 62) criticized
drinking water. The fact that a alternatives and regulatory cost- the Macek et al. approach as flawed and
purported risk relates to a large effectiveness) that may factor into how reevaluated the NHANES data
population is not a basis to relax best to manage unreasonable risks, once comparing systems that used
otherwise applicable scientific particular risks have been determined to silicofluorides to all systems (e.g., a
standards in evaluating the evidence of be unreasonable. See S. Rep. 114–67 at combination of fluoridated,
that purported risk. EPA and other 17 (Ref. 3); H.R. Rep. 114–176 at 23 (Ref. nonfluoridated and naturally
authoritative bodies have previously 4); and 162 Cong. Rec. S3516 (Ref. 60). fluoridated) and found a small
reviewed many of the studies cited as 9. Link to elevated blood lead levels. difference between the number of
evidence of neurotoxic effects of To support the contention that TSCA children in each group with blood lead
fluoride in humans and found (and not the Safe Drinking Water Act levels >5 mg/dL; the results were not
significant limitations in using them to [SDWA]) is the appropriate regulatory evaluated to see if the difference was
draw conclusions on whether authority, the petition asserts an statistically significant. A number of
neurotoxicity is associated with association between fluoridation other chemical characteristics are
fluoridation of drinking water. In chemicals and elevated blood lead known to increase lead release into
contrast, the benefits of community levels and claims that there is laboratory water sources such as pH, natural
water fluoridation have been and epidemiological research linking organic matter, water hardness, oxidant
demonstrated to reduce dental caries, artificial fluoridation chemicals with levels, and type of piping, age of
which is one of the most common pipe corrosion. The petition then argues housing; the Coplan et al. study did not
childhood diseases and continues to be that issuing a rule under TSCA section evaluate these factors.
problematic in all age groups. Left 6 rather than SDWA would allow EPA In any event, the Agency is not
untreated, decay can cause pain, school to specifically target and prohibit the persuaded that the examination of the
absences, difficulty concentrating, and addition of fluoridation chemicals to relationship between fluoridation
poor appearance, all contributing to drinking water. The petition argues that chemicals, pipe corrosion, and elevated
decreased quality of life and ability to SDWA would not allow EPA to blood lead levels nor their bearing on
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succeed (Ref. 54). distinguish between intentionally- the comparative efficacy of TSCA or
8. Consequences of eliminating use of added, artificial and naturally-occurring SDWA is germane to the disposition of
fluoridation chemicals. Apparently fluoride. It is in the public interest, says the petition. Under TSCA, where the
citing to a repealed provision of TSCA the petition, to opt for the regulatory EPA Administrator determines ‘‘that the
(15 U.S.C. 2605(c)[1](A) (2015)) and option that is less expensive and can be manufacture, processing, distribution in
guidance issued with respect to that more narrowly tailored. commerce, use, or disposal of a
statutory provision, the petition argues Regarding the claims about the chemical substance or mixture . . .
that the following factors are germane to relative extent of legal authorities under presents an unreasonable risk of injury
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![11888 Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Proposed Rules
to health or the environment, the does not address whether fluoridation technical person listed under FOR
Administrator shall by rule [regulate a] chemicals would still present an FURTHER INFORMATION CONTACT.
. . . substance or mixture to the extent unreasonable risk, even after 1. Fluoride Action Network. Citizen Petition
necessary so that the chemical implementing the requested relief, Under Section 21 of TSCA. November
substance or mixture no longer presents arising from other conditions of use. As 2016.
such risk’’ 15 U.S.C. 2605(a). As discussed earlier in Unit III., EPA 2. EPA. Procedures for Chemical Risk
previously discussed, the petition does interprets TSCA section 21 as requiring Evaluation Under the Amended Toxic
not demonstrate that purposeful a petition to address the full set of Substances Control Act; Notice. Federal
addition of fluoridation chemicals to conditions of use for a chemical Register (82 FR 7562, January 19, 2017).
U.S. water supplies presents such substance and thereby describe an 3. Senate Report 114–67. June 18, 2015.
unreasonable risk. Available at https://www.congress.gov/
adequate rule under TSCA section 6(a),
10. Regulation of fluoridation 114/crpt/srpt67/CRPT-114srpt67.pdf.
as opposed to a rule that would merely 4. House Report 114–176. June 23, 2015.
chemicals as a category. EPA has broad address a particular subset of uses of Available at https://www.congress.gov/
discretion to determine whether to special interest. The petition at issue 114/crpt/hrpt176/CRPT-114hrpt176.pdf.
regulate by category under TSCA pays little or no attention to the other 5. EPA. Procedures for Prioritization of
section 26(c) rather than by individual conditions of use of the various Chemicals for Risk Evaluation Under the
chemical substances. In a prior fluoridation chemicals (i.e., uses other Toxic Substance Control Act; Notice.
evaluation of a section 21 petition than the eponymous use to treat Federal Register (82 FR 4831, January
seeking the regulation of a category of drinking water) and makes no claim for 17, 2017).
chemical substances, EPA explained 6. Malin, A.J. and Till, C. Exposure to
any of these chemical substances that
that it does so in light of Congress’ fluoridated water and attention deficit
the risks to be addressed by curtailing hyperactivity disorder prevalence among
purpose in establishing the category drinking water fluoridation would be children and adolescents in the United
authority: To ‘‘facilitate the efficient and the only unreasonable risks or even the States: An ecological association.
effective administration’’ of TSCA. See most significant unreasonable risks. Environmental Health. Vol. 14, pp. 1–10.
72 FR 72886 (Ref. 63) (citing Senate This problem is compounded by the 2015.
Report No. 94–698 at 31). It is of course petition’s lack of specificity as to which 7. Peckham, S.; Lowery, D. and Spencer, S.
self-evident that various chemical chemical substances are being construed Are fluoride levels in drinking water
substances constituting ‘‘fluoridation as ‘‘fluoridation chemicals.’’ associated with hypothyroidism
chemicals’’ would have in common prevalence in England? A large
EPA acknowledges that its observational study of GP practice data
their use to fluoridate drinking water.
interpretation of the requirements of and fluoride levels in drinking water.
But as discussed in Unit III., the inquiry
TSCA section 21, for petitions seeking Journal of Epidemiology and Community
does not end there. If EPA were to grant
action under TSCA section 6, was not Health. Vol. 69, pp. 619–624. 2015.
the petitioner’s request, the Agency
available to petitioners at the time they 8. Connett, M. Fluoridation & neurotoxicity:
would become obligated to address all An unreasonable risk. [PowerPoint
conditions of use of the category. If prepared this petition. EPA has issued
general guidance for preparing citizen’s presentation]. Presented on January 30,
certain chemical substances comprising 2017.
the category present conditions of use petitions, 50 FR 56825 (1985), but that
9. Hirzy, W.; Connett, P.; Xiang, Q.; Spittle,
that other members do not, and any of guidance does not account for the 2016
B.J. and Kennedy, D.C. Developmental
those conditions of use would be amendments to TSCA. Particularly neurotoxicity of fluoride: A quantitative
significant to whether the category as a relevant under these circumstances, the risk analysis towards establishing a safe
whole presents an unreasonable risk to Agency wishes to emphasize that its daily dose of fluoride for children.
human health or the environment, then denial does not preclude petitioners Fluoride. Vol. 49, pp. 379–400. 2016.
the overall approach of regulating by from obtaining further substantive 10. National Research Council. Fluoride in
administrative consideration, under drinking water: A scientific review of
category is less suited to the efficient EPA’s standards. The National
and effective administration of TSCA. TSCA section 21, of a substantively
revised petition under TSCA section 21 Academies Press. Washington, DC 2006.
But the petition does not set forth facts 11. Choi, A.L.; Sun, G.; Zhang, Y. and
that would enable the Agency to that clearly identifies the chemical
Grandjean, P. Developmental fluoride
reasonably evaluate whether a category substances at issue, discusses the full neurotoxicity; a systematic review and
approach on fluoridation chemicals conditions of use for those substances, meta-analysis. Environmental Health
would be consistent with the efficient and sets forth facts that would enable Perspectives. Volume 120, pp. 1362–
and effective administration of TSCA. EPA to complete a risk evaluation under 1368. 2012.
Nor does the petition set forth the TSCA section 6(b) for those substances. 12. Tang, Q.; Du, J.; Ma, H.H.; Jiang, S.J. and
Zhou, S.J. Fluoride and children’s
specific chemical substances that VI. References intelligence: A meta-analysis. Biological
should comprise the category of Trace Element Research. Vol. 126, pp.
fluoridation chemicals. As indicated under ADDRESSES, a
115–120. 2008.
11. Specification of an adequate rule docket has been established for this 13. Li, F.; Chen, X.; Huang, R. and Xie, Y.
under TSCA section 6(a). As discussed document under docket ID number The impact of endemic fluorosis caused
earlier, the petition does not set forth EPA–HQ–OPPT–2016–0763. The by the burning of coal on the
facts that satisfactorily demonstrate to following is a listing of documents that development of intelligence in children.
the Agency that fluoridation chemicals are specifically referenced in this notice. Journal of Environment and Health. Vol.
present an unreasonable risk to human The docket itself includes both these 26, pp. 838–840. 2009.
jstallworth on DSK7TPTVN1PROD with PROPOSALS
health, specifically arising from these referenced documents and further 14. Guo, X.; Wang, R.; Cheng, C.; Wei, W.;
chemical substances’ use to fluoridate documents considered by EPA. The Tang, L.; et al. A preliminary
investigation of the IQs of 7–13 year-old
drinking water. But even if the petition docket also includes supporting
children from an area with coal burning-
had done so, it would still be documents provided by the petitioner related fluoride poisoning. Fluoride. Vol.
inadequate as a basis to compel the and cited in the petition, which are not 41, pp. 125–128. 2008.
commencement of section 6(a) available in the electronic version of the 15. Li, Y.; Li, X. and Wei, S. Effects of high
rulemaking proceeding under TSCA docket. For assistance in locating these fluoride intake on child mental work
section 21. This is because the petition printed documents, please consult the capacity: Preliminary investigation into
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![11890 Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Proposed Rules
Supporting the Safety and Effectiveness fluoridation: One of CDC’s ‘‘10 great 62. Coplan, M.J.; Patch, S.C.; Masters, R.D.
of Community Water Fluoridation. public health achievements of the 20th and Bachman, M.S. Confirmation of and
January 30, 2017. Available at https:// century’’. Public Health Reports. Vol. explanations for elevated blood lead and
www.cdc.gov/fluoridation/pdf/cdc- 130, pp. 296–298. 2015. other disorders in children exposed to
statement.pdf. 59. U.S. Department of Health and Human water disinfection and fluoridation
55. U.S. Department of Health and Human Services. U.S. Public Health Service chemicals. NeuroToxicology. Vol. 28, pp.
Services. Water Fluoridation Basics. recommendation for fluoride 1032–1042. 2007.
Retrieved February 1, 2017 from https:// concentration in drinking water for the 63. EPA. Air Fresheners; TSC Section 21
www.cdc.gov/fluoridation/basics/ prevention of dental caries. Public Petition; Notice. Federal Register (72 FR
index.htm. 72886, December 21, 2007).
Health Reports. Vol. 130, pp. 318–331.
56. American Dental Association.
2015. List of Subjects
Fluoridation Facts. 2005. Available at
http://www.ada.org/∼/media/ADA/ 60. Congressional Record S3516. June 7,
2016. Available at https://www.congress. Environmental protection,
Member%20Center/FIles/fluoridation_
gov/crec/2016/06/07/CREC-2016-06-07- Fluoridation chemicals, Drinking water,
facts.ashx.
57. Buzalaf, M.A.R.; Pessan, J.P.; Honorio, pt1-PgS3511.pdf. Toxic Substances Control Act (TSCA).
H.M. and ten Cate, J.M. Mechanisms of 61. Macek, M.D.; Matte, T.D.; Sinks, T. and Dated: February 17, 2017.
action of fluoride for caries control. Malvitz, D.M. Blood lead concentrations
Wendy Cleland-Hamnett,
Monographs in Oral Science: Fluoride in children and method of water
fluoridation in the United States, 1988– Acting Assistant Administrator, Office of
and the Oral Environment. Vol. 22, pp.
97–114. 2011. 1994. Environmental Health Chemical Safety and Pollution Prevention.
58. Murthy, V.H. Surgeon General’s Perspectives. Vol. 114, pp. 130–134. [FR Doc. 2017–03829 Filed 2–24–17; 8:45 am]
Perspectives: Community water 2006. BILLING CODE 6560–50–P
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Document Created: 2017-02-25 01:05:50
Document Modified: 2017-02-25 01:05:50
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Petition; reasons for Agency response. | |
| Dates | EPA's response to this TSCA section 21 petition was signed February 17, 2017. | |
| Contact | For technical information contact: Darlene Leonard, National Program Chemicals Division (7404T), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 566-0516; fax | |
| FR Citation | 82 FR 11878 |
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