Pre-Harvest Agricultural Water
The Pre-Harvest Agricultural Water rule of 2024 replaced the Produce Safety rule's microbial testing requirements for water used before harvest with an annual, systems-based water assessment, and it carries the last FSMA compliance dates still to fall for produce farms.
- What it is
- FSMA final rule
- Where it lives
- 21 CFR part 112, subpart E
- Final rule
- May 2024
- Effective
- July 5, 2024
- Published by
- U.S. Food and Drug Administration
Who it covers
Farms already covered by the Produce Safety rule that use agricultural water before harvest on covered produce other than sprouts. The requirements for harvest and post-harvest water, and the water requirements for sprouts, were not changed by this rule.
What it requires
The original 2015 rule set numeric microbial criteria for pre-harvest water and a testing regime to prove them. Growers said the regime could not be applied across the range of real water systems, and the FDA agreed. This rule replaces the criteria and the testing with an assessment: once a year, and again whenever a significant change raises the likelihood of a hazard, a covered farm must evaluate its water system, its water practices, the crop, the environment and any other relevant factor including test results, and decide whether corrective or mitigation measures are needed and how soon.
The factors are specific. Where the water comes from and whether the system is open or closed; other users of the system, animal impacts and nearby land uses; the application method and the interval between the last application and harvest; how susceptible the crop is to surface adhesion or internalisation; rain, extreme weather, temperature and sun exposure. A hazard found in the water system that is associated with animal activity, soil amendments or human waste on adjacent land calls for expedited mitigation.
In the FDA’s words
“Specifically, this rule replaces the previous microbial quality criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts) with requirements for systems-based, pre-harvest agricultural water assessments for hazard identification and risk management decision-making purposes.”
A numeric standard with a testing regime became an annual assessment. That is the whole of the change, and it is why the compliance dates were reset.
“Covered farms - those that are subject to the requirements in the Produce Safety Rule - that use pre-harvest agricultural water for covered produce (other than sprouts) are required to conduct agricultural water assessments once annually, and whenever a significant change occurs that increases the likelihood that a known or reasonably foreseeable hazard will be introduced into or onto produce or food contact surfaces.”
Once a year and after any significant change: the same two triggers a food safety plan reanalysis has under part 117.
Compliance dates
| Who | Date |
|---|---|
| Large farms, nine months after the effective date | April 7, 2025 |
| Small farms, one year and nine months after the effective date | April 6, 2026 |
| Very small farms, two years and nine months after the effective date | April 5, 2027 |
The dates are the FDA’s, as stated on FSMA Final Rule on Pre-Harvest Agricultural Water, updated 2025-09-30, read 2026-09-16. Compliance dates have been extended before; check that page before planning against any of them.
Exemptions
A farm need not conduct the assessment for pre-harvest water that already meets the harvest and post-harvest requirements, including the prohibition on untreated surface water and the microbial quality criterion; or that comes from a public water system with results or certificates to show it meets the rule; or that is treated to the rule's standards. In each case the quality must be reasonably unlikely to change before the water is used.
Where it is in 21 CFR
The rule is codified at 21 CFR part 112, subpart E, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. Title 21 is a work of the United States government and in the public domain, so the regulation is reproduced in full on this site. These are the sections a reader of this page most often needs.
- 21 CFR Part 112102Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
- § 112.41What requirements apply to the quality of my agricultural water?: the general water requirement
- § 112.43What requirements apply to assessing agricultural water used in growing covered produce (other than sprouts)?: the agricultural water assessment
- § 112.44What requirements apply to agricultural water used as sprout irrigation water and in harvesting, packing, and holding covered produce?: harvest and post-harvest water
What goes wrong in practice
A rule describes the controls; the FDA’s recall records are what happened where a control was missing. These are the hazards and the kinds of food whose records this rule is most often written against.
Questions
- What changed in the 2024 agricultural water rule?
- The microbial quality criteria and the testing requirements for pre-harvest agricultural water on covered produce other than sprouts were replaced with a requirement for a written, systems-based agricultural water assessment, conducted annually and after any significant change, to identify hazards and decide whether corrective or mitigation measures are needed. Harvest and post-harvest water requirements, and the sprout requirements, did not change.
- When do farms have to comply with the pre-harvest agricultural water requirements?
- The rule took effect on July 5, 2024. Large farms had to comply by April 7, 2025, small farms by April 6, 2026, and very small farms by April 5, 2027.
The other FSMA rules
FSMA is enforced as 10 rules, and a single business frequently sits under several. The Act itself, and how the rules fit together.
- Preventive Controls for Human Food21 CFR part 117
- Preventive Controls for Animal Food21 CFR part 507
- Produce Safety21 CFR part 112
- Foreign Supplier Verification Programs21 CFR part 1, subpart L
- Accredited Third-Party Certification21 CFR part 1, subpart M
- Sanitary Transportation of Human and Animal Food21 CFR part 1, subpart O
- Mitigation Strategies to Protect Food Against Intentional Adulteration21 CFR part 121
- Requirements for Additional Traceability Records for Certain Foods21 CFR part 1, subpart S
- Laboratory Accreditation for Analyses of Foods21 CFR part 1, subpart R
An inspection under this rule asks for the records behind each requirement, and finding them is the work. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.