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. 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. EPA Has Made Limited Use of Biomonitoring Data in Assessing Risks Posed by Chemicals

EPA has made limited use of biomonitoring data in its assessments of risks  posed by chemicals. 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. 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. 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. 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 Taken Steps to Improve the Usefulness of Biomonitoring Data but Lacks a Comprehensive Research Strategy

EPA has several biomonitoring research projects under way, but the  agency has no system in place to track progress or assess the resources  needed specifically for biomonitoring research. 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. 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. However, though EPA agreed with our recommendation, th agency still lacks such a comprehensive strategy to guide its own research efforts. EPA’s Authority to Obtain Biomonitoring Data under TSCA Is Untested and May Be Limited

EPA has not determined the extent of its authority to obtain biomonitoring  data under TSCA, and this authority is generally untested and may be  limited. However,  biomonitoring data indicate only the presence of a chemical in a person’s  body and not its impact on the person’s health. 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. 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. 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.
Why GAO Did This Study

Biomonitoring, which measures chemicals in people's tissues or body fluids, has shown that the U.S. population is widely exposed to chemicals used in everyday products. Some of these have the potential to cause cancer or birth defects. Moreover, children may be more vulnerable to harm from these chemicals than adults. The Environmental Protection Agency (EPA) is authorized under the Toxic Substances Control Act (TSCA) to control chemicals that pose unreasonable health risks. One crucial tool in this process is chemical risk assessment, which involves determining the extent to which populations will be exposed to a chemical and assessing how this exposure affects human health This testimony, based on GAO's prior work, reviews the (1) extent to which EPA incorporates information from biomonitoring studies into its assessments of chemicals, (2) steps that EPA has taken to improve the usefulness of biomonitoring data, and (3) extent to which EPA has the authority under TSCA to require chemical companies to develop and submit biomonitoring data to EPA.

What GAO Found

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