[Senate Report 112-213]
[From the U.S. Government Publishing Office]
Calendar No. 514
112th Congress Report
SENATE
2d Session 112-213
======================================================================
STRENGTHENING PROTECTIONS FOR CHILDREN AND COMMUNITIES FROM DISEASE
CLUSTERS ACT
_______
September 19, 2012.--Ordered to be printed
_______
Mrs. Boxer, from the Committee on Environment and Public Works,
submitted the following
R E P O R T
together with
MINORITY VIEWS
[To accompany S. 76]
[Including cost estimate of the Congressional Budget Office]
The Committee on Environment and Public Works, to which was
referred the bill (S. 76) to direct the Administrator of the
Environmental Protection Agency to investigate and address
cancer and disease clusters, including in infants and children,
having considered the same, reports favorably thereon without
amendment and recommends that the bill do pass.
PURPOSES OF THE LEGISLATION
To direct the Administrator of the Environmental Protection
Agency to investigate and address cancer and disease clusters,
including in infants and children.
GENERAL STATEMENT AND BACKGROUND
S. 76 seeks to increase the transparency, accountability
and coordination of federal actions to investigate and address
cancer and disease clusters. The bill authorizes the
Administrator of the Environmental Protection Agency to
investigate and address cancer and disease clusters, in
conjunction with other federal public health agencies. The bill
also increases the involvement of the public in participating
in disease cluster investigations and actions to address the
potential causes of such clusters.
The need to modernize and update the federal government's
approach to addressing disease clusters is clear. Over the last
century, society has made tremendous advances in public health
protections. Clean drinking and wastewater systems have reduced
the number of people who die from typhoid and cholera. New
medical systems, including early detection techniques, have
helped to reduce deaths from heart disease and stroke. However,
studies have shown the rates of some diseases have increased
and the rates of other diseases, and associated deaths, still
impact significant numbers of people, including children.
For example, according to the Environmental Protection
Agency (EPA), from 1975 to 2007, rates of childhood cancer have
increased by almost 30 percent. Leukemia is the most common
form of childhood cancer, accounting for 20 percent of the
incidences. Between 1976 and 2005 there was a 24 percent
increase in acute lymphoblastic leukemia in children.
According to the National Cancer Institute, roughly 2,200
children a year are diagnosed with cancer of the central
nervous system, including of the brain and brain stem. The
Department of Health and Human Services has found that birth
defects are the leading cause of infant death in the first year
of life, accounting for about 20 percent of infant deaths in
2006.
Diseases can have complex causes and researchers can have
great difficulty fully describing the factors that cause
children and other people to contract cancer and other
illnesses. Experts focus on multiple potential causes, which
often involve both environmental and genetic factors.
Recently, the President's Cancer Panel issued its 2008-2009
annual report, titled: ``Reducing Environmental Cancer Risk:
What We Can Do Now.'' The report states that:
``In 2009 alone, approximately 1.5 million American
men, women, and children were diagnosed with cancer,
and 562,000 died from the disease. With the growing
body of evidence linking environmental exposures to
cancer, the public is becoming increasingly aware of
the unacceptable burden of cancer resulting from
environmental and occupational exposures that could
have been prevented through appropriate national
action.''
The President's Cancer Panel went on to highlight the need
to more fully address environmental links to cancer: ``The
Panel was particularly concerned to find that the true burden
of environmentally induced cancer has been grossly
underestimated. . . . The Panel urges you [the President] most
strongly to use the power of your office to remove the
carcinogens and other toxins from our food, water, and air that
needlessly increase health care costs, cripple our Nation's
productivity, and devastate American lives.''
The Committee also received testimony from people who have
been impacted by childhood disease. The Committee notes the
testimony of Mr. Trevor Schaefer, who is a twenty-one-year-old
brain cancer survivor from McCall, ID. Mr. Schaefer was
diagnosed with a malignant medullablastoma in November of 2002
at the age of thirteen. He successfully fought the disease
following treatment for his cancer and, thereafter, has helped
to lead efforts to address the causes of childhood disease
clusters. S. 76, which is also known as ``Trevor's Law,'' is
designed to help children and other people like Mr. Schaefer
who are affected by disease clusters.
To accomplish goal, the bill seeks to strengthen federal
agency coordination and accountability when investigating and
helping to address potential disease clusters; increase
resources to communities who may be impacted by potential
disease clusters, including by providing for community-based
committees that play an integral role in actions to investigate
and help address such clusters; and enhance federal, state and
academic capacity to investigate and help address such
clusters, including through partnerships and grants and by
developing new pollution and disease tracking tools to
facilitate investigation and actions to address clusters.
SECTION-BY-SECTION ANALYSIS
Section 1. Short title
Section 1 provides that the short title of the bill is the
''Strengthening Protections for Children and Communities From
Disease Clusters Act''.
Sec. 2. Findings
Section 2 contains the findings made to highlight the need
for the bill and the actions authorized by the bill.
Sec. 3. Purposes
Section 3 defines the purposes for which the bill was
created.
Sec. 4. Goals
Section 4 defines the goals that the bill seeks to achieve.
Sec. 5. Definitions
Section 5 contains the definitions of the bill.
Sec. 6. Guidelines for environmental investigations of disease clusters
Section 6 describes the establishment and requirements for
federal disease cluster investigation guidelines.
Subsection (a) directs the Administrator of the EPA, in
consultation with the Administrator of the Agency for Toxic
Substances and Disease Registry, the Secretary of Health and
Human Services, and the Director of the National Institute of
Environmental Health Sciences to develop, publish, and
periodically update guidelines that describe a systematic,
integrated approach that uses the best available science to
investigate suspected or potential disease clusters,
environmental pollutants or toxic substances associated with
one or more suspected or potential disease clusters, or the
potential causes of such clusters.
Subsection (b) describes the requirements for these
guidelines, including the definition of key concepts and
actions; identification and reporting protocols; standardized
methods of reviewing and categorizing data, guidance for using,
in a health-protective way, an appropriate epidemiological,
statistical, or other approach for the circumstances of an
investigation; procedures for peer review of key documents by
individuals who have no direct or indirect conflict of
interest; and a description of roles and responsibilities of
federal agencies in conducting investigations.
Subsection (c) describes the timing for the proposed and
final guidelines.
Sec. 7. Enhanced support for environmental investigations of disease
clusters
Subsection (a) describes the establishment of regional
disease cluster information and response centers and teams. The
subsection describes the federal agencies included in the
process of creating these administrative structures and, to
promote accountability and transparency, makes the
Administrator of the EPA principally responsible for directing,
coordinating and approving federal authorized under this
section. This subsection also describes the coordination,
grants and cooperative agreements, timing of creation, and the
authorization of appropriations for these activities.
Subsection (b) describes the response teams' membership and
leadership structure and the activities authorized to be
undertaken by the teams. The subsection provides for a petition
process to request that a response team conduct an
investigation or take other action to address the potential
causes of disease clusters, and requires the issuance of
criteria for the consideration of such petitions. The
subsection describes the response teams' use of data and the
requirements for transparency and accountability in conducting
their activities. The subsection also provides for the creation
of a database to assist the response teams and other efforts in
investigating and addressing disease clusters.
Subsection (c) describes the creation of community disease
cluster advisory committees that are created to provide
oversight, guidance, and advice relating to the investigation
of suspected and potential disease clusters, and for other
purposes. The subsection describes the membership of the
committees and prohibits direct and indirect conflicts of
interest by such members. The subsection authorized technical
assistance, including grants, to groups of individuals that may
be affected by a suspected or potential disease cluster and
allows such grants to be used to facilitate active involvement
in all aspects of Committee activities and to assist Committee
members in obtaining technical assistance in interpreting
information related to the investigation of suspected or
potential disease clusters, and for other purposes.
Subsection (d) describes the types of environmental
research and analysis authorities that federal agencies shall
utilize when undertaking authorized activities.
Sec. 8. Federal reports to Congress
Subsection (a) describes the timing of reports to Congress
on activities authorized to be undertaken by this bill.
Subsection (b) describes the types of activities and
information that should be included in the reports.
Subsection (c) describes the submission and availability of
such reports.
Sec. 9. Authorization of appropriations
This section authorizes appropriations as are necessary to
carry out this Act.
Sec. 10. Effect on other laws
This section states that nothing in this Act modifies,
limits, or otherwise affects the application of, or obligation
to comply with, any law, including any environmental or public
health law.
LEGISLATIVE HISTORY
S. 76 was introduced by Senator Boxer on January 25, 2011.
The bill was received, read twice, and referred to the
Committee on Environment and Public Works. On June 9, 2011, the
Committee on Environment and Public Works met to consider the
bill. The bill was ordered reported favorably without amendment
by voice vote.
HEARINGS
In the 112th Congress, on March 29, 2011, the full
Committee on Environment and Public Works held a hearing
entitled, ``Oversight Hearing on Disease Clusters and
Environmental Health.''
ROLLCALL VOTES
The Committee on Environment and Public Works met to
consider S. 76 on June 9, 2011. The bill was ordered reported
favorably by a vote of 11 yeas to 7 nays.
REGULATORY IMPACT STATEMENT
In compliance with section 11(b) of rule XXVI of the
Standing Rules of the Senate, the Committee makes evaluation of
the regulatory impact of the reported bill. The Committee finds
that this legislation does not have substantial regulatory
impacts.
MANDATES ASSESSMENT
In compliance with the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4), the Committee finds that this legislation does
not impose intergovernmental mandates or private sector
mandates as those terms are defined in the Unfunded Mandates
Reform Act (UMRA). The Congressional Budget Office concurs,
finding S. 76 contains no intergovernmental or private-sector
mandates as defined in the UMRA and would not affect the
budgets of state, local, or tribal governments.
June 22, 2011.
Hon. Barbara Boxer,
Chairman, Committee on Environment and Public Works,
U.S. Senate, Washington, DC.
Dear Madam Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for S. 76, the
Strengthening Protections for Children and Communities from
Disease Clusters Act.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Susanne
Mehlman.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
S. 76--Strengthening Protections for Children and Communities from
Disease Clusters Act
Summary: S. 76 would require the Environmental Protection
Agency (EPA) to develop guidelines for establishing a
systematic and integrated approach to investigating suspected
disease clusters. (Disease clusters are defined as the
occurrence of a greater-than-expected number of cases of a
particular disease within a group of individuals, geographical
area, or time period.) This legislation also would require EPA
to establish and operate two regional response centers and
response teams to investigate potential disease clusters or
environmental pollutants or toxic substances associated with
those disease clusters. In addition, S. 76 would authorize EPA
to provide grants and enter into cooperative agreements with
institutions of higher education to support research and
operational activities performed by the response teams. Under
the bill, EPA also could make technical assistance grants to
any group of individuals affected by a suspected disease
cluster.
Based on information from EPA, CBO estimates that
implementing S. 76 would cost about $76 million over the 2012-
2016 period, subject to appropriation of the necessary amounts.
That funding would provide for additional personnel,
contractors, grants and cooperative agreements, and other
administrative activities.
Pay-as-you-go procedures do not apply to this legislation
because enacting the bill would not affect direct spending or
revenues.
S. 76 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. 76 is shown in the following table. The
costs of this legislation fall within budget function 300
(natural resources and environment).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------
2012 2013 2014 2015 2016 2012-2016
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CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Grants and Cooperative Agreements with Institutions of
Higher Learning:
Estimated Authorization Level....................... 5 5 5 5 5 25
Estimated Outlays................................... 2 4 5 5 5 21
Grants to Affected Groups:
Estimated Authorization Level....................... 0 4 4 4 4 16
Estimated Outlays................................... 0 4 4 4 4 16
Support for Response Centers and Teams:
Estimated Authorization Level....................... 4 4 4 4 4 20
Estimated Outlays................................... 3 4 4 4 4 19
Other EPA Administrative Support:
Estimated Authorization Level....................... 4 4 4 4 4 20
Estimated Outlays................................... 4 4 4 4 4 20
Total Changes:
Estimated Authorization Level................... 13 17 17 17 17 81
Estimated Outlays............................... 9 16 17 17 17 76
----------------------------------------------------------------------------------------------------------------
Note: EPA = Environmental Protection Agency.
Basis of estimate: For this estimate, CBO assumes that S.
76 will be enacted by the end of fiscal year 2011 and that the
necessary amounts will be appropriated each year.
Based on information from EPA, CBO estimates that in 2012
EPA would spend about $9 million to establish the guidelines
for investigating disease clusters and to establish and provide
some initial support for the response centers and teams
responsible for investigating those disease clusters. Included
in that cost is funding for about 25 additional personnel,
contractors, a small number of grants and cooperative
agreements for institutions of higher learning, and other
administrative support. In subsequent years when the response
centers and teams are fully operational, CBO expects that EPA
would spend additional resources to provide grants and enter
into cooperative agreements with institutions of higher
education to support those response centers and teams and to
provide grants to affected groups. As a result, EPA's costs
would increase to $16 million in 2013 and $17 million annually
in subsequent years.
Intergovernmental and private-sector impact: S. 76 contains
no intergovernmental mandates or private-sector mandates as
defined in UMRA and would impose no costs on state, local, or
tribal governments. State, local, and tribal governments could
receive grants and technical assistance authorized by the bill.
Estimate prepared by: Federal Spending: Susanne Mehlman;
Impact on State, Local, and Tribal Governments: Ryan Miller;
Impact on the Private Sector: Amy Petz.
Estimate approved by: Theresa Gullo, Deputy Assistant
Director for Budget Analysis.
MINORITY VIEWS OF SENATORS INHOFE, VITTER
Protecting communities including pregnant women, infants,
and children is of the utmost importance. Physicians and local
public health departments are on the front lines of caring for
these communities and vulnerable subpopulations while defending
them from illness and diseases every day. A ``cluster'' is
defined by the Center for Disease Control (CDC) as ``an unusual
aggregation, real or perceived, of health events that are
grouped together in time and space and that is reported to a
public health department.''
Currently, at the federal level, CDC through the Agency for
Toxic Substances and Disease Registry (ATSDR) investigates and
addresses cancer and disease clusters. ATSDR is an agency with
a long history in public health and possesses the expertise and
knowledge necessary to identify and deal with disease clusters.
It has an existing infrastructure that facilitates cooperation
between states and local public health departments, as well as
local physicians communication ATSDR has labeled ``essential in
recognizing and responding to disease cluster concerns.'' ATSDR
has also outlined procedures for investigating disease clusters
at the federal, state, and local levels.
S. 76, the ``Strengthening Protections for Children and
Communities from Disease Clusters Act,'' needlessly shifts
authorities away from local and federal public health experts
at the CDC, ATSDR, and public health departments, to the
Environmental Protection Agency (EPA), a regulatory agency with
far less expertise and experience in identifying and responding
to disease clusters.
This legislation ignores the critical roles of CDC and
ATSDR, but also of local doctors as well as public health
departments in dealing with disease clusters in favor of a top
down bureaucratic approach. Local physicians have the primary
role in confirming diagnosis and completing applicable exposure
histories as well as recognizing abnormal event patterns. This
information is then reported to the appropriate local public
health departments who have a critical role of their own in the
investigation of disease clusters. They collect case
information, conduct local surveillance and surveys, conduct
environmental and occupational exposure assessments, ensure
appropriate communication and education of the public as well
as health professionals, and initiate effective and timely
actions to allay potential factors associated with disease
clusters.
The stated purposes of this bill are to provide the EPA
Administrator with broad new authorities ``to help conduct
investigations'' and ``to undertake actions'' to help
investigate and address ``potential environmental pollution and
toxic substances that may contribute to the creation of disease
clusters.'' Inclusion of ``potential'' is highly problematic.
Potential refers to the possibility of a relationship, not
likelihood. This would direct EPA onto ``fishing expeditions''
in search of ``potential'' chemical ``causes'' of disease
clusters. It is at odds with EPA's expertise in risk
assessment, under which EPA incorporates chemical specific
hazard and exposure information developed under validated
laboratory screens, tests and assessment of potential
exposures, to determine the potential risk of harm from a
specific exposure to a chemical substance. These risk
assessments do not identify causes of disease and thus EPA's
chemical specific risk assessment expertise is not readily
transferrable to investigations of disease clusters. That
expertise is held by physicians and public health agencies.
Under S. 76, there is no requirement to show causality at all,
let alone a rigorous weight of evidence assessment. EPA is
given, by a literal reading, almost limitless authority. This
new authority is nothing more than an attempt to circumvent
appropriate jurisdictional and congressional limitations on the
EPA, The foremost enumerated goal of this legislation is to
protect individuals ``who have been, are, or could be harmed
by, and become part of, a disease cluster.'' Reading that goal
literally, who does not meet the criteria of someone who
``could be harmed by, and become part of, a disease cluster?''
Throughout this legislation, the rightful responsibilities
of Congress are intentionally subrogated to the EPA, allowing
the Agency great discretion in defining key terms, and even its
own authorities. S. 76 assigns unelected EPA bureaucrats the
lead role in implementing broad and vague authorities in any
manner they desire.
In S. 76, there is no definition of the term ``disease.''
The term ``disease cluster'' is loosely defined in part as
``the occurrence of a greater-than-expected number of cases of
a particular disease within a group of individuals, a
geographical area, or period of time.'' There is no reference
to how or where the ``greater-than-expected'' determination
should be scientifically determined. Moreover, to determine
expected numbers would require an immense database on the
distributions of an array of various health endpoints, taking
into account population statistics and comparative prevalence
of disease within each subpopulation. This database simply does
not exist. The definition goes on to also include ``the
occurrence of a particular disease in such number of cases, or
meeting such other criteria, as the Administrator . . . may
determine,'' leaving EPA in consultation with ATSDR and the
Director of the National Institute of Environmental Health
Sciences (NIEHS)--limitless discretion to label virtually any
situation as a ``disease cluster.''
The terms ``environmental pollutants or toxic substances''
and ``potential causes of a disease cluster'' are defined
similarly to include as wide a range as possible, including
contaminants and pollutants regulated by the Clean Water and
Safe Drinking Water Acts. While these are established
environmental pollutants, this definition also includes any
chemical substance regulated under the Toxic Substances Control
Act regardless of any scientific findings that such substances
are either toxic or pose significant exposures to humans.
Under Section 6 of S. 76, the EPA Administrator is also in
the lead role of developing guidelines for disease cluster
investigations. These guidelines include defining ``key
concepts and actions,'' developing ``disease cluster
identification and reporting protocols,'' and ``guidance for
using . . . appropriate epidemiological, statistical, or other
approach for the circumstances of an investigation'' in a
``health-protective way.'' This is extremely troubling, as the
term ``health-protective'' is not defined and is open for
interpretation, appearing to steer investigations on the use of
overly conservative risk models and assumptions that are often
controversial rather than the best available science. These
guidelines further go on to include allowing the EPA
Administrator the lead in assigning the ``roles and
responsibilities'' of federal officials and creating
``procedures for peer review'' that have no prohibition on
individuals who possess a blatant appearance of partiality.
EPA's largely unfettered grant of power continues into
Section 7, entitled ``Enhanced Support for Environmental
Investigations of Disease Clusters.'' This section directs the
Agency to lead in the establishment and operation of Regional
Disease Cluster Information and Response Centers (``Response
Centers'') and Regional Disease Cluster Information and
Response Teams (``Response Teams''). Under the subsection
(a)(1)(B), the EPA Administrator is directed to ``be
principally responsible for directing, coordinating, and
approving Federal efforts and assistance authorized under this
section.''
The Response Teams, whose scope of activities are
established through an EPA-led consultation process, are to be
staffed using a loose set of criteria including requirements of
individuals with ``community outreach'' experience. Similarly
to S. 76's peer review criteria, Response Team membership has
no prohibition against a lack of appearance of impartiality.
One of the Response Teams' primary responsibilities is
responding to petitions from ``any person . . . that requests
that a Response team conduct an investigation or take other
action to address the potential causes of disease clusters in
accordance with this Act.'' These responses are regarding the
broadly-labeled need ``to investigate suspected or potential
disease clusters, environmental pollutants or toxic substances
associated with these disease clusters, and potential causes of
disease clusters.''
Petitions made to Response Teams are to be considered using
criteria to be established through an EPA-led process, again
using ``health-protective factors'' rather than the best
available science. Considerations are also required to include
evidence of environmental releases of substances without any
reference to human health impacts and the blanket provision
including ``such other factors as the Administrator determines
are necessary.'' This fails to recognize that there are many
biological steps that must occur before exposure to a chemical
or substance can cause an adverse outcome and it is imperative
not to make blanket presuppositions that any exposure to any
chemical or substance necessarily causes harm. Furthermore,
this approach seems to grossly discount factors recognized by
the National Cancer Institute and other reputable health based
scientific organizations that potential causes for cancer and
disease clusters such as heredity and behavior and lifestyle
including diet, use of tobacco, drugs, alcohol, and even
exposure to sunlight.
Another troubling piece of this legislation is Section 7's
requirement of a public database. While there is an important
need for government transparency, there is also a need to
recognize the serious potential for harm to be caused by
disseminating inaccurate and incomplete information. The
required database would be publically accessible through the
internet and provide information relating to ongoing incomplete
reports, substances and illnesses ``associated with suspected
or potential disease clusters'' regardless if this information
is irrefutably shown later to have been groundless--and often
with disease cluster allegations, that is the conclusion. Such
a database, then, could serve as an unsubstantiated inventory
of chemicals for people to fear unnecessarily and even as a
list of chemicals for businesses to avoid absent any scientific
basis. These are just some of the potential pitfalls of this
database that could have devastating impacts on local
economies, businesses, and home values, often with absolutely
no demonstrable health benefits.
In further attempt to usurp and/or duplicate the
authorities of other Federal Agencies and increase the
bureaucratic expansion of EPA, this bill requires the EPA
Administrator alone to establish Community Disease Cluster
Advisory Committees. The purpose of these committees is to
``provide oversight, guidance, and advice'' relating to the
investigations of suspected and potential disease clusters and
associated causes or pollutants. These committees too are
required to have be comprised of a loosely defined membership
which includes any individuals ``as determined by the
Administrator'' of EPA along with some consultation. Of most
concern is the broad required membership category which
includes ``individuals who are or may be impacted by a
suspected or potential disease cluster, and the designee of
such an individual who may participate with or in the place of
such and individual.'' This loose definition could include
almost anyone and to make matters even more troubling, it
includes any individuals ``designee'' which could encompass
activists from outside of the communities or investigated
areas.
Finally, this bill provides no express opportunity for
judicial review of any determinations made, and there is no
requirement for EPA or any other Federal Agency to do any sort
of economic analysis considering potential job losses and
associated health impacts resulting from the implementation of
any potential actions stemming from S. 76. Within S. 76, there
are some areas requiring EPA and other federal agencies to
provide for public notice of draft criteria and guidelines and
some minimal opportunity for public comment; however, the
timeframe for responses is too short to solicit meaningful
review, and there is no requirement for the agencies to respond
to any substantive comments.
It is vitally important that we continue our efforts to
identify, treat, and diagnose disease clusters using the best
available science. S. 76 is nothing more than a misguided
attempt to take authority away from science based public health
and disease experts and give it to a regulatory agency far less
qualified for the job.
CHANGES IN EXISTING LAW
Section 12 of rule XXVI of the Standing Rules of the Senate
requires the committee to publish changes in existing law made
by the bill as reported. Passage of this bill will make no
changes to existing law.