FDA Publishes FSMA Preharvest Agricultural Water Final Rule

In a significant development aimed at enhancing the safety of fresh produce, the U.S. Food and Drug Administration (FDA) has finalized a new rule under the Food Safety Modernization Act (FSMA) that revises preharvest agricultural water standards for covered produce, excluding sprouts. This new rule marks a pivotal shift from prescriptive microbial quality criteria and testing requirements to a more flexible, systems-based approach for conducting preharvest agricultural water assessments. This change is designed to identify hazards and manage risks more effectively, reflecting advancements in agricultural water use and safety science.

Introduction to the New FSMA Preharvest Agricultural Water Rule

The final rule focuses on improving public health protections by enabling more feasible and adaptable implementations across diverse agricultural water systems. It builds on recent scientific insights, feedback from various stakeholders, and lessons learned from investigations into produce-related outbreaks. Unlike the previous regulations, the new rule emphasizes a systems-based risk management approach to agricultural water assessments, replacing the earlier prescriptive testing models.

Key Components of the Final Rule

Systems-Based Agricultural Water Assessments

Under the new rule, farms covered by the FSMA Produce Safety Rule are required to perform detailed agricultural water assessments annually or when significant changes occur that could increase hazard risks. These assessments must evaluate multiple factors that could influence the safety of produce, such as:

• Source and Nature of Water: Assessing whether the water is from surface or groundwater sources and the characteristics of the water distribution system.
• Potential Contamination Sources: Identifying possible contamination from nearby land uses, animal activities, and other environmental factors.
• Water Application Methods: Considering how water is applied to crops, which can affect the potential for contamination.

These factors are critically evaluated to determine if and when corrective actions or mitigation measures should be initiated to minimize risks associated with agricultural water use.

Required Actions Based on Assessment Outcomes

The outcomes of these water assessments dictate specific actions for farms to ensure the safety of their produce:

• If water is found unsafe or unsanitary, its use must be discontinued immediately until corrective measures are effectively implemented.
• If hazards are identified that require mitigation, measures must be applied promptly within the same growing season or as soon as practicable.
• Regular inspections and maintenance of water systems are mandated to uphold their integrity and functionality.

Management and Supervisory Reviews

A key aspect of the rule is the mandatory supervisory review of the agricultural water assessments. This ensures that the assessments are thorough and that the conclusions drawn are based on solid evidence and analysis.

Exemptions and Compliance Dates

The rule provides specific exemptions for farms that can demonstrate their water meets certain safety criteria, such as water from public systems that comply with established standards or treated water that meets the Produce Safety Rule’s requirements.

Conclusion

The FDA's final rule on preharvest agricultural water under FSMA represents a significant advancement in the regulatory approach to enhancing produce safety. By shifting to a systems-based assessment model, the rule allows for greater adaptability and responsiveness to specific farm conditions and practices. This approach not only aims to reduce the incidence of produce-related outbreaks but also supports the industry’s ongoing efforts to ensure the safety and integrity of fruits and vegetables consumed across the United States.