- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition
This guidance is intended to remain in effect until November 7, 2023.
For further information, refer to 88 FR 15417, March 13, 2023.
In April 2023, FDA issued guidance to help explain how farms may transition from this temporary policy back to the usual qualified exempt criteria in the Produce Safety Rule.
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to announce flexibility in the eligibility criteria for the qualified exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule) (21 CFR Part 112) due to disruptions to the supply chain for the duration of the COVID-19 public health emergency.
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, and renewed for 90 days on April 21, 2020, effective April 26, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)). When the public health emergency concludes, FDA intends to issue additional guidance regarding the eligibility criteria for the qualified exemption from the Produce Safety Rule, which depends on the calculation of a three-year average as described below.
Given this public health emergency, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with statutory requirement and the Agency’s good guidance practices.
In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s 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 Agency guidance means that something is suggested or recommended, but not required.
- 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 (Issued April 2023)
- Constituent Update: FDA Issues Guidance for Qualified Exempt Farms that Utilized Temporary Flexibilities During COVID-19 Public Health Emergency (April 13, 2023)
- Constituent Update: FDA Issues Federal Register Notice to Announce Status of COVID-19 Guidance Documents When Public Health Emergency Expires (March 10, 2023)
- Produce & Plant Products Guidance Documents & Regulatory Information
- Food Safety Modernization Act (FSMA)
- FSMA Final Rule on Produce Safety
- Food Safety and the Coronavirus Disease 2019 (ARCHVIED)
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-1386.