United States: Finally Coming To Fruition: FDA's Rule On The Sanitary Transportation Of Food

Last Updated: September 24 2015
Article by Larissa LPC Sneathern and Meghan M. Cloud

Twenty-five years after Congress first tried to ensure that garbage trucks aren’t also used to haul fresh produce, a federal regulation establishing sanitation standards for the transportation of human and animal food by truck and rail is finally imminent − relatively speaking, that is. By court order, the Food and Drug Administration (FDA) must publish its final rule on the matter by March 31, 2016, twenty months after the comment period closed in July 2014.

Affected companies might be forgiven for having bided their time. If all goes according to plan, the final rule will see the light only after three successive pieces of legislation − the Sanitary Food Transportation Act of 1990, the 2005 Sanitary Food Transportation Act, and the Food Safety Modernization Act of 2010 (FSMA) − have mandated its promulgation. As proposed, however, the final regulation will give “businesses other than small businesses” just one year to comply. Companies likely to be affected should start familiarizing themselves with the rule in its proposed form and consider whether changes are warranted. Improperly transported food will be deemed “adulterated” and banned from interstate commerce under the federal Food, Drug and Cosmetic Act, and noncompliance could constitute a crime.

****

The FDA’s proposed Rule on Sanitary Transportation of Human and Animal Food (“Rule”) is one of seven rules that are intended to realize FSMA’s goal of ensuring the safety and security of the nation’s food and feed supply. The Rule establishes criteria − including standards governing cleanliness, temperature control and allergen segregation − for the safe transportation of food by motor or rail vehicle. A shipper or carrier with less than $500,000 in total annual sales, food that is transshipped through the U.S. for consumption in another country, and the transportation of shelf-stable food that is completely enclosed by a container are the most significant exceptions to the Rule.

To whom does the Rule apply?

  • The shipper, defined as “the person who initiates a shipment of food by motor vehicle or rail vehicle.” Because the shipper is presumed to be the party most “knowledgeable about all factors concerning the food, e.g., its packaging and holding temperature requirements, relevant to its sanitary transport,” it bears significant responsibilities under the Rule.
  • The carrier, defined as “the person who owns, leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food.” A person is “ultimately responsible,” and thus a carrier, even if the physical act of carrying is performed by other persons, such as a driver that is either employed or contracted by a trucking firm to operate the vehicle.
  • The receiver, defined as “any person who receives food after transportation, whether or not that person represents the final point of receipt for the food.”

The proposed rule applies with equal force to interstate and intrastate transport of food but − again − not to food that is transshipped through the United States.

What does the Rule require?

Clean vehicles and transportation equipment. The Rule requires that vehicles and transportation equipment be designed, maintained and stored in a manner that prevents transported food from becoming “filthy, putrid, decomposed or otherwise unfit for food and to prevent the harboring of pests.” By way of example, the Rule requires:

  • that all food-contact surfaces be cleanable;
  • that surface coatings on vehicles and transportation equipment be corrosion-resistant and free of chips and flakes;
  • that all pallets be in good working condition, without (for example) jagged wood edges that could damage packaging and lead to a food’s exposure; and
  • that all equipment used in bulk food transfer operations, such as pumps and hoses and tankers, be thoroughly washed after each use.

Policies that ensure compliance and accountability. The Rule requires that shippers, carriers and receivers:

  • establish accountability, by assigning to a competent supervisor the responsibility of ensuring compliance;
  • conduct all transportation operations under conditions and controls that eliminate the risk of contamination or adulteration (for example, by having policies in place that will prevent food requiring refrigeration from being left out on a loading dock); and
  • take effective measures, such as the segregation of raw foods and non-foods and the establishment of strict hand-washing protocols, to protect food from contamination or cross-contact during transportation.
    • N.B. Shippers and receivers should review their transportation contracts to make sure they include provisions aimed at maximizing compliance with the Rule by carriers. For example, carriers should warrant the existence of policies requiring drivers to wash their hands before handling transported food, especially open or exposed raw or fresh foods. Carriers that transport bulk milk for other parties should be contractually obligated to provide wash tickets and maintain records.

Other provisions are specific to shippers, receivers and/or carriers:

  • Each shipper must:
    • specify, in writing, all requirements − including design and cleaning requirements − that carriers must satisfy in order for their vehicles and equipment to be deemed sanitary in the context of specific shipments. For example, shippers are responsible for advising carriers of particularized equipment needs (such as thermally insulated tanks) and preparation steps (such as specific wash procedures) applicable to their shipments. The written specifications are subject to document retention obligations specified elsewhere in the Rule.
    • For products not completely enclosed in containers, shippers must conduct visual inspections of the vehicles and equipment − prior to loading − to ensure cleanliness and compliance with the shipper’s written specifications. Vehicles must be free of pest residue, mold, mildew, excess water, ice buildup, dirt, holes, cracks and other issues that could compromise the shipment’s integrity.
  • Each shipper and receiver must provide vehicle operators who are expected to handle food not completely enclosed by a container with access to a suitable hand-washing facility.
  • Each carrier must:
    • supply vehicles and transportation equipment that conform to the shipper’s specifications, and which are appropriate to the goal of preventing contamination;
    • if transporting bulk food, and unless the shipper and carrier otherwise agree in writing and in advance, advise the shipper of the three previous cargoes transported in the vehicle, and provide the shipper with a description of the most recent cleaning procedures; and
    • develop and implement various written procedures that (like any agreement with a shipper regarding the transportation of bulk foods) are subject to the Rule’s record retention requirements, such as specifications for cleaning, sanitizing, and inspecting vehicles and transportation equipment.
      • N.B. Carriers should not assume that shippers will be held solely responsible if written requirements are not supplied and contamination results. Carriers intent on minimizing liability should make a habit (or a policy) of asking shippers what might be necessary to ensure the safe and sanitary transportation of food and documenting the response. Among other uncertainties, it is far too early to know whether the Rule will pre-empt state law claims against carriers, even if the shipper has provided detailed specifications with which the carrier has fully complied.

Specific precautions for TCS food. As proposed, the Rule has detailed regulations pertaining to foods that require time/temperature controls to limit the growth of pathogens and otherwise ensure their safety, which it refers to as “TCS foods.”

  • Vehicles used to transport TCS foods must be designed and equipped to maintain the food at the requisite temperature. Each freezer and mechanically refrigerated (as opposed to insulated) cold storage compartment must have a thermometer or other temperature-recording device that accurately reflects the temperature.
  • Shippers, carriers and receivers are charged generally with making sure that TCS food is transported in such a way that it remains wholesome. In addition, the Rule sets forth various specific requirements, including the following.
    • Unless TCS food is being transported in a thermally insulated tank, the shipper must provide written specifications to the carrier as to temperature and pre-cooling requirements, and must verify proper pre-cooling before loading.
    • The carrier of TCS food must ensure that the food is transported under acceptable temperature conditions. Upon delivery, the carrier must demonstrate to the shipper (and, upon request, to the receiver) that the food was so transported by “any appropriate means,” such as a printout of the time/temperature recording device. (However, the carrier and the shipper may agree in writing, before the shipment, to shift these obligations to the shipper.)
    • Shippers and receivers must load and unload TCS food under conditions that will prevent microbial growth or other adulteration; for example, they may not leave it on a hot loading dock.
    • Carriers must develop written procedures addressing how they will comply with requirements applicable to TCS foods.

Food safety–specific training for carrier personnel. Under the Rule, carriers must provide training, both upon hire and as needed thereafter, to personnel engaged in the transportation of food. At a minimum, the training must cover:

  • food safety problems that may occur during food transportation,
  • basic sanitary practices to address those potential problems, and
  • carrier responsibilities under the Rule.

FDA envisions that such training could be provided online, in a half-day course similar to basic hazmat employee training. Carriers will need to document and maintain appropriate records of the training, which would be subject to the Rule’s recordkeeping requirements.

The retention of certain records for a designated period of time. Under the Rule, shippers and carriers engaged in the transportation of human and animal food will be required to maintain most documents required by the Rule for a period of 12 months after they have been issued or cease to apply. So, for example, a shipper who provides a carrier with written sanitation specifications applicable to a particular shipment, as required, must retain a copy of those instructions for at least 12 months. Similarly, any written procedures applicable to the cleaning, sanitizing and inspection procedures for vehicles and transportation equipment must be retained for 12 months after they have ceased to be in effect.

In addition to the 12-month rule, the following provisions apply:

  • Shippers and carriers receiving FDA requests for records must comply in a prompt manner, usually within 24 hours.
  • Records must be kept either in their original form, as a true copy, or in electronic form.
  • All records may be stored offsite after six months following the date that the record was made, provided that such records can be retrieved within 24 hours of a request for official review.
    • N.B. Documents that are created pursuant to the Rule, and subject to its record-retention requirements, are likely also subject to public disclosure via the Freedom of Information Act (FOIA) and other statutory authority once obtained by the FDA.

Can the Rule’s applicability be waived?

Yes. As expressly permitted by the regulation's authorizing statute, 21 USC § 350e, the FDA can exempt any persons, vehicles or products from compliance with the Rule, so long as the waiver (1) will not result in conditions that would be unsafe for human or animal health and (2) will not be contrary to the public interest. The FDA can issue a waiver on its own initiative, or any person subject to the regulation can petition for a waiver. Any petition for waiver will be published for comment.

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.

Authors
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
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must 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.

Disclaimer

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.

General

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