Biomonitoring
EPA Could Make Better Use of Biomonitoring Data Gao ID: GAO-10-419T February 4, 2010Biomonitoring, which measures chemicals in people's tissues or body fluids, has shown that the U.S. population is widely exposed to chemicals used in everyday products. Some of these have the potential to cause cancer or birth defects. Moreover, children may be more vulnerable to harm from these chemicals than adults. The Environmental Protection Agency (EPA) is authorized under the Toxic Substances Control Act (TSCA) to control chemicals that pose unreasonable health risks. One crucial tool in this process is chemical risk assessment, which involves determining the extent to which populations will be exposed to a chemical and assessing how this exposure affects human health This testimony, based on GAO's prior work, reviews the (1) extent to which EPA incorporates information from biomonitoring studies into its assessments of chemicals, (2) steps that EPA has taken to improve the usefulness of biomonitoring data, and (3) extent to which EPA has the authority under TSCA to require chemical companies to develop and submit biomonitoring data to EPA.
EPA has made limited use of biomonitoring data in its assessments of risks posed by commercial chemicals. One reason is that biomonitoring data relevant to the entire U.S. population exist for only 212 chemicals. In addition, biomonitoring data alone indicate only that a person was somehow exposed to a chemical, not the source of the exposure or its effect on the person's health. For most of the chemicals studied under current biomonitoring programs, more data on chemical effects are needed to understand if the levels measured in people pose a health concern, but EPA's authorities to require chemical companies to develop such data is limited. However, in September 2009, the EPA Administrator set forth goals for updated legislation to give EPA additional authorities to obtain data on chemicals. While EPA has initiated several research programs to make biomonitoring more useful to its risk assessment process, it has not developed a comprehensive strategy for this research that takes into account its own research efforts and those of the multiple federal agencies and other organizations involved in biomonitoring research. EPA does have several important biomonitoring research efforts, including research into the relationships between exposure to harmful chemicals, the resulting concentration of those chemicals in human tissue, and the corresponding health effects. However, without a plan to coordinate its research efforts, EPA has no means to track progress or assess the resources needed specifically for biomonitoring research. Furthermore, according to the National Academy of Sciences, the lack of a coordinated national research strategy has allowed widespread chemical exposures to go undetected, such as exposures to flame retardants. While EPA agreed with GAO's recommendation that EPA develop a comprehensive research strategy, the agency has not yet done so. EPA has not determined the extent of its authority to obtain biomonitoring data under TSCA, and this authority is untested and may be limited. The TSCA section that authorizes EPA to require companies to develop data focuses on health and environmental effects of chemicals. However, biomonitoring data indicate only the presence of a chemical in the body, not its impact on health. It may be easier for EPA to obtain biomonitoring data under other TSCA sections, which allow EPA to collect existing information on chemicals. For example, TSCA obligates chemical companies to report information that reasonably supports the conclusion that a chemical presents a substantial risk of injury to health or the environment. EPA asserts that biomonitoring data are reportable if a chemical is known to have serious toxic effects and biomonitoring data indicates a level of exposure previously unknown to EPA. EPA took action against a chemical company under this authority in 2004. However, the action was settled without an admission of liability by the company, so EPA's authority to obtain biomonitoring data remains untested. GAO's 2009 report recommended that EPA clarify this authority, but it has not yet done so. The agency did not disagree, but commented that a case-by-case explanation of its authority might be more useful than a global assessment.
GAO-10-419T, Biomonitoring: EPA Could Make Better Use of Biomonitoring Data
This is the accessible text file for GAO report number GAO-10-419T
entitled 'Biomonitoring: EPA Could Make Better Use of Biomonitoring
Data' which was released on February 4, 2010.
This text file was formatted by the U.S. Government Accountability
Office (GAO) to be accessible to users with visual impairments, as
part of a longer term project to improve GAO products' accessibility.
Every attempt has been made to maintain the structural and data
integrity of the original printed product. Accessibility features,
such as text descriptions of tables, consecutively numbered footnotes
placed at the end of the file, and the text of agency comment letters,
are provided but may not exactly duplicate the presentation or format
of the printed version. The portable document format (PDF) file is an
exact electronic replica of the printed version. We welcome your
feedback. Please E-mail your comments regarding the contents or
accessibility features of this document to Webmaster@gao.gov.
This is a work of the U.S. government and is not subject to copyright
protection in the United States. It may be reproduced and distributed
in its entirety without further permission from GAO. Because this work
may contain copyrighted images or other material, permission from the
copyright holder may be necessary if you wish to reproduce this
material separately.
Testimony:
Before the Subcommittee on Superfund, Toxics and Environmental Health,
Committee on Environment and Public Works, U.S. Senate:
United States Government Accountability Office:
GAO:
For Release on Delivery:
Expected at 10:00 a.m. EST:
Thursday, February 4, 2010:
Biomonitoring:
EPA Could Make Better Use of Biomonitoring Data:
Statement of John Stephenson, Director:
Natural Resources and Environment:
Biomonitoring:
GAO-10-419T:
GAO Highlights:
Highlights of GAO-10-419T, a testimony before the Subcommittee on
Superfund, Toxics, and Environmental Health, Committee on Environment
and Public Works, U.S. Senate.
Why GAO Did This Study:
Biomonitoring, which measures chemicals in people‘s tissues or body
fluids, has shown that the U.S. population is widely exposed to
chemicals used in everyday products. Some of these have the potential
to cause cancer or birth defects. Moreover, children may be more
vulnerable to harm from these chemicals than adults.
The Environmental Protection Agency (EPA) is authorized under the
Toxic Substances Control Act (TSCA) to control chemicals that pose
unreasonable health risks. One crucial tool in this process is
chemical risk assessment, which involves determining the extent to
which populations will be exposed to a chemical and assessing how this
exposure affects human health.
This testimony, based on GAO‘s prior work, reviews the (1) extent to
which EPA incorporates information from biomonitoring studies into its
assessments of chemicals, (2) steps that EPA has taken to improve the
usefulness of biomonitoring data, and (3) extent to which EPA has the
authority under TSCA to require chemical companies to develop and
submit biomonitoring data to EPA.
What GAO Found:
EPA has made limited use of biomonitoring data in its assessments of
risks posed by commercial chemicals. One reason is that biomonitoring
data relevant to the entire U.S. population exist for only 212
chemicals. In addition, biomonitoring data alone indicate only that a
person was somehow exposed to a chemical, not the source of the
exposure or its effect on the person‘s health. For most of the
chemicals studied under current biomonitoring programs, more data on
chemical effects are needed to understand if the levels measured in
people pose a health concern, but EPA‘s authorities to require
chemical companies to develop such data is limited. However, in
September 2009, the EPA Administrator set forth goals for updated
legislation to give EPA additional authorities to obtain data on
chemicals.
While EPA has initiated several research programs to make
biomonitoring more useful to its risk assessment process, it has not
developed a comprehensive strategy for this research that takes into
account its own research efforts and those of the multiple federal
agencies and other organizations involved in biomonitoring research.
EPA does have several important biomonitoring research efforts,
including research into the relationships between exposure to harmful
chemicals, the resulting concentration of those chemicals in human
tissue, and the corresponding health effects. However, without a plan
to coordinate its research efforts, EPA has no means to track progress
or assess the resources needed specifically for biomonitoring
research. Furthermore, according to the National Academy of Sciences,
the lack of a coordinated national research strategy has allowed
widespread chemical exposures to go undetected, such as exposures to
flame retardants. While EPA agreed with GAO‘s recommendation that EPA
develop a comprehensive research strategy, the agency has not yet done
so.
EPA has not determined the extent of its authority to obtain
biomonitoring data under TSCA, and this authority is untested and may
be limited. The TSCA section that authorizes EPA to require companies
to develop data focuses on health and environmental effects of
chemicals. However, biomonitoring data indicate only the presence of a
chemical in the body, not its impact on health. It may be easier for
EPA to obtain biomonitoring data under other TSCA sections, which
allow EPA to collect existing information on chemicals. For example,
TSCA obligates chemical companies to report information that
reasonably supports the conclusion that a chemical presents a
substantial risk of injury to health or the environment. EPA asserts
that biomonitoring data are reportable if a chemical is known to have
serious toxic effects and biomonitoring data indicates a level of
exposure previously unknown to EPA. EPA took action against a chemical
company under this authority in 2004. However, the action was settled
without an admission of liability by the company, so EPA‘s authority
to obtain biomonitoring data remains untested. GAO‘s 2009 report
recommended that EPA clarify this authority, but it has not yet done
so. The agency did not disagree, but commented that a case-by-case
explanation of its authority might be more useful than a global
assessment.
View [hyperlink, http://www.gao.gov/products/GAO-10-419T] or key
components. For more information, contact John Stephenson at (202) 512-
3841 or stephensonj@gao.gov.
[End of section]
Mr. Chairman, Ranking Member, and Members of the Subcommittee:
I am pleased to appear here today to discuss EPA's use of
biomonitoring data. Biomonitoring, which measures chemicals in
people's tissues or body fluids, has shown that the U.S. population is
widely exposed to chemicals used in everyday products. Some of these
have the potential to cause cancer or birth defects. Moreover,
children may be more vulnerable to harm from these chemicals than
adults because their biological functions are still developing and
their size and behavior may expose them to proportionately higher
doses.
The mission of the Environmental Protection Agency (EPA) is to protect
human health and the environment. To help EPA achieve this objective,
the Toxic Substances Control Act (TSCA) authorizes it to regulate the
manufacture, processing, and distribution of chemicals. A crucial tool
in this regulatory process is chemical risk assessment, which involves
determining the extent to which populations will be exposed to a
chemical and assessing how this exposure affects human health. EPA
uses such risk assessments to determine if it needs to take any risk
management actions, such as prohibiting or restricting the
manufacture, processing, or distribution of a chemical.
A recent proliferation of biomonitoring data has provided new insights
into the general population's exposure to chemicals. Biomonitoring
studies for certain chemicals, such as lead, have been ongoing for
decades, but recent advances in analytic methods have allowed
scientists to measure more chemicals in smaller concentrations. This
is a promising development. According to the Centers for Disease
Control and Prevention (CDC), "biomonitoring measurements are the most
health-relevant assessments of exposure because they measure the
amount of the chemical that actually gets into people from all
environmental sources, such as the air, soil, water, dust, or food
combined." The CDC conducts the most comprehensive biomonitoring
program in the country, and in December 2009 it published the fourth
in a series of reports on the concentrations of certain chemicals or
their by-products in a representative sample of the U.S. population.
For example, the CDC reported that 90 percent of the people tested had
detectable levels of Bisphenol A (BPA). BPA is an industrial chemical
that has been present in many hard plastic bottles and metal-based
food and beverage cans since the 1960s. On the basis of results from
recent studies using novel approaches to test for subtle effects, the
Food and Drug Administration announced in January of this year that it
and the National Toxicology Program at the National Institutes of
Health (NIH) have some concern about the potential effects of BPA on
the brain, behavior, and prostate gland in fetuses, infants, and young
children.
My testimony today is based on our prior work on federal biomonitoring
efforts and discusses EPA's use of current biomonitoring studies,
EPA's biomonitoring research strategy, and EPA's authorities under
TSCA to obtain biomonitoring data.[Footnote 1] Specifically, my
statement addresses (1) the extent to which EPA incorporates
information from biomonitoring studies into its assessments of
chemicals, (2) steps that EPA has taken to improve the usefulness of
biomonitoring data, and (3) the extent to which EPA has the authority
under TSCA to require chemical companies to develop and submit
biomonitoring data to EPA. Our prior work was conducted in accordance
with generally accepted government auditing standards. Those standards
require that we plan and perform the audit to obtain sufficient,
appropriate evidence to provide a reasonable basis for our findings
and conclusions based on our audit objectives. We believe that the
evidence obtained provides a reasonable basis for our findings and
conclusions based on our audit objectives.
Background:
Biomonitoring--one technique for assessing people's exposure to
chemicals--involves measuring the concentration of chemicals or their
by-products in human specimens, such as blood or urine. While,
biomonitoring has been used to monitor chemical exposures for decades,
more recently, advances in analytic methods have allowed scientists to
measure more chemicals, in smaller concentrations, using smaller
samples of blood or urine. As a result, biomonitoring has become more
widely used for a variety of applications, including public health
research and measuring the impact of certain environmental
regulations, such as the decline in blood lead levels following
declining levels of gasoline lead.
CDC conducts the most comprehensive biomonitoring program in the
country under its National Biomonitoring Program and published the
first, second, third and fourth National Report on Human Exposure to
Environmental Chemicals--in 2001, 2003, 2005, and 2009, respectively--
which reported the concentrations of certain chemicals or their by-
products in the blood or urine of a representative sample of the U.S.
population. For each of these reports, the CDC has increased the
number of chemicals studied--from 27 in the first report, to 116 in
the second, to 148 in the third, and to 212 in the fourth. Each report
is cumulative (containing all the results from previous reports).
These reports provide the most comprehensive assessment to date of the
exposure of the U.S. population to chemicals in our environment
including such chemicals as acrylamide, arsenic, BPA, triclosan, and
perchlorate. These reports have provided a window into the U.S.
population's exposure to chemicals, and the CDC continues to develop
new methods for collecting data on additional chemical exposures with
each report.
For decades, government regulators have used risk assessment to
understand the health implications of commercial chemicals.
Researchers use this process to estimate how much harm, if any, can be
expected from exposure to a given contaminant or mixture of
contaminants and to help regulators determine whether the risk is
significant enough to require banning or regulating the chemical or
other corrective action. Biomonitoring research is difficult to
integrate into this risk assessment process, since estimates of human
exposure to chemicals have historically been based on the
concentration of these chemicals in environmental media and on
information about how people are exposed. Biomonitoring data, however,
provide a measure of internal dose that is the result of exposure to
all environmental media and depend on how the human body processes and
excretes the chemical.
EPA Has Made Limited Use of Biomonitoring Data in Assessing Risks
Posed by Chemicals:
EPA has made limited use of biomonitoring data in its assessments of
risks posed by chemicals. As we previously reported,[Footnote 2] one
major reason for the agency's limited use of such data is that, to
date, there are no biomonitoring data for most commercial chemicals.
The most comprehensive biomonitoring effort providing data relevant to
the entire U.S. population includes only 212 chemicals, whereas EPA is
currently focusing its chemical assessment and management efforts on
the more than 6,000 chemicals that companies produce in quantities of
more than 25,000 pounds per year at one site.[Footnote 3] Current
biomonitoring efforts also provide little information on children.
Large-scale biomonitoring studies generally omit children because it
is difficult to collect biomonitoring data from them. For example,
some parents are concerned about the invasiveness of taking blood
samples from their children, and certain other fluids, such as
umbilical cord blood or breast milk, are available only in small
quantities and only at certain times. Thus, when samples are available
from children, they may not be large enough to analyze.
A second reason we reported for the agency's limited use of
biomonitoring data is that EPA often lacks the additional information
needed to make biomonitoring studies useful in its risk assessment
process. In this regard, biomonitoring provides information only on
the level of a chemical in a person's body but not the health impact.
The detectable presence of a chemical in a person's blood or urine
does not necessarily mean that the chemical causes harm. While
exposure to larger amounts of a chemical may cause an adverse health
impact, a smaller amount may be of no health consequence. In addition,
biomonitoring data alone do not indicate the source, route, or timing
of the exposure, making it difficult to identify the appropriate risk
management strategies. For most of the chemicals studied under current
biomonitoring programs, more data on chemical effects are needed to
understand whether the levels measured in people pose a health
concern, but EPA's ability to require chemical companies to develop
such data is limited. As a result, EPA has made few changes to its
chemical risk assessments or safeguards in response to the recent
proliferation of biomonitoring data. For most chemicals, EPA would
need additional data on the following to incorporate biomonitoring
into risk assessment: health effects; the sources, routes, and timing
of exposure; and the fate of a chemical in the human body. However, as
we have discussed in prior reports, EPA will face difficulty in using
its authorities under TSCA to require chemical companies to develop
health and safety information on the chemicals. In January 2009, we
added transforming EPA's process for assessing and controlling toxic
chemicals to our list of high-risk areas warranting attention by
Congress and the executive branch.[Footnote 4] Subsequently, the EPA
Administrator set forth goals for updated legislation that would give
EPA the mechanisms and authorities to promptly assess and regulate
chemicals.
EPA has used some biomonitoring data in chemical risk assessment and
management, but only when additional studies have provided insight on
the health implications of the biomonitoring data. For example, EPA
was able to use biomonitoring data on methylmercury--a neurotoxin that
accumulates in fish--because studies have drawn a link between the
level of this toxin in human blood and adverse neurological effects in
children. EPA also used both biomonitoring and traditional risk
assessment information to take action on certain perfluorinated
chemicals. These chemicals are used in the manufacture of consumer and
industrial products, including nonstick cookware coatings; waterproof
clothing; and oil-, stain-, and grease-resistant surface treatments.
EPA Has Taken Steps to Improve the Usefulness of Biomonitoring Data
but Lacks a Comprehensive Research Strategy:
EPA has several biomonitoring research projects under way, but the
agency has no system in place to track progress or assess the
resources needed specifically for biomonitoring research. For example,
EPA awarded grants that are intended to advance the knowledge of
children's exposure to pesticides through the use of biomonitoring and
of the potential adverse effects of these exposures. The grants issued
went to projects that, among other things, investigated the
development of less invasive biomarker than blood samples--such as
analyses of saliva or hair samples--to measures of early brain
development. Furthermore, EPA has studied the presence of an herbicide
in 135 homes with preschool-age children by analyzing soil, air,
carpet, dust, food, and urine as well as samples taken from subject's
hands. The study shed important light on how best to collect urine
samples that reflect external dose of the herbicide and how to develop
models that simulate how the body processes specific chemicals.
Nonetheless, EPA does not separately track spending or staff time
devoted to biomonitoring research. Instead, it places individual
biomonitoring research projects within its larger Human Health
Research Strategy. While this strategy includes some goals relevant to
biomonitoring, EPA has not systematically identified and prioritized
the data gaps that prevent it from using biomonitoring data. Nor has
it systematically identified the resources needed to reach
biomonitoring research goals or the chemicals that need the most
additional biomonitoring-related research.
Also, EPA has not coordinated its biomonitoring research with that of
the many agencies and other groups involved in biomonitoring research,
which could impair its ability to address the significant data gaps in
this field of research. In addition to the CDC and EPA, several other
federal agencies have been involved in biomonitoring research,
including the U.S. Department of Health and Human Service's Agency for
Toxic Substances and Disease Registry, entities within the U.S.
Department of Health and Human Service's NIH, and the U.S. Department
of Labor's Occupational Safety and Health Administration. Several
states have also initiated biomonitoring programs to examine state and
local health concerns, such as arsenic in local water supplies or
populations with high fish consumption that may increase mercury
exposure. Furthermore, some chemical companies have for decades
monitored their workforce for chemical exposure, and chemical industry
associations have funded biomonitoring research. Finally, some
environmental organizations have conducted biomonitoring studies of
small groups of adults and children, including one study on infants.
As we previously reported, a national biomonitoring research plan
could help better coordinate research and link data needs with
collection efforts.[Footnote 5] EPA has suggested chemicals for future
inclusion in the CDC's National Biomonitoring Program but has not gone
any further toward formulating an overall strategy to address data
gaps and ensure the progress of biomonitoring research. We have
previously noted that to begin addressing the need for biomonitoring
research, federal agencies will need to strategically coordinate their
efforts and leverage their limited resources.[Footnote 6] Similarly,
the National Academies of Science found that the lack of a coordinated
research strategy allowed widespread exposures to go undetected,
including exposure to flame retardants known as polybrominated
diphenyl ethers--chemicals which may cause liver damage, among other
things, according to some toxicological studies. The academy noted
that a coordinated research strategy would require input from various
agencies involved in biomonitoring and supporting disciplines. In
addition to EPA, these agencies include the CDC, NIH, the Food and
Drug Administration, and the U.S. Department of Agriculture. Such
coordination could strengthen efforts to identify and possibly
regulate the sources of the exposure detected by biomonitoring, since
the most common sources--that is, food, environmental contamination,
and consumer products--are under the jurisdiction of different
agencies.
We have recommended that EPA develop a comprehensive research strategy
to improve its ability to use biomonitoring in its risk assessments.
[Footnote 7] However, though EPA agreed with our recommendation, the
agency still lacks such a comprehensive strategy to guide its own
research efforts. In addition, we recommended that EPA establish an
interagency task force that would coordinate federal biomonitoring
research efforts across agencies and leverage available resources. If
EPA determines that further authority is necessary, we stated that it
should request that the Executive Office of the President establish an
interagency task force to coordinate such efforts. Nonetheless, EPA
has not established such an interagency task force to coordinate
federal biomonitoring research, nor has it informed us that it has
requested the Executive Office of the President do so.
EPA's Authority to Obtain Biomonitoring Data under TSCA Is Untested
and May Be Limited:
EPA has not determined the extent of its authority to obtain
biomonitoring data under TSCA, and this authority is generally
untested and may be limited. Several provisions of TSCA are
potentially relevant. For example, under section 4 of TSCA EPA can
require chemical companies to test chemicals for their effects on
health or the environment.[Footnote 8] However, biomonitoring data
indicate only the presence of a chemical in a person's body and not
its impact on the person's health. EPA told us that biomonitoring data
may demonstrate chemical characteristics that would be relevant to a
chemical's effects on health or the environment and that the agency
could theoretically require that biomonitoring be used as a
methodology for developing such data. EPA's specific authority to
obtain biomonitoring data in this way is untested, however, and EPA is
only generally authorized to require the development of such data
after meeting certain threshold risk requirements that are difficult,
expensive, and time-consuming.[Footnote 9] EPA may also be able to
indirectly require the development of biomonitoring data using the
leverage it has under section 5(e) of TSCA, though it has not yet
attempted to do so.[Footnote 10] Under certain circumstances, EPA can
use this section to seek an injunction to limit or prohibit the
manufacture of a chemical.[Footnote 11] As an alternative, EPA
sometimes issues a consent order that subjects manufacture to certain
conditions, including testing, which could include biomonitoring.
While EPA may not be explicitly authorized to require the development
of such test data under this section, chemical companies have an
incentive to provide the requested test data to avoid a more sweeping
ban on a chemical's manufacture. EPA has not indicated whether it will
use section 5(e) consent orders to require companies to submit
biomonitoring data.
Other TSCA provisions allow EPA to collect existing information on
chemicals that a company already has, knows about, or could reasonably
ascertain.[Footnote 12] For example, section 8(e) requires chemical
companies to report to EPA any information they have obtained that
reasonably supports the conclusion that a chemical presents a
substantial risk of injury to health or the environment.[Footnote 13]
EPA asserts that biomonitoring data are reportable as demonstrating a
substantial risk if the chemical in question is known to have serious
toxic effects and the biomonitoring data indicate a level of exposure
previously unknown to EPA. Industry has asked for more guidance on
this point, but EPA has not yet revised its guidance. Confusion over
the scope of EPA's authority to collect biomonitoring data under
section 8 (e) is highlighted by the history leading up to an EPA
action against the chemical company E. I. du Pont de Nemours and
Company (DuPont). Until 2000, DuPont used the chemical PFOA to make
TeflonŽ. In 1981, DuPont took blood from several female workers and
two of their babies. The levels of PFOA in the babies' blood showed
that PFOA had crossed the placental barrier. DuPont also tested the
blood of twelve community members, 11 of whom had elevated levels of
PFOA in their blood. DuPont did not report either set of results to
EPA. After EPA received the results from a third party, DuPont argued
that the information was not reportable under TSCA because the mere
presence of PFOA in blood did not itself support the conclusion that
exposure to PFOA posed any health risks. EPA subsequently filed two
actions against DuPont for violating section 8(e) of TSCA by failing
to report the biomonitoring data, among other claims. DuPont settled
the claims but did not admit that it should have reported the data.
However, based on the data it had received, EPA conducted a subsequent
risk assessment, which contributed to a finding that PFOA was "likely
to be carcinogenic to humans." In turn, this finding contributed to an
agreement by DuPont and others to phase out the use of PFOA by 2015.
However, EPA's authority to obtain biomonitoring data under section
8(e) of TSCA remains untested in court.
Given the uncertainties regarding TSCA authorities, we have
recommended that EPA should determine the extent of its legal
authority to require companies to develop and submit biomonitoring
data under TSCA. We also recommended that EPA request additional
authority from Congress if it determines that such authority is
necessary. If EPA determines that no further authority is necessary,
we recommended that it develop formal written policies explaining the
circumstances under which companies are required to submit
biomonitoring data. However, EPA has not yet attempted a comprehensive
review of its authority to require the companies to develop and submit
biomonitoring data. The agency did not disagree with our
recommendation, but commented that a case-by-case explanation of its
authority might be more useful than a global assessment. However, we
continue to believe that an analysis of EPA's legal authority to
obtain biomonitoring data is critical.
Mr. Chairman, this concludes my prepared statement. I would be pleased
to respond to any questions that you or other Members of this
Subcommittee may have.
GAO Contact and Staff Acknowledgements:
For further information about this testimony, please contact John B.
Stephenson at (202) 512-3841 or stephensonj@gao.gov. Contact points
for our Offices of Congressional Relations and Public Affairs may be
found on the last page of this statement. Contributors to this
testimony include David Bennett, Antoinette Capaccio, Ed Kratzer, and
Ben Shouse.
[End of section]
Footnotes:
[1] GAO, Biomonitoring: EPA Needs to Coordinate Its Research Strategy
and Clarify Its Authority to Obtain Biomonitoring Data, [hyperlink,
http://www.gao.gov/products/GAO-09-353], (Washington, D.C.: Apr. 30,
2009).
[2] [hyperlink, http://www.gao.gov/products/GAO-09-353].
[3] Companies must report on most chemicals covered by TSCA that they
produce above this 25,000-pound threshold during every fifth year.
EPA's estimate of more than 6,000 is based on data chemical companies
submitted during the 2005 calendar year.
[4] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: January
2009).
[5] [hyperlink, http://www.gao.gov/products/GAO-09-353].
[6] GAO, Toxic Chemicals: Long-Term Coordinated Strategy Needed to
Measure Exposures in Humans, [hyperlink,
http://www.gao.gov/products/GAO/HEHS-00-80] (Washington, D.C.: May 2,
2000).
[7] [hyperlink, http://www.gao.gov/products/GAO-09-353].
[8] 15 U.S.C. § 2603(a) (2006).
[9] To require testing, EPA must determine that there are insufficient
data to reasonably determine or predict the effects of the chemical on
health or the environment, and that testing is necessary to develop
such data. The agency must also make one of two additional findings.
The first is that a chemical may present an unreasonable risk of
injury to human health or the environment. The second is that a
chemical is or will be produced in substantial quantities, and that
either (1) there is or may be significant or substantial human
exposure to the chemical or (2) the chemical enters or may reasonably
be anticipated to enter the environment in substantial quantities.
[10] 15 U.S.C. § 2604(e) (2006).
[11] Under section 5(e), when a company proposes to begin
manufacturing a new chemical or to introduce an existing chemical for
a significant new use, EPA may determine (1) that the available
information is not sufficient to permit a reasoned evaluation of the
health and environmental effects of that chemical and (2) that in the
absence of such information, the manufacture of the chemical may meet
certain risk or exposure thresholds. If the agency does so, the
Administrator can issue a proposed order limiting or prohibiting the
manufacture of the chemical. If a chemical company objects to such an
order, the matter becomes one for the courts. If a court agrees with
the Administrator, it will issue an injunction to the chemical company
to limit or prohibit manufacture of the chemical. If and when the
chemical company submits data to EPA sufficient for the Administrator
to make a reasoned determination about the chemical's health and
environmental effects, which may include test data, the injunction can
be dissolved. Thus, an injunction would provide an incentive for the
chemical company to develop testing data.
[12] 15 U.S.C. §§ 2604(a), 2604(b), 2607(a), 2607(d), 2607(e) (2006).
[13] 15 U.S.C. § 2607(e) (2006).
[End of section]
GAO's Mission:
The Government Accountability Office, the audit, evaluation and
investigative arm of Congress, exists to support Congress in meeting
its constitutional responsibilities and to help improve the performance
and accountability of the federal government for the American people.
GAO examines the use of public funds; evaluates federal programs and
policies; and provides analyses, recommendations, and other assistance
to help Congress make informed oversight, policy, and funding
decisions. GAO's commitment to good government is reflected in its core
values of accountability, integrity, and reliability.
Obtaining Copies of GAO Reports and Testimony:
The fastest and easiest way to obtain copies of GAO documents at no
cost is through GAO's Web site [hyperlink, http://www.gao.gov]. Each
weekday, GAO posts newly released reports, testimony, and
correspondence on its Web site. To have GAO e-mail you a list of newly
posted products every afternoon, go to [hyperlink, http://www.gao.gov]
and select "E-mail Updates."
Order by Phone:
The price of each GAO publication reflects GAO‘s actual cost of
production and distribution and depends on the number of pages in the
publication and whether the publication is printed in color or black and
white. Pricing and ordering information is posted on GAO‘s Web site,
[hyperlink, http://www.gao.gov/ordering.htm].
Place orders by calling (202) 512-6000, toll free (866) 801-7077, or
TDD (202) 512-2537.
Orders may be paid for using American Express, Discover Card,
MasterCard, Visa, check, or money order. Call for additional
information.
To Report Fraud, Waste, and Abuse in Federal Programs:
Contact:
Web site: [hyperlink, http://www.gao.gov/fraudnet/fraudnet.htm]:
E-mail: fraudnet@gao.gov:
Automated answering system: (800) 424-5454 or (202) 512-7470:
Congressional Relations:
Ralph Dawn, Managing Director, dawnr@gao.gov:
(202) 512-4400:
U.S. Government Accountability Office:
441 G Street NW, Room 7125:
Washington, D.C. 20548:
Public Affairs:
Chuck Young, Managing Director, youngc1@gao.gov:
(202) 512-4800:
U.S. Government Accountability Office:
441 G Street NW, Room 7149:
Washington, D.C. 20548:
