47. Who regulates drinking water additives in United States?
The United States Environmental Protection Agency (EPA) regulates drinking water additives.
In 1974, Congress passed the Safe Drinking Water Act (SDWA) which protects the public’s health by regulating the nation’s public drinking water supply.1 The SDWA, as amended in 1986 and 1996,1 requires the Environmental Protection Agency (EPA) to ensure the public is provided with safe drinking water.1 On June 22, 1979, the Food and Drug Administration (FDA) and the EPA entered into a Memorandum of Understanding (MOU) to clarify their roles and responsibilities in water quality assurance.2 The stated purpose of the MOU is to “avoid the possibility of overlapping jurisdiction between the USEPA and FDA with respect to control of drinking water additives.” The two agencies agreed that the Safe Drinking Water Act’s passage in 1974 implicitly repealed FDA’s jurisdiction over drinking water as a ‘food’ under the Federal Food, Drug and Cosmetic Act (FFDCA). Under the MOU, EPA enjoys exclusive regulatory authority over drinking water provided by public water systems, including any additives in such water. FDA retains jurisdiction over bottled drinking water under Section 410 of the FFDCA and “over water (and substances in water) used in food or food processing once it enters the food processing establishment.”2
While drinking water from the tap is regulated by the EPA, bottled water is regulated by the FDA which has established standards for its quality.2 The FDA has noted that fluoride can occur naturally in source waters used for bottled water or may be added by a bottled water manufacturer. Recognizing the benefit of fluoride in water, the FDA has stated that bottled water that meets specific standards of identity and quality set forth by FDA, and the provisions of the authorized health claim related to fluoride, may be labeled with the following health claim: “Drinking fluoridated water may reduce the risk of [dental caries or tooth decay].”3
While drinking water from the tap is regulated by the EPA, bottled water is regulated by the FDA which has established standards for its quality. The FDA has noted that fluoride can occur naturally in source waters used for bottled water or may be added by a bottled water manufacturer. Recognizing the benefit of fluoride in water, the FDA has stated that bottled water that meets specific standards of identity and quality set forth by FDA, and the provisions of the authorized health claim related to fluoride, may be labeled with the following health claim: “Drinking fluoridated water may reduce the risk of [dental caries or tooth decay].”
From time to time, states and communities have had to deal with legislation or ballot initiatives aimed at requiring the approval of the FDA before any agent can be added to community water systems. Often referred to as the Fluoride Product Quality Control Act, Water Product Quality Ordinance or Pure Water Ordinance, the legislation is specifically used by those opposed to water fluoridation as a tool to prevent water systems from providing community water fluoridation. Often this legislation does not specifically mention fluoride or fluoridation. Those supporting this type of legislation may claim that they are not against water fluoridation but are proponents of pure water and do not want anything added to water that has not been approved by the FDA. On the surface, this may appear to be a “common sense” approach. However, its only real purpose is to defeat efforts to provide water fluoridation. That is because this proposed legislation would require the FDA — which does NOT regulate public water systems — to approve any water additive. By mistakenly (and perhaps craftily) naming the wrong federal agency, the probable outcome is to stop or prevent water fluoridation.
48. What standards have been established to ensure the safety of fluoride additives used in community water fluoridation in the United States?
The three fluoride additives used in the U.S. to fluoridate community water systems (sodium fluoride, sodium fluorosilicate, and fluorosilicic acid) meet safety standards established by the American Water Works Association (AWWA) and NSF International (NSF).4
The three fluoride additives used in the U.S. to fluoridate community water systems (sodium fluoride, sodium fluorosilicate, and fluorosilicic acid) meet safety standards established by the American Water Works Association (AWWA) and NSF International (NSF).
Additives used in water treatment meet safety standards prepared in response to a request by the Environmental Protection Agency to establish minimum requirements to ensure the safety of products added to water for its treatment, thereby ensuring the public’s health.4 Specifically, fluoride additives used in water fluoridation meet standards established by the American Water Works Association (AWWA) and NSF International (NSF).4 Additionally, the American National Standards Institute (ANSI) endorses both AWWA and NSF standards for fluoridation additives and includes its name on these standards.4
The American Water Works Association5 is an international nonprofit scientific and educational society dedicated to providing total water solutions to assure the effective management of water. Founded in 1881, the AWWA is the largest organization of water supply professionals in the world. The membership represents the full spectrum of the water community: public water and wastewater systems, environmental advocates, scientists, academicians, and others who hold a genuine interest in water. AWWA unites the diverse water community to advance public health, safety, the economy, and the environment.5
NSF International,6 an independent, accredited organization, is dedicated to being the leading global provider of public health and safety-based risk management solutions. Manufacturers, regulators and consumers look to NSF to develop public health standards and certifications that help protect food, water, consumer products and the environment. Its professional staff includes microbiologists, toxicologists, chemists, engineers, and environmental and public health professionals. Founded in 1944 as the National Sanitation Foundation, NSF’s mission is to protect and improve global human health.6
The American National Standards Institute (ANSI)7 is a private, non-profit organization that administers and coordinates the U.S. voluntary standardization and conformity assessment system. The Institute’s mission is to enhance both the global competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems, and safeguarding their integrity.7
The AWWA documents provide manufacturers, suppliers and purchasers with standards for the manufacturing, quality and verification for each of the three fluoride additives listed below. The AWWA standards set the physical, chemical and impurities standards including information on verification of the standard requirements and requirements for delivery.4
• ANSI/AWWA B701 Sodium Fluoride
• ANSI/AWWA B702 Sodium Fluorosilicate
• ANSI/AWWA B703 Fluorosilicic Acid4
NSF/ANSI Standard 604,6 provides for purity of drinking water additives as it limits an additive’s contribution of harmful contaminants to drinking water. The Standard also provides for safety assurances from production through distribution to ensure product quality is maintained. Additionally, the Standard requires documentation of the purity of the additives including specific criteria for products imported from other countries. NSF/ANSI Standard 614,6 is a related standard that provides guidance for equipment/products used in water treatment plants that come in contact with drinking water. Both NSF/ANSI standards were developed by a consortium of associations including NSF, AWWA, the Association of State Drinking Water Administrators and the Conference of State Health and Environmental Managers with support from the U.S. Environmental Protection Agency.4
Fluoride additives, like all of the more than 40 additives typically used in water treatment, are “water grade” additives. All additives used at the water plant are classified as water grade additives meeting NSF Standard 60 requirements. Examples of other “water grade” additives which are commonly used in water plant operations are chlorine (gas), ferrous sulfate, hydrochloric acid, sulfur dioxide and sulfuric acid.8
Sometimes antifluoridationists express the view that they are not really opposed to fluoridation, but are opposed to the use of “industrial grade” fluoride additives. They may even go so far as to state that they would support fluoridation if the process was implemented with pharmaceutical grade fluoride additives that were approved by the U.S. Food and Drug Administration (FDA). On the surface, this may appear to be a “common sense” approach. In fact, this is usually a ploy whose only real purpose is to stop fluoridation. First, the EPA, not the FDA, has regulatory authority for additives used in public water systems. Second, and perhaps most importantly, the U.S. Pharmacopeia (USP) monograph on sodium fluoride does not provide for certification of quality by an independent credentialing body.4,9 Third, the USP and The National Formulary (USP-NF) standards used to formulate prescription drugs are not appropriate for water fluoridation additives as they could actually allow higher levels of contaminants to be introduced into drinking water than is allowed by the current EPA standards.4,9 According to the CDC:9
The USP does not provide specific protection levels for individual contaminants, but establishes a relative maximum exposure level for a group of related contaminants. Some potential impurities have no restrictions by the USP, including arsenic, some heavy metals regulated by the U.S. EPA, and radionuclides. Given the volumes of chemicals used in water fluoridation, a pharmaceutical grade of sodium fluoride for fluoridation could potentially contain much higher levels of arsenic, radionuclides, and regulated heavy metals than an NSF/ANSI Standard 60-certified product.
Additional information about this topic can be found in this Section, Question 49.
Lastly, USP-grade sodium fluoride product is more likely to result in water plant personnel being exposed to fluoride dust as it is more powder-like than the preferred AWWA-grade sodium fluoride which is crystalline and so minimizes dusting when handled.4
Additional information about this topic can be found in this Section, Question 52.
49. Does fluoridating the community water supply raise concerns about lead, arsenic and other toxic contaminants to the water supply?
No. The concentrations of contaminants in drinking water as a result of fluoridation do not exceed, but are in fact, well below regulatory standards set to ensure the public’s safety.
Fluorosilicic acid is used to fluoridate the majority of community water systems in the United States.10 Because the additive is derived from ore mined from the earth, fluorosilicic acid may contain minute amounts of contaminants such as lead and arsenic. However, existing regulations and standards require that these contaminants, and others, be at levels considered acceptable by the U.S. Environmental Protection Agency when the fluorosilicic acid or other fluoridation additives are diluted to produce optimally fluoridated water.6 NSF International and the American National Standards Institute (NSF/ANSI) Standard 60 as well as AWWA standards are applicable to all fluoride additives.4,6
Testing of fluoride additives provides evidence that the levels of these contaminants do not exceed, but are in fact, well below regulatory standards set to ensure the public’s safety. NSF has prepared a detailed fact sheet, NSF Fact Sheet on Fluoridation Products (2013)11 that provides the documented quality of fluoride additives based on product samples analyzed. The NSF reports that the majority of fluoridation products as a class, based on NSF test results, do not add measurable amounts of arsenic, lead, or other heavy metals, or radionuclides to drinking water.9,11
50. Have fluoride additives been tested for safety?
The claim is sometimes made that no studies on safety exist on the additives used in water fluoridation. This statement is a ruse because the scientific community does not study the health effects of the concentrated additives; studies are done on the health effects of the treated water.
A 1999 study12 charged that fluorosilicic acid and sodium silicofluoride did not disassociate (break down) completely when added to water systems and may be responsible for lower pH (acid) levels of drinking water, leaching lead from plumbing systems and increasing lead uptake by children. Scientists from the U.S. Environmental Protection Agency (EPA) evaluated the disassociation of fluoride additives13 and concluded that at the typical pH level of drinking water (which is normally slightly alkaline) and the fluoride levels used in drinking water, the fluoride additives quickly and completely broke down to fluoride ions and silica.
Published in 2006,14 researchers at the University of Michigan verified for the EPA that theoretical predictions that hexafluorosilicate completely hydrolyzed (broke down) when added to water separating into free fluoride ions and silica ions were confirmed. The research demonstrated that there was no hexafluorosilicate that could be measured in the finished water.14