One of the most persistent and concerning origins of foodborne illness outbreaks in the United States stems from the use of contaminated water in agricultural practices. This contamination occurs when water used to irrigate crops contains harmful pathogens, which are then transferred to the edible portions of plants, posing significant health risks. To address this critical issue, the Food and Drug Administration (FDA) has stepped up its regulatory measures, culminating in the publication of a pivotal final rule in May 2024.
The FDA’s new rule, which amends the provisions for pre-harvest agricultural water on covered produce (excluding sprouts), is a significant update to the 2015 “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” rule. The updated regulation mandates that farms complete annual assessments to evaluate their pre-harvest agricultural water, identify potential contamination conditions, and implement corrective or mitigation measures to combat these risks.
This rule is part of a broader regulatory framework under the Federal Food, Drug, and Cosmetic Act (FDCA), which was significantly updated by the Food Safety Modernization Act (FSMA) in 2011. FSMA represented a paradigm shift in the nation’s food safety system, moving from a reactive approach to a preventive one. The Produce Safety Rule (PSR), one of FSMA’s nine foundational rules, sets science-based minimum standards for the safe production and harvesting of fruits and vegetables, aiming to minimize the risk of serious health consequences or death from foodborne illnesses.
The journey to the 2024 rule began with the 2015 PSR, which included Subpart E, setting standards for agricultural water’s microbial quality. However, stakeholder feedback revealed that the initial rule’s “one-size-fits-all” approach did not adequately account for the diverse conditions in agricultural practices. This led to extensions and reconsiderations, culminating in the 2021 Agricultural Water Proposed Rule, which introduced a more tailored approach focusing on pre-harvest water used for non-sprout covered produce.
The final rule published in 2024 replaces the previous microbial quality criteria with a requirement for systems-based pre-harvest agricultural water assessments. These assessments are designed to identify potential hazards and inform risk management decisions. Farms must evaluate several factors, including the nature and location of water sources, agricultural water practices, crop characteristics, environmental conditions, and any other relevant factors unique to their operations.
For instance, the assessment must consider whether the water source is ground or surface water, the type of irrigation system used, and the degree of protection from contamination sources such as animal activity or nearby land uses. The type of irrigation method (e.g., overhead sprinkler, drip, or flood irrigation) and the time interval between water application and harvest are also crucial factors. Additionally, farms must evaluate environmental conditions like heavy rainfall, which can stir sediments containing pathogens, and the impact of temperature and sunlight exposure.
Upon completing the assessment, farms must determine if corrective or mitigation measures are necessary. If agricultural water is found to be unsafe or of inadequate sanitary quality, its use must be discontinued immediately, and corrective measures must be taken before resuming its use. If hazards related to animal activity, biological soil amendments of animal origin, or untreated human waste are identified, mitigation measures must be implemented promptly, within the same growing season.
The implications of this rule are far-reaching. By enforcing rigorous water quality assessments and encouraging proactive risk management, the FDA aims to significantly reduce the incidence of foodborne illnesses linked to contaminated agricultural water. This regulatory shift not only enhances food safety but also instills greater confidence in the agricultural produce consumed by millions of Americans daily. As farms adapt to these new requirements, the hope is that the nation’s food supply will become safer and more reliable, ultimately protecting public health and ensuring the integrity of the agricultural industry.