What do these changes mean for me?
The U.S. Food and Drug Administration (FDA) has issued a final rule that revises certain pre-harvest agricultural water requirements for covered produce (other than sprouts) in Subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule.
The final rule requires covered farms to conduct systems-based, pre-harvest agricultural water assessments to identify hazards and inform risk management decisions.
What you need to know
All Agricultural Water: Growers must inspect the entire water system under their control (pre-harvest, harvest, and post-harvest) at the beginning of the season. This includes the water source, the extent of the grower’s control, and how each source is protected. For surface water sources, growers must consider whether use of adjacent or nearby land could introduce food safety hazards into the water before it reaches the farm.
Pre-Harvest Agricultural Water: Farms must evaluate and document specific factors that are reasonably likely to introduce known or reasonably foreseeable hazards onto produce or food-contact surfaces. Farms are required to perform a documented agricultural water assessment at least once annually, or whenever a significant change occurs.
Based on assessment results, farms may be required to implement corrective or mitigation measures to reduce contamination risk of covered produce or food-contact surfaces as a result of the use of pre-harvest agricultural water. FDA provides a chart that summarizes these measures.
The Final Rule also requires supervisory review of the written pre-harvest agricultural water assessment, including determinations made from its findings.
What is agricultural water?
Agricultural water refers to water used in covered activities on covered produce when the water is intended to, or is likely to, come into contact with covered produce or food-contact surfaces.
This includes water used during growing, harvesting, packing, and holding.
Harvest and Post-Harvest Water: Used for washing, cooling, making ice, transport, or handwashing after harvest.
Pre-Harvest Water: Used during growing, e.g., for irrigation or pesticide application.
What is covered produce?
According to FSMA Produce Safety Rule, covered produce includes most fruits and vegetables that are typically eaten raw, such as peppers, onions, and lettuce.
Does the final rule apply to you?
As it stands now, the FDA is following an “education before regulation” approach, giving farmers time to adapt to the new water requirements.
While the rule officially took effect July 5, 2024, farms have until the following deadlines to comply:
Large farms (>$500,000): April 7, 2025
Small farms ($250,000 - $500,00): April 6, 2026
Very small farms ($25,000 - $250,000): April 5, 2027
Any covered farm that uses agricultural water in a way that contacts covered produce or food-contact surfaces must comply with Subpart E.
Some exemptions to this rule apply, such as when your pre-harvest water is from a municipal system that has been tested and meets safety standards.
*The FSMA Final Rule does not change harvest/post-harvest water requirements.
Additional Resources
- FSMA Final Rule on Pre-harvest Agricultural Water Fact Sheet
- Annual Agricultural Water Assessments and Risk-Based Outcomes
- Frequently Asked Questions: Agricultural Water Requirements under the FSMA Produce Safety Rule
- FDA and EPA Announce First Registered Pre-Harvest Agricultural Water Treatment
- Webinar on the FSMA Final Rule on Pre-Harvest Agricultural Water – May 20, 2024
This program is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U2FFD007432. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.