§349 — Title 21 Food and Drugs | U.S. Code

Summary

When the Environmental Protection Agency (EPA) issues new or temporary national drinking water rules under section 1412, the Secretary must talk with the EPA and, within 180 days, either update the bottled water rules to match or publish reasons for not doing so. For any EPA rule about a contaminant, the Secretary must issue a bottled water quality rule at least 180 days before the EPA rule’s effective date or say it is not needed because the contaminant is only in public water systems and not in bottled water. The bottled water rule must include monitoring and must be at least as strict as the EPA rule: if EPA sets a maximum contaminant level, bottled water must meet an equal or stricter level; if EPA requires a treatment technique, bottled water must have protections at least as strong. If the Secretary misses the deadline, the EPA rule will count as the bottled water rule. The Secretary must then publish a Federal Register notice saying what the rule requires (including monitoring) and that its effective date matches the EPA rule (or, for certain pre-August 6, 1996 rules, not later than 2 years and 180 days after August 6, 1996).

Title 21, §349

Food and Drugs — Source: USLM XML via OLRC

(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], 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), 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.

(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), 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 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 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).

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Safe Drinking Water Act, referred to in subsec. (b)(4)(B)(ii), is title XIV of act July 1, 1944, as added Dec. 16, 1974, 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), Aug. 6, 1996, 110 Stat. 1641, provided that not later than 18 months after Aug. 6, 1996, 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 Aug. 6, 1996.

§349 Bottled Drinking Water Standards; Publication in Federal Register