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FDA Hosts Webinar on Sanitary Transportation Rule, Recently Finalized under FSMA

On April 25, 2016, the U.S. Food and Drug Administration (FDA) hosted a webinar on the agency’s final rule for Sanitary Transportation of Human and Animal Food.  The rule aims to prevent contamination of food during transportation by establishing requirements for covered businesses to use sanitary transportation practices.  Published on April 6, 2016, the Sanitary Transportation rule is the sixth major rule to be finalized under FDA’s Food Safety Modernization Act (FSMA).

Who is Covered?

Those covered by the Sanitary Transportation rule include shippers, loaders, carriers, and receivers of human and animal food transported by motor or rail vehicle within the United States.  This is true even if the food does not enter interstate commerce.  The rule does not apply to transportation by ship or air due to limitations laid out in the law.

There are some exemptions to the Sanitary Transportation rule.  Examples include:

  • Transportation activities performed by a farm
  • Transportation of food that is transshipped through the United States to another country
  • Transportation of food that is completely enclosed by a container, except a food that requires temperature control for safety
  • Transportation of food located in facilities regulated exclusively by the U.S. Dept. of Agriculture

FDA also intends to publish waivers that would exempt certain groups from the Sanitary Transportation rule. See FDA’s Sanitary Transportation Fact Sheet for a complete list of exemptions and intended waivers.

Key Requirements

The Sanitary Transportation rule requires vehicles and transportation equipment to be designed and maintained so that the food they transport remain safe.  For example, they must be adequately cleanable and capable of maintaining temperatures necessary for the safe transport of food.  The rule also requires that measurements be taken to ensure food is not contaminated by other food or non-food items (raw food, foods containing allergens, or pests, for example).  Shippers, loaders, carriers, and receivers must develop written procedures detailing how they will ensure the safe transportation of food according to their specific requirements under the rule.

In some cases, one responsible party, such as the shipper, can sign their responsibilities over to another party, such as the carrier, in a signed statement of consent.  When a shipper and carrier agree that the carrier is responsible for sanitary conditions during transport, the carrier personnel must be trained in sanitary transportation practices. As with other rules under FSMA, records relating to any activity performed under the rule, including training and any written procedures, must be properly maintained.

Compliance Dates

Most covered businesses are required to comply with FDA’s Sanitary Transportation rule by April 6, 2017 (one year after the rule’s publication).  Small businesses have one additional year to comply.  For purposes of this rule, FDA defines small businesses as “businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts.”

Registrar Corp is a U.S. FDA consulting firm that helps businesses comply with FDA regulations, including new requirements under FSMA.  If you have questions about FDA’s Sanitary Transportation rule or any other FSMA rules, contact Registrar Corp at +1-757-224-0177.  Live help is available 24 hours a day at www.registrarcorp.com/livehelp.