FDA's proposed rules would apply to shippers, carriers and receivers transporting agricultural commodities, food, feed and feed ingredients, and other agricultural products by truck and rail.
The centerpiece of the NGFA's statement presses that FDA's regulations 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 NGFA said.
The NGFA did commend 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.
The NGFA also strongly supported FDA'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 NGFA urged FDA 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. The NGFA noted these intra-company transfers typically involve the use of dedicated fleets of trucks and/or rail cars to move agricultural products, animal food and feed ingredients, and other food products between a company's own facilities, with standard operating procedures implemented for clean-out when necessary.
• 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. In making this recommendation, the NGFA said certain types of transportation movements of raw and processed agricultural commodities, as well as feed and feed ingredients, warrant a prima facie exemption to avoid a deluge of waiver petitions being submitted to the agency. As examples, the NGFA cited dedicated unit train shuttle movements dedicated exclusively to hauling grains and oilseeds; tank car fleets dedicated solely to hauling vegoils and other food-grade oils for human consumption; and dedicated trucks used by animal feed and feed ingredient manufacturers to haul large quantities of bulk and bagged products directly to farms and livestock and poultry operations in a continuous fashion.
• Transportation of live food animals. The NGFA also supported FDA's tentative conclusion to exempt transport of live food-producing animals from the sanitary food transportation regulations. Transportation of such live animals already is subject to the jurisdiction of the U.S. Department of Agriculture's Food Safety and Inspection Service.
In its statement, the NGFA also asked FDA to make numerous other changes to its proposed regulations, including the following:
• Clarify the definition of "shipper" so that the requirement to notify carriers of any special clean-out procedures and to keep records applies to the party that loads a shipment, not to brokers or third-party logistics operators who arrange for the transportation to be provided.
• Modify the proposed requirement that carriers identify the previous three loads hauled in bulk trucks or rail cars. The NGFA said such a requirement is excessive and unnecessary, and that the goal of safe food transport would be accomplished by carriers providing accurate information on the single immediate previous load hauled, as well as whether and what type of clean-out procedure was utilized for the conveyance.
• Eliminate the proposed recordkeeping requirement that electronic records be kept in a manner that complies with the agency's onerous and costly Part 11 rules that stipulate extensive computer validation. Such a requirement would necessitate that current electronic recordkeeping systems used by the vast majority of affected shippers, receivers and carriers would need to be recreated and redesigned, thereby imposing "tremendous burdens and costs," the NGFA said. As an alternative, the NGFA proposed that FDA partner with stakeholders to develop guidance that describes the kinds of practical principles, protocols and systems that may be used to ensure the integrity of electronic records.
• Eliminate the proposal to exempt from the regulations those shippers, carriers and receivers that have less than $500,000 in total annual sales. The NGFA contended, consistent with its comments on other FDA proposed rules implementing FSMA, that size-based exemptions are inappropriate for food safety. Instead, the association recommended that the agency provide small entities with additional time to comply with final regulations before enforcement begins.
• Clarify the definition of "transportation equipment" covered by the proposed regulations to apply only to those items (such as containers, totes and pallets) that actually are loaded onto a truck or railcar, or devices (such as pumps, fittings, hoses and gaskets) that are integral and affixed to the transportation conveyance.
• Delete the proposed requirement that convenient hand-washing facilities be provided for vehicle operators unless human contact with the food poses a hazard of causing the food to become adulterated or unfit for human or animal consumption. FDA proposed that such hand-washing facilities be provided by all receivers of human or animal food unless the products are transported in totally enclosed containers.
Finally, noting that FDA proposed a regulatory exemption for truck transportation of raw agricultural commodities by farms, the NGFA recommended that the agency develop guidance on good transportation practices, as well as user-friendly educational materials, pertaining to the safe transport of such products by farms.
"Such guidance should stress the importance of cleanout procedures in non-dedicated farm transportation conveyances and equipment used to haul raw agricultural commodities and other products, and provide practical, realistic and effective sample clean-out procedures for such conveyances" the NGFA told FDA. "The guidance also could encourage those delivering raw agricultural commodities from farms to inform the first receiver, such as the country elevator, about the previous load hauled in the transportation conveyance used."