The U.S. Food and Drug Administration (FDA) has published its final rule regarding the Sanitary Transportation of Human and Animal Food (“Sanitary Transport Rule”). Applicable to shippers, loaders, receivers, and carriers of food by rail or motor carrier in interstate or intrastate commerce, the rule is intended to ensure that food is transported under conditions that minimize any threat to food safety. Among other things, the rule sets forth requirements relating to vehicle design and maintenance, temperature controls, cross-contamination risks, and training and records requirements.

The Sanitary Transport Rule is the sixth of seven foundational rulemakings mandated under the FDA Food Safety Modernization Act (FSMA), and the final version of the rule contains significant clarifications and changes from the proposed rule in response to public comments during the rulemaking process.

Here are the highlights of the key changes and takeaways from the final rule:

Renewed Focus on Safety

The rule has been revised to focus solely on transportation practices that create risks to food safety, rather than the broader focus in the proposed rule on practices that might lead to spoilage or quality defects but that otherwise pose no threat to public safety. Such practices may still be subject to FDA under the Food, Drug, and Cosmetic Act (FD&C Act), but not under the Sanitary Transport Rule.

Flexible Temperature Controls

Consistent with its renewed focus on safety risks, the final rule provides greater flexibility for shippers and carriers to agree to temperature controls for shipments, alleviating concerns that the proposed rule required both continuous monitoring during transport and per-shipment production of temperature records. Carriers need only demonstrate maintenance with temperature controls upon request, and can do so by any means agreeable to the carrier and the shipper. FDA also clarifies that temperature controls may not be necessary for cold weather shipments or short-hauls, and they are not required under the final rule for shipments that may require temperature controls for reasons unrelated to safety (e.g., for marketability reasons or to prevent spoilage). Perhaps most importantly, the term “Time/Temperature Control for Safety (TCS) Food” has been removed as a defined term and replaced with the concept of “foods that require refrigeration for safety.” Instead of requiring shippers to specify temperatures that would serve as critical safety limits for transported food, the final rule states that shippers must specify an “operating temperature” that is appropriate to control for safety under the conditions of the shipment based on “foreseeable circumstances of temperature variation.”

“Loaders” Are Now Covered Parties

In addition to applying to shippers, receivers, and carriers, the final rule also will apply to “loaders” who physically load food onto rail or motor vehicles for transport in commerce. FDA added this definition in response to concerns that the proposed rule would have required shippers to be responsible for inspecting vehicles prior to shipment when other parties were in fact the responsible parties (e.g., at third-party distribution or storage facilities). Under the final rule, loaders must determine, prior to loading food for transport, that a vehicle is in appropriate sanitary condition consistent with the shipper’s requirements, and that it is adequately prepared to meet any temperature requirements.

Primary Responsibility on “Shippers,” Including Brokers and Intra-Company Shipments

The final rule clarifies that primary responsibility is placed on shippers for determining the conditions necessary to ensure that food is safe during transport, although shippers may enter into agreements to assign responsibilities to other covered entities (e.g., rail or motor carriers). Shippers must specify in writing to carriers or loaders any particular criteria that must be met to ensure safe food transport, and shippers also must develop written procedures relating to sanitary requirements, bulk transport, and temperature controls. FDA declined to exempt intra-company transportation operations. However, entities under the ownership or control of a single entity may comply with the rule by using “common, integrated written procedures” to ensure safe transport procedures. In response to concerns regarding the potentially expansive proposed definition of “shipper,” which focused on the party “initiating” a shipment, FDA largely held its ground and in fact has revised the definition of “shipper” to include any person who “arranges” for transportation, including brokers, by a carrier or multiple carriers.

Carrier Obligations Largely Set by Contract, Plus Training and Records Requirements

A carrier’s obligations for any food shipment essentially will depend on its contract with the shipper. However, if a carrier assumes responsibilities for ensuring sanitary conditions, it must have in place appropriate operating procedures and training procedures, and it also must retain related records. As a practical matter, any carrier who ever transports food will need to have such procedures in place.

Receiver Obligations for Temperature Controls

Upon receiving food that requires temperature controls, receivers must assess whether the food was subjected to “significant temperature abuse,” such as by taking the temperature of the food, assessing the ambient temperature of the vehicle or conducting a sensory inspection (e.g., for potential odors). Relatedly, a new addition to the final rule states that if any person subject to the rule becomes aware of a condition that may render food unsafe, that person must take action to ensure that the food is not sold or distributed until a qualified individual has made a determination that the food is safe.

USDA Facilities Now Included Among the Exemptions

The final rule no longer covers food from facilities regulated exclusively by the U.S. Department of Agriculture (USDA), although “dual jurisdiction” facilities subject both to FDA and USDA oversight will continue to be regulated pursuant to a memorandum of understanding between the agencies. As in the proposed rule, the final rule also exempts businesses with less than $500,000 average annual revenue, food that is trans-shipped through the United States and food that is imported for future export.

Covered “Transportation Operations” More Narrowly Defined

A revised definition of “transportation operations” now excludes transportation of foods completely enclosed in containers (unless temperature controls are required), farm-related transportation activities, transport of human food byproducts for use as animal food without further processing, transport of food contact substances, and transport of live animals other than molluscan shellfish.

Some Recordkeeping Relief, But Bad Recordkeeping Is Still Adulteration

The final rule has been revised so that electronic records are no longer subject to the more rigorous system requirements of 21 CFR Part 11. However, recordkeeping obligations remain significant and can be a basis for deeming food “adulterated” under the FD&C Act. Written procedures, agreements, and training records generally must be retained for up to one year, depending on the type of record.

Coordinated Enforcement and Potential Criminal Penalties

The rule explicitly states that the failure to comply with the Sanitary Transport Rule – including the recordkeeping requirements – is a “prohibited act” under the FD&C Act. This means that violations carry the risk of not only civil enforcement but significantstrict liability criminal penalties. A person who commits a prohibited act under the FD&C Act can be subject to misdemeanor and felony liability regardless of negligence and regardless of whether that person knew of the violation. A second misdemeanor is a felony. As FDA intends to coordinate enforcement with the Department of Transportation (potentially in conjunction with state personnel), covered entities should clarify the scope of what might appear to be routine inspections. Although many companies have been following best practices in accordance with agency guidance, FDA is clear in its comments that “[t]he provisions of this rule are not guidance nor are they recommendations.” Companies that are covered by the Sanitary Transport Rule should take notice.

Litigation Considerations

Companies should remember the litigation risks that are attendant to new regulations. The failure to comply with now mandatory requirements might be used by private plaintiffs to establish negligence per se, and documents created and retained for regulatory compliance may also find their way to litigation through discovery or through Freedom of Information Act requests to FDA. Moreover, to the extent the rule provides flexibility, this flexibility is subject to challenge and presents factual issues that may be difficult to dismiss. The impact of the final rule on cargo-related claims also remains unclear.

Compliance Dates

The Sanitary Transport Rule will be effective 60 days after publication. Although most entities will have one year to comply with the new requirements, smaller entities will have two years to comply.

Conclusion

The Sanitary Transport Rule reaffirms that transportation plays a critical role in preventing risks to the nation’s food supply. Companies that are covered by the new regulations should review their practices and procedures to ensure compliance and to avoid regulatory and litigation risks.