Daily Rules, Proposed Rules, and Notices of the Federal Government
In support of its mission to protect human health and the environment, the EPA routinely conducts risk assessments on chemical agents that may be toxic to humans. A key component of the risk assessment process involves evaluating the dose-response relationship between exposure to the agent and the observed effect. The dose-response assessment is a two-step process: (1) Defining a point of departure (POD); and (2) extrapolating from the POD for relevance to environmental exposures. Traditionally, the no observed adverse effect level (NOAEL) or lowest observed adverse effect level (LOAEL) methods were used for establishing the POD for noncancer endpoints. The BMD method gained favor within the risk assessment community over time because it incorporates and conveys more information than the NOAEL/LOAEL methods. The EPA conducted workshops and symposia about the application of BMD methodology and the development of relevant guidance.
The BMD document focuses on the use of the BMD methodology for human health risk assessments. The document discusses computation of BMD values and their confidence limits, data requirements, dose-response assessment, and reporting recommendations that are specific to BMD values. Although the EPA has generated its own BMD software (