Title 21 — Food and Drugs
Chapter 9 — Federal Food, Drug, and Cosmetic Act
§ 349. Bottled drinking water standards; publication in Federal Register
Statutory text
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], 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.
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), 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))) 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 , for which (as of ) 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 .
A regulation issued by the Secretary as provided in this subsection shall include any monitoring requirements that the Secretary determines appropriate for bottled water.
A regulation issued by the Secretary as provided in this subsection shall require the following:
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), 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.
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), 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.
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.
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—
specifying the contents of such regulation, including monitoring requirements; and
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 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 ).
Legislative history
Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.
Safe Drinking Water Act
Pub. L. 93–523 § 4 · 88 Stat. 1660
Enacted · 21 U.S.C. § 349
June 25, 1938, ch. 675, § 410, as added Pub. L. 93–523, § 4, Dec. 16, 1974, 88 Stat. 1694
Source evidence
Code source credit
June 25, 1938, ch. 675, § 410, as added Pub. L. 93–523, § 4, Dec. 16, 1974, 88 Stat. 1694Enacted provision · exact public law section
Sec. 4. bottled drinking water Chapter IV of the Federal Food. Drug, and Cosmetic Act is 21 USC 348. amended by adding after section 409 the following new section: “Sec. 410. “bottled drinking water standards 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 Ante, p. 1662. Act, 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 Publication in Federal Register. to bottled drinking water or publish in the Federal Register his reasons for not making such amendments.”.Safe Drinking Water Act Amendments of 1996
Pub. L. 104–182 title III § 305 · 110 Stat. 1613
Substituted · 21 U.S.C. § 349
Pub. L. 104–182 substituted “(a) Except as provided in subsection (b), whenever” for “Whenever”
Added · 21 U.S.C. § 349
Pub. L. 104–182 added subsec. (b)
Source evidence
Code amendment note
Pub. L. 104–182 substituted “(a) Except as provided in subsection (b), whenever” for “Whenever” and added subsec. (b).Enacted provision · exact public law section
SEC. 305. BOTTLED DRINKING WATER STANDARDS. Section 410 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 349) is amended as follows: (1) By striking “Whenever” and inserting “(a) Except as provided in subsection (b), whenever”. (2) By adding at the end the following new subsection: “(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), 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))) but not in water Effective date. 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 the date of enactment of the Safe Drinking Water Act Amendments of 1996 for which (as of such date of enactment) 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 such date of enactment. “(2) A regulation issued by the Secretary as provided in this subsection shall include any monitoring requirements that the Secret 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), 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), 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 Federal Register, publication. 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 forpurposes of this paragraph the effective Effective date. date for such regulation is the same as the effective date for the regulation for purposes of the Safe Drinking Water Act (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 the date of enactment of the Safe Drinking Water Act Amendments of 1996).”.
3 of 3 references resolved to an enrolled provision
Editorial Notes
References in Text
The Safe Drinking Water Act, referred to in subsec. (b)(4)(B)(ii), is title XIV of act , as added , Pub. L. 93–523, § 2(a), 88 Stat. 1660, as amended, which is classified generally to subchapter XII (§ 300f et seq.) of chapter 6A of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.
Amendments
1996—Pub. L. 104–182 substituted “(a) Except as provided in subsection (b), whenever” for “Whenever” and added subsec. (b).
Statutory Notes and Related Subsidiaries
Bottled Water Study
Pub. L. 104–182, title I, § 114(b), , 110 Stat. 1641, provided that not later than 18 months after , the Administrator of the Food and Drug Administration would publish for public notice and comment a draft study on the feasibility of appropriate methods, if any, of informing customers of the contents of bottled water, and publish a final study not later than 30 months after .
Credits
1938–1996 · 2 acts
- 1938June 25, 1938, ch. 675, § 410, as added Pub. L. 93–523, § 4, , 88 Stat. 1694
- 1996amended Pub. L. 104–182, title III, § 305, , 110 Stat. 1684.
Show as published
(June 25, 1938, ch. 675, § 410, as added Pub. L. 93–523, § 4, , 88 Stat. 1694; amended Pub. L. 104–182, title III, § 305, , 110 Stat. 1684.)