By Taylor O’Bannon, Matt Krug and Michelle Danyluk
In December 2021, the Food and Drug Administration (FDA) released its proposed changes to the Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) Subpart E, which covers agricultural water. Compliance with the requirements of Subpart E has been delayed, since December 2019, to allow FDA adequate time to identify more appropriate risk-reduction strategies for managing agricultural water quality. These changes result from stakeholder concerns about the complexity and practical implementation in the original rule, as well as outbreak investigation results where irrigation water met the current microbial water quality standards.
The proposed changes to Subpart E focus solely on preharvest agricultural water and make no changes to the requirements of water used for harvest and postharvest activities. If finalized, the proposed rule would replace the microbial water quality profile and testing criteria with a systems-based, preharvest agricultural water assessment. The assessment intends to take a more individualized approach to identify and reduce preharvest water-quality risks.
This assessment significantly builds upon the current requirement that water sources and distribution systems must be inspected at least annually and be kept free of debris, trash, domesticated animals and other hazards. It requires growers look beyond the farm gate. A major focus is on activities being done on adjacent lands. Testing for fecal indicator bacteria is not specifically required in what has been proposed; however, testing can be used to help inform the assessment.
The agricultural water assessment would include five main factors: agricultural water systems, agricultural water practices, crop characteristics, environmental conditions and other relevant factors.
AGRICULTURAL WATER SYSTEMS
The agricultural water systems component focuses on growers assessing risks based on the water source (ground or surface), the water distribution system (closed or open to the environment) and the system’s protection from possible contaminants (adjacent land use, proximity to animals and other uses of the water system). Generally, water obtained from underground aquifers with a properly constructed well is considered lower risk than surface water sources that are open to the environment and more susceptible to contamination.
The water distribution system component identifies risks in open or closed systems. Growers may consider runoff, animal intrusion, upstream usage, discharge, seepage for open systems, and construction and maintenance for closed systems. The system’s protection from possible contamination includes addressing risks such as animal impacts, adjacent or nearby land use, including animal activity, biological soil amendments and applying untreated or improperly treated human waste.
AGRICULTURAL WATER PRACTICES
The agricultural water practices factor focuses on the method and timing of water application. The type of application method influences the extent that water is applied and contacts the harvestable portion of the crop. This factor focuses on the interval between the last direct application and harvest because environmental conditions impact the die-off of foodborne pathogens. Maximizing the time these pathogens are exposed to these conditions impacts their survivability and chances of entering the food-supply chain.
CROP CHARACTERISTICS
The crop characteristics factor intends to identify risks of surface adhesion and internalization of hazards depending on the type of crop or specific weather events. Certain crops will be more susceptible to surface adhesion based on their physical characteristics (porous, netted, etc.). They may also be more susceptible to physical damage during weather events such as freezing temperatures and hail damage. Any damage to fruits and vegetables can increase the risk of bacteria survival and reproduction.
ENVIRONMENTAL CONDITIONS
The environmental conditions factor aims to address risks associated with the survival of pathogens in the growing environment. Conditions such as rainfall, extreme weather events, heavy winds, dry periods and air temperature can impact the physical, chemical and biological conditions that either support bacterial die-off or survival.
OTHER RELEVANT FACTORS
Every farm is different and might consider other factors to make informed decisions about preharvest water quality.
NEXT STEPS
Not long after announcing the proposed changes, the FDA also announced it would be exercising “enforcement discretion” for all agricultural water requirements for covered produce operations. Therefore, farms can expect flexibility from regulators on the enforcement of agricultural water sections of the PSR while the proposed rule is either updated or finalized. In the meantime, growers should continue to meet their audit requirements around testing water, inspect their water source and distribution system, review any microbial data and adjacent land use relevant to their water source, and continue to use practices that lower the potential risk for contamination via preharvest water.
Prior to issuing the final rule, FDA must respond to all the comments received during the comment period that closed in April 2022. This process is expected to take some time.
Once the final rule is released, the University of Florida Institute of Food and Agricultural Sciences (UF/IFAS) Food Safety Extension Team will set up a number of in-person and virtual trainings to communicate the rule expectations and answer any questions growers may have. If the Ag Water Assessment Tool, discussed below, is still used in the final rule, additional trainings will be conducted to help facilitate effective use of this tool.
RESOURCES AVAILABLE
More information about the proposed changes can be found on the FDA website or the Agricultural Water Assessment Fact Sheet (www.fda.gov/media/154334/download). The FDA also has an Expanded Table on the Factors to be Considered as Part of Agricultural Water Assessment (www.fda.gov/media/154447/download) on the risks that may be assessed. In addition, growers may use the FDA Ag Water Assessment Builder (agwaterassessment.fda.gov) to answer questions and/or fill in information specific to their unique conditions.
On-Farm Readiness Reviews (OFRR) are another way growers can receive assistance implementing food safety principles or the PSR on their farms. Visit www.fdacs.gov/OFRR to request an OFRR. Contact UFFoodSafety@ifas.ufl.edu for more information about the PSR requirements or questions about proposed rule changes.
Taylor O’Bannon is a state food safety Extension agent, and Michelle Danyluk is a professor, both at the UF/IFAS Citrus Research and Education Center in Lake Alfred. Matt Krug is a state food science Extension agent at the UF/IFAS Southwest Florida Research and Education Center in Immokalee.