II 

Calendar No. 530 

109TH CONGRESS 

2D SESSION S. 757 

[Report No. 109–290] 

To amend the Public Health Service Act to authorize the Director of the 

National Institute of Environmental Health Sciences to make grants 

for the development and operation of research centers regarding environmental factors that may be related to the etiology of breast cancer. 

IN THE SENATE OF THE UNITED STATES 

APRIL 11, 2005 

Mr. CHAFEE (for himself, Mr. REID, Mr. TALENT, Mrs. CLINTON, Mr. 

HATCH, Ms. CANTWELL, Mr. ALLEN, Ms. COLLINS, Mr. GRASSLEY, Mr. 

CORZINE, Mr. HARKIN, Mrs. MURRAY, Mr. BINGAMAN, Mr. KENNEDY, 

Mr. COCHRAN, Mr. DEWINE, Mr. WARNER, Mr. COLEMAN, Mr. LAUTENBERG, Mr. DAYTON, Mr. BIDEN, Mr. VOINOVICH, Mr. JOHNSON, Mr. 

MCCAIN, Mrs. FEINSTEIN, Mr. SMITH, Ms. MIKULSKI, Mr. REED, Mr. 

FEINGOLD, Mr. SARBANES, Mr. LIEBERMAN, Mr. KOHL, Mr. SCHUMER, 

Mr. SUNUNU, Mrs. HUTCHISON, Ms. MURKOWSKI, Ms. STABENOW, Mr. 

CARPER, Mr. SPECTER, Mr. KERRY, Mr. JEFFORDS, Ms. LANDRIEU, Mr. 

DODD, Mrs. LINCOLN, Mrs. BOXER, Mr. BAYH, Mr. DORGAN, Mr. 

PRYOR, Mr. HAGEL, Mr. BENNETT, Mr. CONRAD, Ms. SNOWE, Mr. 

LEAHY, Mr. VITTER, Mr. SALAZAR, Mr. WYDEN, Mr. LUGAR, Mr. 

GRAHAM, Mr. DOMENICI, Mr. CORNYN, Mr. BAUCUS, Mrs. DOLE, Mr. 

MENENDEZ, Mr. SANTORUM, Mr. BURNS, Mr. KYL, and Mr. NELSON of 

Florida) introduced the following bill; which was read twice and referred 

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

JULY 24, 2006 

Reported by Mr. ENZI, with an amendment 


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[Strike out all after the enacting clause and insert the part printed in italic] 

A BILL 

To amend the Public Health Service Act to authorize the 

Director of the National Institute of Environmental 

Health Sciences to make grants for the development 

and operation of research centers regarding environmental factors that may be related to the etiology of 

breast cancer. 

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 ‘‘Breast Cancer and 

5 Environmental Research Act of 2005’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 

8 (1) Breast cancer is the second leading cause of 

9 cancer deaths among American women. 

10 (2) More women in the United States are living 

11 with breast cancer than any other cancer (excluding 

12 skin cancer). Approximately 3,000,000 women in the 

13 United States are living with breast cancer, about 

14 2,000,000 of which have been diagnosed and an esti15 mated 1,000,000 who do not yet know that they 

16 have the disease. 


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1 (3) Breast cancer is the most commonly diag2 nosed cancer among women in the United States 

3 and worldwide (excluding skin cancer). In 2005, it 

4 is estimated that 269,730 new cases of breast cancer 

5 will be diagnosed among women in the United 

6 States, 211,240 invasive breast cancers and 58,490 

7 cases of ductal carcinoma in situ (DCIS). 

8 (4) Approximately 40,410 women in the United 

9 States will die from the disease in 2005. Breast can10 cer is the leading cause of cancer death for women 

11 in the United States between the ages of 20 and 59, 

12 and the leading cause of cancer death for women 

13 worldwide. 

14 (5) A woman who lives into her 80s in the 

15 United States has a 1 in 7 chance of developing 

16 invasive breast cancer in her lifetime. This risk was 

17 1 in 11 in 1975. In 2005, a new case of breast can18 cer will be diagnosed every 2 minutes and a woman 

19 will die from breast cancer every 13 minutes. 

20 (6) All women are at risk for breast cancer. 

21 About 90 percent of women who develop breast can22 cer do not have a family history of the disease. 

23 (7) The National Action Plan on Breast Can24 cer, a public private partnership, has recognized the 

25 importance of expanding the scope and breadth of 


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1 biomedical, epidemiological, and behavioral research 

2 activities related to the etiology of breast cancer and 

3 the role of the environment. 

4 (8) To date, there has been only a limited re5 search investment to expand the scope or coordinate 

6 efforts across disciplines or work with the commu7 nity to study the role of the environment in the de8 velopment of breast cancer. 

9 (9) In 2003, the National Institute of Environ10 mental Health Sciences awarded grants to four re11 search centers to begin to study the prenatal-to12 adult environmental exposures that may predispose 

13 a woman to breast cancer. The currently funded re14 search is examining the mammary tissue in animals 

15 and young girls and study the subjects’ life expo16 sures to environmental, nutritional, and social fac17 tors that impact menarche. Early menarche, begin18 ning menstruation before the age of 12, has been 

19 shown to increase breast cancer risk later in life. 

20 (10) The National Cancer Institute and the Na21 tional Institute of Environmental Health Sciences 

22 have paired together to make those four centers pos23 sible. The two institutes work well together, com24 bining their respective areas of expertise to the best 

25 advantage of the research. 


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1 (11) In order to take full advantage of the tre2 mendous potential for avenues of prevention, the 

3 Federal investment in the role of the environment 

4 and the development of breast cancer should be ex5 panded. The research conducted at the four centers, 

6 while critically important, is one small facet of the 

7 many issues that must be addressed in order to 

8 gauge the link between environmental factors and 

9 breast cancer. 

10 (12) In order to understand the effect of chemi11 cals and radiation on the development of cancer, 

12 multi-generational, prospective studies are probably 

13 required. 

14 SEC. 3. NATIONAL INSTITUTE OF ENVIRONMENTAL 

15 HEALTH SCIENCES; AWARDS FOR DEVELOP16 MENT AND OPERATION OF RESEARCH CEN17 TERS REGARDING ENVIRONMENTAL FAC18 TORS RELATED TO BREAST CANCER. 

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

20 Service Act (42 U.S.C. 285 l et seq.) is amended by adding 

21 at the end the following section: 


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1 ‘‘SEC. 463C. RESEARCH CENTERS REGARDING ENVIRON2 MENTAL FACTORS RELATED TO BREAST CAN3 CER. 

4 ‘‘(a) IN GENERAL.—The Director of the Institute, 

5 based on recommendations from the Breast Cancer and 

6 Environmental Research Panel established under sub7 section (b) (referred to in this section as the ‘Panel’) shall 

8 make grants, after a process of peer review and pro9 grammatic review, to public or nonprofit private entities 

10 for the development and operation of not more than 8 cen11 ters for the purpose of conducting multidisciplinary and 

12 multi-institutional research on environmental factors that 

13 may be related to the etiology of breast cancer. Each such 

14 center shall be known as a Breast Cancer and Environ15 mental Research Center of Excellence. 

16 ‘‘(b) BREAST CANCER AND ENVIRONMENTAL RE17 SEARCH PANEL.— 

18 ‘‘(1) ESTABLISHMENT.—The Secretary shall es19 tablish in the Institute of Environmental Health 

20 Sciences a Breast Cancer and Environmental Re21 search Panel. 

22 ‘‘(2) COMPOSITION.—The Panel shall be com23 posed of— 

24 ‘‘(A) 9 members to be appointed by the 

25 Secretary, of which— 


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1 ‘‘(i) six members shall be appointed 

2 from among physicians, and other health 

3 professionals, who— 

4 ‘‘(I) are not officers or employees 

5 of the United States; 

6 ‘‘(II) represent multiple dis7 ciplines, including clinical, basic, and 

8 public health sciences; 

9 ‘‘(III) represent different geo10 graphical regions of the United 

11 States; 

12 ‘‘(IV) are from practice settings 

13 or academia or other research set14 tings; and 

15 ‘‘(V) are experienced in bio16 medical review; and 

17 ‘‘(ii) three members shall be appointed 

18 from the general public who are represent19 atives of individuals who have had breast 

20 cancer and who represent a constituency; 

21 and 

22 ‘‘(B) such nonvoting, ex officio members as 

23 the Secretary determines to be appropriate. 


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1 ‘‘(3) CHAIRPERSON.—The members of the 

2 Panel appointed under paragraph (2)(A) shall select 

3 a chairperson from among such members. 

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

5 call of the chairperson or upon the request of the 

6 Director, but in no case less often than once each 

7 year. 

8 ‘‘(5) DUTIES.—The Panel shall— 

9 ‘‘(A) oversee the peer review process for 

10 the awarding of grants under subsection (a) 

11 and conduct the programmatic review under 

12 such subsection; 

13 ‘‘(B) make recommendations with respect 

14 to the funding criteria and mechanisms under 

15 which amounts will be allocated under this sec16 tion; and 

17 ‘‘(C) make final programmatic rec18 ommendations with respect to grants under this 

19 section. 

20 ‘‘(c) COLLABORATION WITH COMMUNITY.—Each 

21 center under subsection (a) shall establish and maintain 

22 ongoing collaborations with community organizations in 

23 the geographic area served by the center, including those 

24 that represent women with breast cancer. 


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1 ‘‘(d) COORDINATION OF CENTERS; REPORTS.—The 

2 Director of the Institute shall, as appropriate, provide for 

3 the coordination of information among centers under sub4 section (a) and ensure regular communication between 

5 such centers, and may require the periodic preparation of 

6 reports on the activities of the centers and the submission 

7 of the reports to the Director. 

8 ‘‘(e) REQUIRED CONSORTIUM.—Each center under 

9 subsection (a) shall be formed from a consortium of co10 operating institutions, meeting such requirements as may 

11 be prescribed by the Director of the Institute. Each center 

12 shall require collaboration among highly accomplished sci13 entists, other health professionals and advocates of diverse 

14 backgrounds from various areas of expertise. 

15 ‘‘(f) DURATION OF SUPPORT.—Support of a center 

16 under subsection (a) may be for a period not exceeding 

17 5 years. Such period may be extended for one or more 

18 additional periods not exceeding 5 years if the operations 

19 of such center have been reviewed by an appropriate tech20 nical and scientific peer review group established by the 

21 Director of the Institute and if such group has rec22 ommended to the Director that such period should be ex23 tended. 

24 ‘‘(g) GEOGRAPHIC DISTRIBUTION OF CENTERS.— 

25 The Director of the Institute shall, to the extent pracVerDate Aug 31 2005 22:33 Jul 24, 2006 Jkt 049196 PO 00000 Frm 00009 Fmt 6652 Sfmt 6401 E:\BILLS\S757.RS S757

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1 ticable, provide for an equitable geographical distribution 

2 of centers under this section. 

3 ‘‘(h) INNOVATIVE APPROACHES.—Each center under 

4 subsection (a) shall use innovative approaches to study un5 explored or under-explored areas of the environment and 

6 breast cancer. 

7 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—For the 

8 purpose of carrying out this section, there is authorized 

9 to be appropriated $30,000,000 for each of the fiscal years 

10 2006 through 2011. Such authorization is in addition to 

11 any other authorization of appropriations that is available 

12 for such purpose.’’. 

13 SECTION 1. SHORT TITLE. 

14 This Act may be cited as the ‘‘Breast Cancer and En15 vironmental Research Act of 2006’’. 

16 SEC. 2. NATIONAL INSTITUTES OF HEALTH; AWARDS FOR 

17 DEVELOPMENT AND OPERATION OF RE18 SEARCH CENTERS REGARDING ENVIRON19 MENTAL FACTORS RELATED TO BREAST CAN20 CER. 

21 Part A of title IV of the Public Health Service Act 

22 (42 U.S.C. 281 et seq.) is amended by adding at the end 

23 the following: 


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1 ‘‘SEC. 404H. RESEARCH CENTERS REGARDING ENVIRON2 MENTAL FACTORS RELATED TO BREAST CAN3 CER. 

4 ‘‘(a) IN GENERAL.—The Secretary, acting through the 

5 Director of NIH, based on recommendations from the Breast 

6 Cancer and Environmental Research Panel established 

7 under subsection (b) (referred to in this section as the 

8 ‘Panel’), shall make grants to public or nonprofit private 

9 entities for the development and operation of collaborative, 

10 multi-institutional centers for the purpose of conducting 

11 multidisciplinary and multi-institutional research on envi12 ronmental factors that may be related to the etiology of 

13 breast cancer. Each such center shall be known as a Breast 

14 Cancer and Environmental Research Center of Excellence. 

15 ‘‘(b) BREAST CANCER AND ENVIRONMENTAL RE16 SEARCH PANEL.— 

17 ‘‘(1) ESTABLISHMENT.—The Secretary shall es18 tablish within the National Institutes of Health a 

19 Breast Cancer and Environmental Research Panel. 

20 ‘‘(2) COMPOSITION.—The Panel shall be com21 posed of— 

22 ‘‘(A) 9 members to be appointed by the Sec23 retary, of which— 

24 ‘‘(i) six members shall be appointed 

25 from among physicians and other health 

26 professionals, who— 


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1 ‘‘(I) are not officers or employees 

2 of the United States; 

3 ‘‘(II) represent multiple dis4 ciplines, including clinical, basic, and 

5 public health sciences; 

6 ‘‘(III) represent different geo7 graphical regions of the United States; 

8 ‘‘(IV) are from practice settings, 

9 academia, or other research settings; 

10 and 

11 ‘‘(V) are experienced in peer re12 view; and 

13 ‘‘(ii) three members shall be appointed 

14 from the general public who are representa15 tives of individuals who have had breast 

16 cancer and who represent a constituency; 

17 and 

18 ‘‘(B) such nonvoting, ex officio members as 

19 the Secretary determines to be appropriate. 

20 ‘‘(3) CHAIRPERSON.—The members of the Panel 

21 appointed under paragraph (2)(A) shall select a 

22 chairperson from among such members. 

23 ‘‘(4) MEETINGS.—The Panel shall meet at the 

24 call of the chairperson or upon the request of the DiVerDate Aug 31 2005 22:33 Jul 24, 2006 Jkt 049196 PO 00000 Frm 00012 Fmt 6652 Sfmt 6203 E:\BILLS\S757.RS S757

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1 rector of NIH, but in no case less often than once each 

2 year. 

3 ‘‘(5) DUTIES.—The Panel shall— 

4 ‘‘(A) develop a comprehensive strategy con5 cerning collaborative centers that would— 

6 ‘‘(i) result in innovative approaches to 

7 study unexplored or underexplored areas of 

8 the environment and breast cancer; 

9 ‘‘(ii) outline key research questions, 

10 methodologies, and knowledge gaps con11 cerning environmental factors that may be 

12 related to the etiology of breast cancer; 

13 ‘‘(iii) outline key issues concerning en14 vironmental factors that may be related to 

15 the etiology of breast cancer; and 

16 ‘‘(iv) result in an overall strategy to 

17 address environmental factors related to 

18 breast cancer; 

19 ‘‘(B) make recommendations to the Sec20 retary with respect to the mechanisms, peer re21 view criteria, and allocations under this section; 

22 ‘‘(C) assist in the overall program evalua23 tion; and 

24 ‘‘(D) make recommendations for the dis25 semination of information on program process. 


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1 ‘‘(c) COLLABORATION WITH COMMUNITY.—Each cen2 ter under subsection (a) shall include community organiza3 tions in the geographic area served by the center, including 

4 those that represent women with breast cancer, as integral 

5 collaborators involved at all levels of the decision-making 

6 and research in such center. 

7 ‘‘(d) COORDINATION OF CENTERS; REPORTS.—The Di8 rector of NIH shall, as appropriate, provide for the coordi9 nation of information among centers under subsection (a) 

10 and ensure regular communication between such centers, 

11 and may require the periodic preparation of reports on the 

12 activities of the centers and the submission of the reports 

13 to the Director. 

14 ‘‘(e) REQUIRED CONSORTIUM.—Each center under 

15 subsection (a) shall be formed from a consortium of cooper16 ating institutions and community groups, meeting such re17 quirements as may be prescribed by the Director of NIH. 

18 Each center shall require collaboration among highly ac19 complished scientists, other health professionals and advo20 cates of diverse backgrounds from various areas of expertise. 

21 ‘‘(f) DURATION OF SUPPORT.—Support of a center 

22 under subsection (a) may be for a period not exceeding 5 

23 years. Such period may be extended for one or more addi24 tional periods not exceeding 5 years if the operations of such 

25 center have been reviewed by an appropriate technical and 


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1 scientific peer review group established by the Director of 

2 NIH and if such group has recommended to the Director 

3 that such period be extended. 

4 ‘‘(g) GEOGRAPHIC DISTRIBUTION OF CENTERS.—The 

5 Director of NIH shall, to the extent practicable, provide for 

6 an equitable geographical distribution of centers under this 

7 section. 

8 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the 

9 purpose of carrying out this section, there is authorized to 

10 be appropriated $30,000,000 for each of the fiscal years 

11 2007 through 2012. Such authorization is in addition to 

12 any other authorization of appropriations that is available 

13 for such purpose.’’. 


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Calendar No. 530 

109TH CONGRESS 

2D SESSION S. 757 

[Report No. 109

–290] 

A BILL 

To amend the Public Health Service Act to authorrelated to the etiology of breast cancer. ters regarding environmental factors that may be the development and operation of research cen- vironmental Health Sciences to make grants for ize the Director of the National Institute of EnJULY 24, 2006 

Reported with an amendment 


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