The much-anticipated Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) Final Rule on Pre-Harvest Agricultural Water is finally here! The revised rule covering pre-harvest water requirements supersedes the previous regulations of the FDA Produce Safety Rule. This article serves to help you better understand the revised requirements and stay in compliance with regulatory criteria.
The Original Water Rule
If you’ve been in the business of growing produce intended for fresh consumption in the past decade, you know the original water rule can be traced back to Subpart E of the 2015 FDA publication of the Produce Safety Rule. The Produce Safety Rule is a science and risk-based set of standards for safe growing, harvesting, packing and holding of produce intended for human consumption. In the years following 2015, the FDA received feedback that maintaining a microbial water quality profile (MWQP) and its associated testing requirements were challenging and even unattainable for some growers.
When the revised rule was proposed, it was stated that there would be updated mitigation measures in response to several produce outbreak investigations. Furthermore, the industry feedback in conjunction with the produce-related outbreaks led us to the current updated requirements. Through this article you will learn about the newly designed systems-based assessment for hazard identification and risk management decision-making.
Assessment vs Inspection
The annual agricultural water assessment (AWA) discussed in this article is replacing the previous microbial water quality profile (MWQP). Moreover, the AWA is separate from the agricultural water system inspection and should be conducted in addition to the inspection. Although similar in concept, the inspection notes system details such as any changes to the water source, water delivery system, or adjacent land. In turn, the AWA evaluates the conditions that would introduce a potential hazard onto produce or a food contact surface. Regardless of if a system change has occurred, a review of the AWA and system inspection should be conducted on an annual basis, at a minimum.
Understanding Your Water Assessments
To assist growers with FSMA compliance, the FDA has provided valuable tools such as the Builder Tool to guide agricultural water assessments. We can use the information below as a starting point in our understanding of this new rule. The goal with the summarized factors below is to identify potential hazards that you may face with your agricultural water.
Agricultural Water Systems Evaluation
- The location and nature of the water source
- The type of water distribution
- Protections from sources of contamination
Agricultural Water Practices
- The type of application method
- The time between the direct application of agricultural water to the harvestable portion of the crop and the harvest of your covered produce
Crop Characteristics
- The susceptibility level of your covered commodity to have adhesions or internalized hazards
Environmental Conditions
- Sun exposure
- Air temperatures
- The frequency of heavy rain and extreme weather. This may impact your water system or damage your produce.
- Damaged produce can increase the chances of contamination
For more details on your water assessment, the FDA has provided an Expanded Table on the Factors for Agricultural Water Assessment to Consider.
Next Steps
The FDA has created an easy-to-follow flow chart to determine what next steps to take to avoid a potential hazard.
Am I Exempt?
At this point, you must be wondering if your agricultural water system is exempt or part of the rule. There are a few qualifications to be considered part of the exemption.
According to the FDA, you must:
- Demonstrate that your pre-harvest agricultural water:
- Meets the specific requirements that apply to harvest and post-harvest agricultural water
- Is received from a public water system
- Is treated in agreement with the standards expressed in the Produce Safety Rule
- Or it is reasonable that the quality of the previously discussed water will not change before being used as agricultural water.
It is good practice to annually test, at a minimum, your water quality to ensure that you are making accurate decisions on the assessment. Third-party labs such as Safe Food Alliance conduct water quality testing.
Timeline
The FDA has stated that they have an “educate before and while we regulate” approach when it comes to compliance with the Final Rule on Pre-Harvest Agricultural Water. The effective date for the Final Rule was July 5th, 2024, but there are three different compliance dates to consider depending on the size of your farm. Keep in mind the FDA defines size based on produce-related sales. The tiers are as follows: Very small businesses (>$25-250K), Small businesses (>$250-500K), All other businesses (>$500K).
- All Other Farms – April 7th, 2025
- Small Farms – April 6th, 2026
- Very Small Farms – April 5th, 2027
The FDA Pre-Harvest Agricultural Water Final Rule is intended to prevent produce-related outbreaks and mitigate water-related risks through the implementation of new system-based requirements. When evaluating your agricultural water, keep in mind the intention behind your assessments. Safe Food Alliance laboratories offer expert microbiological water testing services which can assist you with accurately assessing your agricultural water and delivery system. Let Safe Food Alliance be your reliable partner in water testing.
