I 

112TH CONGRESS 

1ST SESSION H. R. 2521 

To reduce human exposure to endocrine-disrupting chemicals, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 13, 2011 

Mr. MORAN (for himself, Mr. HINCHEY, Mr. CONNOLLY of Virginia, Ms. NORTON, Mr. GEORGE MILLER of California, Ms. RICHARDSON, Mr. GRIJALVA, Ms. SCHAKOWSKY, Mrs. LOWEY, Mr. RUSH, Mrs. CAPPS, Mr. 

MCGOVERN, and Mr. PRICE of North Carolina) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To reduce human exposure to endocrine-disrupting chemicals, 

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 ‘‘Endocrine-Disrupting 

5 Chemicals Exposure Elimination Act of 2011’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 The table of contents of this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

Sec. 3. Findings. 

Sec. 4. Definitions. 


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Sec. 5. Tiering applicable to levels of evidence and concern. 

TITLE I—RESEARCH ON ENDOCRINE-DISRUPTING CHEMICALS 

Sec. 101. National toxicology program activities. 

Sec. 102. Research program of national institute of environmental health 

sciences. 

TITLE II—REDUCING EXPOSURE TO ENDOCRINE-DISRUPTING 

CHEMICALS 

Sec. 201. Federal agency action. 

Sec. 202. Citizen suits. 

TITLE III—TRAINING 

Sec. 301. Training in fields related to the prevention of endocrine disruption. 

TITLE IV—MISCELLANEOUS 

Sec. 401. Authorization of appropriations. 

1 SEC. 3. FINDINGS. 

2 The Congress finds as follows: 

3 (1) There is growing evidence that the human 

4 endocrine system is extremely sensitive to particular 

5 chemicals. 

6 (2) Numerous studies show links between par7 ticular chemicals and hormone functions in animals 

8 and in humans, and those links have been further 

9 connected to numerous disorders. 

10 (3) A targeted research and evaluation program 

11 on suspected endocrine-disrupting chemicals would 

12 establish greater scientific certainty with respect to 

13 the linkage of particular chemicals with endocrine 

14 system effects. 


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1 (4) Credible linkages established by this re2 search will be the basis for regulation under authori3 ties including— 

4 (A) the Federal Food, Drug, and Cosmetic 

5 Act; 

6 (B) the Toxic Substances Control Act; 

7 (C) the Safe Drinking Water Act; 

8 (D) the Food Quality Protection Act; 

9 (E) the Clean Air Act; 

10 (F) the Clean Water Act; and 

11 (G) the Federal Insecticide, Fungicide, and 

12 Rodenticide Act. 

13 (5) Such research, information availability, and 

14 scientific perspective would also promote voluntary 

15 actions to reduce exposure to these harmful chemi16 cals through market forces. 

17 (6) There is a need to educate the public on the 

18 results of research on endocrine-disrupting chemicals 

19 so that manufacturers, processors, retailers, and in20 dividual consumers can make informed decisions 

21 about potential exposure to harmful chemicals. 

22 (7) People should be protected from chemicals 

23 that are found to have endocrine-disrupting effects. 

24 (8) Animal testing should be reduced to the 

25 minimum necessary with the goal of transitioning to 


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1 a predominantly nonanimal paradigm as articulated 

2 in the 2007 National Research Council report ‘‘Tox3 icity Testing in the Twenty-First Century: A Vision 

4 and a Strategy’’. 

5 SEC. 4. DEFINITIONS. 

6 In this Act: 

7 (1) The term ‘‘chemical’’ means an individual 

8 chemical, a combination of chemicals, or a mixture 

9 of chemicals. 

10 (2) The term ‘‘Director’’ means the Director of 

11 the National Institute of Environmental Health 

12 Sciences. 

13 (3) The term ‘‘endocrine-disrupting chemical’’ 

14 means a chemical that interrupts, alters, interferes 

15 with, disturbs, or otherwise changes the human en16 docrine system or cell functioning. 

17 (4) The term ‘‘Endocrine Disruption Expert 

18 Panel’’, ‘‘Expert Panel’’, or ‘‘Panel’’ means the En19 docrine Disruption Expert Panel established under 

20 section 101(a)(2). 

21 SEC. 5. TIERING APPLICABLE TO LEVELS OF EVIDENCE 

22 AND CONCERN. 

23 In identifying, determining, or making a finding with 

24 respect to a level of evidence or a level of concern under 

25 this Act (including sections 101(a)(3), 101(a)(4), 


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1 101(b)(2)(C), and 201(a)(2)(B)), the Director or the Ex2 pert Panel, as applicable, shall select from among the fol3 lowing levels: 

4 (1) High. 

5 (2) Substantial. 

6 (3) Minimal. 

7 (4) None. 

8 TITLE I—RESEARCH ON ENDO9 CRINE-DISRUPTING CHEMI10 CALS 

11 SEC. 101. NATIONAL TOXICOLOGY PROGRAM ACTIVITIES. 

12 (a) IN GENERAL.—As part of the National Toxi13 cology Program, the Director, in consultation with the Na14 tional Toxicology Program Board of Scientific Counselors 

15 (or any successor board or committee), shall— 

16 (1) establish and implement a research program 

17 designed to strengthen the scientific basis of infor18 mation used by Federal agencies to understand the 

19 effects of, and reduce human exposure to, endocrine20 disrupting chemicals; 

21 (2) establish (subject to subsection (b)(1)) an 

22 Endocrine Disruption Expert Panel and direct the 

23 Panel to consider and report to the Director on 

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1 uation of endocrine-disrupting chemicals as specified 

2 in subsection (b)(2); 

3 (3) for each chemical determined by the Direc4 tor to be a potential or actual endocrine-disrupting 

5 chemical— 

6 (A) identify the level of evidence that such 

7 chemical is or may be an endocrine-disrupting 

8 chemical; 

9 (B) identify the level of concern that such 

10 chemical may disrupt the human endocrine sys11 tem; and 

12 (C) identify the pathways of exposure to 

13 the chemical for humans and animals; and 

14 (4) not later than 2 years after the date of the 

15 enactment of this Act, and every 2 years thereafter, 

16 provide to the Congress and each relevant Federal 

17 agency and make publicly available— 

18 (A) an up-to-date list specifying each 

19 chemical identified by the Director to be a po20 tential or actual endocrine-disrupting chemical 

21 and identifying the level of evidence that the 

22 chemical disrupts the human endocrine system, 

23 the level of concern that the chemical disrupts 

24 the human endocrine system, and the pathways 


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1 of exposure to the chemical for humans and 

2 animals; and 

3 (B) a report on— 

4 (i) the National Toxicology Program’s 

5 activities pertaining to endocrine-dis6 rupting chemicals; and 

7 (ii) the activities of Federal agencies 

8 with respect to endocrine-disrupting chemi9 cals, including actions taken or expected to 

10 be taken pursuant to section 201. 

11 (b) EXPERT PANEL.— 

12 (1) APPOINTMENT.—The Director, in consulta13 tion with the National Toxicology Program Board of 

14 Scientific Counselors (or any successor board or 

15 committee), shall appoint the members of the Endo16 crine Disruption Expert Panel (established under 

17 subsection (a)(2)) from among individuals who— 

18 (A) have established expertise in the field 

19 of endocrine disruption research by publishing 

20 research in peer-reviewed literature and have 

21 received Federal endocrine-research-related 

22 funding within the 2 years preceding appoint23 ment under this subsection; 

24 (B) provide assurances they will perform 

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1 terest, as determined by the Director, including 

2 by complying with section 208 of title 18, 

3 United States Code; and 

4 (C) represent diverse disciplines, which 

5 may include endocrinology, developmental and 

6 neurological biology, embryology, biochemistry, 

7 physiology, epidemiology, endocrine-driven on8 cology, in vitro and computational toxicology, 

9 and medical research. 

10 (2) DUTIES.—During each of the 10 years fol11 lowing the date of the enactment of this Act, the Ex12 pert Panel shall— 

13 (A) consider, and report to the Director 

14 on, issues related to identification, classifica15 tion, or evaluation of not more than 10 endo16 crine-disrupting chemicals or groups of endo17 crine-disrupting chemicals; 

18 (B) evaluate existing research aimed at un19 derstanding the biological pathways in humans 

20 by which endocrine-disrupting chemicals operate 

21 and identify future research priorities as appro22 priate; and 

23 (C) maintain a list that identifies chemi24 cals of concern for endocrine disruption effects 


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1 and includes findings, based upon peer-reviewed 

2 studies and other relevant data, regarding— 

3 (i) whether a chemical is a potential 

4 or actual endocrine-disrupting chemical; 

5 (ii) the level of evidence that the 

6 chemical is or may be an endocrine-dis7 rupting chemical; 

8 (iii) the level of concern that the 

9 chemical may disrupt the human endocrine 

10 system; 

11 (iv) the pathways of exposure to the 

12 chemical for humans and animals; and 

13 (v) the need for additional data, as14 says, testing, or research to determine the 

15 level of concern associated with the chemi16 cal’s potential to disrupt the human endo17 crine system. 

18 (3) REPORT.—The Expert Panel shall provide 

19 to the Director and make publicly available a bien20 nial report on the Panel’s activities, including an up21 to-date version of the list under paragraph (2)(C). 

22 (c) PETITIONS.— 

23 (1) IN GENERAL.—Any State, Tribe, local gov24 ernment, Federal agency, or person may petition the 

25 Director— 


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1 (A) to determine whether a chemical 

2 should be identified by the National Toxicology 

3 Program to be a potential or actual endocrine4 disrupting chemical and included in the list 

5 under subsection (a)(4)(A); or 

6 (B) to reclassify a chemical, revise a find7 ing, or amend any other determination of the 

8 National Toxicology Program based upon new 

9 information. 

10 (2) RULES.—The Director shall adopt rules 

11 that provide for— 

12 (A) the form and procedure for filing of 

13 petitions under paragraph (1); and 

14 (B) the procedural rights of entities filing 

15 such petitions. 

16 (d) NO JUDICIAL REVIEW.—A listing, finding, or 

17 other determination under this section shall not be subject 

18 to judicial review, nor to correction under section 515 of 

19 the Treasury and General Government Appropriations 

20 Act, 2001 (commonly referred to as the ‘‘Information 

21 Quality Act’’). 


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1 SEC. 102. RESEARCH PROGRAM OF NATIONAL INSTITUTE 

2 OF ENVIRONMENTAL HEALTH SCIENCES. 

3 Subpart 12 of part C of title IV of the Public Health 

4 Service Act (42 U.S.C. 2851 et seq.) is amended by adding 

5 at the end the following: 

6 ‘‘SEC. 463C. ENDOCRINE DISRUPTION RESEARCH PRO7 GRAM. 

8 ‘‘(a) PROGRAM.—The Director of the Institute shall 

9 conduct and support a research program, to be known as 

10 the Endocrine Disruption Research Program, to improve 

11 the understanding of how chemicals can disrupt the 

12 human endocrine system. Such program shall— 

13 ‘‘(1) be designed— 

14 ‘‘(A) to develop the information needed by 

15 Federal agencies to understand chemical dis16 ruption of the endocrine system and reduce 

17 human and animal exposure to endocrine-dis18 rupting chemicals; 

19 ‘‘(B) to understand the cellular pathways 

20 in humans by which endocrine-disrupting 

21 chemicals are able to cause adverse effects; and 

22 ‘‘(C) to use laboratory practices that will 

23 produce data that are sufficiently accurate and 

24 reproducible to be used for regulatory decisions; 

25 ‘‘(2) include research to design, develop, and 

26 validate appropriately sensitive tests to screen and 


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1 identify chemicals capable of disrupting the human 

2 endocrine system; 

3 ‘‘(3) address the full range of possible human 

4 health impacts, including but not limited to— 

5 ‘‘(A) male and female developmental and 

6 reproductive disorders; 

7 ‘‘(B) brain and neurobehavioral disorders; 

8 ‘‘(C) metabolic syndrome, prediabetes, dia9 betes, improper glucose and fat metabolism, 

10 obesity, and cardiovascular disorders; 

11 ‘‘(D) effects on the pituitary, hypothala12 mus, hippocampus, thyroid, adrenal, immune, 

13 bone, cardiovascular, and other endocrine or14 gans and systems throughout all life stages; 

15 ‘‘(E) hormonally driven cancer; and 

16 ‘‘(F) other related effects; 

17 ‘‘(4) consider the potential for additive and syn18 ergistic effects; 

19 ‘‘(5) be carried out using a multidisciplinary ap20 proach to ensure connections among multiple levels, 

21 including the molecular, organ, and whole animal or 

22 human levels; 

23 ‘‘(6) refine computational modeling tools to in24 tegrate cellular pathway data into a dose-response 

25 framework for risk assessment; 


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1 ‘‘(7) identify biomarkers of exposure and effect 

2 that can be further developed and translated for use 

3 in human epidemiological and public health studies 

4 focused on defining the role of endocrine-disrupting 

5 chemicals in disease etiology across the lifespan; and 

6 ‘‘(8) ensure that research or testing involving 

7 living animals is carried out only when equally effec8 tive and reliable alternative approaches for obtaining 

9 the result sought are not readily available. 

10 ‘‘(b) WORKSHOPS AND FORA.—The Director of the 

11 Institute may conduct workshops and fora and provide in12 formation on the health effects associated with chemicals 

13 that may disrupt the endocrine system in order to— 

14 ‘‘(1) identify chemicals for research under sub15 section (a); 

16 ‘‘(2) strategize on approaches for the develop17 ment of sensitive tests to screen chemicals for endo18 crine-disrupting activity using assays; 

19 ‘‘(3) review the state of the science on endo20 crine-disrupting chemicals and provide recommenda21 tions for a research, testing, and training agenda; 

22 and 

23 ‘‘(4) educate attendees about endocrine-dis24 rupting chemicals. 

25 ‘‘(c) DEFINITIONS.—In this section: 


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1 ‘‘(1) The term ‘chemical’ means an individual 

2 chemical, a combination of chemicals, or a mixture 

3 of chemicals. 

4 ‘‘(2) The term ‘endocrine-disrupting chemical’ 

5 means a chemical that interrupts, alters, interferes 

6 with, disturbs, or otherwise changes the human or 

7 animal endocrine system or its functioning.’’. 

8 TITLE II—REDUCING EXPOSURE 

9 TO ENDOCRINE-DISRUPTING 

10 CHEMICALS 

11 SEC. 201. FEDERAL AGENCY ACTION. 

12 (a) RESPONSE TO LIST AND STRATEGY.— 

13 (1) IN GENERAL.—Not later than 90 days after 

14 receiving each biennial list, strategy, and report 

15 under section 101(a)(4), each Federal agency with 

16 regulatory authority over any chemical included on 

17 the list shall prepare and publish a written response 

18 to the list and strategy. 

19 (2) CONTENTS.—At a minimum, a Federal 

20 agency’s response under paragraph (1) shall— 

21 (A) include an evaluation of the findings 

22 and determinations of the National Toxicology 

23 Program pertaining to each listed chemical sub24 ject to the agency’s regulatory authority; and 


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1 (B) adopt or modify, as scientifically ap2 propriate, each finding of the National Toxi3 cology Program pertaining to— 

4 (i) whether any such chemical dis5 rupts or may disrupt the human endocrine 

6 system; 

7 (ii) the level of concern associated 

8 with any such chemical’s potential to dis9 rupt the human endocrine system; and 

10 (iii) the pathways of exposure to the 

11 chemical for humans and animals. 

12 (b) MINIMAL LEVEL OF CONCERN.—If the Director 

13 finds under section 101(a)(3)(A) that there is at least a 

14 minimal level of concern that a chemical may disrupt the 

15 human endocrine system— 

16 (1) each Federal agency with regulatory author17 ity over the chemical shall— 

18 (A) develop a strategy for reducing human 

19 exposure to the chemical; 

20 (B) make the strategy publicly available 

21 not later than 180 days after the agency re22 ceives the Director’s finding; and 

23 (C) include in the strategy methods to pro24 mote voluntary actions by industry for reducing 

25 human exposure to the chemical; and 


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1 (2) each Federal agency with regulatory author2 ity over the chemical shall take action under such 

3 authority, such as further testing or issuance of or4 ders, regulations, or public notices, to reduce or 

5 eliminate human exposure to the chemical. 

6 (c) HIGHEST LEVEL OF CONCERN.— 

7 (1) PROHIBITION.—Beginning on the date that 

8 is 24 months after the Director makes publicly avail9 able a finding under section 101(a)(3)(B) that there 

10 is a high level of concern that a chemical may dis11 rupt the human endocrine system, it shall be unlaw12 ful to use the chemical in a manner in or affecting 

13 interstate commerce unless the pathway to human 

14 exposure is mitigated before or in conjunction with 

15 such use. 

16 (2) FEDERAL AGENCY ACTION.—Not later than 

17 24 months after the Director makes publicly avail18 able such a finding under section 101(a)(3)(B), each 

19 Federal agency with regulatory authority over the 

20 chemical subject to the finding shall establish regu21 lations or take other actions to implement the prohi22 bition in paragraph (1) with respect to such chem23 ical. 

24 (d) AGGREGATED COMPUTATIONAL TOXICOLOGY RE25 SOURCES DATABASES.—The Administrator of the EnviVerDate Mar 15 2010 04:25 Jul 14, 2011 Jkt 099200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H2521.IH H2521

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1 ronmental Protection Agency shall include the findings 

2 and determinations of the National Toxicology Program 

3 pertaining to endocrine-disrupting chemicals in the Aggre4 gated Computational Toxicology Resource (ACToR) data5 bases (or any successor databases) to the extent otherwise 

6 permitted by law including any restrictions on the disclo7 sure of confidential business information. 

8 SEC. 202. CITIZEN SUITS. 

9 (a) AUTHORITY TO BRING CIVIL ACTIONS.—Any 

10 State, Tribe, local government, or person may commence 

11 a civil action to prevent or restrain a prohibited use of 

12 a chemical in violation of section 201. 

13 (b) JURISDICTION.—The United States courts of ap14 peal shall have exclusive original jurisdiction over such ac15 tion. 

16 TITLE III—TRAINING 

17 SEC. 301. TRAINING IN FIELDS RELATED TO THE PREVEN18 TION OF ENDOCRINE DISRUPTION. 

19 The Director shall establish a program to support, 

20 directly or by making grants, graduate and postdoctoral 

21 training in fields related to the study and prevention of 

22 endocrine disruption. 


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1 TITLE IV—MISCELLANEOUS 

2 SEC. 401. AUTHORIZATION OF APPROPRIATIONS. 

3 To carry out this Act and the amendments made by 

4 this Act, there are authorized to be appropriated such 

5 sums as may be necessary for fiscal years 2012 through 

6 2021. 

Æ 


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