- We reported on FDA's July 30, 2020 release of a testing protocol for the development of new antimicrobial products that could be registered with EPA to treat preharvest agricultural water. More specifically, the FDA protocol is for use in evaluating treatments for inactivating shiga toxin-producing E. coli (STEC), including E. coli O157:H7, and other pathogens that may contaminate water used on agricultural fields. The protocol is an important part of FDA's 2020 Leafy Greens STEC Action Plan. It was formally updated on May 17, 2022 to reflect an April 2021 allowance for some data that do not comply with good laboratory practices (GLP) and an April 2022 amendment changing the maximum contact time from 1 minute to "up to 5 minutes."
- On January 6, 2022, in agreement with EPA, FDA updated the protocol once again to remove Listeria monocytogenes from the organism test panel based on pilot studies finding 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. The April 20, 2020, EPA memorandum shows this change to the protocol at page 2. The agencies expect that removing L. monocytogenes from the test panel will facilitate the registration of antimicrobial treatments against STECs (and other E. coli) and Salmonella in pre-harvest agricultural water.
- FDA concurrently states that companies may continue testing against L. monocytogenes for inclusion in their registration with EPA at their option. We will continue to monitor developments impacting FDA's Leafy Greens STEC Action Plan.
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