May 2, 2024

FDA Publishes the Final Rule on Agricultural Water

On May 2 the U.S. Food and Drug Administration (FDA) announced the release of the Final Rule for Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water. The entirely of Final Rule is available at the Federal Register.

This Final Rule replaces certain pre-harvest agricultural water requirements for covered produce in the 2015 produce safety rule. Table 3 – located on page 44 of the Rule- includes a Summary of Changes Made to Subpart E Requirements since the 2015 Produce Safety Final Rule.

The Final Rule now contains these key requirements for pre-harvest water:

  • Replacing the microbial quality criteria and test requirement in the 2015 final rule. The focus of the Final Rule will be on conducting pre-harvest assessments for hazard identification. This includes evaluation of:
    • Water System: Location of the water source ground or surface water, type of delivery system, protection against contamination
    • Water Practices: Application of water (spray vs. drip irrigation)
    • Crop characteristics: Suspensibility for adhesion and internalization.
    • Environmental conditions such as heavy rain or extreme weather.
    • Impacts from adjacent land use
  • Inclusion of a requirement to test pre-harvest agricultural water in certain circumstances for generic coli to help inform agricultural water assessment.
  • A requirement to expedite the implementation of mitigation measures for known or reasonably foreseeable hazards related to certain adjacent land uses.
    • These must be implemented promptly, and no later than the same growing season as the assessment or reassessment.
  • Inclusion of additional mitigation measures
  • Requirement management review of pre-harvest agricultural water assessments
  • Adding a definition of agricultural water assessment and agricultural water system.

Compliance Dates:

  • For very small farms: Two years, nine months after the effective date of the Final Rule
  • For small farms: One year, nine months after the effective date of the Final Rule
  • For all other farms: Nine months after the effective date of the Final Rule

Additional resources pertaining to the rule can be found here:

FDA Constituent Update

FSMA Final Rule on Pre-Harvest Agricultural Water

FDA Fact Sheet

The Western Growers Science Team will share additional resources surrounding the Final Rule in the next few days. For additional information or questions, contact WG Science at [email protected].