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FDA Releases a New EPA-Approved Protocol for Evaluating the Efficacy of Antimicrobial Pesticides in Agricultural Water

In the United States between 2009 and 2018, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) identified 40 outbreaks of food-borne illness with a confirmed or suspected link to leafy greens and Shiga toxin-producing E. coli (STEC).  Although agricultural water is one of the main vehicles through which leafy greens and other produce can become contaminated with E. coli O157:H7 and other foodborne pathogens, there are no antimicrobial treatment products registered with the Environmental Protection Agency (EPA) for use in agricultural water sources.

On July 30, 2020, FDA announced the release of a new testing protocol, formed in partnership with EPA, to facilitate companies’ efforts to develop and register antimicrobial products designed to treat preharvest agricultural water.  The protocol was first revealed during an FDA Center for Food Safety and Applied Nutrition webinar on its 2020 Leafy Greens STEC Action Plan, and was introduced as a way to address the identified need to further protect agricultural water sources from pathogen contamination.  The new protocol establishes an agricultural water panel assay that companies can use to test the capability of their water treatment products to combat strains of ListeriaSalmonella, and E. coli frequently responsible for foodborne illnesses.  EPA’s endorsement of this protocol enables companies that follow its steps to use the testing data generated to support an application for registration of new products or to revise the labels of existing products as being for use against microbial contamination in preharvest agricultural water.

FDA cites the new EPA-approved protocol for evaluating the efficacy of antimicrobial pesticides in agricultural water as an important prevention step towards food safety, taken as part of its Leafy Greens STEC Action Plan and New Era of Smarter Food Safety Initiative (which includes a 10-year blueprint released on July 13, 2020, as discussed here).

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 216


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...