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21 U.S.C. § 349 — Bottled drinking water standards; publication in Federal Register

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21 U.S.C. § 349 — Bottled drinking water standards; publication in Federal Register

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Source location: Title 21, Chapter 9, § 349; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(a)** Except as provided in subsection (b), whenever the Administrator of the Environmental Protection Agency prescribes interim or revised national primary drinking water regulations under section 1412 of the Public Health Service Act [[42 U.S.C. 300g–1](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300g–1&num=0&edition=prelim)], the Secretary shall consult with the Administrator and within 180 days after the promulgation of such drinking water regulations either promulgate amendments to regulations under this chapter applicable to bottled drinking water or publish in the Federal Register his reasons for not making such amendments. **(b)** (1) Not later than 180 days before the effective date of a national primary drinking water regulation promulgated by the Administrator of the Environmental Protection Agency for a contaminant under section 1412 of the Safe Drinking Water Act ([42 U.S.C. 300g–1](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300g–1&num=0&edition=prelim)), the Secretary shall promulgate a standard of quality regulation under this subsection for that contaminant in bottled water or make a finding that such a regulation is not necessary to protect the public health because the contaminant is contained in water in public water systems (as defined under section 1401(4) of such Act ([42 U.S.C. 300f(4)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300f/4&num=0&edition=prelim))) but not in water used for bottled drinking water. The effective date for any such standard of quality regulation shall be the same as the effective date for such national primary drinking water regulation, except for any standard of quality of regulation promulgated by the Secretary before August 6, 1996, for which (as of August 6, 1996) an effective date had not been established. In the case of a standard of quality regulation to which such exception applies, the Secretary shall promulgate monitoring requirements for the contaminants covered by the regulation not later than 2 years after August 6, 1996. (2) A regulation issued by the Secretary as provided in this subsection shall include any monitoring requirements that the Secretary determines appropriate for bottled water. (3) A regulation issued by the Secretary as provided in this subsection shall require the following: (A) In the case of contaminants for which a maximum contaminant level is established in a national primary drinking water regulation under section 1412 of the Safe Drinking Water Act ([42 U.S.C. 300g–1](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300g–1&num=0&edition=prelim)), the regulation under this subsection shall establish a maximum contaminant level for the contaminant in bottled water which is no less stringent than the maximum contaminant level provided in the national primary drinking water regulation. (B) In the case of contaminants for which a treatment technique is established in a national primary drinking water regulation under section 1412 of the Safe Drinking Water Act ([42 U.S.C. 300g–1](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300g–1&num=0&edition=prelim)), the regulation under this subsection shall require that bottled water be subject to requirements no less protective of the public health than those applicable to water provided by public water systems using the treatment technique required by the national primary drinking water regulation. (4) (A) If the Secretary does not promulgate a regulation under this subsection within the period described in paragraph (1), the national primary drinking water regulation referred to in paragraph (1) shall be considered, as of the date on which the Secretary is required to establish a regulation under paragraph (1), as the regulation applicable under this subsection to bottled water. (B) In the case of a national primary drinking water regulation that pursuant to subparagraph (A) is considered to be a standard of quality regulation, the Secretary shall, not later than the applicable date referred to in such subparagraph, publish in the Federal Register a notice— (i) specifying the contents of such regulation, including monitoring requirements; and (ii) providing that for purposes of this paragraph the effective date for such regulation is the same as the effective date for the regulation for purposes of the Safe Drinking Water Act [[42 U.S.C. 300f](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300f&num=0&edition=prelim) et seq.] (or, if the exception under paragraph (1) applies to the regulation, that the effective date for the regulation is not later than 2 years and 180 days after August 6, 1996).

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 300g–1 — National drinking water regulations

**(a) National primary drinking water regulations; maximum contaminant level goals; simultaneous publication of regulations and goals** (1) Effective on June 19, 1986, each national interim or revised primary drinking water regulation promulgated under this section before June 19, 1986, shall be deemed to be a national primary drinking water regulation under subsection (b). No such regulation shall be required to comply with the standards set forth in subsection (b)(4) unless such regulation is amended to establish a different maximum contaminant level after June 19, 1986. (2) After June 19, 1986, each recommended maximum contaminant level published before June 19, 1986, shall be treated as a maximum contaminant level goal. (3) Whenever a national primary drinking water regulation is proposed under subsection (b) for any contaminant, the maximum contaminant level goal for such contaminant shall be proposed simultaneously. Whenever a national primary drinking water regulation is promulgated under subsection (b) for any contaminant, the maximum contaminant level goal for such contaminant shall be published simultaneously. (4) Paragraph (3) shall not apply to any recommended maximum contaminant level published before June 19, 1986. **(b) Standards** (1) **Identification of contaminants for listing.—** (A) *General authority.—* — The Administrator shall, in accordance with the procedures established by this subsection, publish a maximum contaminant level goal and promulgate a national primary drinking water regulation for a contaminant (other than a contaminant referred to in paragraph (2) for which a national primary drinking water regulation has been promulgated as of August 6, 1996) if the Administrator determines that— (i) the contaminant may have an adver

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42 U.S.C. § 201 — Funding

Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services Emergency Fund such sums as may be necessary to carry out this part.

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42 U.S.C. § 300f — Definitions

For purposes of this subchapter: (1) The term “primary drinking water regulation” means a regulation which— (A) applies to public water systems; (B) specifies contaminants which, in the judgment of the Administrator, may have any adverse effect on the health of persons; (C) specifies for each such contaminant either— (i) a maximum contaminant level, if, in the judgment of the Administrator, it is economically and technologically feasible to ascertain the level of such contaminant in water in public water systems, or (ii) if, in the judgment of the Administrator, it is not economically or technologically feasible to so ascertain the level of such contaminant, each treatment technique known to the Administrator which leads to a reduction in the level of such contaminant sufficient to satisfy the requirements of [section 300g–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300g-1&num=0&edition=prelim); and (D) contains criteria and procedures to assure a supply of drinking water which dependably complies with such maximum contaminant levels; including accepted methods for quality control and testing procedures to insure compliance with such levels and to insure proper operation and maintenance of the system, and requirements as to (i) the minimum quality of water which may be taken into the system and (ii) siting for new facilities for public water systems. At any time after promulgation of a regulation referred to in this paragraph, the Administrator may add equally effective quality control and testing procedures by guidance published in the Federal Register. Such procedures shall be treated as an alternative for public water systems to the quality control and testing procedures listed in the regulatio

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42 U.S.C. § 202 — Definitions

When used in this chapter— **(a)** The term “Service” means the Public Health Service; **(b)** The term “Surgeon General” means the Surgeon General of the Public Health Service; **(c)** Unless the context otherwise requires, the term “Secretary” means the Secretary of Health and Human Services. **(d)** The term “regulations”, except when otherwise specified, means rules and regulations made by the Surgeon General with the approval of the Secretary; **(e)** The term “executive department” means any executive department, agency, or independent establishment of the United States or any corporation wholly owned by the United States; **(f)** Except as provided in sections 246(g)(4)(B),11 See References in Text note below. 247c(c)(1),1 254d(h)(3),1 263c(5),1 264(d), 292a(9),1 300a(c), 300f(13), and 300n(1) 1 of this title, the term “State” includes, in addition to the several States, only the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau. **(g)** The term “possession” includes, among other possessions, Puerto Rico and the Virgin Islands; **(h)** Repealed. Pub. L. 97–35, title IX, § 986(a), Aug. 13, 1981, 95 Stat. 603. **(i)** The term “vessel” includes every description of watercraft or other artificial contrivance used, or capable of being used, as a means of transportation on water, exclusive of aircraft and amphibious contrivances; **(j)** The term “habit-forming narcotic drug” or “narcotic” means opium and coca leaves and the several alkaloids derived therefrom, the best known of these alkaloids being morphia, heroin, and codeine, obtained from opium, and cocaine derived from the coca

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21 U.S.C. § 349 — Bottled drinking water standards; publica-

Page 123 TITLE 21—FOOD AND DRUGS § 349 ‘‘(2) which is not, by design, representation, or cus- tom of usage intended for use by children, is unsafe, the Secretary shall not take any action be- fore January 1, 2003, to ban lead and cadmium based enamel on such glass and ceramic ware. Any action taken after January 1, 2003, to ban such enamel on such glass and ceramic ware as an unapproved food additive shall be taken by regulation and such regulation shall provide that such products shall not be removed from the market before 1 year after publication of the final regulation.’’ MORATORIUM ON AUTHORITY OF SECRETARY WITH RESPECT TO SACCHARIN Pub. L. 95–203, § 3, Nov. 23, 1977, 91 Stat. 1452, as amended by Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 96–273, June 17, 1980, 94 Stat. 536; Pub. L. 97–42, § 2, Aug. 14, 1981, 95 Stat. 946; Pub. L. 98–22, § 2, Apr. 22, 1983, 97 Stat. 173; Pub. L. 99–46, May 24, 1985, 99 Stat. 81; Pub. L. 100–71, title I, § 101, July 11, 1987, 101 Stat. 431; Pub. L. 102–142, title VI, Oct. 28, 1991, 105 Stat. 910; Pub. L. 104–180, title VI, § 602, Aug. 6, 1996, 110 Stat. 1594, provided that: ‘‘During the period ending May 1, 2002, the Secretary— ‘‘(1) may not amend or revoke the interim food ad- ditive regulation of the Food and Drug Administra- tion of the Department of Health and Human Serv- ices applicable to saccharin and published on March 15, 1977 (section 180.37 of part 180, subchapter B, chap- ter 1, title 21, Code of Federal Regulations (42 Fed. Reg. 14638)), or ‘‘(2) may, except as provided in section 4 [enacting section 343a of this title, amending sections 321 and 343 of this title, and enacting provisions set out as notes under section 343 of this title] and the amend- ments made by suc

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42 U.S.C. § 300f — Definitions

Page 1232 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 300f qualified health maintenance organization for purposes of section 300e–9 of this title. (h) Penalties Whoever knowingly and willfully makes or causes to be made any false statement or rep- resentation of a material fact in any statement filed pursuant to this section shall be guilty of a felony and upon conviction thereof shall be fined not more than $25,000 or imprisoned for not more than five years, or both. (July 1, 1944, ch. 373, title XIII, § 1318, as added Pub. L. 95–559, § 9(a), Nov. 1, 1978, 92 Stat. 2135; amended Pub. L. 97–35, title IX, § 948, Aug. 13, 1981, 95 Stat. 577; Pub. L. 99–660, title VIII, § 810, Nov. 14, 1986, 100 Stat. 3801; Pub. L. 108–173, title IX, § 900(e)(2)(E), Dec. 8, 2003, 117 Stat. 2372.) Editorial Notes AMENDMENTS 2003—Subsec. (a)(2). Pub. L. 108–173 substituted ‘‘Cen- ters for Medicare & Medicaid Services’’ for ‘‘Health Care Financing Administration’’. 1986—Subsec. (e). Pub. L. 99–660 struck out subsec. (e) which read as follows: ‘‘The Secretary shall file an an- nual report with the Congress on the operation of this section. Such report shall include— ‘‘(1) an enumeration of standards and norms uti- lized to make the evaluations required under sub- section (d) of this section; ‘‘(2) an assessment of the degree of conformity or nonconformity of each health maintenance organiza- tion evaluated by the Secretary under subsection (d) of this section with such standards and norms; ‘‘(3) what action, if any, the Secretary considers necessary under section 300e–11 of this title with re- spect to health maintenance organizations evaluated under subsection (d) of this section.’’ 1981—Subsec. (a). Pub. L. 97–35, § 948(a), (b), in par. (2) inserted reference to copy

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 300g — Coverage

Subject to sections 300g–4 and 300g–5 of this title, national primary drinking water regulations under this part shall apply to each public water system in each State; except that such regulations shall not apply to a public water system— (1) which consists only of distribution and storage facilities (and does not have any collection and treatment facilities); (2) which obtains all of its water from, but is not owned or operated by, a public water system to which such regulations apply; (3) which does not sell water to any person; and (4) which is not a carrier which conveys passengers in interstate commerce.

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42 U.S.C. § 300g — Coverage

Page 1235 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 300g–1 the reliance for residential water on various nonpublic water systems and to submit a report on the results of the study to Congress within 3 years after Aug. 6, 1996. SAFE DRINKING WATER AMENDMENTS OF 1977 RESTRICTIONS ON APPROPRIATIONS FOR RESEARCH Pub. L. 95–190, § 2(e), Nov. 16, 1977, 91 Stat. 1393, pro- vided that: ‘‘Nothing in this Act [see Short Title of 1977 Amendment note set out under section 201 of this title] shall be construed to authorize the appropriation of any amount for research under title XIV of the Public Health Service Act [42 U.S.C. 300f et seq.] (relating to safe drinking water).’’ SAFE DRINKING WATER AMENDMENTS OF 1977 AS NOT AFFECTING AUTHORITY OF ADMINISTRATOR WITH RE- SPECT TO CONTAMINANTS Pub. L. 95–190, § 3(e)(2), Nov. 16, 1977, 91 Stat. 1394, pro- vided that: ‘‘Nothing in this Act [see Short Title of 1977 Amendment note set out under section 201 of this title] shall be construed to alter or affect the Administra- tor’s authority or duty under title 14 of the Public Health Service Act [42 U.S.C. 300f et seq.] to promul- gate regulations or take other action with respect to any contaminant.’’ RURAL WATER SURVEY; REPORT TO PRESIDENT AND CONGRESS; AUTHORIZATION OF APPROPRIATIONS Pub. L. 93–523, § 3, Dec. 16, 1974, 88 Stat. 1693, as amended by Pub. L. 95–190, §§ 2(d), 3(d), Nov. 16, 1977, 91 Stat. 1393, 1394, directed Administrator of Environ- mental Protection Agency, after consultation with Secretary of Agriculture and the several States, to enter into arrangements with public or private entities to conduct a survey of quantity, quality, and avail- ability of rural drinking water supplies, which survey was to include, but not be limited to, consideration of num

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