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GUIDANCE DOCUMENT

Guidance for Industry: Transition from Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption April 2023

Download the Final Guidance Document
Final
Docket Number:
FDA-2023-D-1031
Issued by:
Guidance Issuing Office
Human Foods Program

This guidance is intended for farms subject to the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule) (21 CFR Part 112). For certain farms, the Produce Safety Rule provides a qualified exemption; qualified exempt farms are subject to modified rule requirements. During the COVID-19 public health emergency as declared by the Secretary of the U.S. Department of Health and Human Services (HHS), FDA provided certain temporary flexibilities related to eligibility criteria for the qualified exemption. This document communicates FDA’s current thinking on how, when the COVID-19 public health emergency expires, qualified exempt farms may transition away from those temporary policies and back to the qualified exemption eligibility criteria as established in the Produce Safety Rule. 

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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All written comments should be identified with this document's docket number: FDA-2023-D-1031.

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