Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic Guidance for Industry May 2020
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary MedicineCenter for Food Safety and Applied Nutrition
This guidance is intended to remain in effect until November 7, 2023, unless superseded by a revised final guidance before that date.
For further information, refer to 88 FR 15417, March 13, 2023.
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA has been asked whether refrigerated food transport vehicles and refrigerated food storage units used for the temporary preservation of human remains during the COVID-19 pandemic subsequently can be used to transport and store human and animal food. FDA is issuing this guidance to provide information and resources related to the cleaning and disinfection of such vehicles and storage units to address food safety before they are used again to transport and store food. The recommendations in this guidance are intended to supplement existing food safety regulations and guidance.  Other aspects of cleaning and disinfection, such as worker, environmental, and vehicle safety, are addressed by other federal agencies, such as the Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency (EPA), The Centers for Disease Control and Prevention, and the Department of Transportation (DOT), as well as State and local government agencies. Several additional resources related to these topics are included in Section IV of this document.
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 our 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.
 For example, FDA’s Sanitary Transportation of Human and Animal Food (21 CFR part 1 subpart O), Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR part 117) and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR part 507) regulations contain requirements regarding the safe storage and transportation of human and animal food that also may apply.
- FDA Issues Federal Register Notice to Announce Status of COVID-19 Guidance Documents When Public Health Emergency Expires March 10, 2023
- FDA COVID-19 Information
- Food Safety and the Coronavirus Disease 2019 (COVID-19)
- Sanitation & Transportation Guidance Documents & Regulatory Information
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-1139 .