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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 
Teflon® 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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