FDA Issues Final Rule on Sanitary Transportation of Food

The regulations may apply to shippers in other countries who ship food to the United States directly by motor or rail vehicle, such as 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 U.S., if that food will be consumed or distributed in the U.S., said FDA in a fact sheet (here). In addition, 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, unless the food was imported for export.

In a change from its proposed rule (see 14020301), FDA is adding flexibility “to allow the transportation industry to continue to use industry best practices concerning cleaning, inspection, maintenance, loading and unloading of, and operation of vehicles and transportation equipment to ensure that food is transported under the conditions and controls necessary to prevent adulteration linked to food safety,” it said. As a result, FDA believes “the impact of our enforcement activities upon international trade will be minimal since this rule allows the transportation industry to continue to use existing practices that have proven to be effective for the safe transportation of food,” the agency said.

The final rule sets specific requirements that shippers, loaders, carriers, and receivers of human and animal food shipments must each follow. Certain types of food are exempt from the sanitary transportation requirements, as are very small businesses with less than $500,000 in sales per year. FDA may also issue waivers of the requirements when no danger is posed to food safety.

Effective Dates Staggered for Small Businesses

As planned, FDA is setting staggered compliance dates for its final rule on sanitary transportation. Small businesses, defined as (a) businesses employing fewer than 500 people or (b) carriers by motor that are not also shippers or receivers that have less than $27,500,000 in annual receipts, have two years to comply with the requirements, until April 6, 2018. All others subject to the rule have to be in compliance one year after the final rule’s publication, or until April 6, 2017.

Final Rule Sets Requirements for Truck and Rail ‘Transportation Operations’

FDA’s final rule on “Sanitary Transportation of Human and Animal Food” sets food safety requirements for sanitary “transportation operations” by truck and rail. According to FDA, “transportation operations” include all activities associated with food transportation that may affect food sanitation, including cleaning, inspection, maintenance, loading and unloading, and the operation of vehicles and transportation equipment.

Exempt activities. According to FDA’s definition of “transportation operations,” sanitary transportation requirements do not apply if a shipment only includes (i) compressed food gases; (ii) live food animals except molluscan shellfish; or (iii) transportation activities performed by a farm. The final rule expands the exemption for (iv) food completely enclosed by a container so that it includes all food, whether or not shelf-stable, unless it requires temperature controls; and adds new exemptions for (v) food contact surfaces; and (vi) human food byproducts transported for use as animal food without further processing.

Applies to Shippers, Receivers, Loaders and Carriers, Including Some Foreign Activities

FDA’s sanitary transportation requirements apply to shippers, receivers, carriers and, in a change from its proposed rule, loaders, engaged in transportation operations by truck or rail. Entities covered by these regulations may be subject to the requirements of multiple types of entities (i.e., shipper and carrier requirements), said FDA. Entities may also contract other parties to perform their responsibilities, with FDA examining the terms of the written contract to decide who is ultimately responsible for compliance.

The final rule adopts more “simplified” and “activity based” definitions than those initially proposed by FDA, defining each role as follows:

Shipper. A person, e.g., the manufacturer or a freight broker, who arranges for the transportation of food in the United States by a carrier or multiple carriers sequentially.

Receiver. Any person who receives food at a point in the United States after transportation, whether or not that person represents the final point of receipt for the food.

Carrier. A person who physically moves food by rail or motor vehicle in commerce within the United States. The term carrier does not include any person who transports food while operating as a parcel delivery service.

Loader. A person that loads food onto a motor or rail vehicle during transportation operations.

Small Business Exemption if Sales Under $500,000

FDA’s final regulations on sanitary transportation exempt “non-covered businesses” from complying with its requirements. The rule defines a “non-covered business” as a shipper, receiver, or carrier engaged in transportation operations that has less than $500,000 in average annual revenues, as adjusted for inflation, over the preceding three years.

Foreign Entities Must Comply if Arranging Truck or Rail Transport

The requirements apply to foreign entities if they are responsible for the transportation of food in the U.S. by truck or rail, said FDA. For example, foreign shippers and carriers that transport food by truck or rail from Canada or Mexico into the U.S. have to meet the sanitary transportation requirements. Sanitary transportation requirements also apply to an exporter that ships food in a container by air or ocean vessel, and then arranges for the transfer of the intact container is onto a train or truck for transportation in the United States. That entity would still be arranging for truck or rail transport in the U.S., even if from abroad.

If a foreign entity is required to meet sanitary transportation requirements, but fails to comply, FDA may consider the food shipped to the U.S. to be adulterated and refuse admission when offered for entry into the United States.

In the final rule, FDA noted some international transactions, such as shipments originating from small shippers in less developed countries, can present difficulties for U.S. firms subject to this rule when it may be necessary to investigate the history of a shipment. “In circumstances where it would normally be necessary for a U.S. receiver or carrier to contact the foreign shipper under the requirements of this rule (e.g., if a question arose concerning temperature control during shipment) if the shipper is not readily accessible for any reason, the carrier or receiver would have the responsibility,” said FDA.

Doesn’t apply to air/ocean shipments, transit, import for export. Shippers and carriers that only transport food by air or ocean vessel to the U.S are not be subject to FDA’s sanitary transportation requirements. The sanitary transportation requirements also do not apply to (i) food that is transshipped through the U.S. to another country, (ii) food that is imported for future export, and that is neither consumed nor distributed in the United States, and (iii) food located and food facilities regulated exclusively by the Department of Agriculture.

Requirements for Shippers, Receivers, Loaders and Carriers

Under FDA’s final rule, all shippers, carriers, loaders and receivers are responsible for ensuring that transportation operations comply with FDA regulations through the use of competent supervisory personnel; segregation and isolation to prevent contamination; and temperature controls. Unlike in the proposed rule, which included protections against spoilage and quality defects, the final form of FDA’s regulations focuses solely on food safety concerns, said FDA. Shippers, carriers, loaders and receivers under the ownership of a single legal entity have the option of meeting certain modified requirements. All parties, when they become aware of potential food safety issues, would have the responsibility of stopping the shipment from being sold or distributed.

The final rule also sets individual requirements for shippers, receivers, loaders and carriers, as follows:

Shippers. The shipper bears the main “responsibility for determinations about appropriate transportation operations (e.g., whether food needs temperature control for safety and the relevant operating temperature and mode of temperature monitoring, whether particular clean out procedures are needed, and whether previous cargo must be identified), said FDA. They must either take steps to ensure vehicles and equipment used in transportation are sanitary, or specify their requirements to the carrier and/or loader, including sanitation conditions and temperature controls. Shippers must also implement written procedures and keep records to ensure sanitary conditions, protections from cross-contamination and adequate temperature controls.

Loaders. Before loading food, the loader must determine whether transportation equipment is in adequate sanitary condition, according to the shipper’s instructions, and verify that the transportation equipment meets any temperature control requirements provided by the shipper.

Receivers. Upon receipt of food that requires temperature controls, the receiver must take steps to assess that the food was not subjected to significant temperature abuse, such as determining the food’s temperature, the ambient temperature of the vehicle and its temperature setting, and conducting a sensory inspection, such as for “off-odors.”

Carriers. When the carrier and shipper have a written agreement that the carrier is responsible, in whole or in part, for sanitary conditions during the transportation operation, the carrier is responsible for ensuring transportation equipment meets the shipper’s specifications, demonstrating adequate temperature controls were maintained, pre-cooling transportation equipment, and maintaining and providing information to the shipper about the equipment. The carrier is also responsible for maintaining written records and training its personnel.

Recordkeeping

Records required by the sanitary transportation regulations, including shippers’ specifications and agreements for other parties to assume their responsibilities under the rule, and carrier written procedures and training records, must be maintained for a one year period beyond when they are no longer in use.

Waivers Available if No Effect on Food Safety

FDA said it will grant waivers to any requirement of the sanitary transportation rule, as long as the agency determines that the waiver won’t result in the unsafe transportation of food and wouldn’t be against the public interest. To request a waiver, a petition must be submitted to the agency that includes grounds for the waiver. Comments would then be requested in a Federal Register notice. Another Federal Register notice would then by published if the petition is granted. The wavier would be subject to modification or revocation by FDA.

In its final rule, FDA says it has already identified two waivers to the sanitary transportation rule that it plans to publish in the Federal Register: grade A milk and food establishments like restaurants and caterers with valid permits. The agency said it still needs to consider comments, but intends to issue the waivers before the final rule’s compliance date.