[Senate Report 109-290]
[From the U.S. Government Publishing Office]
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;
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 worldwide. 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 due to an inherited genetic defect since
inherited cancer usually shows up at anearlier 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
multi-disciplinary and multi-institution research on
environmental factors that may be related to breast
cancer.
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;
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 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 appropriation 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.
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 themselves, 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--
(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 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.
* * * * * * *