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
 
In association with
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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.