The FDA Food Safety Modernization Act (FSMA) sets forth sweeping reforms of US food safety laws with the primary goal of strengthening the food safety system through prevention of food safety problems rather than relying primarily on reacting to problems after they occur.

The FSMA aims to preempt safety concerns at all levels of the supply chain – including transportation.  The Final Rule governing the safe transportation of food is expected to be enacted today, March 31, 2016.

Who Must Comply?

With some exceptions, this proposed rule would apply to:

  • Shippers, receivers, and carriers who transport food in the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce.
  • Persons outside of the United States, such as exporters, who ship food to the United States in an international freight container by oceangoing vessel or in an air freight container, and arrange for the transfer of the intact container in the United States onto a motor vehicle or rail vehicle for transportation in U.S. commerce, if that food will be consumed or distributed in the United States. 

What Is Required?

The proposed rule would establish requirements for:

  • 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 contaminated.
  • Transportation operations: The measures taken during transportation to ensure food is not contaminated, such as adequate temperature controls and separation of food from non-food items in the same load.
  • Information exchange: Procedures for exchange of information about prior cargos, cleaning of transportation equipment, and temperature control between the shipper, carrier, and receiver, as appropriate to the situation. For example, a carrier transporting bulk liquid non-dairy foods would want to ensure that vehicles that have previously hauled milk will not introduce allergens into non-dairy foods through cross contact.
  • Training: Training of carrier personnel in sanitary transportation practices and documentation of the training.
  • Records: Maintenance of written procedures and records by carriers and shippers related to transportation equipment cleaning, prior cargos, and temperature control.
  • Waivers: Procedures by which the FDA will waive any of these requirements if it determines that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health and that it is in the public interest.

When Do I Need to Comply?

  • Effective and Compliance Dates and Definitions for Small Businesses:The FDA is proposing the effective date for businesses subject to the new requirements to be 60 days after the final rule is published. Recognizing that small businesses may need more time to comply with the requirements, the compliance dates are adjusted accordingly.
  • Compliance Dates:
    • Small Businesses—businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $25.5 million in annual receipts would have to comply two years after the publication of the final rule.
    • Other Businesses—a business that is not small and is not otherwise excluded from coverage would have to comply one year after the publication of the final rule.