The history of statistics in statistically valid regulation

This paper uses the introduction at the US Food and Drug Administration of dose-response extrapolation for ascertaining toxicity between 1950 and 1980 to analyse the negotiations between statistical knowledge and regulation. Those statistical methods enabled experimental results to be translated into a 'safe dose' of a substance for human consumption, but different methods continued to give different estimates of effects, and there was little basis for determining which methods were most accurate. I argue that statisticians were not proposing their discipline so much as a tool for mechanical decision making than as a set of methods for establishing a regulatory procedure that made assumptions and judgements visible. Consequently, their use did not bring debates about low-dose toxicity to a close even as they promoted a regulatory ethos and enabled regulators to act, even in cases of inherent uncertainty and inescapable variability.