GUIDANCE DOCUMENT
Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency Guidance for Industry April 2020
- Docket Number:
- FDA–2020–D–1139
- Issued by:
-
Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition,Office of Food Safety
The Food and Drug Administration (FDA or we) 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.
We encourage all shell egg producers to continue to comply with applicable requirements of 21 CFR part 118 (the Egg Safety Rule). However, due to the increased consumer demand for eggs in the table egg market (e.g., sold directly to consumers in retail establishments), we are providing temporary flexibility to allow producers who currently only sell eggs to facilities for further processing (e.g., into “egg products”) to sell to the table egg market, provided certain circumstances are present.
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Services (PHS) Act (42 U.S.C. 247d(a)(2)).
Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled “Process for Making Available Guidance Documents Related to Coronavirus Disease 2019,” available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf, 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 FD&C Act and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the FDA’s good guidance practices.
Related Information
- FDA COVID-19 Information
- Food Safety and the Coronavirus Disease 2019 (COVID-19)
- Eggs Guidance Documents & Regulatory Information
- Retail Food Protection
Submit Comments
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:
Dockets Management
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–1139.