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GUIDANCE DOCUMENT

Guidance for Industry: Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains September 2023

Download the Final Guidance Document Read the Federal Register Notice
Final Level 2 Guidance
Docket Number:
FDA-2020-D-1139
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Human Foods Program

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases. 

During the Coronavirus Disease 2019 (COVID-19) pandemic, FDA was asked whether refrigerated food transport vehicles and refrigerated food storage units used for the temporary preservation of human remains subsequently can be used to transport and store human and animal food.  In May 2020, FDA issued a previous version of 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 information in the guidance, however, also can be applied to situations where there is a temporary need for refrigerated food transport vehicles and refrigerated food storage units to temporarily hold human remains and where those vehicles and storage units are to be used subsequently to transport and hold human and animal food.  Thus, we have revised the guidance so that it is no longer limited to the COVID-19 pandemic.

The recommendations in this guidance are intended to supplement existing food safety regulations and guidance. [1] 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), Environmental Protection Agency (EPA), Centers for Disease Control and Prevention, and 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.

In general, 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 guidance means that something is suggested or recommended, but not required. 

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[1] 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. 

Related Information

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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 .

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