The U.S. Food and Drug Administration (FDA) published its long-awaited regulations on pre-harvest agricultural water in summer 2024, representing an important evolution of the agency's stance toward water safety management on farms. Released July 5, the final rule amends existing provisions within the Food Safety Modernization Act's Produce Safety Rule. The change represents a significant shift from strict microbial quality criteria to a more nuanced, systems-based assessment approach, with the goal of supporting food safety by addressing contamination risks through a more adaptive and comprehensive framework.

Changes to Pre-Harvest Ag Water Monitoring and Testing

FDA's final rule introduces a notable departure from previous regulations on pre-harvest water safety. Rather than putting into place stringent microbial quality standards for farms, the rule mandates a systems-based approach for pre-harvest agricultural water assessments. The new approach requires farmers and inspectors to consider a more expansive set of factors that could impact water safety, including the design of water distribution systems and potential contamination risks from water sources and other external sources.

"The new systems-based approach allows us to tailor our education and compliance strategies to the specific characteristics of each farm," said Emily Harris, Program Manager for the New Mexico Department of Agriculture. "Instead of relying on a universal standard, the rule will give us the flexibility to really think about the unique factors that influence water quality on each farm, in each county, in each state."

As part of the holistic monitoring and compliance framework, farms will need to assess whether their water systems are protected from contamination, which will require them to consider land use in neighboring areas and potential livestock operations that could affect the water sources used on their farm. By addressing some of these external conditions, FDA has signaled a shift toward more preventive measures and management of external environmental risk.

Key Requirements and Compliance Timelines

While FDA has yet to announce its rollout of the new rule, the agency has offered initial guidance on what actions farmers should take to stay in compliance with the rule. First, FDA will require an annual assessment of agricultural water systems on each farm. If a farm identifies an issue, it must take corrective actions to address the identified contamination or water safety risk before it can continue use of the water source.

"The new rule emphasizes the need for ongoing, preventive management on farms," said Joe Reardon, Senior Director of Food Safety Programs at the National Association of State Departments of Agriculture (NASDA) Foundation. "By requiring regular, annual assessments and encouraging quick responses to correct contamination risks, the FDA is creating an increased emphasis on education and training instead of penalization."

“By focusing on numerous factors affecting water quality on farms, the purpose of the new rule suggests a shift toward addressing the root causes of contamination instead of only reacting to water quality issues as or after they arise.”

The deadline for compliance with the new rule is staggered depending on the size of farms. Large farms must comply with the rule by April 7, 2025, small farms by April 6, 2026, and very small farms by April 5, 2027. These deadlines are intended to provide enough time for FDA to create a strategic rollout and allow state departments of agriculture to form education and outreach programs. The staggered deadlines will also help farms adapt to the new requirements and implement necessary changes to their operations and testing.

Impact on Food Safety

The transition to a systems-based assessment approach represents an evolution of FDA's focus on preventive measures. By focusing on numerous factors affecting water quality on farms, the purpose of the new rule suggests a shift toward addressing the root causes of contamination instead of only reacting to water quality issues as or after they arise.

"We are always going to be 'educate before, during, and while we regulate,'" Harris said. "But we see this especially as something that we are going to hit harder with our education and outreach efforts. We are going to focus and rely heavily on partnerships with our NGOs and with people who are already working with farms and see the gaps of knowledge and needs of farms."

The rule's impact on food safety is underscored by statistics on waterborne illnesses linked to pre-harvest agricultural practices, particularly from surface waters. U.S. Department of Agriculture (USDA) researchers have indicated¹ that domestic agricultural production uses an estimated 118 million gallons of water per day. Of this amount, over 50 percent of the irrigation water use is sourced from surface waters.

NASDA Foundation's Role in Implementation

As state departments of agriculture wait to hear additional announcements from FDA and prepare for their own rollout strategies, the National Association of State Departments of Agriculture (NASDA) Foundation supports coordination efforts by FDA regulators and state inspectors. NASDA Foundation's food safety team continues to provide training and resources to help state inspectors and decision-makers navigate the potential challenges of communicating and enforcing the new requirements.

"The goal of our workshops and training sessions is to equip state departments with the set of tools they need to effectively implement the new rule in a way that makes sense for their state's producers," Reardon said.

As an organization that represents state departments of agriculture across the country, NASDA Foundation's training sessions are designed to address the unique characteristics of water quality inspection programs that vary significantly depending on the state agency and landscape of agriculture in the sub-region. The trainings move from region to region, offering states an opportunity to share best practices and creating a direct communications line between FDA regulators and state inspectors.

Regional Perspectives and Challenges

FDA recognizes that implementation of the new rule will look different depending on the region, reflecting the diverse agricultural practices and environmental conditions of the U.S. agricultural landscape. For example, states with extensive irrigation practices, like New Mexico, will need to adapt the rule's provisions to address specific challenges related to surface water management.

"This new change has allowed a lot more leniency with our farms—and that's not just New Mexico-based, that's across the board," Harris said. "One thing that you'll hear, especially in produce safety, is 'once you've seen one farm, you've seen one farm.' And I think that remains entirely true, especially in New Mexico, but also in farming in general."

Harris noted that water issues can also look entirely different within a state, depending on the climate zone, the natural resources present in the region, and the crops that are grown.

"We have a lot of different water issues here in our state, and they're going to differ from the southern part of the state to the northern part of the state," Harris said. "So, we realize that water and agriculture is a vital part of the conversation and also a huge risk that can be present for our produce safety."

The NASDA Foundation food safety team continues to advocate to FDA and other federal agencies the importance of recognizing and addressing these variations, particularly as questions continue to arise during the state implementation phase of the rule.

“As states and farmers prepare for the staggered enforcement dates of the new pre-harvest agricultural water rule, FDA recognizes that the success of its implementation will depend on ongoing collaboration and communications among the agency, state inspectors, and impacted farms.”

Supporting Historically Underserved Farmers

In addition to supporting state departments of agriculture with inspection training, the NASDA Foundation manages programs that support historically underserved farmers and ranchers through a U.S. Environmental Protection Agency (EPA)-funded water safety grant program. The initiative has awarded 14 sub-awardee organizations with funds to lead projects and conduct outreach to ensure that farming operations in the Gulf of Mexico watershed support habitat resilience and healthy ecosystems in the waterways that pass either through their farms or are indirectly impacted. The organizations are located in Virginia, Kentucky, West Virginia, Pennsylvania, and Tennessee.

The program also focuses on promoting diversity, equity, and inclusivity in the movement toward a greater appreciation for water safety in the agricultural sector. By offering technical assistance, training, and direct project support to groups like military veterans, Spanish-speaking producers, and new and beginning farmers, it aims to ensure that all producers have access to the education and implementation tools required to meet and exceed water safety requirements.

"The EPA Historically Underserved Farmers Program plays a crucial role in ensuring that all farmers have the opportunity to support and lead as stewards toward a healthier and more resilient Gulf of Mexico watershed," NASDA Foundation Senior Director Chris Jones said. "By providing funding to organizations that have established trust in those producer communities, we are helping promote a mentality of prevention and risk management that can ultimately pay dividends for farmers and ranchers."

Along with direct financial investment for farms, states and federal agencies also promote increased access to educational resources that can support compliance with food safety requirements. For example, the Farm2Food Accelerator program, which teaches farmers how to develop a value-added product that incorporates specialty crop ingredients, includes training modules on food safety laws relevant to the states in which they produce and sell their products. The program, which has hosted cohorts in Florida, Washington, Nevada, Oregon, and California, will expand to Virginia, Colorado, and a new group in Nevada for the 2024–2025 session year.

Outlook and Next Steps

As states and farmers prepare for the staggered enforcement dates of the new pre-harvest agricultural water rule, FDA recognizes that the success of its implementation will depend on ongoing collaboration and communications among the agency, state inspectors, and impacted farms.

"We have definitely been talking to adjacent states around us and making sure that we are implementing the same rule and on the same page about all of this," Harris said. "So, I think as we move into that education and compliance phase of this rule, we are going to have to listen, listen, listen—because all of these farms are going to be unique. They're all going to have their own risks to identify and deal with. We also hope to see region-specific research come out of this, because we know that is still necessary—and at this point, looking to back up what we are doing in the regulatory portion of it."

The NASDA Foundation food safety team is in discussions with FDA regarding the training needed for state inspectors as they plan for the implementation of the new rule.

"Our focus will be on supporting a smooth transition with the new rule and ensuring that all relevant groups are confident and prepared to meet the requirement shifts," Reardon said. "Announcements like these always include a little trial and error, and we will continue to provide resources and guidance to help farmers and state officials navigate the changes effectively."

References

1. Gurtler, J.B. and K.E. Gibson. "Irrigation water and contamination of fresh produce with bacterial foodborne pathogens." Current Opinion in Food Science 47 (October 2022). https://www.sciencedirect.com/science/article/abs/pii/S2214799322000911.