Codifying the Risk Assessment–Risk Management Framework

Abstract

to different degrees. By the early 1980s, the notion of risk encapsulated a first design, according to which the agency produces decisions that are adjusted to the level of risk, determined by toxicological and statistical analysis and concurring policy assumptions about the nature of these risks. This design was embodied by cancer risk assessment methods. It was advanced by a fringe of the agency’s scientists and adopted by a couple of its programs. It materialized in guidelines and improved communication between scientists, who were calculating the risks and estimating the hazards, and the various other actors involved in writing rules and standardseconomists, policy analysts, lawyers, or office chiefs. Another design, a commensurative one, aimed at comprehensively reviewing agency activities against risk, cost, and benefit indicators, with a view to taking control over the agenda of the agency’s offices in order to produce a more controlled and integrated image of what the agency was addressing. One design responded to industry judicial challenges against the ban of its chemicals, using the uncertainty surrounding carcinogenesis; the other tried to limit controversies stemming from the application of various risk criteria by separate regulatory offices to similar chemical conditions. At the end of the 1980s, the risk assessment guidelines developed by the EPA— as well as other agencies— sparked more controversy. They displaced the legitimacy problem of the agency. It was no longer an issue of whether the agency had the authority to ban chemicals, but whether its mode of reasoning and making decisions about chemicals was right. For the chemical industry, these guidelines embodied an overly conservative and stringent regulatory philosophy of risk elimination, producing many false positives, and the action on cancer and chemicals was misguided. The chemical 4 Codifying the Risk Assessment– Risk Management Framework