Biomonitoring: EPA Needs to Coordinate Its Research Strategy and Clarify Its Authority to Obtain Biomonitoring Data

According to EPA officials, the Office of Research and Development's Chemical Safety for Sustainability Research (CSS) Program implements EPA's integrated biomonitoring research which addresses the needs of EPA's Program Offices and provides science for EPA to respond to GAO's recommendations. These officials indicated that the main biomonitoring research priority within the EPA CSS program studies is not to engage in a chemical by chemical approach but to study how chemicals interact with humans and the environment, and what biomarkers and bioindicators of these interactions impact key biological events that lead to adverse effects. These adverse effects may be such things as reproductive and developmental toxicity and cancer. While EPA has identified the purpose of the research as identifying the biomarkers and bioindicators that are relevant to an adverse outcome pathway (AOP), these elements address the general intent of our recommendation. Agency officials indicated that. AOPs provide an approach to evaluating all the existing information concerning the linkage between an event at the molecular level and an adverse outcome at a biological level that may be relevant to risk assessment. They added that the identification of key biomarkers and bioindicators will be used to develop models to predict chemical exposure and hazard and to help evaluate chemicals for potential risks to human health and the environment.

According to EPA officials, the agency has identified federal partners and efforts that it can leverage to address the development of a comprehensive biomonitoring research strategy. By building on the recent National Academy of Sciences report on Exposure Science in the 21st Century, the Toxics and Risk (T&R) Subcommittee of the Office of Science and Technology Policy (OSTP)'s Committee on the Environment and Natural Resources (CENR) has established an interagency workgroup to examine priorities and opportunities for collaboration to address those priorities. EPA officials indicated that a charter is under review by the workgroup which will be chaired by EPA with vice chairs from CDC, NIEHS and DoD. Also, EPA is continuing its work under the agency's own Biomonitoring Workgroup comprised of senior scientists from the agency's program and regional offices. These officials indicate that EPA's meetings provide an opportunity to discuss CDC's Human Biomonitoring Program (as part of NHANES) as well as the status on chemicals in which the agency has an interest. These various coordination efforts address the intent of our recommendation to leverage available resources for the creation and interpretation of biomonitoring research.

EPA officials indicated that as the agency considers the usefulness of biomonitoring data in specific contexts, it can determine the extent of its legal authority. These officials believe that assessment of its legal authority is necessarily context-specific. Whether EPA may require biomonitoring data may depend upon variables such as the nature of the data, how the data will be used, and how submission of such data may advance existing knowledge. Further, EPA officials stated that they can explain the basis for any data development and/or reporting requirement, consistent with the statutory requirement, in any regulatory action requiring such data. In considering the question of authority for requiring submission of biomonitoring data, EPA officials indicated that they believe that in many cases sufficient authority exists. Where a lack of authority regarding a data need is identified, EPA officials acknowledged the need to address questions regarding additional authority and the possibility of an assessment of EPA authority to collect such data, consistent with the general intent of our recommendation.