Citing it as a landmark achievement, FDA announced the first-ever EPA registration of an antimicrobial product using the revised efficacy protocol for pre-harvest agricultural water. The early November-announced approval provides a treatment for use against foodborne pathogens (i.e., Salmonella and E. coli) in the agricultural water used to grow produce. Given the recent outbreaks, such as the current recall of carrots due to potential E. coli contamination, and recent recall of cucumbers for Salmonella contamination, this product registration has come none too soon.
The new approval is also of interest as it comes as the result of a collaborative effort between government, academia, and industry to develop and refine an efficacy protocol to support registration. It is due to the product’s ability to directly reduce the presence of human pathogens, not just manage algae and biofilm formation or produce rot as were the limits of previous treatment options, that the registration is considered to be so momentous. That ability, and the product’s alignment with FDA’s final rule on agricultural water is expected to significantly mitigate risks and improve the safety of the water used in growing crops.
Along with the University of Arizona collaboration with industry, the university also worked with FDA to provide feedback that led to the 2023 efficacy protocol update. The update optimized testing parameters removing Listeria monocytogenes (Lm) from the organism test panel, because pilot studies showed that treatments likely effective against E. coli and Salmonella may be different from those that are most effective for Lm.
Although the rule does not require farmers to treat their agricultural water, such treatment is one option for the food safety protection of produce. Thus, this first EPA authorization of an antimicrobial product for use against pathogens of public health concern in pre-harvest agricultural water provides farmers with a new option for the safety of their produce.
As TAG discussed in a May 2024 Insights article, compliance with the final rule on pre-harvest ag water is based on the execution and results of a risk assessment to drive your compliance and any corrective action. The final rule replaced certain pre-harvest requirements with requirements for written systems-based assessments to determine and guide measures to minimize risks. Covered farms are required to conduct assessments annually and whenever a significant change occurs; then based on findings, implement effective corrective or mitigation measures. Incorporating the new antimicrobial product could, thus, be a mitigation step incorporated as a preventive or a corrective action.
With the FDA and EPA continuing to encourage future registrations using the revised efficacy protocol, the industry could be seeing more treatment product options, with diversity for managing various crops.
One note of caution: Despite the enthusiasm about this new product, don’t forget the fundamental value of Good Agricultural Practices designed to prevent contamination of fresh produce in the first place. While the treatment is exciting, we should not forget our fundamental preventive approaches.
With scientific expertise in agriculture and regulation, TAG can assist farms in your ag water assessment and mitigation measures, as well as with other aspects of the final produce rule, including the determination of trigger points for re-analysis of your ag water assessment appropriate to your specific farm risks; providing analysis of the susceptibility of your crop to surface adhesion of pathogens; and recommending a validation approach for using alternative indicators for water testing.
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