The U.S. Food and Drug Administration (FDA) recently announced the successful EPA registration of the first antimicrobial product using the revised efficacy protocol for pre-harvest agricultural water. The registration of SANIDATE 12.0 is the result of a collaborative effort between government, academia, and industry.
This marks the first-ever FDA approval of a treatment for use against foodborne pathogens, such as salmonella and E. coli, in the agricultural water used to grow produce.
The FDA heralds the registration as “a landmark achievement in our collective efforts to improve food safety,” according to the FDA Constituent Update webpage.
“Using the revised efficacy protocol, industry worked with the University of Arizona to leverage their expertise in taking the steps to successfully register the antimicrobial treatment for use against foodborne pathogens like E. coli and Salmonella in preharvest water,” the FDA webpage adds. “The University of Arizona also worked through their partnership with FDA to provide feedback on the protocol that has led to recent updates to optimize the testing parameters, and to provide clarity for future users.”
Foodborne illnesses are often associated with produce consumption. One example is “the recent multistate Escherichia coli outbreak linked to fresh onions served at McDonald’s restaurants.” This and other examples “have highlighted the need for additional tools to help control foodborne pathogens in agricultural water,” according to Food Safety Magazine. “While farmers are not required to treat their agricultural water, treatment can serve as one option that can be used to help protect the safety of produce. As there were previously no EPA-registered antimicrobial products authorized for use against pathogens of public health concern in preharvest agricultural water, the availability of SANIDATE 12.0, as well as others that may be registered in the future, represent an important step towards providing farmers with additional tools to manage the safe use of their preharvest agricultural water. Utilization of the newly registered product aligns with FDA’s Food Safety Modernization Act (FSMA) Preharvest Agricultural Water Final Rule.”
Both the FDA and the EPA encourage future registrations using the revised efficacy protocol for registering new treatment products or amending current labels for combating foodborne pathogens in pre-harvest agricultural water.
“This initiative is crucial given the diversity within the produce industry, so having a variety of options to manage pre-harvest water risks is essential,” states the FDA Constituent Update webpage. “Additionally, ongoing collaboration remains vital among the EPA, antimicrobial product manufacturers, the produce industry, and academia. These partnerships are fundamental in supporting the registration of additional products and advancing our shared goal of enhancing agricultural water safety to help ensure the supply of safe produce for consumers.”
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