Biomonitoring
EPA Needs to Coordinate Its Research Strategy and Clarify Its Authority to Obtain Biomonitoring Data Gao ID: GAO-09-353 April 30, 2009Biomonitoring, 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. GAO was asked to review 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 148 of the over 6,000 chemicals EPA considers the most likely sources of human or environmental exposure. 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 ability to require chemical companies to develop such data is limited. Thus, the agency has made few changes to its chemical risk assessments or safeguards in response to the recent increase in available biomonitoring data. 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. The development of such a strategy could enhance biomonitoring research and link data needs with collection efforts. 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 provision that authorizes EPA to require companies to develop data focuses on the health and environmental effects of chemicals. Since biomonitoring data alone may not demonstrate the effects of a chemical, EPA may face difficulty in using this authority to obtain biomonitoring data. It may be easier for EPA to obtain biomonitoring data under other TSCA provisions, 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 the chemical in question is known to have serious toxic effects and biomonitoring information 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 View GAO-09-353 or key components. company, so EPA's authority to obtain biomonitoring data remains untested.
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
April 2009:
Biomonitoring:
EPA Needs to Coordinate Its Research Strategy and Clarify Its Authority
to Obtain Biomonitoring Data:
GAO-09-353:
GAO Highlights:
Highlights of GAO-09-353, a report to congressional requesters.
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.
GAO was asked to review 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 148 of the
over 6,000 chemicals EPA considers the most likely sources of human or
environmental exposure. 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 ability to require chemical
companies to develop such data is limited. Thus, the agency has made
few changes to its chemical risk assessments or safeguards in response
to the recent increase in available biomonitoring data.
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. The
development of such a strategy could enhance biomonitoring research and
link data needs with collection efforts.
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 provision that authorizes EPA to require companies
to develop data focuses on the health and environmental effects of
chemicals. Since biomonitoring data alone may not demonstrate the
effects of a chemical, EPA may face difficulty in using this authority
to obtain biomonitoring data. It may be easier for EPA to obtain
biomonitoring data under other TSCA provisions, 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 the chemical in question is known to have serious toxic
effects and biomonitoring information 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.
What GAO Recommends:
GAO recommends that EPA develop a comprehensive research strategy to
improve its ability to use biomonitoring in its risk assessments;
establish an interagency task force to coordinate federal biomonitoring
research; and determine the extent of its legal authority to obtain
biomonitoring data under TSCA, asking Congress for more authority if
necessary. EPA agreed with the first two recommendations and did not
disagree with the third, but provided substantive comments on its
implementation.
View [hyperlink, http://www.gao.gov/products/GAO-09-353] or key
components. For more information, contact John Stephenson at (202) 512-
3841 or stephensonj@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
EPA Has Made Limited Use of Biomonitoring Data to Assess Risks Posed by
Chemicals:
EPA Lacks a Comprehensive Research Strategy and Has Taken Limited Steps
to Improve the Usefulness of Biomonitoring Data:
EPA's Authority to Obtain Biomonitoring Data under TSCA Is Untested and
May Be Limited:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: Information on Selected EPA Programs to Gather Chemical
Data:
Appendix III: Comments from the Environmental Protection Agency:
Appendix IV: GAO Contact and Staff Acknowledgments:
Table:
Table 1: Selected TSCA Provisions That Address Data Development and
Reporting:
Abbreviations:
CDC: Centers for Disease Control and Prevention:
EPA: Environmental Protection Agency:
HPV: high production volume:
IUR: Inventory Update Reporting:
NHANES: National Health and Nutrition Examination Survey:
NIH: National Institutes of Health:
NOAEL: no observable adverse effect level:
OPP: Office of Pesticide Programs:
OPPT: Office of Pollution Prevention and Toxics:
ORD: Office of Research and Development:
PFOA: perfluorooctanoic acid:
PFOS: perfluorooctanesulfonic acid:
TSCA: Toxic Substances Control Act:
VCCEP: Voluntary Children's Chemical Evaluation Program:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
April 30, 2009:
The Honorable Barbara Boxer:
Chairman:
Committee on Environment and Public Works:
United States Senate:
The Honorable Frank R. Lautenberg:
Chairman:
Subcommittee on Superfund, Toxics and Environmental Health:
Committee on Environment and Public Works:
United States Senate:
Biomonitoring, which measures chemicals or their by-products in living
tissue or body fluids, has shown that the U.S. population is widely
exposed to commercial chemicals, such as phthalates in plastic and
brominated flame retardants in furniture. While chemicals are important
in the manufacture of a wide variety of products, some chemicals have
the potential to cause serious health problems, such as cancer or birth
defects. In addition, children may be more vulnerable to certain
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 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
(e.g., air, soil, water, dust, or food) combined." The CDC conducts the
most comprehensive biomonitoring program in the country and has
recently published the first, second, and third National Report on
Human Exposure to Environmental Chemicals in 2001, 2003, and 2005,
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 example, the CDC reported in 2005 that 93
percent of the people tested had detectable levels of Bisphenol A, a
chemical used to make plastics, in their urine. 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. The CDC
expects to report the concentrations of about 250 chemicals in a fourth
report, to be released sometime in 2009.
In this context, in response to your request, we reviewed the (1)
extent to which EPA incorporates information from human biomonitoring
studies into its assessments of risks of commercial chemicals, (2)
steps that EPA has taken to improve the usefulness of biomonitoring
data for risk assessment, and (3) extent to which EPA has the authority
under TSCA to require chemical companies to develop and submit
biomonitoring data to EPA. We focused on whether TSCA impacts EPA's
ability to collect chemical data because our prior reports have noted
challenges the agency faces in using TSCA to collect chemical
information. Specifically, TSCA places most of the burden of obtaining
chemical data on EPA, rather than on the chemical industry.
To determine the extent to which EPA incorporates data from human
biomonitoring studies into its assessments of risks from chemicals, we
reviewed relevant laws, agency policies, and guidance; prior GAO
reports; and academic publications. We also interviewed EPA officials
and subject matter experts on the current state of biomonitoring
research. To determine the steps that EPA has taken to improve the
usefulness of biomonitoring data for risk assessment and management
activities, we reviewed and analyzed documentation on EPA's
biomonitoring-related research efforts and interviewed relevant
stakeholders, including special interest groups and members of EPA's
Children's Health Protection Advisory Committee. To determine the
extent to which EPA has the authority to obtain biomonitoring data from
the chemical industry, we interviewed EPA officials and reviewed TSCA
and its implementing regulations, EPA's Human Health Research Strategy,
and other relevant documents.
Appendix I contains a detailed description of our scope and
methodology. We conducted this performance audit from October 2007 to
April 2009 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.
Results in Brief:
EPA has made limited use of biomonitoring data in its assessments of
risks posed by chemicals. 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 148
chemicals, whereas EPA is currently focusing its chemical assessment
and management efforts on the more than 6,000 chemicals that it
considers the most likely sources of human or environmental exposure. A
second reason 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. This
process requires information on how people are exposed--whether through
air, water, food, or some other medium--and on the potential health
effects of that exposure. Biomonitoring data, on the other hand,
indicate only that a person was somehow exposed to a chemical and how
much remains in the person's body, but not how the person was exposed
or what may be the effect of the chemical. 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. Therefore, the agency has made few
changes to its chemical risk assessments or safeguards in response to
the recent proliferation of biomonitoring data. However, in a few
cases, there is enough existing research for EPA to incorporate
biomonitoring information into risk assessment. 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.
While EPA has taken a number of promising steps to better understand
and use biomonitoring data, it does not yet have a coordinated strategy
for biomonitoring research or for integrating biomonitoring data into
its chemical risk assessment process. EPA does have several research
efforts with a biomonitoring focus, including research into the
relationships between exposure to harmful chemicals, the resulting
concentration of those chemicals in human tissue, and the corresponding
health effects. For example, EPA is funding a program that collects
biomonitoring data in an attempt to understand the environmental causes
of autism. Nonetheless, without a coordinated strategy that takes into
account EPA's various research efforts, and also those of the CDC and
other federal agencies and stakeholders with substantial biomonitoring
research efforts, it is unclear how EPA is prioritizing its
biomonitoring research, what resources it needs to identify and address
the data gaps that prevent it from making better use of biomonitoring
data, and what opportunities exist to coordinate federal efforts. In
addition, 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. The
development of a coordinated strategy could enhance research efforts
and link data needs with collection efforts.
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. The provision that authorizes EPA to require data development
focuses on data that demonstrate the health and environmental effects
of a chemical. While EPA points out that under this provision it may
also collect information on chemical characteristics that may affect
health, EPA may only do so after meeting certain threshold risk
requirements. Therefore, EPA may face difficulty in using this
provision to obtain biomonitoring data, since biomonitoring data alone
only indicate the presence of a chemical in the body, which by itself
may not demonstrate the effects of the chemical. Other TSCA provisions
allow EPA to collect existing information on chemicals. While these
provisions are limited to information the company already has, knows
about, or could easily ascertain, EPA's authority to obtain such
information is clearer. For example, TSCA obligates chemical companies
to report to EPA any information that reasonably supports the
conclusion that a chemical presents a substantial risk of injury to
health or the environment. EPA asserts in informal guidance that
biomonitoring data are reportable if the chemical in question is known
to have serious toxic effects, and if the biomonitoring information
indicates a level of exposure previously unknown to EPA. The agency
took action against a chemical company under this authority in 2004 for
failing to report two sets of biomonitoring data, among other claims.
However, this action was settled without an admission of liability by
the company, so EPA's authority to obtain biomonitoring data remains
untested.
We are recommending that EPA develop a comprehensive research strategy
to improve its ability to use biomonitoring in its risk assessments,
establish an interagency task force to coordinate federal biomonitoring
research, and determine the extent of its legal authority to obtain
biomonitoring data under TSCA. In addition, EPA should request legal
authority specific to biomonitoring from the Congress if the agency
determines that doing so is necessary.
In commenting on a draft of this report, EPA generally agreed with the
first two recommendations and did not disagree with the third, but
provided substantive comments on its implementation. EPA's comments are
reprinted in appendix III. See the Agency Comments and Our Evaluation
section of this report for our responses to these comments. EPA also
provided technical comments, which we incorporated into the report as
appropriate.
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. Biomonitoring
has been used to monitor certain workers' lead exposure for many
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.
The CDC began collecting health statistics on the U.S. population
through its National Health and Nutrition Examination Survey (NHANES)
in 1971. This effort evolved over time to include the CDC collecting
biomonitoring data in 1976, but only for a handful of chemicals, such
as lead and certain pesticides. In 1999, the CDC substantially
increased the number of chemicals in the biomonitoring component of the
program to 116 and began analyzing and reporting these biomonitoring
data in its versions of the National Report on Human Exposure to
Environmental Chemicals. These three 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. The NHANES design does not select or
exclude participants on the basis of their potential for low or high
exposure to a chemical. The current design of the biomonitoring program
does not permit examination of exposure levels by locality, state, or
region; seasons of the year; proximity to sources of exposure; or use
of particular products. For example, it is not possible to extract a
subset of the data and examine levels of blood lead that represent
levels in a particular state's population. Some specific uses of data
from the CDC's biomonitoring program are to:
* determine which chemicals are present in individuals in the U.S.
population, and at what concentrations;
* determine, for chemicals with a known toxicity level, the prevalence
of people with levels above those toxicity levels;
* establish reference ranges that can be used by physicians and
scientists to determine whether a person or group has an unusually high
exposure;
* assess the effectiveness of public health efforts to reduce exposure
of individuals to specific chemicals;
* determine whether exposure levels are higher among minorities,
children, women of childbearing age, or other potentially vulnerable
groups;
* track, over time, trends in levels of exposure of the population;
and:
* set priorities for research on human health effects.
Some states have enacted local biomonitoring programs to identify and
address health concerns. For example, Alaska is collecting women's hair
samples to test them for mercury and is supplementing those data with
information on the women's fish consumption and data on local fish
mercury levels collected by the U.S. Fish and Wildlife Service. As
another example, California is planning how to implement a statewide
biomonitoring program and is currently selecting which chemicals to
include in the program. As more data have become available regarding
the general population's exposure to a variety of commercial chemicals,
public concerns have been aroused over the health risks posed by
exposures to chemicals, such as flame retardants used in furniture or
common pesticides used in and around the home. However, the utility and
interpretation of biomonitoring data remain controversial, and the
challenge for environment and health officials is to understand the
health implications and to craft the appropriate policy responses.
For decades, government regulators have used a process called "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. The National Academy of Sciences--a private,
nonprofit institution that provides science, technology, and health
policy advice under a congressional charter--described the four stages
of health risk assessment in 1983.[Footnote 1] The first stage is
hazard identification, the determination of whether a particular
chemical is or is not causally linked to particular health effects. The
second stage is dose-response assessment, which involves determining
the relationship between the magnitude of exposure to a contaminant and
the probability and severity of adverse effects. These two stages
generally involve studies that expose animals to high doses of a
chemical and observe the adverse effects. The third stage is exposure
assessment--that is, identifying the extent to which exposure is likely
to occur. For this stage, risk assessors generally use data on chemical
concentrations in the air, water, food, or other environmental media,
combined with assumptions about how and at what rate the body is
exposed to or absorbs the chemicals. Risk assessors also use
assumptions about human behavior based on observational studies--such
as the time spent outdoors or, for children, the amount of time spent
on the floor--to better estimate an individual's true exposure. The
fourth stage of the health risk assessment process is risk
characterization--that is, combining the information from the first
three stages into a conclusion about the nature and magnitude of the
risk, including attendant uncertainty. These assessments typically
result in the creation of chemical-specific "reference values" that are
based on an intake level or a concentration in an environmental medium.
An example of such a reference value is a "reference dose," which is an
estimate (with uncertainty spanning perhaps an order of magnitude) of a
daily oral exposure to the human population (including sensitive
subgroups) that is likely to be without an appreciable risk of
deleterious effects during a lifetime. A reference dose can be derived
from a no observable adverse effect level (NOAEL), lowest observed
adverse effect level, or benchmark dose, with uncertainty factors
generally applied to reflect limitations of the data used. Uncertainty
factors are used to account for interspecies extrapolation, and
intraspecies variation, and, in some cases, to account for the duration
of the study or a lack of a NOAEL. In addition, some legislation is
based on the default assumption that children may be more sensitive to
chemicals than adults. For example, the Food Quality Protection Act
requires a 10-fold safety factor to protect children.
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. To integrate
biomonitoring into traditional risk assessment, researchers must
determine how to correlate this internal exposure with their prior
understanding of how external exposure affects human health.
Although the CDC has been the primary agency collecting biomonitoring
data, EPA has specific authority to assess and manage chemical risks,
often in coordination with other federal agencies. Several EPA offices
are involved in collecting chemical data and assessing chemical risks.
The Office of Pollution Prevention and Toxics (OPPT) manages programs
under TSCA. The act provides EPA with the authority to collect
information about chemical substances or, upon making certain
determinations, to require companies to develop information and take
action to control unreasonable risks by either preventing or limiting
the introduction of dangerous chemicals into commerce or by placing
restrictions on those already in the marketplace. TSCA also creates an
Interagency Testing Committee to recommend chemicals for priority
consideration for further testing to EPA. Furthermore, the EPA
Administrator is specifically directed to coordinate with the
Department of Health and Human Services and other federal agencies to
conduct research, development, and monitoring as necessary to carry out
the purposes of TSCA, and to establish and coordinate a system for
exchange among federal, state, and local authorities of research and
development results respecting toxic chemicals. The Office of Pesticide
Programs (OPP) manages programs under the Federal Insecticide,
Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic
Act, which require that EPA review pesticide risks to the environment
before allowing a pesticide to be sold or distributed in the United
States, and to set maximum pesticide residue levels allowed in or on
food.
Risk assessment activities at EPA are carried out by the agency's
Office of Research and Development (ORD)--its principal scientific and
research arm--and its program and regional offices, including the
Office of Air and Radiation, OPP, OPPT, and the Office of Water. ORD's
role is to provide program and regional office scientific advice and
information for use in developing and implementing environmental
policies, regulations, and practices. In fulfilling this role, ORD
issues guidance documents for risk assessors, such as its Exposure
Factors Handbook, and conducts and funds research aimed at addressing
data gaps and reducing scientific uncertainty. This research is divided
into two categories: core research and problem-driven research. Core
research seeks to produce a fundamental understanding of the key
biological, chemical, and physical processes that underlie
environmental systems, thus forging basic scientific capabilities that
can be applied to a wide range of environmental problems. Core research
addresses questions common to many EPA programs and provides the
methods and models needed to confront unforeseen environmental
problems. Problem-driven research, however, focuses on regulatory,
program office, or regional needs and may focus on specific pollutants
or the development of models or methods to address specific questions.
EPA Has Made Limited Use of Biomonitoring Data to Assess Risks Posed by
Chemicals:
EPA makes limited use of current biomonitoring studies because such
studies cover relatively few chemicals, and EPA rarely knows whether
the measured amounts in people indicate a risk to human health.
Nonetheless, EPA has taken action in a few cases, when biomonitoring
studies showed that people were widely exposed to a chemical that
appeared to pose health risks.
The CDC's biomonitoring program provides the most comprehensive
biomonitoring data relevant to the U.S. population. The results of the
program are summarized in three versions of the National Report on
Human Exposure to Environmental Chemicals. The latest report, issued in
2005, covered 148 chemicals, and the forthcoming version in 2009 will
provide data on about 250 chemicals. However, there are over 83,000
chemicals on the TSCA Chemical Substance Inventory. Of those chemicals,
EPA focuses on screening and prioritizing the more than 6,200 chemicals
that companies produce in quantities of more than 25,000 pounds per
year at one site.[Footnote 2] About 3,000 of these 6,200 chemicals are
produced at more than 1 million pounds per year in total.
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. When samples are available from
children, they may not be large enough to analyze because the test
requires more fluids than is available because of the reasons we have
previously mentioned. In other cases, the sampling effort uses the
sample for other purposes. For example, the CDC collects samples
through its health and nutrition survey, but uses these samples to
study biological indicators related to nutrition, such as the amount of
water soluble or fat soluble vitamins, iron, or trace elements. Thus,
the only biomonitoring analysis that the CDC has performed on samples
from children under 6 are for cadmium, lead, mercury, cotinine--a by-
product of tobacco smoke--and certain perfluorinated chemicals.
Even if biomonitoring information is available for a chemical, it is
often of limited use. EPA indicated that it often lacks the additional
information needed to make biomonitoring results useful for risk
assessment. Biomonitoring provides information only on the level of a
chemical in a person's body. The detectable presence of a chemical in a
person's blood or urine may not mean that the chemical causes disease.
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. 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,
additional data on health effects; on the sources, routes, and timing
of exposure; and on the fate of a chemical in the human body would be
needed to incorporate biomonitoring into risk assessment. 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 they produce. We have
designated the assessment and control of toxic chemicals as a "high-
risk" area of government that requires broad-based transformation.
[Footnote 3]
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
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. In 1999, EPA began an
investigation after receiving biomonitoring data from a chemical
company indicating that perfluorooctanesulfonic acid (PFOS) was found
in the general population. Further testing showed that PFOS also was
persistent in the environment, was unexpectedly toxic, tended to
accumulate in the human body, and was present in low concentrations in
the blood of the general population and wildlife worldwide. The
principal PFOS manufacturer voluntarily phased out its production in
2002, and EPA then required manufacturers and importers to notify EPA
90 days before manufacturing or importing PFOS and PFOS-related
chemicals for certain new uses.[Footnote 4]
In addition, in September 2002, EPA initiated a review of
perfluorooctanoic acid (PFOA)--another perfluorinated chemical. The
agency cited biomonitoring data indicating widespread human exposure in
the United States, and animal toxicity studies that linked PFOA
exposure to developmental effects on the liver and the immune system.
EPA has sought to work with multiple parties to produce missing
information on PFOA through the negotiation of enforceable consent
agreements, memorandums of understanding, and voluntary commitments. In
2006, EPA also launched the a 2010/15 PFOA Stewardship Program, in
which eight companies voluntarily committed to reduce facility
emissions and product content of PFOA and related chemicals by 95
percent no later than 2010, and to work toward eliminating emissions
and product content by 2015.
EPA also used biomonitoring data in a few other cases. In the 1980s,
EPA was considering whether to make permanent a temporary ban on lead
in gasoline. National data on lead exposure showed a decline in average
blood lead levels that corresponded to the declining amounts of lead in
gasoline. On the basis of these data and other information, EPA
strengthened its restrictions on lead. In the 1990s, EPA used
biomonitoring studies to develop a reference dose for methylmercury, a
neurotoxin. Mercury occurs naturally and in industrial pollution. In
water, it can turn into methylmercury and then accumulate in fish.
These studies showed that elevated levels of mercury in women's hair
and their infants' umbilical cord blood correlated with adverse
neurological effects when the children reached aged 6 or 7 years. In
its fiscal year 2008 Performance and Accountability Report, EPA used
results from biomonitoring studies to track its performance in reducing
blood levels of lead, mercury, certain pesticides, and polychlorinated
biphenyls. Furthermore, EPA used biomonitoring data in evaluating the
safety of two pesticides: triclosan in 2008 and chlorpyrifos in 2006.
Finally, EPA officials told us that the agency may adopt the use of
biomonitoring data as a tool to evaluate the long-term outcomes of risk
mitigation efforts.
EPA Lacks a Comprehensive Research Strategy and Has Taken Limited Steps
to Improve the Usefulness of Biomonitoring Data:
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. EPA also 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 identified
which chemicals most need additional biomonitoring-related research.
EPA intends to revise its Human Health Research Strategy for 2009, and
it said that it may include a greater focus on how the agency can
interpret biomonitoring data and use them in risk assessments.
Also, EPA lacks a coordinated national strategy for 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
Agency for Toxic Substances and Disease Registry, the Occupational
Safety and Health Administration, and entities within the National
Institutes of Health (NIH). 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.
A national biomonitoring research plan could help better coordinate
research and link data needs with collection efforts. 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
5] Similarly, the National Academy of Sciences found that the lack of a
coordinated research strategy allowed widespread exposures to go
undetected, including exposures to PFOA and flame retardants known as
polybrominated diphenyl ethers. 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.
EPA has taken some promising steps to address data gaps relevant to
biomonitoring, which we discuss in the remaining paragraphs of this
section. For example, EPA has funded research to address certain links
between chemical exposure, biomonitoring measurements, and health
effects. The agency worked with NIH to establish and fund several
Centers for Children's Environmental Health and Disease Prevention
Research (Children's Centers). One of these centers is conducting a
large-scale study exploring the environmental and genetic causes of
autism, and plans to use various types of biomonitoring data collected
from parents and children to quantify chemical exposures and examine
whether samples from children with autism contained different
biomarkers than samples from children without autism. EPA's Children's
Health Protection Advisory Committee stated that EPA's Children's
Centers program represents an excellent investment that provides both
short-and long-term benefits to children's health.
In addition, EPA also awards grants that are intended to advance the
knowledge of children's exposures to pesticides through the use of
biomarkers, 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 biomarkers for common
pesticides, related biomarkers to indices of early neurological
development, and analyzed the association between pesticide levels in
environmental samples and pesticide body burdens. According to EPA,
this research has helped the agency to better assess children's
exposure to chemicals and assess the risk of certain pesticides.
Furthermore, EPA pursues internal research to develop and analyze
biomonitoring data. For example, EPA has studied the presence of the
herbicide 2, 4-D in 135 homes with preschool-age children by analyzing
soil, outdoor air, indoor air, carpet dust, food, urine, and samples
taken from subjects' hands. The study shed important light on how best
to collect urine samples that reflect an external dose of the
herbicide. It is also helping EPA researchers develop models that
simulate how the body processes specific chemicals, which will help
them understand the links between biomonitoring data and initial
sources and routes of chemical exposure. In another area of research,
EPA has partially implemented a National Academy of Sciences
recommendation by collecting biomonitoring data during some animal
toxicology studies. Collecting this information allows EPA to relate
animal biomonitoring data to animal health effects, which is likely to
be useful in interpreting human biomonitoring data. However, EPA does
not routinely collect this information.
Finally, EPA has collaborated with other agencies and industry on
projects that may improve the agency's ability to interpret and use
biomonitoring data. For example, EPA collaborated with other federal
agencies in the development of the National Children's Study, a long-
term study of environmental and genetic effects on children's health,
which is slated to begin collecting data later in 2009. The agency
proposes to examine the effects of environmental influences on the
health and development of approximately 100,000 children across the
country, following them from before birth until age 21. Several
researchers have noted that since the study is slated to collect
biomonitoring samples and data on environmental exposures in the home
while tracking children's health status, the study would provide a
unique opportunity to address data gaps and begin linking external
exposure sources, biomonitoring measurements, and health outcomes.
However, the study depends upon a sustained funding commitment, which
it has not yet received, and the National Academy of Sciences has noted
concerns regarding funding uncertainty. In a separate effort, EPA
cosponsored a private consultant's pilot project to create
"biomonitoring equivalents" for four chemicals. These are biomonitoring
measurements intended to have a well-understood relationship to
existing measures of exposure, such as oral reference doses. This
relatively new concept could help better interpret the biomonitoring
results for these and other chemicals and could highlight when
additional research and analysis are needed.
EPA has other programs that it uses to gather additional chemical test
data or to gather production and use information from companies, but
these programs are not designed to interpret biomonitoring data. We
discuss some of these programs in more detail in appendix II.
EPA's Authority to Obtain Biomonitoring Data under TSCA Is Untested and
May Be Limited:
EPA's authorities under TSCA to obtain biomonitoring data are generally
untested. While our analysis of the relevant TSCA provisions and of
recent administrative action suggests that EPA may be able to craft a
strategy for obtaining biomonitoring data under some provisions of
TSCA, EPA has not determined the full extent of its authority or the
full extent of chemical companies' responsibilities with respect to
biomonitoring.
Several provisions of TSCA address data development and reporting.
These relevant provisions are shown in table 1 and detailed in the text
that follows.
Table 1: Selected TSCA Provisions That Address Data Development and
Reporting:
TSCA provision: Section 4;
Scope of data that can be required: Development of data on health and
environmental effects and chemical characteristics;
EPA's position on whether scope includes biomonitoring data: No formal
position, but EPA stated that biomonitoring data can theoretically be
obtained under this section.
TSCA provision: Sections 5(a) and 5(b);
Scope of data that can be required: Test data developed per a section 4
test rule;
EPA's position on whether scope includes biomonitoring data: No formal
position, but EPA stated that its authority to obtain biomonitoring
data under this section would be the same as under section 4.
TSCA provision: Sections 5(a) and 5(d);
Scope of data that can be required: Test data that company has or
description of data company knows of or should know of regarding health
and environmental effects;
EPA's position on whether scope includes biomonitoring data: No formal
position, but EPA stated that it has very strong authority to require
submission of existing biomonitoring data under these sections.
TSCA provision: Section 5(e);
Scope of data that can be required: EPA can restrict manufacture of a
chemical, which may result in an agreement to develop additional data;
EPA's position on whether scope includes biomonitoring data: No formal
position, but EPA stated that it has broad authority to create orders
under this section, which might theoretically include generation of
biomonitoring data as a support for lifting an order.
TSCA provision: Section 8(a);
Scope of data that can be required: A variety of chemical data,
including data on health and environmental effects;
EPA's position on whether scope includes biomonitoring data: No formal
position, but EPA stated that it has strong authority to require the
reporting of biomonitoring data under this section.
TSCA provision: Section 8(d);
Scope of data that can be required: Health and safety studies;
EPA's position on whether scope includes biomonitoring data: No formal
position, but EPA stated that biomonitoring data can be obtained under
this section given TSCA's broad definition of a health and safety
study.
TSCA provision: Section 8(e);
Scope of data that can be required: Information that reasonably
supports the conclusion that the chemical presents a substantial risk
of injury to health or the environment;
EPA's position on whether scope includes biomonitoring data: EPA has
stated in a court filing and in nonbinding guidance that biomonitoring
data can be obtained under this section.
Source: GAO analysis of the Toxic Substances Control Act.
[End of table]
Under section 4 of TSCA, EPA can require chemical companies to test
chemicals for their effects on health or the environment, but this
process is difficult, expensive, and time-consuming.[Footnote 6] 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.
EPA has said that it could theoretically require the development of
biomonitoring data under section 4 of TSCA, but the agency's authority
to do so has not yet been tested. Generally, section 4 allows EPA, if
it makes the necessary findings, to promulgate a "test rule" requiring
a company to "develop data with respect to the health and environmental
effects for which there is an insufficiency of data." Biomonitoring
data indicate only the presence of a chemical in a person's body, and
not its impact on the person's health. However, EPA told us that
biomonitoring data may in some cases demonstrate chemical
characteristics--such as persistence, uptake, or fate--that could be
relevant to the health and environmental effects of the chemical.
Section 4 lists several chemical characteristics as items for which EPA
can prescribe standards for development under a test rule, explicitly
including persistence but also including any other characteristic that
may present an unreasonable risk. Although biomonitoring may not be the
only way to demonstrate persistence, uptake, or fate, section 4 also
authorizes EPA to prescribe certain methodologies for conducting tests
under a test rule, including but not limited to epidemiologic studies,
serial or hierarchical tests, in vitro tests, and whole-animal tests.
Biomonitoring is not a listed methodology, but EPA stated it could
publish a standard test guideline for using biomonitoring as a
methodology for obtaining data on health effects and chemical
characteristics, or it could include biomonitoring in a section 4 test
rule where warranted.
Sections 5(a) and 5(b) of TSCA may be of limited use to EPA in
obtaining biomonitoring data from chemical companies. Specifically,
section 5(a) requires chemical companies to notify EPA at least 90 days
before beginning to manufacture a new chemical or before manufacturing
or processing a chemical for a use that EPA has determined by rule is a
significant new use. The notice provided by the company must include
"any test data in the possession or control of the person giving such
notice which are related to the effect of any [manufacture, etc.] on
health or the environment," as well as "a description of any other data
concerning the environmental and health effects of such substance,
insofar as known to the person making the notice or insofar as
reasonably ascertainable." As we have previously described, EPA told us
that data concerning "environmental and health effects" could include
biomonitoring data. While a notice under section 5 may include test
data required to be developed under a section 4 test rule, section 5(b)
does not provide independent authority for EPA to require the
development of any new data. Thus, section 5(b) can only be used by EPA
to obtain data that the chemical companies have on hand. EPA has noted
that companies are particularly unlikely to have biomonitoring data for
new chemicals on hand because there is little opportunity for exposure
to the chemical prior to full-scale manufacture.
Under certain circumstances, EPA may be able to indirectly require the
development of new test data using the leverage that it has under
section 5(e) to limit the manufacture of chemicals, although the agency
has never attempted to do so. 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. Also under
this section, EPA sometimes issues a consent order that does not
prohibit the manufacture of the chemical, but subjects it to certain
conditions, including additional testing. EPA typically uses such
consent orders to require testing of toxic effects and a chemical's
fate in the environment. 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.
EPA's authority to obtain biomonitoring data under sections 8(a) and
8(d) is also untested, but EPA told us that it has broad authority to
collect biomonitoring data under these sections. Under section 8(a),
EPA can require chemical companies to maintain records and submit
reports on a variety of data, including "all existing data concerning
the environmental and health effects of the chemical." EPA believes
that "data concerning environmental and health effects" could include
biomonitoring data; however, only existing data would be obtainable
under section 8(a). Under section 8(d), EPA can require chemical
companies to submit lists or copies of any existing health or safety
studies known or reasonably ascertainable by them. TSCA defines "health
and safety study" very broadly as:
"...any study of any effect of a chemical substance or mixture on
health or the environment or on both, including underlying data and
epidemiological studies, studies of occupational exposure to a chemical
substance or mixture, toxicological, clinical, and ecological studies
of a chemical, substance or mixture, and any test performed pursuant to
this chapter."
While the agency has no formal position on whether biomonitoring data
can be obtained under section 8(d), an EPA official stated that this
provision authorizes the agency to promulgate a rule requiring a
company to submit existing biomonitoring data. EPA explained that the
presence of a chemical in blood or tissues of workers could indicate
occupational exposure to the chemical, qualifying such information as
reportable under this section.
Section 8(e) has in recent years garnered more attention than any other
section of TSCA as a potential means of collecting biomonitoring
information, but this potential remains unclear. Section 8(e) requires
chemical companies, on their own initiative, 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. "Substantial risk" is currently defined by EPA in
nonbinding guidance as "a risk of considerable concern because of (a)
the seriousness of the effect, and (b) the fact or probability of its
occurrence." 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. However, this is the
extent of EPA's current guidance on the subject. Industry has asked for
expanded guidance covering specific criteria for when biomonitoring
data are reportable, specific guidance on the reportability of
occupational biomonitoring results versus biomonitoring results from
the general population, and factors that would render biomonitoring
data unreportable. EPA has not yet revised its guidance in response to
industry request.
This difficulty of enforcement 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 at a plant in West Virginia. In 1981, DuPont took blood samples
of several female workers and two babies born to those workers. The
levels of PFOA in the blood from the babies showed a measurable amount
of PFOA crossed the placental barrier. DuPont moved its female
employees away from work in areas of the plant where PFOA was used.
However, after conducting additional animal testing, DuPont concluded
that the exposure levels associated with workers posed no reproductive
risks and moved the women back into these areas. DuPont did not report
the human blood sampling results to EPA, even when EPA requested all
toxicology data associated with PFOA. DuPont also did not report to EPA
the results of blood testing of 12 people living near the plant, 11 of
whom had never worked in the plant and had elevated levels of PFOA in
their blood. EPA initially received the 1981 blood sampling information
from counsel for a class action lawsuit by citizens living near the
West Virginia facility. DuPont argued that none of the blood sampling
information was reportable under TSCA because the mere presence of PFOA
in workers' and community members' 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. In December 2005, EPA and DuPont settled both of these actions.
DuPont did not admit that it should have reported the biomonitoring
data, but it agreed to a settlement totaling $16.5 million.
Furthermore, EPA used the biomonitoring data it received in a
subsequent risk assessment, which was reviewed by the Science Advisory
Board, together with other information that was available at that time.
Upon review, the board suggested that the PFOA cancer data are
consistent with the category of "likely to be carcinogenic to humans"
described in EPA Guidelines for Carcinogen Risk Assessment. As a result
of this finding and other concerns associated with PFOA and PFOA-
related chemicals, DuPont finally agreed to phase out the use of PFOA
by 2015, in tandem with seven other companies. Thus, while EPA
ultimately succeeded in using TSCA to remove PFOA from the market, it
encountered great difficulty in doing so--that is, even when
biomonitoring data, coupled with animal toxicity studies, arguably
helped point out serious risks to human health associated with PFOA,
DuPont's position was that section 8(e) did not require it to submit
the biomonitoring data it had collected on PFOA. DuPont did not provide
the biomonitoring data on its own initiative, and EPA may never have
received these data if they had not been originally provided by a third
party. Without the biomonitoring information, EPA may never have
completed the risk assessment that led to the phaseout of PFOA.
Conclusions:
Biomonitoring provides new insight into the general population's
exposure to chemicals. However, scientists have linked biomonitoring
data with human health effects for only a handful of chemicals to date.
As the volume of biomonitoring data continues to increase, EPA will
need to strategically plan future research that links environmental
contamination, biomonitoring measurements of exposure, and adverse
health effects. The nation thus far has no long-term strategy to
coordinate the biomonitoring research that EPA and other stakeholders
perform. Nor does the agency gather reliable information on the amount
of resources needed for addressing data gaps and incorporating
biomonitoring research results into its chemical risk assessment and
management programs. In addition, while federal agencies and other
stakeholders could pursue various methods to address biomonitoring data
gaps, such as routinely collecting biomonitoring in animal toxicology
studies, coordination and agreements among EPA and the various other
entities are needed to systematically pursue these options. A national
biomonitoring research strategy could enhance the usefulness of
biomonitoring data by identifying linkages between data needs and
collection efforts and providing a framework for coordinating research
efforts and leveraging stakeholder expertise.
One of the first steps in interpreting biomonitoring data is to better
understand how chemicals impact human health, including how we might be
exposed to them and what levels of exposure pose a risk. However,
information is sparse on how people are exposed to commercial chemicals
and on the potential health risks for the general population. We have
previously noted that EPA faces challenges in using TSCA to obtain the
information needed to assess the risks of chemicals. These challenges
also affect EPA's ability to require that chemical companies provide
biomonitoring data. Such data can provide additional insights on
exposure levels and susceptible populations. However, EPA has not
determined the extent of its authority to require a company to develop
and submit biomonitoring data that may aid EPA in assessing chemicals'
risks, and EPA has not developed regulations or formal guidance
concerning the conditions under which biomonitoring data might be
required. While EPA has attempted to get additional information on
chemical risks from voluntary programs, such programs have had mixed
results and are unlikely to be a complete substitute for a more robust
chemical regulatory program.
Recommendations for Executive Action:
To ensure that EPA effectively obtains the information needed to
integrate biomonitoring into its chemical risk assessment and
management programs, coordinates with other federal agencies, and
leverages available resources for the creation and interpretation of
biomonitoring research, we recommend that the EPA Administrator take
the following two actions:
* Develop a comprehensive biomonitoring research strategy that includes
the data EPA needs to incorporate biomonitoring information into
chemical risk assessment and management activities, identifies federal
partners and efforts that may address these needs, and quantifies the
time frames and resources needed to implement the strategy. Such a
strategy should:
- identify and prioritize the chemicals for which biomonitoring data or
research is needed,
- categorize existing biomonitoring data,
- identify limitations in existing data approaches,
- identify and prioritize data gaps, and:
- estimate the time and resources needed to implement this strategy.
* Assess EPA's authority to establish an interagency task force that
would coordinate federal biomonitoring research efforts across agencies
and leverage available resources, and establish such a task force if it
determines that it has the authority. If EPA determines that further
authority is necessary, it should request that the Executive Office of
the President establish an interagency task force (or other mechanism
as deemed appropriate) to coordinate such efforts.
In addition, to ensure that EPA has sufficient information to assess
chemical risks, the EPA Administrator should take the following action:
* Determine the extent of EPA's legal authority to require companies to
develop and submit biomonitoring data under TSCA. EPA should request
additional authority from the Congress if it determines that such
authority is necessary. If EPA determines that no further authority is
necessary, it should develop formal written policies explaining the
circumstances under which companies are required to submit
biomonitoring data.
Agency Comments and Our Evaluation:
We provided a draft of this report to the EPA Administrator for review
and comment. EPA generally agreed with our first two recommendations,
and did not disagree with the third, but it provided substantive
comments on its implementation. We present EPA's written comments in
appendix III. EPA also provided technical comments, which we
incorporated into the report as appropriate. The following paragraphs
summarize EPA's comments and our responses.
While EPA agreed that it should develop a comprehensive biomonitoring
research strategy, the agency noted that its research program is
addressing important questions relevant to interpreting biomonitoring
data. We agree that EPA is conducting important biomonitoring related
research. However, as noted in our report, while EPA has biomonitoring
research projects under way, it has no system in place to track overall
progress or assess the resources needed specifically for biomonitoring
research. EPA also agreed that an interagency task force is needed to
coordinate federal biomonitoring research, and says that such a task
force should be developed under the auspices of the Office of Science
and Technology Policy. We do not disagree with this approach. EPA said
that our report underemphasized the importance of considering
assumptions about human behavior and the need to collect biomonitoring
data for young children. We agree that EPA needs to consider human
behavior and other factors that impact human health risk, and we note
in the report that EPA uses assumptions about human behavior on the
basis of observational studies--such as the time spent outdoors or, for
children, the amount of time spent on the floor--to better estimate an
individual's true exposure. We also note that current biomonitoring
efforts provide little information on children and that children may be
more vulnerable to certain chemicals than adults because (1) their
biological functions are still developing and (2) their size and
behavior may expose them to proportionately higher doses. In our
recommendations, we indicate that EPA should prioritize data gaps, and
we believe that the lack of data on children should be a priority.
Regarding our recommendation that EPA should determine the extent of
its legal authority to obtain biomonitoring data, EPA commented that a
case-by-case explanation of its authority might be more useful than a
global assessment of that authority. However, we continue to believe
that an analysis of EPA's legal authority to obtain biomonitoring data
is critical. Fuller consideration of EPA's authority is a necessary
precondition of the two other recommendations that we make in this
report, with which the agency agreed. That is, EPA would be best
equipped to formulate a biomonitoring research strategy and contribute
to an interagency task force if it were more fully aware of what data
it can obtain. Furthermore, while we understand that EPA can clarify
its authority to obtain biomonitoring data in individual regulatory
actions, few such opportunities have arisen with regard to
biomonitoring so far, and EPA provided no information suggesting it
will have more opportunities to consider the issue in the near future.
In addition, companies must sometimes submit chemical information
independent of an EPA rule requiring submission of the data. For
example, under section 8(e), chemical companies must submit certain
adverse health and safety information at their own initiative. Such
situations do not provide EPA with an initial opportunity to clarify
its authority to obtain biomonitoring data. We continue to believe that
formal written guidance would be useful in these circumstances.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from the report date. At that time, we will send copies to other
appropriate congressional committees, the EPA Administrator, and other
interested parties. In addition, the report will be available at no
charge on the GAO Web site at [hyperlink, http://www.gao.gov].
If you or your staffs have any questions about this report, please
contact me 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 report. GAO staff who made major contributions
to this report are listed in appendix IV.
Signed by:
John B. Stephenson:
Director, Natural Resources and Environment:
[End of section]
Appendix I: Objectives, Scope, and Methodology:
To determine the extent to which the Environmental Protection Agency
(EPA) incorporates data from human biomonitoring studies into its
assessments of risks from chemicals, we reviewed relevant laws, agency
policies and guidance, and our prior reports relevant to EPA's
assessment of chemicals and to EPA's activities related to children's
health issues. In addition, we reviewed EPA's prior and planned uses of
these data, academic publications, National Academy of Sciences
reports, and government and industry-sponsored conference proceedings
to gain an understanding of the current state of biomonitoring
research. We supplemented this information with that obtained from
interviews with EPA officials working on biomonitoring and risk
assessment issues in the Office of Research and Development, the Office
of Children's Health Protection, the Office of Water, the Office of Air
and Radiation, the Office of Pesticide Programs, and the Office of
Pollution Prevention and Toxics. To review how EPA addresses challenges
that limit the usefulness of biomonitoring data for risk assessment and
management activities, we collected documentation on EPA's
biomonitoring-related research efforts, including EPA's Human Health
Research Strategy, and financial and program data for grant programs
that have funded biomonitoring research. In addition, we interviewed
stakeholders--such as the Centers for Disease Control and Prevention
(CDC) and the Children's Health Protection Advisory Committee as well
as the American Chemistry Council, the Environmental Defense Fund, and
the Environmental Working Group--to gauge EPA's involvement with a
variety of stakeholders working to further biomonitoring research. To
determine the extent to which EPA has the authority to obtain
biomonitoring data from the chemical industry, we reviewed relevant
legislation and prior legal actions, and interviewed officials from
EPA's Office of General Counsel to understand EPA's authorities for
collecting biomonitoring data from companies.
We conducted this performance audit from October 2007 to April 2009, 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.
[End of section]
Appendix II: Information on Selected EPA Programs to Gather Chemical
Data:
EPA has programs intended to increase its knowledge of the toxic
effects and levels of human exposure to certain chemicals, such as the
agency's Inventory Update Reporting (IUR) rule and voluntary programs,
such as the Voluntary Children's Chemical Evaluation Program (VCCEP)
and the High Production Volume Challenge Program (HPV Challenge
Program). However, these programs have significant limitations and no
clear link to biomonitoring. For example, EPA's IUR rule is intended to
gather more information on how existing chemicals are used and how they
come into contact with people. However, the agency does not collect
biomonitoring data as part of this program. Furthermore, in 2003 and
2005, EPA amended the rule in ways that may reduce the amount of
certain information that companies report about chemicals they produce.
Although the 2003 amendments added inorganic chemicals to the
substances for which companies were required to report and required
other potentially useful information, the agency also raised the
reporting threshold. This threshold is the level of production above
which a company must provide data on a chemical to EPA. The agency
increased the threshold from 10,000 pounds at a single site to 25,000
pounds, which may reduce the number of chemicals for which companies
provide production data to EPA. In 2005, the agency also reduced the
frequency with which chemical companies must report their production
volume of chemicals. Before 2005, companies were required to report the
production volume every 4 years for a chemical that met the reporting
threshold in the 4th year. In 2003, the agency changed the reporting
requirement so that companies have to report every 5 years, thus
reducing the availability of production volume data. As with the
earlier rule, companies are only required to report data for a single
year, not for any of the years prior to the reporting year. However,
EPA officials are considering ways to collect additional production
volume information, such as requiring companies to report production
volume for each of the 5 years whenever a company meets the reporting
requirement of 25,000 pounds of production for the 5th year.
EPA did require chemical companies to report some new information when
it made these changes in 2003. Companies must now supply additional
information relating to the manufacture of the reported chemicals, such
as the number of workers reasonably likely to be exposed to the
chemical, and relating to the physical form and maximum concentration
of the chemical. In addition, for those chemicals produced in
quantities of 300,000 pounds or more at one site, companies must now
report "readily obtainable" information on how the chemicals are
processed or used in industrial, commercial, or consumer settings,
including whether such chemicals will be found in or on products
intended for children. However, the definition of "readily obtainable"
excludes information that requires extensive file searches or surveys
of the manufacturers that purchase the chemicals. Furthermore, an
industry representative told us that it is often difficult for chemical
companies to determine whether a chemical they produce will eventually
be used in a product intended for children, since the companies do not
directly sell children's products and may not know how manufacturers
will use their product. Therefore, it is unclear whether EPA will
receive significant information as a result of this new reporting
requirement.
EPA has also attempted to collect data on toxicity and human exposure
using voluntary programs. For example, in 2000 the agency launched
VCCEP to ensure that it had adequate information to assess the
potential risks to children posed by certain chemicals. EPA asked
companies that produce or import 23 specific chemicals to volunteer to
"sponsor" their chemical by making certain data on the chemical's
toxicity available to the public. The companies volunteered to sponsor
20 of the 23 chemicals. However, VCCEP has proceeded slowly and has not
provided EPA with the data needed to interpret biomonitoring research.
Of the 23 VCCEP chemicals, EPA has received what it deems to be
sufficient data for only 6 chemicals. In addition, it has asked for
additional data that some of the sponsors declined to provide. For
example, one sponsor declined to conduct additional reproductive
toxicity testing for 2 chemicals, which EPA needed to use biomonitoring
data in exposure assessments. Several environmental and children's
health groups, including EPA's Children's Health Protection Advisory
Committee, have stated that VCCEP has not met its goal of ensuring that
there are adequate publicly available data to assess children's health
risks from exposure to toxic commercial chemicals. Specifically, the
groups have noted the lack of risk-based prioritization for collecting
chemical data; the lack of specific guidance and criteria for the
sponsor-developed studies and data; inadequate involvement of
stakeholders; and problems with accountability, credibility, and data
transparency. In 2008, EPA requested public comments on the VCCEP
program and held a listening session. Nonetheless, EPA is still
considering what further actions to take and has not set a goal for
when it will complete its review of the program.
In another voluntary program, begun in 1998, EPA attempted to collect
certain information on the health and environmental effects of high
production volume (HPV) chemicals, which are those manufactured or
imported in amounts of at least 1 million pounds per year.
Approximately 3,000 chemicals meet this criterion. Before the start of
the program, EPA found that data on basic toxicity were available for
only 57 percent of these chemicals, and that the full set of six basic
chemical safety tests (i.e., acute toxicity, chronic toxicity,
reproductive toxicity, mutagenicity, ecotoxity, and environmental fate)
were available for only 7 percent. This information is necessary for
EPA to conduct even a preliminary screening-level assessment of the
hazards and risks of these chemicals, and for it to interpret any
relevant biomonitoring data. Through the HPV Challenge Program, EPA
asked chemical manufacturers and importers to voluntarily sponsor
chemicals by submitting information on the chemicals' physical
properties, environmental fate, and health and environmental effects.
The agency also asked companies to propose a strategy to fill data
gaps.
However, the HPV Challenge Program has serious limitations. First, EPA
has been slow to evaluate chemical risks. More than a decade after
starting the program, the agency has completed "risk-based
prioritizations" for only 151 of the more than 3,000 HPV chemicals.
Risk-based prioritizations are preliminary evaluations that summarize
basic hazard and exposure information known to EPA. The agency intends
to use these evaluations to assign priorities for future action on the
basis of the risks presented by these chemicals. Second, data on almost
300 HPV chemicals are lacking because they were not sponsored by any
chemical company--these unsponsored chemicals are referred to as
"orphans." The exact number of HPV orphan chemicals changes over time,
with changes in sponsorship and production. EPA can require companies
that manufacture or process orphan chemicals to conduct tests, but it
has done so for only 16 of these almost 300 chemicals. This is largely
because it is difficult to make certain findings regarding hazard or
exposure, which section 4 of TSCA requires before EPA may issue a "test
rule." However, EPA did issue a second proposed HPV test rule in July
2008 for 19 additional chemicals and anticipates proposing a third test
rule in 2009 for approximately 30 chemicals. Third, the HPV Challenge
Program does not include inorganic chemicals, or the approximately 500
emerging chemicals that reached the HPV production threshold after
1994. EPA recently introduced a proposal for an inorganic HPV program,
but officials did not provide us with a date regarding when they expect
to launch this program. Finally, EPA allowed chemical companies to
group the chemicals they sponsored into categories and to apply testing
data from only a handful of the chemicals to the entire category. Some
environmental advocacy organizations have claimed that such categories
will not adequately identify the hazards of all the chemicals in the
category.
Despite the limitations of the available data on toxicity and exposure,
EPA plans by 2012 to conduct a basic screening-level assessment of the
potential risks of more than 6,200 chemicals and to prioritize these
chemicals for possible future action as the first step in its new
Chemical Assessment and Management Program. EPA intends to apply the
information on chemical hazards obtained from the HPV Challenge
Program, among other programs, and extend its efforts to cover moderate
production volume chemicals--those produced or imported in quantities
of more than 25,000 and less than 1 million pounds per year. EPA plans
to use any available biomonitoring data to help prioritize the
chemicals for further review but does not have a formal plan for doing
so. Although EPA has occasionally used biomonitoring in connection with
these voluntary programs, it is not attempting to use these programs as
a means to make biomonitoring data more useful. To do so, the agency
would not only have to collect data more effectively from companies,
but also collect the specific kinds of data that would allow it to
understand the human health implications of biomonitoring data.
[End of section]
Appendix III: Comments from the Environmental Protection Agency:
United States Environmental Protection Agency:
Washington, D.C. 20460:
[hyperlink, http://www.epa.gov]
April 13, 2009:
John B. Stephenson:
Director:
Natural Resources & Environment:
United States Government Accountability Office:
441 G Street, N.W. Room 2075:
Washington D.C. 20548:
Dear Mr. Stephenson:
Thank you for the opportunity to review and comment on the draft report
of the Government Accountability Office (GAO) entitled "Biomonitoring -
EPA Needs to Coordinate Its Research Strategy and Clarify Its Authority
to Obtain Biomonitoring Data." The draft report recommends that the
Environmental Protection Agency (EPA) develop a comprehensive research
strategy to improve its ability to use biomonitoring in its risk
assessments, establish an interagency task force to coordinate federal
biomonitoring research, and determine the extent of its legal authority
to obtain biomonitoring data under Toxic Substances Control Act (TSCA).
EPA agrees with the first two GAO recommendations, specifically. that
EPA develop a comprehensive research strategy to improve its ability to
use biomonitoring data in its risk assessments. and that EPA establish
an interagency task force to coordinate federal biomonitoring research.
Consistent with our comments on the Statement of Facts, EPA agrees that
the GAO report accurately reflects the current problems and challenges
inherent in using biomarkers data in risk assessment.
EPA's research program is addressing important research questions
relevant to interpreting biomonitoring data. This research is directed
at understanding the linkages between biomarker data and health
outcomes in the forward direction from source to outcome, and in the
reverse direction from outcome to source. Furthermore, EPA has used
biomonitoring data in some of its chemical assessments. For example,
EPA's National Center for Environmental Assessment in the Office of
Research and Development (ORD) used biomonitoring data in the
Integrated Science Assessment for lead (Pb) in support of the Pb NAAQS,
although this is barely noted in the GAO report. In addition, the
Office of Air Quality Planning and Standards (OAQPS) uses biomonitoring
data to estimate risk reductions.
EPA agrees that inter-agency partnerships and their coordination are of
paramount importance. We agree that a coordinated, cross-agency
research strategy should be developed and then implemented. However, we
would recommend that such a strategy be developed under the auspices of
the Office of Science and Technology Policy (OSTP)/National Science and
Technology Council (NSTC) Committee on the Environment and Natural
Resources (CENR), and specifically its Toxics and Risk Subcommittee
(T&R). This is consistent with the CENR's purpose, which is to advise
and assist the NSTC on how to increase the overall effectiveness and
productivity of Federal R&D efforts in the area of the environment and
natural resources. In that regard, the T&R Subcommittee has
successfully established inter-agency workgroups (e.g., Endocrine
Disruptors, Pharmaceuticals in the Environment) in a manner that
obligates Federal agencies to work together to formulate and implement
such national strategies.
With respect to the Draft Report, EPA's comments (enclosed) emphasize
several important issues that are insufficiently addressed or under-
emphasized including: I) the importance of considering assumptions
about human behavior and other factors that impact health risk; 2) the
need to collect biomonitoring data for young children; 3) ongoing
biomarker and Children's Health research in EPA under the Human Health
and Safe Pesticides/Safe Products Research Programs; and 4) an existing
biomonitoring research framework. Specific comments also point out a
few inaccuracies in the report.
EPA agrees that any action to require submission of biomonitoring data
should be informed by an understanding of the legal authority for such
a requirement. However, EPA's assessment of its authority is
necessarily context-specific. Whether EPA may require biomonitoring
data may depend upon variables such as the nature of the biomonitoring
data, the use to which the data will be put, and the state of existing
knowledge that might be advanced through submission of such data, just
to mention a few. Therefore a global assessment of EPA's legal
authority, such as is suggested in the draft report, in advance of a
specific data need may be of limited value to the Agency, and might
even mislead policymakers if they wrongly believe that a particular
authority applies in all circumstances. Rather, as EPA considers the
usefulness of biomonitoring data in specific contexts, the Agency can
determine the extent of its legal authority. Further. EPA can explain
the basis for any data development and/or reporting requirement.
consistent with the statutory requirement. in any regulatory action
requiring such data. EPA typically assesses questions of legal
authority in the context of specific matters and issues, rather than in
the abstract.
However, as indicated in the draft Report, EPA has given some
consideration to the question of authority for requiring submission of
biomonitoring data, and believes that in many cases sufficient
authority already exists. In the event that a lack of authority
regarding a data need is identified. EPA can then more appropriately
address questions regarding additional authority.
Thank you again for the opportunity to comment on this report. If you
have any questions relating to our response, please contact EPA's GAO
Liaison. Bobbie Trent at 02-S66-0983.
Sincerely,
Signed by:
James J. Jones, Acting Assistant Administrator:
Office of Prevention, Pesticides and Toxic Substances:
Signed by:
Lek Kadeli, Acting Assistant Administrator:
Office of Research and Development:
Enclosure:
[End of section]
Appendix IV: GAO Contact and Staff Acknowledgments:
GAO Contact:
John B. Stephenson, (202) 512-3841 and stephensonj@gao.gov:
Staff Acknowledgments:
In addition to the contact named above, Ed Kratzer, Assistant Director;
Elizabeth Beardsley; David Bennett; Antoinette Capaccio; Crystal
Huggins; Karen Keegan; Ben Shouse; and Peter Singer also made important
contributions to this report.
[End of section]
Footnotes:
[1] National Academy of Sciences, Risk Assessment in the Federal
Government: Managing the Process (Washington, D.C.: 1983).
[2] Companies must report on most chemicals covered by TSCA that they
produce above this 25,000-pound threshold during every 5th year. EPA
chose this as a reporting threshold to approximate the premanufacture
low volume exemption threshold described in section 5 of TSCA. This
reporting threshold captures information on chemicals accounting for
most of the total U.S. production volume that is covered by TSCA.
[3] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: January
2009).
[4] EPA excluded certain low volume, controlled exposure uses of PFOS
and PFOS-related chemicals--including certain aspects of semiconductor
manufacture, aviation hydraulics, photography, and fume/mist
suppressant in metal finishing and plating baths--from the definition
of a significant new use.
[5] 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).
[6] GAO, Chemical Regulation: Options Exist to Improve EPA's Ability to
Assess Health Risks and Manage Its Chemical Review Program, [hyperlink,
http://www.gao.gov/products/GAO-05-458] (Washington, D.C.: June 13,
2005).
[End of section]
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