While the risk of food product contamination during transport is low, there have been serious documented cases—as well as evidence of unsanitary practices—which warrant the formalization of existing best transport practices to lower the risk of contamination.
One regulation of the Food Safety Modernization Act (FSMA) is small in scope compared with others, however its importance should not be underestimated. Section 111, Sanitary Transport of Human and Animal Food, addresses the potential of food becoming contaminated during transport operations. While this risk is low, there have been serious documented cases—as well as evidence of unsanitary practices—which warrant the formalization of existing best transport practices to lower the risk of contamination.
The final rule, which will be published by March 31, 2016, addresses the responsibilities of the parties involved in the transportation of food, namely shippers, carriers, and receivers, and how such responsibilities will be met and documented. It applies to both domestic and international transportation of food in the U.S. With few exemptions, affected parties will have 12 months to come into compliance, which will impact several programs.
Key Elements of the Transportation Rule
Sanitary Operations. Transportation vehicles such as trailers, railcars, and shipping containers must be designed, constructed, and maintained in appropriate sanitary conditions to prevent food adulteration during transport operations. This applies to ambient, refrigerated, and frozen modes of food transportation vehicles. Transportation equipment, such as pumps, fittings, hoses, gaskets, pallets, and bulk loading/unloading systems, must also be designed, constructed, and maintained in appropriate sanitary conditions for its intended purpose.
When temperature or time/temperature criteria is essential for food safety (e.g., microbiological growth), the shipper and/or carrier must apply and document appropriate temperature or time/temperature procedures to demonstrate whether or not the relevant food safety parameters have been met during the entire transport operation. Temperature monitoring includes staging food products for shipping, precooling reefers and cold storage compartments before loading, maintaining temperatures during transport, and receiving at appropriate temperatures. The method or methods for reading and recording temperatures during transport must be agreed to in writing by the shipper and the carrier.
The rule requires the application of proper segregation and protection from contamination of foods by non-food items in the same load. While not specifically addressed in the rule, the same concept applies when allergen and non-allergen foods are shipped in the same load.
Food shipped in a container that is partially open to the environment, such as a box, a crate, a vented box with a top, or a vented plastic bag, can become contaminated during transportation. Both the shipper and the receiver will have to have a readily accessible handwashing station for personnel handling loading and unloading activities.
When using a bulk carrier, the carrier must provide the shipper with documented information about the previous three cargoes. This can be avoided if other procedures are in place to ensure that the bulk vehicles meet sanitation requirements, such as dedicated vehicles, vehicles under contract, or owned by the shipper and subject to an appropriate and verifiable cleaning/sanitation schedule. Any alternatives must be documented.
All activities associated with the transportation of food, such as vehicle cleaning and sanitation, maintenance, inspection, staging, loading and unloading, as well as handling transportation equipment must be carried out in a sanitary manner to avoid contamination of vehicles, equipment, and the food product being transported.
Information Exchange. The rule requires that certain information be transferred between the shipper, carrier, and receiver to ensure proper implementation and documentation related to food safety during transport operations. The shipper must specify in writing the conditions the carrier’s vehicle needs to meet to avoid contamination during transport. This includes the design, construction, sanitary, and food safety maintenance requirements.
If temperature or time/temperature requirements are essential for food safety, they must be documented. Maintenance of temperature conditions are subject to documentation and must be demonstrated at the end of the transport operation. The methods and procedures for temperature monitoring must be in writing. The shipper must also develop, implement, and document a written shipper-carrier contract that covers the sanitary transport rule requirements.
Driver Education and Training. Carriers will be responsible for educating and training drivers on potential food safety problems that can occur during transport. This training will provide drivers with the necessary knowledge on how to address food safety issues and must take place when a driver is hired as well as periodically thereafter. All training must be documented.
Records. Certain records need to be maintained. Shippers must provide carriers with information regarding design, construction, sanitation, and maintenance requirements of transportation vehicles and equipment, as well as temperature requirements for food safety, if applicable. Carriers must maintain records regarding compliance with shippers’ requirements and have written procedures on how such requirements will be carried out and documented. Records regarding temperature compliance can be the responsibility of the shipper or the carrier, depending on the written contractual agreement. Documented compliance will need to be shared with the receiver, if requested. Original records or true copies must be maintained for 12 months. Off-site record storage is allowed after six months, but all records must be made available to the FDA within 24 hours upon request.
Summary
The sanitary transport requirements are truly a formalization of current best transportation practices within the food industry. Shippers and carriers should review their written transportation programs and contracts to identify and address potential gaps. A simple checklist based on the requirements of the rule would suffice as an effective gap analysis. Shippers will benefit from including transportation activities in the facility’s hazard analysis and risk-based preventive control (HARPC) program to identify preventive controls essential for food safety and develop appropriate management plans. These may include temperature control and sanitation requirements. Carriers will need to develop and maintain documented education and training for drivers.
Shippers, carriers, and receivers should remember that their written transportation program and associated documentation is subject to review by the FDA under new FSMA rules. Good record control is an essential component of the sanitary transport rule.
The author is Global Manager, Food Safety Services Innovation, AIB International.
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