As a practical matter, however, it may make sense to have a qualified individual review all instances of temperature abuse or other “material failures” (e.g., shifting in transit where produce comes loose from shipping containers and comes into contact with the floor and/or walls of the trailer) to decide if food safety concerns preclude the sale or distribution of the product.
Just what constitutes temperature abuse or a material failure that poses a threat to food safety is not specifically defined by the Rule, and it is therefore left for the company and its qualified individual(s) to decide on a case-by-case basis. Of course, if people become ill as a result of the incident, qualified individuals can expect their decision-making process to come under FDA scrutiny.
The third fundamental requirement applicable to every entity subject to the Rule is recordkeeping. Section 1.912 specifies what records should be maintained under the Rule. Suffice it to say, all documentation generated in compliance with this Rule must be retained for a period of twelve (12) months after the documentation is no longer in use.
Similarly, documentation of training (applicable to carrier personnel) must be retained for a period of twelve (12) months after the individual “stops performing the duties for which the training was provided.” Husk cautions against oversimplifying this requirement: “It’s sometimes referred to as a ‘twelve (12) month requirement,’ but this could be misleading because, in most cases, you’ll need to retain the documentation much longer.”
DeMatteis summarizes the Rule’s basic requirements as follows: “You have to know the key people from each company, consistently follow your documented process, communicate with all parties any changes or discrepancies, and maintain records for each transaction.”
What to Do If… You Arrange for Transportation by Motor Carrier
Under the Rule, “shippers” are those that arrange for the transportation of food by motor or rail carrier within the United States. This definition explicitly includes freight brokers.
Under Section 1.908(b), shippers have specific responsibilities related to common produce shipments, including developing and implementing written procedures that are adequate to ensure vehicles and equipment meet design specifications, are properly cleaned, and are otherwise in “appropriate sanitary condition” for the transportation of food; and, ensuring adequate temperature control is provided if needed for safety, as opposed to merely preventing spoilage.
For example, Section 1.908(b)(2) provides that a shipper of food that requires temperature control for safety (e,g. fresh-cut produce) must “specify in writing to the carrier…and, when necessary, the loader, an operating temperature for the transportation operation including, if necessary, the pre-cooling phase.”
