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Summary: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Final Rule)

The rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. The rule addresses microbiological risks from certain routes of contamination, including workers, agricultural water, biological soil amendments of animal origin, buildings, tools and equipment and sanitation, and wild and domesticated animals. The rule also includes specific requirements for sprouts.  Using a science-based framework, we characterized the public health risks associated with the consumption of produce and are establishing specific provisions that address the risks of microbial contamination from these routes of contamination. The primary benefits of the provisions in this rule are an expected decrease in the incidence of illnesses related to microbial contamination of produce. Annualizing benefits over the first ten years after the effective date of this final rule at seven percent, benefits are expected to derive from averting approximately 331,964 illnesses per year (362,059 at three percent), valued at $925 million annually ($976 million at three percent). Similarly, annualized costs, estimated at seven percent, are expected to be approximately $366 million annually ($387 million at three percent).Additionally, annualized costs for foreign farms are estimated to be approximately $138 million annualized at seven percent ($146 million at three percent).

Regulatory Impact Anaysis

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Final Rule) (PDF - 1763KB)

Federal Register Notice

Docket: FDA–2011–N–0921disclaimer icon

Page Last Updated: 11/13/2015
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