Breaking Down FSMA’s Sanitary Transportation of Human and Animal Food Rule

With respect to temperature, the rule only requires temperature control during transportation when it is necessary to prevent the food from becoming unsafe. That is, the rule does not establish requirements for temperature control during food transportation for any other purpose, such as for marketability purposes, or to preclude the spoilage of food subject to this rule. By way of example, whole, fresh apples, cherries, pears, and potatoes are all examples of foods that generally do not require temperature control for safety. FDA has stated it intends to ensure that inspectors understand which factors generally distinguish foods that require temperature control to prevent the food from becoming unsafe from other foods that are transported under temperature control for quality purposes. This is a gray area that may cause some discord until further guidance and/or agreement is reached.

Shippers are responsible for determining whether a food is subject to the temperature control provisions of the rule. The rules do not specifically require any given type of monitoring, but it will be important to establish a means of showing that no temperature deviations occurred. This could include independently recording temperatures from time to time, or otherwise effectively showing, to the extent specific data is not available, that no deviations occurred. Put differently, this means that for food that requires temperature control for safety, the shipper must develop and implement written procedures, subject to the rule’s recordkeeping requirements, to ensure that the food is transported under adequate temperature control. The recordkeeping requirements for transportation operations require shippers to retain records, for a period of 12 months, that demonstrate effective procedures to prevent the food from becoming unsafe during the transportation operation, to ensure that previous cargo does not make the food unsafe, and to ensure that the food is transported under adequate temperature control.

Deviations from the temperature control rules can render a shipment adulterated, but do not necessarily do so. To paraphrase FDA on this issue, inconsequential failures to maintain temperature controls will not necessarily render the affected food adulterated. However, if an individual subject to the rule is aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe, the person must ensure the food is not sold or otherwise distributed, unless a qualified individual determines that the temperature deviation did not cause the food to become unsafe.

Importantly, these requirements apply to all shippers, carriers, loaders, and receivers engaged in transportation operations. A person may be subject to these requirements in multiple capacities, e.g., the shipper may also be the loader and the carrier, if the same person also performs those functions.

Notwithstanding the previous provisions, parties can reassign their responsibilities to another party, provided that reassignment is set forth in a written agreement. To the extent that such responsibilities are reassigned, there may be additional requirements that are triggered. For example, when the carrier and shipper have agreed in a written contract that the carrier is responsible, in whole or in part, for the sanitary conditions during transportation operations, the carrier must provide adequate training to personnel engaged in transportation operations. The training must provide instruction on the potential food safety problems that can occur during transportation and on basic sanitary transportation practices to address those potential problems, and must also specifically delineate the responsibilities of the carrier to ensure the transport of food in compliance with the Rule. Additionally, the training must be provided upon hiring and as needed thereafter. To ensure adequate compliance with the rule, carriers are required to create and maintain records documenting the training, including the date of the training, the type of training, and the person or people trained.