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.