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The Sanitary Transportation Rule

Putting it into practice
Trading Assistance

According to the FDA, only carriers have a training requirement because shippers, loaders, and receivers have training requirements under other FSMA rules (e.g., Produce Safety and Preventative Controls) sufficient for the purposes of the Sanitary Transportation rule.

Operationally, Section 1.908(e) requires produce carriers perform in accordance with their agreements with shippers, insofar as sanitary transportation is concerned. Consequently, a carrier’s breach of contract may also be a violation of the Sanitary Transportation rule, giving the FDA grounds for taking action against the carrier.

The text of this section (which dovetails with Section 1.908(b) and other sections of the Rule) states, in part—

When the carrier and shipper have a written agreement that the carrier is responsible, in whole or in part, for sanitary conditions during transportation operation, the carrier is responsible for the following functions as applicable per the agreement: (1) A carrier must ensure that vehicles and transportation equipment meet the shipper’s specifications and are otherwise appropriate to prevent the food from becoming unsafe during the transportation operation.
(2) A carrier must, once the transportation operation is complete and if requested by the receiver, provide the operating temperature specified by the shipper….and, if requested by the shipper or receiver, demonstrate that it has maintained temperature conditions during the transportation operation….

The Rule, therefore, requires carriers to read, understand, and execute, according to the shipper’s instructions. If the carrier is not prepared to do so, other arrangements must be made. “Read every document and understand what is expected of you,” suggests attorney Dan Sullivan of Oak Brook, IL-based Sullivan Hincks & Conway. “The cost of compliance will always be less than the cost of litigation.”

In addition to following the shipper’s instructions, carriers that take responsibility for the sanitary condition of the conveyance (motor carriers, generally; note that rail cars, for example, may be left in the possession and control of shippers or loaders prior to shipping, in which case the carrier would not take on this responsibility), are required, under paragraph (6) of this section, to develop and implement written procedures that:

(i) Specify practices for cleaning, sanitizing if necessary, and inspecting vehicles and transportation equipment that the carrier provides for use in the transportation of food to maintain the vehicles and the transportation equipment in appropriate sanitary condition…(ii) Describe how it will comply with the provisions for temperature control….

For carriers that already have adequate standard operating procedures in place for cleaning their trailers and maintaining temperature control, simply documenting these procedures and ensuring they are followed should be sufficient to satisfy the Rule.

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