The Rule is broad in scope and reaches nearly every party involved in the shipment of food through the United States.

On April 6, the Food and Drug Administration (FDA) published its final rule governing the sanitary transportation of human and animal food (the Rule), 81 Fed. Reg. 20,091. The Rule focuses on the supply chain for food and establishes a framework for the use of sanitation and temperature controls to prevent the adulteration of food products as they travel by road or rail. This is the sixth of seven foundational rules enacted under the Food Safety and Modernization Act (FSMA). The FDA has moved at a glacial pace in finalizing FSMA, which was signed into law almost five years ago.

This long-awaited Rule marks the culmination of numerous legislative and regulatory attempts to improve food transportation safety over the past two decades. The first of these attempts was in 1990, with the passage of the Sanitary Food Transportation Act (SFTA), Pub. L. 101-500. The SFTA gave the Department of Transportation (DOT) the authority to promulgate regulations to advance food safety in transportation. Although there were initial attempts at proposed rulemaking under the SFTA, the DOT soon acknowledged that it did not have the expertise to get the job done, and primary oversight shifted to the FDA with the passage of an amended SFTA in 2005. The Rule is the first rule promulgated by the FDA to address the sanitary transportation of food within the larger context of its oversight of the supply chain as a whole.

What Does the Rule Require?

The goal of the Rule is to prevent transported food products from becoming contaminated or adulterated by microbes, vermin, allergens or other food or nonfood contaminants. The Rule requires that those involved in the food transportation industry implement sanitary practices to ensure that food does not become contaminated or adulterated when transported by motor vehicle or by rail, either by exposure to the environment or by direct contact with the surfaces of transportation containers. The Rule also requires that companies stop the sale or distribution of any potentially unsafe food once the company becomes “aware of an indication” of a condition that may render the food unsafe.

Notably, food companies may continue to use existing industry-recognized best practices to prevent food adulteration. However, the Rule places the ultimate responsibility on the shipper (i.e., the party that arranges for the transportation of a food) to identify, implement, document and oversee any necessary specifications, procedures and/or controls, which may require the shipper to do more than industry standards require. In addition to the responsibilities placed on shippers, the Rule requires loaders to ensure that transportation equipment is clean and pre-cooled (if necessary for appropriate temperature controls) and requires receivers to ensure that goods have not been subject to temperature abuse while in transit.

Who Is Affected by the Rule?

The Rule applies to virtually every entity involved in the transportation of food that travels within the United States, including:

  • shippers
  • receivers
  • loaders
  • carriers
  • companies that import food into the United States, if they subsequently arrange to have these imported goods transported by road or by rail for consumption or distribution within the United States.

The Rule does not apply to companies that transport food through the United States for distribution or consumption outside of the United States. The Rule also does not apply to farms or to companies that have less than $500,000 in average annual revenue.

What Conduct Is Covered Under the Rule?

The Rule requires that companies implement sanitary practices as to all “transportation operations,” which the Rule broadly defines as “all activities associated with food transportation that may affect the sanitary condition of food.” Transportation operations include activities relating to the design, operation, cleaning, inspection, maintenance, and loading and unloading of motor vehicles, rail vehicles and transportation equipment. Transportation operations do not include the transportation of foods that are completely enclosed by a container (e.g., foods that are packaged in metal cans, glass or plastic bottles, or sealed bags or boxes), except to the extent that temperature controls are necessary to protect those foods from adulteration. Transportation operations also exclude the transportation of foods by ship or air.

The Rule does not detail what practices or procedures a company must implement, but it states that companies must adequately document those practices and procedures as set forth below:

  • A shipper must document all specifications and operating temperatures on which the shipper relies to prevent transported food products from becoming unsafe and must document that those specifications are provided to any carriers with which the shipper enters into an agreement. Records must be maintained for at least 12 months beyond the termination of any such agreements.
  • A carrier must document the cleaning, sanitization, inspection and training procedures on which the carrier relies to prevent transported food products from becoming unsafe and must maintain such records for at least 12 months after such procedures are last used.
  • Any company subject to the Rule must maintain records of written agreements relating to the assignment of any tasks under the Rule. These records must be maintained for at least12 months after the termination of said agreements.

When Must Companies Comply with the Rule?

Small businesses must comply with the Rule by April 5, 2018. All other businesses must comply with the Rule by April 5, 2017.

Implications

The Rule is broad in scope and reaches nearly every party involved in the shipment of food through the United States. These companies need to understand the Rule and should partner with regulatory advisers to ensure their policies and procedures are robust. Although the Rule does not set out specific guidelines or requirements to ensure sanitary transportation of food, it places the ultimate responsibility on the shipper to ensure safe transportation. Companies should revisit their transportation policies and, importantly, ensure that they are adequately documented. The Rule emphasizes recordkeeping as a necessary element of regulatory compliance. This is likely because food companies have not always properly documented their procedures. Although transportation recordkeeping was an original component of the revised SFTA, a 2009 report by the Office of the Inspector General showed that fewer than half of the 118 reviewed food facilities actually complied with the SFTA directives. This may have led the FDA to include detailed recordkeeping provisions in the Rule. Equally important, food companies need to ensure that their policies and procedures governing transportation are adhered to, by conducting adequate and continual training of employees and agents.