§ 349. — Bottled drinking water standards; publication in Federal Register.
[Laws in effect as of January 7, 2003]
[Document not affected by Public Laws enacted between
January 7, 2003 and December 19, 2003]
[CITE: 21USC349]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV--FOOD
Sec. 349. Bottled drinking water standards; publication in
Federal Register
(a) Except as provided in subsection (b) of this section, 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).
(June 25, 1938, ch. 675, Sec. 410, as added Pub. L. 93-523, Sec. 4, Dec.
16, 1974, 88 Stat. 1694; amended Pub. L. 104-182, title III, Sec. 305,
Aug. 6, 1996, 110 Stat. 1684.)
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, Sec. 2(a), 88 Stat. 1660, as amended, which is classified generally
to subchapter XII (Sec. 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) of this section, whenever'' for ``Whenever'' and added
subsec. (b).
Bottled Water Study
Section 114(b) of Pub. L. 104-182 provided that: ``Not later than 18
months after the date of enactment of this Act [Aug. 6, 1996], the
Administrator of the Food and Drug Administration, in consultation with
the Administrator of the Environmental Protection Agency, shall 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. The Administrator of the Food and Drug Administration
shall publish a final study not later than 30 months after the date of
enactment of this Act.''
