Outline of FSMA’s Transportation Rule’s Impact
AFI Staff Report
The Sanitary Transportation of Human and Animal Food Rule within FSMA establishes requirements for shippers, loaders, carriers and receivers engaged in the transportation of human and animal food by truck or rail.
The requirements do not apply to transportation by vessel or air because of limitations established by the Sanitary Food Transportation Act of 2005. (However, transportation issues related to food safety are a necessary component of the supply chain management requirements in other FSMA rules.)
Among the operations covered by the rule are shippers, loaders, carriers and receivers involved with motor or rail vehicle transportation of raw agricultural commodities (e.g., grains and oilseeds), animal feed and feed ingredients and human food and food ingredients.
The requirements of the rule do not apply to shippers, receivers, loaders or carriers when they are engaged in transportation operations of food that is transshipped through the United States (e.g., from Canada or Mexico by truck or rail) to another foreign country; or food imported for future export, in accordance with the Federal Food, Drug and Cosmetic Act, and that is neither consumed nor distributed in the United States; or food when it is located in food facilities regulated exclusively by USDA.
“Non-covered businesses” (shipper, loader, receiver or carrier with less than $500,000 in revenues) also are exempt from the rule.
In addition, the rule defines “transportation operations” to mean “all activities associated with food transportation that may affect the sanitary condition of food, including cleaning, inspection, maintenance, loading and unloading, and operation of vehicles and transportation equipment.
Transportation operations do not include any activities associated with the transportation of food that is completely enclosed by a container, except a food that requires temperature control for safety, compressed food gases, food contact substances as defined in section 409(h)(6) of the Federal Food, Drug and Cosmetic Act, human food byproducts transported for use as animal food without further processing or live food animals except molluscan shellfish. In addition, transportation operations do not include any transportation activities performed by a farm.
Vehicles and Transportation Equipment
FDA’s final rule establishes requirements that vehicles and transportation equipment used in transportation operations are to be designed of such material and workmanship so as to be suitable and adequately cleanable for their intended use to prevent the food they transport from becoming unsafe.
In addition, the sanitary condition of vehicles and transportation equipment is to be maintained to prevent food from becoming unsafe during transportation operations. Further, vehicles and transportation equipment are to be stored in a manner that prevents it from harboring pests or becoming contaminated in any other manner that could result in unsafe food. The rule does not prescribe how the sanitary condition of vehicles and transportation equipment is to be maintained. This is consistent with the flexibility granted throughout the other FSMA regulations. Companies may come up with their own procedures but everything must be documented and must ensure compliance with the regulation.
The rule requires competent supervisory personnel be assigned to ensure transportation operations are conducted under conditions and controls necessary to prevent the food from becoming unsafe, including: taking effective measures, such as segregation, isolation or the use of packaging, to protect food from being contaminated by raw foods and non-food items in the same load; taking effective measures, such as segregation, isolation or other protective measures, such as hand washing, to protect food transported in bulk vehicles or food not completely enclosed by a container from contamination during transportation operations.
If a shipper, loader, receiver or carrier becomes aware of an indication of conditions that may render the food unsafe during transportation, the food is not to be sold or otherwise distributed and these persons are to take appropriate action. These actions are to include, as necessary, communication with other parties to ensure the food is not sold or otherwise distributed unless a determination is made by a qualified individual that the condition did not render the food unsafe.
Requirements for Shippers
FDA’s final rule places most of the responsibility on the shipper for ensuring sanitary transportation of food and feed. In the preamble to the rule, FDA states its belief that shippers should be charged with developing and implementing written procedures that address how the safety of food they ship will be assured relative to the “three major focus areas” of the rule: 1) assurance that the vehicles and equipment used in the shipper’s transportation operations are in appropriate sanitary condition; 2) assurance that, for bulk cargo, a previous cargo does not make the food unsafe; and 3) assurance that, for foods that require refrigeration for safety, the food is transported under adequate temperature control.
“Shipper” is defined as “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.”
Responsibilities for shippers established by the rule include requirements that the shipper specify in writing to the carrier and, when necessary, to the loader, all sanitary specifications necessary for the carrier’s vehicle and transportation equipment pursuant to the product to be transported, unless the shipper itself develops and implements written procedures to ensure appropriate sanitary conditions. A one-time notification from the shipper to the carrier is sufficient unless the design requirements and cleaning procedures required for sanitary transport change based upon the type of food being transported. If such changes occur, the rule requires the shipper to notify the carrier in writing before the shipment.
Shippers are required to develop, implement and maintain records of written procedures adequate to ensure vehicles and equipment used in its transportation operations “are in appropriate sanitary condition” for the product to be moved. Measures to implement these procedures “may be accompanied by the shipper or by the carrier or another party covered by the rule under a written agreement” subject to records retention.
Shippers also are required to maintain records of written procedures that ensure a previous cargo does not make the food unsafe. In the preamble to the rule, FDA noted that its current good manufacturing practice regulations already require that storage and transportation of food occur under conditions that protect against allergen cross contact, as well as against biological, chemical (including radiological) and physical contamination that would cause the food to become unsafe.
Requirements for Loaders
The rule defines a “loader” as “a person that loads food onto a motor or rail vehicle during transportation operations.” The rule’s requirements for loaders include determining that the vehicle or transportation equipment is “in appropriate sanitary condition for the transport” (in adequate physical condition and free of visible evidence of pest infestation and previous cargo that could cause the food to become unsafe during transportation) of the type of food to be shipped prior to loading onto a vehicle or into transportation equipment, except in instances where the food is completely enclosed by a container
Requirements for Receivers
A “receiver,” means “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.” The rule requires receivers to take steps to adequately assess that food requiring temperature control for safety under the conditions of shipment was not subjected to significant temperature abuse during transport.
Requirements for Carriers
The rule largely exempts rail carriers and truckers from the requirements unless the shipper and carrier have a written agreement (e.g., contractual arrangement) making the carrier or another party responsible, in whole or in part, for sanitary conditions during the transportation operation.
The rule defines a “carrier” to mean “a person who physically moves food by rail or motor vehicle in commerce within the United States,” excluding persons who transport food while operating as a parcel delivery service.
If the carrier has agreed to be responsible for sanitary conditions during the transportation operation, a carrier is to ensure vehicles and transportation equipment meet the shipper’s specifications and are otherwise appropriate to prevent the food from becoming unsafe during the transportation operation.
If requested by the shipper, a carrier that offers a bulk vehicle for food transportation is to provide information to the shipper that identifies the previous cargo transported in the vehicle and information to the shipper that describes the most recent cleaning of the bulk vehicle.
A carrier is to develop and implement written procedures and maintain records that:
● Specify practices for cleaning, sanitizing, if necessary, and inspecting vehicles and transportation equipment it provides for use in the transportation of food to maintain the vehicles and the transportation equipment in appropriate sanitary condition.
● Describe how it will comply with the provisions for the use of bulk vehicles pertaining to identifying the previous cargo transported in the vehicle and describing the most recent cleaning of the vehicle.
In addition, training of carrier personnel in sanitary transportation practices and records documenting the training is required only if and when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.
In the preamble to the final rule, FDA states that shippers or loaders generally are responsible for inspecting a railcar to ensure it is suitable for the particular food cargo to be transported, regardless of which party owns the car. FDA also asserts that rail carriers “generally do not clean the cars they provide and do not maintain documented cleaning procedures. FDA added that the use of railcars in interchange service “would likely mean that the railroad operator would not be able to provide information about the identity of a bulk vehicle’s previous cargoes and its most recent cleaning if requested by the shipper.”
While the agency concedes that motor carriers generally do own the vehicles they provide for transport and “are directly involved in transportation operations, such as the loading and unloading of the trailers that they haul, and therefore can comply” with the rules. Yet, the agency decided to exempt motor carriers, as well, from the requirement to comply with the rules unless they are assigned to perform certain functions through written agreement with the shipper.
The agency concludes with this statement in its preamble discussion of this issue: “...[W]e have concluded that the appropriate solution with regard to the definition and the overall carrier regulatory requirements is: 1) a simplified definition of carrier that ties it to the movement of the food; 2) removal from the carrier definition of any assignment of duties; and 3) a default assignment of responsibility to the shipper for the activities assigned to carriers in the proposed rule, unless a written contract between the shipper and carrier assigns them to the carrier (or another party covered by this regulation, as may be the case)....Therefore, linking responsibility for the carrier to perform such functions to the existence of a contract with the shipper, in which such functions are specified, seems appropriate and consistent with current industry best practice.”
Compliance dates for the rule’s requirements are based upon business size as follows:
● Small Businesses: Businesses other than motor carriers that are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts are to comply two years after the publication of the final rule – on or about April 5, 2018.
● Other Businesses: A business that is not small and is not otherwise excluded from coverage under the rule is to comply one year after the publication of the final rule – on or about April 5, 2017.