The 2011 Food Safety Modernization Act (FSMA) ushered in a new federal food safety regime. After a series of disease outbreaks in the United States were linked to foods like carrot juice, peanut butter, bagged spinach, pepper, cookie dough, and even dog food, consensus grew that legal and policy change was needed. Although there was no shortage of disagreement on particulars, consumers, producers, activists, and politicians all agreed on the need for change. One of FSMA’s key principles is an emphasis on prevention. To oversimplify a bit, in the old regime agencies would use establishment-by-establishment inspections to detect safety risks and then use warning letters and enforcement actions to bring the wrongdoers into compliance. Given the number of establishments, the number of inspectors, and resources available to federal inspectors, truly protecting food safety with intermittent inspections is all but impossible. FSMA’s so-called risk-based approach seeks to focus regulatory attention on the points in the production and distribution of food most likely to produce safety problems and to require ex ante development of hazard management plans by each food producer.
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