I 

112TH CONGRESS 

1ST SESSION H. R. 553 

To amend the Safe Drinking Water Act regarding an endocrine disruptor 

screening program. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 8, 2011 

Mr. MARKEY (for himself, Mr. GRIJALVA, Mr. MORAN, and Ms. NORTON) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Safe Drinking Water Act regarding an 

endocrine disruptor screening program. 

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 ‘‘Endocrine Disruptor 

5 Screening Enhancement Act of 2011’’. 

6 SEC. 2. ENDOCRINE DISRUPTOR SCREENING PROGRAM. 

7 Section 1457 of the Safe Drinking Water Act (42 

8 U.S.C. 300j–17) is amended to read as follows: 

9 ‘‘ENDOCRINE DISRUPTOR SCREENING PROGRAM

10 ‘‘SEC. 1457. (a) TESTING OF SUBSTANCES.— 


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1 ‘‘(1) IN GENERAL.—In carrying out the screening 

2 program under section 408(p) of the Federal Food, Drug, 

3 and Cosmetic Act, the Administrator shall provide for the 

4 testing of substances described in paragraph (2) in addi5 tion to the substances described in section 408(p)(3) of 

6 such Act. 

7 ‘‘(2) COVERED SUBSTANCES.—A substance is subject 

8 to testing pursuant to paragraph (1) if— 

9 ‘‘(A) the substance may be found in sources of 

10 drinking water; and 

11 ‘‘(B) the Administrator determines that a sub12 stantial population may be exposed to such sub13 stance. 

14 ‘‘(3) SUBSTANCES ALREADY SUBJECT TO TEST15 ING.—Notwithstanding paragraph (2), a substance is not 

16 subject to testing pursuant to paragraph (1) if— 

17 ‘‘(A) the substance is already subject to evalua18 tion determined by the Administrator to be equiva19 lent to testing pursuant to paragraph (1); or 

20 ‘‘(B) the Administrator has already determined 

21 the effect of the substance on the endocrine system. 

22 ‘‘(4) SUBSTANCES DERIVED FROM DEGRADATION OR

23 METABOLISM OF ANOTHER SUBSTANCE.—If a substance 

24 subject to testing pursuant to paragraph (1) (in this para25 graph referred to as the ‘covered substance’) is derived 


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1 from the degradation or metabolism of another substance, 

2 or is used in or generated by the manufacture of another 

3 substance, the Administrator shall provide for such testing 

4 of the covered substance by the importer or manufacturer 

5 of the other substance. 

6 ‘‘(b) IDENTIFICATION AND TESTING OF ENDOCRINE

7 DISRUPTING SUBSTANCES THAT MAY BE IN DRINKING

8 WATER.— 

9 ‘‘(1) IDENTIFICATION.—Not later than 1 year 

10 after the date of the enactment of the Endocrine 

11 Disruptor Screening Enhancement Act of 2011, 

12 after opportunity for comment, the Administrator 

13 shall publish— 

14 ‘‘(A) a plan for the identification of sub15 stances for testing pursuant to subsection 

16 (a)(1); and 

17 ‘‘(B) a schedule for issuing test orders for 

18 all substances by not later than 10 years after 

19 the date of the enactment of the Endocrine 

20 Disruptor Screening Enhancement Act of 2011, 

21 with the goal of testing, at a minimum and con22 sistent with subsection (a), all substances that 

23 have been placed on the Drinking Water Pre24 liminary Contaminant Candidate List published 

25 pursuant to section 1412(b)(1)(B)(i) and all 


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1 substances for which a national primary drink2 ing water regulation has been promulgated pur3 suant to section 1412(b)(1)(A). 

4 In publishing the plan and schedule required by this 

5 paragraph, the Administrator shall obtain advice 

6 and direction from the Science Advisory Board. 

7 ‘‘(2) PRIORITIZATION; CONSIDERATIONS.—In 

8 selecting substances for identification pursuant to 

9 the plan under paragraph (1)(A), the Adminis10 trator— 

11 ‘‘(A) shall prioritize the selection of sub12 stances that pose the greatest public health con13 cern, taking into consideration (among other 

14 factors of public health concern) the effect of 

15 such substances on subgroups that comprise a 

16 meaningful portion of the general population 

17 (such as infants, children, pregnant women, the 

18 elderly, individuals with a history of serious ill19 ness, and other subpopulations) that are identi20 fiable as being at greater risk of adverse health 

21 effects due to exposure to substances in drink22 ing water; and 

23 ‘‘(B) shall take into consideration— 


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1 ‘‘(i) available information on the ex2 tent of potential public exposures to the 

3 substances through drinking water; 

4 ‘‘(ii) the Drinking Water Preliminary 

5 Contaminant Candidate List published 

6 pursuant to section 1412(b)(1)(B)(i); and 

7 ‘‘(iii) substances for which a national 

8 primary drinking water regulation has 

9 been proposed or promulgated pursuant to 

10 1412(b)(1)(A). 

11 ‘‘(c) TESTING PROTOCOL PROCESS.— 

12 ‘‘(1) IN GENERAL.—Not later than 2 years 

13 after the date of the enactment of the Endocrine 

14 Disruptor Screening Enhancement Act of 2011, the 

15 Administrator shall, after opportunity for comment, 

16 and after obtaining advice and direction from the 

17 Science Advisory Board, publish guidance on devel18 oping or updating protocols for testing of possible 

19 endocrine disruptors. The guidance shall specify— 

20 ‘‘(A) the manner in which the Adminis21 trator will evaluate and, where necessary, revise 

22 such protocols; 

23 ‘‘(B) the manner in which the Adminis24 trator will determine when testing of substances 

25 will be required; and 


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1 ‘‘(C) the procedures by which other sci2 entifically relevant information can be used in 

3 lieu of some or all of the information that oth4 erwise would be collected pursuant to testing 

5 under section 408(p) of the Federal Food, 

6 Drug, and Cosmetic Act. 

7 ‘‘(2) MINIMUM CONTENTS.—The procedures 

8 specified pursuant to paragraph (1)(C) shall ensure 

9 that the Administrator may use information that is 

10 prepared or provided by any person (including a reg11 istrant, manufacturer, or importer of a substance for 

12 which testing is required, and any other entity) and 

13 shall apply equally with respect to any such person. 

14 ‘‘(3) AMENDMENTS.—The Administrator may, 

15 after opportunity for comment, and after obtaining 

16 advice and direction from the Science Advisory 

17 Board, amend any guidance published pursuant to 

18 this subsection. 

19 ‘‘(d) REVISION OF TESTING PROTOCOLS.—Not later 

20 than 2 years after the date of the enactment of the Endo21 crine Disruptor Screening Enhancement Act of 2011, the 

22 Administrator shall, after opportunity for comment, deter23 mine whether sufficient scientific information has been de24 veloped to warrant updating the screening protocols devel25 oped under section 408(p) of the Federal Food, Drug, and 


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1 Cosmetic Act. Not later than 5 years after the date of 

2 the enactment of the Endocrine Disruptor Screening En3 hancement Act of 2011, and every 3 years thereafter, the 

4 Administrator shall determine, consistent with the guid5 ance published under subsection (c), whether to revise 

6 screening protocols under such section based on signifi7 cant improvements in the sensitivity, accuracy, reliability, 

8 reproducibility, or efficiency of such protocols. In carrying 

9 out the preceding sentence the Administrator shall re10 quire, where practicable, the use of screening protocols 

11 that eliminate or reduce the number of animals used. 

12 Whenever the Administrator revises such a protocol, the 

13 Administrator shall also determine, after obtaining advice 

14 and direction from the Science Advisory Board or the ad15 visory panel referred to in section 25(d) of the Federal 

16 Insecticide, Fungicide, and Rodenticide Act, as appro17 priate, whether any substance that has already been sub18 jected to testing should be tested using the revised pro19 tocol. 

20 ‘‘(e) ACCELERATION OF TESTING FOR CERTAIN SUB21 STANCES.— 

22 ‘‘(1) IN GENERAL.—If the Administrator deter23 mines that— 

24 ‘‘(A) a substance is known to be found in 

25 sources of drinking water; 


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1 ‘‘(B) a substantial population is known to 

2 be exposed to the substance; and 

3 ‘‘(C) the substance is either suspected to 

4 be an endocrine disruptor or has a structural 

5 similarity to a substance known to be an endo6 crine disruptor; 

7 the Administrator shall determine whether to require 

8 the completion of testing for such substance on an 

9 accelerated schedule, to enable the Administrator to 

10 determine the effect of such substance on the endo11 crine system and ensure the protection of public 

12 health. 

13 ‘‘(2) SCIENTIFICALLY RELEVANT INFORMA14 TION.—The Administrator shall make any deter15 mination under paragraph (1) using scientifically 

16 relevant information. In carrying out the preceding 

17 sentence, the Administrator may rely on any avail18 able scientifically relevant information, prepared or 

19 provided by any person. 

20 ‘‘(3) GUIDANCE.—Not later than 1 year after 

21 the date of the enactment of the Endocrine 

22 Disruptor Screening Enhancement Act of 2011, the 

23 Administrator shall, after opportunity for comment, 

24 publish guidance on how the Administrator will 

25 make determinations under paragraph (1). 


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1 ‘‘(f) RESULTS OF TESTING.— 

2 ‘‘(1) PUBLICATION OF DATA EVALUATION

3 RECORDS.—Not later than 6 months after receipt of 

4 testing results for a substance, the Administrator 

5 shall prepare and, consistent with subsection (g), 

6 publish data evaluation records for such results in a 

7 publicly searchable database. 

8 ‘‘(2) ADMINISTRATIVE ACTION.—Not later than 

9 6 months after receipt of testing results for a sub10 stance, the Administrator shall— 

11 ‘‘(A) determine whether to take action re12 lated to the substance under section 1412(b) or 

13 1445, or other appropriate statutory authority; 

14 and 

15 ‘‘(B) consistent with subsection (g), pub16 lish such determination in a publicly searchable 

17 database. 

18 ‘‘(3) STRUCTURED EVALUATION FRAME19 WORK.—To assess the overall weight of the evidence 

20 and relevance to humans and wildlife of results of 

21 testing, the Administrator shall develop and use a 

22 structured evaluative framework consisting of 

23 science-based criteria, consistent with the protection 

24 of public health and the environment, for systematiVerDate Mar 15 2010 03:48 Feb 10, 2011 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H553.IH H553

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1 cally evaluating endocrine mode of action and for de2 termining data relevance, quality, and reliability. 

3 ‘‘(g) PUBLIC DATABASE.—Beginning not later than 

4 180 days after the date of the enactment of the Endocrine 

5 Disruptor Screening Enhancement Act of 2011 and con6 sistent with section 552 of title 5, United States Code, 

7 the Administrator shall publish, in electronic format, a 

8 publicly searchable database that contains information re9 garding the testing program. Not later than 30 days after 

10 the date on which the information becomes available, the 

11 Administrator shall ensure that, at a minimum, the data12 base— 

13 ‘‘(1) identifies the substances selected for test14 ing under the program; and 

15 ‘‘(2) includes the documents and information 

16 pertaining to the status of testing activities for each 

17 such substance, including test orders, deadlines for 

18 submission, the Environmental Protection Agency’s 

19 data evaluation records, the Administrator’s deter20 mination on whether regulatory action will be taken 

21 under subsection (f), and the summary of chemical 

22 test results. 

23 ‘‘(h) PETITION FOR INCLUSION OF A SUBSTANCE IN

24 THE PROGRAM.— 


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1 ‘‘(1) IN GENERAL.—Any person may submit a 

2 petition to the Administrator to— 

3 ‘‘(A) identify a substance pursuant to the 

4 plan under subsection (b)(1)(A); or 

5 ‘‘(B) issue a test order requiring that a 

6 substance be tested on an accelerated basis in 

7 accordance with subsection (e). 

8 ‘‘(2) SPECIFICATION OF FACTS.—Any petition 

9 under paragraph (1) shall specify the facts that are 

10 claimed to establish that an action described in sub11 paragraph (A) or (B) of paragraph (1) is warranted. 

12 ‘‘(3) ADMINISTRATIVE ACTION.—Not later than 

13 90 days after the filing of a petition described under 

14 paragraph (1), the Administrator shall determine 

15 whether the petition has established that an action 

16 described in subparagraph (A) or (B) of paragraph 

17 (1) is warranted and shall grant or deny the peti18 tion. If the Administrator grants such petition, the 

19 Administrator shall promptly identify the substance 

20 pursuant to the plan under subsection (b)(1)(A), or 

21 issue an order requiring testing on an accelerated 

22 basis in accordance with subsection (e), as applica23 ble. If the Administrator denies the petition, the Ad24 ministrator shall publish the reasons for such denial 

25 in the Federal Register. 


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1 ‘‘(i) COORDINATION WITH OTHER FEDERAL AGEN2 CIES.—After the Administrator— 

3 ‘‘(1) requires testing of a substance; or 

4 ‘‘(2) based in whole or in part on the results of 

5 testing, takes action related to a substance under 

6 section 1412(b) or 1445, or other appropriate statu7 tory authority; 

8 the Administrator shall give notice of such testing or ac9 tion to Federal agencies which are authorized by other 

10 provisions of law to regulate the substance or products, 

11 materials, medications, processes, or practices that use the 

12 substance. 

13 ‘‘(j) REPORTING REQUIREMENT.—Not later than 1 

14 year after the date of the enactment of the Endocrine 

15 Disruptor Screening Enhancement Act of 2011, and every 

16 3 years thereafter, the Administrator shall provide a re17 port to the Committee on Energy and Commerce of the 

18 House of Representatives and the Committee on Environ19 ment and Public Works of the Senate that describes— 

20 ‘‘(1) progress made in identifying, testing, and 

21 regulating endocrine disruptors as well as plans for 

22 future activities; 

23 ‘‘(2) any change in screening or testing method24 ology and evaluation or criteria for evaluating sci25 entifically relevant information; 


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1 ‘‘(3) actions taken to ensure communication 

2 and sharing of scientific information with other Fed3 eral agencies and the public; and 

4 ‘‘(4) any deviations from the plan or schedule 

5 published under subsections (b)(1)(A) and (b)(1)(B) 

6 as well as the reasons therefor. 

7 ‘‘(k) TESTING CONSORTIA, COMPENSATION, AND

8 COMPLIANCE.— 

9 ‘‘(1) IN GENERAL.—Any person required by the 

10 Administrator to conduct testing of an endocrine 

11 disruptor may— 

12 ‘‘(A) submit, on its own, data in response 

13 to an order for such testing; and 

14 ‘‘(B) form (on a voluntary basis) a consor15 tium in order to satisfy the requirements of one 

16 or more orders for such testing. 

17 ‘‘(2) RELIANCE ON CONSORTIUM SUBMIS18 SIONS.—Each member of a consortium described in 

19 paragraph (1)(B) shall have full rights to rely on all 

20 submissions of the consortium to satisfy the require21 ments of any order for testing, but continues to be 

22 individually subject to such requirements. 

23 ‘‘(3) SHARING OF COSTS.— 

24 ‘‘(A) IN GENERAL.—Each member of a 

25 consortium described in paragraph (1)(B) shall 


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1 share the applicable costs according to appro2 priate arrangements established by the consor3 tium members. 

4 ‘‘(B) BINDING OFFER.—Whenever, to sat5 isfy the requirements of one or more orders for 

6 testing, any person offers to form or join a con7 sortium described in paragraph (1)(B), or of8 fers compensation to a person that has already 

9 submitted data to the Administrator satisfying 

10 an order for testing, such offer shall constitute 

11 a binding offer to share an appropriate portion 

12 of the applicable costs. 

13 ‘‘(C) APPLICABLE COSTS.—In this sub14 section, the term ‘applicable costs’ includes the 

15 costs— 

16 ‘‘(i) incurred to generate and report 

17 information to comply with an order for 

18 testing; or 

19 ‘‘(ii) associated with the organization 

20 and administration of the consortium. 

21 ‘‘(4) DISPUTE RESOLUTION.— 

22 ‘‘(A) IN GENERAL.—In the event of any 

23 dispute about an appropriate share or a fair 

24 method of determining an appropriate share of 

25 applicable costs of the testing requirements in 


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1 a test order, any person involved in the dispute 

2 may initiate binding arbitration proceedings by 

3 requesting the Federal Mediation and Concilia4 tion Service to appoint an arbitrator from the 

5 roster of arbitrators maintained by such Service 

6 or a hearing with a regional office of the Amer7 ican Arbitration Association. A copy of the re8 quest shall be sent to each person from whom 

9 the requesting party seeks compensation or who 

10 seeks compensation from that party. 

11 ‘‘(B) NO REVIEW OF FINDINGS AND DE12 TERMINATION.—The findings and determina13 tion of the arbitrator in a dispute initiated pur14 suant to subparagraph (A) shall be final and 

15 conclusive, and no official or court of the 

16 United States shall have power or jurisdiction 

17 to review any such findings and determination, 

18 except in the case of fraud, misrepresentation, 

19 or other misconduct by one of the parties to the 

20 arbitration or by the arbitrator. 

21 ‘‘(C) PAYMENT OF FEE AND EXPENSES.— 

22 The parties to arbitration initiated pursuant to 

23 subparagraph (A) shall share equally in the 

24 payment of the fee and expenses of the arbi25 trator. 


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1 ‘‘(5) ENFORCEMENT.—If the Administrator de2 termines that any person seeking to comply with an 

3 order for testing by relying on a submission made by 

4 a consortium or an original data submitter has 

5 failed to make an offer in accordance with para6 graph (3)(B), to participate in an arbitration pro7 ceeding under paragraph (4), or to comply with the 

8 terms of an agreement or arbitration decision con9 cerning sharing of applicable costs under paragraph 

10 (3), that person is deemed to have failed to comply 

11 with an order under subparagraph (A) of section 

12 408(p)(5) of the Federal Food, Drug, and Cosmetic 

13 Act for purposes of subparagraphs (B) and (C) of 

14 such section. 

15 ‘‘(l) DEFINITIONS.—In this section: 

16 ‘‘(1) The term ‘endocrine disruptor’ means an 

17 exogenous agent or mixture of agents that interferes 

18 with or alters the synthesis, secretion, transport, me19 tabolism, binding action, or elimination of hormones 

20 that are present in the body and are responsible for 

21 homeostasis, growth, neurological signaling, repro22 duction and developmental process, or any other ef23 fect that the Administrator has designated as an 

24 ‘endocrine effect’ pursuant to section 408(p)(1) of 

25 the Federal Food, Drug, and Cosmetic Act. 


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1 ‘‘(2) The term ‘testing’ means the testing of a 

2 substance pursuant to the screening program under 

3 section 408(p) of the Federal Food, Drug, and Cos4 metic Act, including a test of a substance that is in5 tended to identify substances that have the potential 

6 to interact with the endocrine system or that is in7 tended to determine the endocrine-related effects 

8 caused by such substance and obtain information 

9 about effects at various doses. 

10 ‘‘(m) AUTHORIZATION OF APPROPRIATIONS.—To 

11 carry out this section, there is authorized to be appro12 priated $5,000,000 for each of fiscal years 2012 through 

13 2016.’’. 

Æ 


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