Regulatory decisions should be made in the most expert and informed way since they are precipitated by real and perceived threats to human health, under the glare of public scrutiny.

In 1994, the National Research Council (NRC) reported that the U.S. Environmental Protection Agency's (USEPA's) overall approach to assessing risks is fundamentally sound, but the Agency must more clearly establish the scientific and policy basis for risk estimates and better communicate the associated uncertainties.

On March 21,1995, USEPA issued a risk characterization policy and guidance.

In this policy, an effective risk characterization must fully and clearly characterize risks and disclose the scientific analysis, uncertainties, assumptions, and science policy that underlie decisions throughout the risk assessment process.

A number of regulatory reform bills which required risk characterization as part of all Federal risk assessments were introduced by the 104th Congress.

The purpose of this workshop was to familiarize Society of Toxicology members with : (1) key elements to be considered in risk characterization and (2) new advances in risk characterization addressed by Federal and State agencies, industry, academia, NRC, and Presidential/Congressional Commission on Risk Assessment and Risk Management. (...)