FDA finalizes FSMA sanitary transportation rule

Industry says FDA provides adequate flexibility to address many concerns expressed in comment period of food transport rule.

The U.S. Food & Drug Administration finalized a new rule that will help prevent food contamination during transportation as part of the overarching Food Safety Modernization Act (FSMA). The rule will require those involved in transporting human and animal food by motor or rail vehicle to follow such practices as properly refrigerating food, adequately cleaning vehicles between loads and properly protecting food during transportation.

The rule was proposed in February 2014 and takes into consideration more than 200 comments submitted by the transportation industry, food industry, government regulatory partners, international trading partners, consumer advocates, tribal organizations and others. It also builds on the transportation industry’s best practices for cleaning, inspecting, maintaining, loading/unloading and operating vehicles and transportation equipment.

Changes from the proposed rule to the final rule seemed to take to heart many of the comments received from those in the animal feed industry, sources said.

Dave Fairfield, vice president of feed services for the National Grain & Feed Assn. (NGFA), said the impact of the final rule should be “fairly minimal,” adding that the final regulation offers more flexibility to all the parties involved and reflects good practices already in place by the industry.

NGFA previously submitted a statement to FDA urging that it make significant changes to its proposed rule implementing the sanitary food transportation provisions of FSMA.

FDA’s proposed rules would apply to shippers, carriers and receivers transporting agricultural commodities, feed and feed ingredients, food and other agricultural products by rail and truck. Fairfield explained that the centerpiece of NGFA’s statement was that FDA’s regulations should not undermine the fundamental responsibility of railroads and truckers to provide conveyances that are clean, appropriate and in safe condition suitable for the type of human or animal food being transported.

The proposed rule also required carriers provide shippers with information on the three prior loads of any given conveyance. The issue drew plenty of attention from commenters, and FDA ultimately provided significant flexibility in the final rule, which says a shipper may request that information from a carrier if they think it’s necessary in order to transport the current load in a safe manner.

The American Feed Industry Assn. (AFIA) also asked FDA that 21 CFR, Part 11 (electronic records and signature rule) should not be mandated for records required under this rule. FDA agreed that redesigning large numbers of existing electronic records and recordkeeping systems would create a substantial burden disproportionate to the public health need and electronic records are exempt from the requirements of Part 11. This change is the same that FDA made to the "Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Food for Animals" final rule. AFIA is appreciative of this change. 

NGFA’s statement urged FDA to grant three additional exemptions from its proposed regulations to cover: (1) transfers of human and animal food between facilities operating under the ownership of the same legal entity, (2) dedicated rail and truck transportation conveyances and equipment used to haul the same type of human or animal food, including raw agricultural commodities and processed products, on a continual basis (such as grain shuttle trains and feed trucks) and (3) transportation of live food-producing animals that already are regulated by the U.S. Department of Agriculture’s Food Safety & Inspection Service.

Fairfield said FDA, in its preamble, said it was unable to provide those exemptions or waivers, but throughout all the requirements, FDA offers a great deal of flexibility to shippers, carriers, receivers and loaders. He said the final rule is not overly prescriptive, and if appropriate communications exist either within a contract or a one-time notification, it should be sufficient to meet the rule requirements.

AFIA said FDA did change the transportation operations for human food coproducts intended for animal food that are not further processed are exempt from the requirements of the rule. If the human food coproducts are being sent for further processing, then FDA concluded they are not exempt as the recordkeeping and inspection requirements are appropriate and not burdensome.

AFIA questions why this exemption was given for a product that is not further processed going straight to a farm, but AFIA's request of exemption for finished animal feed going to a farm was not granted. The risk based determination FDA used for human food coproducts should be the same for finished animal feed.

An exemption relevant to the animal feed industry is that any transportation solely consisting of packaged feed is exempt. Farms are also exempt from the rule, and smaller entities with under $500,000 of goods would also not be covered.

Fairfield said when it comes to implementation, operations will need to take the time to read requirements and understand how the new regulations apply to their operations. “In terms of compliance, people need to understand the requirements of the rule, look at existing contracting practices, details and specifications currently in place for transportation activities and figure out where gaps are and start filling them in,” Fairfield said. “We’re hopeful, in many respects, the industry has a lot of these details covered, but everyone needs to do that gap analysis and decided where they’re at on the curve.”

AFIA still questions the costs versus implementing versus benefit. AFIA said while the cost of implementing these requirements remain high, FDA estimates $113 to $117 million per year, FDA is still unable to quantify any benefit to implementing this final rule.

Businesses would be required to comply with the new regulation one year after publication of the final rule, with smaller businesses having two years to comply with the new requirements.

“We recognize the importance of education and training in achieving widespread compliance, and we are committed to working with both industry and our government partners to ensure effective implementation of all of the new food safety rules under the Food Safety Modernization Act,” said Michael R. Taylor, FDA deputy commissioner for foods and veterinary medicine.

Read more about the final rule here.

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