II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Bottled Water Safety 

5 and Right to Know Act of 2008’’. 

6 SEC. 2. CONSUMER CONFIDENCE REPORTS. 

7 Section 410 of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 349) is amended— 


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1 (1) in subsection (b), by adding at the end the 

2 following: 

3 ‘‘(5) IDENTIFICATION OF CONTAMINANTS; IN4 TERIM AND FINAL STANDARDS.—The Secretary 

5 shall— 

6 ‘‘(A) not later than 180 days after the date 

7 of enactment of this paragraph identify each 

8 contaminant for which— 

9 ‘‘(i) the Administrator of the Environ10 mental Protection Agency has established 

11 a national primary drinking water regula12 tion under section 1412 of the Safe Drink13 ing Water Act (42 U.S.C. 300g–1) and the 

14 Secretary— 

15 ‘‘(I) has not established a stand16 ard of quality regulation; or 

17 ‘‘(II) has established a standard 

18 of quality regulation or monitoring re19 quirement that may be less protective 

20 of public health than the national pri21 mary drinking water regulation; or 

22 ‘‘(ii) the Secretary has established a 

23 standard of quality regulation that may be 

24 less protective of public health than the 

25 standard for the contaminant issued by the 


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1 World Health Organization, the European 

2 Union, or the State of California; 

3 ‘‘(B) not later than 1 year after the date 

4 of enactment of this paragraph, propose an in5 terim standard of quality regulation for each 

6 contaminant identified under subparagraph (A) 

7 that contains a standard or monitoring require8 ment that is at least as protective of public 

9 health as the more protective of— 

10 ‘‘(i) the national primary drinking 

11 water regulation described in subparagraph 

12 (A); or 

13 ‘‘(ii) a standard issued by the World 

14 Health Organization, the European Union, 

15 or the State of California; and 

16 ‘‘(C) not later than 2 years after the date 

17 of enactment of this paragraph, issue a final 

18 regulation establishing the standard described 

19 in subparagraph (B) for each contaminant iden20 tified under subparagraph (A). 

21 ‘‘(6) GRANTS TO STATES.—The Secretary may 

22 award grants to the States for the enforcement of 

23 the regulations described in paragraph (5). 

24 ‘‘(7) FINAL REGULATIONS.— 


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1 ‘‘(A) DEFINITION OF FEDERAL AGENCY.— 

2 In this paragraph, the term ‘Federal agency’ 

3 has the meaning given the term ‘agency’ by sec4 tion 551(1) of title 5, United States Code. 

5 ‘‘(B) PUBLICATION.—Not later than 2 

6 years after the date of enactment of this para7 graph, the Secretary shall publish in the Fed8 eral Register the final regulation as described in 

9 paragraph (5)(C). 

10 ‘‘(C) FAILURE TO PUBLISH.—If the Sec11 retary fails to publish the regulation described 

12 in subparagraph (A)— 

13 ‘‘(i) all functions of the Secretary be14 fore date of enactment of this paragraph 

15 (including all related functions of any offi16 cer or employee of the Department of 

17 Health and Human Services) relating to 

18 inspections and enforcement concerning 

19 bottled water shall be transferred to the 

20 Environmental Protection Agency; 

21 ‘‘(ii) each reference to the Secretary 

22 contained in paragraph (5) (except for the 

23 references contained in clauses (i) and (ii) 

24 of paragraph (5)(A)), paragraph (6), and 

25 subsections (c), (d), and (e) shall be conVerDate Aug 31 2005 03:11 Sep 12, 2008 Jkt 069200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3475.IS S3475

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1 sidered to be a reference to the Adminis2 trator of the Environmental Protection 

3 Agency; 

4 ‘‘(iii) except as otherwise provided in 

5 this subparagraph, the assets, liabilities, 

6 grants, contracts, property, records, and 

7 unexpended balances of appropriations, au8 thorizations, allocations, and other funds 

9 employed, used, held, arising from, avail10 able to, or to be made available in connec11 tion with the functions transferred under 

12 clause (i), subject to section 1531 of title 

13 31, United States Code, shall be trans14 ferred to the Environmental Protection 

15 Agency, and the unexpended funds trans16 ferred pursuant to this subparagraph shall 

17 be used only for the purposes for which the 

18 funds were originally authorized and ap19 propriated; 

20 ‘‘(iv) until modified, terminated, su21 perseded, set aside, or revoked in accord22 ance with applicable law by the President, 

23 the Administrator or other authorized offi24 cial, or a court of competent jurisdiction, 

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1 mination, rule, regulation, permit, agree2 ment, grant, contract, certificate, license, 

3 registration, privilege, and other adminis4 trative action shall continue in force and 

5 effect if the action— 

6 ‘‘(I) has been issued, made, 

7 granted, or allowed to become effec8 tive by the President or any Federal 

9 agency or official, or by a court of 

10 competent jurisdiction, in the per11 formance of functions that are trans12 ferred under this subparagraph; and 

13 ‘‘(II) was in effect before the 

14 date of enactment of this subpara15 graph, or was final before that date 

16 and is scheduled to become effective 

17 on or after the effective date of this 

18 subparagraph; 

19 ‘‘(v)(I) this subparagraph shall not af20 fect any proceeding, including notices of 

21 proposed rulemaking, or any application 

22 for any license, permit, certificate, or fi23 nancial assistance pending before the Sec24 retary on the date of enactment of this 


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1 subparagraph with respect to any function 

2 transferred by this subparagraph; and 

3 ‘‘(II)(aa) a proceeding or application 

4 described in subclause (I) shall be contin5 ued, orders shall be issued in such a pro6 ceeding and appeals taken from the orders, 

7 and payments shall be made pursuant to 

8 such an order, as if this subparagraph had 

9 not been enacted; and 

10 ‘‘(bb) orders issued in such a pro11 ceeding shall continue in effect until modi12 fied, terminated, superseded, set aside, or 

13 revoked by a duly authorized official, a 

14 court of competent jurisdiction, or oper15 ation of law; 

16 ‘‘(vi) nothing in this subparagraph 

17 prohibits the discontinuance or modifica18 tion of any proceeding described in clause 

19 (v) under the same terms and conditions 

20 and to the same extent that the proceeding 

21 could have been discontinued or modified if 

22 this subparagraph had not been enacted; 

23 ‘‘(vii) this subparagraph shall not af24 fect any civil action commenced before the 

25 date of enactment of this subparagraph, 


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1 and proceedings shall be had, appeals 

2 taken, and judgments rendered regarding 

3 such a civil action in the same manner and 

4 with the same effect as if this subpara5 graph had not been enacted; 

6 ‘‘(viii) no civil action or other pro7 ceeding commenced by or against the Sec8 retary, or by or against any individual in 

9 the official capacity of the individual as an 

10 officer of the Secretary, shall abate by rea11 son of the enactment of this subparagraph; 

12 ‘‘(ix) any administrative action relat13 ing to the preparation or promulgation of 

14 a regulation by the Secretary relating to a 

15 function transferred under this subpara16 graph may be continued by the Adminis17 trator of the Environmental Protection 

18 Agency with the same effect as if this sub19 paragraph had not been enacted; and 

20 ‘‘(x) a reference in any other Federal 

21 law, Executive order, rule, regulation, or 

22 delegation of authority, or any document of 

23 or relating to— 

24 ‘‘(I) the Secretary, with regard to 

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1 paragraph, shall be considered to be a 

2 reference to the Administrator; and 

3 ‘‘(II) the Department of Health 

4 and Human Services, with regard to 

5 functions transferred under this sub6 paragraph, shall be considered to be a 

7 reference to the Environmental Pro8 tection Agency.’’; and 

9 (2) by adding at the end the following: 

10 ‘‘(c) CONSUMER CONFIDENCE REPORTS.— 

11 ‘‘(1) IN GENERAL.—Not later than 18 months 

12 after the date of enactment of this subsection, the 

13 Secretary shall promulgate regulations that require 

14 each manufacturer of bottled water to submit re15 ports and display information as required under 

16 paragraph (2). 

17 ‘‘(2) REQUIREMENTS.—The regulations promul18 gated under paragraph (1) shall require that each 

19 manufacturer of bottled water shall— 

20 ‘‘(A) not later than 3 years after the date 

21 of enactment of this subsection and annually 

22 thereafter, prepare and submit in electronic 

23 form, on a form provided by the Secretary, an 

24 annual report to the Secretary that describes, 

25 at a minimum— 


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1 ‘‘(i) the source of the water purveyed; 

2 ‘‘(ii) the type of treatment to which 

3 the water has been subjected and whether 

4 such treatment meets the criteria of the 

5 Secretary for full protection of 

6 immunocompromised individuals from 

7 cryptosporidium and other microbial patho8 gens; 

9 ‘‘(iii) the quantity and range of any 

10 regulated contaminant detected in the 

11 water during the reporting year, the max12 imum contaminant level goal for the con13 taminant, if any, and whether the goal was 

14 exceeded during the reporting year; and 

15 ‘‘(iv) the quantity and range of any 

16 unregulated contaminant detected in the 

17 water during the reporting year that is 

18 subject to unregulated contaminant moni19 toring or notification requirements under 

20 sections 1445 or 1414, respectively, of the 

21 Safe Drinking Water Act (42 U.S.C. 300j– 

22 4; 300g–3), or that the Secretary deter23 mines may present a threat to public 

24 health; and 


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1 ‘‘(B) for the second and each subsequent 

2 reporting year, display on the labels of the bot3 tled water— 

4 ‘‘(i) if the maximum contaminant level 

5 goal or lowest health advisory level under 

6 the Safe Drinking Water Act (whichever is 

7 lower) for a regulated contaminant is ex8 ceeded during the preceding reporting 

9 year— 

10 ‘‘(I) the quantity and range of 

11 the regulated contaminant in the bot12 tled water; 

13 ‘‘(II) the maximum contaminant 

14 level goal for the contaminant; and 

15 ‘‘(III) a plain definition of the 

16 term ‘maximum contaminant level 

17 goal’ as determined by the Adminis18 trator; 

19 ‘‘(ii) the quantity and range of any 

20 unregulated contaminant detected in the 

21 water during the preceding reporting year 

22 that is subject to unregulated contaminant 

23 monitoring or notification requirements 

24 under sections 1445 or 1414, respectively, 

25 of the Safe Drinking Water Act (42 U.S.C. 


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1 300j–4; 300g–3) or that the Secretary has 

2 determined may present a threat to public 

3 health; 

4 ‘‘(iii) the source of the water; 

5 ‘‘(iv) the type of treatment, if any, to 

6 which the water has been subjected and 

7 whether such treatment meets the criteria 

8 of the Secretary for full protection of 

9 immunocompromised individuals for 

10 cryptosporidium and other microbial patho11 gens; 

12 ‘‘(v) the address for the Internet 

13 website described in paragraph (3)(A); and 

14 ‘‘(vi) the toll-free telephone number 

15 described in paragraph (3)(B). 

16 ‘‘(3) PUBLIC AVAILABILITY.—Not later than 

17 180 days after the date on which an annual report 

18 referred to in paragraph (2) is submitted to the Sec19 retary, the Secretary shall make the report available 

20 to the public— 

21 ‘‘(A) on an Internet website maintained by 

22 the Secretary; and 

23 ‘‘(B) in paper form, in English, Spanish, 

24 and in any other language determined to be ap25 propriate by the Secretary, upon request made 


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1 through use of a toll-free telephone number 

2 maintained by the Secretary. 

3 ‘‘(4) SUPPLEMENT.— 

4 ‘‘(A) IN GENERAL.—In addition to submit5 ting an annual report under paragraph (2), the 

6 manufacturer may submit to the Secretary a 

7 supplement that contains additional information 

8 that the manufacturer determines to be appro9 priate for public education. 

10 ‘‘(B) PUBLIC AVAILABILITY.—The Sec11 retary may make the supplement available to 

12 the public in the same manner as the annual 

13 report is made available to the public under 

14 paragraph (3). 

15 ‘‘(5) ADDITIONAL INFORMATION.—In the same 

16 manner as the annual report is made available to the 

17 public under paragraph (3), the Secretary shall 

18 make the following information available to the pub19 lic: 

20 ‘‘(A) The definitions of the terms ‘max21 imum contaminant level goal’ and ‘maximum 

22 contaminant level’. 

23 ‘‘(B) For any regulated contaminant de24 scribed in paragraph (2)(A), a statement set25 ting forth— 


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1 ‘‘(i) the maximum contaminant level 

2 goal; 

3 ‘‘(ii) the maximum contaminant level; 

4 and 

5 ‘‘(iii) if a violation of the maximum 

6 contaminant level has occurred during the 

7 reporting year, the potential health con8 cerns associated with such a violation. 

9 ‘‘(C) For any unregulated contaminant de10 scribed in paragraph (2)(A), a statement de11 scribing the health advisory or explaining the 

12 reasons for determination by the Secretary that 

13 the contaminant may present a threat to public 

14 health. 

15 ‘‘(D) A statement explaining that the pres16 ence of contaminants in bottled drinking water 

17 does not necessarily create a health risk. 

18 ‘‘(E) The date of the last Federal and 

19 State inspections of the bottled water facilities 

20 relating to the safety of the water. 

21 ‘‘(F) A statement describing any violations 

22 discovered at the facilities during the inspec23 tions described in subparagraph (E) and any 

24 enforcement actions that were taken as a con25 sequence of the violations. 


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1 ‘‘(G) The date of recall of any bottled 

2 water and the reasons for the recall. 

3 ‘‘(d) RECORDS, REPORTS, AND MONITORING.—Every 

4 manufacturer of bottled water who is subject to any re5 quirement of this section shall maintain such records, 

6 make such reports, conduct such monitoring, and provide 

7 such information as the Secretary may reasonably require 

8 by regulation in order to assist the Secretary in promul9 gating regulations under this section, in determining 

10 whether the manufacturer has acted or is acting in compli11 ance with this section, in evaluating the health risks of 

12 unregulated contaminants, or in advising the public of 

13 those risks. 

14 ‘‘(e) INFORMATION ON VIOLATIONS.— 

15 ‘‘(1) IN GENERAL.—Not later than 1 year after 

16 the date of enactment of this subsection, and annu17 ally thereafter, the Secretary shall make available to 

18 the public, in the same manner as the annual report 

19 is made available under subsection (c)(3), informa20 tion regarding violations of bottled water regulations 

21 relating to inspections, and any enforcement actions 

22 taken in regards to such violations. 

23 ‘‘(2) GRANT PROGRAM.—The Secretary shall es24 tablish and administer a grant program to fund the 

25 gathering of information described in paragraph (1). 


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1 ‘‘(f) DEFINITIONS.—In this section: 

2 ‘‘(1) BOTTLED WATER.—The term ‘bottled 

3 water’ means all water sold in the United States 

4 that— 

5 ‘‘(A) is intended for human consumption; 

6 ‘‘(B) is sealed in bottles or other con7 tainers; and 

8 ‘‘(C) may be still or carbonated, but has no 

9 sweeteners or juices added to the water, except 

10 for trace levels of flavorings. 

11 ‘‘(2) CONTAMINANT.—The term ‘contaminant’ 

12 means any physical, chemical, biological, or radio13 logical substance or matter in water. 

14 ‘‘(3) MAXIMUM CONTAMINANT LEVEL.—The 

15 term ‘maximum contaminant level’ has the meaning 

16 given the term in section 1401 of the Safe Drinking 

17 Water Act (42 U.S.C. 300f). 

18 ‘‘(4) MAXIMUM CONTAMINANT LEVEL GOAL.— 

19 The term ‘maximum contaminant level goal’ means 

20 a goal established by the Administrator of the Envi21 ronmental Protection Agency under section 1412 of 

22 the Safe Drinking Water Act (42 U.S.C. 300g–1). 

23 ‘‘(5) REGULATED CONTAMINANT.—The term 

24 ‘regulated contaminant’ means a contaminant that is 


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1 regulated under section 1412 of the Safe Drinking 

2 Water Act (42 U.S.C. 300g–1). 

3 ‘‘(6) UNREGULATED CONTAMINANT.—The term 

4 ‘unregulated contaminant’ means a contaminant 

5 that is not regulated under section 1412 of the Safe 

6 Drinking Water Act (42 U.S.C. 300g–1).’’. 

7 SEC. 3. PROHIBITED ACTS. 

8 Section 301 of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 331) is amended by adding at the end the 

10 following: 

11 ‘‘(oo) The failure by a manufacturer of bottled water 

12 to submit an annual report or display the required infor13 mation on labels of bottled water in accordance with sec14 tion 410(c).’’. 

Æ 


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