FSMA Food Transportation Rules Issued: Now What?

This year the U.S. Food and Drug Administration (FDA) issued a new rule governing the sanitary transportation of human and animal food products as part of the Food Safety Modernization Act (FSMA). According to the FDA, the goal of the FSMA transportation rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food. As part of the rule, shippers and carriers must agree to certain practices to assure safe transport of food.

The FDA has indicated that the overall intent is to establish greater accountability in maintaining food safety throughout the transportation process as required by a previous law, the Sanitary Food Transportation Act of 2005 (SFTA). The FDA has also repeatedly indicated that its intent was to make a flexible rule that would allow fleets to continue using industry best practices.

What should shippers and haulers know about the new regulations?

With some exceptions, the transportation rule applies to shippers, receivers, loaders and carriers who transport food in the U.S. by motor vehicle or rail.

The FDA has placed primary responsibility on the shipper of food to develop and implement written procedures covering temperature control for food safety. The shipper needs to specify in writing to the carrier and loader the necessary cleanliness specifications of the vehicle, operating temperature during transport and any pre-cooling, if necessary. Reassignment of responsibility to other parties via written contractual agreement is permitted by the FDA, provided that the other parties agree to accept the responsibility. The FDA acknowledges that practices will vary depending on the type of food being transported and has determined that the shipper is in the best position to determine the manner in which the product should be maintained during shipment.

In cases where the shipper is performing the functions of a loader or a carrier, there will be training and record-keeping requirements to ensure personnel receive proper instruction about the procedures.

What technologies can help them comply?

Examples of accountability methods that shippers and carriers could agree to may range from manually recording temperatures periodically to temperature record printouts and data downloads from the refrigeration system, the use of product temperature data loggers or the use of refrigeration unit telematics for data transmission, which may help to automate and simplify the record-keeping process. However, the law does not specify techniques – just that accountability practices are agreed to and deployed.

How does Carrier Transicold’s equipment provide information needed for temperature verification?

Carrier Transicold refrigeration equipment plays an important role in the cold chain by managing load temperatures and safely preserving food during transport. Additionally, this equipment has the capability to monitor and record conditions inside a truck or trailer throughout a delivery, which will be useful in helping to maintain the chain of accountability established by FSMA.

The refrigeration unit’s control system continuously records data from temperature sensors while the unit is on, and multiple sensors may be placed inside a trailer for monitoring purposes. This information is stored in the controller and can be downloaded if needed. If the refrigeration unit is equipped with telematics, Carrier Transicold’s DataTrak™ protocol enables the temperature information captured by the refrigeration system to be wirelessly transmitted to a fleet’s central operations.

Carrier Transicold’s APX™ controller also has the unique ability to display temperature trip graphs (shown above), providing an additional point of temperature verification.

For temperature verification independent of the refrigeration system, Carrier Transicold also offers the DataLink™ 2 recorder. It uses up to three independent temperature sensors to provide an added layer of monitoring beyond the refrigeration system’s built-in recording ability. Its built-in printer produces trip reports for receivers. (See related story for full capabilities.)

Is proof of temperature maintenance required with every shipment?

In keeping with industry best practices, the FSMA transportation rule requires that carriers have the ability to provide a record if the shipper or receiver requests it, but does not mandate a record to be provided with every delivery. The FDA indicated that this would likely only be done in situations where it is suspected that there may have been a failure of temperature control.

What are potential FSMA pitfalls for shippers?

Shippers should discuss their requirements with all of those involved in the process – loaders, carriers, brokers, etc. – to make sure everyone understands their responsibilities and is able to meet the requirements as determined by the shipper. The shipper then needs to make sure that the agreed upon processes are documented and communicated to the correct parties in writing.

The shipper also needs to understand some of the more subtle nuances of the rules to make certain they are adequately addressing food safety for the correct foods, and be cautious about making the process overly onerous on themselves; for example, by addressing food quality on exempt foods.

What is the timetable for compliance?

Except for those businesses defined as small by the FDA or otherwise excluded, compliance is required by April 2017 (one year after the publication of the final rule). Small businesses must comply by April 2018.