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. In addition, some legislation is based on the default  assumption that children may be more sensitive to chemicals than adults. EPA Has Made Limited Use of Biomonitoring Data to Assess Risks Posed by Chemicals

EPA makes limited use of current biomonitoring studies because such  studies cover relatively few chemicals, and EPA rarely knows whether the  measured amounts in people indicate a risk to human health. The CDC’s biomonitoring program provides the most comprehensive  biomonitoring data relevant to the U.S. population. As a result, EPA has made few changes to its  chemical risk assessments or safeguards in response to the recent  proliferation of biomonitoring data. 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. EPA Lacks a Comprehensive Research Strategy and Has Taken Limited Steps to Improve the Usefulness of Biomonitoring Data

EPA has several biomonitoring research projects under way, but the  agency has no system in place to track progress or assess the resources  needed specifically for biomonitoring research. A national biomonitoring research plan could help better coordinate  research and link data needs with collection efforts. 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. However, EPA does not routinely collect this  information. EPA’s Authority to Obtain Biomonitoring Data under TSCA Is Untested and May Be Limited

EPA’s authorities under TSCA to obtain biomonitoring data are generally  untested. 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. . . 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. 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. These challenges also  affect EPA’s ability to require that chemical companies provide  biomonitoring data. 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. Recommendations for Executive Action

To ensure that EPA effectively obtains the information needed to integrate  biomonitoring into its chemical risk assessment and management  programs, coordinates with other federal agencies, and leverages available  resources for the creation and interpretation of biomonitoring research,  we recommend that the EPA Administrator take the following two actions:    Develop a comprehensive biomonitoring research strategy that includes  the data EPA needs to incorporate biomonitoring information into  chemical risk assessment and management activities, identifies federal  partners and efforts that may address these needs, and quantifies the time  frames and resources needed to implement the strategy. Of the 23 VCCEP  chemicals, EPA has received what it deems to be sufficient data for only   6 chemicals. Approximately  3,000 chemicals meet this criterion.
Why GAO Did This Study

Biomonitoring, which measures chemicals in people's tissues or body fluids, has shown that the U.S. population is widely exposed to chemicals used in everyday products. Some of these have the potential to cause cancer or birth defects. Moreover, children may be more vulnerable to harm from these chemicals than adults. The Environmental Protection Agency (EPA) is authorized under the Toxic Substances Control Act (TSCA) to control chemicals that pose unreasonable health risks. GAO was asked to review the (1) extent to which EPA incorporates information from biomonitoring studies into its assessments of chemicals, (2) steps that EPA has taken to improve the usefulness of biomonitoring data, and (3) extent to which EPA has the authority under TSCA to require chemical companies to develop and submit biomonitoring data to EPA.

What GAO Found

EPA has made limited use of biomonitoring data in its assessments of risks posed by commercial chemicals. One reason is that biomonitoring data relevant to the entire U.S. population exist for only 148 of the over 6,000 chemicals EPA considers the most likely sources of human or environmental exposure. In addition, biomonitoring data alone indicate only that a person was somehow exposed to a chemical, not the source of the exposure or its effect on the person's health. For most of the chemicals studied under current biomonitoring programs, more data on chemical effects are needed to understand if the levels measured in people pose a health concern, but EPA's ability to require chemical companies to develop such data is limited. Thus, the agency has made few changes to its chemical risk assessments or safeguards in response to the recent increase in available biomonitoring data. While EPA has initiated several research programs to make biomonitoring more useful to its risk assessment process, it has not developed a comprehensive strategy for this research that takes into account its own research efforts and those of the multiple federal agencies and other organizations involved in biomonitoring research. EPA does have several important biomonitoring research efforts, including research into the relationships between exposure to harmful chemicals, the resulting concentration of those chemicals in human tissue, and the corresponding health effects. However, without a plan to coordinate its research efforts, EPA has no means to track progress or assess the resources needed specifically for biomonitoring research. Furthermore, according to the National Academy of Sciences, the lack of a coordinated national research strategy has allowed widespread chemical exposures to go undetected, such as exposures to flame retardants. The development of such a strategy could enhance biomonitoring research and link data needs with collection efforts. EPA has not determined the extent of its authority to obtain biomonitoring data under TSCA, and this authority is untested and may be limited. The TSCA provision that authorizes EPA to require companies to develop data focuses on the health and environmental effects of chemicals. Since biomonitoring data alone may not demonstrate the effects of a chemical, EPA may face difficulty in using this authority to obtain biomonitoring data. It may be easier for EPA to obtain biomonitoring data under other TSCA provisions, which allow EPA to collect existing information on chemicals. For example, TSCA obligates chemical companies to report information that reasonably supports the conclusion that a chemical presents a substantial risk of injury to health or the environment. EPA asserts that biomonitoring data are reportable if the chemical in question is known to have serious toxic effects and biomonitoring information indicates a level of exposure previously unknown to EPA. EPA took action against a chemical company under this authority in 2004. However, the action was settled without an admission of liability by the View GAO-09-353 or key components. company, so EPA's authority to obtain biomonitoring data remains untested.