Regulatory decisions should be made in the most expert and informed wa
y since they are precipitated by real and perceived threats to human h
ealth, under the glare of public scrutiny. In 1994, the National Resea
rch Council (NRC) reported that the U.S. Environmental Protection Agen
cy's (USEPA's) overall approach to assessing risks is fundamentally so
und, but the Agency must more clearly establish the scientific and pol
icy basis for risk estimates and better communicate the associated unc
ertainties. On March 21, 1995, USEPA issued a risk characterization po
licy 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 regulat
ory reform bills which required risk characterization as part of all F
ederal risk assessments were introduced by the 104th Congress. The pur
pose 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 Sta
te agencies, industry, academia, NRC, and Presidential/Congressional C
ommission on Risk Assessment and Risk Management. Furthermore, the mai
n objective was to engage the audience in discussing the proper role o
f science in risk assessment-risk management interface to make informe
d decisions in the face of scientific uncertainty. (C) 1997 Society of
Toxicology.