Grain shipment on railroad
Issues may result from F.D.A. final rule on sanitary transport.

WASHINGTON — During a meeting with Food and Drug Administration officials on July 6 and in a follow-up letter to the agency delivered on Aug. 19,  associations representing grain, oilseed and flour shippers warned the final rule on Sanitary Transportation of Human and Animal Food as written may have “the unintended effect of disrupting current, widely observed prudent practices that exist between shippers, receivers and carriers in obtaining information on the condition and suitability of vehicles and transportation equipment used to transport human and animal food, and, thereby, ultimately be counterproductive to food safety.”

At issue, representatives of the National Grain and Feed Association, the North American Millers’ Association and the National Oilseed Processors Association said, was that the final rule created a significant imbalance by shifting to shippers and loaders the lion’s share of the responsibility for ensuring the safe transport of food. In contrast, rail and truck carriers, under the final rule, would not be required to share in the responsibility for ensuring vehicles and transportation equipment they convey are safe and suitable for human and animal food or provide previous-load-hauled and conveyance cleanout information absent a formal written agreement with each shipper.

The F.D.A. acknowledged the final rule took into consideration comments from rail carriers. In its fact sheet summary of the final rule, the F.D.A. said, “Commenters raised concerns that rail operators often do not own, prepare or operate equipment, e.g. refrigeration units, in the rail cars they transport, and do not have the ability to ensure that certain requirements, such as temperature control and sanitary conditions, are met.

“The shipper or loader, and not the rail carrier, has generally assumed responsibilities such as inspecting a rail car, to ensure that it is suitable. Shippers will continue to hold primary responsibility for sanitary conditions of transport under this rule unless the carrier has entered into a written agreement with the shipper to assume this responsibility.”

Under the final rule, absent a written agreement with carriers, shippers and loaders alone will be required to develop and implement written procedures to ensure that equipment and vehicles are in appropriate sanitary condition, ensure that a previous cargo hauled in a rail car or truck does not make food transported in bulk unsafe, and ensure food is transported under adequate temperature control.

In contrast, under the proposed rule issued in 2014, carriers were the primary subject of regulation because they are the party supplying equipment and conducting the transportation activity. Under the proposed rule, shippers would have been responsible for informing the carrier of the necessary sanitary and temperature requirements for the food to be transported, and carriers would have been responsible for supplying vehicles that meet those requirements. Receivers would have been responsible for unloading activities required to maintain the sanitary nature of the food upon delivery.

Shippers advised the F.D.A. rail carriers and truck carriers may refrain from entering into written agreements that may make them subject to F.D.A. regulation.

“We have little to no expectation that carriers — particularly Class I railroads — will willingly enter into formal written agreements with shippers under which they would willingly become subject to F.D.A. regulatory oversight for compliance with Food Safety Modernization Act sanitary food transportation rules,” the shippers said.

The shippers also argued the final rule’s exemption of rail carriers and truckers from certain requirements unless the shipper and carrier have a written agreement would prove to be a disincentive for carriers to provide information to shippers that is necessary to facilitate the safe and cost-effective transportation of food. The absence of such information, in turn, would place costly burdens on shippers forced to operate in the absence of such information, the associations asserted.

The shipper associations requested the F.D.A. administratively stay the enforcement of the ‘written agreement’ requirements in the final rule and reopen and amend the rule to require carriers to provide information such as the last cargo hauled and on how and when a rail car or truck was cleaned to the shipper or receiver on request, with no stipulation that a written agreement exist with the carrier.

The final rule on Sanitary Transportation of Human and Animal Food was published in the Federal Register in April 2016. Compliance dates begin one year after publication, or April 6, 2017, with two years from publication allowed for small businesses to become complaint.

The shipper associations were hopeful the F.D.A. will address their concerns before the final rule’s April 2017 implementation date.