I 

111TH CONGRESS 

1ST SESSION H. R. 4190 

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

of Environmental Health Sciences to conduct a research program on 

endocrine disruption, to prevent and reduce the production of, and exposure to, chemicals that can undermine the development of children before 

they are born and cause lifelong impairment to their health and function, 

and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 3, 2009 

Mr. MORAN of Virginia (for himself, Mrs. LOWEY, Mr. GEORGE MILLER of 

California, Ms. MCCOLLUM, Mr. GRIJALVA, Mr. MCGOVERN, Mr. HINCHEY, and Mr. KENNEDY) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to authorize the 

National Institute of Environmental Health Sciences to 

conduct a research program on endocrine disruption, to 

prevent and reduce the production of, and exposure to, 

chemicals that can undermine the development of children before they are born and cause lifelong impairment 

to their health and function, 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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Endocrine Disruption 

3 Prevention Act of 2009’’. 

4 SEC. 2. FINDINGS, POLICIES, AND GOALS. 

5 (a) FINDINGS.—The Congress finds that— 

6 (1) a disturbing increase in the number of dis7 orders of the human endocrine system is seriously 

8 undermining the health and wealth of the Nation; 

9 (2) these disorders include attention deficit hy10 peractivity disorder (ADHD), autism, learning dis11 abilities, asthma, juvenile cancer, juvenile and adult 

12 diabetes, autoimmune diseases, cryptorchidism, 

13 hypospadias, endometriosis, obesity, osteoporosis, 

14 testicular cancer, male dysgenesis syndrome, breast 

15 cancer, prostate cancer, Parkinson’s disease, and 

16 Alzheimer’s dementia; 

17 (3) these disorders began to increase noticeably 

18 at the population level in the early 1970s when the 

19 first generation exposed in the womb to post-World 

20 War II synthetic chemicals reached maturity; 

21 (4) prior to 1950, these disorders were rare, 

22 which rules out the influence of inherited disorders; 

23 (5) today, among the fourth generation of chil24 dren exposed in the womb, one in three children and 

25 one in two minority children will develop diabetes; 

26 one in six children is born with neurological damage; 


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1 one in 100 children has an autism spectrum disorder 

2 and among boys the occurrence is one in 58; one in 

3 125 boys is born with hypospadias, a condition 

4 where the urethra does not open at the end of the 

5 penis; in 2007, an age-independent decline in testos6 terone levels over the past twenty years was discov7 ered in American men; and declines in male repro8 ductive health have been traced back to damage in 

9 the womb; 

10 (6) evidence from human epidemiological and 

11 laboratory animal studies links these disorders to 

12 prenatal and later life exposure to endocrine dis13 rupting chemicals (EDCs); 

14 (7) the endocrine system is a complex system of 

15 organs regulated by over eighty known hormones as 

16 well as hundreds of auxiliary chemical signaling sys17 tems, and it assures the perpetuity and integrity of 

18 human life; 

19 (8) recent bio-monitoring demonstrates that 

20 embryos, fetuses, infants, and children in the United 

21 States carry hundreds of synthetic chemicals in their 

22 blood and tissue, including EDCs, and similar re23 sults have been found for adults; 

24 (9) thousands of chemicals have become an in25 tegral part of confined environments (homes, 


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1 schools, cars, planes, offices, theaters, malls), con2 tributing to continual, ubiquitous exposure, and it is 

3 vital to be able to identify which are EDCs; 

4 (10) many plant and animal species are show5 ing signs of ill health due to exposure to endocrine 

6 disrupting chemicals, which can cause small, but 

7 critical, changes in the chemical makeup of an envi8 ronment that are enough to trigger outcomes that 

9 could lead to population decline and loss of biodiver10 sity; 

11 (11) one out of five male black bass in nine 

12 river basins across the United States exhibit intersex 

13 organs and up to 100 percent of smallmouth bass at 

14 some sites in the Potomac River basin during 

15 spawning season exhibit the same organ changes, 

16 which scientists say suggests they have been exposed 

17 to EDCs; 

18 (12) all vertebrates (fish, amphibians, reptiles, 

19 birds, and mammals, including humans) are fun20 damentally similar during early embryonic develop21 ment, so scientists can use the evidence acquired on 

22 other species to make predictions about endocrine 

23 disrupting effects on humans; 

24 (13) traditional toxicology and risk assessment, 

25 which evaluate one chemical at a time, and only at 


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1 high concentrations, have failed to sufficiently ad2 dress the effects of low doses of chemicals at mul3 tiple early life stages and have not prevented the 

4 alarming increase of endocrine disorders sweeping 

5 across the Northern Hemisphere; 

6 (14) since the early 1990s, independent govern7 ment-funded scientists in academic and institutional 

8 laboratories around the world have published data 

9 demonstrating the ability of a broad selection of 

10 chemicals to interfere with human development and 

11 function by affecting a number of endocrine mecha12 nisms, and have discovered endocrine disruptive ef13 fects for some widely used chemicals at concentra14 tions several thousand times lower than government 

15 ‘‘safe’’ levels derived through traditional toxicological 

16 tests; 

17 (15) these scientists have developed a new para18 digm for disease, the developmental basis of disease, 

19 which states that disease starts during development 

20 and is influenced by exposures to environmental 

21 chemicals, stress and nutrition interacting on the de22 veloping organism; 

23 (16) the developmental basis of disease changes 

24 the focus from curing disease to prevention and to 


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1 understanding gene-environment-nutrition inter2 actions during development; 

3 (17) the National Institute of Environmental 

4 Health Sciences (NIEHS) and the National Toxi5 cology Program (NTP) have conducted important 

6 studies on the environmental connection to human 

7 diseases, and have in place a 5-tier scale of concern 

8 by which to evaluate chemicals based on the weight 

9 of scientific evidence and toxicity and exposure infor10 mation; 

11 (18) while research has established that expo12 sure to EDCs induces delayed toxicity that results in 

13 disease weeks, months, years, or decades later in 

14 life, Federal regulatory agencies generally are not 

15 using the results of this research to restrict produc16 tion and use of even the most egregious chemicals; 

17 (19) although Congress directed the Environ18 mental Protection Agency in the Food Quality Pro19 tection Act of 1996 to develop, not later than Au20 gust 3, 1998, ‘‘a screening program using appro21 priate validated test systems and other scientifically 

22 relevant information, to determine whether certain 

23 substances may have an effect in humans that is 

24 similar to an effect produced by a naturally occur25 ring estrogen, or such other endocrine effect as the 


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1 Administrator may designate’’, the Agency did not 

2 release test orders announcing the availability of ini3 tial standardized screens and testing protocols until 

4 October 21, 2009, and no chemical has been tested 

5 for its impact on development and function from fer6 tilization to birth, despite the expenditure of more 

7 than $100,000,000; 

8 (20) given these delays and the alarming trends 

9 in endocrine-related disorders, the United States 

10 must expeditiously take preventive action based on 

11 an entirely new approach to reducing children’s ex12 posure before birth to EDCs; and 

13 (21) the costs to society of not taking action in14 clude medical expenses of treating these chronic dis15 eases, lost productivity, impaired fertility, com16 promised quality of life for those affected, their fam17 ilies and communities, so prevention is the key. 

18 (b) POLICIES AND GOALS.—It is the policy of the 

19 United States— 

20 (1) to promote family health and the perpetua21 tion of the human species as a paramount national 

22 goal, recognizing that in order to protect the em23 bryo, fetus, and infant during their most vulnerable 

24 stages of development, parents’ bodies must be free 


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1 of EDCs prior to conception, during gestation, and 

2 throughout lactation; 

3 (2) to prevent harmful exposure to EDCs in 

4 homes, workplaces, schools, public and private trans5 portation vehicles, indoor and outdoor recreational 

6 environments, and in drinking water, foods, and con7 sumer products; 

8 (3) to develop scientific support for Federal 

9 public health strategies based on the entire body of 

10 peer-reviewed public literature in an environment 

11 that is free from conflicts of interest; 

12 (4) to promote research into endocrine disrup13 tion by encouraging the multidisciplinary, multi-in14 stitutional, and international collaborations that in 

15 the past have produced many breakthroughs in 

16 knowledge; 

17 (5) to create graduate-level scholarships and 

18 post-doctoral fellowships to train young scientists 

19 who can meet the demand for technicians and public 

20 health and health care personnel in endocrine dis21 ruption prevention; 

22 (6) to determine which chemicals in commerce 

23 have the potential to disrupt the human endocrine 

24 system and to remove these chemicals, and products 

25 containing them, from the market; and 


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1 (7) to prevent the introduction of new chemi2 cals, and products containing them, that have the 

3 potential to disrupt the human endocrine system by 

4 requiring testing for these effects before these 

5 chemicals and products are released on the market. 

6 SEC. 3. ENDOCRINE DISRUPTION PREVENTION PROGRAM. 

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

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

9 at the end the following: 

10 ‘‘SEC. 463C. ENDOCRINE DISRUPTION PREVENTION. 

11 ‘‘(a) PROGRAM.—The Director of the National Insti12 tute of Environmental Health Sciences shall establish a 

13 program, to be known as the Endocrine Disruption Pre14 vention Program, consisting of research, workshops, and 

15 fora under subsection (b). 

16 ‘‘(b) RESEARCH, WORKSHOPS, AND FORA.— 

17 ‘‘(1) RESEARCH.—The Director of the Institute 

18 shall conduct and support multidisciplinary research, 

19 to improve the understanding of endocrine disrup20 tion. Such research shall— 

21 ‘‘(A) include research to design and de22 velop sensitive tests to screen chemicals using 

23 assays that are effective for identifying chemi24 cals with the potential to disrupt the human en25 docrine system; 


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1 ‘‘(B) address the full range of possible 

2 health outcomes, including— 

3 ‘‘(i) male and female developmental 

4 and reproductive disorders; 

5 ‘‘(ii) brain (behavioral and intellec6 tual) disorders; 

7 ‘‘(iii) metabolic syndrome, pre-diabe8 tes, diabetes, improper glucose and fat me9 tabolism, obesity, and cardiovascular dis10 orders; 

11 ‘‘(iv) effects on the pituitary, 

12 hypothalamus, hippocampus, thyroid, adre13 nal, immune, bone, cardiovascular, and 

14 other endocrine organs and systems 

15 throughout all life stages; 

16 ‘‘(v) hormonally driven cancer; and 

17 ‘‘(vi) other related effects; 

18 ‘‘(C) be appropriately sensitive to detect a 

19 chemical’s potential to disrupt the human endo20 crine system at ambient exposure dosing levels; 

21 ‘‘(D) consider the potential for additive 

22 and synergistic effects and need not be based 

23 solely on expectations of monotonic effects 

24 where the dose reflects the toxicity; 


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1 ‘‘(E) be carried out using a multidisci2 plinary approach to assure connections among 

3 multiple levels, from molecular to organ to 

4 whole animal or human research; and 

5 ‘‘(F) be designed to develop biomarkers of 

6 exposure and effect that can be further devel7 oped and translated for use in human epidemio8 logical and public health studies focused on de9 fining the role of endocrine disrupting chemicals 

10 in disease etiology across the lifespan. 

11 ‘‘(2) WORKSHOPS AND FORA.— 

12 ‘‘(A) IN GENERAL.—The Director of the 

13 Institute shall conduct workshops and fora on 

14 the health effects associated with environmental 

15 agents that may affect the endocrine system in 

16 order to— 

17 ‘‘(i) identify new chemicals of concern 

18 for research under paragraph (1); 

19 ‘‘(ii) strategize on approaches for the 

20 development of sensitive tests to screen 

21 chemicals for endocrine disrupting activity 

22 using assays; 

23 ‘‘(iii) review the state of the science 

24 and provide recommendations for a re25 search, testing, and training agenda; and 


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1 ‘‘(iv) educate attendees about endo2 crine disrupting chemicals. 

3 ‘‘(B) WORKSHOPS.— 

4 ‘‘(i) FIRST WORKSHOP.—The Director 

5 of the Institute shall invite the Secretary 

6 of the Interior, the Administrator of the 

7 Environmental Protection Agency, and the 

8 Director of the Centers for Disease Control 

9 and Prevention to participate in a work10 shop under subparagraph (A) not later 

11 than 150 days after the date of the enact12 ment of this section. 

13 ‘‘(ii) SUBSEQUENT WORKSHOPS.—The 

14 Director of the Institute shall convene sub15 sequent workshops under subparagraph 

16 (A) as the Director determines appro17 priate. 

18 ‘‘(iii) PARTICIPANTS.—The Director 

19 of the Institute shall— 

20 ‘‘(I) invite additional participants 

21 to each workshop under subparagraph 

22 (A); 

23 ‘‘(II) in selecting such partici24 pants, include scientists and health 

25 professionals who are knowledgeable 


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1 about the endocrine system and envi2 ronmental exposures that may influ3 ence the endocrine system; 

4 ‘‘(III) select as participants only 

5 those individuals who the Director de6 termines will participate in a manner 

7 free of conflicts of interest; and 

8 ‘‘(IV) in addition to the partici9 pants invited under subclause (I), 

10 allow representatives of nongovern11 mental organizations to attend each 

12 workshop under subparagraph (A) as 

13 observers. 

14 ‘‘(C) FORA.—At least every 3 years, the 

15 Director of the Institute shall convene an open 

16 forum for all stakeholders— 

17 ‘‘(i) to review the state of the science 

18 relevant to environmental agents that in19 fluence the endocrine system; and 

20 ‘‘(ii) to discuss the future direction of 

21 the Endocrine Disruption Prevention Pro22 gram. 

23 ‘‘(c) EXPERT PANEL.— 

24 ‘‘(1) ESTABLISHMENT.—The Director of the 

25 Institute shall establish an Endocrine Disruption 


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1 Program Panel (in this section referred to as the 

2 ‘Panel’) not later than one year after the date of the 

3 enactment of this section. 

4 ‘‘(2) MEMBERS.—The Director of the Institute 

5 shall appoint the members of the Panel from among 

6 individuals who— 

7 ‘‘(A) have established expertise in the field 

8 of endocrine disruption research by publishing 

9 research in peer-reviewed literature; 

10 ‘‘(B) provide assurances they will perform 

11 their duties in a manner free of conflicts of in12 terest (as determined by the Director), includ13 ing by complying with section 208 of title 18, 

14 United States Code; and 

15 ‘‘(C) represent diverse disciplines, includ16 ing developmental biology, endocrinology, devel17 opmental and neurological biology, embryology, 

18 biochemistry, physiology, epidemiology, endo19 crine driven oncology, and medical research. 

20 ‘‘(3) DUTIES.—The Panel shall— 

21 ‘‘(A) provide advice to the Director of the 

22 Institute on the conduct and support of re23 search under subsection (b); 

24 ‘‘(B) evaluate existing population-level bio25 monitoring and biobanking surveillance and reVerDate Nov 24 2008 00:08 Dec 04, 2009 Jkt 089200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H4190.IH H4190

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1 search programs and recommend changes need2 ed to develop data on human exposures and ef3 fects to support the Endocrine Disruption Pre4 vention Program; and 

5 ‘‘(C) develop a list of chemicals of concern 

6 for endocrine disruption effects and make find7 ings with respect to such chemicals in accord8 ance with paragraph (4). 

9 ‘‘(4) CHEMICALS OF CONCERN.— 

10 ‘‘(A) LIST.—The Panel shall— 

11 ‘‘(i) develop a list of chemicals of con12 cern for endocrine disruption effects; and 

13 ‘‘(ii) update such list annually. 

14 ‘‘(B) QUALITATIVE EVALUATION SYS15 TEM.—The Panel shall create a tiered quali16 tative evaluation system, modeled after that of 

17 the National Toxicology Program, in order to 

18 express the Panel’s level of concern that a 

19 chemical on the list under subparagraph (A) 

20 has the potential to disrupt the human endo21 crine system. 

22 ‘‘(C) REQUIRED FINDINGS.—For each 

23 chemical identified in the list under subpara24 graph (A), the Panel shall review peer-reviewed 

25 studies and other relevant data and issue a 


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1 finding, based on all of the available evidence, 

2 regarding— 

3 ‘‘(i) the level of the Panel’s concern, 

4 under the tiered qualitative evaluation sys5 tem, that the chemical has the potential to 

6 disrupt the human endocrine system; 

7 ‘‘(ii) the need for additional data to 

8 determine the level of concern associated 

9 with the chemical’s potential to disrupt the 

10 human endocrine system; or 

11 ‘‘(iii) the need for assays to be devel12 oped to provide the data necessary to sup13 port a determination as to the level of con14 cern associated with the chemical’s poten15 tial to disrupt the human endocrine sys16 tem. 

17 ‘‘(D) SUFFICIENT DATA.—If the Panel 

18 finds under subparagraph (C)(i) that data are 

19 sufficient to determine the extent to which a 

20 chemical has the potential to disrupt the human 

21 endocrine system, the Panel shall publish an ex22 planation of this determination and include the 

23 supporting data. 

24 ‘‘(E) MINIMAL LEVEL OF CONCERN.—If 

25 the Panel finds under subparagraph (C)(i) that 


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1 data are sufficient to determine (under the 

2 tiered qualitative evaluation system established 

3 under subparagraph (B)) that there is at least 

4 a minimal level of concern associated with a 

5 chemical’s potential to disrupt the human endo6 crine system, the Panel shall describe the routes 

7 and sources of exposure to the chemical that 

8 may cause effects to human health. 

9 ‘‘(F) ADDITIONAL DATA NEEDED.—If the 

10 Panel finds under subparagraph (C)(ii) that ad11 ditional data are needed to determine the level 

12 of concern associated with the chemical’s poten13 tial to disrupt the human endocrine system, the 

14 Panel shall— 

15 ‘‘(i) identify such data; and 

16 ‘‘(ii) recommend a process for devel17 oping such data directly or by grant or 

18 contract. 

19 ‘‘(G) ASSAYS NEEDED.—If the Panel finds 

20 under subparagraph (C)(iii) that assays need to 

21 be developed to provide the data necessary to 

22 support a determination as to the level of con23 cern associated with the chemical’s potential to 

24 disrupt the human endocrine system, the Panel 

25 shall identify such assays to the extent possible. 


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1 ‘‘(H) ANNUAL REPORT.—The Panel shall 

2 submit to the Director of the Institute and to 

3 the Congress an annual report on the Panel’s 

4 activities. Each such report shall include— 

5 ‘‘(i) an updated version of the list de6 veloped under subparagraph (A); and 

7 ‘‘(ii) for each chemical on the list, the 

8 findings and recommendations of the Panel 

9 under subparagraphs (D) through (G). 

10 ‘‘(I) NO JUDICIAL REVIEW.—A finding or 

11 other determination of the Panel under this 

12 paragraph shall not be subject to judicial re13 view, nor to correction under section 515 of the 

14 Treasury and General Government Appropria15 tions Act, 2001 (commonly referred to as the 

16 ‘Information Quality Act’). 

17 ‘‘(J) PETITIONS.— 

18 ‘‘(i) IN GENERAL.—Any person may 

19 petition the Panel to determine whether a 

20 chemical should be listed pursuant to sub21 paragraph (A) or revise a finding or other 

22 determination under this paragraph based 

23 on new information. 

24 ‘‘(ii) RULES.—The Director shall 

25 adopt rules that provide for— 


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1 ‘‘(I) the form and procedure for 

2 filing of petitions under this subpara3 graph; and 

4 ‘‘(II) the procedural rights of 

5 persons filing such petitions. 

6 ‘‘(d) TRANSMISSION OF CERTAIN FINDINGS TO

7 OTHER AGENCIES.— 

8 ‘‘(1) IN GENERAL.—If the Panel finds under 

9 subsection (c)(4)(C)(i) that data are sufficient to de10 termine (under the tiered qualitative evaluation sys11 tem established under subsection (c)(4)(B)) that 

12 there is at least a minimal level of concern associ13 ated with a chemical’s potential to disrupt the 

14 human endocrine system, the Director of the Insti15 tute shall transmit the finding, including the Panel’s 

16 description of the routes and sources of exposure to 

17 the chemical and any other relevant information, to 

18 each Federal agency with authority to regulate the 

19 chemical or the route or source of human exposure 

20 to the chemical. 

21 ‘‘(2) PUBLIC AVAILABILITY.—Whenever the Di22 rector of the Institute transmits to one or more 

23 agencies a finding under paragraph (1) regarding a 

24 chemical, the Director shall publish in the Federal 

25 Register the names of the agencies and the chemical. 


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1 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To 

2 carry out this section, there are authorized to be appro3 priated such sums as may be necessary for fiscal years 

4 2011 through 2021.’’. 

5 SEC. 4. FEDERAL AGENCY ACTION. 

6 (a) REQUIREMENTS.—Upon receipt of a transmission 

7 under section 463C(d) of the Public Health Service Act, 

8 as added by section 3 of this Act, containing a finding 

9 that there is at least a minimal level of concern associated 

10 with a chemical’s potential to disrupt the human endocrine 

11 system, a Federal agency— 

12 (1) not later than 180 days after the date of 

13 such receipt, shall issue a reply in writing to the Di14 rector of the National Institute of Environmental 

15 Health Sciences (in this Act referred to as the ‘‘In16 stitute’’) describing— 

17 (A) the agency’s authorities in connection 

18 with the chemical; 

19 (B) any past or ongoing actions taken by 

20 the agency in connection with the chemical; and 

21 (C) the proposed course of action to be 

22 taken by the agency in response to the Panel’s 

23 finding, including but not limited to further 

24 testing by the Institute or the issuance of regu25 lations, orders, or public notices under the 


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1 agency’s existing authorities, in furtherance of 

2 protecting human health from the potential en3 docrine disruption effects of exposure to the 

4 chemical; and 

5 (2) not later than one year after the date of 

6 such receipt, shall submit to the Congress and shall 

7 publish a report summarizing the actions taken by 

8 the agency in response to the Panel’s finding, as well 

9 as proposed future actions to be taken by the agen10 cy. 

11 (b) NO ADDITIONAL REGULATORY AUTHORITY.— 

12 This section does not vest any agency with additional au13 thority to regulate a chemical or the route or source of 

14 human exposure to a chemical. 

15 (c) CITIZEN SUITS.— 

16 (1) AUTHORITY TO BRING CIVIL ACTIONS.—Any 

17 person may commence a civil action to compel any 

18 agency action required by subsection (a). 

19 (2) JURISDICTION.—The United States courts 

20 of appeals shall have exclusive original jurisdiction 

21 over such an action. 

22 SEC. 5. TRAINING IN FIELDS RELATED TO THE PREVEN23 TION OF ENDOCRINE DISRUPTION. 

24 (a) IN GENERAL.—The Director of the Institute shall 

25 establish a program to support, directly or by making 


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1 grants, graduate and postdoctoral training in fields related 

2 to the prevention of endocrine disruption. 

3 (b) AUTHORIZATION OF APPROPRIATIONS.—To carry 

4 out this section, there are authorized to be appropriated 

5 $2,500,000 for fiscal year 2011 and such sums as may 

6 be necessary for fiscal years 2012 through 2021. 

Æ 


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