United States: How The FDA's New Sanitary Transport Rule Affects Food Shipping

The FDA is continuing its implementation of the Food Safety and Modernization Act (FSMA) with the "Sanitary Transportation of Human and Animal Food" final rule (Sanitary Transport Rule or Rule) published in the Federal Register on April 6, 2016. (See, 21 C.F.R. § 1.900 et seq). This Rule is a result of both the FSMA and the 2005 Sanitary Food Transportation Act (SFTA). The Rule is the sixth of seven finalized under FSMA and is meant to work alongside the other recent FDA regulatory rules deriving from the FSMA, including the  HARPC and  cGMP rule, the  VQIP rule and the Produce Safety rule. However, the new Rule adds FSMA-mandated requirements on top of these other rules. Together, these rules form the backbone of the FDA's recent efforts to both create a safer food supply and ensure that food is not contaminated or otherwise adulterated during transport.

The Sanitary Transport Rule is different from the others passed so far under the FSMA, as it is not focused on the manufacturing, packing, growing, labeling or other aspects of food creation. Rather, it is focused on ensuring that food and food ingredients are properly transported "from farm to table" to ensure that contamination and adulteration are avoided en route and applies to both human and animal food.

What's the scope of the Sanitary Transportation Rule?

The new Rule applies to entities that are engaged in the shipping, receiving, loading and carrying of food as defined under 21 U.S.C. §321(f) in the Food, Drug and Cosmetics Act. Loading and loaders are a new category found in the final Rule. This Rule does include exemptions for small businesses (less than $500,000 in annual revenue), foods which are simply passing through the U.S. en route to foreign countries (also known as "transshipping"), and food in facilities that only handle food regulated by the USDA. Transportation activities conducted by farms are not covered by the Rule, although consideration by the FDA is underway for a companion rule outlining what it considers to be good farm practices. These exemptions apply only to the requirements of the Sanitary Food Transport Rule and do not exempt these entities from other transportation sanitation requirements under other regulations.

Furthermore, the Rule explicitly states that the new regulations apply in addition to any other transportation requirements, and do not supplant them, including the new cGMPs and HARPC requirements in 21 C.F.R. §117 (human foods) and §507 (animal feeds), the regulations covering the handling of eggs in 21 C.F.R. § 118, and the cGMPs for medicated feeds under 21 C.F.R. §225. Finally, the Rule states that any food that is not transported in a manner compliant with the Sanitary Transport Rule may be deemed adulterated under 21 U.S.C. §342.

To whom does the Sanitary Transportation Rule apply?

The Rule is expansive and serves to include a large segment of the transportation market and the most common shipping methods in the U.S. A handful of definitions in 21 C.F.R. §1905 provide the scope of the Rule:

  • 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 U.S. The term carrier does not include any person who transports food while operating as a parcel delivery service.
  • Transportation means any movement of food by motor vehicle or rail vehicle in commerce within the U.S.
  • 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.

It is clear that foods transported in the U.S. using any "motor vehicle or rail vehicle" are covered by the new Rule. However, conspicuously absent from any of the regulations is any mention of aircraft, ships, barges or boats. While commonly used intermodal shipping containers are arguably included under the definition of "bulk container," (unless on a waterway) these containers are often moved from rail to container ships and back to rails or onto trucks. Although the Rule does not cover certain forms of intermodal shipping, what is clear is that once the intact bulk container is moved onto a motor or rail vehicle for transportation within the U.S., that container and its loading and off-loading comes within the scope of this Rule.

Barges used to ship grains and other products also appear to avoid coverage under the Rule. This is echoed in the FDA's comments in the Federal Register Notice. In Response 40, the FDA responded to a question regarding the responsibilities of loaders of vessels meant for export over the ocean. The FDA responded in relevant part:

Further, the statute defines "transportation" as any movement in commerce by motor vehicle or rail vehicle. Thus, persons engaged in the transportation of food that is intended for export are subject to all applicable requirements of this Rule when the food is in transit by motor vehicle or rail vehicle to the land-based U.S. border point of export or a port facility.... The loader for the trans-oceanic ship transport segment is not subject to the Rule because the Rule does not cover transportation operations for water borne transportation.

The reason for this distinction between covered rail and road-covered vehicles, and uncovered boats and aircraft transportation, is the SFTA, passed in 2005. The SFTA, as mentioned in the FDA's Response 40 and echoed in responses to several other comments during the rulemaking process, sufficiently limits the transportation that is covered by the law. Specifically, the FDA stated:

The 2005 SFTA, as passed by Congress ... expressly mandates that FDA issue regulations to "require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices ... to ensure that food is not transported under conditions that may render the food adulterated" (21 U.S.C. 350e(b)).... The 2005 SFTA does not mandate that we issue regulations applicable to the sanitary transportation of food by any other conveyances, including barges or ships and aircraft. However, if we find that there is a public health need for us to regulate air and barge or ship transportation, we will consider whether we want to pursue covering these routes under a non-SFTA authority in the future.

As a result, the Sanitary Transport Rule does not generally apply to food products while they are being transported by air or water.

Are there new requirements for transportation equipment?

The new Rule requires equipment used in transportation (trucks, containers, tanks, etc) to be adequate for its intended uses, specifically considering the types of food products that will be transported. Under the Rule, this equipment must be:

  • Adequately cleanable to prevent allergen cross-contact and contamination between loads
  • Adequately maintained
  • Able to properly manage temperature for shipments that require temperature control
  • Stored in a manner to prevent contamination by pests or other materials

Although it would be expected with the implementation of the HARPC rules that these covered activities are already in place, the Rule now clearly makes these activities required activities regardless of the applicability of HARPC. Further, it is well worth noting that the FDA intends to work with the Department of Transportation to develop procedures for safety inspections designed to identify contamination or adulteration of food products in transit.

How do covered entities respond to suspected contamination or adulteration of food during transport?

Under 21 C.F.R. § 1.908(6), if a company involved in the transportation of food products detects or suspects possible contamination, the Rule establishes procedures to be followed. These possible contamination situations which require action include (1) failure to adequately clean the transport container, (2) cross-contamination, (3) a possible material failure of temperature controls, or (4) other conditions that may render the food unsafe during transportation. When these conditions are suspected, the covered transport entity must take all appropriate steps to ensure that the food is not sold or otherwise distributed until a qualified individual makes a determination that the suspected failure did not render the food unsafe. These covered entities will need to have in place written corrective action plans which include FDA-mandated actions, such as reporting to the reportable food registry, as well as corrective actions including, but not limited to, ensuring that the food is not used or sold, possible market withdrawal or recall.

Shippers are required to supply to the transporter, in writing, shipping conditions that ensure safe transport of the food. If these conditions vary per load, these conditions must be provided before each shipment.

What records-keeping responsibilities does the new Rule impose?

Under 21 C.F.R. § 1.912, each entity in the chain of transportation has specific records-keeping requirements. Some entities involved with multiple steps of the transportation process (manufacturers that act as shippers, loaders and carriers, for example) must complete all requirements relevant to the steps in which they are involved. Some examples of these records- keeping requirements are:

  • Shippers must retain records that demonstrate they provided specifications and written agreements under 21 C.F.R. § 1.908(b) for 12 months after they were in use.
  • Carriers must retain records of the specifications received from shippers under 21 C.F.R. § 1.908 for 12 months after they were in use. Carriers must also keep records of all training of employees as required by 21 C.F.R. § 1.908 for 12 months after any trained employee ceases performing the procedures that were the subject of the training.
  • Electronic storage of records is allowed. Also, off-site storage of some records is also allowed if they can be retrieved within 24 hours.
    It is important to note that these records-keeping requirements are in addition to requirements already under other applicable federal or state requirements.

Are waivers available for the requirements of the Sanitary Transport Rule?

Yes, under 21 C.F.R. § 1.914, the FDA allows entities to submit citizen petitions to request a waiver of the requirements set forth under this new Rule. Waivers may be granted if the granting does not result in a risk to the safety of the food being transported and is not contrary to public policy. However, it is expected that waivers will be difficult to obtain in light of the concern for ensuring a safe food supply.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions