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[Senate Report 110-484]
[From the U.S. Government Publishing Office]

                                                      Calendar No. 1055
110th Congress                                                   Report
                                 SENATE
 2d Session                                                     110-484

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  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.

           *       *       *       *       *       *       *

                                  
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