II

106TH CONGRESS

1ST SESSION S. 790

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

APRIL 13, 1999

Mr. LAUTENBERG 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 1999’’.

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—

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

10 following:
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1 ‘‘(5) The Secretary shall—

2 ‘‘(A) not later than 6 months after the date of

3 enactment of this paragraph identify contaminants

4 for which—

5 ‘‘(i) the Administrator has established a

6 national primary drinking water regulation

7 under section 1412 of the Safe Drinking Water

8 Act (42 U.S.C. 300g–1) and the Secretary has

9 not established a standard of quality regulation

10 for such contaminant or has established a

11 standard of quality regulation or monitoring re12 quirement that may be less protective of public

13 health than the national primary drinking water

14 regulation; or

15 ‘‘(ii) the Secretary has established a stand16 ard of quality regulation for such contaminant

17 that may be less protective of public health

18 than the standard for such a contaminant

19 issued by the World Health Organization, the

20 European Union, or the State of California; and

21 ‘‘(B) not later than 12 months after that date

22 of enactment, propose an interim standard of quality

23 regulation, for each contaminant identified under

24 subparagraph (A), that contains a standard or moni-
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1 toring requirement that is at least as protective of

2 public health as the more protective of—

3 ‘‘(i) the national primary drinking water

4 regulation described in subparagraph (A); or

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

6 Health Organization, European Union, or the

7 State of California; and

8 ‘‘(C) not later than 24 months after that date

9 of enactment, issue a final regulation of the stand10 ard described in subparagraph (B), for each identi11 fied contaminant.

12 ‘‘(6) The Secretary is authorized to award grants to

13 the States for the enforcement of the regulations described

14 in paragraph (5).

15 ‘‘(7)(A) Not later than 24 months after the date of

16 enactment of this paragraph, the Secretary shall publish

17 final regulations as described in paragraph (5) in the Fed18 eral Register.

19 ‘‘(B) If the Secretary fails to publish the regulations

20 described in subparagraph (A), then—

21 ‘‘(i) all functions that the Secretary of Health

22 and Human Services exercised before the effective

23 date of this subparagraph (including all related

24 functions of any officer or employee of the Depart25 ment of Health and Human Services) relating to in-
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1 spections and enforcement concerning bottled water

2 shall be transferred to the Environmental Protection

3 Agency;

4 ‘‘(ii) all references to the Secretary in para5 graph (5), notwithstanding the references in clause

6 (i) and (ii) of subparagraph (A), and all references

7 in paragraph (6) and subsections (c), (d), and (e)

8 shall instead be to the Administrator;

9 ‘‘(iii) except as otherwise provided in this sub10 paragraph, the assets, liabilities, grants, contracts,

11 property, records, and unexpended balances of ap12 propriations, authorizations, allocations, and other

13 funds employed, used, held, arising from, available

14 to, or to be made available in connection with the

15 functions transferred under clause (i), subject to sec16 tion 1531 of title 31, United States Code, shall be

17 transferred to the Environmental Protection Agency,

18 and unexpended funds transferred pursuant to this

19 subparagraph shall be used only for the purposes for

20 which the funds were originally authorized and ap21 propriated;

22 ‘‘(iv) all orders, determinations, rules, regula23 tions, permits, agreements, grants, contracts, certifi24 cates, licenses, registrations, privileges, and other

25 administrative actions—
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1 ‘‘(I) that have been issued, made, granted,

2 or allowed to become effective by the President,

3 any Federal agency or official of a Federal

4 agency, or by a court of competent jurisdiction,

5 in the performance of functions that are trans6 ferred under this subparagraph; and

7 ‘‘(II) that were in effect before the effec8 tive date of this subparagraph, or were final be9 fore the effective date of this subparagraph and

10 are to become effective on or after the effective

11 date of this subparagraph;

12 shall continue in effect according to their terms until

13 modified, terminated, superseded, set aside, or re14 voked in accordance with law by the President, the

15 Administrator or other authorized official, a court of

16 competent jurisdiction, or by operation of law;

17 ‘‘(v) this subparagraph shall not affect any pro18 ceedings, including notices of proposed rulemaking,

19 or any application for any license, permit, certificate,

20 or financial assistance pending before the Secretary

21 on the effective date of this subparagraph, with re22 spect to functions transferred by this subparagraph;

23 ‘‘(vi) such proceedings and applications de24 scribed in clause (v) shall be continued and orders

25 shall be issued in such proceedings and appeals
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1 taken from the orders, and payments shall be made

2 pursuant to the orders, as if this subparagraph had

3 not been enacted, and orders issued in any such pro4 ceedings shall continue in effect until modified, ter5 minated, superseded, set aside, or revoked by a duly

6 authorized official, by a court of competent jurisdic7 tion, or by operation of law;

8 ‘‘(vii) nothing in this subparagraph shall be

9 construed to prohibit the discontinuance or modifica10 tion of any such proceeding described in clause (v)

11 under the same terms and conditions and to the

12 same extent that such proceeding could have been

13 discontinued or modified if this subparagraph had

14 not been enacted;

15 ‘‘(viii) this subparagraph shall not affect suits

16 commenced before the effective date of this subpara17 graph, and in all such suits, proceedings shall be

18 had, appeals taken, and judgments rendered in the

19 same manner and with the same effect as if this

20 subparagraph had not been enacted;

21 ‘‘(ix) no suit, action, or other proceeding com22 menced by or against the Secretary, or by or against

23 any individual in the official capacity of such indi24 vidual as an officer of the Secretary, shall abate by

25 reason of the enactment of this subparagraph;
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1 ‘‘(x) any administrative action relating to the

2 preparation or promulgation of a regulation by the

3 Secretary relating to a function transferred under

4 this subparagraph may be continued by the Adminis5 trator with the same effect as if this subparagraph

6 had not been enacted; and

7 ‘‘(xi) a reference in any other Federal law, Ex8 ecutive order, rule, regulation, or delegation of au9 thority, or any document of or relating to—

10 ‘‘(I) the Secretary with regard to functions

11 transferred under this subparagraph, shall be

12 deemed to refer to the Administrator; and

13 ‘‘(II) the Department of Health and

14 Human Services with regard to functions trans15 ferred under this subparagraph, shall be

16 deemed to refer to the Environmental Protec17 tion Agency.

18 ‘‘(C) As used in subparagraph (B), the term ‘Federal

19 agency’ has the meaning given the term ‘agency’ by sec20 tion 551(1) of title 5, United States Code.’’; and

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

22 ‘‘(c)(1) Not later than 18 months after the date of

23 enactment of this subsection, the Secretary shall issue reg24 ulations that require each manufacturer of bottled water
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1 to submit reports and display information as required

2 under paragraph (2).

3 ‘‘(2) The regulations issued under paragraph (1)

4 shall require that each manufacturer of bottled water

5 shall—

6 ‘‘(A) not later than 36 months after the date of

7 enactment of this subsection and annually there8 after, prepare and submit in electronic form, on a

9 form provided by the Secretary, an annual report to

10 the Secretary that describes, at a minimum—

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

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

13 water has been subjected and whether such

14 treatment meets the Secretary’s criteria for full

15 protection of immuno-compromised individuals

16 from cryptosporidium and other microbial

17 pathogens;

18 ‘‘(iii) the amount and range of any regu19 lated contaminant detected in the water during

20 the reporting year, the maximum contaminant

21 level goal for the contaminant, if any, and

22 whether the goal was exceeded during the re23 porting year; and

24 ‘‘(iv) the amount and range of any unregu25 lated contaminant detected in the water during
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1 the reporting year that is subject to unregu2 lated contaminant monitoring or notification re3 quirements under sections 1445 or 1414, re4 spectively, of the Safe Drinking Water Act (42

5 U.S.C. 300j–4; 300g–3), or that the Secretary

6 determines may present a threat to public

7 health; and

8 ‘‘(B) for the second and each subsequent re9 porting year, display on the labels of the bottled

10 water—

11 ‘‘(i) if the maximum contaminant level goal

12 or lowest health advisory level under the Safe

13 Drinking Water Act (whichever is lower) for a

14 regulated contaminant is exceeded during the

15 preceding reporting year—

16 ‘‘(I) the amount and range of the reg17 ulated contaminant in the bottled water;

18 ‘‘(II) the maximum contaminant level

19 goal for the contaminant; and

20 ‘‘(III) a plain definition of ‘maximum

21 contaminant level goal’ as determined by

22 the Administrator;

23 ‘‘(ii) the amount and range of any unregu24 lated contaminant detected in the water during

25 the preceding reporting year that is subject to
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1 unregulated contaminant monitoring or notifi2 cation requirements under sections 1445 or

3 1414, respectively, of the Safe Drinking Water

4 Act (42 U.S.C. 300j–4; 300g–3) or that the

5 Secretary has determined may present a threat

6 to public health;

7 ‘‘(iii) the source of the water;

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

9 which the water has been subjected and wheth10 er such treatment meets the Secretary’s criteria

11 for full protection of immuno-compromised indi12 viduals for cryptosporidium and other microbial

13 pathogens;

14 ‘‘(v) the address for the Internet website

15 described in paragraph (3)(A); and

16 ‘‘(vi) the toll-free telephone number de17 scribed in paragraph (3)(B).

18 ‘‘(3) Not later than 6 months after the date on which

19 an annual report referred to in paragraph (2) is submitted

20 to the Secretary, the Secretary shall make the report avail21 able to the public—

22 ‘‘(A) on an Internet website maintained by the

23 Secretary; and

24 ‘‘(B) in paper form, in English, Spanish, and in

25 any other language determined to be appropriate by
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1 the Secretary, upon request made through use of a

2 toll-free telephone number maintained by the Sec3 retary.

4 ‘‘(4) In addition to submitting an annual report

5 under paragraph (2), the manufacturer may also submit

6 a supplement to the Secretary that contains additional in7 formation that the manufacturer determines to be appro8 priate for public education. The Secretary may make the

9 supplement available to the public in the same manner as

10 the annual report is made available to the public under

11 paragraph (3).

12 ‘‘(5) In the same manner as the annual report is

13 made available to the public under paragraph (3), the Sec14 retary shall make the following information available to

15 the public:

16 ‘‘(A) The definitions of the terms ‘maximum

17 contaminant level goal’ and ‘maximum contaminant

18 level’.

19 ‘‘(B) For any regulated contaminant described

20 in paragraph (2)(A), a statement setting forth—

21 ‘‘(i) the maximum contaminant level goal;

22 ‘‘(ii) the maximum contaminant level; and

23 ‘‘(iii) if a violation of the maximum con24 taminant level has occurred during the report-
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1 ing year, the potential health concerns associ2 ated with such a violation.

3 ‘‘(C) For any unregulated contaminant de4 scribed in paragraph (2)(A), a statement describing

5 the health advisory or explaining the reasons for de6 termination by the Secretary that the contaminant

7 may present a threat to public health.

8 ‘‘(D) A statement explaining that the presence

9 of contaminants in bottled drinking water does not

10 necessarily create a health risk.

11 ‘‘(E) The date of the last Federal and State in12 spections of the bottled water facilities relating to

13 the safety of the water.

14 ‘‘(F) A statement describing any violations dis15 covered at the facilities during the inspections de16 scribed in subparagraph (E) and any enforcement

17 actions that were taken as a consequence of the vio18 lations.

19 ‘‘(G) The date of recall of any bottled water

20 and the reasons for the recall.

21 ‘‘(d) Every manufacturer of bottled water who is sub22 ject to any requirement of this section shall maintain such

23 records, make such reports, conduct such monitoring, and

24 provide such information as the Secretary may reasonably

25 require by regulation in order to assist the Secretary in
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1 establishing regulations under this section, in determining

2 whether the manufacturer has acted or is acting in compli3 ance with this section, in evaluating the health risks of

4 unregulated contaminants, or in advising the public of

5 such risks.

6 ‘‘(e) Not later than 12 months after the date of en7 actment of this subsection, and annually thereafter, the

8 Secretary shall make available to the public, in the same

9 manner as the annual report is made available under sub10 section (c)(3), information regarding violations of bottled

11 water regulations relating to inspections, and any enforce12 ment actions taken in regards to such violations. The Sec13 retary shall establish and administer a grant program to

14 fund the gathering of such information.

15 ‘‘(f) In this section:

16 ‘‘(1) The term ‘bottled water’ means all water

17 sold in the United States that—

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

19 ‘‘(B) is sealed in bottles or other con20 tainers; and

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

22 sweeteners or juices added to the water, except

23 for trace levels of flavorings.
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1 ‘‘(2) The term ‘contaminant’ means any phys2 ical, chemical, biological, or radiological substance or

3 matter in water.

4 ‘‘(3) The term ‘maximum contaminant level’

5 has the meaning given the term in section 1401 of

6 the Safe Drinking Water Act (42 U.S.C. 300f).

7 ‘‘(4) The term ‘maximum contaminant level

8 goal’ means a goal established by the Administrator

9 under section 1412 of the Safe Drinking Water Act

10 (42 U.S.C. 300g–1).

11 ‘‘(5) The term ‘regulated contaminant’ means a

12 contaminant that is regulated under section 1412 of

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

14 ‘‘(6) The term ‘unregulated contaminant’

15 means a contaminant that is not regulated under

16 section 1412 of the Safe Drinking Water Act (42

17 U.S.C. 300g–1).’’.

18 SEC. 3. PROHIBITED ACTS.

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

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

21 following:

22 ‘‘(aa) The failure by a manufacturer of bottled water

23 to submit an annual report or display the required infor-
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1 mation on labels of bottled water in accordance with sec2 tion 410(c).’’.

Æ