Biomonitoring: EPA Needs to Coordinate Its Research Strategy and Clarify Its Authority to Obtain Biomonitoring Data
Published: 2009-04-30T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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.
subsections: section_title: Background
paragraphs: 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. 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.
section_title: EPA Has Made Limited Use of Biomonitoring Data to Assess Risks Posed by Chemicals
paragraphs: 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. 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.
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.
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.
section_title: EPA Lacks a Comprehensive Research Strategy and Has Taken Limited Steps to Improve the Usefulness of Biomonitoring Data
paragraphs: 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. 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.
section_title: EPA’s Authority to Obtain Biomonitoring Data under TSCA Is Untested and May Be Limited
paragraphs: 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.
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. 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  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. “. . . 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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 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.
section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: 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.
section_title: Appendix II: Information on Selected EPA Programs to Gather Chemical Data
paragraphs: 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.
section_title: Appendix III: Comments from the Environmental Protection Agency
section_title: Appendix IV: GAO Contact and Staff Acknowledgments
subsections: section_title: Staff Acknowledgments
paragraphs: 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.