Introduction

This factsheet outlines the update on Subpart E pre-harvest agricultural water releases in 2024 and requirements for post-harvest activities, according to the Food Safety Modernization Act (FSMA) Produce Safety Rule, published in 2015.

Pre-harvest agricultural water refers to water used during growing activities, such as for irrigation, and crop protection sprays.

On May 6, 2024, the U.S. Food and Drug Administration (FDA) published a final rule regarding pre-harvest agricultural water provision for those crops covered under (other than sprouts) Subpart E of the FSMA Produce Safety Rule.

The new rule introduces systems-based assessments, at least once annually. Assessments help to identify hazards, as well and allow growers to make informed risk management decisions. These decisions are aimed at minimizing potential risks associated with pre-harvest agricultural water, replacing previous microbial quality criteria and testing requirements.

The requirements for pre-harvest and post-harvest uses of agricultural water, and the agricultural water requirements for sprouts have not changed. Sprouts are subject to specific pre-harvest agricultural water requirements, and the compliance dates for sprouts requirements have passed.

Agricultural Water Assessment

As part of pre-harvest agricultural water assessments, farms covered under the Act are required to evaluate certain factors, once annually (or on any occasion in the event of a significant change) that could elevate risk due to known or reasonably foreseeable hazards into or onto produce, or food contact surfaces.

• Agricultural water system(s): Location and nature of the water source (groundwater, surface water, etc.); The type of water distribution system (open or closed to the environment); the degree to which the system is protected from possible sources of contamination, including other users of water system, animal impacts (grazing, working, or animal intrusion), adjacent land use, application of biological soil amendments of animal origin (BSAAO), or untreated or improperly treated human waste.
• Agricultural water practices: The type of application method (such as overhead sprinkler, drip irrigation, farrow); the time between last application of agricultural water and harvest of the covered produce.
• Crop characteristics: Aspects that make produce covered under the Act vulnerable to contamination, such as susceptibility to surface adhesion or internalization of microbial hazards (such as physical damage from weather events, biological damage, physical characteristics of the produce, growth characteristics.)
• Environmental conditions: Frequency of heavy rain, or extreme weather events and their impact on the water system, or that may impact per damage produce. Damage can increase susceptibility to contamination; air temperature; UV exposure (sun).
• Other relevant factors: If applicable, test results to inform the assessment.

Outcomes

Based on assessments findings, farms covered under the Act must evaluate and determine if mitigation or corrective actions need to be implemented, to reduce potential contamination of applicable produce or food contact surfaces.

FSMA Final Rule on Pre-harvest and Post-harvest

Agricultural Water

Exemptions

The final rule exempts covered farms from conducting a pre-harvest agricultural water assessment if they demonstrate:

• Their pre-harvest agricultural water meets requirements that apply for harvest and post-harvest agricultural water (microbial quality criterion and testing requirements, prohibition of untreated surface water, and if applicable, the testing requirements for untreated groundwater);
• That agricultural water, received from a public water system or supply, meets requirement established in the rule (provided that the farm has public water system results or certificates of compliance demonstrating that the water meets relevant requirements);
• Agricultural water is treated in accordance with the standards outlined in the Produce Safety Rule.
• Reasonably likely that the quality of the water will not change prior to the use of the agricultural water (how the water is held, stored or moved).

Compliance Dates

The rule is effective 60 days after publication of the final rule, and establishes compliance dates for pre-harvest agricultural water provisions for non-sprout covered produce as follows. The effective dates was July 5, 2024.

*Final Rule does not change harvest/post-harvest water requirements.

Harvest and post-harvest agricultural water refers to water used in harvesting, packing, and holding activities (such as water used to prevent dehydration), for transport, cooling, and washing. This includes water used to make ice that contacts applicable produce, or food contact surfaces, and water used for handwashing during and after harvest activities.

In July 2022, the FDA announced dates for the end of the intended enforcement discretion period for harvest and post-harvest agricultural water requirements for applicable produce other than sprouts.

• What dates should covered farms be aware of regarding the end of the intended enforcement discretion period for the harvest and post-harvest requirements in Subpart E?

These dates, as listed on the right chart, are staggered by farm size:

• What are the Produce Safety Rule requirements for harvest and post-harvest agricultural water?

Water specifically used for harvest and post-harvest must meet the requirements in Subpart E – Agricultural water $ 112.44 (a) Microbial quality criterion. Growers must ensure there is no detectable generic E. coli in 100 milliliters (mL) of agricultural water, and not use untreated surface water for any of these purposes:

1. Used as sprout irrigation.
2. Used during or after harvest activities in a manner that directly contacts covered produce.
3. Used to contact food contact surfaces or to make ice that will contact food contact surfaces.
4. Used for washing hands during and after harvest activities.

More information is available regarding the requirements applied to agricultural water use in harvesting, packing, and holding applicable produce.

Resources

Food and Drug Administration (FDA). 2024. FSMA Final Rule on Pre-Harvest Agricultural Water. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-pre-harvest-agricultural-water

Food and Drug Administration (FDA). 2023. Requirements for Harvest and Post-Harvest Agricultural Water in Subpart E for Covered Produce Other than Sprouts https://www.fda.gov/food/food-safety-modernization-act-fsma/requirements-harvest-and-post-harvest-agricultural-water-subpart-e-covered-produce-other-sprouts

• UConn Extension Food Safety
• CT DoAg Produce Safety
• fda.gov/FSMA

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