Biomonitoring: EPA Could Make Better Use of Biomonitoring Data
Published: 2010-02-04T00:00:00

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. One crucial tool in this process is chemical risk assessment, which involves determining the extent to which populations will be exposed to a chemical and assessing how this exposure affects human health This testimony, based on GAO's prior work, reviews the (1) extent to which EPA incorporates information from biomonitoring studies into its assessments of chemicals, (2) steps that EPA has taken to improve the usefulness of biomonitoring data, and (3) extent to which EPA has the authority under TSCA to require chemical companies to develop and submit biomonitoring data to EPA.
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 212 chemicals. In addition, biomonitoring data alone indicate only that a person was somehow exposed to a chemical, not the source of the exposure or its effect on the person's health. For most of the chemicals studied under current biomonitoring programs, more data on chemical effects are needed to understand if the levels measured in people pose a health concern, but EPA's authorities to require chemical companies to develop such data is limited. However, in September 2009, the EPA Administrator set forth goals for updated legislation to give EPA additional authorities to obtain data on chemicals. While EPA has initiated several research programs to make biomonitoring more useful to its risk assessment process, it has not developed a comprehensive strategy for this research that takes into account its own research efforts and those of the multiple federal agencies and other organizations involved in biomonitoring research. EPA does have several important biomonitoring research efforts, including research into the relationships between exposure to harmful chemicals, the resulting concentration of those chemicals in human tissue, and the corresponding health effects. However, without a plan to coordinate its research efforts, EPA has no means to track progress or assess the resources needed specifically for biomonitoring research. Furthermore, according to the National Academy of Sciences, the lack of a coordinated national research strategy has allowed widespread chemical exposures to go undetected, such as exposures to flame retardants. While EPA agreed with GAO's recommendation that EPA develop a comprehensive research strategy, the agency has not yet done so. EPA has not determined the extent of its authority to obtain biomonitoring data under TSCA, and this authority is untested and may be limited. The TSCA section that authorizes EPA to require companies to develop data focuses on health and environmental effects of chemicals. However, biomonitoring data indicate only the presence of a chemical in the body, not its impact on health. It may be easier for EPA to obtain biomonitoring data under other TSCA sections, which allow EPA to collect existing information on chemicals. For example, TSCA obligates chemical companies to report information that reasonably supports the conclusion that a chemical presents a substantial risk of injury to health or the environment. EPA asserts that biomonitoring data are reportable if a chemical is known to have serious toxic effects and biomonitoring data indicates a level of exposure previously unknown to EPA. EPA took action against a chemical company under this authority in 2004. However, the action was settled without an admission of liability by the company, so EPA's authority to obtain biomonitoring data remains untested. GAO's 2009 report recommended that EPA clarify this authority, but it has not yet done so. The agency did not disagree, but commented that a case-by-case explanation of its authority might be more useful than a global assessment.

section_title: Letter
paragraphs: I am pleased to appear here today to discuss EPA’s use of biomonitoring  data. Biomonitoring, which measures chemicals in people’s tissues or  body fluids, has shown that the U.S. population is widely exposed to  chemicals used in everyday products. Some of these have the potential to  cause cancer or birth defects. Moreover, children may be more vulnerable  to harm from these chemicals than adults because their biological  functions are still developing and their size and behavior may expose them  to proportionately higher doses.
The mission of the Environmental Protection Agency (EPA) is to protect  human health and the environment. To help EPA achieve this objective,  the Toxic Substances Control Act (TSCA) authorizes it to regulate the  manufacture, processing, and distribution of chemicals. A crucial tool in  this regulatory process is chemical risk assessment, which involves  determining the extent to which populations will be exposed to a chemical  and assessing how this exposure affects human health. EPA uses such risk  assessments to determine if it needs to take any risk management actions,  such as prohibiting or restricting the manufacture, processing, or  distribution of a chemical.
A recent proliferation of biomonitoring data has provided new insights  into the general population’s exposure to chemicals. Biomonitoring  studies for certain chemicals, such as lead, have been ongoing for decades,  but recent advances in analytic methods have allowed scientists to  measure more chemicals in smaller concentrations. This is a promising  development. According to the Centers for Disease Control and  Prevention (CDC), “biomonitoring measurements are the most health- relevant assessments of exposure because they measure the amount of the  chemical that actually gets into people from all environmental sources,  such as the air, soil, water, dust, or food combined.” The CDC conducts  the most comprehensive biomonitoring program in the country, and in  December 2009 it published the fourth in a series of reports on the  concentrations of certain chemicals or their by-products in a  representative sample of the U.S. population. For example, the CDC  reported that 90 percent of the people tested had detectable levels of  Bisphenol A (BPA). BPA is an industrial chemical that has been present in  many hard plastic bottles and metal-based food and beverage cans since  the 1960s. On the basis of results from recent studies using novel  approaches to test for subtle effects, the Food and Drug Administration  announced in January of this year that it and the National Toxicology  Program at the National Institutes of Health (NIH) have some concern  about the potential effects of BPA on the brain, behavior, and prostate  gland in fetuses, infants, and young children.
My testimony today is based on our prior work on federal biomonitoring  efforts and discusses EPA’s use of current biomonitoring studies, EPA’s  biomonitoring research strategy, and EPA’s authorities under TSCA to  obtain biomonitoring data. Specifically, my statement addresses (1) the  extent to which EPA incorporates information from biomonitoring studies  into its assessments of chemicals, (2) steps that EPA has taken to improve  the usefulness of biomonitoring data, and (3) the extent to which EPA has  the authority under TSCA to require chemical companies to develop and  submit biomonitoring data to EPA. Our prior work was conducted in  accordance with generally accepted government auditing standards. Those  standards require that we plan and perform the audit to obtain sufficient,  appropriate evidence to provide a reasonable basis for our findings and  conclusions based on our audit objectives. We believe that the evidence  obtained provides a reasonable basis for our findings and conclusions  based on our audit objectives.
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. While,  biomonitoring has been used to monitor chemical exposures for decades,  more recently, advances in analytic methods have allowed scientists to  measure more chemicals, in smaller concentrations, using smaller samples  of blood or urine. As a result, biomonitoring has become more widely used  for a variety of applications, including public health research and  measuring the impact of certain environmental regulations, such as the  decline in blood lead levels following declining levels of gasoline lead.
CDC conducts the most comprehensive biomonitoring program in the  country under its National Biomonitoring Program and published the first,  second, third and fourth National Report on Human Exposure to  Environmental Chemicals—in 2001, 2003, 2005, and 2009, respectively— which reported the concentrations of certain chemicals or their by- products in the blood or urine of a representative sample of the U.S.  population. For each of these reports, the CDC has increased the number  of chemicals studied—from 27 in the first report, to 116 in the second, to  148 in the third, and to 212 in the fourth. Each report is cumulative  (containing all the results from previous reports). These reports provide  the most comprehensive assessment to date of the exposure of the U.S.  population to chemicals in our environment including such chemicals as  acrylamide, arsenic, BPA, triclosan, and perchlorate. These reports have  provided a window into the U.S. population’s exposure to chemicals, and  the CDC continues to develop new methods for collecting data on  additional chemical exposures with each report.
For decades, government regulators have used risk assessment to  understand the health implications of commercial chemicals. Researchers  use this process to estimate how much harm, if any, can be expected from  exposure to a given contaminant or mixture of contaminants and to help  regulators determine whether the risk is significant enough to require  banning or regulating the chemical or other corrective action.  Biomonitoring research is difficult to integrate into this risk assessment  process, since estimates of human exposure to chemicals have historically  been based on the concentration of these chemicals in environmental  media and on information about how people are exposed. Biomonitoring  data, however, provide a measure of internal dose that is the result of  exposure to all environmental media and depend on how the human body  processes and excretes the chemical.
section_title: EPA Has Made Limited Use of Biomonitoring Data in Assessing Risks Posed by Chemicals
paragraphs: EPA has made limited use of biomonitoring data in its assessments of risks  posed by chemicals. As we previously reported, one major reason for the  agency’s limited use of such data is that, to date, there are no  biomonitoring data for most commercial chemicals. The most  comprehensive biomonitoring effort providing data relevant to the entire  U.S. population includes only 212 chemicals, whereas EPA is currently  focusing its chemical assessment and management efforts on the more  than 6,000 chemicals that companies produce in quantities of more than  25,000 pounds per year at one site. Current biomonitoring efforts also  provide little information on children. Large-scale biomonitoring studies  generally omit children because it is difficult to collect biomonitoring data  from them. For example, some parents are concerned about the  invasiveness of taking blood samples from their children, and certain other  fluids, such as umbilical cord blood or breast milk, are available only in  small quantities and only at certain times. Thus, when samples are  available from children, they may not be large enough to analyze.
A second reason we reported for the agency’s limited use of biomonitoring  data is that EPA often lacks the additional information needed to make  biomonitoring studies useful in its risk assessment process. In this regard,  biomonitoring provides information only on the level of a chemical in a  person’s body but not the health impact. The detectable presence of a  chemical in a person’s blood or urine does not necessarily mean that the  chemical causes harm. While exposure to larger amounts of a chemical  may cause an adverse health impact, a smaller amount may be of no health  consequence. In addition, biomonitoring data alone do not indicate the  source, route, or timing of the exposure, making it difficult to identify the  appropriate risk management strategies. For most of the chemicals studied  under current biomonitoring programs, more data on chemical effects are  needed to understand whether the levels measured in people pose a health  concern, but EPA’s ability to require chemical companies to develop such  data is limited. As a result, EPA has made few changes to its chemical risk  assessments or safeguards in response to the recent proliferation of  biomonitoring data. For most chemicals, EPA would need additional data  on the following to incorporate biomonitoring into risk assessment: health  effects; the sources, routes, and timing of exposure; and the fate of a  chemical in the human body. However, as we have discussed in prior  reports, EPA will face difficulty in using its authorities under TSCA to  require chemical companies to develop health and safety information on  the chemicals. In January 2009, we added transforming EPA’s process for  assessing and controlling toxic chemicals to our list of high-risk areas  warranting attention by Congress and the executive branch.  Subsequently, the EPA Administrator set forth goals for updated  legislation that would give EPA the mechanisms and authorities to  promptly assess and regulate chemicals.
EPA has used some biomonitoring data in chemical risk assessment and  management, but only when additional studies have provided insight on  the health implications of the biomonitoring data. For example, EPA was  able to use biomonitoring data on methylmercury—a neurotoxin that  accumulates in fish—because studies have drawn a link between the level  of this toxin in human blood and adverse neurological effects in children.  EPA also used both biomonitoring and traditional risk assessment  information to take action on certain perfluorinated chemicals. These  chemicals are used in the manufacture of consumer and industrial  products, including nonstick cookware coatings; waterproof clothing; and  oil-, stain-, and grease-resistant surface treatments.
section_title: EPA Has Taken Steps to Improve the Usefulness of Biomonitoring Data but Lacks a Comprehensive Research Strategy
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. For example, EPA  awarded grants that are intended to advance the knowledge of children’s  exposure to pesticides through the use of biomonitoring and of the  potential adverse effects of these exposures. The grants issued went to  projects that, among other things, investigated the development of less  invasive biomarker than blood samples—such as analyses of saliva or hair  samples—to measures of early brain development. Furthermore, EPA has  studied the presence of an herbicide in 135 homes with preschool-age  children by analyzing soil, air, carpet, dust, food, and urine as well as  samples taken from subject’s hands. The study shed important light on  how best to collect urine samples that reflect external dose of the  herbicide and how to develop models that simulate how the body  processes specific chemicals. Nonetheless, EPA does not separately track  spending or staff time devoted to biomonitoring research. Instead, it  places individual biomonitoring research projects within its larger Human  Health Research Strategy. While this strategy includes some goals relevant  to biomonitoring, EPA has not systematically identified and prioritized the  data gaps that prevent it from using biomonitoring data. Nor has it  systematically identified the resources needed to reach biomonitoring  research goals or the chemicals that need the most additional  biomonitoring-related research.
Also, EPA has not coordinated its biomonitoring research with that of the  many agencies and other groups involved in biomonitoring research,  which could impair its ability to address the significant data gaps in this  field of research. In addition to the CDC and EPA, several other federal  agencies have been involved in biomonitoring research, including the U.S.  Department of Health and Human Service’s Agency for Toxic Substances  and Disease Registry, entities within the U.S. Department of Health and  Human Service’s NIH, and the U.S. Department of Labor’s Occupational  Safety and Health Administration. Several states have also initiated  biomonitoring programs to examine state and local health concerns, such  as arsenic in local water supplies or populations with high fish  consumption that may increase mercury exposure. Furthermore, some  chemical companies have for decades monitored their workforce for  chemical exposure, and chemical industry associations have funded  biomonitoring research. Finally, some environmental organizations have  conducted biomonitoring studies of small groups of adults and children,  including one study on infants.
As we previously reported, a national biomonitoring research plan could  help better coordinate research and link data needs with collection  efforts. 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 Academies of Science found that the  lack of a coordinated research strategy allowed widespread exposures to  go undetected, including exposure to flame retardants known as  polybrominated diphenyl ethers—chemicals which may cause liver  damage, among other things, according to some toxicological studies. The  academy noted that a coordinated research strategy would require input  from various agencies involved in biomonitoring and supporting  disciplines. In addition to EPA, these agencies include the CDC, NIH, the  Food and Drug Administration, and the U.S. Department of Agriculture.  Such coordination could strengthen efforts to identify and possibly  regulate the sources of the exposure detected by biomonitoring, since the  most common sources—that is, food, environmental contamination, and  consumer products—are under the jurisdiction of different agencies.
We have recommended that EPA develop a comprehensive research  strategy to improve its ability to use biomonitoring in its risk  assessments. However, though EPA agreed with our recommendation, th agency still lacks such a comprehensive strategy to guide its own research efforts. In addition, we recommended that EPA establish an interagency  e  task force that would coordinate federal biomonitoring research effor across agencies and leverage available resources. If EPA determines that  further authority is necessary, we stated that it should request that the  Executive Office of the President establish an interagency task force to  coordinate such efforts. Nonetheless, EPA has not established such an  interagency task force to coordinate federal biomonitoring research, nor  has it informed us that it has requested the Executive Office of the  President do so.
section_title: EPA’s Authority to Obtain Biomonitoring Data under TSCA Is Untested and May Be Limited
paragraphs: EPA has not determined the extent of its authority to obtain biomonitoring  data under TSCA, and this authority is generally untested and may be  limited. Several provisions of TSCA are potentially relevant. For example,  under section 4 of TSCA EPA can require chemical companies to test  chemicals for their effects on health or the environment.  However,  biomonitoring data indicate only the presence of a chemical in a person’s  body and not its impact on the person’s health. EPA told us that  biomonitoring data may demonstrate chemical characteristics that would  be relevant to a chemical’s effects on health or the environment and that  the agency could theoretically require that biomonitoring be used as a  methodology for developing such data. EPA’s specific authority to obtain  biomonitoring data in this way is untested, however, and EPA is only  generally authorized to require the development of such data after meeting  certain threshold risk requirements that are difficult, expensive, and time- consuming. EPA may also be able to indirectly require the development of  biomonitoring data using the leverage it has under section 5(e) of TSCA,  though it has not yet attempted to do so. Under certain circumstances,  EPA can use this section to seek an injunction to limit or prohibit the  manufacture of a chemical. As an alternative, EPA sometimes issues a  consent order that subjects manufacture to certain conditions, including  testing, which could include biomonitoring. While EPA may not be  explicitly authorized to require the development of such test data under  this section, chemical companies have an incentive to provide the  requested test data to avoid a more sweeping ban on a chemical’s  manufacture. EPA has not indicated whether it will use section 5(e)  consent orders to require companies to submit biomonitoring data.
Other TSCA provisions allow EPA to collect existing information on  chemicals that a company already has, knows about, or could reasonably  ascertain. For example, section 8(e) requires chemical companies to  report to EPA any information they have obtained that reasonably  supports the conclusion that a chemical presents a substantial risk of  injury to health or the environment. EPA asserts that biomonitoring data  are reportable as demonstrating a substantial risk if the chemical in  question is known to have serious toxic effects and the biomonitoring data  indicate a level of exposure previously unknown to EPA. Industry has  asked for more guidance on this point, but EPA has not yet revised its  guidance. Confusion over the scope of EPA’s authority to collect  biomonitoring data under section 8 (e) is highlighted by the history leading  up to an EPA action against the chemical company E. I. du Pont de  Nemours and Company (DuPont). Until 2000, DuPont used the chemical  PFOA to make Teflon®. In 1981, DuPont took blood from several female  workers and two of their babies. The levels of PFOA in the babies’ blood  showed that PFOA had crossed the placental barrier. DuPont also tested  the blood of twelve community members, 11 of whom had elevated levels  of PFOA in their blood. DuPont did not report either set of results to EPA.  After EPA received the results from a third party, DuPont argued that the  information was not reportable under TSCA because the mere presence of  PFOA in blood did not itself support the conclusion that exposure to  PFOA posed any health risks. EPA subsequently filed two actions against  DuPont for violating section 8(e) of TSCA by failing to report the  biomonitoring data, among other claims. DuPont settled the claims but did  not admit that it should have reported the data. However, based on the  data it had received, EPA conducted a subsequent risk assessment, which  contributed to a finding that PFOA was “likely to be carcinogenic to  humans.” In turn, this finding contributed to an agreement by DuPont and  others to phase out the use of PFOA by 2015. However, EPA’s authority to  obtain biomonitoring data under section 8(e) of TSCA remains untested in  court.
Given the uncertainties regarding TSCA authorities, we have  recommended that EPA should determine the extent of its legal authority  to require companies to develop and submit biomonitoring data under  TSCA. We also recommended that EPA request additional authority from  Congress if it determines that such authority is necessary. If EPA  determines that no further authority is necessary, we recommended that it  develop formal written policies explaining the circumstances under which  companies are required to submit biomonitoring data. However, EPA has  not yet attempted a comprehensive review of its authority to require the  companies to develop and submit biomonitoring data. The agency did not  disagree with our recommendation, but commented that a case-by-case  explanation of its authority might be more useful than a global assessment.  However, we continue to believe that an analysis of EPA’s legal authority  to obtain biomonitoring data is critical.
Mr. Chairman, this concludes my prepared statement. I would be pleased  to respond to any questions that you or other Members of this  Subcommittee may have.
section_title: GAO Contact and Staff Acknowledgements
paragraphs: For further information about this testimony, please contact John B.  Stephenson at (202) 512-3841 or stephensonj@gao.gov. Contact points for  our Offices of Congressional Relations and Public Affairs may be found on  the last page of this statement. Contributors to this testimony include  David Bennett, Antoinette Capaccio, Ed Kratzer, and Ben Shouse.
This is a work of the U.S. government and is not subject to copyright protection in the  United States. The published product may be reproduced and distributed in its entirety  without further permission from GAO. However, because this work may contain  copyrighted images or other material, permission from the copyright holder may be  necessary if you wish to reproduce this material separately.