The Food and Drug Administration received 126 comments in connection with its proposed rule on the Sanitary Transportation of Human and Animal Food, which it posted in the Feb. 5, 2014, edition of the Federal Register. The extended comment period on the proposed rule closed on July 30. The food industry has had its say, and the F.D.A. will consider its comments as it begins preparing its final rule on the subject. The F.D.A. is required under court order to issue the final rule by March 31, 2016.

The proposed regulation would establish criteria for sanitary transportation practices, such as properly refrigerating food, adequately cleaning vehicles between loads and properly protecting food during transportation.

The proposed rule would apply to shippers, carriers and receivers who transport food that will be consumed or distributed in the United States and is intended to ensure that persons engaged in the transportation of food that is at the greatest risk for contamination during transportation follow appropriate sanitary transportation measures.

Additionally, the rule would apply to international shippers who transport food for U.S. consumption or distribution in an international freight container by air or by oceangoing vessel and arrange for the transfer of the intact container onto a motor vehicle or rail vehicle in the United States.

The F.D.A. said the proposed rule would not cover shippers, receivers or carriers engaged in food transportation operations that have less than $500,000 in total annual sales. In addition, the requirements in the proposed rule would not apply to the transportation of shelf-stable foods, live food animals, and raw agricultural commodities when transported by farms. The rule also would not apply for food transshipped through the United States to foreign destinations.

The F.D.A. proposed staggered implementation dates for the proposal based on business size, ranging from one to two years after the publication of the final rule.

The proposal elicited comments from several food industry associations and companies, including the Grocery Manufacturers Association (G.M.A.), the National Grain and Feed Association (N.G.F.A), the American Meat Institute, the American Frozen Food Institute, Kraft, and PepsiCo, Inc. Associations representing owner-operator truck drivers, railroads and producers also weighed in. All comments may be viewed at by referencing the docket FDA-2013-N-0013.

The food industry weighs in

Among the most extensive comments were those provided by the G.M.A. and the N.G.F.A.

“G.M.A. supports F.D.A.’s generally flexible approach in the proposed rule that sets broad expectations without prescribing exactly what companies need to do to achieve those requirements,” the G.M.A. said. “This approach allows companies to tailor their practices, as appropriate and necessary, based on the nature of the food and the transportation conveyance and to adapt new practices when there are new advances in technology. We also appreciate the recognition that industry can diverge from certain proposed requirements, such as those for bulk shipments, by contractual agreement. This reflects a practical understanding of the way business is conducted and how flexibility is essential because of the highly complex nature of the transportation chain.”

At the same time, the G.M.A. said its members think aspects of the proposal need further refinement.

“That is, the rule needs to be revised so that it reflects current practices, as is the agency’s intent,” the G.M.A. said. “For example, the proposed temperature control requirements suggest a need for continuous monitoring that is routinely communicated to the shipper by the carrier. The proposed approach would add considerable cost in an area where there is no demonstrated food safety problem that needs to be rectified.”

The G.M.A. also indicated some aspects of the proposed rule take a simplified view of current transportation operations.

“For example, the regulation focuses on shippers, carriers and receivers, but there often are many other important intermediaries in the chain that play an integral role (e.g., brokers, traders, third-party warehouses). Moreover, the receiver often fills responsibilities that F.D.A. assigns to carriers under the regulation.”

Comments in part were intended to educate the F.D.A. about how food transportation works today, the G.M.A. said.

The G.M.A. said the F.D.A. should revise the temperature monitoring requirements to align with current “effective industry transportation practices that ensure food safety.” The association noted the F.D.A. should tailor the scope of the proposed rule so it is even more risk-based, and that the proposed rule should allow flexibility in allocation of responsibilities between shippers, carriers and receivers by contractual agreements. The G.M.A. said the rule should provide modified requirements for intra-company shipments and short-haul shipments. The association further asked that the F.D.A. provide stakeholders with information about implementation and enforcement plans.

The G.M.A. also stated the final rule should be cost neutral for food companies with advanced food safety programs.

Significant changes urged

The N.G.F.A. in its comments urged the F.D.A. to make significant changes in its proposed rule. The N.G.F.A. stressed it was important F.D.A. regulations do not undermine the fundamental responsibility of carriers to comply with their statutory obligation to provide conveyances that are clean, appropriate and in safe condition suitable for the type of human or animal food intended to be shipped.

“This legal obligation is reasonable because the carrier or other provider of the transportation conveyance is in the best position to monitor the use of transportation conveyances and equipment, know the contents of the previous load(s) hauled, and implement prudent and effective clean-out procedures to protect product safety,” the N.G.F.A. said.

The N.G.F.A. commended the agency for not applying the proposed rules to barge and vessel transportation, as well as for not prescribing specific sanitation practices for clean-out of rail and truck transportation conveyances and equipment, thereby giving shippers, carriers and receivers the flexibility to continue to utilize appropriate sanitary transportation practices that have evolved over time. Strong support also was given for the F.D.A.’s decision not to restrict access for human and animal food to certain classes or types of rail or truck conveyances or transportation equipment, which it said was particularly important given constrained U.S. transportation capacity and severe rail service disruptions.

The F.D.A. was urged by the N.G.F.A. to grant three additional exemptions from the proposed regulations to cover transfers of human and animal food between facilities operating under the ownership of the same legal entity, such as the same parent or corporate entity; dedicated rail and truck transportation conveyances and transportation equipment used to haul the same type of human or animal food, including raw agricultural commodities and processed products, on a continual basis; and the transportation of live food animals.

The N.G.F.A. enumerated several additional strongly suggested changes to the proposed rule and provided alternative language where it deemed appropriate.

Given the extensive changes it and other stakeholders believe are warranted, the F.D.A. should reissue significant sections of this proposed rule for additional public comment, the N.G.F.A. said.

“Making available a second draft of sanitary transportation proposed rules would provide stakeholders with another opportunity to offer informed and meaningful comment on the requirements that F.D.A. envisions, including its final rule,” the N.G.F.A. said. “Given the very significant nature of these regulations, we believe that a second opportunity for stakeholder comment is essential to ensure that the requirements in the final rule are practical, achievable and foster the safe transport and distribution of human and animal food. Further, we believe F.D.A. has the ability and authority to re-propose the regulations and still comply with the court-order deadline to publish a final rule by March 31, 2016.”