A Review of the Reference Dose and Reference Concentration Processes (External Review Draft)

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The RfD/RfC Technical Panel was established in response to a request from the Agency's 10X Food Quality Protection Act Task Force to the Science Policy Council and the Risk Assessment Forum. A draft toxicology report developed by the 10X Task Force raised a number of issues that relate to the derivation of the oral reference dose (RfD) and inhalation reference concentration (RfC). The Science Policy Council and the Risk Assessment Forum agreed that these issues should be examined on a broader scale than just for pesticides, with input from various program offices within the Agency and from the outside scientific/policy community. This charge was expanded by the Forum to include a more in-depth review of a number of issues related to the RfD/RfC process, in part because of several other Forum activities that were underway (e.g., development of the Framework for the Harmonization of Cancer and Noncancer Risk Assessment, revision of the Benchmark Dose Guidance Document, and revision of the Guidelines for Carcinogen Risk Assessment). In addition, the RfD/RfC derivation process had not been evaluated in detail for a number of years, and several scientific issues concerning children's health, e.g., neurotoxicity and immunotoxicity, have become increasingly important in risk assessment. These activities have prompted the need to re-examine the RfD/RfC process and to coordinate these efforts with other related activities. In particular, it was important that efforts continue to focus on moving toward the goal of harmonization of risk assessment approaches for all health endpoints and making efficient use of animal testing to achieve this goal.

The draft report entitled, A Review of the Reference Dose and Reference Concentration Processes is not a guidance document but represents an analysis of the current RfD/RfC processes. The draft report summarizes the review and deliberations of the Technical Panel and presents a number of recommendations to improve the RfD/RfC processes. The review further documents recommendations that should be considered in the implementation of changes in the current process and/or development of needed guidance.


U.S. EPA. A Review of the Reference Dose and Reference Concentration Processes (External Review Draft). U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, EPA/630/P-02/002A, 2002.

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