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regulatory action in instances where false or misleading statements concerning the source or treatment of bottled water are made and that specific statements to this effect in the standard are unnecessary (FDA. 1973a, p. 32561).

Although several parties filed objections to the final rule, FDA concluded that they did not justify changing the regulation or conducting a hearing, and the quality standard became effective on June 19, 1975 (FDA, 1975).

In 1974, passage of the Safe Drinking Water Act codified the division of labor between FDA and EPA for regulating water. In addition to directing EPA to promulgate National Primary Drinking Water Standards, the Safe Drinking Water Act also added Section 410 to FDCA. Section 410 directs FDA to consult with EPA whenever the latter issues interim or revised national primary drinking water standards and, within 180 days of EPA's promulgations, to either amend the bottled water standard or explain in the Federal Register why it was not doing so. In 1975, FDA adopted Good Manufacturing Practice (GMP) regulations for bottled water, including bottled mineral water (21 CFR §129.1 et seq.). Among other things, these regulations specify the kinds of facilities that must be used and process controls that are required to ensure a safe product. Recently, as part of hearings before the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations, FDA indicated that it was reconsidering the coverage of the bottled water standards to include mineral water and the water component in flavored beverage products fabricated from bottled water ingredients. The agency further noted that it was considering a new quality standard to require the water component of such products as seltzer, tonic water, and colas to meet quality standards based on EPA's primary drinking water standards (Shank, 1991).

A total of 16 States have expressed their dissatisfaction with FDA's regulation of bottled water by adopting laws or regulations to provide additional controls. These laws vary, but in general they address two basic issues: the nomenclature of various types of bottled waters and the purity of these products.8 Many States have adopted the model bottled water regulation of the Association of Food and Drug Officials (AFDO) or some variation of it. This regulation contains definitions for artesian well, bottled, demineralized, drinking, light mineral, mineral, mineralized, natural, purified, spring, and well water. It requires that all bottled waters bear one of the

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Ariz. Ag. Rule 290.063 R9-8-20.4; Cal. Health & Safety Code §26591 to §26594; Conn. Gen. Stat Ann. §21a-150; Del. Code Ann. §4315; Fla. Admin. Rule 500.455; Haw. Rev. Stat. §328D-6; La. Rev. Stat. Ann. §608(12) and reg. 49:2.1110; Me. Rev. Stat. Ann. Title 36, §1572; Md. Code Ann. §21-336; Miss. reg. §15.18; Mont. Code Ann. §50-31-236; NJ. Stat. Ann. §24.12-9; N.D. Cent. Code §19-08-02; Ohio Rev. Code Ann. Title 9, §913.24; Okla. Stat. Ann. §1-917; Tex. Rule §229.81 to §229.88.



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