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FDA Finalizes Ag Water Rule
Tuesday, May 7, 2024
  • On May 2, 2024, FDA published a final rule on agricultural water to enhance produce safety. The rule, titled Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water, amends the agricultural water provisions of the 2015 produce safety regulation by replacing microbial criteria and testing requirements for pre-harvest water with a systems-based assessment approach.
  • As we have previously blogged, FDA issued the proposed rule in December 2021 followed by an announcement in January 2022 that the Agency would exercise enforcement discretion for agricultural water requirements for covered produce other than sprouts.
  • 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 the water system, water use practices, crop characteristics, environmental conditions, potential impacts of 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 the assessments.
    • Adds new options for mitigation measures, providing additional flexibility in responding to findings from pre-harvest agricultural water assessments.
  • The rule also finalizes compliance dates as follows:
    • 2 years and 9 months after the effective date for very small farms;
    • 1 year and 9 months after the effective date for small farms;
    • 9 months after the effective date for all other farms.
  • The final rule is effective July 5, 2024.
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