The U.S. Food and Drug Administration (FDA) published its long-awaited regulations on pre-harvest agricultural water in summer 2024, representing an important evolution of the agency’s stance toward water safety management on farms. Released July 5, the final rule amends existing provisions within the Food Safety Modernization Act’s Produce Safety Rule. The change represents a significant shift from strict microbial quality criteria to a more nuanced, systems-based assessment approach, with the goal of supporting food safety by addressing contamination risks through a more adaptive and comprehensive framework.
FDA’s final rule introduces a notable departure from previous regulations on pre-harvest water safety. Rather than putting into place stringent microbial quality standards for farms, the rule mandates a systems-based approach for pre-harvest agricultural water assessments. The new approach requires farmers and inspectors to consider a more expansive set of factors that could impact water safety, including the design of water distribution systems and potential contamination risks from water sources and other external sources.
“The new systems-based approach allows us to tailor our education and compliance strategies to the specific characteristics of each farm,” said Emily Harris, Program Manager for the New Mexico Department of Agriculture. “Instead of relying on a universal standard, the rule will give us the flexibility to really think about the unique factors that influence water quality on each farm, in each county, in each state.”
As part of the holistic monitoring and compliance framework, farms will need to assess whether their water systems are protected from contamination, which will require them to consider land use in neighboring areas and potential livestock operations that could affect the water sources used on their farm. By addressing some of these external conditions, FDA has signaled a shift toward more preventive measures and management of external environmental risk.
While FDA has yet to announce its rollout of the new rule, the agency has offered initial guidance on what actions farmers should take to stay in compliance with the rule. First, FDA will require an annual assessment of agricultural water systems on each farm. If a farm identifies an issue, it must take corrective actions to address the identified contamination or water safety risk before it can continue use of the water source.
“The new rule emphasizes the need for ongoing, preventive management on farms,” said Joe Reardon, Senior Director of Food Safety Programs at the National Association of State Departments of Agriculture (NASDA) Foundation. “By requiring regular, annual assessments and encouraging quick responses to correct contamination risks, the FDA is creating an increased emphasis on education and training instead of penalization.”
The deadline for compliance with the new rule is staggered depending on the size of farms. Large farms must comply with the rule by April 7, 2025, small farms by April 6, 2026, and very small farms by April 5, 2027. These deadlines are intended to provide enough time for FDA to create a strategic rollout and allow state departments of agriculture to form education and outreach programs. The staggered deadlines will also help farms adapt to the new requirements and implement necessary changes to their operations and testing.
