I 

109TH CONGRESS 

1ST SESSION H. R. 2231 

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 HOUSE OF REPRESENTATIVES 

MAY 10, 2005 

Mrs. LOWEY (for herself and Mrs. MYRICK) 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 

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’’. 
2 

•HR 2231 IH 

1 SEC. 2. FINDINGS. 

2 The Congress finds as follows: 

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

4 cancer deaths among American women. 

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

6 with breast cancer than any other cancer (excluding 

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

8 United States are living with breast cancer, about 

9 2,000,000 of which have been diagnosed and an esti10 mated 1,000,000 who do not yet know that they 

11 have the disease. 

12 (3) Breast cancer is the most commonly diag13 nosed cancer among women in the United States 

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

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

16 will be diagnosed among women in the United 

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

18 cases of ductal carcinoma in situ (DCIS). 

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

20 States will die from the disease in 2005. Breast can21 cer is the leading cause of cancer death for women 

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

23 and the leading cause of cancer death for women 

24 worldwide. 

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

26 United States has a 1 in 7 chance of developing 
3 

•HR 2231 IH 

1 invasive breast cancer in her lifetime. This risk was 

2 1 in 11 in 1975. In 2005, a new case of breast can3 cer will be diagnosed every 2 minutes and a woman 

4 will die from breast cancer every 13 minutes. 

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

6 About 90 percent of women who develop breast can7 cer do not have a family history of the disease. 

8 (7) The National Action Plan on Breast Can9 cer, a public private partnership, has recognized the 

10 importance of expanding the scope and breadth of 

11 biomedical, epidemiological, and behavioral research 

12 activities related to the etiology of breast cancer and 

13 the role of the environment. 

14 (8) To date, there has been only a limited re15 search investment to expand the scope or coordinate 

16 efforts across disciplines or work with the commu17 nity to study the role of the environment in the de18 velopment of breast cancer. 

19 (9) In 2003, the National Institute of Environ20 mental Health Sciences awarded grants to four re21 search centers to begin to study the prenatal-to22 adult environmental exposures that may predispose 

23 a woman to breast cancer. The currently funded re24 search is examining the mammary tissue in animals 

25 and young girls and study the subjects’ life expo-
4 

•HR 2231 IH 

1 sures to environmental, nutritional, and social fac2 tors that impact menarche. Early menarche, begin3 ning menstruation before the age of 12, has been 

4 shown to increase breast cancer risk later in life. 

5 (10) The National Cancer Institute and the Na6 tional Institute of Environmental Health Sciences 

7 have paired together to make those four centers pos8 sible. The two institutes work well together, com9 bining their respective areas of expertise to the best 

10 advantage of the research. 

11 (11) In order to take full advantage of the tre12 mendous potential for avenues of prevention, the 

13 Federal investment in the role of the environment 

14 and the development of breast cancer should be ex15 panded. The research conducted at the four centers, 

16 while critically important, is one small facet of the 

17 many issues that must be addressed in order to 

18 gauge the link between environmental factors and 

19 breast cancer. 

20 (12) In order to understand the effect of chemi21 cals and radiation on the development of cancer, 

22 multi-generational, prospective studies are probably 

23 required. 
5 

•HR 2231 IH 

1 SEC. 3. NATIONAL INSTITUTE OF ENVIRONMENTAL 

2 HEALTH SCIENCES; AWARDS FOR DEVELOP3 MENT AND OPERATION OF RESEARCH CEN4 TERS REGARDING ENVIRONMENTAL FAC5 TORS RELATED TO BREAST CANCER. 

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

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

8 at the end the following section: 

9 ‘‘SEC. 463C. RESEARCH CENTERS REGARDING ENVIRON10 MENTAL FACTORS RELATED TO BREAST CAN11 CER. 

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

13 based on recommendations from the Breast Cancer and 

14 Environmental Research Panel established under sub15 section (b) (referred to in this section as the ‘Panel’), shall 

16 make grants, after a process of peer review and pro17 grammatic review, to public or nonprofit private entities 

18 for the development and operation of not more than 8 cen19 ters for the purpose of conducting multidisciplinary and 

20 multi-institutional research on environmental factors that 

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

22 center shall be known as a Breast Cancer and Environ23 mental Research Center of Excellence. 

24 ‘‘(b) BREAST CANCER AND ENVIRONMENTAL RE25 SEARCH PANEL.— 
6 

•HR 2231 IH 

1 ‘‘(1) ESTABLISHMENT.—The Secretary shall es2 tablish in the Institute of Environmental Health 

3 Sciences a Breast Cancer and Environmental Re4 search Panel. 

5 ‘‘(2) COMPOSITION.—The Panel shall be com6 posed of— 

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

8 Secretary, of which— 

9 ‘‘(i) six members shall be appointed 

10 from among physicians, and other health 

11 professionals, who— 

12 ‘‘(I) are not officers or employees 

13 of the United States; 

14 ‘‘(II) represent multiple dis15 ciplines, including clinical, basic, and 

16 public health sciences; 

17 ‘‘(III) represent different geo18 graphical regions of the United 

19 States; 

20 ‘‘(IV) are from practice settings 

21 or academia or other research set22 tings; and 

23 ‘‘(V) are experienced in bio24 medical review; and 
7 

•HR 2231 IH 

1 ‘‘(ii) three members shall be appointed 

2 from the general public who are represent3 atives of individuals who have had breast 

4 cancer and who represent a constituency; 

5 and 

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

7 the Secretary determines to be appropriate. 

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

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

10 a chairperson from among such members. 

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

12 call of the chairperson or upon the request of the 

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

14 year. 

15 ‘‘(5) DUTIES.—The Panel shall— 

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

17 the awarding of grants under subsection (a) 

18 and conduct the programmatic review under 

19 such subsection; 

20 ‘‘(B) make recommendations with respect 

21 to the funding criteria and mechanisms under 

22 which amounts will be allocated under this sec23 tion; and 
8 

•HR 2231 IH 

1 ‘‘(C) make final programmatic rec2 ommendations with respect to grants under this 

3 section. 

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

5 center under subsection (a) shall establish and maintain 

6 ongoing collaborations with community organizations in 

7 the geographic area served by the center, including those 

8 that represent women with breast cancer. 

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

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

11 the coordination of information among centers under sub12 section (a) and ensure regular communication between 

13 such centers, and may require the periodic preparation of 

14 reports on the activities of the centers and the submission 

15 of the reports to the Director. 

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

17 subsection (a) shall be formed from a consortium of co18 operating institutions, meeting such requirements as may 

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

20 shall require collaboration among highly accomplished sci21 entists, other health professionals and advocates of diverse 

22 backgrounds from various areas of expertise. 

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

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

25 5 years. Such period may be extended for one or more 
9 

•HR 2231 IH 

1 additional periods not exceeding 5 years if the operations 

2 of such center have been reviewed by an appropriate tech3 nical and scientific peer review group established by the 

4 Director of the Institute and if such group has rec5 ommended to the Director that such period should be ex6 tended. 

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

8 The Director of the Institute shall, to the extent prac9 ticable, provide for an equitable geographical distribution 

10 of centers under this section. 

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

12 subsection (a) shall use innovative approaches to study un13 explored or under-explored areas of the environment and 

14 breast cancer. 

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

16 purpose of carrying out this section, there is authorized 

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

18 2006 through 2011. Such authorization is in addition to 

19 any other authorization of appropriations that is available 

20 for such purpose.’’. 

Æ