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U.S. Department of Health and Human Services

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Summary: Regulatory Impact Analysis of Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption

FDA has released for public comment its proposed rule to establish science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. The proposed rule for preventive controls for human food is being published at the same time. The proposed rules build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow. These are two of the proposed rules that are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act.

The proposed produce rule sets science-based standards for the safe production and harvesting of fruits and vegetables to minimize the risk of serious adverse health consequences or death. FDA proposes to set standards associated with identified routes of microbial contamination of produce, including: (1) agricultural water; (2) biological soil amendments of animal origin; (3) health and hygiene; (4) animals in the growing area; and (5) equipment, tools and buildings.

Regulatory Impact Analysis