FDA Updates Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water

FDA Produce May 18, 2022

Two updates have been made since we first released the protocol in July 2020:

  • On April 12, 2021, the FDA announced that they had worked with EPA to update the protocol to allow companies and other agricultural water stakeholders to use non-GLP (Good Laboratory Practice) data in their submissions, provided that the submissions accurately represent how the study differs from the GLP standards in the 40 CFR 160.12 statement of non-compliance. This action gives companies and other agricultural stakeholders access to more laboratories that can conduct the efficacy studies needed to aid in the registration of antimicrobial treatments for preharvest agricultural water. 
  • In April 2022, the FDA again worked with the EPA to amend the contact time in the protocol, changing it from a maximum of 1-minute to “up to 5 minutes.” This change is being made to meet the current need scientifically and practically.

These changes are reflected in the Efficacy Protocol and U.S. Environmental Protection Agency Protocol Review. 

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