FDA Sends OMB Proposed Rule on Produce Safety Standards
The Food and Drug Administration has submitted to the Office of Management and Budget a proposed rule required by the Food Safety Modernization Act (FSMA) that would establish and publish 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, at risk of contamination and serious adverse health consequences or death.
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Based on prevention. The proposed rule will be based on prevention-oriented public health principles and incorporate what FDA have learned in the past decade since the agency issued general good agricultural practice guidelines entitled "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables" (GAPs Guide). The proposed rule also will reflect comments received on the agency's 1998 update of its GAPs guide and its July 2009 draft commodity specific guidances for tomatoes, leafy greens, and melons.
Modern standards. Although the proposed rule will be based on recommendations that are included in the GAPs guide, FDA does not intend to make the entire guidance mandatory. FDA's proposed rule would, however, set out clear standards for implementation of modern preventive controls. The proposed rule also would emphasize the importance of environmental assessments to identify hazards and possible pathways of contamination and provide examples of risk reduction practices recognizing that operators must tailor their preventive controls to particular hazards and conditions affecting their operations.
Guidance to industry. The requirements of the proposed rule would be scale appropriate and commensurate with the relative risks and complexity of individual operations. FDA intends to issue guidance to assist industry in complying with the requirements of the new regulation.
(Proposed rule submitted to OMB on December 9, 2011.)