Safe Drinking Water Act
Improvements in Implementation Are Needed to Better Assure the Public of Safe Drinking Water Gao ID: GAO-11-803T July 12, 2011This testimony discusses highlights of GAO's report on the Environmental Protection Agency's (EPA) implementation of requirements for determining whether additional drinking water contaminants warrant regulation. The number of potential drinking water contaminants is vast--as many as tens of thousands of chemicals may be used across the country, and EPA has identified more than 6,000 chemicals that it considers to be the most likely source of human or environmental exposure. The potential health effects of exposure to most of these chemicals, and the extent of their occurrence in drinking water, are unknown. Under 1996 amendments to the Safe Drinking Water Act, every 5 years EPA is to determine for at least five contaminants whether regulation is warranted, considering those that present the greatest public health concern. EPA issued final regulatory determinations in 2003 and 2008 on a total of 20 contaminants, deciding in each case not to regulate. EPA did not recommend any new contaminants for regulation until February 2011, when it reversed its controversial 2008 preliminary decision to not regulate perchlorate, an ingredient in rocket fuel and other products. This statement summarizes our report being released today that (1) evaluates the extent to which EPA's implementation of the 1996 amendments has helped assure the public of safe drinking water and (2) reviews the process and scientific analyses EPA used to develop the 2008 preliminary decision to not regulate perchlorate.
EPA has not effectively implemented the 1996 amendments' requirement to consider, for regulatory determinations, contaminants that present the greatest public health concern. The contaminant candidate list that the amendments require EPA to develop every 5 years represents one level of prioritization as EPA selects from a larger universe those contaminants the agency believes warrant consideration for regulation. However, EPA officials told us that its Office of Water, which has primary responsibility for implementing the requirements of the Safe Drinking Water Act, has not (1) further ranked or otherwise prioritized the contaminants on the list on the basis of public health concern or (2) prioritized contaminants on the basis of public health concern when selecting them for regulatory determinations. For 16 of the 20 regulatory determinations made through January 2011, EPA based its decisions to not regulate on its assessment that public exposure to these drinking water contaminants was minimal--that is, there was limited or no occurrence of them in public drinking water systems. An EPA official described these determinations as addressing the "low hanging fruit"--rather than the contaminants of greatest public health concern. Overall, data availability--not consideration of greatest public health concern--has been the primary driver of EPA's selection of contaminants for regulatory determinations. In contrast to EPA's usual regulatory determination process, which is managed by a work group of professional staff with relevant expertise from across the agency, EPA officials decided that the agency's continuing deliberations on perchlorate would be managed by a less inclusive, small group of high-level officials, such as the Deputy Administrator and several Assistant Administrators. Notably, EPA did not include the Office of Children's Health Protection in its small group despite EPA's and the National Academies' conclusion that iodide uptake inhibition from perchlorate exposure had been identified as a concern in connection with increasing the risk of neurodevelopmental impairment in fetuses of pregnant women with iodine deficiency and to developmental delays and decreased learning capability in infants and children. This group of high-level officials managed the regulatory determination process for perchlorate both within EPA and externally with the Perchlorate Interagency Working Group, whose work was coordinated by the Council on Environmental Quality. According to an EPA briefing document, the Perchlorate Interagency Working Group was established in 2002 "to identify and help resolve perchlorate science and science policy issues."
GAO-11-803T, Safe Drinking Water Act: Improvements in Implementation Are Needed to Better Assure the Public of Safe Drinking Water
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United States Government Accountability Office:
GAO:
Testimony:
Before the Committee on Environment and Public Works, U.S. Senate:
For Release on Delivery:
Expected at 10:00 a.m. EDT:
Tuesday, July 12, 2011:
Safe Drinking Water Act:
Improvements in Implementation Are Needed to Better Assure the Public
of Safe Drinking Water:
Statement of David C. Trimble, Director:
Natural Resources and Environment:
GAO-11-803T:
Madam Chairman Boxer, Ranking Member Inhofe, and Members of the
Committee:
I am pleased to be here today to discuss highlights of GAO's report on
the Environmental Protection Agency's (EPA) implementation of
requirements for determining whether additional drinking water
contaminants warrant regulation. As you know, the number of potential
drinking water contaminants is vast--as many as tens of thousands of
chemicals may be used across the country, and EPA has identified more
than 6,000 chemicals that it considers to be the most likely source of
human or environmental exposure. The potential health effects of
exposure to most of these chemicals, and the extent of their
occurrence in drinking water, are unknown. Under 1996 amendments to
the Safe Drinking Water Act, every 5 years EPA is to determine for at
least five contaminants whether regulation is warranted, considering
those that present the greatest public health concern. EPA issued
final regulatory determinations in 2003 and 2008 on a total of 20
contaminants, deciding in each case not to regulate. In fact, EPA did
not recommend any new contaminants for regulation until February 2011,
when it reversed its controversial 2008 preliminary decision to not
regulate perchlorate, an ingredient in rocket fuel and other products.
This statement summarizes our report being released today that (1)
evaluates the extent to which EPA's implementation of the 1996
amendments has helped assure the public of safe drinking water and (2)
reviews the process and scientific analyses EPA used to develop the
2008 preliminary decision to not regulate perchlorate.[Footnote 1] In
preparing this testimony, we relied on our work supporting the
accompanying report, which contains a detailed description of our
scope and methodology. All of the work for this report was performed
in accordance with generally accepted government auditing standards.
Systemic Limitations in EPA's Implementation of Requirements for
Determining Whether to Regulate Additional Contaminants Have Impeded
Progress in Helping Assure the Public of Safe Drinking Water:
As detailed in our report, we found the following concerning the
extent to which EPA's implementation of the 1996 amendments has helped
assure the public of safe drinking water.
EPA Has Neither Identified the Drinking Water Contaminants of Greatest
Public Health Concern Nor Fully Used Its Authority to Obtain Data for
Making Regulatory Determinations:
EPA has not effectively implemented the 1996 amendments' requirement
to consider, for regulatory determinations, contaminants that present
the greatest public health concern. The contaminant candidate list
[Footnote 2] that the amendments require EPA to develop every 5 years
represents one level of prioritization as EPA selects from a larger
universe those contaminants the agency believes warrant consideration
for regulation. However, EPA officials told us that its Office of
Water, which has primary responsibility for implementing the
requirements of the Safe Drinking Water Act, has not (1) further
ranked or otherwise prioritized the contaminants on the list on the
basis of public health concern or (2) prioritized contaminants on the
basis of public health concern when selecting them for regulatory
determinations. In fact, for 16 of the 20 regulatory determinations
made through January 2011, EPA based its decisions to not regulate on
its assessment that public exposure to these drinking water
contaminants was minimal--that is, there was limited or no occurrence
of them in public drinking water systems. An EPA official described
these determinations as addressing the "low hanging fruit"--rather
than the contaminants of greatest public health concern. Overall, data
availability--not consideration of greatest public health concern--has
been the primary driver of EPA's selection of contaminants for
regulatory determinations.
To assess unregulated contaminants against the statutory criteria, EPA
needs sufficient information on both (1) the occurrence of these
contaminants in drinking water--called occurrence data--to assess the
population potentially being exposed and the levels of that exposure
and (2) the human health effects that may result from exposure to the
contaminants in drinking water. EPA has made some progress in
developing the occurrence and health effects data it needs, but for
many contaminants EPA lacks sufficient occurrence and health effects
data to support regulatory determinations, which continues to limit
its ability to make these decisions. Specifically, in finalizing its
current candidate list comprising 116 contaminants, EPA indicated that
the agency lacked sufficient occurrence or health effects data, or
both, for making regulatory determinations for at least 100 of the
contaminants. Moreover, in 2009 EPA's Science Advisory Board
recommended that the agency further prioritize among the contaminants
on the candidate list because the list was too large, noting that
prioritizing the contaminants on the list would help the agency meet
its goal of selecting contaminants for regulatory determinations that
"have the greatest opportunity to improve the safety of drinking water
and protect public health."
In addition, in its testing program for unregulated contaminants--
which can provide key occurrence data to inform regulatory
determinations--EPA has fallen short in both the number of
contaminants tested and the utility of the data provided because of
management decisions and program delays. For example, despite having
the authority to require testing for up to 30 drinking water
contaminants in each 5-year cycle, in implementing the first two
cycles of the testing program, EPA required that only 51 contaminants
be tested--thereby not availing itself of its authority to obtain
occurrence data for 9 additional contaminants. Moreover, in some
cases, the occurrence data EPA used to support its regulatory
determinations were based on testing (analytic) methods that were not
sufficiently sensitive to identify the presence of contaminants at
EPA's health reference level--the level that EPA uses in assessing
whether to regulate specific contaminants.[Footnote 3] For 9 of the 20
contaminants for which EPA made regulatory determinations in 2003 and
2008, the minimum reporting level--the lowest level of a contaminant
at which detections can be reported under testing protocols--exceeded
EPA's health reference level. For example, for dieldrin--an
insecticide banned by EPA for all uses in 1987 because of concerns
about harm to human health and its ability to persist in the
environment for decades--the agency relied on testing data obtained
using minimum reporting levels ranging from 10 to 2,200 times higher
than EPA's health reference level.[Footnote 4] EPA reported in its
regulatory determination documents for dieldrin that it was detected
in 0.06 percent of samples.[Footnote 5] However, in subsequent testing
of source water for drinking water wells using more sensitive tests
with minimum reporting levels near and below EPA's health reference
level, the U.S. Geological Survey (USGS) detected dieldrin in 3.1
percent of public well samples. Importantly, nearly all of USGS's
detections were at levels above EPA's health reference level. USGS was
able to detect dieldrin--and determine its presence above EPA's level
of public health concern--in these groundwater well samples because it
used a lower minimum reporting level for its testing than EPA used for
its regulatory determinations. This is significant because, as USGS
has reported, when a reporting level exceeds a health benchmark, a
contaminant may be present at a concentration greater than the health
benchmark but remain undetected, resulting in greater uncertainty in
evaluating the contaminant concentration in the context of public
health. EPA's testing program obtains data using minimum reporting
levels that are often higher than those used by the USGS in its
National Water Quality Assessment Program--ranging from 2 to more than
600 times higher.
In addition, the lack of timely health assessment data on drinking
water contaminants continues to limit EPA's ability to make regulatory
determinations. As a result of long-standing productivity problems in
EPA's Integrated Risk Information System (IRIS) program--managed by
the Office of Research and Development--EPA has not been able to keep
its existing chemical toxicity assessments current or to complete
assessments of the most important chemicals of concern.[Footnote 6],
[Footnote 7] For example, from 1998 through 2008, the Office of Water
lacked current IRIS assessments[Footnote 8] or other sufficient health
information for 24 chemical contaminants on the candidate lists, and
the Office of Research and Development completed assessments for only
2 of the 24. Moreover, the Office of Water's current needs for health
effects information for contaminants on the current candidate list
have roughly doubled--when publishing the third candidate list in
2009, EPA identified health effects information gaps for 44 of the 104
chemicals on the list. Importantly, most of these contaminants with
information gaps (1) are not on the IRIS agenda (i.e., assessments are
neither under way nor planned) and (2) have not been identified by the
Office of Water as priorities for IRIS assessments.
EPA Lacks Policies or Guidance on Applying the Broad Statutory
Criteria for Selecting Contaminants for Regulatory Determinations and
Making the Determinations:
The Safe Drinking Water Act requires EPA to select contaminants for
regulatory determinations that present the greatest public health
concern. However, EPA has not defined the characteristics of
contaminants of greatest public health concern or developed a process
for prioritizing the contaminants on its candidate list for regulatory
determination on this basis. As a result, EPA lacks criteria and a
process for identifying those contaminants on its candidate list that
pose the greatest public health concern.
Moreover, under the act, in selecting contaminants that present the
greatest public health concern, EPA is to consider the effect of these
contaminants on subpopulations at greater risk of adverse health
effects from exposure to drinking water contaminants. In addition, EPA
has stated that in making regulatory determinations, the act requires
the agency to consider the effects the contaminants have on sensitive
subpopulations, such as infants, children, those with kidney or liver
diseases or weakened immune systems, and the elderly. Children, for
example, represent a sensitive subpopulation because they may be more
highly exposed to toxic substances in drinking water and at greater
risk of adverse health effects than adults as a result of consuming
more water per unit of body weight than adults. Children may also have
increased susceptibility following exposure to drinking water
contaminants because they continue to develop both behaviorally and
physiologically throughout childhood. Furthermore, in 1995, EPA
published its Policy on Evaluating Health Risks to Children, which
states that the agency will "consider the risks to infants and
children consistently and explicitly as a part of risk assessments
generated during its decision making process," and to "the degree
permitted by available data in each case, the Agency will develop a
separate assessment of risks to infants and children or state clearly
why this is not done." In 2006, EPA developed a general guidance
document for all EPA program offices on implementing its 1995
children's health policy, as well as several technical guidance
documents that could help the Office of Water develop its own guidance
specific to assessing the sensitivity of children to drinking water
contaminants.
Notwithstanding the requirements of the Safe Drinking Water Act and
EPA's 1995 children's health policy, the Office of Water did not
implement a specific approach for considering children's health in
developing its 2003 and 2008 regulatory determinations. In addition,
the Office of Water has not developed guidance for its staff on when
and how to analyze the effects of drinking water contaminants on
children--or other sensitive subpopulations--for the purposes of
identifying the drinking water contaminants of greatest concern on
which to make regulatory determinations and to ensure it consistently
and explicitly considers risks to children in making these
determinations, such as by developing separate health reference levels
for children. While EPA identified children as a sensitive population
in 11 of the 20 regulatory determinations it completed in 2003 and
2008, Office of Water officials confirmed that for these 20
determinations, EPA did not develop separate health reference levels
for children or make adjustments to its health assessments.
The 1996 amendments also provide three broad criteria for EPA to use
in making regulatory determinations, all of which must be met for EPA
to determine that regulation is warranted. Notably, two of the
criteria are so broadly stated that they could potentially be
interpreted so as to lead to regulating all of the contaminants on
candidate lists, some of them, or none of them. Specifically, the
second statutory criterion--that a 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"--is susceptible to varying interpretations. For example,
different people may reasonably have differing views on the frequency
and levels of occurrence that represent a public health concern. The
third criterion--that regulation of the contaminant presents "in the
sole judgment of the Administrator ... a meaningful opportunity for
health risk reduction"--is expressly discretionary, and similarly open
to differing interpretations.
Importantly, the Office of Water has not developed policies or
guidance to help EPA staff apply these broad criteria. Guidance that
might help EPA staff apply the criteria transparently and consistently
could, among other things, (1) define or set thresholds or parameters
for assessing whether a contaminant occurs, or is substantially likely
to occur, in public water systems with a frequency and at levels of
public health concern and (2) provide factors or characteristics of
situations that would present meaningful opportunities for health risk
reduction. We note that such guidance could also serve as the basis
for an internal review mechanism to help EPA ensure consistent
implementation of the statutory criteria. Office of Water officials
could not describe examples of what would meet the three criteria
beyond stating that "there are no bright lines" and that they would
"know it when we see it." Without clarifying guidance, EPA's
regulatory determinations lack transparency, and EPA is at risk of
making inconsistent determinations, undermining the program's
credibility and the agency's ability to assure the public of safe
drinking water.
In the absence of regulations or guidance for applying the broad
statutory criteria, EPA appears to apply an informal policy that
contaminants warranting regulation should occur in public water
systems on a "national" scale. For example, documents supporting EPA's
2003 regulatory determinations state that the consideration of
geographic distribution "is important because the agency is charged
with developing national regulations, and it may not be appropriate to
develop [national primary drinking water regulations] for regional or
local contamination problems." In addition, some EPA officials serving
on regulatory determination work groups told us that a contaminant
must occur "nationally" to warrant a determination to regulate.
Notably, however, the Safe Drinking Water Act does not require that
contaminants be found in public water systems on a national basis for
an Administrator to find a meaningful opportunity for health risk
reduction. In fact, other parts of the statute provide for relief from
monitoring and flexibilities for instances in which a contaminant
occurs in certain areas but not in others. Moreover, there is nothing
in the act's committee reports suggesting that a contaminant need
occur nationally to support a decision to regulate. Without EPA
guidance providing a definition or parameters, an informal "national
occurrence" standard is open to shifting interpretations, potentially
affecting the consistency and credibility of EPA's decision making. To
the extent EPA is informally applying an unspecified national
occurrence requirement for contaminants to be evaluated as occurring
"with a frequency and at levels of public health concern," EPA is
implementing a critical policy and interpretation of the Safe Drinking
Water Act that has neither been defined nor subjected to public review.
Further, regarding the third statutory criterion, EPA has not
articulated guidelines or thresholds for how it is to assess whether
regulating a specific contaminant would provide a meaningful
opportunity for health risk reduction. The absence of guidelines on
what scenario or scenarios might illustrate "a meaningful opportunity
for health risk reduction" increases the potential for inconsistent
decision making and reduces the decisions' transparency.
In addition, EPA has not developed any guidance on the circumstances
that would trigger a re-evaluation of a prior decision to not regulate
or the process the agency would use in conducting a re-evaluation. In
at least one instance--1,1,2,2-tetrachloroethane--an updated IRIS
assessment became available after EPA's determination to not regulate,
but the agency has not announced whether it will reconsider the
determination. In addition, as discussed in the following section, the
credibility of some of EPA's regulatory determinations was limited. As
we reported, we believe EPA should consider whether it needs to re-
evaluate any of its past determinations to not regulate in light of
the systemic and individual shortcomings we identified. In the absence
of policies or guidance that identifies the circumstances that would
trigger such re-evaluations and the process the agency would use in
conducting them, it is not clear how and when such re-evaluations
would occur.
The Credibility of Some of EPA's Regulatory Determinations As
Presented in Federal Register Notices and Support Documents Is Limited
by a Lack of Transparency, Clarity, and Consistency:
The Safe Drinking Water Act requires EPA to ensure that, in its
regulatory determinations, among other things, the presentation of
information on public health effects is comprehensive, informative,
and understandable. In addition, to the extent that EPA's regulatory
determination notices and key support documents are transparent,
clear, and consistent regarding the occurrence and health effects data
the agency relied on, the credibility of the determinations is
enhanced. However, for the regulatory determinations that EPA has made
to date, some of the notices and support documents lack these key
qualities. For example, as reflected in the following excerpts from
EPA's regulatory determination documents for manganese and boron,
EPA's presentation of health effects information on some contaminants
lacked clarity, consistency, and transparency.
* EPA's 2003 regulatory determination support document for manganese
states unequivocally that there are "no data to indicate children are
more sensitive to manganese than adults." However, EPA's 2003 health
effects support document for manganese discusses studies that identify
an association between exposure to manganese in drinking water and
learning disabilities in children and concludes that additional
studies are needed to investigate the possibility that children are
more sensitive than adults.
* EPA's regulatory determination support document for manganese notes
that infants and newborns may be potentially susceptible to manganese
toxicity, but this key document does not disclose that newborns may be
exposed to high levels of manganese from infant formula or that these
high levels of manganese in formula can be magnified when it is
reconstituted with manganese-contaminated water.
* In its regulatory support document for boron, the Office of Water
(1) identified the primary adverse effects identified from studies of
animals after chronic exposure to low doses of boron as generally
involving the testes and the developing fetus and (2) stated that
animal studies identify the developing fetus as "potentially sensitive
to boron" and concluded that boron concentrations greater than the
health reference level "might" have an effect on prenatal development.
In contrast, the Office of Water's May 2008 Drinking Water Health
Advisory for Boron--developed in conjunction with the regulatory
determination and published just 2 months before the regulatory
determination was issued--states that there are "compelling lines of
evidence to suggest that the testicular morphological effects"
reported in studies of animals are applicable to children. Also, the
Office of Water's health advisory was not limited to prenatal exposure
as it concluded that exposure to boron between birth and puberty may
result in adverse cellular effects that would "affect testicular
function."
* EPA's Summary Document from the Health Advisory for Boron and
Compounds provides an important warning regarding infants' exposure to
boron in drinking water that is not included in either EPA's drinking
water advisory for boron or its regulatory determination support
document discussed above. Specifically, the summary document states
that water containing boron "at levels above the HA [health advisory]"
should not be used to prepare food or formula for infants. EPA does
not identify which of the exposure duration health advisories it is
referring to in this warning.
In addition, EPA's regulatory determination documents lack
transparency and clarity regarding how EPA determined its health
reference levels were protective of children. In addressing seven of
the contaminants in its 2003 regulatory determination notice for which
EPA identified children as a sensitive subpopulation, EPA did not
explain the potential effect of not developing separate health
reference levels for children (or not making adjustments to its health
assessments to reflect increased sensitivity) on its ability to ensure
that the health reference levels used in the regulatory determinations
were protective of children. Instead, EPA stated that the agency had
not yet determined a protocol for making a regulatory determination
for a chemical for which body weight and drinking water intake of
infants or a particular childhood age group would be the basis of a
regulatory action. As discussed earlier, health assessments based on
adult weight and drinking water intake may not fully account for the
risks to children of exposure to drinking water because they consume
more water per unit of body weight and may have other
susceptibilities, as well. Regarding its 2008 notice that included
four contaminants for which children were identified as a sensitive
subpopulation, Office of Water officials told us they would have
developed separate assessments for children if they had determined
children were "particularly sensitive" to the adverse health effects
of contaminants being considered for regulation. However, EPA did not
explain in its regulatory determination notices or support documents
the basis for its determinations that children were not particularly
sensitive to the adverse health effects of the contaminants considered
for regulation--even for those contaminants, such as manganese and
boron, for which EPA had determined children were a sensitive
subpopulation. EPA also did not explain how the sensitivity of
children can be evaluated in the absence of a separate assessment
based on the weight and drinking water intake of children.
Also, EPA's regulatory determination notices lack transparency and
clarity regarding the limitations of new or updated health advisories
the agency issued in conjunction with 9 decisions to not regulate.
According to EPA, the advisories are to provide, for example,
"guidance to communities that might be exposed to elevated
concentrations." However, the regulatory determination notices do not
acknowledge that when EPA determines regulation is not warranted but a
health advisory is needed, it will generally be up to states,
localities, and consumers to determine whether such contaminant levels
are found in public water systems in their jurisdiction. Importantly,
because public water systems are not typically required to test for
the presence of unregulated contaminants, information on the levels of
the contaminants in individual public water systems may be outdated or
unavailable. While some states--such as California and Massachusetts--
can promulgate their own drinking water regulations, others are
statutorily prohibited from, or otherwise constrained in, enacting
more stringent regulations than EPA has promulgated or promulgating
their own drinking water regulations for contaminants that EPA does
not regulate. In addition, individuals may have to have their water
tested by a laboratory to determine how much of these unregulated
contaminants are present in their drinking water to heed, for example,
EPA's warning in some cases to not use drinking water with
contaminants in excess of certain levels to prepare infant food or
formula. Moreover, EPA releases its drinking water advisories by
posting them on its Web site and does not issue public notification of
them, such as a press release, which potentially limits awareness of
the health advisories.
Our report provides information on the following limitations that also
reduce the credibility of EPA's completed regulatory determinations:
(1) EPA's explanations of the occurrence data EPA relied on to assess
known and likely occurrence of contaminants in drinking water lack
transparency, clarity, and consistency; (2) EPA's regulatory
determinations lack clarity regarding its reliance on outdated and
limited occurrence data to support some determinations; (3) the
regulatory determination documents lack transparency and clarity
regarding EPA's reliance on minimum reporting levels greater than its
health reference levels; and (4) EPA lacked consistency and clarity in
making determinations when IRIS assessments were either in process or
needed to be updated.
The Process and Analyses EPA Relied on to Support Its Preliminary
Determination on Perchlorate Were Atypical, Lacked Transparency, and
Limited the Agency's Independence in Developing and Communicating Its
Scientific Findings:
As detailed in our report, we found the following concerning the
process and scientific analyses EPA used to develop its 2008
preliminary determination to not regulate perchlorate.
EPA Used a Less Inclusive, Less Transparent, and More Directive
Process in Developing Its Preliminary Regulatory Determination on
Perchlorate Than Its Usual Process:
In contrast to EPA's usual regulatory determination process, which is
managed by a work group of professional staff with relevant expertise
from across the agency, EPA officials decided that the agency's
continuing deliberations on perchlorate would be managed by a less
inclusive, small group of high-level officials, such as the Deputy
Administrator and several Assistant Administrators. Notably, EPA did
not include the Office of Children's Health Protection in its small
group despite EPA's and the National Academies' conclusion that iodide
uptake inhibition from perchlorate exposure had been identified as a
concern in connection with increasing the risk of neurodevelopmental
impairment in fetuses of pregnant women with iodine deficiency and to
developmental delays and decreased learning capability in infants and
children. This group of high-level officials managed the regulatory
determination process for perchlorate both within EPA and externally
with the Perchlorate Interagency Working Group,[Footnote 9] whose work
was coordinated by the Council on Environmental Quality.[Footnote 10]
According to an EPA briefing document, the Perchlorate Interagency
Working Group was established in 2002 "to identify and help resolve
perchlorate science and science policy issues."
In contrast to the usual process EPA used for its regulatory
determinations, in which EPA staff with relevant expertise develop and
submit options to the Assistant Administrator for the Office of Water
for review and selection, the Assistant Administrator directed the
Office of Water staff in developing the preliminary determination for
perchlorate to draft a preliminary determination that reflected the
agency's decision to not regulate perchlorate and to support it with a
detailed and specific rationale that EPA and other members of the
Perchlorate Interagency Working Group had agreed to, under the
leadership and coordination of the Council on Environmental
Quality.[Footnote 11] EPA Office of Water officials told us that they
believed this agreement--which is not part of the record for the
preliminary regulatory determination--was developed by senior
officials from the Council on Environmental Quality, the Department of
Health and Human Services (HHS), EPA, the Office of Management and
Budget (OMB), and the U.S. Department of Agriculture. The agreement
focused on how EPA should address the key science issues concerning
perchlorate in its preliminary regulatory determination and specified
(1) a health reference level of 15 parts per billion of perchlorate in
drinking water and (2) the rationale for EPA to support the conclusion
that this health reference level would be protective of pregnant women
and their fetuses as well as of infants and children.
EPA Established a Reference Dose for Perchlorate but Subjected It to a
More Limited Review Than the Agency's Standard IRIS Assessment Review
Process:
In developing an IRIS assessment of perchlorate, EPA established a
reference dose[Footnote 12] on the basis of the National Academies'
recommendations, but subjected it to a more limited review than the
agency's standard IRIS assessment review process.[Footnote 13] EPA's
2002 draft IRIS assessment of perchlorate--from which EPA derived a
drinking water equivalent level of 1 part per billion[Footnote 14]--
drew significant attention--including from such federal agencies as
the Department of Defense, the Department of Energy, and the National
Aeronautics and Space Administration, because of the implications such
a level could have on their operations if EPA were to develop a
drinking water regulation for perchlorate. According to a senior EPA
official, the controversy that arose over the draft IRIS assessment of
perchlorate "was like nothing I had ever seen or have seen since." As
a result of the divergent views between EPA and the other federal
agencies, the Administrator of OMB's Office of Information and
Regulatory Affairs urged the four interested agencies to convene a
National Academies panel to review the draft IRIS assessment. Convened
in October 2003, the panel conducted this review and issued its report
in January 2005.[Footnote 15]
The National Academies 2005 perchlorate report made several key
recommendations to EPA on the basis of a different study from those on
which EPA had based its 2002 draft IRIS assessment on perchlorate. The
National Academies' recommended reference dose was more than 20 times
higher than the one proposed in EPA's draft IRIS assessment. EPA's
final internal review of the revised IRIS assessment for perchlorate--
termed a consensus review--differed from the agency's usual consensus
review process. For example, the scope of the internal review was
limited in that the IRIS program did not seek input from consensus
reviewers on the scientific basis for the assessment as it typically
does; rather, it sought input only on the extent to which the science
in the IRIS Summary was not inconsistent with the major conclusions of
the National Academies' report. At least two EPA offices essentially
opted out of the consensus review process because of this limitation,
which was a significant departure from the usual IRIS consensus
practice.
EPA Relied on an Estimate of the Relative Exposure to Perchlorate from
Drinking Water and Food That It Derived from a Novel Analysis and Used
a Nontraditional Method to Calculate the Relative Source Contribution:
In developing its regulatory determination on perchlorate, EPA
conducted a novel analysis to develop estimates of exposure to
perchlorate for various subpopulations, which the agency subsequently
used to calculate the relative source contribution--the allocated
exposure to perchlorate from drinking water alone.[Footnote 16]
Independent scientists who reviewed EPA's analysis noted that it had
several limitations--in particular, uncertainties specific to the
exposure estimate for pregnant women. Nonetheless, EPA relied on the
exposure estimate for pregnant women to calculate the relative source
contribution, stating that the National Academies had identified
pregnant women and their fetuses as the most sensitive subpopulation.
[Footnote 17]
In calculating the relative source contribution, EPA used a
nontraditional method--called the subtraction method[Footnote 18]--
that was less conservative than the approach it had used for its other
completed regulatory determinations. While EPA identified some of the
limitations of the exposure analysis in its preliminary regulatory
determination notice for perchlorate, it did not discuss the effects
of the limitations on EPA's exposure analysis. Although the agency's
guidance for calculating the relative source contribution cautions
against using the subtraction method in the absence of adequate data
representative of at-risk populations--and EPA lacked data to estimate
exposure to perchlorate for certain populations--the agency did not
explain that the method it used to calculate the relative source
contribution for perchlorate was the subtraction method or its
reasoning for selecting this method.
According to Key EPA Scientists, the Agency Mischaracterized Important
Scientific Findings That Emerged from Its Novel Analysis of the
Sensitivity of Various Age Groups to Perchlorate in Drinking Water:
In early 2008, EPA used a physiologically based pharmacokinetic (PBPK)
model[Footnote 19] to (1) evaluate the relative sensitivity of
sensitive subpopulations to the health reference level the agency had
developed based on pregnant women and their fetuses and (2) address
concerns that some sensitive subpopulations, such as infants, exposed
at the health reference level may receive concentrations of
perchlorate above the reference dose. For its preliminary regulatory
determination, the agency used the model in a novel way and, according
to some key EPA scientists, mischaracterized the findings of the
modeling analyses by selecting and presenting information in such a
way as to support the agreed-upon conclusion that a health reference
level of 15 parts per billion was protective of all sensitive
subpopulations, including infants.
While EPA's Office of Research and Development conducted numerous
sensitivity analyses with the PBPK model, EPA presented the results of
a PBPK analysis in its October 2008 preliminary regulatory
determination for perchlorate to support its conclusion that a health
reference level of 15 parts per billion was protective of all
sensitive subpopulations, including infants, and stated that using the
model in this way could reduce some of the uncertainty regarding the
sensitivities of subpopulations other than pregnant women. However,
Office of Research and Development officials disagreed with the way
EPA presented the information in its preliminary regulatory
determination notice, saying the agency did not sufficiently explain
the uncertainties and limitations of the analysis, presenting the
information more conclusively than was appropriate.
Further, the table EPA published in the preliminary regulatory
determination notice presenting the results of the PBPK analysis
included data that may not be consistent with EPA's conclusion that a
health reference level of 15 parts per billion was protective of all
subpopulations. That is, the table provided sufficient data for
informed readers of the preliminary determination to calculate that
infants and young children could be exposed to doses of perchlorate at
levels as high as 5.5 times greater than the reference dose,
supporting the concern that infants and young children may, in fact,
be more vulnerable to perchlorate exposure. While EPA's regulatory
determination notice stated that the modeled exposure exceeds the
reference dose for some subpopulations, the agency was not explicit
about the extent to which the reference dose is exceeded--as
calculated above--and did not explain the implications of this result
on its conclusion that the health reference level of 15 parts per
billion is protective of all subpopulations. In providing comments on
the draft notice to the Office of Water, an Office of Research and
Development scientist noted that the agency's failure to present a
comparison of the estimated daily exposure with the reference dose
constituted a "serious omission," and characterized the infants'
estimated exposure as "substantially higher" than the reference dose.
EPA's limited presentation of the PBPK analyses conducted by the
Office of Research and Development in its preliminary regulatory
determination notice validated the concern expressed at the time by
Office of Research and Development scientists who conducted the
analyses: that individual analyses could be used out of context in a
way that could be misleading. Specifically, an Office of Research and
Development official stated in September 2008 that while his office
and the Office of Water had developed careful and sophisticated PBPK
analyses to support the agency's preliminary regulatory determination,
"the use of these science results in [the] draft regulatory
determination is seriously flawed and misleading." As a result, Office
of Research and Development officials and scientists that conducted
the analyses concluded that the PBPK analysis done by the office did
not support the draft preliminary regulatory determination's suggested
health reference level of 15 parts per billion as being health
protective for all sensitive subpopulations of concern to EPA.
EPA's Independence in Developing and Communicating Its Scientific
Findings Was Limited by Its Acceptance of External Input on the
Preliminary Determination Notice:
Compounding scientists' concerns about the mischaracterization and
lack of transparency regarding relevant scientific analyses, key
language in EPA's preliminary regulatory determination notice appears
to have been drafted by OMB rather than EPA. In working to finalize
the preliminary regulatory determination notice, EPA's Office of Water
worked with OMB, whose clearance of the notice was required per EPA's
policy implementing Executive Order 12866 before the Office of Water
could provide it to the EPA Administrator for review, approval, and
publication in the Federal Register.[Footnote 20] According to the
Office of Water, in four iterations of review, OMB sent EPA a
substantial number of comments on the notice; in response, EPA
"clarified its description of the supporting analysis and strengthened
the rationale for the determination." The following example highlights
OMB's role in reviewing and approving the specific wording of EPA's
scientific analyses regarding perchlorate exposure in infants and
children:
Text EPA provided to OMB: "Because infants and children eat and drink
more on a per body weight basis than adults, eating a normal diet and
drinking water with 15 [micrograms per liter] of perchlorate is likely
to result in exposure that is greater than the reference dose in these
groups."
Revised text provided to EPA by OMB: "Because infants and children eat
and drink more on a per body weight basis than adults, eating a normal
diet and drinking water with 15 [micrograms per liter] of perchlorate
may result in exposure that is greater than the reference dose in
these groups."
By changing three words, OMB downplayed EPA's characterization of the
health risks of perchlorate exposure. Importantly, the EPA scientist
who wrote the text provided to OMB noted to EPA reviewers--before it
was sent to OMB in August 2008--that the PBPK model actually showed
exposures at levels "much higher" than the reference dose, but also
said that he believed describing the exposure scenario as "likely" was
the strongest characterization that might be retained through OMB
review. In addition, in September 2008, during its review of the draft
preliminary determination notice and before clearing it for
publication, OMB reminded EPA that it expected the notice to "state a
clear conclusion that the HRL [health reference level] is protective
of all subpopulations, as agreed to in the August framework"--and
accordingly, this conclusion appeared in the agency's October 2008
preliminary determination notice.[Footnote 21]
EPA's Response to Our Recommendations Does Not Appear to Acknowledge
the Scope and Significance of the Implementation Limitations We
Identified:
We provided a draft of this report to the Administrator of EPA for
review and comment. In commenting on the draft report, EPA agreed with
2 of the 17 recommendations we made to improve its implementation of
the Safe Drinking Water Act. Specifically, EPA agreed with our
recommendations regarding its drinking water health advisories,
stating that it would evaluate their utility and determine whether and
how to revise the advisories to better serve states, localities,
public water systems, and the public. However, EPA did not agree to
implement the remaining 15 recommendations we made, including an
overarching recommendation that EPA develop policies or guidance that
clearly articulate the agency's interpretation of the Safe Drinking
Water Act's broad statutory criteria--as well as eight additional
recommendations identifying specific components of this guidance and
calling for review of the draft guidance by one of EPA's independent
advisory committees and the establishment of an internal review
mechanism to help ensure the determinations are consistent with the
guidance. Another key recommendation with which EPA disagreed was for
EPA to include in the public record OMB's and other federal agencies'
comments on and revisions to regulatory determination notices and
support documents to improve transparency and help EPA ensure that it
maintains the fairness and openness of its operations.
We made these recommendations to support the development of regulatory
determinations that are transparent, clear, and consistent and that
follow applicable agency policy. However, EPA said it believed that
establishing policies or guidance for regulatory determinations was
not "practicable" because of the many combinations of health effects
factors and potential ranges of frequencies and levels of contaminants
measured in drinking water. We do not believe that the existence of
variables or complexities is a basis for not developing guidance for
EPA staff to implement the statutory requirements for regulatory
determinations. In fact, the complexities cited would argue for,
rather than against, the need to develop guidance for staff on
applying the criteria. EPA also did not agree with these
recommendations on the basis that policies or guidance could "inhibit
its ability to continually improve its actions." This perspective
suggests that guidance per se lacks flexibility. We do not agree that
guidance and flexibility are incompatible or that developing guidance
would inhibit EPA's ability to improve its actions. Rather,
flexibility can and should be incorporated into guidance by
establishing parameters or options for areas in which flexibility is
deemed appropriate.
Moreover, consistency and accountability are lacking in this important
program because EPA has not developed guidance on the application of
the broad statutory criteria, which are susceptible to varying
interpretations. In its comments, EPA highlighted that, under these
criteria, ultimately it is the Administrator's judgment as to whether
regulation of a contaminant in drinking water presents a meaningful
opportunity for health risk reduction, after considering the
information presented by agency staff. As stated in our report, the
statutory criteria are so broadly stated that they could potentially
be interpreted so as to lead to regulating all the contaminants on the
candidate list, some of them, or none of them. It is precisely for
these reasons that we believe it is essential for the staff to have
sufficient guidance on applying the broad criteria consistently and
transparently so that the Administrator's judgment can be based on
sound and consistent information. Without such guidance, the basis for
EPA's determinations and the quality of the documentation the staff
use to support them can fluctuate over time as a result of, among
other reasons, changes in agency leadership and staff. In addition,
regarding our recommendation that EPA provide in the public record
OMB's and other federal agencies' comments on and revisions to
regulatory determination documents, EPA's position is that unless
required by law, it is not a good policy because, among other things,
the documents may be confusing to the public and undermine the
ultimate policy choice. We disagree and believe that to improve
transparency of these determinations, which are by law committed to
the Administrator's judgment, EPA should consistently make these
documents available in the public record, regardless of whether there
is a specific legal requirement for disclosure.
In large measure, EPA's response to our recommendations essentially
endorses conducting business as usual; a response that does not seem
to acknowledge the scope and significance of the implementation
limitations we identified. We are concerned that EPA's lack of
responsiveness to our recommendations may reflect a misplaced reliance
on the Office of Water to independently improve the management of this
important program in the absence of (1) regulations, policies, or
guidance that we believe are needed to provide a framework for current
and future staff to apply in identifying and evaluating contaminants
for regulation; (2) the identification of clear and specific actions
needed to address our recommendations; and (3) an internal review
mechanism to ensure identified actions are implemented effectively. We
believe that EPA needs to adopt all of the recommendations in our
report to better assure the public of safe drinking water.
Madam Chairman Boxer, Ranking Member Inhofe, and Members of the
Committee, this concludes our prepared statement. I would be happy to
respond to any questions that you or other Members of the Committee
may have.
Contacts and Acknowledgment:
For further information about this testimony, please contact me at
(202) 512-3841. Christine Fishkin, Jamie Meuwissen, Elizabeth
Beardsley, Kiki Theodoropoulos, and Michael Derr also made key
contributions to this statement.
[End of section]
Footnotes:
[1] GAO, Safe Drinking Water Act: EPA Should Improve Implementation of
Requirements on Whether to Regulate Additional Contaminants,
[hyperlink, http://www.gao.gov/products/GAO-11-254] (Washington, D.C.:
May 27, 2011).
[2] The 1996 amendments require that EPA identify and publish a list
every 5 years of unregulated contaminants that may require regulation;
the list is called the contaminant candidate list.
[3] The health reference level is the estimated level of exposure to a
contaminant in drinking water below which adverse health effects are
not likely.
[4] EPA did not disclose that the data presented were not sufficiently
sensitive to detect occurrence at the agency's health reference level.
[5] In this testimony, as in our report, we refer to Federal Register
notices regarding EPA's regulatory determinations (notices) and EPA's
regulatory determination support documents individually and
collectively, as appropriate. When referring to these documents
collectively, we use the term "regulatory determination documents."
[6] See GAO, Chemical Assessments: Low Productivity and New
Interagency Review Process Limit the Usefulness and Credibility of
EPA's Integrated Risk Information System, [hyperlink,
http://www.gao.gov/products/GAO-08-440] (Washington, D.C.: Mar. 7,
2008).
[7] In January 2009 we added transforming EPA's processes for
assessing and controlling toxic chemicals as a high-risk area in our
report--updated in February 2011--on governmentwide high-risk areas
requiring increased attention by executive agencies and Congress. See
GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: January
2009); and High Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-11-278] (Washington, D.C.: February
2011).
[8] IRIS assessments provide EPA's toxicity assessments of
contaminants that may cause cancer and those that may cause
neurological or other noncancer effects, or both. EPA uses IRIS or
comparable toxicity assessments to develop health reference levels for
the drinking water contaminants.
[9] The Perchlorate Interagency Working Group includes officials from
the Office of Management and Budget (OMB) and the Office of Science
and Technology Policy, both part of the Executive Office of the
President; Department of Defense; National Aeronautics and Space
Administration; Department of Energy; the Department of Health and
Human Services' Food and Drug Administration and the Agency for Toxic
Substances and Disease Registry; Department of Agriculture; and
Department of the Interior.
[10] The Council on Environmental Quality, which is part of the
Executive Office of the President, coordinates federal environmental
efforts in the development of environmental policies and initiatives.
[11] According to an EPA official, the agreement was documented in an
unattributed two-page white paper and faxed to EPA from the Council on
Environmental Quality in early August 2008; EPA made some editorial
changes to the document but did not alter the substance of the
agreement.
[12] A reference dose is an estimate of the total daily oral exposure
to a contaminant--for example, from food and water--that is not likely
to cause "appreciable risk of deleterious effects during a lifetime."
A reference dose is a key component of the calculation EPA uses to
derive a health reference level for drinking water contaminants.
[13] The National Academies consists of four private, nonprofit
organizations that advise the federal government on scientific and
technical matters: the National Academy of Sciences, National Academy
of Engineering, Institute of Medicine, and National Research Council.
[14] A drinking water equivalent level represents the estimated
exposure to a contaminant that is assumed to be protective for
noncarcinogenic health effects during a lifetime of exposure. EPA
calculated this drinking water equivalent level using the reference
dose that EPA proposed in its 2002 draft IRIS assessment and the
agency's default assumptions for adult weight and daily drinking water
intake.
[15] National Academies, Health Implications of Perchlorate Ingestion
(Washington, D.C., 2005).
[16] The relative source contribution is an allocation of the
estimated oral exposure to the contaminant from drinking water alone;
it has a significant impact on the health reference level that the
agency derives for contaminants with noncancer adverse health effects.
[17] The 2005 National Academies report on perchlorate contained
varying characterizations of sensitive subpopulations, sometimes
referring to pregnant women and their fetuses alone as the most
sensitive subpopulation and other times including infants in this
designation. In addition, the National Academies identified developing
children as a sensitive population and people with compromised thyroid
function and people who are iodide-deficient as potentially sensitive
populations.
[18] The subtraction method allocates the entire reference dose to the
known sources of exposure by subtracting the known nontarget sources
of exposure and allocating the remainder of the reference dose to the
target--in this case, drinking water--even in cases where the total
estimated exposure is less than the reference dose. This method has
the effect of removing any cushion between the existing exposure
levels and the reference dose.
[19] PBPK models are complex and involve numerous underlying
assumptions that are imbedded in mathematical representations of the
processes associated with how a contaminant behaves within, and is
eliminated from, the body.
[20] The objectives of this executive order are to enhance planning
and coordination with respect to both new and existing regulations; to
reaffirm the primacy of federal agencies in the regulatory decision-
making process; to restore the integrity and legitimacy of regulatory
review and oversight; and to make the process more accessible and open
to the public.
[21] According to an EPA official, "August framework" refers to the
agreement that was faxed to EPA from the Council on Environmental
Quality that included this conclusion as a key component of the
rationale EPA and other federal agencies agreed to in August 2008.
[End of section]
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