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Source: FDA, 5/17/22 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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