FDA Draft Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

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Draft Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption[附网盘链接]是FDA于过去发布的FDA标准，适用于US。

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Draft-Not for Implementation I. Introduction In the Federal Register of November 27, 2015, we published a final rule titled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (80 FR 74353) (Produce Safety Rule). The Produce Safety Rule established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption and is part of our implementation of the FDA Food Safety Modernization Act (FSMA). This draft guidance is intended to help the owner, operator, or agent in charge of a covered farm (i.e., “you”) to comply with the requirements of the Produce Safety Rule. FDA's guidance documents, including this draft guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required. II. Background Produce is usually grown outdoors in soil, with influences from weather and other environmental factors, and often does not receive treatment after harvesting that adequately removes pathogens that can cause human illness (referred to in this draft guidance as microorganisms of public health significance). Therefore, we place emphasis on preventive measures throughout growing, harvesting, packing, and holding produce to reduce the incidence of contamination of produce that can lead to foodborne illness. The Produce Safety Rule established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption. The rule requires covered farms to take appropriate measures to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, covered produce, including those measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into covered produce, and to provide reasonable assurances that the produce is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). (21 CFR 112.11). Requirements of the rule focus on major routes of contamination, including: health and hygiene; agricultural water; biological soil amendments of animal origin; domesticated and wild animals; equipment, tools, buildings and sanitation; and related topics that include personnel qualifications and training; growing, harvesting, packing, and holding activities; and sprouts. This draft guidance relates to compliance and implementation of the following subparts of the Produce Safety Rule: • Subpart A–General Provisions; • Subpart C–Personnel Qualifications and Training; • Subpart D–Health and Hygiene; • Subpart F–Biological Soil Amendments of Animal Origin and Human Waste; • Subpart I–Domesticated and Wild Animals;

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