FSMA: Pre-Harvest Agricultural Water Rule

The Pre-Harvest Agricultural Water Rule requires farms to conduct systematic water safety assessments to prevent foodborne illness. Pre-harvest agricultural water is water used for fertigation, crop protection sprays, irrigation, or otherwise used on crops before harvesting. 

Key requirements

The Rule, included in the Food Safety Management Act (FSMA) and enforced by the Food & Drug Administration (FDA), requires farms to:

• Conduct annual assessments examining water systems, agricultural water practices, crop characteristics, environmental conditions, and other relevant factors.
• Implement immediate corrective actions if water is unsafe or risks arise from nearby animal activity or waste.
• Complete mitigation measures within the same growing season for high-priority risks and within the following year for lower-priority risks.
• Maintain documentation of assessments and have them reviewed by supervisors.

In 2024, the FDA issued the final rule. The updated Pre-Harvest Agricultural Water mandates farms to conduct water system testing annually and after significant changes that affect water supply, application, or food contact surfaces. It established systems-based water assessments for hazard identification and risk management on covered produce (excluding sprouts, covered separately under the produce safety rule.) 

• Agricultural water system(s): This is the most comprehensive category, requiring evaluation of water supply location and source, system exposure to the environment, and protection from animals, Biological Soil Amendments of Animal Origin (BSAAOs), and human waste.

• Agricultural water practices: Farms must consider the type of water application method and timing of application before harvest. Different water application methods (spray irrigation, drip, furrow, flood, etc) present different risks at different times of the year. 

• Crop characteristics: Farms must account for contamination risks that increase with crops having large rough surfaces, ground contact, or high porosity that facilitate bacterial growth. Microbial hazards can also internalize through damage from weather events or plant pathogens.

• Environmental conditions: Farms must assess how ecological factors affect pathogen survival. Factors include heavy rainfall, flooding, UV exposure, and temperature fluctuations that can cause freezing, hail, or wind.

• Other relevant factors: This category covers other factors that could reasonably introduce risk into a farm water system. An example is water testing, which is part of a farm’s assessment process. 

How the Rule achieves its goal

Pre-harvest agriculture water assessments prevent foodborne illness by identifying and mitigating water contamination risks before there is a chance to contaminate produce.

The updated rule provides a framework for continuous water supply vulnerability assessment and guidance on when to reevaluate, such as after severe or unexpected weather events.