The first-ever registration of an antimicrobial treatment for foodborne pathogens in preharvest agricultural water has been approved by the U.S. Environmental Protection Agency (EPA), setting a new precedent for preharvest agricultural water treatments specifically intended to reduce the presence of pathogens that affect food safety.

The successful registration of SANIDATE 12.0 is the result of a collaborative effort between EPA and the U.S. Food and Drug Administration (FDA) to develop and refine an efficacy protocol to support such registrations. Using the revised efficacy protocol, the University of Arizona and industry members worked together to register SANIDATE 12.0 for use against foodborne pathogens like Escherichia coli and Salmonella in preharvest agricultural water, and to provide feedback on the protocol that informed updates regarding testing parameters and to clarify the protocol for future users.

Prior to this registration, chemical applications for use in preharvest agricultural water were limited to treatments for the management of algae and biofilm formation or to mitigate produce rot.

Outbreaks of foodborne illness associated with the consumption of produce (for example, the recent multistate Escherichia coli outbreak linked to fresh onions served at McDonald’s restaurants) have highlighted the need for additional tools to help control foodborne pathogens in agricultural water.

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.

FDA and EPA encourage future registrations using the revised efficacy protocol for registering new treatment products or to amend current labels for combating foodborne pathogens in preharvest agricultural water.