The FDA Pre-Harvest Agricultural Water Rule: Essential Insights for Produce Growers and Manufacturers

For the FDA, the safety of agricultural water is a fundamental concern for produce growers and the food and beverage manufacturers that rely on them. The FDA’s Final Pre-Harvest Agricultural Water Rule, part of the Food Safety Modernization Act (FSMA), establishes several requirements to ensure that water contacting the edible portions of crops is free from contamination. This article, informed by Dr. Angela Ferelli Gruber of The Acheson Group, provides a structured overview of the key elements that growers and manufacturers need to understand and act on to remain compliant.

Who Needs to Know and What’s the Goal?

The Final Pre-Harvest Agricultural Water Rule is crucial for both produce growers, and food and beverage manufacturers with produce in their supply chains. Ensuring compliance is not just about meeting regulatory requirements; it’s about safeguarding public health and maintaining the integrity of the food supply chain. This rule mandates that any water that comes into contact with the edible portions of crops must be carefully monitored, tested, and documented.

Key Stakeholders:

• Produce Growers: Directly responsible for managing and documenting water safety at the source.

• Manufacturers: Need to ensure their suppliers (produce growers) comply with the rule to protect their supply chains and maintain product safety.

Critical Factors to Consider

Several factors influence how growers and manufacturers should approach compliance with the Pre-Harvest Agricultural Water Rule. Understanding these factors is essential for developing a robust compliance strategy:

1.) Nature of Each Agricultural Water System:

The specific characteristics of your water system, including the source (e.g., well, river, reservoir) and delivery method, play a significant role in determining the frequency and type of testing required. Each system has unique risks and challenges that must be addressed.

2.) Agricultural Water Practices:

The types of irrigation methods used (e.g., drip, overhead) and their frequency can affect water quality. For instance, overhead irrigation systems that apply water directly to the edible portion of crops require more stringent monitoring and documentation than drip systems that deliver water at the root level.

3.) Crop Characteristics:

The physical characteristics of the crops themselves are also important. Crops that grow close to the ground or have complex surfaces (like leafy greens) are more likely to retain contaminants from water. This makes the type of crop a critical factor in determining the necessary precautions.

4.) Environmental Conditions:

Weather and other environmental factors can significantly impact water quality. Rainfall, wind, and temperature fluctuations can introduce contaminants into water sources or exacerbate existing issues. Monitoring these conditions and adjusting testing and documentation practices accordingly is crucial.

5.) Other Influencing Factors:

Additional considerations include the geographical location of the farm, the proximity of potential contamination sources (like livestock or industrial activities), and historical water quality data. These factors can influence both the risk level and the required frequency of testing and documentation.

Real-Life Scenarios: How These Factors Play Out

To better illustrate the practical implications of the Pre-Harvest Agricultural Water Rule, consider these real-world scenarios:

1.) Irrigation Systems:

A farm utilizing both well water for drip irrigation and river water for overhead sprinklers faces different compliance challenges. While drip irrigation systems may require less frequent testing, the river water used for sprinklers, which directly contacts the crops, necessitates more frequent and rigorous testing. This scenario underscores the importance of tailoring water safety practices to the specific type of irrigation system in use.

2.) Frost Protection:

In regions prone to frost, growers often use overhead irrigation systems to protect crops. The water used in this process directly contacts the plants, making it subject to the strict testing and documentation requirements of the Pre-Harvest Agricultural Water Rule. Given the unpredictable nature of frost events, maintaining up-to-date records of water testing and source documentation is essential.

3.) Crop Protection Sprays:

When water is mixed with pesticides or fungicides for crop protection, the source and quality of that water must be meticulously documented. For example, if surface water is used, it should be tested for contaminants before application to ensure it doesn’t introduce harmful substances to the crops. This scenario highlights the critical need for thorough documentation at every stage of the water’s use.

Corrective Measures for Non-Compliant Water

When water testing reveals contamination or other non-compliance issues, swift corrective action is required. The following measures are essential for maintaining compliance:

1.) Switching Water Sources:

If testing indicates contamination, switching to a safer, tested water source is necessary. This change must be thoroughly documented, including the reasons for the switch and the results of any follow-up testing on the new water source.

2.) Treating Contaminated Water:

In some cases, water treatment may be necessary to bring the water up to safety standards. This could involve chemical treatment or filtration. Detailed records of the treatment process, the effectiveness of the treatment, and subsequent water quality tests must be kept.

3.) Adjusting Agricultural Practices:

In certain situations, it may be necessary to adjust agricultural practices to mitigate risks. This could include altering irrigation schedules to avoid using surface water during times when contamination is more likely (e.g., after heavy rainfall). Any such changes should be documented to show proactive management of water safety.

For an in-depth resource on actions to consider, visit this FDA resource.

How to Prepare for Compliance

Ensuring compliance with the Pre-Harvest Agricultural Water Rule requires careful planning and diligent record-keeping. Here are the steps to prepare:

1.) Assess Current Practices:

Start by conducting a comprehensive assessment of your current water management and documentation practices. Identify any gaps that could lead to non-compliance and address them promptly.

2.) Implement a Robust Record-Keeping System:

A reliable record-keeping system, preferably digital, is essential for managing the volume of data required by the rule. This system should allow for easy access to records, especially during audits or inspections.

3.) Training and Awareness:

All personnel involved in water management must be trained on the requirements of the rule and the importance of accurate documentation. Regular training updates should be provided to ensure ongoing compliance.

4.) Continuous Monitoring and Audit Readiness:

Regular monitoring of water quality and ongoing reviews of documentation are critical. Being audit-ready means having all records up-to-date and easily accessible, with clear documentation of any corrective actions taken.

5.) Supplier Management:

For food and beverage manufacturers, a critical part of mitigating risk in the supply chain is ensuring your suppliers have consistent and up-to-date (compliant) practices. Water assessments are now a federal requirement and insight into a supplier’s ongoing compliance is crucial. SafetyChain’s supplier management enables control of that risk, allowing task assignment, verification, compliance document uploads, and timely communication.

Conclusion

The Final Pre-Harvest Agricultural Water Rule is a key component of FSMA designed to protect the safety of our food supply. Compliance requires a thorough understanding of the factors that influence water quality, rigorous testing and documentation practices, and the ability to quickly respond to any issues. By following these guidelines, produce growers and manufacturers can ensure they meet regulatory requirements and continue to provide safe, high-quality products to their customers.