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A Better Partnership


Apr 2016
April 05, 2016

FDA Releases Final Rule for Sanitary Transportation of Human and Animal Food

Today, the Food and Drug Administration (FDA) released its final rule governing the sanitary transportation of food as part of its continued rollout of new food safety regulations under the Food Safety Modernization Act (FSMA). This is the FDA’s sixth new FSMA regulation in the past seven months. (See our previous alerts here and here.) Like previous FSMA regulations, the transportation rule is geared toward implementing risk-based controls to prevent food contamination.

Are you covered?

The sanitary transportation rule applies to all shippers, receivers, loaders and carriers that transport food in the U.S. The rule defines transport as “any movement of food in commerce by motor vehicle or rail vehicle.” The rule does not apply to shipment of food by air or sea, or transportation of food by farms. Waivers will be available for retail food establishments (e.g. restaurants, supermarkets and home grocery delivery operations) and businesses transporting milk and milk products inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety program.

What is required?

The rule provides requirements for:
  • Vehicles and transportation equipment: All vehicles must be designed and regularly maintained to be suitable and cleanable to avoid transported food from becoming unsafe. Vehicles transporting food requiring temperature control must have adequate controls to maintain and measure temperatures. Vehicles must be stored in ways to prevent contamination and infiltration by pests.
  • Transportation operations: Certain controls must be in place in transportation operations to ensure food safety: segregation of raw foods and nonfood items; maintaining adequate temperature controls; and isolation/segregation and other controls (e.g. hand washing) to protect food not completely enclosed by container from cross-contamination.
  • Training of employees: When the shipper and carrier agree that a carrier will be responsible for sanitary conditions during transport, the carrier must implement a training program for employees (beginning at time of hiring and continuing throughout employment). The program must cover awareness of food safety problems, sanitary transportation practices to address those potential problems and the responsibilities of the carrier. 
  • Recordkeeping: Shippers, carriers, receivers and loaders each have specific document creation and retention requirements. Generally, all businesses covered by the rule must maintain records (including written procedures, agreements and training documents) and make them available for inspection for up to one year.
Compliance Date: Most covered businesses must comply by April 2017. Delayed compliance is available for smaller (less than 500 employees) businesses and certain motor carriers.

The rule will be formally published in the Federal Register on April 6, 2016, but an advance copy is available here.

We are advising clients on all of the new FSMA requirements and scheduling private educational seminars and Q&A sessions. If you have questions about the new FSMA regulations or other food regulatory questions, please contact Chris Predko at 616.752.2190 or

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