I 

111TH CONGRESS 

2D SESSION H. R. 5210 

To amend the Safe Drinking Water Act regarding an endocrine disruptor 

screening program. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 5, 2010 

Mr. MARKEY of Massachusetts (for himself and Mr. MORAN of Virginia) 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 2010’’. 

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 2010, 

12 after opportunity for comment, the Administrator 

13 shall publish— 

14 ‘‘(A) a list of no fewer than 100 sub15 stances for testing pursuant to subsection 

16 (a)(1) (in accordance with the schedule speci17 fied in paragraph (3)); and 

18 ‘‘(B) a plan for the identification of addi19 tional substances for testing pursuant to sub20 section (a)(1), and a schedule for issuing test 

21 orders for all such additional substances by not 

22 later than 10 years after the date of the enact23 ment of the Endocrine Disruptor Screening En24 hancement Act of 2010, with the goal of test25 ing, at a minimum and consistent with subVerDate Mar 15 2010 23:56 May 05, 2010 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5210.IH H5210

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1 section (a), all substances that have been placed 

2 on the Drinking Water Preliminary Contami3 nant Candidate List published pursuant to sec4 tion 1412(b)(1)(B)(i). 

5 In publishing the plan and schedule required by sub6 paragraph (B), the Administrator shall obtain advice 

7 and direction from the Science Advisory Board. 

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

9 selecting substances for listing under paragraph 

10 (1)(A) or identification pursuant to the plan under 

11 paragraph (1)(B), the Administrator— 

12 ‘‘(A) shall prioritize the selection of sub13 stances that pose the greatest public health con14 cern, taking into consideration (among other 

15 factors of public health concern) the effect of 

16 such substances on subgroups that comprise a 

17 meaningful portion of the general population 

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

19 elderly, individuals with a history of serious ill20 ness, and other subpopulations) that are identi21 fiable as being at greater risk of adverse health 

22 effects due to exposure to substances in drink23 ing water; and 

24 ‘‘(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; and 

4 ‘‘(ii) the Drinking Water Preliminary 

5 Contaminant Candidate List published 

6 pursuant to section 1412(b)(1)(B)(i). 

7 ‘‘(3) SCHEDULE.—After publication of the list 

8 under paragraph (1)(A), the Administrator shall 

9 issue test orders for— 

10 ‘‘(A) at least 25 substances on the list by 

11 the end of each year during the 4-year period 

12 following the date of the enactment of the En13 docrine Disruptor Screening Enhancement Act 

14 of 2010; and 

15 ‘‘(B) all substances on the list by the end 

16 of such 4-year period. 

17 ‘‘(c) TESTING PROTOCOL PROCESS.— 

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

19 after the date of the enactment of the Endocrine 

20 Disruptor Screening Enhancement Act of 2010, the 

21 Administrator shall, after opportunity for comment, 

22 and after obtaining advice and direction from the 

23 Science Advisory Board, publish guidance on devel24 oping and updating protocols for testing of possible 

25 endocrine disruptors. The guidance shall specify— 


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1 ‘‘(A) the manner in which the Adminis2 trator will evaluate and, where necessary, revise 

3 such protocols; 

4 ‘‘(B) the manner in which the Adminis5 trator will determine when testing of substances 

6 will be required; and 

7 ‘‘(C) the procedures by which other sci8 entifically relevant information can be used in 

9 lieu of some or all of the information that oth10 erwise would be collected pursuant to testing 

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

12 Drug, and Cosmetic Act. 

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

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

15 that the Administrator may use information that is 

16 prepared or provided by any person (including a reg17 istrant, manufacturer, or importer of a substance for 

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

19 shall apply equally with respect to any such person. 

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

21 after opportunity for comment, and after obtaining 

22 advice and direction from the Science Advisory 

23 Board, amend any guidance published pursuant to 

24 this subsection. 


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

2 than 2 years after the date of the enactment of the Endo3 crine Disruptor Screening Enhancement Act of 2010, the 

4 Administrator shall, after opportunity for comment, deter5 mine whether sufficient scientific information has been de6 veloped to warrant updating the screening protocols devel7 oped under section 408(p) of the Federal Food, Drug, and 

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

9 the enactment of the Endocrine Disruptor Screening En10 hancement Act of 2010 and every 3 years thereafter, the 

11 Administrator shall determine, consistent with the guid12 ance published under subsection (c), whether to revise 

13 screening protocols under such section based on signifi14 cant improvements in the sensitivity, accuracy, reliability, 

15 reproducibility, or efficiency of such protocols. Whenever 

16 the Administrator revises such a protocol, the Adminis17 trator shall also determine, after obtaining advice and di18 rection from the Science Advisory Board or the advisory 

19 panel referred to in section 25(d) of the Federal Insecti20 cide, Fungicide, and Rodenticide Act, as appropriate, 

21 whether any substance that has already been subjected to 

22 testing should be tested using the revised protocol. 

23 ‘‘(e) ACCELERATION OF TESTING FOR CERTAIN SUB24 STANCES.— 


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1 ‘‘(1) IN GENERAL.—If the Administrator deter2 mines that— 

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

4 sources of drinking water, 

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

6 be exposed to the substance, and 

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

8 be an endocrine disruptor or has a structural 

9 similarity to a substance known to be an endo10 crine disruptor, 

11 the Administrator shall determine whether to require 

12 the completion of testing for such substance on an 

13 accelerated schedule, to enable the Administrator to 

14 determine the effect of such substance on the endo15 crine system and ensure the protection of public 

16 health. 

17 ‘‘(2) SCIENTIFICALLY RELEVANT INFORMA18 TION.—The Administrator shall make any deter19 mination under paragraph (1) using scientifically 

20 relevant information. In carrying out the preceding 

21 sentence, the Administrator may rely on any avail22 able scientifically relevant information, prepared or 

23 provided by any person. 

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

25 the date of the enactment of the Endocrine 


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1 Disruptor Screening Enhancement Act of 2010, the 

2 Administrator shall, after opportunity for comment, 

3 publish guidance on how the Administrator will 

4 make determinations under paragraph (1). 

5 ‘‘(f) RESULTS OF TESTING.— 

6 ‘‘(1) PUBLICATION OF DATA EVALUATION

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

8 testing results for a substance, the Administrator 

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

10 publish data evaluation records for such results in a 

11 publicly searchable database. 

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

13 6 months after receipt of testing results for a sub14 stance, the Administrator shall— 

15 ‘‘(A) determine whether to take action re16 lated to the substance under section 1412(b) or 

17 1445, or other appropriate statutory authority; 

18 and 

19 ‘‘(B) consistent with subsection (g), pub20 lish such determination in a publicly searchable 

21 database. 

22 ‘‘(3) STRUCTURED EVALUATION FRAME23 WORK.—To assess the overall weight of the evidence 

24 and relevance to humans and wildlife of results of 

25 testing, the Administrator shall develop and use a 


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1 structured evaluative framework consisting of 

2 science-based criteria, consistent with the protection 

3 of public health and the environment, for systemati4 cally evaluating endocrine mode of action and for de5 termining data relevance, quality, and reliability. 

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

7 180 days after the date of the enactment of the Endocrine 

8 Disruptor Screening Enhancement Act of 2010 and con9 sistent with section 552 of title 5, United States Code, 

10 the Administrator shall publish, in electronic format, a 

11 publicly searchable database that contains information re12 garding the testing program. Not later than 30 days after 

13 the date on which the information becomes available, the 

14 Administrator shall ensure that, at a minimum, the data15 base— 

16 ‘‘(1) identifies the substances selected for test17 ing under the program; and 

18 ‘‘(2) includes the documents and information 

19 pertaining to the status of testing activities for each 

20 such substance, including test orders, deadlines for 

21 submission, the Environmental Protection Agency’s 

22 data evaluation records, the Administrator’s deter23 mination on whether regulatory action will be taken 

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

25 test results. 


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

2 THE PROGRAM.— 

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

4 petition the Administrator to— 

5 ‘‘(A) add a substance to the list under sub6 section (b)(1)(A) or identify a substance pursu7 ant to the plan under subsection (b)(1)(B); or 

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

9 substance be tested on an accelerated basis in 

10 accordance with subsection (e). 

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

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

13 claimed to establish that an action described in sub14 paragraph (A) or (B) of paragraph (1) is warranted. 

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

16 90 days after the filing of a petition described under 

17 paragraph (1), the Administrator shall determine 

18 whether the petition has established that an action 

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

20 (1) is warranted and shall grant or deny the peti21 tion. If the Administrator grants such petition, the 

22 Administrator shall promptly add the substance to 

23 the list under subsection (b)(1)(A), identify the sub24 stance pursuant to the plan under subsection 

25 (b)(1)(B), or issue an order requiring testing on an 


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1 accelerated basis in accordance with subsection (e), 

2 as applicable. If the Administrator denies the peti3 tion, the Administrator shall publish the reasons for 

4 such denial in the Federal Register. 

5 ‘‘(i) COORDINATION WITH OTHER FEDERAL AGEN6 CIES.—After the Administrator— 

7 ‘‘(1) requires testing of a substance, or 

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

9 testing, takes action related to a substance under 

10 section 1412(b) or 1445 or other appropriate statu11 tory authority, 

12 the Administrator shall give notice of such testing or ac13 tion to Federal agencies which are authorized by other 

14 provisions of law to regulate the substance or products, 

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

16 substance. 

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

18 year after the date of the enactment of the Endocrine 

19 Disruptor Screening Enhancement Act of 2010 and every 

20 3 years thereafter, the Administrator shall provide a re21 port to the Committee on Energy and Commerce of the 

22 House of Representatives and the Committee on Environ23 ment and Public Works of the Senate that describes— 


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

2 regulating endocrine disruptors as well as plans for 

3 future activities; 

4 ‘‘(2) any change in screening or testing method5 ology and evaluation or criteria for evaluating sci6 entifically relevant information; and 

7 ‘‘(3) actions taken to ensure communication 

8 and sharing of scientific information with other Fed9 eral agencies and the public; and 

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

11 published under subsection (b)(1)(B) as well as the 

12 reasons therefor. 

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

14 COMPLIANCE.— 

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

16 Administrator to conduct testing of an endocrine 

17 disruptor may— 

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

19 to an order for such testing; and 

20 ‘‘(B) form (on a voluntary basis) a consor21 tium in order to satisfy the requirements of one 

22 or more orders for such testing. 

23 ‘‘(2) RELIANCE ON CONSORTIUM SUBMIS24 SIONS.—Each member of a consortium described in 

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


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1 submissions of the consortium to satisfy the require2 ments of any order for testing, but continues to be 

3 individually subject to such requirements. 

4 ‘‘(3) SHARING OF COSTS.— 

5 ‘‘(A) IN GENERAL.—Each member of a 

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

7 share the applicable costs according to appro8 priate arrangements established by the consor9 tium members. 

10 ‘‘(B) BINDING OFFER.—Whenever, to sat11 isfy the requirements of one or more orders for 

12 testing, any person offers to form or join a con13 sortium described in paragraph (1)(B), or of14 fers compensation to a person that has already 

15 submitted data to the Administrator satisfying 

16 an order for testing, such offer shall constitute 

17 a binding offer to share an appropriate portion 

18 of the applicable costs. 

19 ‘‘(C) APPLICABLE COSTS.—In this sub20 section, the term ‘applicable costs’ includes the 

21 costs— 

22 ‘‘(i) incurred to generate and report 

23 information to comply with an order for 

24 testing; or 


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1 ‘‘(ii) associated with the organization 

2 and administration of the consortium. 

3 ‘‘(4) DISPUTE RESOLUTION.— 

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

5 dispute about an appropriate share or a fair 

6 method of determining an appropriate share of 

7 applicable costs of the testing requirements in 

8 a test order, any person involved in the dispute 

9 may initiate binding arbitration proceedings by 

10 requesting the Federal Mediation and Concilia11 tion Service to appoint an arbitrator from the 

12 roster of arbitrators maintained by such Service 

13 or a hearing with a regional office of the Amer14 ican Arbitration Association. A copy of the re15 quest shall be sent to each person from whom 

16 the requesting party seeks compensation or who 

17 seeks compensation from that party. 

18 ‘‘(B) NO REVIEW OF FINDINGS AND DE19 TERMINATION.—The findings and determina20 tion of the arbitrator in a dispute initiated pur21 suant to subparagraph (A) shall be final and 

22 conclusive, and no official or court of the 

23 United States shall have power or jurisdiction 

24 to review any such findings and determination, 

25 except in the case of fraud, misrepresentation, 


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1 or other misconduct by one of the parties to the 

2 arbitration or by the arbitrator. 

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

4 The parties to arbitration initiated pursuant to 

5 subparagraph (A) shall share equally in the 

6 payment of the fee and expenses of the arbi7 trator. 

8 ‘‘(5) ENFORCEMENT.—If the Administrator de9 termines that any person seeking to comply with an 

10 order for testing by relying on a submission made by 

11 a consortium or an original data submitter has 

12 failed to make an offer in accordance with para13 graph (3)(B), to participate in an arbitration pro14 ceeding under paragraph (4), or to comply with the 

15 terms of an agreement or arbitration decision con16 cerning sharing of applicable costs under paragraph 

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

18 with an order under subparagraph (A) of section 

19 408(p)(5) of the Federal Food, Drug, and Cosmetic 

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

21 such section. 

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

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

24 exogenous agent or mixture of agents that interferes 

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1 lism, binding action, or elimination of hormones that 

2 are present in the body and are responsible for ho3 meostasis, growth, neurological signaling, reproduc4 tion and developmental process, or any other effect 

5 that the Administrator has designated as an ‘endo6 crine effect’ pursuant to section 408(p)(1) of the 

7 Federal Food, Drug, and Cosmetic Act. 

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

9 substance pursuant to the screening program under 

10 section 408(p) of the Federal Food, Drug, and Cos11 metic Act, including a test of a substance that is in12 tended to identify substances that have the potential 

13 to interact with the endocrine system or that is in14 tended to determine the endocrine-related effects 

15 caused by such substance and obtain information 

16 about effects at various doses. 

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

18 carry out this section, there is authorized to be appro19 priated $5,000,000 for each of fiscal years 2011 through 

20 2015.’’. 

Æ 


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