I

104TH CONGRESS

2D SESSION H. R. 3293

To amend title XIV of the Public Health Service Act (commonly known

as the Safe Drinking Water Act) to establish a screening program for

estrogenic substances.

IN THE HOUSE OF REPRESENTATIVES

APRIL 23, 1996

Mrs. LOWEY introduced the following bill; which was referred to the

Committee on Commerce

A BILL

To amend title XIV of the Public Health Service Act (commonly known as the Safe Drinking Water Act) to establish a screening program for estrogenic substances.

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 ‘‘Safe Drinking Water

5 Estrogenic Substances Screening Program Act’’.
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1 SEC. 2. SAFE DRINKING WATER ACT; ESTABLISHMENT OF

2 SCREENING PROGRAM FOR ESTROGENIC

3 SUBSTANCES.

4 Title XIV of the Public Health Service Act (com5 monly known as the Safe Drinking Water Act) (42 U.S.C.

6 300f et seq.), as amended by Public Law 104–66, is

7 amended in section 1442 by adding at the end the follow8 ing subsection:

9 ‘‘(f) SCREENING PROGRAM.—

10 ‘‘(1) DEVELOPMENT.—Not later than 1 year

11 after the date of enactment of this subsection, the

12 Administrator shall develop a screening program,

13 using appropriate validated test systems, to deter14 mine whether certain substances may have an effect

15 in humans that is similar to an effect produced by

16 a naturally occurring estrogen, or such other endo17 crine effect as the Administrator may designate.

18 ‘‘(2) IMPLEMENTATION.—Not later than 2

19 years after the date of enactment of this subsection,

20 after obtaining review of the screening program de21 scribed in paragraph (1) by the scientific advisory

22 panel established under section 25(d) of the Act of

23 June 25, 1947 (chapter 125), and the Science Advi24 sory Board established by section 8 of the Environ25 mental Research, Development, and Demonstration
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1 Act of 1978 (42 U.S.C. 4365), the Administrator

2 shall implement the program.

3 ‘‘(3) SUBSTANCES.—In carrying out the screen4 ing program described in paragraph (1), the Admin5 istrator shall provide for the testing of all active and

6 inert ingredients used in products described in sec7 tion 103(e) of the Comprehensive Environmental Re8 sponse, Compensation, and Liability Act of 1980 (42

9 U.S.C. 9603(e)), and may provide for the testing of

10 any other substance if the Administrator determines

11 that a widespread population may be exposed to the

12 substance.

13 ‘‘(4) EXEMPTION.—Notwithstanding paragraph

14 (3), the Administrator may, by regulation, exempt

15 from the requirements of this subsection a biologic

16 substance or other substance if the Administrator

17 determines that the substance does not have any ef18 fect in humans similar to an effect produced by a

19 naturally occurring estrogen.

20 ‘‘(5) COLLECTION OF INFORMATION.—

21 ‘‘(A) IN GENERAL.—The Administrator

22 shall issue an order to a person that manufac23 tures a substance for which testing is required

24 under this subsection to conduct testing in ac25 cordance with the screening program described
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1 in paragraph (1), and submit information ob2 tained from the testing to the Administrator,

3 within a time period that the Administrator de4 termines is sufficient for the generation of the

5 information.

6 ‘‘(B) FAILURE TO SUBMIT INFORMA7 TION.—

8 ‘‘(i) SUSPENSION.—If a person re9 ferred to in subparagraph (A) fails to sub10 mit the information required under such

11 subparagraph within the time period estab12 lished by the order, the Administrator shall

13 issue a notice of intent to suspend the sale

14 or distribution of the substance by the per15 son. Any suspension proposed under this

16 subparagraph shall become final at the end

17 of the 30-day period beginning on the date

18 that the person receives the notice of in19 tent to suspend, unless during that period

20 a person adversely affected by the notice

21 requests a hearing or the Administrator

22 determines that the person referred to in

23 subparagraph (A) has complied fully with

24 this paragraph.
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1 ‘‘(ii) HEARING.—If a person requests

2 a hearing under clause (i), the hearing

3 shall be conducted in accordance with sec4 tion 554 of title 5, United States Code.

5 The only matter for resolution at the hear6 ing shall be whether the person has failed

7 to submit information required under this

8 paragraph. A decision by the Adminis9 trator after completion of a hearing shall

10 be considered to be a final agency action.

11 ‘‘(iii) TERMINATION OF SUSPEN12 SIONS.—The Administrator shall terminate

13 a suspension under this subparagraph is14 sued with respect to a person if the Ad15 ministrator determines that the person has

16 complied fully with this paragraph.

17 ‘‘(6) AGENCY ACTION.—In the case of any sub18 stance that is found to have a potential adverse ef19 fect on humans as a result of testing and evaluation

20 under this subsection, the Administrator shall take

21 such action, including appropriate regulatory action

22 by rule or by order under statutory authority avail23 able to the Administrator, as is necessary to ensure

24 the protection of public health.
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1 ‘‘(7) REPORT TO CONGRESS.—Not later than 4

2 years after the date of enactment of this subsection,

3 the Administrator shall prepare and submit to Con4 gress a report containing—

5 ‘‘(A) the findings of the Administrator re6 sulting from the screening program described in

7 paragraph (1);

8 ‘‘(B) recommendations for further testing

9 and research needed to evaluate the impact on

10 human health of the substances tested under

11 the screening program; and

12 ‘‘(C) recommendations for any further ac13 tions (including any action described in para14 graph (6)) that the Administrator determines

15 are appropriate based on the findings.’’.

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