Contains Nonbinding Recommendations 
 
Draft Not for Implementation 
 
 
 
Supplemental Questions and 
Answers Regarding Food 
Facility Registration: Draft Guidance 
for Industry 
 
Draft Guidance 
This guidance is being distributed for comment purposes only. 
 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure 
that the Agency considers your comment on this draft guidance before it begins work on the 
final version of the guidance, submit either electronic or written comments on the draft guidance 
within 60 days of publication in the Federal Register of the notice announcing the availability of 
the draft guidance.  Submit electronic comments to https://www.regulations.gov.  Submit 
written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should be identified with 
the docket number FDA-2012-D-1002 listed in the notice of availability that publishes in the 
Federal Register. 
 
For questions regarding this draft document, contact FDAs Technical Assistance Network by 
submitting the form available at 
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm. 
 
You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to https://www/regulations.gov.  Submit written comments on the guidance 
to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.  All comments should be identified with the docket 
number FDA-2012-D-1002 listed in the notice of availability that publishes in the Federal 
Register.   
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration  
Office of Foods and Veterinary Medicine 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
Office of Regulatory Affairs 
 
August 2018 
1 
    Contains Nonbinding Recommendations 
 
Draft Not for Implementation 
 
 
Table of Contents 
 
 
I. INTRODUCTION .................................................................................................... 3 
II. QUESTIONS AND ANSWERS ............................................................................. 4 
A.  Who Must Register? ........................................................................................... 4 
 
2 
    Contains Nonbinding Recommendations 
 
Draft Not for Implementation 
 
 
Supplemental Questions and Answers 
Regarding Food 
Facility Registration: Draft Guidance 
1
for Industry
 
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration (FDA or we) on this topic.  It does not establish any rights for any person and is 
not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative approach, contact 
FDAs Technical Assistance Network by submitting your information at 
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.     
 
I. INTRODUCTION 
 
On October 10, 2003, the Food and Drug Administration (FDA or we) issued an interim final 
rule to implement amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 
(Bioterrorism Act) (Pub. L. 107-188) (68 FR 58894). Section 415 of the FD&C Act (21 
U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold 
food for human or animal consumption in the United States to register with FDA.  This 
guidance was developed to answer frequently asked questions relating to the registration 
requirements of section 415 of the FD&C Act. 
 
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011, 
amended the food facility registration requirements in section 415 of the FD&C Act. 
 
FDA first issued a guidance document with questions and answers regarding food facility 
registration requirements on December 4, 2003.  That guidance was issued as Level 2 guidance 
pursuant to Title 21, Code of Federal Regulations (CFR), Section 10.115 (21 CFR 10.115).  The 
most recent edition of the guidance (the Seventh Edition) was issued as Level 1 guidance pursuant 
to 21 CFR 10.115 in August 2018, and includes updated questions and answers relating to food 
facility registration.   
 
                                                           
1 This guidance has been jointly prepared by the Office of Compliance in the Center for Food Safety and Applied 
Nutrition, the Office of Surveillance and Compliance in the Center for Veterinary Medicine, and the Office of 
Regulatory Affairs at the U.S. Food and Drug Administration 
3 
    Contains Nonbinding Recommendations 
 
Draft Not for Implementation 
 
We are issuing these supplemental questions and answers as draft guidance pursuant to 21 CFR 
10.115.   We are issuing this supplement because FDA continues to receive questions that highlight 
the need to provide guidance on registration requirements in situations where multiple entities are 
involved in the use of shared physical space, such as where one entity owns a building and lessees 
manufacture/process, pack or hold food in the building.  FDA has drafted several questions and 
answers to clarify our thinking about who should register in these situations.  We intend to finalize 
this guidance by incorporating these questions and answers into a future edition of the Questions 
and Answers Regarding Food Facility Registration: Guidance for Industry. 
 
I, you, your or registrant are used in this guidance to refer to the owner, operator, or 
agent in charge of a facility that manufacturers/processes, packs, or holds food for consumption 
in the United States. 
 
FDAs 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 Agency guidances means that something is suggested or 
recommended, but not required. 
 
II. QUESTIONS AND ANSWERS 
 
A.  Who Must Register? 
 
A.22  If a manufacturer leases the building where it manufactures food, is the manufacturer 
required to register?  Is the owner of the building where the food is manufactured required 
to register the building?   
 
An establishment under one ownership at one general physical location that 
manufactures/processes food in a leased space is a food facility.  Therefore, food manufacturers 
are required to register even if the physical location where they conduct manufacturing is leased.   
If the building owner/lessor never has physical control over the food, then the owner/lessor is not 
manufacturing/processing, packing, or holding food.  Consequently, the building owner/lessor is 
not required to register the building as a facility.   
 
A.3  If a manufacturer stores food in a self-storage warehouse, is the manufacturer 
required to register its storage unit? Is the warehouse required to be registered?  Is the 
answer different if the food is stored in a third-party logistics warehouse?     
 
Manufacturer Storing Food in Self-Storage Warehouse 
An establishment under one ownership at one general physical location that holds food in a leased 
space is a facility required to register.  If the manufacturer keeps physical control over the food in 
                                                           
2 We start the numbering here at A.2 because question A.1 already exists in the Seventh Edition of the Questions and 
Answers Regarding Food Facility Registration Guidance. 
4 
    Contains Nonbinding Recommendations 
 
Draft Not for Implementation 
 
its storage unit, the manufacturer is holding food and is required to register the self-storage unit as 
a facility.   
 
Owner of a Self-Storage Warehouse 
In a typical self-storage warehouse, the owner of the warehouse/lessor has no physical control 
over the food and therefore is not holding food.  Consequently, the warehouse owner/lessor is not 
required to register the warehouse as a facility.       
 
Third-Party Logistics Warehouse 
In contrast, a typical third-party logistics warehouse has sole physical control over the food stored 
in the warehouse.  In this case the warehouse is a structure (or establishment) under one 
ownership at one general physical location that holds food. Therefore, the owner, operator, or 
agent in charge of the warehouse must register the warehouse as a facility.   
 
A.4  Some manufacturers use a commercial communal kitchen that is used by multiple 
manufacturers that share responsibility with the landlord for maintenance of common 
facility infrastructure and common equipment.  Who is required to register?  
 
Each manufacturer using the kitchen is an establishment under one ownership at one general 
physical location that manufactures/processes, packs, or holds food and therefore is a facility 
required to register.  In addition, a landlord/lessor that has physical control over food at any time 
(e.g., responsibility for food in a common storage area in a communal kitchen) is required to 
register because it is an establishment or structure under one ownership at one general physical 
location holding food.     
 
 
 
5