21 U.S.C. § 349 — Bottled drinking water standards; publication in Federal Register
submitted 88 years ago by Pub. L. 93-523 to r/title-21-FOOD-AND-DRUGS · 664 words · no verdicts yet
When the EPA sets new drinking water safety rules, the Secretary must decide within 180 days whether to apply matching rules to bottled water. If the Secretary decides not to, the reasons must be published. For newer EPA rules, the Secretary must set a matching bottled-water standard, or explain why one is not needed, before the EPA rule takes effect.
(a) Except as subsection (b) provides, whenever the Administrator* of the Environmental Protection Agency prescribes interim or revised national primary drinking water regulations under the Public Health Service Act, the Secretary* must consult with the Administrator. Within 180 days after those drinking water regulations are issued, the Secretary must either promulgate matching amendments to the bottled drinking water regulations under this chapter, or publish in the Federal Register the reasons for not making such amendments.
(b) (1) At least 180 days before a national primary drinking water regulation the EPA Administrator issues for a contaminant takes effect, the Secretary must promulgate a matching "standard of quality" regulation for that contaminant in bottled water, or find that such a regulation is not necessary because the contaminant is present in water used by public water systems but not in water used for bottled water. The effective date for the bottled-water standard must match the effective date of the national primary drinking water regulation — except for a standard of quality regulation the Secretary issued before August 6, 1996, that as of that date still lacked an established effective date; for those, the Secretary must issue monitoring requirements within 2 years of August 6, 1996. (2) A regulation the Secretary issues under this subsection must include whatever monitoring requirements the Secretary determines are appropriate for bottled water. (3) Such a regulation must require: (A) for contaminants where the EPA's national rule sets a maximum contaminant level, the bottled water rule must set a maximum contaminant level no less strict than the EPA's; (B) for contaminants where the EPA's national rule instead requires a treatment technique, the bottled water rule must require protections no less protective of public health than what public water systems using that technique must meet. (4) (A) If the Secretary does not issue a regulation under this subsection within the period described in paragraph (1), the EPA's national primary drinking water regulation automatically becomes, as of the date the Secretary was required to act, the regulation that applies to bottled water. (B) When that happens, the Secretary must, by that same date, publish a Federal Register notice specifying the content of the now-applicable regulation, including its monitoring requirements, and stating that its effective date matches the effective date of the underlying Safe Drinking Water Act regulation — or, if the pre-1996 exception in paragraph (1) applies, that the effective date is no later than 2 years and 180 days after August 6, 1996.
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 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.
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 August 6, 1996).
Source credit: (June 25, 1938, ch. 675, § 410, as added Pub. L. 93–523, § 4, Dec. 16, 1974, 88 Stat. 1694; amended Pub. L. 104–182, title III, § 305, Aug. 6, 1996, 110 Stat. 1684.)
- 1938Enacted · Pub. L. 93-523 · 88 Stat. 1694
- 1996Amended · Pub. L. 104-182 · 110 Stat. 1684
A history note hasn’t been published yet. The record shows enactment by Pub. L. 93-523 on 1938-06-25.
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