[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 3475 Introduced in Senate (IS)]
110th CONGRESS
2d Session
S. 3475
To amend the Federal Food, Drug, and Cosmetic Act to require
manufacturers of bottled water to submit annual reports, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 11, 2008
Mr. Lautenberg (for himself and Mrs. Boxer) introduced the following
bill; which was read twice and referred to the Committee on Environment
and Public Works
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to require
manufacturers of bottled water to submit annual reports, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Bottled Water Safety and Right to
Know Act of 2008''.
SEC. 2. CONSUMER CONFIDENCE REPORTS.
Section 410 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
349) is amended--
(1) in subsection (b), by adding at the end the following:
``(5) Identification of contaminants; interim and final
standards.--The Secretary shall--
``(A) not later than 180 days after the date of
enactment of this paragraph identify each contaminant
for which--
``(i) the Administrator of the
Environmental Protection Agency has established
a national primary drinking water regulation
under section 1412 of the Safe Drinking Water
Act (42 U.S.C. 300g-1) and the Secretary--
``(I) has not established a
standard of quality regulation; or
``(II) has established a standard
of quality regulation or monitoring
requirement that may be less protective
of public health than the national
primary drinking water regulation; or
``(ii) the Secretary has established a
standard of quality regulation that may be less
protective of public health than the standard
for the contaminant issued by the World Health
Organization, the European Union, or the State
of California;
``(B) not later than 1 year after the date of
enactment of this paragraph, propose an interim
standard of quality regulation for each contaminant
identified under subparagraph (A) that contains a
standard or monitoring requirement that is at least as
protective of public health as the more protective of--
``(i) the national primary drinking water
regulation described in subparagraph (A); or
``(ii) a standard issued by the World
Health Organization, the European Union, or the
State of California; and
``(C) not later than 2 years after the date of
enactment of this paragraph, issue a final regulation
establishing the standard described in subparagraph (B)
for each contaminant identified under subparagraph (A).
``(6) Grants to states.--The Secretary may award grants to
the States for the enforcement of the regulations described in
paragraph (5).
``(7) Final regulations.--
``(A) Definition of federal agency.--In this
paragraph, the term `Federal agency' has the meaning
given the term `agency' by section 551(1) of title 5,
United States Code.
``(B) Publication.--Not later than 2 years after
the date of enactment of this paragraph, the Secretary
shall publish in the Federal Register the final
regulation as described in paragraph (5)(C).
``(C) Failure to publish.--If the Secretary fails
to publish the regulation described in subparagraph
(A)--
``(i) all functions of the Secretary before
date of enactment of this paragraph (including
all related functions of any officer or
employee of the Department of Health and Human
Services) relating to inspections and
enforcement concerning bottled water shall be
transferred to the Environmental Protection
Agency;
``(ii) each reference to the Secretary
contained in paragraph (5) (except for the
references contained in clauses (i) and (ii) of
paragraph (5)(A)), paragraph (6), and
subsections (c), (d), and (e) shall be
considered to be a reference to the
Administrator of the Environmental Protection
Agency;
``(iii) except as otherwise provided in
this subparagraph, the assets, liabilities,
grants, contracts, property, records, and
unexpended balances of appropriations,
authorizations, allocations, and other funds
employed, used, held, arising from, available
to, or to be made available in connection with
the functions transferred under clause (i),
subject to section 1531 of title 31, United
States Code, shall be transferred to the
Environmental Protection Agency, and the
unexpended funds transferred pursuant to this
subparagraph shall be used only for the
purposes for which the funds were originally
authorized and appropriated;
``(iv) until modified, terminated,
superseded, set aside, or revoked in accordance
with applicable law by the President, the
Administrator or other authorized official, or
a court of competent jurisdiction, or by
operation of law, each order, determination,
rule, regulation, permit, agreement, grant,
contract, certificate, license, registration,
privilege, and other administrative action
shall continue in force and effect if the
action--
``(I) has been issued, made,
granted, or allowed to become effective
by the President or any Federal agency
or official, or by a court of competent
jurisdiction, in the performance of
functions that are transferred under
this subparagraph; and
``(II) was in effect before the
date of enactment of this subparagraph,
or was final before that date and is
scheduled to become effective on or
after the effective date of this
subparagraph;
``(v)(I) this subparagraph shall not affect
any proceeding, including notices of proposed
rulemaking, or any application for any license,
permit, certificate, or financial assistance
pending before the Secretary on the date of
enactment of this subparagraph with respect to
any function transferred by this subparagraph;
and
``(II)(aa) a proceeding or application
described in subclause (I) shall be continued,
orders shall be issued in such a proceeding and
appeals taken from the orders, and payments
shall be made pursuant to such an order, as if
this subparagraph had not been enacted; and
``(bb) orders issued in such a proceeding
shall continue in effect until modified,
terminated, superseded, set aside, or revoked
by a duly authorized official, a court of
competent jurisdiction, or operation of law;
``(vi) nothing in this subparagraph
prohibits the discontinuance or modification of
any proceeding described in clause (v) under
the same terms and conditions and to the same
extent that the proceeding could have been
discontinued or modified if this subparagraph
had not been enacted;
``(vii) this subparagraph shall not affect
any civil action commenced before the date of
enactment of this subparagraph, and proceedings
shall be had, appeals taken, and judgments
rendered regarding such a civil action in the
same manner and with the same effect as if this
subparagraph had not been enacted;
``(viii) no civil action or other
proceeding commenced by or against the
Secretary, or by or against any individual in
the official capacity of the individual as an
officer of the Secretary, shall abate by reason
of the enactment of this subparagraph;
``(ix) any administrative action relating
to the preparation or promulgation of a
regulation by the Secretary relating to a
function transferred under this subparagraph
may be continued by the Administrator of the
Environmental Protection Agency with the same
effect as if this subparagraph had not been
enacted; and
``(x) a reference in any other Federal law,
Executive order, rule, regulation, or
delegation of authority, or any document of or
relating to--
``(I) the Secretary, with regard to
a function transferred under this
subparagraph, shall be considered to be
a reference to the Administrator; and
``(II) the Department of Health and
Human Services, with regard to
functions transferred under this
subparagraph, shall be considered to be
a reference to the Environmental
Protection Agency.''; and
(2) by adding at the end the following:
``(c) Consumer Confidence Reports.--
``(1) In general.--Not later than 18 months after the date
of enactment of this subsection, the Secretary shall promulgate
regulations that require each manufacturer of bottled water to
submit reports and display information as required under
paragraph (2).
``(2) Requirements.--The regulations promulgated under
paragraph (1) shall require that each manufacturer of bottled
water shall--
``(A) not later than 3 years after the date of
enactment of this subsection and annually thereafter,
prepare and submit in electronic form, on a form
provided by the Secretary, an annual report to the
Secretary that describes, at a minimum--
``(i) the source of the water purveyed;
``(ii) the type of treatment to which the
water has been subjected and whether such
treatment meets the criteria of the Secretary
for full protection of immunocompromised
individuals from cryptosporidium and other
microbial pathogens;
``(iii) the quantity and range of any
regulated contaminant detected in the water
during the reporting year, the maximum
contaminant level goal for the contaminant, if
any, and whether the goal was exceeded during
the reporting year; and
``(iv) the quantity and range of any
unregulated contaminant detected in the water
during the reporting year that is subject to
unregulated contaminant monitoring or
notification requirements under sections 1445
or 1414, respectively, of the Safe Drinking
Water Act (42 U.S.C. 300j-4; 300g-3), or that
the Secretary determines may present a threat
to public health; and
``(B) for the second and each subsequent reporting
year, display on the labels of the bottled water--
``(i) if the maximum contaminant level goal
or lowest health advisory level under the Safe
Drinking Water Act (whichever is lower) for a
regulated contaminant is exceeded during the
preceding reporting year--
``(I) the quantity and range of the
regulated contaminant in the bottled
water;
``(II) the maximum contaminant
level goal for the contaminant; and
``(III) a plain definition of the
term `maximum contaminant level goal'
as determined by the Administrator;
``(ii) the quantity and range of any
unregulated contaminant detected in the water
during the preceding reporting year that is
subject to unregulated contaminant monitoring
or notification requirements under sections
1445 or 1414, respectively, of the Safe
Drinking Water Act (42 U.S.C. 300j-4; 300g-3)
or that the Secretary has determined may
present a threat to public health;
``(iii) the source of the water;
``(iv) the type of treatment, if any, to
which the water has been subjected and whether
such treatment meets the criteria of the
Secretary for full protection of
immunocompromised individuals for
cryptosporidium and other microbial pathogens;
``(v) the address for the Internet website
described in paragraph (3)(A); and
``(vi) the toll-free telephone number
described in paragraph (3)(B).
``(3) Public availability.--Not later than 180 days after
the date on which an annual report referred to in paragraph (2)
is submitted to the Secretary, the Secretary shall make the
report available to the public--
``(A) on an Internet website maintained by the
Secretary; and
``(B) in paper form, in English, Spanish, and in
any other language determined to be appropriate by the
Secretary, upon request made through use of a toll-free
telephone number maintained by the Secretary.
``(4) Supplement.--
``(A) In general.--In addition to submitting an
annual report under paragraph (2), the manufacturer may
submit to the Secretary a supplement that contains
additional information that the manufacturer determines
to be appropriate for public education.
``(B) Public availability.--The Secretary may make
the supplement available to the public in the same
manner as the annual report is made available to the
public under paragraph (3).
``(5) Additional information.--In the same manner as the
annual report is made available to the public under paragraph
(3), the Secretary shall make the following information
available to the public:
``(A) The definitions of the terms `maximum
contaminant level goal' and `maximum contaminant
level'.
``(B) For any regulated contaminant described in
paragraph (2)(A), a statement setting forth--
``(i) the maximum contaminant level goal;
``(ii) the maximum contaminant level; and
``(iii) if a violation of the maximum
contaminant level has occurred during the
reporting year, the potential health concerns
associated with such a violation.
``(C) For any unregulated contaminant described in
paragraph (2)(A), a statement describing the health
advisory or explaining the reasons for determination by
the Secretary that the contaminant may present a threat
to public health.
``(D) A statement explaining that the presence of
contaminants in bottled drinking water does not
necessarily create a health risk.
``(E) The date of the last Federal and State
inspections of the bottled water facilities relating to
the safety of the water.
``(F) A statement describing any violations
discovered at the facilities during the inspections
described in subparagraph (E) and any enforcement
actions that were taken as a consequence of the
violations.
``(G) The date of recall of any bottled water and
the reasons for the recall.
``(d) Records, Reports, and Monitoring.--Every manufacturer of
bottled water who is subject to any requirement of this section shall
maintain such records, make such reports, conduct such monitoring, and
provide such information as the Secretary may reasonably require by
regulation in order to assist the Secretary in promulgating regulations
under this section, in determining whether the manufacturer has acted
or is acting in compliance with this section, in evaluating the health
risks of unregulated contaminants, or in advising the public of those
risks.
``(e) Information on Violations.--
``(1) In general.--Not later than 1 year after the date of
enactment of this subsection, and annually thereafter, the
Secretary shall make available to the public, in the same
manner as the annual report is made available under subsection
(c)(3), information regarding violations of bottled water
regulations relating to inspections, and any enforcement
actions taken in regards to such violations.
``(2) Grant program.--The Secretary shall establish and
administer a grant program to fund the gathering of information
described in paragraph (1).
``(f) Definitions.--In this section:
``(1) Bottled water.--The term `bottled water' means all
water sold in the United States that--
``(A) is intended for human consumption;
``(B) is sealed in bottles or other containers; and
``(C) may be still or carbonated, but has no
sweeteners or juices added to the water, except for
trace levels of flavorings.
``(2) Contaminant.--The term `contaminant' means any
physical, chemical, biological, or radiological substance or
matter in water.
``(3) Maximum contaminant level.--The term `maximum
contaminant level' has the meaning given the term in section
1401 of the Safe Drinking Water Act (42 U.S.C. 300f).
``(4) Maximum contaminant level goal.--The term `maximum
contaminant level goal' means a goal established by the
Administrator of the Environmental Protection Agency under
section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g-1).
``(5) Regulated contaminant.--The term `regulated
contaminant' means a contaminant that is regulated under
section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g-1).
``(6) Unregulated contaminant.--The term `unregulated
contaminant' means a contaminant that is not regulated under
section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g-
1).''.
SEC. 3. PROHIBITED ACTS.
Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
331) is amended by adding at the end the following:
``(oo) The failure by a manufacturer of bottled water to submit an
annual report or display the required information on labels of bottled
water in accordance with section 410(c).''.
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