[Senate Report 110-484]
[From the U.S. Government Publishing Office]
Calendar No. 1055
110th Congress Report
SENATE
2d Session 110-484
======================================================================
PROTECTING PREGNANT WOMEN AND CHILDREN FROM PERCHLORATE ACT OF 2008
_______
September 24 (legislative day, September 17), 2008.--Ordered to be
printed
_______
Mrs. Boxer, from the Committee on Environment and Public Works,
submitted the following
R E P O R T
[To accompany S. 150]
together with
MINORITY VIEWS
[Including cost estimate of the Congressional Budget Office]
The Committee on Environment and Public Works, to which was
referred the bill (S. 150) to amend the Safe Drinking Water Act
to protect the health of pregnant women, fetuses, infants, and
children by requiring a health advisory and drinking water
standard for perchlorate, reports favorably thereon with an
amendment and recommends the bill (as amended) do pass.
Purpose and Summary of the Legislation
The purpose of S. 150, the Protecting Pregnant Women and
Children from Perchlorate Act of 2008 is to require a health
advisory and national primary drinking water regulation for
perchlorate. The bill would also require EPA to create a public
health advisory for perchlorate that is fully protective, with
an adequate margin of safety, of the health of vulnerable
persons, including pregnant women, infants, and children,
taking into consideration body weight, exposure patterns and
all routes of exposure. S. 150 as amended would also require
the EPA to propose a national primary drinking water regulation
for perchlorate within 9 months of the date of enactment of S.
150, and to finalize a national primary drinking water standard
for perchlorate within 18 months of the date of enactment.
Background and Need for the Legislation
BACKGROUND
Perchlorate is a salt used to create flares, fireworks, and
other items. It also occurs naturally in some areas, including
in fertilizers imported from Chile. Once released into the
environment, perchlorate can move through soil, into water, and
then into food. People's health may be harmed by exposure to
perchlorate, through eating food or drinking water contaminated
with this toxic substance. According to the National Academy of
Sciences (NAS), certain exposure levels of perchlorate can
affect ``thyroid hormone production by inhibiting the uptake of
iodine . . . .''\1\ Also, according to the NAS: ``Thyroid
hormones are critical for normal growth and development of the
central nervous system of fetuses and infants.'' Vulnerable
persons, including pregnant women, infants, and children are
especially vulnerable to perchlorate's impact on iodine uptake
in the body.
---------------------------------------------------------------------------
\1\National Research Council, National Academy of Sciences, Health
Implications of Perchlorate Ingestion (2005), available online at
http://www.nap.edu/catalog.php?record_id=11202.
---------------------------------------------------------------------------
In 2005, the Government Accountability Office (GAO) found
395 sites in 35 states with more than 4 parts per billion (ppb)
of perchlorate. The Environmental Protection Agency (EPA) knows
of 160 drinking water systems, serving almost 17 million people
in 26 states, with perchlorate levels of at least 4 ppb. The
State of California knows of perchlorate contamination in 274
active or standby water wells at levels of at least 4 ppb.
In 2005, the National Academy of Sciences (NAS) report
found that low levels of perchlorate may pose health risks and
recommended a safe level of exposure to perchlorate from all
sources--contaminated drinking water and food.\2\
---------------------------------------------------------------------------
\2\Ibid.
---------------------------------------------------------------------------
Since 2005, several studies show widespread perchlorate
exposure. In October 2006, researchers at the federal Centers
for Disease Control (CDC) found detectable levels of
perchlorate in all urine samples taken during the 2001-2002
National Health and Nutrition Examination Survey (NHANES) of
U.S. residents age six and older, with significantly higher
levels found in children than in adults.\3\ In December 2006,
researchers at the CDC published a follow-up study that showed
that there was a ``significant'' relationship between the
amount of urinary perchlorate and two different thyroid
hormones in women. It was the first study to show a
correlation.\4\
---------------------------------------------------------------------------
\3\Blount, et al.; Perchlorate Exposure of the U.S. Population,
2001-2002; Journal of Exposure Science and Environmental Epidemiology
(2007) 17, 400-407; doi:10.1038/sj.jes.7500535; published online 18
October 2006.
\4\Blount, et al.; Urinary Perchlorate and Thyroid Hormone Levels
in Adolescent and Adult Men and Women Living in the United States;
Environmental Health Perspectives Volume 114, Number 12, December 2006.
---------------------------------------------------------------------------
A 2007 study in the Proceedings of the National Academy of
Sciences found that perchlorate concentrates in breast milk. A
January 2008 broad study by the U.S. Food and Drug
Administration found perchlorate in 74% of all foods tested,
including baby food, and the study found: ``Infants and
children demonstrated the highest estimated intakes of
perchlorate on a body weight basis.''
While science increasingly raises health concerns about
perchlorate, EPA has not issued a drinking water standard for
perchlorate and has ended monitoring requirements for
perchlorate in drinking water, stating that the agency believed
that it had adequate monitoring data. In February 2005, EPA
issued perchlorate drinking water guidance of 24.5 parts per
billion that failed to account for perchlorate exposures from
food and water combined, and the guidance failed to lower
levels of allowed exposure to account for childhood exposures
or non-drinking water exposures. In August 2006, EPA issued
perchlorate cleanup guidance, which EPA's Children's Health
Protection Advisory Committee stated ``is not protective of
children's health.''
In 2007, EPA decided not to begin the process to regulate
perchlorate in public drinking water, and said it would review
new scientific information and make a final determination at a
later date. The Agency said that it expected to make an initial
determination of whether to regulate perchlorate in drinking
water in 2008.
NEED FOR LEGISLATION
EPA has known about perchlorate's health risks since before
2002. Scientific studies since that time have demonstrated that
perchlorate contamination of drinking water and food sources is
widespread, and that current levels of exposure in some areas
are sufficient to affect the hormone system of vulnerable
persons.
In the face of this scientific information, states have
taken action, including California and Massachusetts, to create
perchlorate drinking water standards; EPA has not taken action
and has eliminated its perchlorate monitoring requirements.
S. 150 will help to protect vulnerable persons, including
pregnant women, infants, children, and others in our country
from dangerous perchlorate exposures. It will also ensure that
the public is fully informed about perchlorate exposures and
the potential health effects from such exposures. These are
common sense and long-overdue actions needed to protect public
health.
Summary of Major Provisions of the Bill
The purpose of S. 150, the Protecting Pregnant Women and
Children from Perchlorate Act of 2008, is to require a health
advisory and national primary drinking water regulation for
perchlorate. The bill would also require EPA to create a public
health advisory for perchlorate that is fully protective, with
an adequate margin of safety, of the health of vulnerable
persons, including pregnant women, infants, and children,
taking into consideration body weight, exposure patterns and
all routes of exposure.
S. 150 would also require the EPA to propose a national
primary drinking water regulation for perchlorate within 9
months of the date of enactment of S. 150, and to finalize a
national primary drinking water standard for perchlorate within
18 months of the date of enactment. The proposed and final
standards must be protective, with an adequate margin of
safety, of the health of vulnerable persons, including pregnant
women, infants, and children, taking into consideration body
weight, exposure patterns and all routes of exposure. The
standard must establish a maximum contaminant level which is as
close to the maximum contaminant goal for perchlorate, and as
protective of vulnerable persons, as is feasible. Regulation of
perchlorate under the Safe Drinking Water Act would also apply
all of the Act's other safeguards, including monitoring and
public right-to-know protections, to drinking water supplies.
Section-by-Section Analysis
Section 1. Short title
Section 1 establishes the short title of the Act as the
``Protecting Pregnant Women and Children from Perchlorate Act
of 2008''.
Section 2. Findings
This section contains findings related to perchlorate
contamination and health effects.
Section 3. Monitoring and health advisory for perchlorate
Section 3 amends section 1412 of the Safe Drinking Water
Act by requiring EPA to create a health advisory and national
primary drinking water regulation for perchlorate, a health
advisory for perchlorate that is fully protective, with an
adequate margin of safety, of the health of vulnerable persons,
including pregnant women, infants, and children, taking into
consideration body weight, exposure patterns and all routes of
exposure.
The section requires that EPA propose a national primary
drinking water regulation for perchlorate within 9 months of
the date of enactment of S. 150, and finalizes a national
primary drinking water standard for perchlorate within 18
months of the date of enactment.
Legislative History and Votes
VOTES
On July 31, 2008, the Committee on Environment and Public
Works held a business meeting to consider Chairman Boxer's
amendment in the nature of a substitute to S. 150. The
Committee favorably adopted the Boxer substitute by voice vote,
with Senators Inhofe, Craig, and Alexander going on record as
opposing passage of the bill.
On May 6, 2008, the Committee held a legislative hearing
titled, ``Perchlorate and TCE in Drinking Water''. On April 29,
2008 the Committee held a hearing titled, ``Oversight on EPA
Toxic Chemicals Policies.'' On February 6, 2007, the Committee
held a hearing titled, ``Oversight on Recent EPA Decisions,''
at which perchlorate was discussed.
Regulatory Impact Statement
In compliance with section 11(b) of rule XXVI of the
Standing Rules of the Senate, the committee notes that the
Congressional Budget Office has found that it ``cannot
determine the nature or extent of possible regulations that
would result from this bill, and consequently cannot determine
whether the costs of the mandate in the bill would exceed the
intergovernmental threshold established in UMRA. . . .'' In
addition, CBO found that ``because most of the water systems
owned by private entities are small, CBO estimates that in any
one year the costs to comply with the mandate would fall below
the threshold established for private-sector entities ($136
million in 2008, adjusted annually for inflation).''
Mandates Assessment
In compliance with the Unfunded Mandates Reform Act of 1995
(Public Law 104-4), the Committee notes that the Congressional
Budget Office has said that it ``cannot determine the nature or
extent of possible regulations that would result from this bill
and consequently cannot determine whether the costs of the
mandate in the bill would exceed the intergovernmental
threshold established in UMRA ($68 million in 2008, adjusted
annually for inflation). Because most of the water systems
owned by private entities are small, CBO estimates that in any
one year the costs to comply with the mandate would fall below
the threshold established for private-sector entities ($136
million in 2008, adjusted annually for inflation).''
S. 150--Protecting Pregnant Women and Children from Perchlorate Act of
2008
S. 150 would require the Environmental Protection Agency
(EPA), no later than 90 days after the bill's enactment, to
issue a health advisory for perchlorate in drinking water that
fully protects susceptible populations, including pregnant
women, infants, and children. (Perchlorate is a chemical used
in rocket fuel.) EPA also would be required under this
legislation to establish a final regulation governing the
amount of perchlorate that is permissible in drinking water.
Based on information from EPA, CBO estimates that enacting
S. 150 would cost about $4 million over the 2009-2011 period,
subject to the availability of appropriations. That funding
would be used to support about 10 additional personnel as well
as contractor costs to meet the requirements of this
legislation.
Enacting the legislation would not affect direct spending
or revenues.
By requiring EPA to establish and enforce a drinking water
regulation for perchlorate, S. 150 would impose an
intergovernmental and private-sector mandate as defined in the
Unfunded Mandates Reform Act (UMRA). The mandate would require
operators of public water systems to monitor for the presence
of perchlorate and to decrease its presence in water supplies.
CBO cannot determine the nature or extent of possible
regulations that would result from this bill and consequently
cannot determine whether the costs of the mandate in the bill
would exceed the intergovernmental threshold established in
UMRA ($68 million in 2008, adjusted annually for inflation).
Because most of the water systems owned by private entities are
small, CBO estimates that in any one year the costs to comply
with the mandate would fall below the threshold established for
private-sector entities ($136 million in 2008, adjusted
annually for inflation).
The total cost of the intergovernmental mandate would
depend on the level of perchlorate allowed by the regulation,
which would affect the number of water systems that need to
comply and the resulting monitoring and construction costs
faced by operators of those systems. Over 40,000 public systems
would be subject to new monitoring requirements once EPA
establishes a regulation. Those monitoring costs could total
about $5 million annually in the first three years the
regulation would be effective, but those costs could decrease
significantly in subsequent years.
Total construction costs to install equipment or build new
treatment facilities could be significant but would vary
substantially depending on the number and size of water systems
that would need to treat for perchlorate. Annual costs for
construction also would depend on how long EPA allows for such
activities. Based on discussions with industry sources and
information from states and EPA officials, CBO expects that
total construction costs could range from less than $30 million
to more than $80 million annually over a 3-5-year period once
the regulation is effective. The annual costs would depend in
part on how long operators would be given to complete
construction.
The CBO staff contacts for this estimate are Susanne S.
Mehlman (for federal costs), Burke Doherty (for the state and
local impact), and Amy Petz (for the private-sector impact).
This estimate was approved by Theresa Gullo, Deputy Assistant
Director for Budget Analysis.
MINORITY VIEWS
Safe and affordable drinking water is a critical component
for healthy and economically prosperous communities. The Safe
Drinking Water Act is the legal authority for the Environmental
Protection Agency (EPA) to ensure that Americans continue to
receive the safest water in the world for consumption and also
adequately address new drinking water contaminants and
concerns. The Safe Drinking Water Act provides significant
opportunity for transparent scientific review and processes for
regulatory determinations. S. 150, the Protecting Pregnant
Women and Children from Perchlorate Act of 2007, disregards
scientific review, critical drinking water act processes, and
is misleading in the bill's findings. For these reasons, we
oppose this legislation.
The bill's findings are disingenuous and ignore several
important facts. The findings strongly suggest the Department
of Defense (DOD) and industry are responsible for any
perchlorate found in water. Research by the Center for Disease
Control (CDC) and others indicates that perchlorate is found as
a naturally occurring substance and shows up in many areas
around the country, even where there is no, and never has been,
a DOD or industrial presence. Further, a recent collaborative
effort in California found that 100% of DOD sites pose ``No
Threat'' to drinking water.
Naturally occurring perchlorate has been found in large
quantities in West Texas and from unknown sources in Hills,
Iowa. Perchlorate doesn't only appear in water, but is also
commonly found in the food supply. A recent Food and Drug
Administration (FDA) study found that when people with diets
high in perchlorate were tested, the sensitive subpopulations
were below the reference dose established by the National
Academies of Science (NAS). The study included sampling
populations that had high levels of perchlorate in their
drinking water.
The Environmental Protection Agency (EPA) knows of 160
drinking water systems in 26 states with perchlorate levels of
at least 4 ppb. EPA states: ``There are approximately 156,000
public drinking water systems,'' and ``perchlorate was detected
at levels above the minimum reporting level of 4 parts per
billion (ppb) in approximately 2 percent of the more than
34,000 samples analyzed.'' Those numbers are very similar to
the findings in a 2005 GAO report.
The findings dismiss the National Academy of Sciences'
recommended daily dosage of perchlorate. The NAS reference dose
of 24.5 parts per billion (ppb) is fully protective of the most
sensitive subpopulations and is very conservative as it uses a
precursor to an adverse health effect as a jumping off point.
In 2005, a panel of the National Academy of Sciences (NAS)
concluded that perchlorate caused no observable health effects,
adverse or otherwise, at levels as high as 0.007 mg/kg/day,
equivalent to drinking water levels of 245 parts per billion
(ppb). To ensure an adequate margin of safety for even
potentially vulnerable subpopulations (e.g., pregnant and
nursing mothers and their children) the NAS panel applied a
ten-fold safety factor, resulting in a perchlorate Reference
Dose of 0.0007 mg/kg/day, equivalent to a drinking water level
of 24.5 ppb.
The CDC does not suggest that people in the United States
are suffering health consequences at doses lower than the
current EPA reference dose of 24.5 ppb. The underlying bill's
findings do not take into account new and ongoing studies of
perchlorate. Additional work is needed to determine whether
some unknown factor associated with perchlorate exposure might
be the cause of the observed changes in thyroid function. In
addition, the EPA's Children's Health Protection Advisory
Committee's (CHPAC) August 2006 statement referenced in the
committee report is not fully inclusive of all current
scientific findings available. For instance, the CHPAC
statement was unable to consider the 2007 findings of a study
that measured perchlorate and iodine levels in the milk of 57
lactating Boston-area women. No correlation was found between
breast milk perchlorate and iodine levels. Additionally, the
lack of correlation between breast milk perchlorate and iodine
levels seemingly corroborates the Chilean findings which were
unfortunately discounted in the CHPAC letter.
According to Jonathan Borak (MD, FACP, FACOEM) Clinical
Professor of Epidemiology and Public Health at Yale School of
Medicine, ``The ongoing public debate about environmental
perchlorate exposure has led to misstatements and
misinterpretations of the relevant scientific findings. The
current state of knowledge should be clear. There is no
evidence of excessive perchlorate in the U.S. diet and little
likelihood that routine perchlorate ingestion would exceed the
EPA and NAS Reference Dose. There is no evidence that
perchlorate is a human carcinogen. There is evidence that the
U.S. diet contains sufficient iodine, and sufficient iodine
intake is protective against effects that might result from
perchlorate excess.''
The Environmental Protection Agency has the legal authority
to regulate perchlorate in public water systems if `` . . . the
contaminant may have an adverse effect on the health of
persons; the contaminant is known to occur or there is a
substantial likelihood that the contaminant will occur in
public water systems with a frequency and at levels of public
health concern; and in the sole judgment of the Administrator,
regulation of such contaminant presents a meaningful
opportunity for health risk reduction for persons served by
public water systems [Section 1412(b)(1)(A)(i)-(iii) of the
Safe Drinking Water Act].'' Currently, EPA is weighing the
various scientific studies that have been released as late as
January of this year in accordance with the Safe Drinking Water
Act requirements to determine whether regulating perchlorate in
drinking water is warranted. Congress should not undermine the
sanctity of the Safe Drinking Water Act by politicizing and
predetermining outcomes prior to the completion of the
scientific review process. The Safe Drinking Water Act
procedures were enacted to discontinue this type of
Congressional intervention and require EPA to base rules and
regulations on science, not individual members' political
gains.
Larry E. Craig.
James M. Inhofe.
Changes in Existing Law
In compliance with section 12 of rule XXVI of the Standing
Rules of the Senate, changes in existing law made by the bill
as reported are shown as follows: 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:
* * * * * * *
----------
SAFETY OF PUBLIC WATER SYSTEMS (SAFE DRINKING WATER ACT)
* * * * * * *
Sec. 1400. This title may be cited as the ``Safe Drinking
Water Act''.
* * * * * * *
Sec. 1412. (a)(1) Effective on the enactment of the Safe
Drinking Water Act Amendments of 1986, each national interim or
revised primary drinking water regulation promulgated under
this section before such enactment shall be deemed to be a
national primary drinking water regulation under subsection
(b). No such regulation shall be required to comply with the
standards set forth in subsection (b)(4) unless such regulation
is amended to establish a different maximum contaminant level
after the enactment of such amendments.
(2) * * *
* * * * * * *
(b) Standards.--
(1) Identification of contaminants for listing.--
(A) General authority.--* * *
* * * * * * *
(12) Certain contaminants.--
(A) Arsenic.--
(i) Schedule and standard.--* * *
* * * * * * *
(C) Perchlorate.--
(i) Health advisory.--Notwithstanding
any other provision of this section,
not later than 90 days after the date
of enactment of this subparagraph, the
Administrator shall publish a health
advisory for perchlorate that is fully
protective, with an adequate margin of
safety, of the health of vulnerable
persons (including pregnant women,
infants, and children), taking into
consideration body weight, exposure
patterns, and all routes of exposure.
(ii) Proposed regulations.--
Notwithstanding any other provision of
this section, the Administrator shall
propose (within 9 months of the date of
enactment of this subparagraph) and
shall finalize (within 18 months of the
date of enactment) a national primary
drinking water regulation for
perchlorate--
(I) that based on the factors
in clause (i) and other
relevant data, is protective,
with an adequate margin of
safety, of vulnerable persons
(including pregnant women,
infants, and children); and
(II) the maximum contaminant
level of which is as close to
the maximum contaminant level
goal for perchlorate, and as
protective of vulnerable
persons, as is feasible.
* * * * * * *