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

FDA has finalized seven major rules that collectively account for the majority of the Food Safety Modernization Act (FSMA). One of those rules, and the subject of this article, is the Sanitary Transportation of Human and Animal Food Rule. According to FDA, the rule is intended to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.

The Sanitary Transportation of Human and Animal Food Rule (also referred to as the Sanitary Transport Rule) establishes food safety and sanitation requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food. Specifically, the rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training, and waivers pertaining to the safety of food in transport. In essence, it’s an enhanced version of the 2005 Sanitary Food Transportation Act, which was enacted to combat concerns arising from reports of unsanitary transportation practices and foodborne illness outbreaks caused by contamination that occurred while food was being transported.

Generally, the rule applies to shippers, receivers, loaders, and carriers who transfer food in the U.S. by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce. This is somewhat unusual. The rule does not apply to transport by ship or air. Although, as noted, the rule is applicable to various individuals and entities throughout the supply chain, it is the shippers who have the greatest degree of responsibility under the rule, including for the development and implementation of written procedures that address how the safety of the food will be assured.

The rule is focused on three major areas, which are:

1. Assurance that vehicles and equipment used in transportation operations are in appropriate sanitary condition;
2. Assurance that, for bulk cargo, a previous cargo does not make the food unsafe; and
3. Assurance that foods requiring refrigeration as a matter of safety are transported under adequate temperature control.

The rule allows the transportation industry to continue to use best practices, i.e., commercial or professional procedures that are accepted or prescribed as being correct or most effective, concerning cleaning, inspection, maintenance, loading and unloading, and operation of vehicles and transportation equipment that it has developed to ensure that food is transported under the conditions and controls necessary to prevent adulteration linked to food safety.

Requirements Applicable to Vehicles and Transportation Equipment

The requirements applicable to equipment are stated in very general terms, which is ostensibly necessary given the breadth and variation among the types of equipment and modalities used for the transportation of food.

Under the rule, vehicles and transportation equipment used in transportation operations must be designed and constructed in a manner that is suitable and adequately cleanable for their intended use in order to prevent the food they transport from becoming unsafe, i.e., adulterated. FDA defines the term “adequate” to mean that which is needed to accomplish the intended purpose in keeping with good public health practice.

Ultimately, this will likely be interpreted from an engineering standpoint, meaning FDA will want independent supporting information that is based on scientific data and that supports the adequacy of any measures. Although there are many ways to achieve the objectives, it will be important for stakeholders to ensure they are doing their due diligence with respect to ensuring that the equipment used to transport products is adequately constructed to ensure the safety of food. This means carefully working with carriers to ensure they are meeting their obligations.

Requirements Applicable to Carriers Engaged in Transportation Operation

According to the rule, transportation operations must be conducted under such conditions and subject to any controls necessary to prevent the food from becoming unsafe during transportation operations. Although this is broadly stated, it means that all stakeholders must work together to ensure that food is being safely transported. This necessitates measures such as segregation, isolation, or the use of packaging to protect food from cross-contamination with other foods or nonfood items in the same load. Likewise, protective measures must be put in place to protect food transported in bulk vehicles or food not completely enclosed by a container from contamination and cross-contact during transport; it also requires ensuring that food requiring temperature control for safety is transported under adequate measures.