[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).''.
                                 <all>