Contains Nonbinding Recommendations 
 
 
 
 
Sanitary Transportation of Human and 
Animal Food: What You Need to Know 
About the FDA Regulation:  
Guidance for Industry  
Small Entity Compliance Guide 
Additional copies are available from: 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740 
(Tel) 240-402-1700 
 http://www.fda.gov/FoodGuidances 
 
You may submit either 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-2013-N-0013 listed in the notice of availability that publishes in the 
Federal Register.   
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition  
November 2017 
 
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TABLE OF CONTENTS
I.  INTRODUCTION ................................................................................................................... 5 
A.  Purpose of this Compliance Guide ...................................................................................... 6 
B.  Key Requirements ................................................................................................................ 6 
II.  WHO MUST COMPLY WITH THE RULE? ........................................................................ 6 
A.  Definitions............................................................................................................................ 7 
B.  Who is exempt from the requirements for the Sanitary Transportation Rule? .................... 8 
C.  Has FDA issued any waivers? ............................................................................................. 9 
D.  Do I have any modified requirements if I am a small business? ....................................... 10 
III.  WHEN DO I HAVE TO COMPLY WITH THE RULE?..................................................... 10 
IV.  VEHICLES AND TRANSPORTATION EQUIPMENT ..................................................... 10 
A.  What is a vehicle? .............................................................................................................. 10 
B.  What can be considered transportation equipment? .......................................................... 11 
C.  What requirements apply to vehicles and transportation equipment? ............................... 11 
D.  Are there specific requirements for vehicles and transportation equipment for food 
requiring temperature control for safety? .................................................................................. 11 
V.  TRANSPORTATION OPERATIONS.................................................................................. 11 
A.  General Requirements ........................................................................................................ 11 
1.  If I am both a shipper and a carrier, what requirements am I subject to? ...................... 11 
2.  Can I reassign my responsibilities under the rule to another person? ............................ 12 
3.  Who in my company is responsible for making sure that we are following the 
requirements of this rule? ...................................................................................................... 12 
4.  Are there requirements for transportation operations that everyone subject to the rule 
must meet, in addition to the specific requirements that only apply to specific persons, such 
as shippers or carriers? .......................................................................................................... 12 
5.  Are the requirements of the rule the same for the transportation of human and animal 
food? ...................................................................................................................................... 13 
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6.  What am I required to do if I notice that food that requires temperature control has been 
transported in a way in which it could become unsafe, such as in very hot weather on a truck 
without a refrigeration unit? .................................................................................................. 13 
B.  Requirements Applicable To Shippers Engaged In Transportation Operations ................ 13 
1.  As a shipper, what are my responsibilities under this rule? ........................................... 13 
2.  If I establish an agreement with my carrier to implement some of my written 
procedures, what are my responsibilities with respect to working with my carrier? ............ 14 
C.  Requirements Applicable To Loaders Engaged in Transportation Operations ................. 15 
D.  Requirements Applicable To Receivers Engaged in Transportation Operations .............. 15 
E.  Requirements Applicable To Carriers Engaged In Transportation Operations ................. 15 
1.  Do the requirements of the rule always apply to carriers who transport food? ............. 15 
2.  What are the specific requirements for carriers when a shipper-carrier agreement has 
been established? ................................................................................................................... 15 
VI.  TRAINING ............................................................................................................................ 16 
A.  What training requirements apply to carriers? ................................................................... 16 
B.  When must training be provided? ...................................................................................... 17 
C.  Do I have to keep records of the training? ......................................................................... 17 
D.  Where can I get training for this rule? ............................................................................... 17 
VII. Records .................................................................................................................................. 17 
A.  What records am I required to make and keep? ................................................................. 17 
B.  What are the requirements for my records? ....................................................................... 19 
C.  Do my records have to be in electronic format? ................................................................ 19 
D.  How long must I retain my records? .................................................................................. 19 
E.  Can I store my records offsite? .......................................................................................... 19 
F.  Do I have to make my records available to FDA officials? ............................................... 20 
G.  If FDA collects or copies my records are they protected from public disclosure? ............ 20 
VIII.  WAIVERS ...................................................................................................................... 20 
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A.  What is a waiver? ............................................................................................................... 20 
B.  How does FDA issue a waiver? ......................................................................................... 20 
C.  When will FDA consider issuing a waiver? ...................................................................... 21 
D.  Can FDA modify or revoke a waiver it has issued? .......................................................... 21 
E.  Has FDA issued any waivers? ........................................................................................... 21 
IX.  DEFINITIONS ...................................................................................................................... 21 
 
   
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Sanitary Transportation of Human and 
Animal Food: What You Need to Know 
About the FDA Regulation: Guidance for 
1
Industry   
Small Entity Compliance Guide 
This guidance represents the Food and Drug Administrations (FDA or Agency) current thinking 
on this topic.  It does not establish any rights for any person and does not bind 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 using the contact information on the title page. 
I.  INTRODUCTION 
The FDA Food Safety Modernization Act of 2011 (FSMA) directs the Food and Drug 
Administration (FDA) as the food regulatory agency of the U.S. Department of Health and 
Human Services to better protect public health by, among other things, adopting a modern, 
preventive, and risk-based approach to food safety regulation.  On April 6, 2016, FDA published 
in the Federal Register a final rule, Sanitary Transportation of Human and Animal Food 
(Sanitary Transportation rule) (81 FR 20091), that establishes requirements for shippers, loaders, 
carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, 
including food for animals, to use sanitary transportation practices to ensure the safety of the 
food they transport.  The final rule became effective on June 6, 2016. Compliance dates are 
staggered  see WHEN DO I HAVE TO COMPLY WITH THE RULE? 
 
We have prepared this Small Entity Compliance Guide in accordance with section 212 of the 
Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by 
Public Law 110-28).  This guidance document is intended to assist small entities in complying 
                                                 
1 This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and Applied Nutrition 
at the U.S. Food and Drug Administration. 
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  Contains Nonbinding Recommendations 
 
 
with the rule set forth in 21 CFR Part 1, subpart O concerning Sanitary Transportation of Human 
and Animal Food.  The rule is binding and has the full force and effect of law. 
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.  
A.  Purpose of this Compliance Guide  
 
This guide was developed to inform shippers, receivers, loaders, and carriers engaged in 
transportation operations about the Sanitary Transportation rule and how to comply with it.  It 
contains important information that may affect your business. 
 
For additional information on the Sanitary Transportation rule, see 
https://www.fda.gov/food/guidanceregulation/fsma/ucm383763. 
B.  Key Requirements 
 
The rule establishes requirements for: 
 
  Vehicles and transportation equipment:  The design and maintenance of vehicles and 
transportation equipment to ensure that it does not cause the food that it transports to 
become unsafe.  (21 CFR 1.906)  
  Transportation operations: The measures taken during transportation to ensure food 
safety.  (21 CFR 1.908) 
  Training:  Training of carrier personnel in sanitary transportation practices and 
documentation of the training.  This training is required when the carrier and shipper 
establish an agreement that the carrier is responsible for sanitary conditions during 
transport. (21 CFR 1.910) 
  Records: Maintenance of records of written procedures, agreements and training 
(required of carriers).  (21 CFR 1.912) 
II.  WHO MUST COMPLY WITH THE RULE?  
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Generally, the requirements of the Sanitary Transportation rule apply to shippers, receivers, 
loaders, and carriers engaged in transportation operations whether or not the food is being 
offered for or enters interstate commerce.  (21 CFR 1.900(a)) 
A.  Definitions  
The Sanitary Transportation rule uses a number of terms in very specific ways. A full list of 
these terms appears in this guide in section IX. The terms defined here and in the section Who 
is exempt from the requirements of the Sanitary Transportation rule? will help you determine if 
your business is subject to the rule. (21 CFR 1.904) 
Table 1--Key Terms Used in Part 1, Subpart O 
Term  Definition 
Carrier  A person who physically moves food by rail or motor vehicle 
in commerce within the United States. The term carrier does 
not include any person who transports food while operating as 
a parcel delivery service.   
Loader  A person that loads food onto a motor or rail vehicle during 
transportation operations.   
Non-covered business  A shipper, loader, receiver, or carrier engaged in transportation 
  operations that has less than $500,000, as adjusted for 
inflation, in average annual revenues, calculated on a rolling 
basis, during the 3-year period preceding the applicable 
calendar year.  The baseline year for calculating the adjustment 
for inflation is 2011. 
Receiver  Any person who receives food at a point in the United States 
after transportation, whether or not that person represents the 
final point of receipt for the food.   
Shipper  A person, e.g., the manufacturer or a freight broker, who 
arranges for the transportation of food in the United States by a 
carrier or multiple carriers sequentially. 
Small business  1.  A business that is not a motor vehicle carrier and that 
employs fewer than 500 full-time equivalent 
employees, or 
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2.  A motor vehicle carrier that is not a shipper or receiver 
that has less than $27,500,000 in annual receipts. 
Transportation  Any movement of food in by motor vehicle or rail vehicle in 
commerce within the United States. 
B.  Who is exempt from the requirements for the Sanitary Transportation Rule?  
Non-covered businesses (see definition in Table 1) are not subject to the rule and therefore do 
not need to comply with the rule.  In addition, shippers, receivers, loaders, or carriers subject to 
the Sanitary Transportation rule do not need to comply with the rule when they are engaged in 
the following transportation operations and activities. 
Table 2--Exemptions for Part 1, Subpart O 
Exemption  Conditions 
Transportation operations of food that is   
transshipped through the U.S. to another 
country 
 
21 CFR 1.900(b)(1) 
 
Transportation operations of food that is   
imported for future export 
21 CFR 1.900(b)(2) 
Transportation operations of food located in   
food facilities that are regulated exclusively, 
throughout the entire facility, by the U.S. 
Department of Agriculture under the Federal 
Meat Inspection Act, the Poultry Products 
Inspection Act, or the Egg Products Inspection 
Act 
21 CFR 1.900(b)(3) 
Transportation activities performed by a farm   
21 CFR 1.904 Transportation operations 
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Exemption  Conditions 
Transportation of compressed food gases   
21 CFR 1.904 Transportation operations 
Transportation of food contact substances  Food contact substances as defined in section 
409(h) of the Federal Food, Drug, and 
21 CFR 1.904 
Cosmetic Act 
Transportation of human food byproducts for  See definition of Transportation operations 
use as animal food without further processing 
21 CFR 1.904 Transportation operations 
Transportation of food that is completely  Except a food that requires temperature control 
enclosed by a container   for safety 
21 CFR 1.904 Transportation operations 
Transportation of live food animals  Except molluscan shellfish 
21 CFR 1.904 Transportation operations 
 
C.  Has FDA issued any waivers? 
Yes, FDA has waived the requirements of the Sanitary Transportation rule for three classes of 
businesses (see Section VIII for additional information about waivers): 
1.  Businesses holding valid permits that are inspected under the National Conference on 
Interstate Milk Shipments Grade A Milk Safety Program, only when transporting bulk 
and finished Grade A milk and milk products. 
2.  Businesses authorized by the regulatory authority to operate a food establishment (e.g., 
restaurants, grocery stores) when engaged in transportation as receivers, or as shippers 
and carriers in operations in which food is delivered directly to consumers, or to other 
locations the establishments or affiliates operate that serve or sell food directly to 
consumers. (This waiver applies to establishments that provide food for human 
consumption such as restaurants, supermarkets and home grocery delivery services.  
Establishments that only sell animal food are not included under this waiver.  For 
additional information refer to the Clarification on Food Establishment Waiver from 
Requirements of the Sanitary Transportation of Human and Animal Food Rule guidance 
at: 
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  Contains Nonbinding Recommendations 
 
 
https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulato
ryInformation/UCM571341.pdf). 
3.  Businesses that are certified and inspected under the requirements established by the 
Interstate Shellfish Sanitation Conferences (ISSC) National Shellfish Sanitation Program 
(NSSP) when transporting shellfish (such as oysters, clams, mussels or scallops) in 
vehicles permitted under ISSC authority. 
D.  Do I have any modified requirements if I am a small business? 
No, all of the requirements of the Sanitary Transportation rule apply to a small business. 
However a small business has an additional year before it is required to comply with the rule (see 
Section III).  (Also, a shipper, loader, receiver, or carrier engaged in transportation operations 
that has less than $500,000 in average annual revenues is not covered by the rule.  See section 
II.B.) 
III.  WHEN DO I HAVE TO COMPLY WITH THE RULE?  
We encourage you to comply with the Sanitary Transportation rule as soon as possible.  
However, we are not requiring you to comply with the rule right away. As shown in the table 
below, the amount of time we are allowing you to comply with the Sanitary Transportation rule 
depends on the size of your particular business. 
Table 3--Compliance Dates for the Sanitary Transportation Rule Based on Size of Business 
Size of Business  Compliance Date 
Small businesses, i.e., a business other  April 6, 2018 
than a motor vehicle carrier with fewer 
than 500 full-time equivalent 
employees, or a motor vehicle carrier 
that is not also a shipper or a receiver 
that has less than $27,500,000 in 
annual receipts 
 
Other businesses that do not qualify  April 6, 2017 
for exemptions 
IV.  VEHICLES AND TRANSPORTATION EQUIPMENT 
A.  What is a vehicle? 
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A vehicle is a land conveyance that is motorized, such as a motor vehicle, or that moves on 
rails, such as a railcar, which is used in food transportation operations. (21 CFR 1.904) 
B.  What can be considered transportation equipment? 
Transportation equipment means equipment used in food transportation operations and 
includes items such as bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, 
gaskets, loading systems, and unloading systems. Transportation equipment also includes a 
railcar not attached to a locomotive or a trailer not attached to a tractor. (21 CFR 1.904) 
C.  What requirements apply to vehicles and transportation equipment? 
Vehicles and transportation equipment used in transportation operations must:  
  Be designed and of such material and workmanship as to be suitable and adequately 
cleanable for their intended use to prevent the food they transport from becoming unsafe 
during transportation;  (21 CFR 1.906(a)) 
  Be maintained in such a sanitary condition for their intended use as to prevent the food 
they transport from becoming unsafe during transportation; and (21 CFR 1.906(b)) 
  Be stored in a manner that prevents their harboring pests or becoming contaminated in 
any other manner that could result in food for which they will be used becoming unsafe 
during transportation.  (21 CFR 1.906(d)) 
D.  Are there specific requirements for vehicles and transportation equipment for food 
requiring temperature control for safety? 
Yes, vehicles and transportation equipment used in the transportation of food requiring 
temperature control for safety must be designed, maintained, and equipped as necessary to 
provide adequate temperature control to prevent the food from becoming unsafe during 
transportation. (21 CFR 1.908(c)) 
V.  TRANSPORTATION OPERATIONS 
A.  General Requirements 
1.  If I am both a shipper and a carrier, what requirements am I subject to? 
You must meet the requirements for each function you perform that is subject to the rule, i.e., as 
a shipper, receiver, loader or carrier. Therefore if you are functioning as both the shipper and the 
carrier, you must meet both the shippers and the carriers requirements.  (21 CFR 1.908(a)(1)) 
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If you perform multiple functions under the rule, and are under the ownership or operational 
control of a single legal entity, as an alternative to meeting the rules specific requirements for 
shippers, receivers and carriers, you may operate under common, integrated written procedures 
that ensure the sanitary transportation of food consistent with the requirements of the Sanitary 
Transportation rule. Establishing these common integrated procedures may make it easier for 
you to comply with the rules requirements. These written procedures are subject to the records 
requirements of the rule which are discussed in Section VII. (21 CFR 1.908(a)(5)) 
2.  Can I reassign my responsibilities under the rule to another person?  
Yes you can, if the other person is also subject to the rule. For example, if you are a loader, under 
the rule you would be responsible for verifying that a truck has been pre-cooled as specified by 
the shipper prior to loading food that requires temperature control for safety. However, you may 
establish an agreement with the carrier to perform this verification check for you. The carrier will 
then have this responsibility under the rule. Your agreement with the carrier is subject to the 
records requirements of the rule discussed in Section VII. (21 CFR 1.908(a)(1)). 
3.   Who in my company is responsible for making sure that we are following the 
requirements of this rule? 
Supervisory level personnel in your company must be assigned the responsibility for making 
sure that your company is meeting the requirements of the Sanitary Transportation rule. (21 CFR 
1.908(a)(2)) 
4.   Are there requirements for transportation operations that everyone subject to the rule 
must meet, in addition to the specific requirements that only apply to specific persons, 
such as shippers or carriers? 
Yes. Everyone subject to the rule must do these things in their transportation operations: 
  You must take effective measures such as segregation, isolation, or the use of packaging 
to protect food from contamination by raw foods and nonfood items in the same load. (21 
CFR 1.908(a)(3)(i)) 
  You must take effective measures such as segregation, isolation, or other protective 
measures, such as hand washing, to protect food transported in bulk vehicles or food not 
completely enclosed by a container from contamination and cross-contact during 
transportation operations. (21 CFR 1.908(a)(3)(ii)) 
  You must take effective measures to ensure that food that requires temperature control 
for safety is transported under adequate temperature control. (21 CFR 1.908(a)(3)(iii)) 
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5.   Are the requirements of the rule the same for the transportation of human and animal 
food? 
Yes they are the same inasmuch as they require that food, whether human or animal food, be 
transported in a manner in which it will not become unsafe during transportation. However, we 
recognize that in certain instances, different practices to effectively accomplish this purpose have 
been established for the transportation of human and animal food. For example, certain types of 
equipment used for the transportation of human food and pet food use stainless steel food contact 
surfaces, while comparable equipment used for the transportation of animal feed uses a suitable 
non-stainless grade of steel called mild steel. (21 CFR 1.908(a)(4)) 
6.   What am I required to do if I notice that food that requires temperature control has 
been transported in a way in which it could become unsafe, such as in very hot weather 
on a truck without a refrigeration unit? 
If a person subject to this rule becomes aware of an indication of a possible material failure of 
temperature control or other conditions that may render the food unsafe during transportation, 
you must not sell or distribute the food and you must take appropriate action including, as 
necessary, communication with other parties to ensure that the food is not sold or otherwise 
distributed unless a determination is made by a qualified individual that the temperature 
deviation or other condition did not render the food unsafe.  (21 CFR 1.908(a)(6)) 
Therefore, if you are a receiver and your standard procedure is to reject a delivery if it shows an 
indication of severe temperature abuse or another serious problem, you must also take additional 
action such as calling the shipper or carrier and informing them of what you observed that may 
indicate that the food has become unsafe. It then becomes that persons responsibility to ensure 
that the food is not sold or otherwise distributed unless a determination is made by a qualified 
individual that the temperature deviation or other condition did not render the food unsafe.   
B.  Requirements Applicable To Shippers Engaged In Transportation Operations 
1.  As a shipper, what are my responsibilities under this rule? 
As a shipper, you must establish written procedures subject to the records requirements discussed 
in Section VII, that describe how you conduct your operations to ensure that food does not 
become unsafe during transportation. There are as many as 3 specific types of written procedures 
you must establish, depending upon the type of food you ship: 
  In all cases, as a shipper, you must develop and implement written procedures adequate 
to ensure that vehicles and equipment used in your transportation operations are in 
appropriate sanitary condition for the transportation of the food, i.e., they will prevent the 
food from becoming unsafe during the transportation operation. You may perform the 
measures to implement these procedures yourself, or they may be accomplished by the 
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carrier or another party subject to the rule under a written agreement subject to the 
records requirements discussed in Section VII.  (21 CFR 1.908(b)(3)) 
  If you ship food in bulk, you must also develop and implement written procedures 
adequate to ensure that a previous cargo does not make the food unsafe. You may 
perform the measures to implement these procedures yourself, or they may be 
accomplished by the carrier or another party subject to the rule under a written agreement 
subject to the records requirements discussed in Section VII.  (21 CFR 1.908(b)(4)) 
  If you ship food that requires temperature control for safety under the conditions of 
shipment you must also develop and implement written procedures to ensure that the 
food is transported under adequate temperature control. You may perform the measures 
to implement these procedures yourself, or they may be accomplished by the carrier or 
another party subject to the rule under a written agreement subject to the records 
requirements discussed in Section VII. These measures must include measures equivalent 
to those specified for carriers under 21 CFR 1.908(e)(1), (2) and (3) discussed in Section 
V. E.  (21 CFR 1.908(b)(2)) 
2.  If I establish an agreement with my carrier to implement some of my written 
procedures, what are my responsibilities with respect to working with my carrier? 
Depending upon the type of food you ship, you would have one or both of the following 
responsibilities: 
  Unless you take other measures as allowed by 21 CFR 1.908(b)(3) to ensure that vehicles 
and equipment used in your transportation operations are in appropriate sanitary 
condition for the transportation of the food, you must specify to the carrier and, when 
necessary, the loader, in writing, all necessary sanitary specifications for the carrier's 
vehicle and transportation equipment to achieve this purpose, including any specific 
design specifications and cleaning procedures. A one-time notification is sufficient unless 
the design requirements and cleaning procedures required for sanitary transport change 
based upon the type of food being transported, in which case you must notify the carrier 
in writing before the shipment. (21 CFR 1.908(b)(1)) 
  In addition, if you ship food that requires temperature control for safety under the 
conditions of shipment, unless you take other measures as allowed by 21 CFR 
1.908(b)(5) to ensure that adequate temperature control is provided during transportation 
of the food, you must specify in writing to the carrier, except a carrier who transports the 
food in a thermally insulated tank, and, when necessary, the loader, an operating 
temperature for the transportation operation including, if necessary, the pre-cooling 
phase. A one-time notification is sufficient unless a factor, e.g., the conditions of 
shipment, changes, necessitating a change in the operating temperature, in which case 
you must so notify the carrier in writing before the shipment. The information you submit 
to the carrier is subject to the records requirements discussed in Section VII. (21 CFR 
1.908(b)(2)) 
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C.  Requirements Applicable To Loaders Engaged in Transportation Operations 
As a loader, what are my responsibilities under the rule? 
  Before loading food not completely enclosed by a container onto a vehicle or into 
transportation equipment, you must determine, considering, as appropriate, any 
specifications provided by the shipper, that the vehicle or transportation equipment is in 
appropriate sanitary condition for the transport of the food, for example, it is in adequate 
physical condition, and free of visible evidence of pest infestation and previous cargo that 
could cause the food to become unsafe during transportation. You may accomplish this 
by any appropriate means. (21 CFR 1.908(c)(1)) 
  Before loading food that requires temperature control for safety, you must verify, 
considering, as appropriate, specifications provided by the shipper, that each 
mechanically refrigerated cold storage compartment or container is adequately prepared 
for the transportation of such food, including that it has been properly pre-cooled, if 
necessary, and meets other sanitary conditions for food transportation. (21 CFR 
1.908(c)(2)) 
D.  Requirements Applicable To Receivers Engaged in Transportation Operations 
As a receiver, what are my responsibilities under the rule? 
Upon receipt of food that requires temperature control for safety under the conditions of 
shipment, you must take steps to adequately assess that the food was not subjected to significant 
temperature abuse, such as determining the food's temperature, the ambient temperature of the 
vehicle and its temperature setting, and conducting a sensory inspection, e.g., for off-odors. (21 
CFR 1.908(d)) 
E.  Requirements Applicable To Carriers Engaged In Transportation Operations 
1.  Do the requirements of the rule always apply to carriers who transport food? 
The general requirements of the rule apply to all persons subject to the rule, i.e., shippers, 
receivers, loaders and carriers, at all times when they are engaged in the transportation of food. 
However the specific requirements for carriers in 21 CFR 1.908(e) only apply to the carrier when 
the carrier and shipper have established a written agreement that the carrier is responsible, in 
whole or in part, for sanitary conditions during the transportation operation. (21 CFR 1.908(e)) 
2.  What are the specific requirements for carriers when a shipper-carrier agreement has 
been established? 
When a shipper-carrier agreement has been established, the carrier is responsible for the 
following functions as applicable under the agreement: 
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  The carrier must ensure that vehicles and transportation equipment meet the shipper's 
specifications and are otherwise appropriate to prevent the food from becoming unsafe 
during the transportation operation. (21 CFR 1.908(e)(1)) 
  The carrier must, once the transportation operation is complete and if requested by the 
receiver, provide the operating temperature specified by the shipper, as discussed in 
Section V. B. 2, and, if requested by the shipper or receiver, demonstrate that it has 
maintained temperature conditions during the transportation operation consistent with the 
operating temperature. The demonstration may be accomplished by any appropriate 
means agreeable to the carrier and shipper, such as the carrier presenting measurements 
of the ambient temperature upon loading and unloading or time/temperature data taken 
during the shipment.  (21 CFR 1.908(e)(2)) 
  Before offering a vehicle or transportation equipment with an auxiliary refrigeration unit 
for use for the transportation of food that requires temperature control for safety under the 
conditions of the shipment during transportation, the carrier must pre-cool each 
mechanically refrigerated cold storage compartment as specified by the shipper, as 
discussed in Section V. B. 2.  (21 CFR 1.908(e)(3)) 
  If requested by the shipper, a carrier that offers a bulk vehicle for food transportation 
must provide information to the shipper that identifies the previous cargo transported in 
the vehicle. (21 CFR 1.908(e)(4)) 
  If requested by the shipper, a carrier that offers a bulk vehicle for food transportation 
must provide information to the shipper that describes the most recent cleaning of the 
bulk vehicle. (21 CFR 1.908(e)(5)) 
  A carrier must develop and implement written procedures subject to the records 
requirements discussed in Section VII that: 
  Specify practices for cleaning, sanitizing if necessary, and inspecting vehicles and 
o
transportation equipment that the carrier provides for use in the transportation of 
food to maintain the vehicles and the transportation equipment in appropriate 
sanitary condition as required by 21 CFR 1.906(b); 
  Describe how it will comply with the provisions for temperature control in 21 
o
CFR 1.908(e)(2), and; 
  Describe how it will comply with the provisions for the use of bulk vehicles in 21 
o
CFR 1.908(e)(4) and (5).  (21 CFR 1.908(e)(6)) 
VI.  TRAINING 
A.  What training requirements apply to carriers?  
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If you are a carrier and you have a contract with the shipper to be responsible for any sanitary 
conditions during transportation, you must provide adequate training for your personnel involved 
in food transportation operations. The training must provide an awareness of potential food 
safety problems that may occur during food transportation, basic sanitary transportation practices 
to address those potential problems, and the responsibilities of the carrier under the rule. (21 
CFR 1.910(a)) 
B.  When must training be provided? 
You must provide the training when you hire personnel for food transportation operations and as 
necessary thereafter. For example, you may need to provide additional training if you previously 
transported only fully packaged refrigerated items but you now begin transporting produce in 
open containers and begin using different cleaning procedures for your trucks. (21 CFR 1.910(a)) 
C.  Do I have to keep records of the training? 
Yes, you must establish and maintain records documenting the training. The requirements for 
these records are described in the table in Section VII A. (21 CFR 1.910(b)) 
D.  Where can I get training for this rule? 
To assist carriers in their efforts to provide training to personnel, FDA offers a free web-based 
training module that covers the required training elements described above.  You may offer this 
module to your personnel as a means of satisfying the rules training requirement.  The training 
module is available at: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm576097.htm.  
The FDA training module touches on a wide range of transportation food safety topics in a non-
detailed manner.  We anticipate that some carriers will wish to provide additional training that 
focuses on company-specific operations and procedures related to food safety.  
You are not required to use the FDA training module. You may use training offered by third 
parties training vendors or you may train your personnel yourself.  We do not require training 
offered by a company or a third party to be approved by FDA or that the instructors be certified. 
VII.  Records 
A.  What records am I required to make and keep? 
You are required to make and keep the records shown in Table 4. (21 CFR 1.912) 
 
Table 4--Records Required Under 21 CFR Part 1, subpart O  
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Required Records  Description 
Information provided by shippers to carriers  Shipper records must demonstrate that the 
shipper: 
(21 CFR 1.912(a)(1)) 
Provided, as a regular part of transportation 
operations, specifications and operating 
temperatures to carriers as required by 21 
CFR 1.908(b)(1)  
Written agreements and the written  The shippers written agreements and written 
procedures of a shipper  procedures must meet the requirements of 21 
CFR 1.908(b)(3), (4), and (5). 
(21 CFR 1.912(a)(2)) 
 
 
 
Written procedures of a carrier  The carriers written procedures must meet 
the requirements of 21 CFR 1.908(e)(6) 
(21 CFR 1.912(b)) 
  
 
Any written agreements subject to the rule  Written agreements that assign tasks required 
that are not otherwise noted   by the rule to another person 
(21 CFR 1.912(d)) 
Records documenting required training by  The training records must: 
carriers 
(1) Include the date of training, the type of 
(21 CFR 1.912(c))  training, and the persons trained; and  
  (2) Be established and maintained in 
accordance with other records requirements.  
 
(21 CFR 1.910(b)) 
Written procedures of firms that operate in  The written procedures must: 
more than one capacity under the rule, under 
Be common integrated procedures that ensure 
the ownership or operational control of a 
the sanitary transportation of food consistent 
single legal entity, for example, as a shipper 
with the requirements of the rule. 
and a carrier. 
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(21 CFR 1.912(e))    (21 CFR 1.908(a)(5)) 
This requirement is an alternative to meeting   
the requirements of 21 CFR 1.908 (b), (d) and 
(e) 
B.  What are the requirements for my records?  
Your records must be kept as original records, true copies (such as photocopies, pictures, 
scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), 
or electronic records. (21 CFR 1.912(g)) 
C.  Do my records have to be in electronic format?  
Your records do not have to be in electronic format.   
 
Records that are established or maintained for the Sanitary Transportation rule that meet the 
definition of electronic records in 21 CFR 11.3(b)(6) are exempt from the requirements of 21 
CFR Part 11.  However, records that satisfy the requirements of this rule, but that also are 
required under other applicable statutory provisions or regulations, remain subject to part 11.  (21 
CFR 1.912(h)) 
D.  How long must I retain my records? 
All persons subject to this rule must retain records of written procedures and written agreements 
(except as described in the next paragraph) for a period of 12 months beyond when the 
procedures or agreements are in use in your transportation operations. (21 CFR 1.912(a)(2), (b) 
and (e)) 
 
All persons subject to this rule must retain records of written agreements that assign tasks 
required by this rule to another person for a period of 12 months beyond the termination of the 
agreements. (21 CFR 1.912(d)) 
 
Shippers must retain records that demonstrate that they provide specifications and operating 
temperatures to carriers as a regular part of their transportation operations for a period of 12 
months beyond the termination of the agreements with the carriers. (21 CFR 1.912(a)(1)) 
 
Carriers must retain training records required by 21 CFR 1.910(b) for a period of 12 months 
beyond when the person identified in the record stops performing the duties for which the 
training was provided. (21 CFR 1.912(d)) 
E.  Can I store my records offsite? 
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Yes, you can store your records offsite, except for records of a carriers written procedures 
required by 21 CFR 1.908(e)(6)(i) that describe practices for cleaning, sanitizing and inspecting 
vehicles and transportation equipment that the carrier provides for use in the transportation of 
food.  These carrier written procedures must remain onsite as long as the procedures are in use in 
your transportation operations. (21 CFR 1.912(i)) 
However any records stored offsite must be able to be retrieved and you must provide the records 
to us onsite within 24 hours of request for official review. (21 CFR 1.912(i)) 
Your electronic records are considered to be onsite if they are accessible from an onsite location. 
(21 CFR 1.912(i)) 
F.  Do I have to make my records available to FDA officials?  
Yes, you must make all records required by the Sanitary Transportation rule available to FDA 
promptly upon oral or written request. (21 CFR 1.912(f))  
G.  If FDA collects or copies my records are they protected from public disclosure? 
Records collected or copied by FDA will be protected from public disclosure to the extent 
allowable under 21 CFR Part 20 and under applicable Freedom of Information Act exemptions. 
(21 CFR 1.912(j))  
VIII.  WAIVERS 
A.  What is a waiver? 
A waiver is a notice published in the Federal Register by which FDA grants that all or some of 
the requirements of the Sanitary Transportation rule will not be applied to persons, vehicles, 
food, or nonfood products identified in the notice.  A waiver is effective on the date the notice is 
published.  (21 CFR 1.930)  
B.  How does FDA issue a waiver? 
We will issue a waiver by publishing a notification of the waiver in the Federal Register, when 
we determine that: 
(a) The waiver will not result in the transportation of food under conditions that would be 
unsafe for human or animal health; and 
(b) The waiver will not be contrary to the public interest.  
(21 CFR 1.914) 
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C.  When will FDA consider issuing a waiver? 
We will consider whether to waive a requirement of the Sanitary Transportation rule on our own 
initiative or in response to a petition submitted under 21 CFR 10.30. (21 CFR 1.916  1.926) 
D.  Can FDA modify or revoke a waiver it has issued? 
Yes, we will modify or revoke a waiver if we determine that the waiver could result in the 
transportation of food under conditions that would be unsafe for human or animal health or that 
the waiver could be contrary to the public interest. (21 CFR 1.932) 
If we modify or revoke a waiver, we will follow the procedures set forth in the Sanitary 
Transportation rule to inform the person who requested the waiver of our determination and to 
seek public input through the publication of a notice in the Federal Register. We will also publish 
a notice of our decision and the effective date in the Federal Register. (21 CFR 1.934) 
E.  Has FDA issued any waivers? 
Yes, see Section II C. 
IX.  DEFINITIONS 
Below is the full list of definitions in the rule (21 CFR 1.904): 
Adequate means that which is needed to accomplish the intended purpose in keeping with good 
public health practice.  
Animal food means food for animals other than man, and includes pet food, animal feed, and raw 
materials and ingredients.   
Bulk vehicle means a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, 
freight container, or hopper bin, or any other vehicle in which food is shipped in bulk, with the 
food coming into direct contact with the vehicle. 
Carrier means a person who physically moves food by rail or motor vehicle in commerce within 
the United States. The term carrier does not include any person who transports food while 
operating as a parcel delivery service.   
Cross-contact means the unintentional incorporation of a food allergen as defined in section 
201(qq) of the Federal Food, Drug, and Cosmetic Act into food, except animal food. 
Farm has the meaning given in 21 CFR 1.227. 
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Food not completely enclosed by a container means any food that is placed into a container in 
such a manner that it is partially open to the surrounding environment.  Examples of such 
containers include an open wooden basket or crate, an open cardboard box, a vented cardboard 
box with a top, or a vented plastic bag.  This term does not include food transported in a bulk 
vehicle. 
Full-time equivalent employee is a term used to represent the number of employees of a business 
entity for the purpose of determining whether the business is a small business.  The number of 
full-time equivalent employees is determined by dividing the total number of hours of salary or 
wages paid directly to employees of the business entity and of all of its affiliates and subsidiaries 
by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 weeks).  If the result is 
not a whole number, round down to the next lowest whole number. 
Loader means a person that loads food onto a motor or rail vehicle during transportation 
operations.   
Non-covered business means a shipper, loader, receiver, or carrier engaged in transportation 
operations that has less than $500,000, as adjusted for inflation, in average annual revenues, 
calculated on a rolling basis, during the 3-year period preceding the applicable calendar year.  
For the purpose of determining an entitys 3-year average revenue threshold as adjusted for 
inflation, the baseline year for calculating the adjustment for inflation is 2011.   
Operating temperature means a temperature sufficient to ensure that under foreseeable 
circumstances of temperature variation during transport, e.g., seasonal conditions, refrigeration 
unit defrosting, multiple vehicle loading and unloading stops, the operation will meet the 
requirements of 21 CFR 1.908(a)(3).   
Pest means any objectionable animals or insects including birds, rodents, flies, and larvae. 
Receiver means any person who receives food at a point in the United States after transportation, 
whether or not that person represents the final point of receipt for the food.   
Shipper means a person, e.g., the manufacturer or a freight broker, who arranges for the 
transportation of food in the United States by a carrier or multiple carriers sequentially. 
Small business means a business employing fewer than 500 full-time equivalent employees 
except that for carriers by motor vehicle that are not also shippers and/or receivers, this term 
would mean a business subject to 21 CFR 1.900(a) having less than $27,500,000 in annual 
receipts. 
Transportation means any movement of food in by motor vehicle or rail vehicle in commerce 
within the United States. 
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Transportation equipment means equipment used in food transportation operations, e.g., bulk 
and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, loading systems, and 
unloading systems.  Transportation equipment also includes a railcar not attached to a 
locomotive or a trailer not attached to a tractor.   
Transportation operations means all activities associated with food transportation that may 
affect the sanitary condition of food including cleaning, inspection, maintenance, loading and 
unloading, and operation of vehicles and transportation equipment.  Transportation operations do 
not include any activities associated with the transportation of food that is completely enclosed 
by a container except a food that requires temperature control for safety, compressed food gases, 
food contact substances as defined in section 409(h)(6) of the Federal Food, Drug, and Cosmetic 
Act, human food byproducts transported for use as animal food without further processing, or 
live food animals except molluscan shellfish.  In addition, transportation operations do not 
include any transportation activities that are performed by a farm. 
Vehicle means a land conveyance that is motorized, e.g., a motor vehicle, or that moves on rails, 
e.g., a railcar, which is used in transportation operations. 
 
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