On May 2, 2024, the United States Food and Drug Administration (FDA) published a final rule, The Pre-Harvest Agricultural Water Final Rule, which fulfills Subpart E of the Food Safety Modernization Act (FSMA) Produce Safety Rule. The new approach emphasizes system-based assessments to identify hazards and make decisions based on risk management. The rule will go into effect on July 5, 2024.
Overview of Changes:
- Covered farms (farms which are required to comply with all Produce Safety Rule requirements) that use pre-harvest agricultural water for covered produce (other than sprouts) must annually conduct agricultural water assessments. Additionally, covered farms need to conduct agricultural water assessments whenever there is a significant change in their operation that increases the likelihood of a known or reasonably foreseeable hazard being introduced into or onto covered produce or food contact surfaces.
- Factors to consider during agricultural water assessments:
- Agricultural water systems: location of water source, type of water distribution system, and the degree to which the system is protected from contamination (including other uses of the water system, animal impacts, and human/animal waste)
- Agricultural water practices: application method and time interval between last application of agricultural water and harvest of produce
- Crop characteristics: susceptibility of produce surface to adhesion or internalization of hazards
- Environmental conditions: frequency of heavy rain, air temperatures, UV exposure
- Other relevant factors, such as results of testing
- Farms must implement effective mitigation measures within specific timeframes based on the findings from their agricultural water assessments. There are also new options for mitigation measures, so farms have more options in how to respond to findings from their pre-harvest agricultural water assessments.
- Management must review the written pre-harvest agricultural water assessment and the determinations that were made based on the outcomes of the assessment.
The new rule does not change requirements for harvest and post-harvest agricultural water nor for the agricultural requirements for sprouts.
The compliance dates for the final rule are based on farm size:
- Very small farms: April 5, 2027
- Small farms: April 6, 2026
- Large farms: April 7, 2025
For more information on the final rule as well as well as a link to the Federal Register Notice, please see the FDA website.