FDA Sanitary Transportation Proposal Covers Rail/Truck, Some International Shipments

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

The sanitary transport proposed rule is the last in a series of proposed regulations required by the Food Safety Modernization Act, including rules on produce safety, preventative controls for human and animal food, the Foreign Supplier Verification Program, third-party accreditation, and intentional adulteration. FDA was under a Jan. 31 deadline set by the Northern California U.S. District Court to issue the proposal (see 13081418). All of FDA’s final rules for its FSMA regulations are currently due by June 30, 2015 (see 13062412), although the case is currently under appeal at the U.S. Court of Appeals for the 9th Circuit.

At the same time that it released its sanitary transportation proposal, FDA also issued a press release (here) and posted a fact sheet (here) on the proposed rule (see 14013125). In its press release, FDA said it will hold three public meetings on the sanitary transportation proposed in Chicago on Feb. 27, Anaheim, Calif. on March 13, and College Park, Md. on March 20.

Proposal Sets Requirements for Truck and Rail ‘Transportation Operations’

FDA’s proposed rule on “Sanitary Transportation of Human and Animal Food” would set 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 would not apply if a shipment only includes (i) shelf-stable food that is completely enclosed by a container; (ii) compressed food gases; or (iii) live food animals. Also exempt would be the transportation of raw agricultural commodities from farm to market by farms. If a farm contracts out the transportation to a carrier, then the shipment would be subject to sanitary transportation regulations, said FDA.

Applies to ‘Shippers, Receivers, and Carriers,’ Including Some Foreign Activities

FDA’s sanitary transportation requirements would apply to “shippers, receivers, and carriers” engaged in either interstate or intrastate transportation operations by truck or rail. The shipper, receiver or carrier would still be ultimately responsible for meeting sanitary transportation requirements even if they contract out to other entities, said FDA. The proposed rule defines each role as follows:

Shipper. A person who initiates a shipment of food by motor vehicle or rail vehicle. A shipper may also be a receiver or a carrier.

Receiver. Any person who receives food after transportation, whether or not that person is the final destination of the food. This does not include a person acting on behalf of another customer that is not a party to the transaction and that is not a food distributor, such as a hotel concierge or a reception desk, said FDA.

Carrier. A person owns, leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food. The carrier is the physical transporter of the food, and is responsible for the actions of its drivers.

Small Business Exemption if Sales Under $500,000

As proposed, the sanitary transportation rule exempts “non-covered businesses” from complying with its requirements. The proposed rule defines a “non-covered business” as a shipper, receiver, or carrier engaged in transportation operations that has less than $500,000 in total annual sales.

Foreign Entities Must Comply if Arranging Truck or Rail Transport

The proposed requirements would also 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. would have to meet the sanitary transportation requirements. Sanitary transportation requirements would 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, said FDA.

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

Doesn’t apply to air/ocean shipments, transit, import for export. Foreign shippers and carriers that only transport food by air or ocean vessel to the U.S. would not be subject to FDA’s sanitary transportation requirements. The sanitary transportation requirements would also not apply to (i) food that is transshipped through the U.S. to another country, and (ii) food that is imported for future export, and that is neither consumed nor distributed in the United States.

Requirements for Shippers, Receivers, Carriers

Under FDA’s proposed rule, all shippers, carriers, and receivers would be responsible for ensuring that transportation operations comply with FDA regulations through the use of competent supervisory personnel. Transportation operations would have to be conducted in such a way to prevent food from becoming filthy, putrid, decomposed, or otherwise unfit for food, or injurious to health, by taking effective measures such as:

• Segregation or isolation to protect food from contamination by raw foods and non-food items in the same load
• Segregation, isolation, or other protective measures, such as hand washing, to protect food transported in bulk vehicles or not enclosed completely by containers from contamination and cross-contact during transportation
• Temperature control for food that can support the rapid growth of microorganisms without such controls

Shippers

Some requirements of the sanitary transportation rule would only apply to shippers engaged in “transportation operations.” These requirements are as follows:

Instructions. The shipper must specify to the carrier, in writing, all necessary sanitary requirements for the carrier’s vehicle and transportation equipment that are necessary to keep the food safe. For food whose temperature must be controlled to prevent the growth of microorganisms, the shipper must also include instructions on temperature controls, including pre-cooling. Shippers would have to keep records of these instructions for 12 months.

Inspection. Before food that isn’t completely enclosed by a container is loaded onto the carrier’s vehicle, the shipper must visually inspect the vehicle or transportation equipment provided by the carrier for cleanliness. If a food requires temperature controls, the shipper must verify that each freezer or refrigerated compartment or container has been pre-cooled in accordance with instructions.

Demonstration of temperature controls. If agreed to in writing between the shipper and the carrier, the shipper may also be responsible for demonstrating to the receiver that the food was held during transportation in accordance with its temperature instructions. If such an agreement is in place, the shipper would also be responsible for keeping corresponding records.

Shippers and Receivers

Other requirements would be applicable to both shippers and receivers of food shipments under the sanitary transportation rule. These requirements are as follows:

Hand-washing facilities. Shippers and receivers must provide vehicle operators that are expected to handle food not completely enclosed by a container with access to a convenient hand washing facility with running water.

Temperature controls. Shippers and receivers of food that can be contaminated by the growth of microorganisms without temperature controls must load and unload the food under conditions that will prevent that growth.

Carriers

Carriers engaged in “transportation operations” under the sanitary transportation rule would be subject to the following requirements:

Demonstration of temperature controls. The carrier is responsible for demonstrating to the shipper and, if requested, the receiver that the food was held during transportation in accordance with the shipper’s temperature instructions, unless the shipper agrees in writing to be held responsible for monitoring.

Pre-cooling. Before loading a vehicle or transportation equipment with an auxiliary refrigeration unit for the temperature-controlled transportation of food, the carrier must pre-cool each freezer and cold storage department in accordance with the shipper’s instructions.

Previous cargo and cargo. For bulk vehicles, the carrier must provide information to the shipper on the previous three cargoes held by the container and describes the most recent cleaning, unless the shipper waives this requirement by written agreement and procedures have been established to ensure food safety.

Written plan. Carriers must develop written procedures for cleaning and inspecting equipment, complying with temperature control requirements, and provisions for bulk vehicles. This plan is subject to recordkeeping requirements.

Training. Carriers must, upon hiring and “as needed” thereafter, provide training to personnel on food safety problems that may occur during transportation, sanitary transportation practices, and the responsibilities of the carrier. Records must be kept on this training for 12 months.

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 would have to 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 proposed rule, FDA says it has already identified two waivers to the sanitary transportation rule that it plans to publish in the Federal Register at the same time as the final rule on sanitary transportation, as follows:

Grade A milk. Shippers, carriers and receivers who hold valid permits and are inspected by the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety Program would not be subject to sanitary transportation regulations when engaged in transportation operations involving Grade A milk and milk products.

Establishments with permits. Food establishments like restaurants and caterers with valid permits would also be exempt when engaging as receivers, or as shippers and carriers in operations in which food is provided to consumers after transportation from the establishment, like home delivery of grocery orders or restaurant takeout orders.

Effective Dates Staggered for Small Businesses

FDA plans on setting staggered compliance dates when it eventually issues its final rule on sanitary transportation of food. Small businesses, defined as (a) businesses employing fewer than 500 people or (b) carriers that are not also shippers or receivers that have less than $25,500,000 in annual receipts, would have two years to comply with the requirements. All others subject to the rule would have to be in compliance one year after the final rule’s publication.

(See FDA’s proposed rule for other provisions, including definitions and requirements for vehicles and transportation equipment.)