Risk Characterization: A Bridge to Informed Decision Making,

Abstract

identification, dose-response assessment, human exposure Risk Characterization: A Bridge to Informed Decision Making. assessment) that is relevant to human risk. Each question Ohanian, E. V., and Moore, J. A. (1997). Fundam. Appl. Toxicol. calls for analysis and interpretation of available studies, se-39, 81-88.lection of the concepts and data that are most scientifically Regulatory decisions should be made in the most expert and reliable and most relevant to the problem at hand, and scieninformed way since they are precipitated by real and perceived tific conclusions regarding the question presented. Risk charthreats to human health, under the glare of public scrutiny. In acterization is the summarizing step of risk assessment. The 1994, the National Research Council (NRC) reported that the U.S. risk characterization integrates information from the preced-Environmental Protection Agency's (USEPA's) overall approach ing components of the risk assessment and synthesizes an to assessing risks is fundamentally sound, but the Agency must overall conclusion about risk that is complete, informative, more clearly establish the scientific and policy basis for risk estiand useful for decision makers or risk managers. According mates and better communicate the associated uncertainties. On to the March 1995 Risk Characterization Policy and Guid-March 21, 1995, USEPA issued a risk characterization policy andance (Ohanian, 1995; USEPA, 1995 USEPA, , 1996, each risk characguidance. In this policy, an effective risk characterization must terization should be prepared in a manner that is clear, transfully and clearly characterize risks and disclose the scientific analysis, uncertainties, assumptions, and science policy that underlie parent, reasonable, and consistent with other risk characterdecisions throughout the risk assessment process. A number of izations of similar scope prepared by the USEPA. Risk regulatory reform bills which required risk characterization as part assessors are charged with (1) generating a credible, objecof all Federal risk assessments were introduced by the 104th Contive, realistic, and scientifically balanced analysis; and (2) gress. The purpose of this workshop was to familiarize Society of explaining confidence in each assessment by clearly deline-Toxicology members with: (1) key elements to be considered in ating strengths, limitations, uncertainties, default assumprisk characterization and (2) new advances in risk characterization tions, along with the impacts of these factors on the overall addressed by Federal and State agencies, industry, academia, assessment. Since every assessment carries uncertainties, a NRC, and Presidential/Congressional Commission on Risk Assesssimplified numerical presentation of health risk is always ment and Risk Management. Furthermore, the main objective was incomplete and often misleading. Characterizing risk to to engage the audience in discussing the proper role of science include qualitative information should be encouraged to in risk assessment-risk management...

Risk Analysis, Decision Analysis, Causal Analysis, and Economics: A Personal Perspective from More Than 40 years Experience

“…In my judgment, the Commission's report had much in common with the Orange Book in advocating two-way communication with stakeholders, and an iterative six-stage process leading to evaluation of decision alternatives. See the Society of Toxicology Workshop report on Risk Communication from 1997 (Ohanian et al, 1997), and the article by Omenn (2003) in the HERA special issue on the Red Book. Sadly, the commission did not continue its work after this report, and its influence on EPA and other agencies was not large and lasting.…”

Risk Characterization for Nanotechnology

“…It should discuss the quality of these data and any ancillary information used such as pharmacokinetics 1 and the approach used to assess the scientific evidence (e.g., weight of evidence). 2 From the exposure assessment, there should be a description of the concentration of the hazardous substance (nanomaterials) in the product, human intake on a body-weight basis, the route(s) of exposure (i.e., oral, inhalation, absorption), and the frequency and duration of exposure. It should discuss which populations were studied, including populations that are highly exposed.…”

“….The principle is generalizable to most risk assessment and management situations. (2) For some products and technologies, the precautionary approach does not guarantee that society will be safer overall for some types of risks. This is particularly the case when new technologies or products not only improve our overall well-being but, more specifically, reduce existing risks.…”

“…Pharmacokinetics is the study of the bodily absorption, distribution, metabolism, and excretion of drugs 2. A weight-of-evidence evaluation takes into account the strengths and weaknesses of different measurement methods when determining whether the results show that a stressor has caused, or could cause, a harmful environmental effect.…”