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FDA Releases FSMA Final Rule on Pre-Harvest Agricultural Water (Subpart E)

Written by Claire Murphy, School of Food Science, WSU Integrated Agriculture Research and Extension Center. June 5, 2024

On May 6, 2024, the Food and Drug Administration (FDA) published a final rule on pre-harvest agricultural water. The final rule replaces requirements for covered produce (other than sprouts) in the 2015 Produce Safety Rule with new requirements for systems-based, pre-harvest agricultural water assessments to inform hazard identification and risk management decision-making.

The New Rule

The new rule establishes the requirement for annual agricultural water assessments where farms are required to evaluate a variety of factors that could impact contamination risks associated with pre-harvest agricultural water:

  • water system (e.g., ground vs surface, open or closed to the environment)
  • water use practices (e.g., sprinkler or spray vs drip vs furrow)
  • crop characteristics (e.g., susceptibility of internalization)
  • environmental conditions (e.g., air temperatures, extreme weather events)
  • impacts from adjacent and nearby land (e.g., animal activity)
  • other relevant factors (e.g., testing results)

Based on their agricultural water assessments, covered farms must determine if corrective actions or mitigation measures are necessary:

Type of action needed

Corrective Actions

    • Agricultural water is not safe or is not of adequate sanitary quality for intended use.

Mitigation Measures

    • There is one or more known or reasonably foreseeable hazards.

When to implement

Corrective Actions

    • Immediately discontinue use and take corrective measures before resuming use of the water for pre-harvest activities.

Mitigation Measures

    • If foreseeable hazards are related to animal activity, biological soil amendments of animal origins, or untreated or improperly treated human waste on adjacent or nearby land then implement mitigation measures no later than the same growing season.
    • If foreseeable hazards are not related to animal activity, BSAAOs, or untreated or improperly treated human waste then implement mitigation measures no later than the following year.

Allow actions or measures

Corrective Actions:

    • Re-inspecting the entire affected agricultural water, making necessary changes and taking adequate measures to determine if your changes were effective (e.g., identify and remove dead animal from water system).
    • Treating agricultural water.

Mitigation Measures:

    • Make necessary changes
    • Increase the time interval between the last direct application of agricultural water and harvest of the covered produce to allow for microbial die-off, provided there is relevant supporting scientific data
    • Increase the time interval between harvest and end of storage to allow for microbial die-off, provided there is relevant supporting scientific data
    • Change the water application method
    • Treating agricultural water

The dates for compliance with the final rule are:

  • Large Farms (>$500,000 average annual produce sales): April 7, 2025
  • Small Farms ($250,000 – $500,000 average annual produce sales): April 6, 2026
  • Very Small Farms ($25,000 – $250,000 average annual produce sales): April 5, 2027

Resources:

Contact

Claire Murphy professional photo
Claire Murphy
School of Food Science, WSU Integrated Agriculture Research and Extension Center
claire.murphy@wsu.edu
509-786-9201


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