On April 5, 2016, the U.S. Food and Drug Administration (FDA)1 announced final promulgation and issuance of a new food safety rule under the FDA Food Safety Modernization Act (FSMA)2 that governs transportation of food. The new rule on Sanitary Transportation of Human and Animal Food, which goes into effect either one or two years following official publication depending on the size of the regulated business,3 will require those involved in transporting human and animal food by motor or rail vehicle to follow recognized best practices for sanitary transportation, such as properly refrigerating food, adequately cleaning vehicles between loads and properly protecting food during transportation. 4
The new regulation generally applies to food transported within the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce. Shippers, loaders, carriers and receivers engaged in transportation operations of food imported by motor or rail vehicle and consumed or distributed in the United States also are subject to the final rule, unless exempted.
Core Requirements of the New Food Transport Rule
The 283-page Sanitary Transportation of Human and Animal Food rule has fashioned a broad array of regulatory requirements based on food industry members’ best practices. The new requirements range from formalizing quality assurance operations and complying with detailed guidelines for refrigerating and transporting food, to record-keeping and reporting obligations intended to assure both compliance and traceability. FDA has enumerated four key requirements of the new rule:
- Vehicles and transportation equipment: The design and maintenance of vehicles and transportation equipment to ensure that it does not cause the food that it transports to become unsafe. For example, they must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food.
- Transportation operations: The measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready to eat food from touching raw food, protection of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact, i.e., the unintentional incorporation of a food allergen.
- Training: Training of carrier personnel in sanitary transportation practices and documentation of the training. This training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.
- Records: Maintenance of records of written procedures, agreements and training (required of carriers). The required retention time for these records depends upon the type of record and when the covered activity occurred, but does not exceed 12 months.5
The FDA’s new rule is part of a larger effort to focus on prevention of food safety problems throughout the food chain, and implements the Sanitary Food Transportation Act of 2005 (SFTA) as well as the requirement in section 111 of FSMA that instructed FDA to issue SFTA regulations.
Who Is, and Is Not, Covered By the New Rule
The Sanitary Transportation of Human and Animal Food rule applies broadly6 to shippers, receivers, loaders and carriers who transport food in the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce. It also applies to shippers in other countries who transport food to the United States directly by motor or rail vehicle (from Canada or Mexico), or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the United States, if that food will be consumed or
distributed in the United States.7 Also, companies involved in the transportation of food intended for export are covered by the rule until the shipment reaches a port or U.S. border. The rule does not apply to exporters who ship food through the United States (for example, from Canada to Mexico) by motor or rail vehicle if the food does not enter U.S. distribution.
While the new rule has broad application, there are key exemptions. The following businesses and activities are exempt from compliance:
- Shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue;
- Transportation activities performed by a farm;
- Transportation of food that is transshipped through the United States to another country;
- Transportation of food that is imported for future export and that is neither consumed or distributed in the United States;
- Transportation of compressed food gases, e.g., carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products, as well as food contact substances;
- Transportation of human food byproducts transported for use as animal food without further processing;
- Transportation of food that is completely enclosed by a container except a food that requires temperature control for safety; and
- Transportation of live food animals, except molluscan shellfish.8
Moving to Completion of the Major 7
With the final issuance of its Sanitary Transportation of Human and Animal Food rule, the FDA has now promulgated six of the seven major rules that implement the core of FSMA. This latest regulation builds on the Preventive Controls for Human Food rule,9 the Preventive Controls for Animal Food rule,10 the Produce Safety rule (which includes standards for the growing, harvesting, packing and holding of produce for human consumption),11 the Foreign Supplier Verification Programs rule,12 and the Accreditation of Third-Party Certification rule,13 all of which FDA finalized in 2015. The seventh rule, which focuses on mitigation strategies to protect food against intentional adulteration, is expected to be finalized later in 2016.14