Weekly Compliance Digest - FDA Food Safety During Transport Rule

April 15, 2016
By Jean-Grégoire Manoukian

In this edition of the Weekly Compliance Digest, we cover the FDA’s Food Safety Modernization Act (FSMA), which aims to strengthen the food safety system in the U.S.

Sanitary Transportation of Human and Animal Food

What is it?

Last week, the U.S. Food and Drug Administration (FDA) announced a new food safety rule under the Food Safety Modernization Act (FSMA). The final rule aims to prevent food contamination during transportation. The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law. Specifically, the FSMA rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training and waivers.

With this new rule, the FDA has now finalized six of the seven major rules that implement the core of FSMA:

The final rules for Produce Safety and Foreign Supplier Verification Programs were .

The seventh rule, which focuses on mitigation strategies to protect food against intentional adulteration, is expected to be finalized later in 2016, according to the FDA.

Who is affected?

The final rule applies to the following:

  • Shippers, receivers, loaders and carriers who transport food in the U.S. by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce. Companies involved in the transportation of food intended for export are covered by the rule until the shipment reaches a port or U.S. border.
  • Persons and companies (e.g. shippers) in other countries who ship food to the U.S. directly by motor or rail vehicle (from Canada or Mexico), or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the U.S., if that food will be consumed or distributed in the U.S.

The rule does not apply to exporters who ship food through the U.S. (for example, from Canada to Mexico) by motor or rail vehicle if the food does not enter U.S. distribution. The rule includes a number of other exceptions, such as:

  • Transportation activities performed by a farm.
  • Transportation of food that is imported for future export and that is neither consumed or distributed in the U.S.
  • Transportation of food that is completely enclosed by a container except a food that requires temperature control for safety.

What are the requirements?

The rule includes four main categories of key requirements:

  • Vehicles and transportation equipment: The design and maintenance of vehicles and transportation equipment to ensure that it does not cause the food that it transports to become unsafe. For example, they must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food.
  • Transportation operations: 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 previous load, and protection of food from cross-contact, i.e. the unintentional incorporation of a food allergen.
  • Training: Training of carrier personnel in sanitary transportation practices and documentation of the training. This training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.
  • Records: Maintenance of records of written procedures, agreements and training (required of carriers). The required retention time for these records depends upon the type of record and when the covered activity occurred, but does not exceed 12 months.

What is next?

The final rule was published in the Federal Register on April 6, 2016. Companies would have to comply with the rule one year after the publication of the rule, i.e. April 6, 2017. Small businesses would have to comply with the rule two years after the publication of the rule. Small businesses are defined 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”.

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