Date and Title of Milestone


GAO 2006 Human Health Risk Assessmentg

GAO evaluated EPA’s progress in human risk assessment since release of the 1994 NRC report Science and Judgment. Indicates that EPA has strengthened its risk-assessment process by, for example, increasing planning for assessments, using new methods, developing guidance documents, improving its ability to characterize variability, and initiating steps to address cumulative risk. However, improvements are needed, including in the planning process, training for staff, and transparency in documenting analytic choices.

2006 EPA Changes to development of risk ranges for estimates in IRIS database

Office of Research and Development sets priorities for development of risk ranges for estimates in IRIS chemical risk value database to reflect uncertainty (see Risk Policy Report 2006a,b).

2006 European Parliament passes REACH legislation (Registration, Evaluation and Authorisation of Chemicals)

Sweeping new chemical regulation (REACH) places burden of assessing safety on industry for high-production-volume chemicals.

NRC 2007 Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget

Reviews OMB 2006 and recommends that it be withdrawn. One criticism concerned OMB’s definition of risk assessment as documents that synthesize science. Recommends reverting to NRC Red Book definition as a process involving hazard identification, dose-response assessment, exposure assessment, and risk characterization.

2006 EPA Immunotoxicity Guidelines, In development (personal communication, EPA’s Mary Jane Selgrade 12/15/06)

First-time effort will address challenging subject of immune-system biology and toxicants.

EPA 2006b Framework for Assessing Health Risks of Environmental Exposures to Children

Emphasizes need to account for potential exposures to environmental agents during all stages of development and to consider relevant adverse health outcomes that may occur as a result of such exposures.

EPA SAB 2007 Consultation on Enhancing Risk Assessment Practice and Updating EPA’s Exposure Guidance

The SAB recommends that the Agency “incrementally replace the current system of single-point uncertainty factors with a set of distributions, using probabilistic methods.”

aIncluded are definitions of risk assessment cited in the documents to illustrate the various definitions discussed in Chapter 3.


DeWoskin, R.S., J.C. Lipscomb, C. Thompson, W.A. Chiu, P. Schlosser, C. Smallwood, J. Swartout, L. Teuschler, and A. Marcus. 2007. Pharmacokinetic/physiologically based pharmacokinetic models in integrated risk information system assessments. Pp. 301-348 in Toxicokinetics and Risk Assessment, J.C. Lipscomb, and E.V. Ohanian, eds. New York: Informa Healthcare.

EC (European Commission). 2000. First Report on the Harmonisation of Risk Assessment Procedures [online]. Available: [accessed June 3, 2007].

EPA (U.S. Environmental Protection Agency). 1976. Interim Procedures and Guidelines for Health Risk and Economic Impact Assessments of Suspected Carcinogens. U.S. Environmental Protection Agency, Washington, DC.

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