US FSMA: 21 CFR Part 112 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule)

What US FSMA: 21 CFR Part 112 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule) requires

the US FSMA produce safety rule (Produce Safety Rule) establishes minimum science-based standards for the safe growing, harvesting, packing, and holding of produce for human consumption on farms. the relevant subpart requires personnel qualifications and training; the relevant subpart covers health and hygiene; the relevant subpart sets agricultural water standards including microbial water quality criteria; the relevant subpart addresses biological soil amendments of animal origin; the relevant subpart covers domesticated and wild animals; the relevant subpart covers growing/harvesting/packing/holding activities; the relevant subpart addresses equipment, tools, buildings, and sanitation; the relevant subpart covers sprouts (additional pathogen testing requirements); the relevant subpart requires records retained minimum 2 years. The rule applies to farms growing covered produce with annual food sales above the qualified-exemption threshold. Major industry impact includes mandatory agricultural water testing, training of personnel and supervisors per FDA-recognised curriculum, and recordkeeping aligned with FDA inspection.

Pillar: Agriculture & Agritech · Authority: US Food and Drug Administration (FDA), Department of Health and Human Services · Version: 1.0.0 · Last updated: 2026-05-30

Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-112

SHA-256 integrity: f271a9d602f961f977dce11ae416a34be1d2b98ba185be7c3da63d045a401c8b

Primary Citations — 7 traced to source

• 21 CFR Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, final rule 27 November 2015 (80 FR 74353)
• FSMA Final Rule on Standards for Agricultural Water (88 FR 27074, May 2023) - revised agricultural water requirements

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