49–010 

Calendar No. 530 

109TH CONGRESS REPORT " ! SENATE 2d Session 109–290 

BREAST CANCER AND ENVIRONMENTAL RESEARCH ACT 

OF 2006 

JULY 24, 2006.—Ordered to be printed 

Mr. ENZI, from the Committee on Health, Education, Labor, and 

Pensions, submitted the following 

R E P O R T 

[To accompany S. 757] 

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

which was referred the bill (S. 757) 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, having 

considered the same, reports favorably thereon with an amendment 

in the nature of a substitute and recommends that the bill (as 

amended) do pass. 

CONTENTS 

Page 

I. Purpose and summary of the bill ................................................................. 1 

II. Background and need for legislation ............................................................ 2 

III. Legislative history and committee action .................................................... 3 

IV. Explanation of bill and committee views ..................................................... 5 

V. Cost estimate .................................................................................................. 6 

VI. Application of law to the legislative branch ................................................ 8 

VII. Regulatory impact statement ........................................................................ 8 

VIII. Section-by-section analysis ............................................................................ 8 

IX. Changes in existing law ................................................................................ 9 

I. PURPOSE AND SUMMARY OF THE BILL

S. 757, the Breast Cancer and Environmental Research Act of 

2006, does the following: 

• Creates a national strategy to conduct research into the 

possible links between breast cancer and the environment; 


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• Establishes a peer-reviewed grant program within the National Institutes of Health to fund collaborative Centers that 

would work across institutions, across disciplines, and with 

community organizations to study environmental factors that 

may cause breast cancer; and • Includes researchers and consumers in an Advisory Panel 

that will make recommendations on how to determine the 

grant mechanisms, peer review criteria and, once peer review 

is conducted, make funding allocation recommendations to the 

Secretary. 

This legislation would authorize the Secretary of Health and 

Human Services, working through the Director of the National Institutes of Health (NIH), to develop a research program of peer-reviewed grants for the establishment of collaborative Centers of research to study environmental factors that are believed to contribute to the development of breast cancer. The Secretary will establish an Advisory Panel that will: develop a national strategy regarding the collaborative Centers; make recommendations on how 

to design the grant mechanisms and peer review criteria; and, after 

peer review has been carried out, make recommendations for allocation of funds to the Centers to prevent unnecessary duplication 

of research and ensure consistency with the national strategy and 

its programmatic priorities. 

Under a competitive process of peer-reviewed research that includes trained consumers who represent a breast cancer constituency in the decisionmaking process, the NIH Director, in cooperation with the Director of the National Institute of Environmental 

Health Sciences (NIEHS) and the Director of the National Cancer 

Institute (NCI), would award grants to conduct multi-institutional 

and multi-disciplinary research using a broad definition of environment through a national network of collaborative Centers. The bill 

requires each Center to be multi-institutional and to establish and 

maintain collaborations at all levels with community organizations 

in its area of influence, including those community organizations 

that represent a breast cancer constituency. Each collaborative 

Center will be required to network with the other funded Centers. 

Up to eight collaborative, multi-institutional Centers may be funded each year. 

II. BACKGROUND AND NEED FOR THE LEGISLATION

Estimates by the American Cancer Society indicate that a 

woman in the United States has a 1 in 8 chance of developing 

invasive breast cancer during her lifetime. This risk was about 1 

in 11 in 1975. In fact, more women in the United States are living 

with breast cancer than any other cancer (excluding skin cancer). 

Approximately 3 million women in the U.S. are living with breast 

cancer: about 2.3 million have been diagnosed with the disease and 

an estimated 1 million do not yet know they have it. In 2006, it 

is estimated that 274,900 new cases of breast cancer will be diagnosed among women in the United States: 212,920 invasive and 

61,980 cases of in situ breast cancer. Breast cancer is the second 

leading cause of cancer death for women in the U.S.; approximately 

40,970 women in the U.S. will die in 2006. Breast cancer is the 

leading cause of cancer death for U.S. women between the ages of 

20 and 59, and the leading cause of cancer death for women worldVerDate Aug 31 2005 03:20 Jul 25, 2006 Jkt 049010 PO 00000 Frm 00002 Fmt 6659 Sfmt 6602 E:\HR\OC\SR290.XXX SR290

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wide. While breast cancer is about 100 times more common in 

women, it is important to note that the American Cancer Society 

estimates that in 2006, about 1,720 new cases of invasive breast 

cancer will be diagnosed among men in the United States. 

Despite these statistics, we still do not know what causes breast 

cancer. We do know that all women are at risk for breast cancer. 

We also know that about 90 percent of women who develop breast 

cancer do not have a family history of the disease. Although scientists have discovered some risk factors for breast cancer, the 

known risk factors account for only a small percentage (∼ 30 percent) of breast cancer cases. There are no proven interventions to 

prevent breast cancer and there is no cure. 

Because many women, and men, have no family history, or 

known genetic links to breast cancer it is generally believed that 

the environment plays a role in the development of breast cancer. 

However, we still do not understand the extent of that role. The 

committee recognizes the need to create a national strategy to 

study environmental factors so that we can learn what, if anything, 

in our environment might be contributing to the breast cancer epidemic and lead to preventive actions. 

This legislation came about as a result of two Environmental Policy Summits sponsored by the National Breast Cancer Coalition 

(NBCC). At the first NBCC Environmental Policy Summit in 1998, 

more than 50 experts, including scientists, advocates, government 

officials, and policy-makers, came together to begin developing a 

strategy for studying the links between breast cancer and the environment. Participants agreed that in order to truly understand 

what causes breast cancer, and how to prevent it, we must first 

focus on formulating the right questions. Summit participants emphasized the need to correct the persistent under-funding of research in this important area, while also increasing opportunities 

for innovative research. NBCC held a second summit in 2000, 

where more specific recommendations were made in order to accomplish this goal. The Breast Cancer and Environmental Research Act was developed in order to satisfy the recommendations 

and accomplish the goals set forth at both Summits. 

III. LEGISLATIVE HISTORY AND COMMITTEE ACTION

The Breast Cancer and Environmental Research Act was first introduced in the 106th Congress. In 1999 Representative Nita 

Lowey introduced the bill, and in the Senate it was introduced in 

2000 by Senators Lincoln Chafee and Harry Reid. By the end of 

2000, the proposed legislation had yielded 16 Senate cosponsors 

and 98 House cosponsors. 

In the 107th Congress, it was reintroduced by Senators Chafee 

and Reid, and Representatives Lowey and Sue Myrick. In 2001, 

NBCC advocate Gail Frankel testified at a Senate Environment 

and Public Works Field Hearing, hosted by Senator Hillary 

Rodham Clinton and attended by Senators Chafee and Reid, in 

Garden City, NY regarding the need for such legislation: 

We all wonder what causes breast cancer. I, too, have 

questions about what caused my breast cancer. Diagnosed 

at 53, I was told that even though my mother died at age 

48 from the disease, my breast cancer was unlikely to be 


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due to an inherited genetic defect since inherited cancer 

usually shows up at an earlier age in offspring. No other 

high risk factors applied to me. Did my diagnosis have 

something to do with where I live? The sad truth is nobody 

knows; there is no conclusive evidence about what causes 

this disease. 

In 2002, the Senate Labor HHS Appropriations Subcommittee 

agreed that a strategic approach—like the one taken in this legislation—is needed to study breast cancer and the environment, and 

included the following language in their committee report: 

The committee recognizes the serious lack of research on 

the relationship between the environment and breast cancer, and believes that it is essential for the Institute to 

support such research. The committee understands that 

the Institute will establish a Breast Cancer and Environmental Research Advisory Board to make recommendations to the director with regard to the development of 

Breast Cancer and Environmental Research Centers. The 

committee is aware of the tremendous success of the DOD 

Breast Cancer Research Program and its grant process. 

The committee expects the Advisory Board to integrate a 

peer review and planning process along the lines of the 

DOD integration panel. The committee is pleased that the 

Advisory Board will include representatives from the 

breast cancer community who have had breast cancer. The 

committee further strongly urges the NIEHS to establish 

centers to conduct multi-disciplinary and multi-institution 

research on environmental factors that may be related to 

breast cancer. 

The legislation was re-introduced in the 108th Congress by Senators Chafee and Reid, and Representatives Lowey and Myrick. By 

the end of that Congress, the number of Congressional cosponsors 

for the Breast Cancer Environmental Research Act increased to 62 

in the Senate and 210 in the House. In 2003, the following was included in the fiscal year 2003 Labor-HHS Conference Report language: 

The conferees commend NIEHS for its recent efforts to 

bolster research initiatives on the environmental influences of breast cancer. The conferees recognize the serious 

lack of research on the relationship between the environment and breast cancer, and believe that it is important 

for the Institute to support such research. The conferees 

urge the Institute to establish a group of breast cancer and 

environmental research advisers to make recommendations to the Director with regard to the support of the 

breast cancer and environmental research, and to include 

in the group representatives from the breast cancer community who have had breast cancer. The conferees request 

an update at the fiscal year 2004 hearings on the progress 

in establishing an advisory group. The conferees encourage 

NIEHS to consider establishing centers to conduct multidisciplinary and multi-institution research on environmental factors that may be related to breast cancer. 


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In response to the fiscal year 2003 Labor-HHS Conference Report 

language, NIEHS announced a collaborative program with NCI to 

fund four research Centers. The specific goal of these Centers is focused on the environmental determinants of puberty and mammary gland development that may increase a woman’s risk of 

breast cancer, which is only one of many questions of interest in 

this field. Funding for these Centers combined is $5 million per 

year over 7 years, for a total of $35 million. The current Centers 

do not have an overall national strategy for the field of potential 

environmental links to breast cancer. Conversely, the strategy developed by the Panel and implemented by the Centers in this legislation will expand the field to all questions that need to be studied 

to determine any links between the environment and breast cancer. 

In the 109th Congress, the legislation was once again re-introduced by Senators Chafee, Reid, Orrin Hatch, Hillary Rodham 

Clinton, and Jim Talent in the Senate, and by Representatives 

Lowey, Myrick, Charlie Bass, and Lois Capps. The cosponsorship 

has reached 65 Senators and 244 Representatives. After accepting 

a substitute amendment offered by Senator Enzi and cosponsored 

by Senators Kennedy, Hatch, Clinton, DeWine, Jeffords, Murray, 

Mikulski, and Reid, the Committee on Health, Education, Labor, 

and Pensions reported the bill favorably by unanimous voice vote 

on June 28, 2006. 

IV. EXPLANATION OF BILL AND COMMITTEE VIEWS

This legislation is based on the successful Department of Defense 

Peer Reviewed Breast Cancer Research Program (DOD BCRP), 

which has been a model program for innovative breast cancer research. The structure of the DOD BCRP was based in large part 

from recommendations in a report issued by the Institute of Medicine at the request of the U.S. Army. The DOD Program’s unique 

and highly effective structure, its focus on innovation and relevance, its accountability to the public, and its ability to focus on 

important funding and knowledge gaps, are important characteristics that would be replicated at the NIH through this legislation. 

The Breast Cancer and Environmental Research Act includes 

this effective review structure, involving consumers in the Advisory 

Panel as well as in peer review. Consumers are defined as educated 

advocates who represent a constituency of individuals who have 

had breast cancer. The Panel develops and implements an overall 

structure that seeks to create a comprehensive strategy for studying the linkage between breast cancer and the environment. When 

developing this strategy, it is important to include innovative 

mechanisms and research proposals from a global research community. 

Specifically, the Panel’s duties would include: 

• recommendations for research investment strategy; 

• advice on the content and type of solicitation announcements and on the timing and number of solicitations; 

• recommendations on proposal format; 

• recommendations for review criteria of research proposals 

to be applied by peer review committees; 

• assistance in overall program evaluation; 

• budget modifications of proposals recommended for funding; 


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• recommendations on whether funds should be transferred 

from one category to another; • recommendations for selection of proposals for funding by 

matching scientific merit from peer review with the programmatic goals set for the program; and • recommendations for dissemination of information on program process. 

The Panel would first develop and recommend to the Secretary, 

a strategy for the grant mechanisms and the peer review criteria. 

After peer review committees review and score the grant proposals, 

the Panel would then make recommendations to the Secretary regarding the allocations for the grants, ensuring the grants fulfill 

the goals of the national strategy. The Panel’s recommendations 

will prevent unnecessary duplication of research and confirm that 

the grants address a broad range of issues and form the basis of 

the national strategy. The Panel will be made up of researchers 

and other health professionals, as well as consumers, who represent organizations of individuals who have had breast cancer. 

The Centers, established through the grant process, will be made 

up of collaborative groups of research scientists from various institutions, and different scientific disciplines as well as community organizations representing individuals with breast cancer who come 

together to address the issue of exploring the links between breast 

cancer and the environment. The Centers will develop innovative 

approaches to study knowledge gaps of research with regard to the 

environment and breast cancer. Each Center funded by the grants 

will be expected to collaborate with the other Centers, and to report to the Director of NIH, in order for the highest level of cooperation and accountability to the public and to eliminate unnecessary duplication of research. 

V. COST ESTIMATE

U.S. CONGRESS, 

CONGRESSIONAL BUDGET OFFICE, 

Washington, DC, July 14, 2006. 

Hon. MIKE ENZI, 

Chairman, Committee on Health, Education, Labor, and Pensions, 

U.S. Senate, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for S. 757, the Breast Cancer and 

Environmental Research Act of 2006. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Sarah Evans. 

Sincerely, 

DONALD B. MARRON, 

Acting Director. 

Enclosure. 

S. 757—Breast Cancer and Environmental Research Act of 2006 

Summary: S. 757 would amend the Public Health Service Act to 

authorize the Director of the National Institutes of Health (NIH) 

to make grants to public or nonprofit organizations to develop and 

operate centers that would conduct research on environmental factors that may contribute to the development of breast cancer. The 


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bill also would direct the Secretary of Health and Human Services 

(HHS) to establish a Breast Cancer and Environmental Research 

Panel, whose task would be to develop research priorities and make 

recommendations for the program. 

For the activities described above, S. 757 would authorize the ap- propriation of $30 million each fiscal year from 2007 through 2012. 

CBO estimates that implementing the bill would cost $10 million 

in 2007 and $123 million over the 2007–2011 period, assuming the 

appropriation of the authorized amounts. Enacting S. 757 would 

have no effect on direct spending or revenues. 

The bill contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act (UMRA) 

and would impose no costs on state, local, or tribal governments. 

Estimated cost to the Federal Government: The estimated budgetary impact of S. 757 is shown in the following table. The costs 

of this legislation fall within budget function 550 (health). 

By fiscal year, in millions of dollars— 

2007 2008 2009 2010 2011 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Authorization Level ........................................................................................ 30 30 30 30 30 

Estimated Outlays ......................................................................................... 10 26 29 29 29 

Basis of estimate: Two institutes of the NIH, the National Cancer Institute and the National Institute of Environmental Health 

Sciences (NIEHS), currently support four collaborative Breast Cancer and the Environment Research Centers that study how chemical, physical, and social factors in the environment affect the development of breast cancer. According to officials at NIEHS, those 

institutes spent approximately $5 million on those research centers 

in fiscal year 2005 and plan to spend a similar amount each year 

through fiscal year 2009. S.757 would provide statutory authorization for similar Breast Cancer and Environmental Research Centers of Excellence administered through the NIH. The bill would 

authorize those centers for fiscal years 2007 through 2012. 

In addition, S. 757 would require the Secretary of HHS to establish within the NIH a nine-member Breast Cancer and Environmental Research Panel, which would set research priorities and 

make recommendations for the Centers for Excellence program. 

For carrying out the above activities, the bill would authorize the 

appropriation of $30 million for each of the fiscal years 2007 

through 2012. Such authorization would be in addition to any currently authorized appropriations for those activities. For this estimate, CBO assumes that S. 757 will be enacted near the start of 

fiscal year 2007 and that the authorized amounts will be appropriated for each year. Using historical patterns of spending for 

similar programs, CBO estimates that implementing the bill would 

cost $10 million in 2007 and $123 million over the 2007–2011 period. 

Intergovernmental and private-sector impact: S. 757 contains no 

intergovernmental or private-sector mandates as defined in UMRA 

and would impose no costs on state, local, or tribal governments. 

Estimate prepared by: Federal Costs; Sarah Evans. Impact on 

State, Local, and Tribal Governments: Leo Lex. Impact on the Private Sector: Jennifer Doleac. 


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Estimate approved by: Robert A. Sunshine, Assistant Director for 

Budget Analysis. 

VI. APPLICATION OF LAW TO THE LEGISLATIVE BRANCH

S. 757 amends the PHSA to authorize this grant program. 

VII. REGULATORY IMPACT STATEMENT

This legislation requires the Secretary, working through the Director of NIH, to establish grants for the development and operation of research Centers regarding environmental factors that may 

be related to the etiology of breast cancer. The committee has determined that the bill will not have a significant regulatory impact. 

VIII. SECTION-BY-SECTION ANALYSIS

Sec. 1. Short title 

The Breast Cancer and Environmental Research Act of 2006. 

Sec. 2. National Institutes of Health; awards for development and 

operation of research centers regarding environmental factors 

related to breast cancer 

Instructs the Secretary, acting through the Director of NIH, and 

working in cooperation with the Directors of NIEHS and NCI to establish a Breast Cancer and Environmental Research Panel and 

make grants to develop and operate collaborative Centers that 

would conduct research on environmental factors that may be 

linked to the development of breast cancer. 

Establishes the Breast Cancer and Environmental Research 

Panel that will be made up of six researchers and other health professionals, and three members from the general public who are 

breast cancer survivors, or their representatives. The Secretary 

may choose to include non-voting, ex-officio members as well. The 

Panel members will elect the Chair of the Panel. The Panel will 

meet as often as the Director of NIH or the Chair of the Panel determine, but no less than once a year. 

The Panel duties include developing a comprehensive strategy regarding collaborative Centers, making recommendations to the Secretary with respect to the mechanisms, peer review criteria, and allocations for the Centers, assisting in the overall program evaluation, and providing recommendations for disseminating information 

on the process of the program. 

The Centers funded by the grants will develop innovative approaches to study unexplored or under-explored areas of the environment and breast cancer. They will also be responsible for identifying key research questions, and knowledge gaps in this area. In 

addition, the Centers will address key issues regarding environmental factors that may be related to breast cancer, and as a result, contribute to a strategy to address those factors. Each Center 

must include community organizations in the geographic areas 

served by the Center that represent individuals with breast cancer. 

These organizations would be integral collaborators involved at all 

levels of the decision-making and research in each Center. The 

Centers will also need to communicate regularly among themVerDate Aug 31 2005 03:20 Jul 25, 2006 Jkt 049010 PO 00000 Frm 00008 Fmt 6659 Sfmt 6602 E:\HR\OC\SR290.XXX SR290

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selves, and, at the direction of the Director of NIH, submit reports 

on their activities. 

The Centers would be funded for up to 5 years. The funding may 

be extended up to 5 more years after a peer review committee has 

recommended to the Director of NIH that the Center’s funding 

should be extended. Finally, the Director of NIH will be responsible 

for ensuring, to the extent practicable, that the Centers are distributed equitably across the country. Authorization of Appropriations—$30,000,000 per year for 5 

years is authorized by this legislation. 

IX. CHANGES IN EXISTING LAW

In compliance with rule XXVI paragraph 12 of the Standing 

Rules of the Senate, the following provides a print of the statute 

or the part or section thereof to be amended or replaced (existing 

law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, existing law in which no change is proposed 

is shown in roman): 

PUBLIC HEALTH SERVICE ACT 

* * * * * * * 

TITLE IV—NATIONAL RESEARCH INSTITUTES 

PART A—NATIONAL INSTITUTES OF HEALTH 

ORGANIZATION OF THE NATIONAL INSTITUTES OF HEALTH

SEC. 401. * * * 

* * * * * * * 

SEC. 404A. * * * 

* * * * * * * 

SEC. 404G. (a) COOPERATIVE AGREEMENTS AND GRANTS.— 

(1) IN GENERAL.—* * * 

* * * * * * * 

SEC. 404H. RESEARCH CENTERS REGARDING ENVIRONMENTAL FACTORS RELATED TO BREAST CANCER. 

(a) IN GENERAL.—The Secretary, acting through the Director of 

NIH, based on recommendations from the Breast Cancer and Environmental Research Panel established under subsection (b) (referred 

to in this section as the ‘Panel’), shall make grants to public or nonprofit private entities for the development and operation of collaborative, multi-institutional centers for the purpose of conducting multidisciplinary and multi-institutional research on environmental 

factors that may be related to the etiology of breast cancer. Each 

such center shall be known as a Breast Cancer and Environmental 

Research Center of Excellence. 

(b) BREAST CANCER AND ENVIRONMENTAL RESEARCH PANEL.— 

(1) ESTABLISHMENT.—The Secretary shall establish within 

the National Institutes of Health a Breast Cancer and Environmental Research Panel. 

(2) COMPOSITION.—The Panel shall be composed of— 


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(A) 9 members to be appointed by the Secretary, of 

which— 

(i) six members shall be appointed from among physicians and other health professionals, who— 

(I) are not officers or employees of the United 

States; 

(II) represent multiple disciplines, including 

clinical, basic, and public health sciences; 

(III) represent different geographical regions of 

the United States; 

(IV) are from practice settings, academia, or 

other research settings; and 

(V) are experienced in peer review; and 

(ii) three members shall be appointed from the general public who are representatives of individuals who 

have had breast cancer and who represent a constituency; and 

(B) such nonvoting, ex officio members as the Secretary 

determines to be appropriate. 

(3) CHAIRPERSON.—The members of the Panel appointed 

under paragraph (2)(A) shall select a chairperson from among 

such members. 

(4) MEETINGS.—The Panel shall meet at the call of the chairperson or upon the request of the Director of NIH, but in no 

case less often than once each year. 

(5) DUTIES.—The Panel shall— 

(A) develop a comprehensive strategy concerning collaborative centers that would— 

(i) result in innovative approaches to study unexplored or underexplored areas of the environment and 

breast cancer; 

(ii) outline key research questions, methodologies, 

and knowledge gaps concerning environmental factors 

that may be related to the etiology of breast cancer; 

(iii) outline key issues concerning environmental factors that may be related to the etiology of breast cancer; 

and 

(iv) result in an overall strategy to address environmental factors related to breast cancer; 

(B) make recommendations to the Secretary with respect 

to the mechanisms, peer review criteria, and allocations 

under this section; 

(C) assist in the overall program evaluation; and 

(D) make recommendations for the dissemination of information on program process. 

(c) COLLABORATION WITH COMMUNITY.—Each center under subsection (a) shall include community organizations in the geographic 

area served by the center, including those that represent women 

with breast cancer, as integral collaborators involved at all levels of 

the decision-making and research in such center. 

(d) COORDINATION OF CENTERS; REPORTS.—The Director of NIH 

shall, as appropriate, provide for the coordination of information 

among centers under subsection (a) and ensure regular communication between such centers, and may require the periodic preparation 


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of reports on the activities of the centers and the submission of the 

reports to the Director. 

(e) REQUIRED CONSORTIUM—Each center under subsection (a) 

shall be formed from a consortium of cooperating institutions and 

community groups, meeting such requirements as may be prescribed 

by the Director of NIH. Each center shall require collaboration 

among highly accomplished scientists, other health professionals 

and advocates of diverse backgrounds from various areas of expertise. 

(f) DURATION OF SUPPORT.—Support of a center under subsection 

(a) may be for a period not exceeding 5 years. Such period may be 

extended for one or more additional periods not exceeding 5 years 

if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the 

Director of NIH and if such group has recommended to the Director 

that such period be extended. 

(g) GEOGRAPHIC DISTRIBUTION OF CENTERS.—The Director of 

NIH shall, to the extent practicable, provide for an equitable geographical distribution of centers under this section. 

(h) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized to be appropriated 

$30,000,000 for each of the fiscal years 2007 through 2012. Such 

authorization is in addition to any other authorization of appropriations that is available for such purpose. 

* * * * * * * 

Æ 


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