Scale and Capacity Limits in Decentralized FDA Food-Safety Enforcement

Abstract

This paper asks whether regulatory monitoring exhibits nonlinear capacity limits as the scale and complexity of the regulated environment increase. Using a county--year panel of U.S. Food and Drug Administration (FDA) inspections merged with local establishment counts, we identify a sharp breakpoint: beyond a threshold scale, severe inspection findings rise while inspection effort per establishment flattens or declines. The threshold and the post-break deterioration vary across food-related industry groups and shift with proxies for local density and connectedness, consistent with monitoring becoming ``too big to monitor" in more interconnected production environments rather than driven by simple reallocation or delay. Methodologically, we provide a portable breakpoint selection and piecewise-estimation framework that can be applied to other enforcement settings.