Clarification on Food Establishment 
Waiver from Requirements of the 
Sanitary Transportation of Human and 
Animal Food Rule: Guidance for 
Industry  
 
 
      Additional copies are available from:    
Office of Food Safety HFS-300 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
  College Park, MD  20740   
(Tel) 240-402-2166 
http://www.fda.gov/FoodGuidances 
 
 
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 Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should 
be identified with the title of the guidance document.   
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
August 2017  Contains Nonbinding Recommendations 
Table of Contents  
 
 
 
I.    Introduction   
 
II.    Background  
 
III.   Discussion  
 
IV.  References  
   
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  Contains Nonbinding Recommendations 
 
 
Clarification on Food Establishment 
Waiver from Requirements of the 
Sanitary Transportation of Human and 
Animal Food Rule: Guidance for 
1
Industry   
 
 
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA, that 
Agency, 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 the FDA staff 
responsible for this guidance as listed on the title page.  
 
 
 
I.  Introduction  
 
This guidance is intended for those persons who are subject to the Sanitary Transportation of 
Human and Animal Food Rule (81 FR 20091), published on April 6, 2016.  Specifically, this 
guidance provides clarification on the scope of the waiver for food establishments that provide 
food directly to consumers from the requirements of the Sanitary Transportation of Human and 
Animal Food Rule (the food establishment waiver) in response to questions the Agency has 
received since publication of the final rule.  
 
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 guidances means that something is suggested or 
recommended, but not required.  
   
                                                 
1 This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and Applied Nutrition. 
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  Contains Nonbinding Recommendations 
 
II.  Background  
 
In a proposed rule published on February 5, 2014 (79 FR 7006), entitled Sanitary 
Transportation of Human and Animal Food, the Agency announced that it had tentatively 
determined that, in accordance with the provisions of Section 416 [21 U.S.C  305e] of the 
Federal Food, Drug & Cosmetics Act (FD&C Act), it would be appropriate to waive the 
applicable provisions of the rule under specific circumstances.  The final rule was published on 
April 6, 2016 (81 FR 20091) with an effective date of June 6, 2016, and an initial compliance 
date of April 6, 2017.  FDA published three waivers from the requirements of the Sanitary 
Transportation of Human and Animal Food Rule in the Federal Register on April 6, 2017 (82 FR 
16733).  Following publication of the waivers, FDA received questions regarding the scope of 
the food establishment waiver, which waives the requirements of the rule for:  
 
1.  Businesses subject to the requirements of part 1, subpart O, that are permitted or 
otherwise authorized by the regulatory authority to operate a food establishment that 
provides food directly to consumers (i.e., restaurants, retail food establishments2, and 
nonprofit food establishments as defined in 21 CFR 1.227), only when engaged in 
transportation operations as: 
a.  Receivers, whether the food is received at the establishment itself or at a location 
where the authorized establishment receives and immediately transports the food 
to the food establishment; 
b.  shippers and carriers in operations in which food is transported from the 
establishment as part of the normal business operations of a retail establishment, 
such as: 
i.  Delivery of the food directly to the consumer(s) by the authorized 
establishment or a third-party delivery service, or 
ii.  Delivery of the food to another location operated by the authorized 
establishment or an affiliated establishment where the food is to be sold or 
served directly to the consumer(s). 
 
Specifically, the Agency received questions asking if the term retail food establishment applies 
to businesses that only sell animal food, because retail food establishments, as defined by 21 
CFR 1.227, can encompass establishments that sell human food as well as establishments that 
sell food for animals.  We are issuing this guidance to clarify that the retail food establishment 
waiver applies to establishments that are permitted or otherwise authorized by the regulatory 
authority to sell human food.  We are also clarifying that these establishments, that are permitted 
or otherwise authorized by the regulatory authority to sell human food, that sell both human and 
animal food also fall under the retail food establishment waiver.  The retail food establishment 
                                                 
2 For more information on the types of animal food establishments that may meet the definition of a retail food 
establishment, please see Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration 
(Seventh Edition) at B.2.16, available at: 
https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/fooddefense/ucm331959.ht
m 
 
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waiver does not extend to establishments that sell food for animals and do not sell food for 
humans.   
 
III.  Discussion  
 
The purpose of this guidance is to clarify what is meant by the term "permitted or otherwise 
authorized" and retail food establishment as used in the waiver, in light of questions that have 
arisen since the publication of the final waiver about whether this waiver extends to 
establishments that only sell animal food.  
When the waivers were published on April 6, 2017 (82 FR 16733), FDA clarified that the term 
food establishment collectively represents specific types of establishments subject to the 
waiver, which are defined in 21 CFR 1.227, including restaurants, retail food establishments and 
non-profit food establishments, that hold valid permits as initially described in the proposed rule 
published on February 5, 2014 (79 FR 7006).  Using the term food establishment in this 
manner does not broaden the scope of this waiver to include establishments that only provide 
food for animals directly to consumers.  This is because the agencys intent in granting this 
waiver is that it only be applicable to establishments that are permitted or otherwise authorized 
by regulatory authorities under each regulatory authority's adoption of requirements that are 
based on FDAs Food Code.  These regulatory authorities are already performing food safety and 
regulatory oversight and inspection activities for their permitted or otherwise authorized retail 
food establishments through state and local regulations modeled after the FDAs Food Code.  
This intent was expressed in the preamble of the proposed rule in which FDA discussed the 
reasons why it intended to grant the food establishment waiver.  FDA stated that for the purpose 
of establishing the scope of this waiver, we intend to define food establishment using the 
definition set forth in the 2009 edition of the FDAs Food Code, which includes only operations 
that provide food for human consumption (79 FR 7030). In this regard, in both the 2009 and the 
current (2013) editions of the FDAs Food Code, food establishment means an operation that: 
  Stores, prepares, packages, serves, vends food directly to the consumer, or otherwise 
provides food for human consumption such as a restaurant; satellite or catered feeding 
location; catering operation if the operation provides food directly to a consumer or to a 
conveyance used to transport people; market; vending location; conveyance used to 
transport people; institution; or food bank; and 
  Relinquishes possession of food to a consumer directly or indirectly through a delivery 
service such as home delivery of grocery orders or restaurant takeout orders, or delivery 
service that is provided by common carriers. 
Therefore, consistent with the discussion of the scope of the food establishment waiver in the 
proposed rule, the waiver only applies to establishments that are permitted or otherwise 
authorized by the regulatory authority to sell human food.  
With regard to such retail food establishments that also sell food for animal consumption, the 
waiver would also cover any animal food that they handle.  For any animal food that is covered 
under the rule, the same public health practices that they are implementing to ensure the safety of 
human food at their establishments (e.g., temperature controls) would also apply to their 
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handling of animal food.  As a result, we do not think that this waiver will result in the 
transportation of food under conditions that will be unsafe for human or animal health or that 
will be contrary to the public interest. 
 
IV. References  
The following references are on display in the Division of Dockets Management, Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov.  FDA has verified the Web site 
addresses, as of the date this document publishes in the Federal Register, but Web sites are 
subject to change over time.  
 
 
1. FDA, "Food Code 2009, 2009, available at: 
https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/ucm2019396.ht
m 
 
2. FDA, "Food Code 2013, 2013, available at: 
https://www.fda.gov/food/guidanceregulation/retailfoodprotection/foodcode/ucm374275.htm  
 
 
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