The U.S. Food and Drug Administration (FDA) has published the long-anticipated Pre-Harvest Agricultural Water Final Rule, fulfilling Subpart E of the Food Safety Modernization Act (FSMA) Produce Safety Rule. The rule is intended to enhance the safety of water used for produce cultivation by setting requirements for systems-based, pre-harvest agricultural water assessments to inform hazard identification and risk management decision-making.

The dates for compliance (for non-sprout covered produce) with the final rule are: two years and nine months after the effective date of July 5, 2024 for very small farms, one year and nine months after the effective date for small farms, and nine months after the effective date for all other farms.

The Pre-Harvest Agricultural Water Final Rule assessments are used to identify conditions that are likely to introduce known or foreseeable hazards into or onto produce or food contact surfaces, and to determine whether, and how soon, corrective or mitigating measures must be implemented to minimize risks associated with pre-harvest agricultural water. Farms are required to conduct assessments of their pre-harvest agricultural water annually, and whenever a significant change occurs, to identify any conditions likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces.

Requirements for harvest and post-harvest uses of agricultural water, as well as the agricultural water requirements for sprouts, have not changed. Sprouts are subject to specific pre-harvest agricultural water requirements, for which the compliance date has already passed.

Specifically, the final rule:

  • Establishes requirements for agricultural water assessments that evaluate a variety of factors that are key determinants of contamination risks associated with pre-harvest agricultural water, including an evaluation of the water system, water use practices, crop characteristics, environmental conditions, potential impacts on water from adjacent and nearby land, and other relevant factors
  • Includes testing pre-harvest agricultural water as part of an assessment in certain circumstances
  • Requires farms to implement effective mitigation measures within specific timeframes based on findings from assessments; hazards related to certain activities associated with adjacent and nearby land uses are subject to expedited mitigation
  • Adds new options for mitigation measures, providing farms with additional flexibility in responding to findings from their pre-harvest agricultural water assessments.

The new requirements reflect recent science, findings from investigations of several produce-related outbreaks, and feedback from a variety of stakeholders on the agricultural water requirements in the Produce Safety Rule, which were previously published in 2015. The new final rule will more comprehensively address known routes of microbial contamination that can lead to preventable foodborne illnesses.

Along with publication of the final rule, FDA also released a number of fact sheets, including one that provides an overview of agriculture water assessments and mitigation measures, and another that offers more details on factors for conducting these assessments. FDA also updated the Agriculture Water Assessment Builder. In the future, the agency is planning a webinar for all interested stakeholders, for which registration information will be provided in a forthcoming announcement.

To implement the Pre-Harvest Agricultural Water Final Rule and provide training, FDA intends to work closely with its partners including state regulators, the National Association of State Departments of Agriculture (NASDA), educators, and groups like the Produce Safety Alliance.