The Red Book: A Reassessment of Risk Assessment

Abstract

The risk assessment process as spelled out in the National Research Council's (NRC's) report Risk Assessment in the Federal Government: Managing the Process, called the “Red Book,” has created a framework for incorporation of toxicology into environmental decision-making that has withstood the test of time. However, the time has come for a reassessment of this framework. Risk assessment is often unsuccessful as a public health tool when data are limited and it does not, in itself, provide an incentive for the generation of new data. The risk assessment framework did not envision the need to develop formal methods for the incorporation of precautionary approaches into the formal regulatory/analytical process. This needs to be addressed, as we see a widening gulf in approaches between the U.S. and Europe. Likewise, the process has not provided a clear road map for the utilization of epidemiology and health tracking information to guide environmental regulation. Finally, the concept of separating the intellectual exercise of risk assessment from the process of risk management and decision-making, while sound, has been misused such that scientists have been excluded from aspects of the regulatory process, to the detriment of the quality of decisions. The essay concludes that it is time for a fundamental reexamination of the process to address these public health issues.

Keywords:

• risk assessment
• risk management
• Red Book
• National Research Council
• regulatory approaches.