SPSG #4: The Risk Assessment Paradigm

This chapter is about the Risk Assessment Paradigm (RAP) that was originally introduced to chemical safety in food and the environment as a mechanism for dealing with carcinogens in food. The advantages of the RAP were touted by a 1983 report from the National Academy of Sciences (NAS) that is often referred to as the Redbook. In particular, the RAP was widely heralded as a democratic alternative to the technocratic SAP. This was accomplished by distinguishing a risk assessment process that characterizes what the risks are and a risk management process that uses the information from the risk assessment to make a decision. However, the Redbook version of the RAP had some significant flaws that kept it from really accomplishing the goal of separating science from policy.  Therefore, this book also uses a more basic definition of RAP called "the Guillotine Paradigm", that is predicated on the separation of "Is" from "Ought": The scientific discussion of what is known is a separate endeavor from the policy decision of what ought to be done.  The problems with the Redbook were identified in subsequent NRC reports.  First, the Redbook paradigm begins with a Hazard identification step.  Since this is to be done by scientific experts, it gave them control over what questions are to be answered.  That problem can be addressed by viewing the RAP as an iterative process, where the policy deliberation identifies the questions, and the risk assessment provides the answers.  Veiwing the RAP as a dialogue istead of a monologue opens the decision process up to democratic participation.  Secondly, the Redbook embraced the notion of the “default option”, where theoretical probabilities were to be resolved by giving one theoretical alternative preference as a matter of regulatory policy.  That problem can be solved with a probability tree that acknowledges the theoretical alternatives.  Thirdly, the Redbook paradigm was derived from procedures used at the FDA for dealing with cancer and the Delaney Clause, and it was therefore sometimes interpreted as being applicable only to cancer.  Although the RAP is named after the analytical component, the fact that policymaking (aka Risk Management) is recognized as a distinct process is at least as important.  The RAP is especially indispensable when regulatory decision making requires a rational process where the risk is balanced against something else, such as a benefit, another risk, or the cost of avoiding it.