On February 5, 2014, the Food and Drug Administration (FDA) published in the Federal Register its proposed rule on “Sanitary Transportation of Human and Animal Food.” The proposed rule would require shippers, carriers, and receivers that transport food by motor or rail vehicles to use certain sanitary transportation practices to ensure the safety of the food they transport.
As the seventh and final major rule mandated by the Food Safety Modernization Act (FSMA), the rule would likely have the most impact in terms of the shear number of businesses that would be covered. The rule would apply to the transportation of all human and animal food, regardless of whether the transportation would be across state lines. Unlike the other proposed rules under FSMA, the transportation rule would also not be limited to “registered” facilities under the Bioterrorism Act, and would apply to businesses that are regulated by both FDA and the USDA Food Safety and Inspection Service. Although certain businesses (e.g., businesses with less than $500,000 total sales) and transportation activities (e.g., transportation of live animals) would be exempt from the rule and the rule would provide a process for seeking a waiver of regulatory requirements, most companies involved in the transportation of food would likely be covered—estimated by FDA to be over 83,000 businesses.
If finalized, the proposed rule would require shippers, carriers and receivers of food to meet certain performance based requirements. Among other things, all three entities would be required to maintain vehicles and transportation equipment in a sanitary condition and in a manner that prevents pest harborage, make vehicles and equipment suitable for cleaning, and design and equip vehicles and equipment to ensure appropriate temperature control. All three entities would also be required to take effective measures to ensure that foods are not contaminated from other foods or non-foods during transportation, and to ensure foods are transported under proper temperature conditions. Shippers and receivers would also be required to provide handwashing facilities for vehicle operators loading and unloading food not completely enclosed, and to carry out loading and unloading operations under proper temperature conditions.
Shippers and carriers of food would have to comply with additional recordkeeping and information exchange requirements. Among other things, shippers would have to provide written specifications to carriers regarding: (1) appropriate sanitary conditions for vehicles and transportation equipment, and (2) proper temperature conditions for food that supports microbial growth in absence of temperature control. They would also have to maintain these records. Carriers, in turn, would have to:
- Demonstrate to the shipper, and upon request, to the receiver, that it has maintained temperature conditions consistent with the shipper’s specifications (the shipper may assume the duty to notify the receiver if there is an agreement in writing with the carrier; the carrier would have to maintain this written agreement and provide it to the receiver if requested);
- Identify to the shipper the three previous cargoes transported in bulk vehicles and the most recent cleaning of the vehicle, unless otherwise agreed in writing with the shipper that other procedures would be adequate for the intended transportation operation (the agreement would have to be maintained by the carrier and shipper);
- Develop, implement and maintain written procedures that: (1) specify how vehicles and equipment will be cleaned, sanitized (if necessary) and inspected to ensure sanitary conditions, (2) describe how the carrier will maintain temperature conditions in compliance with the shipper’s specifications, and (3) how it will provide information to the shipper regarding the three previous cargoes and most recent cleaning of a bulk vehicle; and
- Provide training to transportation personnel on potential food safety issues and sanitary practices and maintain training documentation
Most of the proposed requirements should not have a significant impact on shippers and receivers of food as most are heavily regulated by FDA, FSIS and/or state governments, and have already adopted good manufacturing practice (GMP) procedures and policies that largely comport with FDA’s proposed rule. However, some of the proposed requirements, particularly the recordkeeping, information-exchange and training requirements, would be new to carriers of food and could present challenges. Although transportation companies have long adhered to good sanitary practices in the transportation of food, many companies may not be familiar with developing and maintaining the type of detailed written procedures and records, or providing the type of training, that the proposed rule would require. To that extent, if the proposed rule is finalized, transportation companies may wish to seek the assistance of FDA experts in meeting the regulatory requirements. Moreover, if there are transportation operations that are unlikely to result in the shipment of foods under unsafe conditions, regulatory experts may also assist transportation companies in seeking a waiver from all, or specific, regulatory requirements.
Comments on the proposed rule are due by May 21, 2014.
