FDA's Long-Awaited Ag Water Final Rule Finally Surfaces

The long-anticipated publication¹ of the U.S. Food and Drug Administration's (FDA's) Pre-Harvest Agricultural Water Final Rule,² which falls under Subpart E of the Food Safety Modernization Act's (FSMA's) Produce Safety Rule, received widespread acknowledgment on May 2. The rule has been a long time in the making—punted between two presidential administrations, criticized in its early development by industry as being too complex, and widely encouraged by produce safety advocates and consumer groups.

"Much progress has been made from the original proposal, which was overly complex, one-size-fits-all, and didn't allow for flexibility considering existing scientific limitations," commented Natalie Dyenson, the International Fresh Produce Association's Chief Food Safety and Regulatory Officer, in response to the rule's release. "This final rule highlights FDA's willingness to incorporate stakeholder feedback and ultimately put forth a rule that protects public health."³

The Final Rule, Explained

The final rule, fully described as Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water, is intended to enhance the safety of water used for produce cultivation. It will also, hopefully, help reduce the number of foodborne illness outbreaks associated with fresh produce—of which there have been several in the past few years. The early-May publication of the final rule set off a compliance countdown for all non-sprout covered produce, as follows:

• Nine months from the effective date (listed as July 5, 2024) for large farms (April 7, 2025)
• One year and nine months from the effective date for small farms (April 6, 2026)
• Two years and nine months from the effective date for very small farms (April 5, 2027).

The final rule is hoped to facilitate an improvement in pre-harvest agricultural water quality by setting new requirements for annual, systems-based water assessments. These assessments will, in turn, inform hazard identification and risk management decision-making. By assisting growers in identifying conditions that are likely to introduce known or foreseeable hazards into or onto produce or food contact surfaces, the final rule will help them decide whether, and when, mitigation or corrective measures must be implemented to minimize or remove food safety risks from pre-harvest agricultural water. 

The final rule also requires growers to conduct a hazard assessment whenever a significant change occurs. This systems-based approach to risk assessment and hazard analysis for pre-harvest agricultural water is anticipated to result in better food safety for covered produce, versus the previous approach that focused mainly on repeated microbiological water testing.

Requirements for harvest and post-harvest agricultural water, as well as special agricultural water requirements for sprouts, have not changed. 

Specifically, the final rule:

• Establishes requirements for water assessments that evaluate a variety of factors associated with contamination risks for pre-harvest agricultural water, including the water system structure, water use practices, crop characteristics, environmental conditions, potential impacts from adjacent and nearby land, and other relevant factors
• Includes testing of pre-harvest agricultural water as part of an assessment, in certain circumstances
• Requires farms to implement effective mitigation measures within specific time frames based on findings from assessments; hazards related to adjacent and nearby land uses—such as animal activity or human waste—are subject to prompt mitigation measures to be implemented no later than the same growing season
• Adds new options for mitigation measures, providing farms with flexibility in responding to findings from their water assessments.

In a nutshell, the final rule is intended to better address known routes of microbial contamination that can lead to preventable foodborne illnesses.

To assist growers with compliance, FDA released several factsheets and additional resources that describe factors to consider during pre-harvest agricultural water assessments, mitigation and corrective measures, equivalent testing methodology, and other requirements outlined in the final rule.

“Much progress has been made from the original proposal, which was overly complex, one-size-fits-all, and didn't allow for flexibility considering existing scientific limitations.”

—Natalie Dyenson, IFPA

FDA Shares Insight, Answers Questions

FDA held a webinar on the final rule on May 20, which encompassed answers to pre-submitted and live questions from stakeholders. During the webinar, James (Jim) Jones, Deputy Commissioner for Human Foods, opened the webinar by stating that he believes the shift to a systems-based approach will result in better adherence to the rule and an improved approach to reducing the incidence of foodborne illness outbreaks.

Kruti Ravaliya, M.S., Consumer Safety Officer with the Center for Food Safety and Applied Nutrition (CFSAN)—with whom we spoke about the in-progress ag water rule back in August 2022, on a segment included in Episode 125 of the Food Safety Matters podcast⁴—next shared a high-level overview of the final rule and the comments received. Ravaliya noted that the final rule was developed in response to new science demonstrating the limitations of the previous testing requirements, as well as findings from several previous produce-related outbreaks.

Ravaliya also provided further details on water reassessments and exemptions to the rule. Farms must conduct ag water reassessments at least once per year, or whenever a significant change occurs. Examples of significant changes include a change from groundwater to surface water; changes in water use practices; growth of a different type of produce; and some types of environmental conditions, such as flooding.

Additionally, Ravaliya explained that some growers may be exempt from the rule if a farm can demonstrate that its water meets certain requirements for harvest/post-harvest water, including the microbial criterion, prohibition on the use of untreated surface water, and relevant testing requirements. A farm can also meet certain requirements (with certified compliance) for water received from a public water system or supply. Growers must also show that their water is treated in accordance with the final rule.

During the Q&A session following Ravaliya's overview of the rule, Ravaliya was joined by Chelsea Davidson, Policy Analyst with FDA; Christopher Brown, Compliance Expert with FDA; and Jennifer Thomas, Senior Advisor with FDA. The Q&A panel clarified final rule content in response to a variety of questions from attendees, such as when testing will be required. Davidson and Ravaliya explained that water quality testing will be required for farms that do not implement mitigation measures following water quality assessments that identify risks, or when testing will help further inform the grower's water quality assessment. Previously, growers were required to test their ag water five times per year; a revised testing frequency under the final rule will be determined by the water assessment results, E. coli testing results, and other factors, for those growers that must implement testing as part of their annual reassessments.

Another attendee asked how to conduct an ag water assessment. Ravaliya explained that FDA's Agriculture Water Assessment Builder⁵ tool helps walk growers through conducting a water assessment, step by step. FDA's risk-based outcomes flowchart⁶ for water assessments, which Ravaliya highlighted during the webinar, also provides growers with an easy tool for making appropriate decisions based on assessment outcomes.

At the end of the webinar, FDA moderator Laura Finnegan announced that FDA will be holding additional webinars on the ag water rule for international growers, and said that more resources for complying with the rule will be made available in the coming months—all in the spirit of what Jim Jones described in his introduction as "educating before and while we regulate."

Gauging by the high number of questions during the Q&A and attendees' keen desire for clarification, it appears that growers will be sending many more questions FDA's way in the coming months. It is probably a good thing that large farms still have the better part of a year to plan their water assessment strategies and make sure they are in compliance with the final rule.

References

1. Food Safety Magazine Editorial Team. "FDA Publishes FSMA Pre-Harvest Agricultural Water Final Rule." Food Safety Magazine. May 2, 2024. https://www.food-safety.com/articles/9449-fda-publishes-fsma-preharvest-agricultural-water-final-rule.
2. U.S. Food and Drug Administration (FDA). FSMA Final Rule on Pre-Harvest Agricultural Water. Current as of May 8, 2024. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-pre-harvest-agricultural-water.
3. International Fresh Produce Association (IFPA). "FDA Issues Final Ag Water Rule, IFPA Reacts." May 6, 2024. https://www.freshproduce.com/who-we-are/press-center/2024/fda-issues-final-ag-water-rule-ifpa-reacts/.
4. Food Safety Magazine. "Ep. 125. Dr. Conrad Choiniere: Moving 'Closer to Zero' Through Collaboration." Food Safety Matters Podcast. August 23, 2022. https://www.food-safety.com/articles/7959-ep-125-dr-conrad-choiniere-moving-closer-to-zero-through-collaboration.
5. FDA. "Agricultural Water Assessment Builder." https://agwaterassessment.fda.gov/.
6. FDA. "Annual Agricultural Water Assessments and Risk-Based Outcomes." https://www.fda.gov/media/178219/download?attachment.