Sometimes referred to as the “weakest link” in the food safety system, many responsible for the transportation of food feared that the Food Safety Modernization Act (FSMA) would be particularly harsh on the transportation industry. For all of the trepidation and foreboding, the initial 2014 proposed regulation was surprisingly benign, with the U.S. Food and Drug Administration (FDA) actually praising the transportation industry’s current best practices. If the draft regulation was a surprise, the final regulation for the Sanitary Transportation of Human and Animal Food, published April 6, 2016, is worthy of cartwheels as it further dials back even the provisions in the draft regulation.

What may not automatically occur to those in the food industry is that the rules applying to the safe transportation of food apply not only to transportation carriers, but also to shippers, receivers and loaders. In fact, under the final regulation primary responsibility for nearly all safety risks during transportation falls to the shipper. It is the shipper who must determine appropriate transportation operations. The shipper must develop and implement written procedures to ensure that equipment and vehicles are in appropriate sanitary condition. Shippers of bulk food must develop and implement written procedures to ensure that a previous cargo does not cross-contaminate. Shippers of food which require temperature control for safety must also develop and implement written procedures to ensure adequate temperature control during transport. These responsibilities may be contractually assigned to other entities, such as the carrier or loader, if they agree to accept the responsibility. FDA’s logic is that it is the shipper who is in the best position to know the appropriate specifications for the transportation of its food product.

The general categories within the transportation regulation can be divided as follows:

A. Coverage: The transportation regulation generally applies to shippers, loaders, carriers by motor vehicle or rail vehicle, and receivers engaged in the transportation of food, including food for humans and for animals. Transportation is defined as any movement of food in commerce, including both interstate and intrastate commerce. 

Excluded from the definition of “transportation operations” are foods completely enclosed by a container, except foods that require temperature control. Also excluded are all transportation activities performed by a farm and the transportation of live food animals (with limited exceptions). The transport of human food byproducts for use as animal food without further processing is also excluded.
The transportation rule does not apply to transportation by ship or air within the U.S. It does not apply to food imported, transported through the U.S. and then exported, if the food does not enter U.S. distribution. Conversely, food manufactured in the U.S. for export is covered under the rule until transported to the U.S. point of export. The rule would not cover shippers, receivers or carriers engaged in food transportation operations which have less than $500,000 of total annual sales. FDA also has the authority to waive the rule in part or altogether if such waiver will not result in unsafe food conditions. FDA has already announced it will publish the following waivers:

•    Shippers, carriers and receivers subject to the National Conference on Interstate Milk Shipments for Grade A milk and milk products.

•    Shippers, carriers and receivers in operations in which food is relinquished to customers after being transported from a food establishment. Examples include restaurants, supermarkets and home grocery delivery operations. Such transportation operations are regulated under the Retail Food Program, with state, territorial, tribal and local enforcement, and FDA oversight.

B. Vehicles and Equipment: Vehicles and transportation equipment used in the transportation of food must be made so that they are usable for their intended purposes and maintained in such a way as to be suitable and adequately cleanable to prevent the food they transport from becoming unsafe, that is, adulterated. The shipper must specify to the carrier, in writing, all necessary sanitary requirements for the carrier’s vehicle and equipment, including any specific design requirements and cleaning procedures deemed necessary by the shipper to ensure that the vehicle and equipment are in appropriate sanitary condition for the particular food product. The shipper also must visually inspect the carrier’s vehicle for cleanliness and compliance with its written sanitary specifications prior to loading the shipment
Bulk tankers are of particular concern as they are more difficult to both clean and to inspect. The regulation will require a carrier operating a bulk vehicle to provide information to the shipper that describes the most recent cleaning of the vehicle. The regulation will also require a carrier operating a bulk vehicle to provide information to the shipper that identifies the three previous cargoes transported in the vehicle.

C. Temperature Controls: One of the biggest risks to foods in transit relates to the transport of foods that require temperature controls to limit pathogenic microorganism growth or toxin formation. In the regulation, FDA has clarified that the shipper is the one with the knowledge and responsibility to establish all preventive controls, including the temperature controls required during transport. The shipper is responsible to communicate those necessary temperature controls in writing to the carrier. The shipper must also verify prior to loading that the vehicle has been precooled in accordance with the shipper’s written controls.
The regulation requires that vehicles and transportation equipment used to transport temperature sensitive foods be designed, maintained and equipped to be able to maintain the food under temperature conditions identified by the shipper as necessary to prevent it from supporting microbial growth. Although the proposed regulation required the use of a temperature indicating or recording device during transport, the final regulation is much more flexible. The shipper and carrier can agree to any temperature monitoring mechanism for foods that require temperature control for safety.

D. Transportation Operations: After temperature control, cross-contamination is the second leading biological abuse of food during transport. A concern of many food safety groups has been the practice of transporting certain combinations of food cargo with either raw food and/or non-food cargo, either as co-cargo or subsequent cargo. The Sanitary Transportation regulation requires that effective measures be taken to protect food from exposure to raw foods or non-food items in the same or subsequent loads. Appropriate protective measures must be designed by the shipper and may include segregation, isolation or packaging of the subject food and/or sanitation measures.

E. Training: The regulation requires that carriers provide training to all personnel engaged in transportation operations. That training must provide an awareness of potential food safety problems which may occur during food transportation, basic sanitary transportation practices to address those potential problems and the responsibilities of the carrier under the various regulations. This training is required to occur upon hiring and on an as-needed basis thereafter. FDA is developing an online course that would meet these training requirements. The agency anticipates that the course will be available before the first compliance dates.

F. Records: The regulation contains certain record keeping requirements. Shippers must retain records demonstrating that they provided specifications and operating temperatures to carriers for 12 months after the termination of the contract with the carrier. Carriers must retain training records for 12 months after the person identified in the records stops performing the duties for which they were trained.

G. Compliance: Small businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts must comply within two years after the publication date (April 6, 2016). All other covered businesses not otherwise excluded from coverage must comply within one year after the publication date.   

For particular questions, FDA’s FSMA Food Safety Technical Assistance Network is already operational to provide informational support to the industry in understanding and implementing FSMA. Questions submitted online or by mail will be answer by FDA personnel.   

Kathy Hardee, Esq., is co-chair of the Food & Agriculture Industry Group at Polsinelli, PC, which is composed of a team of attorneys from every legal practice area and who each have a focused background in the food industry.