The proposed regulation is designed to meet Section 105(a) of the FDA Food Safety and Modernization Act (FSMA) requirement that “not later than 1 year after enactment, the Secretary . . . shall publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.”
The FDA argues that the proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. It would address microbiological risks from all agricultural inputs (people, agricultural water, biological soil amendments, and tools and equipment), from unsanitary conditions in buildings, and from contact with wild and domesticated animals during growing, harvesting, packing, and holding activities of covered produce, including sprouts intended for human consumption. The primary benefit of the provisions in this rule is an expected decrease in the incidence of illnesses relating microbial contamination of produce.
I argue that the FDA needs to conduct a more comprehensive analysis. There is insufficient effort to establish the current state of food safety practices and little to no connection is made between those practices and public health. The FDA has not even presented a careful economic modeling of what an optimal set of rules for food safety practices would look like. Rather, the FDA wants to impose a “shotgun” approach on all covered foods rather than one that focuses on those foods or farms that pose the greatest risks. The FDA has acknowledged that it is required by law, by the Food Safety Modernization Act, to pass these standards. However, it is also required by OMB guidelines to analyze options that are not currently legal so as to inform the President and Congress when there are more efficient ways of solving a particular social problem than Congress had envisioned. The FDA should rethink its proposed regulation since there is little to suggest that it is the most efficient or effective option to improve public health.