Small Farms, Big Costs


by Sofie E. Miller, Senior Policy Analyst, & Cassidy B. West

September 10, 2013

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The Food and Drug Administration recently extended to November 15 the deadline for public comment on its proposed rule, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. This is the second extension, providing the public an unusually long 304 days to comment on the proposed regulation and offer suggestions for its improvement. It is also a welcome opportunity, as the draft rule does not meet statutory and executive requirements and may needlessly harm consumers as well as small farmers domestically and abroad.

The proposed rule, which would implement the Food Safety Modernization Act of 2011 (FSMA), establishes certain standards for farm-grown produce that are intended to reduce the presence of microbiological hazards that can lead to food-borne illness. It includes requirements related to worker training, worker health and hygiene, agricultural water quality, soil treatment, the presence of domesticated animals on produce fields, and for equipment, tools, and buildings.

The FDA estimates the cost of complying with these requirements at $630.18 million per year. It also predicts benefits of $1.04 billion per year; however, the benefit estimates are based on very limited data and unscientific methods. The agency concedes that it probably overstates the likely incidence of food-borne illness in the absence of the proposed regulations, and its estimates of the effectiveness of the proposed requirements at reducing microbial hazards are based on nothing more scientific than surveys of its own staff.

However, even accepting the FDA’s analysis at face value, the proposed rule does not maximize net benefits as required by Executive Orders 12866 and 13563, which require agencies to “select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity).” In its proposal, the FDA rejected alternatives that it estimates would provide more than $100 million in net benefits annually above the benefits of its selected alternative.

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