I 

111TH CONGRESS 

1ST SESSION H. R. 4160 

To amend the Public Health Service Act to authorize the National Institute 

of Environmental Health Sciences to conduct and coordinate a research 

program on hormone disruption, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 1, 2009 

Ms. SLAUGHTER (for herself, Mrs. CAPPS, Mr. ELLISON, Mr. HINCHEY, Ms. 

MCCOLLUM, Ms. SCHAKOWSKY, Ms. WOOLSEY, Mr. GRIJALVA, Mr. 

MCGOVERN, Mr. GEORGE MILLER of California, Mr. ISRAEL, Mr. 

DOGGETT, and Mr. STARK) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to 

the Committee on Rules, for a period to be subsequently determined by 

the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To amend the Public Health Service Act to authorize the 

National Institute of Environmental Health Sciences to 

conduct and coordinate a research program on hormone 

disruption, 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 ‘‘Environmental Hor5 mone Disruption Research Act of 2009’’. 


smartinez on DSKB9S0YB1PROD with BILLS
2 

•HR 4160 IH

1 SEC. 2. FINDINGS. 

2 The Congress finds as follows: 

3 (1) Many compounds found or introduced into 

4 the environment by human activity are capable of 

5 disrupting the hormone system of humans and ani6 mals. The consequences of such disruption can be 

7 profound because of the crucial role hormones play 

8 in controlling development and metabolism. Few 

9 standardized and validated screens or tests have 

10 been developed to routinely and systematically assess 

11 chemicals for disruptive effects on hormone systems. 

12 Even fewer have statistical power to detect sufficient 

13 problems. 

14 (2) In the last 30 years, the United States has 

15 experienced an increase in the incidence of such 

16 human disorders as childhood cancers, testicular 

17 cancer, hypospadias, juvenile diabetes, attention def18 icit disorder and attention deficit hyperactivity dis19 order, autism, thyroid disorders, learning disabilities, 

20 cognitive impairment, and auto-immune disorders. 

21 Exposure to hormone-disrupting pollutants may be 

22 contributing to these increases. The impact on chil23 dren’s health as a result of prenatal exposures in 

24 particular needs further research. 

25 (3) In 2001, the Centers for Disease Control 

26 and Prevention’s ‘‘National Report on Human ExpoVerDate Nov 24 2008 01:42 Dec 02, 2009 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4160.IH H4160

smartinez on DSKB9S0YB1PROD with BILLS
3 

•HR 4160 IH

1 sure to Environmental Chemicals’’ reported on 

2 human exposure to 27 chemicals, and found unex3 pectedly high levels of certain chemicals used in con4 sumer products. The hazards to humans of these 

5 chemicals, singly and in combination, are not well 

6 understood. 

7 (4) Many wildlife populations have disrupted re8 production or development, including birds, fish, am9 phibians, and mammals. The effects vary among 

10 species, and some are due to exposure to hormone11 disrupting substances. 

12 (5) Observed disruptions in wildlife include thy13 roid dysfunction, decreased fertility, decreased 

14 hatching success, gross birth deformities, metabolic 

15 and behavioral abnormalities, demasculinization and 

16 feminization of male organisms, deformation and 

17 masculinization of female organisms, and com18 promised immune systems. If due to exposure to 

19 hormone-disrupting substances, then these effects 

20 may signal hazards to human health. 

21 (6) Laboratory studies have corroborated stud22 ies of some effects in wildlife and have identified bio23 logical mechanisms to explain the effects shown. The 

24 chemicals found in wildlife are also found in hu25 mans. 


smartinez on DSKB9S0YB1PROD with BILLS
4 

•HR 4160 IH

1 (7) Hormone disruption might occur at very low 

2 environmental doses, especially when exposure oc3 curs in the womb or immediately after birth, periods 

4 during which rapid development is occurring. 

5 (8) In 1998, a research committee on hormone 

6 disrupters, organized under the auspices of the Of7 fice of Science and Technology Policy, concluded 

8 that ‘‘scientific knowledge is inadequate to fully in9 form public policy, and a government-wide coordi10 nated research effort that addresses the key sci11 entific uncertainties . . . is needed’’. 

12 (9) In 1999, in response to a request from Con13 gress and funded through the Environmental Protec14 tion Agency and the Department of the Interior, the 

15 National Academy of Sciences compiled a lengthy 

16 list of research, monitoring, and testing priorities re17 lated to hormone disruption. 

18 (10) The National Institute of Environmental 

19 Health Sciences conducts much of the Federal Gov20 ernment’s research on hormone disruption, often 

21 working in partnership with other agencies. 

22 (11) While recognizing the many contributions 

23 of animal testing to understanding toxic hazards, the 

24 Congress also recognizes the desirability of speeding 

25 the use of validated nonanimal screens and tests (to 


smartinez on DSKB9S0YB1PROD with BILLS
5 

•HR 4160 IH

1 reduce animal suffering and to reduce costs) and ex2 pediting judgments about hazards from toxic chemi3 cals. 

4 (12) The Department of the Interior has con5 siderable experience assessing the occurrence of 

6 chemicals in the environment, ecological health, and 

7 the hazards to wildlife health and associated human 

8 health posed by chemicals in the environment, as a 

9 result of monitoring by the Department of the Na10 tion’s water resources and wildlife disease, and re11 search by the Department on the effects of chemi12 cals on wildlife. 

13 (13) The National Academy of Sciences has 

14 recognized the expertise of the United States Geo15 logical Survey (‘‘USGS’’) in such areas as food web 

16 contamination and water quality assessment and has 

17 encouraged more coordinated work on human health 

18 between the USGS and the National Institutes of 

19 Health. 


smartinez on DSKB9S0YB1PROD with BILLS
6 

•HR 4160 IH

1 SEC. 3. NATIONAL INSTITUTE OF ENVIRONMENTAL 

2 HEALTH SCIENCES; DIRECTED NATIONAL 

3 PROGRAM OF RESEARCH ON HORMONE DIS4 RUPTION. 

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

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

7 at the end the following: 

8 ‘‘SEC. 463C. DIRECTED NATIONAL PROGRAM OF RESEARCH 

9 ON HORMONE DISRUPTION. 

10 ‘‘(a) RESEARCH.— 

11 ‘‘(1) IN GENERAL.—The Director of the Insti12 tute shall establish within the Institute a comprehen13 sive program to— 

14 ‘‘(A) carry out research on the health ef15 fects on women and children that may result 

16 through disruption of the hormone systems; 

17 ‘‘(B) carry out research, development, and 

18 demonstrations with respect to technologies to 

19 mitigate the occurrence of hormone-disrupting 

20 pollutants in the environment and their unin21 tended effects on ecological and wildlife health, 

22 in cooperation with the United States Geologi23 cal Survey (referred to in this section as the 

24 ‘USGS’); 


smartinez on DSKB9S0YB1PROD with BILLS
7 

•HR 4160 IH

1 ‘‘(C) coordinate research on hormone dis2 ruption in the United States with such research 

3 conducted in other nations; and 

4 ‘‘(D) provide for the dissemination of in5 formation described in paragraph (2) to the 

6 public. 

7 ‘‘(2) ISSUES.—The program established under 

8 paragraph (1) shall provide for the following: 

9 ‘‘(A) Collection, compilation, publication, 

10 and dissemination of scientifically valid infor11 mation on— 

12 ‘‘(i) possible unintended human health 

13 effects of hormone-disrupting pollutants, 

14 with emphasis on exposures to low doses of 

15 individual chemicals and chemical mixtures 

16 during critical life stages of development, 

17 particularly effects of prenatal exposures 

18 on children’s health; 

19 ‘‘(ii) the extent of human exposure to 

20 hormone-disrupting pollutants, with par21 ticular emphasis on exposures during crit22 ical life stages of development and in resi23 dential and occupational settings; and 

24 ‘‘(iii) exposure of wildlife species to 

25 hormone-disrupting pollutants and possible 


smartinez on DSKB9S0YB1PROD with BILLS
8 

•HR 4160 IH

1 health effects associated with such expo2 sures. 

3 ‘‘(B) Research, in coordination with the 

4 Environmental Protection Agency and the 

5 USGS, on mechanisms by which hormone-dis6 rupting pollutants interact with biological sys7 tems. 

8 ‘‘(C) Research on improved in vitro, in 

9 vivo, and in silico methods to screen and test 

10 hormone disruption. 

11 ‘‘(D) Research on the identity, levels, 

12 transport, and fate of hormone-disrupting pol13 lutants in the environment. 

14 ‘‘(b) DIRECTOR’S DUTIES.— 

15 ‘‘(1) IN GENERAL.—The Director of the Insti16 tute shall have principal responsibility, in consulta17 tion with the Director of the USGS, for conducting 

18 and coordinating research on the unintended effects 

19 of hormone-disrupting pollutants on human health 

20 and the environment. 

21 ‘‘(2) AGREEMENT.—Not later than 6 months 

22 after the date of the enactment of the Environ23 mental Hormone Disruption Research Act of 2009, 

24 the Director of the Institute and the Director of the 


smartinez on DSKB9S0YB1PROD with BILLS
9 

•HR 4160 IH

1 USGS shall enter into an agreement to carry out the 

2 research program established under subsection (a). 

3 ‘‘(3) TRANSFER OF FUNDS.—The Director of 

4 the Institute may transfer funds to other Federal 

5 agencies to carry out the Director’s responsibilities 

6 under paragraph (1). 

7 ‘‘(4) REPORT.—The Director of the Institute, 

8 in consultation with the Director of the USGS, shall 

9 make available to the public, every 2 years following 

10 the date of the enactment of the Environmental 

11 Hormone Disruption Research Act of 2009, a report 

12 summarizing findings and conclusions on the extent 

13 to which hormone disruption by pollutants in the en14 vironment poses a threat to human health and the 

15 environment. 

16 ‘‘(c) INTERAGENCY COMMISSION.— 

17 ‘‘(1) ESTABLISHMENT.—The Secretary shall es18 tablish a commission to be known as the Hormone 

19 Disruption Research Interagency Commission (re20 ferred to in this section as the ‘Interagency Commis21 sion’) to advise the Director of the Institute and the 

22 Director of the USGS on the development of a com23 prehensive agenda for conducting research on hor24 mone disruption. 


smartinez on DSKB9S0YB1PROD with BILLS
10 

•HR 4160 IH

1 ‘‘(2) MEMBERSHIP.—The Interagency Commis2 sion shall be composed of 14 members, as follows: 

3 ‘‘(A) The Director of the Institute, who 

4 shall serve as the Chairperson. 

5 ‘‘(B) The Director of the USGS, who shall 

6 serve as the Vice Chairperson. 

7 ‘‘(C) The Director of the National Insti8 tute of Child Health and Human Development. 

9 ‘‘(D) The Commissioner of Food and 

10 Drugs. 

11 ‘‘(E) The Director of the Centers for Dis12 ease Control and Prevention. 

13 ‘‘(F) The Administrator of the National 

14 Oceanic and Atmospheric Administration. 

15 ‘‘(G) The Director of the National Insti16 tute for Occupational Safety and Health. 

17 ‘‘(H) The Administrator of the Agency for 

18 Toxic Substances and Disease Registry. 

19 ‘‘(I) The Director of the Fish and Wildlife 

20 Service. 

21 ‘‘(J) The Secretary of Defense. 

22 ‘‘(K) The Administrator of the Environ23 mental Protection Agency. 

24 ‘‘(L) The Chairman of the Consumer 

25 Product Safety Commission. 


smartinez on DSKB9S0YB1PROD with BILLS
11 

•HR 4160 IH

1 ‘‘(M) The Director of the National Science 

2 Foundation. 

3 ‘‘(N) The Director of the National Insti4 tute of Neurological Disorders and Stroke. 

5 ‘‘(3) STAFF.—Each department or agency rep6 resented by a member on the Interagency Commis7 sion shall provide appropriate staff to carry out the 

8 duties of the Interagency Commission. 

9 ‘‘(4) RECOMMENDATIONS.—Not later than 12 

10 months after the date of the enactment of the Envi11 ronmental Hormone Disruption Research Act of 

12 2009, the Interagency Commission shall recommend 

13 to the Director of the Institute and the Director of 

14 the USGS a research program, including levels of 

15 funding for intramural and extramural research. 

16 ‘‘(5) PUBLIC COMMENT.—The Director of the 

17 Institute, through publication of notice in the Fed18 eral Register, shall provide the general public with 

19 an opportunity to comment on the recommendations 

20 of the Interagency Commission. 

21 ‘‘(6) REPORT.—Not later than 4 years after the 

22 date of the enactment of the Environmental Hor23 mone Disruption Research Act of 2009, the Inter24 agency Commission shall conduct a review of the 

25 program established under subsection (a) and subVerDate Nov 24 2008 01:42 Dec 02, 2009 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H4160.IH H4160

smartinez on DSKB9S0YB1PROD with BILLS
12 

•HR 4160 IH

1 mit a report on the results of such review to the Di2 rector of the Institute and to the Hormone Disrup3 tion Research Panel established under subsection 

4 (e). 

5 ‘‘(7) TERMINATION.—The Interagency Commis6 sion shall terminate not later than the end of the 5- 

7 year fiscal period described in subsection (j)(1). 

8 ‘‘(d) FINANCIAL ASSISTANCE.—The Director of the 

9 Institute may provide financial assistance and enter into 

10 grants, contracts, and interagency memoranda of under11 standing to conduct activities under this section. Research 

12 conducted pursuant to interagency memoranda of under13 standing may be conducted through intramural and extra14 mural agency research programs, subject to appropriate 

15 scientific peer review. 

16 ‘‘(e) HORMONE DISRUPTION RESEARCH PANEL.— 

17 ‘‘(1) ESTABLISHMENT.—There is established in 

18 the Institute a Hormone Disruption Research Panel 

19 (referred to in this subsection as the ‘Panel’). 

20 ‘‘(2) DUTIES.—The Panel shall make rec21 ommendations to the Interagency Commission with 

22 respect to the duties of the Interagency Commission 

23 under subsection (c)(1) and advise the Secretary and 

24 the Director of the Institute with respect to the de25 sign and implementation of the program under subVerDate Nov 24 2008 01:42 Dec 02, 2009 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H4160.IH H4160

smartinez on DSKB9S0YB1PROD with BILLS
13 

•HR 4160 IH

1 section (a), including preparation of solicitations for 

2 proposals to conduct research under the program. 

3 ‘‘(3) MEMBERSHIP.—The Panel shall be com4 posed of the following: 

5 ‘‘(A) 15 voting members to be appointed 

6 by the President, in consultation with the Di7 rector of the Institute. 

8 ‘‘(B) Such nonvoting, ex officio members 

9 as the Director of the Institute determines to 

10 be appropriate. 

11 ‘‘(4) VOTING MEMBERS.—Of the 15 voting 

12 members of the Panel— 

13 ‘‘(A) at least 2 members shall be from en14 vironmental protection organizations; 

15 ‘‘(B) at least 2 members shall be from 

16 public health and consumer organizations; 

17 ‘‘(C) at least 2 members but not more 

18 than 7 shall be from industry; 

19 ‘‘(D) at least 1 member shall be from an 

20 animal welfare organization; and 

21 ‘‘(E) a majority of the members shall be 

22 selected from among scientists and environ23 mental health professionals who— 

24 ‘‘(i) are not officers or employees of 

25 the United States; 


smartinez on DSKB9S0YB1PROD with BILLS
14 

•HR 4160 IH

1 ‘‘(ii) represent multiple disciplines, in2 cluding clinical, basic, public, and ecologi3 cal health sciences; 

4 ‘‘(iii) represent different geographical 

5 regions of the United States; 

6 ‘‘(iv) are from practice settings, aca7 demic settings, and for-profit or not-for8 profit research settings; 

9 ‘‘(v) have experience in review of re10 search on endocrine disruption; and 

11 ‘‘(vi) possess a relevant advanced de12 gree from an accredited college or univer13 sity. 

14 ‘‘(5) TERMS.—The members of the Panel shall 

15 be appointed for an initial term of 3 years and shall 

16 be eligible for reappointment for 1 additional term 

17 of 2 years. 

18 ‘‘(6) CHAIRPERSON.—The members of the 

19 Panel appointed under paragraph (3) shall elect a 

20 chairperson from among such members. 

21 ‘‘(7) MEETINGS.—The Panel shall meet at the 

22 call of the chairperson or upon the request of the 

23 Director of the Institute, but in no case less often 

24 than once each year. 


smartinez on DSKB9S0YB1PROD with BILLS
15 

•HR 4160 IH

1 ‘‘(8) ADMINISTRATIVE SUPPORT.—The Institute 

2 shall provide administrative support to the Panel. 

3 ‘‘(9) TERMINATION.—The Panel shall terminate 

4 not later than the end of the 5-year fiscal period de5 scribed in subsection (j)(1). 

6 ‘‘(f) SOLICITATION AND SELECTION OF PRO7 POSALS.— 

8 ‘‘(1) IN GENERAL.—Within 15 months after the 

9 date of the enactment of the Environmental Hor10 mone Disruption Research Act of 2009, and as often 

11 thereafter as appropriate, the Director of the Insti12 tute shall, in consultation with the Interagency Com13 mission, solicit and select proposals to conduct ac14 tivities under the program under subsection (a). 

15 ‘‘(2) CONSULTATION WITH PANEL.—In pre16 paring solicitations for such proposals, the Director 

17 of the Institute shall consult with the Hormone Dis18 ruption Research Panel. 

19 ‘‘(3) PEER REVIEW PANELS.—Before a pro20 posal to conduct activities under the program under 

21 subsection (a) may be selected by the Director of the 

22 Institute, such proposal shall be submitted to, and 

23 evaluated by, at least one scientific and technical 

24 peer review panel. 

25 ‘‘(g) REPORTS.— 


smartinez on DSKB9S0YB1PROD with BILLS
16 

•HR 4160 IH

1 ‘‘(1) REPORT UPON COMPLETION OF ACTIV2 ITY.—Any person who conducts activities under the 

3 program under subsection (a) shall, upon completion 

4 of the activity, submit to the National Academy of 

5 Sciences, the Interagency Commission, and the Hor6 mone Disruption Research Panel a report summa7 rizing the activities and results thereof. 

8 ‘‘(2) REPORT TO INTERAGENCY COMMISSION

9 AND PANEL.—The Director of the Institute shall 

10 enter into appropriate arrangements with the Na11 tional Academy of Sciences under which the Acad12 emy shall periodically submit to the Interagency 

13 Commission and the Hormone Disruption Research 

14 Panel a report that evaluates the research activities 

15 under the program under subsection (a). The report 

16 shall include recommendations to promote the effec17 tive transfer of information derived from such re18 search activities. The Director of the Institute shall 

19 be responsible for expenses incurred by the Academy 

20 in connection with the preparation of such reports. 

21 ‘‘(3) REPORT TO CONGRESS.—The Interagency 

22 Commission, in consultation with the Hormone Dis23 ruption Research Panel, shall submit to the Sec24 retary and the Congress— 


smartinez on DSKB9S0YB1PROD with BILLS
17 

•HR 4160 IH

1 ‘‘(A) not later than December 31, 2013, a 

2 report summarizing the progress of the research 

3 program under subsection (a); and 

4 ‘‘(B) not later than September 30, 2016, a 

5 final report stating the Interagency Commis6 sion’s findings and conclusions on the effects, if 

7 any, of hormone-disrupting pollutants in the en8 vironment on human health and remedial ac9 tions, if any, that may be needed to minimize 

10 any such health effects. 

11 ‘‘(h) CONFLICTS OF INTEREST.—All grants and con12 tracts entered into under this section shall include conflict13 of-interest provisions that require any person conducting 

14 a project under this section to disclose any other source 

15 of funding received by the person to conduct other related 

16 projects. 

17 ‘‘(i) DEFINITIONS.—For purposes of this section: 

18 ‘‘(1) HORMONE.—The term ‘hormone’ means a 

19 substance produced in a cell or tissue that triggers 

20 a biological response. Hormone activity may be local21 ized to the cell in which the substance is produced, 

22 or may be in nearby or distant tissues or organs. 

23 ‘‘(2) HORMONE-DISRUPTING.—The term ‘hor24 mone-disrupting’ means producing effects similar to 

25 those of naturally occurring hormones or interfering 


smartinez on DSKB9S0YB1PROD with BILLS
18 

•HR 4160 IH

1 with hormone signaling or hormone interaction with 

2 receptors. 

3 ‘‘(3) HORMONE DISRUPTION.—The term ‘hor4 mone disruption’ means interference with the syn5 thesis, secretion, transport, binding, action, or elimi6 nation of natural hormones in the body that are re7 sponsible for the maintenance of homeostasis, repro8 duction, development, function, or behavior. 

9 ‘‘(j) AUTHORIZATION OF APPROPRIATIONS.— 

10 ‘‘(1) GENERAL AUTHORIZATION.—There are 

11 authorized to be appropriated such sums as may be 

12 necessary for the 5-fiscal-year period beginning with 

13 fiscal year 2011 to carry out this section. Amounts 

14 appropriated pursuant to this paragraph shall re15 main available until expended. 

16 ‘‘(2) RESTRICTIONS ON USE OF FUNDS.— 

17 ‘‘(A) CONSTRUCTION AND REHABILITA18 TION OF FACILITIES AND EQUIPMENT.—Not 

19 more than 0.5 percent of the funds made avail20 able under this section may be used for the con21 struction or rehabilitation of facilities or fixed 

22 equipment. 

23 ‘‘(B) ADMINISTRATIVE EXPENSES OF THE

24 DIRECTOR.—Of the total amount of funds made 

25 available under this section for any fiscal year, 


smartinez on DSKB9S0YB1PROD with BILLS
19 

•HR 4160 IH

1 not more than 2 percent of such funds may be 

2 used for administrative expenses of the Director 

3 of the Institute in carrying out this section. 

4 ‘‘(C) PUBLIC OUTREACH.—Of the total 

5 amount of funds made available under this sec6 tion for any fiscal year, at least 1 percent, but 

7 not more than 5 percent, shall be used for out8 reach to the public concerning the activities and 

9 results of the program.’’. 

10 SEC. 4. COMMITTEE HEARING ON IMPLEMENTATION. 

11 (a) IN GENERAL.—The Committee on Energy and 

12 Commerce of the House of Representatives shall hold a 

13 hearing on the implementation by the Director of the Na14 tional Institute of Environmental Health Sciences of sec15 tion 463C of the Public Health Service Act, as added by 

16 section 3 of this Act. 

17 (b) EXERCISE OF RULEMAKING AUTHORITY.—Sub18 section (a)— 

19 (1) is enacted as an exercise of the rulemaking 

20 power of the House of Representatives and, as 

21 such— 

22 (A) shall be considered as part of the rules 

23 of the House; and 


smartinez on DSKB9S0YB1PROD with BILLS
20 

•HR 4160 IH

1 (B) shall supersede any other rule of the 

2 House only to the extent that rule is incon3 sistent therewith; and 

4 (2) is enacted with full recognition of the con5 stitutional right of the House to change such rules 

6 (so far as relating to the procedure in the House) 

7 at any time, in the same manner, and to the same 

8 extent as in the case of any other rule of the House. 

Æ 


smartinez on DSKB9S0YB1PROD with BILLS