Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
The FSMA Produce Safety Rule — the first US regulation setting enforceable, science-based standards on farms: growing, harvesting, packing, and holding of produce for human consumption. It covers worker health and hygiene, agricultural water, biological soil amendments of animal origin, domesticated and wild animals, equipment and sanitation, and sprouts. The pre-harvest agricultural water provisions were rebuilt by a final rule of 6 May 2024 around annual systems-based water assessments.
What this does not cover
stated in the document's own scope- Covers farms and covered produce; once activities cross into processing, the facility and its activities fall under Part 117, not Part 112.
- Produce rarely consumed raw (per the rule's list) and produce destined for commercial processing that adequately reduces pathogens can be exempt or eligible for modified requirements.
- The 2024 agricultural-water amendment rewrote pre-harvest water requirements only — sprout water and harvest/post-harvest water requirements were not changed by it.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 112 is the FSMA Produce Safety Rule — the first enforceable federal standards for producing food on farms. It sets requirements for the growing, harvesting, packing, and holding of covered produce across the routes by which contamination actually reaches fresh produce: worker health and hygiene, agricultural water, biological soil amendments of animal origin such as raw manure, domesticated and wild animals in growing areas, equipment, tools and buildings, and — with the strictest requirements in the rule — sprouts. The pre-harvest agricultural water provisions were rewritten by a 2024 final rule that replaced fixed microbial testing criteria with annual, systems-based agricultural water assessments through which farms identify conditions likely to introduce hazards and take risk-based measures.
Scope & applicability
Farms and farm mixed-type facilities growing, harvesting, packing, or holding covered produce for the US market, with exemptions and modified requirements keyed to farm size, sales, and commodity risk (e.g. produce rarely consumed raw). Processing facilities fall under Part 117 instead.
Legal basis & how it acquires force
A regulation issued under the FDA Food Safety Modernization Act's produce-safety mandate (FD&C Act section 419), published as a final rule on 27 November 2015, with the pre-harvest agricultural water requirements of Subpart E replaced by the final rule of 6 May 2024 (effective 5 July 2024, compliance phased from 2025 by farm size). Coverage, exemptions, and modified requirements — including the qualified exemption for small farms selling predominantly to qualified end users — are defined in the rule itself.
Document structure
| Part | Covers |
|---|---|
| Subparts A–B — General provisions and applicability | Covered produce, covered farms, exemptions, and the qualified exemption |
| Subparts C–D — Worker training, health and hygiene | Qualification, training, and hygienic practices for personnel handling covered produce |
| Subpart E — Agricultural water (as amended 2024) | Pre-harvest agricultural water assessments, and quality/testing requirements for harvest and post-harvest water uses |
| Subpart F — Biological soil amendments of animal origin | Treatment processes and application intervals for manure-derived amendments |
| Subparts I–L — Animals, growing areas, equipment and sanitation | Domesticated and wild animal contact, and sanitation of equipment, tools, and buildings |
| Subpart M — Sprouts | The dedicated, stricter regime for sprout operations, including spent sprout irrigation water testing |
Key requirements
- Worker training, health, and hygiene controls (Subparts C–D)
- Agricultural water: annual pre-harvest water assessments identifying conditions likely to introduce hazards (Subpart E as amended 2024)
- Controls on biological soil amendments of animal origin, including treatment and application intervals
- Sanitation of equipment, tools, and buildings used for covered produce
- Dedicated, stricter requirements for sprout operations
Implementation tips
- For pre-harvest water, run the assessment as a living document — it must be redone when anything changes that raises the likelihood of hazard introduction, not just annually
Revision notes
Original final rule 27 November 2015; the pre-harvest agricultural water requirements of Subpart E were replaced by the final rule of 6 May 2024 (effective 5 July 2024, compliance staggered from 2025 by farm size). Sprout and harvest/post-harvest water requirements were not changed by the 2024 rule.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Part 112 is the on-farm member of the FSMA family: Part 117 governs facilities that process food, the FSVP rule (Part 1 Subpart L) makes importers verify foreign produce against the same standard, and intentional-adulteration and sanitary-transport rules complete the set. Internationally, the EU reaches primary production through Annex I of Regulation (EC) 852/2004 and national good-agricultural-practice schemes; Part 112 is distinctive in codifying farm-level requirements as directly enforceable federal law.
21 CFR Part 112: frequently asked questions
Quick answers to common questions about 21 CFR Part 112.
What did the 2024 agricultural water final rule change?
It replaced the pre-harvest microbial water-quality criteria and testing regime for covered produce (other than sprouts) with annual systems-based agricultural water assessments: farms evaluate their water systems, uses, and conditions for hazards, then apply risk-based measures. It became effective 5 July 2024, with compliance dates from April 2025 staggered by farm size.
Which farms are covered by Part 112?
Farms growing, harvesting, packing, or holding covered produce above the rule's sales thresholds. A qualified exemption with modified requirements exists for smaller farms selling predominantly directly to qualified end users, and produce rarely consumed raw or destined for validated pathogen-reducing processing can fall outside the full requirements.
Why do sprouts have their own subpart?
Because the warm, wet sprouting environment grows pathogens as effectively as sprouts. Subpart M imposes the rule's strictest requirements, including treatment of seeds, environmental monitoring for Listeria, and testing of spent sprout irrigation water — and the 2024 water amendment deliberately left the sprout requirements unchanged.
How does Part 112 relate to Part 117?
They divide the supply chain: Part 112 governs farms and on-farm activities within the farm definition; Part 117 governs facilities that manufacture, process, pack, or hold food. A farm mixed-type facility can be subject to both, each for the activities in its lane.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.