II 

112TH CONGRESS 

1ST SESSION S. 1361 

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

purposes. 

IN THE SENATE OF THE UNITED STATES 

JULY 13, 2011 

Mr. KERRY introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

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. 

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

TITLE I—RESEARCH ON ENDOCRINE-DISRUPTING CHEMICALS 


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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 Congress finds that— 

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 both ani8 mals and humans, and those links have been further 

9 connected to numerous disorders; 

10 (3) a research and evaluation program that tar11 gets suspected endocrine-disrupting chemicals would 

12 establish greater scientific certainty with respect to 

13 the linkage of particular chemicals with endocrine 

14 system effects; 

15 (4) credible linkages established by the research 

16 described in paragraph (3) would establish a basis 

17 for regulation under authorities that include— 


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1 (A) the Federal Insecticide, Fungicide, and 

2 Rodenticide Act (7 U.S.C. 136 et seq.); 

3 (B) the Food Quality Protection Act of 

4 1996 (7 U.S.C. 136 note; Public Law 104– 

5 170); 

6 (C) the Toxic Substances Control Act (15 

7 U.S.C. 2601 et seq.); 

8 (D) the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 301 et seq.); 

10 (E) the Federal Water Pollution Control 

11 Act (33 U.S.C. 1251 et seq.); 

12 (F) the Safe Drinking Water Act (42 

13 U.S.C. 300f et seq.); and 

14 (G) the Clean Air Act (42 U.S.C. 7401 et 

15 seq.); 

16 (5) the research described in paragraph (3), as 

17 well as availability of information and the scientific 

18 perspective derived from that research, would pro19 mote voluntary actions to reduce exposure to those 

20 harmful endocrine-disrupting chemicals through 

21 market forces; 

22 (6) there is a need to educate the public on the 

23 results of research on endocrine-disrupting chemicals 

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1 dividual consumers can make informed decisions 

2 about potential exposure to harmful chemicals; 

3 (7) people should be protected from chemicals 

4 that are found to have endocrine-disrupting effects; 

5 and 

6 (8) animal testing should be reduced to the 

7 minimum necessary with the goal of transitioning to 

8 a predominantly nonanimal paradigm as articulated 

9 in the 2007 National Research Council report enti10 tled ‘‘Toxicity Testing in the Twenty-First Century: 

11 A Vision and a Strategy’’. 

12 SEC. 4. DEFINITIONS. 

13 In this Act: 

14 (1) CHEMICAL.—The term ‘‘chemical’’ means 

15 an individual chemical, a combination of chemicals, 

16 or a mixture of chemicals. 

17 (2) DIRECTOR.—The term ‘‘Director’’ means 

18 the Director of the National Institute of Environ19 mental Health Sciences. 

20 (3) ENDOCRINE-DISRUPTING CHEMICAL.—The 

21 term ‘‘endocrine-disrupting chemical’’ means a 

22 chemical that interrupts, alters, interferes with, dis23 turbs, or otherwise changes the human endocrine 

24 system or cell functioning. 


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1 (4) ENDOCRINE DISRUPTION EXPERT PANEL; 

2 EXPERT PANEL; PANEL.—The terms ‘‘endocrine dis3 ruption expert panel’’, ‘‘expert panel’’, and ‘‘panel’’ 

4 mean the endocrine disruption expert panel estab5 lished under section 101(a)(2). 

6 SEC. 5. TIERING APPLICABLE TO LEVELS OF EVIDENCE 

7 AND CONCERN. 

8 In identifying, determining, or making a finding with 

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

10 this Act (including under sections 101(a)(3), 101(a)(4), 

11 101(b)(2)(C), and 201(a)(2)(B)), the Director or the ex12 pert panel, as applicable, shall select from among the fol13 lowing levels: 

14 (1) High. 

15 (2) Substantial. 

16 (3) Minimal. 

17 (4) None. 

18 TITLE I—RESEARCH ON ENDO19 CRINE-DISRUPTING CHEMI20 CALS 

21 SEC. 101. NATIONAL TOXICOLOGY PROGRAM ACTIVITIES. 

22 (a) IN GENERAL.—As part of the National Toxi23 cology Program, the Director, in consultation with the Na24 tional Toxicology Program Board of Scientific Counselors 

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


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1 (1) establish and implement a research program 

2 designed to strengthen the scientific basis of infor3 mation used by Federal agencies to understand the 

4 effects of, and reduce human exposure to, endocrine5 disrupting chemicals; 

6 (2) subject to subsection (b)(1), establish an en7 docrine disruption expert panel and direct the panel 

8 to consider and report to the Director on issues re9 lating to the identification, classification, or evalua10 tion of endocrine-disrupting chemicals under sub11 section (b)(2); 

12 (3) for each chemical determined by the Direc13 tor to be a potential or actual endocrine-disrupting 

14 chemical identify— 

15 (A) the level of evidence that the chemical 

16 is or may be an endocrine-disrupting chemical; 

17 (B) the level of concern that the chemical 

18 may disrupt the human endocrine system; and 

19 (C) the pathways of exposure to the chem20 ical for humans and animals; and 

21 (4) not later than 2 years after the date of en22 actment of this Act and every 2 years thereafter, 

23 make publicly available and submit to Congress and 

24 each relevant Federal agency— 

25 (A) an up-to-date list that— 


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1 (i) specifies each chemical identified 

2 by the Director to be a potential or actual 

3 endocrine-disrupting chemical; and 

4 (ii) identifies— 

5 (I) the level of evidence that the 

6 chemical disrupts the human endo7 crine system; 

8 (II) the level of concern that the 

9 chemical disrupts the human endo10 crine system; and 

11 (III) the pathways of exposure to 

12 the chemical for humans and animals; 

13 and 

14 (B) a report on— 

15 (i) the activities of the National Toxi16 cology Program pertaining to endocrine17 disrupting chemicals; and 

18 (ii) the activities of Federal agencies 

19 with respect to endocrine-disrupting chemi20 cals, including actions taken or expected to 

21 be taken pursuant to section 201. 

22 (b) EXPERT PANEL.— 

23 (1) APPOINTMENT.—The Director, in consulta24 tion with the National Toxicology Program Board of 

25 Scientific Counselors (or any successor board or 


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1 committee), shall appoint the members of the endo2 crine disruption expert panel from among individuals 

3 who— 

4 (A) have established expertise in the field 

5 of endocrine disruption research by publishing 

6 research in peer-reviewed literature; 

7 (B) have received Federal endocrine re8 search-related funding during the 2 years pre9 ceding the date of appointment under this sub10 section; 

11 (C) provide assurances that the member 

12 will carry out the duties of that member in a 

13 manner free of conflicts of interest, as deter14 mined by the Director, including by complying 

15 with section 208 of title 18, United States 

16 Code; and 

17 (D) represent diverse disciplines, which 

18 may include endocrinology, developmental and 

19 neurological biology, embryology, biochemistry, 

20 physiology, epidemiology, endocrine-driven on21 cology, in vitro and computational toxicology, 

22 and medical research. 

23 (2) DUTIES.—For each of the 10 fiscal years 

24 following the date of enactment of this Act, the ex25 pert panel shall— 


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1 (A) consider and report to the Director on 

2 issues relating to the identification, classifica3 tion, or evaluation of not more than 10 endo4 crine-disrupting chemicals or groups of endo5 crine-disrupting chemicals; 

6 (B) evaluate existing research aimed at un7 derstanding the biological pathways in humans 

8 by which endocrine-disrupting chemicals operate 

9 and as appropriate, identify future research pri10 orities; and 

11 (C) maintain a list that identifies chemi12 cals of concern for endocrine disruption effects, 

13 including findings based on peer-reviewed stud14 ies and other relevant data that relate to— 

15 (i) whether a chemical is a potential 

16 or actual endocrine-disrupting chemical; 

17 (ii) the level of evidence that the 

18 chemical is or may be an endocrine-dis19 rupting chemical; 

20 (iii) the level of concern that the 

21 chemical may disrupt the human endocrine 

22 system; 

23 (iv) the pathways of exposure to the 

24 chemical for humans and animals; and 


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1 (v) the need for additional data, as2 says, testing, or research to determine the 

3 level of concern associated with the poten4 tial of the chemical to disrupt the human 

5 endocrine system. 

6 (3) REPORT.—The expert panel shall submit to 

7 the Director and make publicly available a biennial 

8 report on the activities of the panel, including an up9 to-date version of the list under paragraph (2)(C). 

10 (c) PETITIONS.— 

11 (1) IN GENERAL.—Any Federal agency, State, 

12 local, or tribal government, or person may petition 

13 the Director— 

14 (A) to determine whether a chemical 

15 should be identified by the National Toxicology 

16 Program to be a potential or actual endocrine17 disrupting chemical and included in the list 

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

19 (B) to reclassify a chemical, revise a find20 ing, or amend any other determination of the 

21 National Toxicology Program based on new in22 formation. 

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

24 that provide for— 


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1 (A) the form and procedure for filing a pe2 tition under paragraph (1); and 

3 (B) the procedural rights of an entity that 

4 files a petition under paragraph (1). 

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

6 other determination under this section shall not be subject 

7 to— 

8 (1) judicial review; or 

9 (2) correction under section 515 of the Treas10 ury and General Government Appropriations Act, 

11 2001 (114 Stat. 2763A–153). 

12 SEC. 102. RESEARCH PROGRAM OF NATIONAL INSTITUTE 

13 OF ENVIRONMENTAL HEALTH SCIENCES. 

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

15 Service Act (42 U.S.C. 281 et seq.) is amended by adding 

16 at the end the following: 

17 ‘‘SEC. 463C. ENDOCRINE DISRUPTION RESEARCH PRO18 GRAM. 

19 ‘‘(a) DEFINITIONS.—In this section: 

20 ‘‘(1) CHEMICAL.—The term ‘chemical’ means 

21 an individual chemical, a combination of chemicals, 

22 or a mixture of chemicals. 

23 ‘‘(2) ENDOCRINE-DISRUPTING CHEMICAL.—The 

24 term ‘endocrine-disrupting chemical’ means a chem25 ical that interrupts, alters, interferes with, disturbs, 


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1 or otherwise changes the human or animal endocrine 

2 system or its functioning. 

3 ‘‘(b) ENDOCRINE DISRUPTION RESEARCH PRO4 GRAM.— 

5 ‘‘(1) IN GENERAL.—The Director of the Insti6 tute shall conduct and support a research program, 

7 to be known as the ‘Endocrine Disruption Research 

8 Program’, to improve the understanding of the man9 ner in which chemicals can disrupt the human endo10 crine system. 

11 ‘‘(2) CONTENTS.—The Endocrine Disruption 

12 Research Program shall— 

13 ‘‘(A) be designed— 

14 ‘‘(i) to develop the information needed 

15 by Federal agencies to understand chem16 ical disruption of the endocrine system and 

17 reduce human and animal exposure to en18 docrine-disrupting chemicals; 

19 ‘‘(ii) to understand the cellular path20 ways in humans by which endocrine-dis21 rupting chemicals are able to cause adverse 

22 effects; and 

23 ‘‘(iii) to use laboratory practices that 

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1 curate and reproducible to be used for reg2 ulatory decisions; 

3 ‘‘(B) include research to design, develop, 

4 and validate appropriately sensitive tests to 

5 screen and identify chemicals capable of dis6 rupting the human endocrine system; 

7 ‘‘(C) address the full range of potential 

8 human health impacts, including— 

9 ‘‘(i) male and female developmental 

10 and reproductive disorders; 

11 ‘‘(ii) brain and neurobehavioral dis12 orders; 

13 ‘‘(iii) metabolic syndromes, 

14 prediabetes, diabetes, improper glucose and 

15 fat metabolisms, obesity, and cardio16 vascular disorders; 

17 ‘‘(iv) effects on the pituitary, 

18 hypothalamus, hippocampus, thyroid, adre19 nal system, immune system, bones, cardio20 vascular system, and other endocrine or21 gans and systems throughout all life 

22 stages; 

23 ‘‘(v) hormonally driven cancer; and 

24 ‘‘(vi) other related effects; 


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1 ‘‘(D) consider the potential for additive 

2 and synergistic effects; 

3 ‘‘(E) be carried out using a multidisci4 plinary approach to ensure connections among 

5 multiple levels, including the molecular, organ, 

6 and whole animal or human levels; 

7 ‘‘(F) refine computational modeling tools 

8 to integrate cellular pathway data into a dose9 response framework for risk assessment; 

10 ‘‘(G) identify biomarkers of exposure and 

11 effect that can be further developed and trans12 lated for use in human epidemiological and pub13 lic health studies focused on defining the role of 

14 endocrine-disrupting chemicals in disease eti15 ology across the lifespan; and 

16 ‘‘(H) ensure that research or testing in17 volving living animals is carried out only when 

18 equally effective and reliable alternative ap19 proaches for obtaining the result sought are not 

20 readily available. 

21 ‘‘(c) WORKSHOPS AND FORUMS.—The Director of 

22 the Institute may conduct workshops and forums and pro23 vide information on the health effects associated with 

24 chemicals that may disrupt the endocrine system— 


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1 ‘‘(1) to identify chemicals for research under 

2 subsection (b); 

3 ‘‘(2) to strategize on approaches for the devel4 opment of sensitive tests to screen chemicals for en5 docrine-disrupting activity using assays; 

6 ‘‘(3) to review the state of the science on endo7 crine-disrupting chemicals and provide recommenda8 tions for a research, testing, and training agenda; 

9 and 

10 ‘‘(4) to educate attendees about endocrine-dis11 rupting chemicals.’’. 

12 TITLE II—REDUCING EXPOSURE 

13 TO ENDOCRINE-DISRUPTING 

14 CHEMICALS 

15 SEC. 201. FEDERAL AGENCY ACTION. 

16 (a) RESPONSE TO LIST AND STRATEGY.— 

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

18 receiving each biennial list, strategy, and report 

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

20 regulatory authority over any chemical included on 

21 the list shall prepare and publish a written response 

22 to the list and strategy. 

23 (2) CONTENTS.—At a minimum, the response 

24 of a Federal agency under paragraph (1) shall— 


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1 (A) include an evaluation of the findings 

2 and determinations of the National Toxicology 

3 Program pertaining to each listed chemical sub4 ject to the regulatory authority of that Federal 

5 agency; and 

6 (B) adopt or modify, as scientifically ap7 propriate, each finding of the National Toxi8 cology Program pertaining to— 

9 (i) whether the chemical disrupts or 

10 may disrupt the human endocrine system; 

11 (ii) the level of concern associated 

12 with the potential of the chemical to dis13 rupt the human endocrine system; and 

14 (iii) the pathways of exposure to the 

15 chemical for humans and animals. 

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

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

18 minimal level of concern that a chemical may disrupt the 

19 human endocrine system each Federal agency with regu20 latory authority over the chemical shall— 

21 (1) develop a strategy for reducing human ex22 posure to the chemical that— 

23 (A) is made publicly available not later 

24 than 180 days after the date on which the 

25 agency receives the finding of the Director; and 


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1 (B) includes methods to promote voluntary 

2 actions by industry for reducing human expo3 sure to the chemical; and 

4 (2) take any necessary action under that regu5 latory authority, including further testing or 

6 issuance of orders, regulations, or public notices, to 

7 reduce or eliminate human exposure to the chemical. 

8 (c) HIGHEST LEVEL OF CONCERN.— 

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

10 is 2 years after the date on which the Director 

11 makes publicly available a finding under section 

12 101(a)(3)(B) that there is a high level of concern 

13 that a chemical may disrupt the human endocrine 

14 system, it shall be unlawful to use the chemical in 

15 interstate commerce or in a manner that affects 

16 interstate commerce, unless the pathway to human 

17 exposure is mitigated before or in conjunction with 

18 that use. 

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

20 the date that is 2 years after the date on which the 

21 Director makes publicly available a finding described 

22 in paragraph (1), each Federal agency with regu23 latory authority over the chemical subject to the 

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1 propriate actions to implement paragraph (1) with 

2 respect to the chemical. 

3 (d) AGGREGATED COMPUTATIONAL TOXICOLOGY RE4 SOURCES DATABASES.—The Administrator of the Envi5 ronmental Protection Agency shall include the findings 

6 and determinations of the National Toxicology Program 

7 pertaining to endocrine-disrupting chemicals in the Aggre8 gated Computational Toxicology Resource (ACToR) data9 bases (or any successor databases) to the extent otherwise 

10 permitted by law, including any restrictions on the disclo11 sure of confidential business information. 

12 SEC. 202. CITIZEN SUITS. 

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

14 State, local, or tribal government, or any other person, 

15 may commence a civil action to prevent or restrain a pro16 hibited use of a chemical in violation of section 201. 

17 (b) JURISDICTION.—The United States Court of Ap18 peals for the circuit in which the person commencing the 

19 civil action resides shall have exclusive original jurisdiction 

20 over an action described in subsection (a). 

21 TITLE III—TRAINING 

22 SEC. 301. TRAINING IN FIELDS RELATED TO THE PREVEN23 TION OF ENDOCRINE DISRUPTION. 

24 The Director shall establish a program to support, 

25 either directly or by making grants, graduate and 


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1 postdoctoral training in fields relating to the study and 

2 prevention of endocrine disruption. 

3 TITLE IV—MISCELLANEOUS 

4 SEC. 401. AUTHORIZATION OF APPROPRIATIONS. 

5 There are authorized to be appropriated to carry out 

6 this Act and the amendments made by this Act such sums 

7 as are necessary for each of fiscal years 2012 through 

8 2021. 

Æ 


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