United States: Sanitary Food Transportation: New Rules May Require A Fresh Look

Last Updated: April 27 2016
Article by Michael A. Walsh

Prompted by the Sanitary Food Transportation Act of 2005 and the Food Safety Modernization Act of 2011 (FSMA), the Food and Drug Administration (FDA) issued a new rule entitled "Sanitary Transportation of Human and Animal Food" (the SFT Rule). The SFT Rule establishes the requirements for sanitary transportation practices that will apply beginning April 6, 2017.

The SFT Rule does not solve or purport to solve any clearly identified problem but is part of an overall "paradigm shift" that switches priorities from responding to outbreaks to preventing them in the first place. Under the SFT Rule, when any covered person at any point in the transportation supply chain becomes aware of a condition, including temperature control failure, that could render the food unsafe, that food must not be sold or distributed until a determination of safety is made.

Prevention is accomplished through a set of seven new rules and upcoming agency guidance documents. In the past manufacturing and distribution agreements would dispose of FDA regulatory requirements with sleight of hand, but requiring practices focused on "prevention" requires a fresh look at policies and procedures and supplier and vendor agreements to ensure upstream and downstream compliance.

The SFT Rule applies to shippers, loaders, receivers, and carriers involved in transportation operations for human and animal food by rail or motor vehicle within the United States. The Rule defines shippers to include freight brokers and shippers have primary responsibility for sanitary conditions unless otherwise assigned by contract. A carrier is a person who physically moves food by rail or motor vehicle but excludes parcel delivery services. The SFT Rule requires carriers to provide training on food-safety and basic sanitary food-transportation practices for their employees, contractors and agents. The term "loader" defines a new category of persons who have responsibility for vehicle inspection before loading and verifying that vehicles and transportation equipment are adequate. The rule requires that receivers to ensure that the food was not subjected to significant temperature abuse during transport.

Responsibility for ensuring that transportation operations are carried out in compliance with the SFT Rule must be assigned to "competent supervisory personnel". The SFT Rule does not specifically address the issue of personal liability for responsible individuals but it should be expected that the FDA will apply its ordinary rules in this regard which impose liability on individuals in position of responsibility for compliance.

A failure to comply with the SFT Rule requirements that causes the food to be "actually unsafe," thereby rendering the food adulterated remains a prohibited act under the Federal Food, Drug, and Cosmetic Act (FDCA). However, an "inconsequential failure" to meet transportation specifications will not create a "per se presumption of adulteration." Nonetheless, if a covered person "becomes aware" or there is evidence of a "material" deviation from the transportation specifications, a "qualified individual" must determine that the food is not unsafe. The failure to take such action may render the food adulterated. The rule does not require actual knowledge of a material deviation.

The SFT Rule sets out equipment, operational, training, and records requirements and the same person may act and be responsible in more than one capacity, and it is now necessary to have policies in place and contractual provisions specifying how the responsibilities under the Rule have been assigned.

The SFT Rule imposes requirements for the design, maintenance, and storage of vehicles and transportation equipment used in transportation operations. The "intended use" of the vehicle will determine the material and workmanship necessary for it to be "suitable." Each participant in the supply chain is responsible and must have procedures in place to ensure compliance.

Operational responsibilities under the SFT Rule include responsibilities for the measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready to eat food from touching raw food, protection of food from contamination by non-food items in the same load or a previous load, and protection of food from cross-contact, such as an unintentional incorporation of a food allergen. All parties should also ensure that their procedures address documentation and records necessary to support their compliance. Contracts should include a mechanism for ensuring others in the supply chain are compliant.

The SFT Rule requires shippers, carriers, loaders, and receivers engaged in transportation operations to maintain records of all written procedures, agreements and training (required of carriers) for 12 months, including any agreement assigning responsibilities under the SFT Rule.

Conclusion

The "science" behind the law's paradigm shift is of dubious validity as the often-cited statistic that 1 in 6 Americans per year contract a foodborne illness fails to exclude consumer handling as a cause. Nonetheless, and irrespective of the true incidence of foodborne illness, a number of high-profile incidents involving serious adverse health outcomes for susceptible populations, including children and the elderly, are perceived by the FDA as providing a sufficient rationale for new regulatory controls. In addition, the food system in the United States is an open system that depends on the integrity of those operating within the supply chain to ensure safety. Congress and the FDA believe they are being forward thinking in working to prevent future outbreaks through the SFT Rule, other recent rules issued under FSMA, and upcoming rules that will address preventing outbreaks caused by the intentional acts of those seeking to contaminate the food supply and causing widespread adverse health outcomes.

Stay tuned for further updates on the additional rules and guidance as well as information concerning enforcement deadlines.

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
Michael A. Walsh
 
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.