Fluoridation Practice l Fluoridation Facts 75 Fluoridation Practice 47. Who regulates?......................................................75 48. Standards for additives?......................................76 49. Lead, arsenic and other contamination?. ...........77 50. Additives safety?...................................................78 51. Source of additives?.............................................78 52. System safety concerns?.....................................79 53. Engineering?..........................................................80 54. Corrosion of water pipes?. ...................................81 55. Damage to water facilities?.................................81 56. Environment?.........................................................82 47. Who regulates drinking water additives in United States? Answer. The United States Environmental Protection Agency (EPA) regulates drinking water additives. Fact. 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 The two agencies agreed that the Safe Drinking Water Act’s passage in 1974 implicitly repealed FDA’s jurisdiction over drinking water as a ‘food’ under the Federal Food, Drug and Cosmetic Act (FFDCA).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