Public Comments

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Public Interest Comment on the Food and Drug Administration’s Proposed Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

August 12, 2013

The Food and Drug Administration’s (FDA) proposed rule establishing standards for growing, harvesting, packing and holding raw produce does not fully meet its statutory obligations and fails to satisfy the regulatory analysis requirements in Executive Orders 12866 and 13563. The rule’s authorizing statue, the Food Safety Modernization Act (FSMA), requires science-based standards and provision of flexibility to all businesses, especially small businesses. However, the proposed rule relies on highly uncertain data to calculate its benefits, and the current formulation of the rule is likely to have a disproportionately negative impact on the small and very small farms covered by the rule. Furthermore, according to FDA’s Preliminary Regulatory Impact Analysis, the regulatory option chosen in the proposed rule does not maximize net benefits. The comment recommends exempting farms with less than $100,000 in annual sales, removing expensive and relatively ineffective standards from the rule, using more realistic statistical representation to calculate the benefits, and explicitly providing for biannual retrospective review to facilitate future improvements to the rule.