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  1. Food Safety Modernization Act (FSMA)

Efficacy Protocol for Reduction of Foodborne Bacteria in Preharvest Agricultural Water

Update: January 6, 2023

The U.S. Food and Drug Administration has worked with the Environmental Protection Agency (EPA) to update the protocol to remove Listeria monocytogenes (L. monocytogenes) from the organism test panel. This change is being made because pilot studies have found that sanitizer treatments that will likely be effective for E. coli and Salmonella may be different from those that are most effective for L. monocytogenes. This is likely due to the physical characteristics of E. coli and Salmonella being distinctly different from those of L. monocytogenes. In light of recent outbreaks of Shiga toxin-producing E. coli (STEC) and Salmonella linked to produce, FDA and EPA agreed and decided to move forward with removing L. monocytogenes from the panel. We expect that doing so will facilitate the registration of antimicrobial treatments against STECs (and other E. coli) and Salmonella in pre-harvest agricultural water, the availability of which will be a significant resource for farms to protect their crops against these pathogens. While we are removing L. monocytogenes from the protocol at this time, companies may opt to continue testing against L. monocytogenes for inclusion in their registration with EPA.

Update: May 17, 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

Agricultural water can be a major conduit of pathogens that can contaminate produce. FDA recognizes that effective treatments could be a valuable tool in helping to prevent foodborne illness associated with the consumption of produce. However, there are currently no registered antimicrobial treatment products that are authorized to control microorganisms of public health significance for use on agricultural fields, or for treatment of irrigation water systems or ponds.

A testing protocol, which is intended to help companies develop data on the effectiveness of their products in inactivating pathogens, such as E. coli or Salmonella, in preharvest agricultural water, was developed through a collaboration between scientists in FDA’s Center for Food Safety and Applied Nutrition and subject matter experts at the Environmental Protection Agency (EPA). EPA’s approval of this protocol means that companies and other agricultural water stakeholders may use the data developed using the protocol to support registration of new treatment products, or amendments to current products’ labels, for use against foodborne pathogens in preharvest agricultural water.

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