FDA has issued a final rule on Sanitary Transportation of Human and Animal Food. The rule creates new requirements for shippers, loaders, carriers, and receivers of food transported by rail or motor vehicle in the United States. A fact sheet and other information about the final rule are available here and here. FDA will hold a webinar on the rule on April 25, 2016 and plans to issue a guidance document.
Under the final rule, different requirements apply to shippers, loaders, carriers, and receivers. However, the same entity may function in more than one capacity with respect to any given shipment of food and, if so, must comply with the requirements applicable to each role (e.g., the same entity may act as shipper, loader, and carrier). In addition, two entities subject to the rule may, by written agreement, reassign their responsibilities from one to the other (e.g., the shipper may assign certain responsibilities to the carrier).
The final rule defines each entity involved in food transportation as follows:
Shipper is a person, e.g., the manufacturer or freight broker, who arranges for the transportation of food in the U.S. by a carrier or multiple carriers sequentially.
Loader means a person that loads food onto a motor or rail vehicle during transportation operations.
Carrier is a person who physically moves food by rail or motor vehicle in commerce within the U.S. (excluding parcel delivery services).
Receiver is any person who receives food at a point in the U.S. after transportation, whether or not that person represents the final point of receipt for the food.
The rule establishes requirements for vehicles and transportation equipment, conduct of transportation operations, training, and recordkeeping. The following are highlights of the new requirements:
- Vehicles and transportation equipment (e.g., containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, loading and unloading systems) must be designed and maintained so as to prevent the food they transport from becoming unsafe (i.e., from becoming adulterated within the meaning of Federal Food, Drug, and Cosmetic Act § 402(a)(1), (2) or (4)). They must be stored to prevent contamination and infestation with pests. Vehicles and transportation equipment used in transportation of food requiring temperature control for safety must be designed, maintained, and equipped to provide adequate temperature control.
- Shippers must develop and implement written procedures to ensure vehicles and transportation equipment are in appropriate sanitary condition, that food requiring temperature control for safety is transported under temperature control, and that previous cargoes do not make food unsafe. They must provide written specifications to the carrier and, when necessary, the loader with all necessary sanitary specifications for the vehicle and transportation equipment and, for food that requires temperature control for safety, the operating temperature during transportation.
- Loaders, before loading food that is not completely enclosed by its container, must determine that the vehicle and transportation equipment are in appropriate sanitary condition. Before loading food that requires temperature control for safety, loaders must verify that each mechanically refrigerated cold storage compartment or container has been properly pre-cooled.
- Carriers must develop and implement written procedures for cleaning, sanitizing, and inspecting vehicles and transportation equipment, maintaining temperature control, and complying with requirements for bulk vehicles. They must ensure that vehicles and transportation equipment meet the shipper’s specifications and are appropriate to prevent food from becoming unsafe. If the carrier and shipper have agreed in writing that the carrier is responsible for sanitary conditions during transportation, the carrier must provide adequate training to personnel engaged in transportation operations. FDA intends to develop an online course for this purpose.
- Receivers, upon receipt of food that requires temperature control for safety, must adequately assess that the food was not subject to temperature abuse.
- If a shipper, loader, carrier, or receiver becomes aware of an indication of a possible material failure of temperature control or any other condition that may render food unsafe during transportation, that person must take appropriate action to ensure that the affected food is not sold or distributed unless a safety determination is made by a qualified individual.
- Shippers, loaders, carriers, and receivers must maintain a number of records, all of which must be made available to FDA promptly upon oral or written request.
The Sanitary Transportation Rule does not apply to the following:
- Transportation of food by air or ship (However, it does apply to shippers, including those in other countries, who ship food to the U.S. by air or ship and arrange for the transfer of the intact container onto a rail or motor vehicle for transportation within the U.S.);
- Transportation activities performed by a farm;
- Transportation of live food animals, except molluscan shellfish;
- Transportation of food that is completely enclosed by a container, except if such food requires temperature control for safety;
- Transportation of human food byproducts intended for use as animal food without further processing;
- Transportation of compressed food gasses;
- Transportation of food contact substances (i.e., food packaging);
- Transportation of food that is transshipped through the U.S.;
- Transportation of food that is imported for future export and is not consumed or distributed in the U.S.;
- Shippers, loaders, carriers, or receivers that have <$500,000 in average annual revenue; and
- Food when it is located in a food facility that is regulated throughout the entire facility by the U.S. Department of Agriculture.
The rule also provides a process whereby FDA may grant a waiver, on its own initiative or in response to a petition, of any requirement to a class of persons, vehicles, foods, or non-food products. FDA already intends to issue two waivers to:
- Shippers, carriers, and receivers that hold valid permits and are inspected under the National Conference on Interstate Milk Shipments’ (NCIMS) Grade “A” Milk Safety program, because shipments of Grade “A” milk and milk products by such entities are already subject to NCIMS controls subject to state enforcement with FDA oversight; and
- Food establishments that hold valid permits issued by state, local, territorial, or tribal regulatory agencies (e.g., restaurants, grocery stores) when acting as shippers, carriers, or receivers, because food shipments are already subject to controls under the Retail Food Program with state or local enforcement and FDA oversight.
Most businesses must comply one year after publication of the final rule, on April 6, 2017. However, small businesses must comply two years after publication of the final rule, on April 6, 2018. A “small business” is defined as a business with <500 full-time equivalent employees, except that for motor carriers that are not also shippers and/or receivers a small business is a business having <$27.5 million in annual receipts.
Failure to comply with the rule is a prohibited act, subject to injunction and criminal prosecution. Perhaps more importantly, a food is deemed to be adulterated if it is transported or offered for transport by a shipper, loader, carrier, or receiver under conditions that do not comply with the rule. While FDA intends to conduct some inspections, the Department of Transportation (DOT) will establish procedures for transportation safety inspections to be conducted by DOT or state agencies.
The rule implements the Sanitary Food Transportation Act of 2005 (21 U.S.C. § 350e) and the Food Safety Modernization Act (FSMA). This is the sixth of seven “foundational regulations” that have been finalized implementing FSMA.