June 26, 2022

Volume XII, Number 177

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June 24, 2022

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FDA Updates Agricultural Water Protocol

  • As previously reported, on July 30, 2020, FDA worked with EPA to release a protocol to evaluate the efficacy of antimicrobial pesticides in agricultural water. The protocol established an agricultural water panel assay that companies could use to test the capability of their water treatment processes to combat strains of Listeria, Salmonella and E. coli frequently responsible for foodborne illnesses.

  • On May 17, 2022, FDA announced that it had formally updated its protocol to reflect two earlier changes that had been made since the protocol was first released.  In April 2021, FDA updated the protocol to allow companies and other agricultural water stakeholders to use data that did not comply with good laboratory practices (non-GLP) in their submissions, provided that the submissions accurately represented how the study differed from GLP standards. This change was intended to give companies and agricultural stakeholders access to more laboratories.  In April 2022, FDA amended the contact time in the protocol, changing the maximum from 1 minute to “up to 5 minutes.” This change was intended to meet current practical and scientific needs.

  • The changes are now reflected in the Efficacy Protocol and EPA Protocol Review although this document continues to be dated April 29, 2020.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 139
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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...

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