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Sanitary transportation rule follows FSMA preventive model

In 2006 when an E. coli outbreak linked to fresh spinach spurred recalls, some truckers were left holding the bag, semi-trailers full of bags of spinach that shippers refused to take back and receivers refused to take.

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Commercial drivers and members of the national trade association OOIDA (Owner Operator Independent Drivers Association) called the organization’s headquarters in Grain Valley, MO, with questions ranging from how to make shippers pay for dumping fees to what cleaning products to use to sanitize their trailers.

Few answers were available for drivers from the U.S. Department of Transportation during the 2006 outbreak that sickened 205 and killed three people.

A decade later, the U.S. Food and Drug Administration has developed many of the answers as part of a congressional mandate to switch to a preventive approach to food safety. The answers are in the sanitary transportation rule, the sixth of seven rules FDA was required to develop as part of the Food Safety Modernization Act (FSMA) of 2011.

Compliance is mandatory next April for larger and otherwise non-exempt businesses and motor carriers. Smaller businesses and motor carriers have until April 2018 to comply.

“This new rule is focused on ensuring that individuals who transport human and animal food by motor and rail vehicle follow appropriate sanitary transportation practices and do not create food safety risks,” said FDA’s Rebecca Buckner during an April 25 teleconference with industry.

“Practices that create such risk include failure to properly refrigerate food requiring temperature control for food safety, the inadequate cleaning of vehicles between loads and the failure to otherwise properly protect food during transportation.”

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While the basic tenants of the sanitary transportation rule are not complicated, the government did not specify which links in the supply chain have to bear the costs of compliance. The rule includes multiple references to agreements and contract requirements that shipping partners must have, but not who has to pay for them.

“Shippers will continue to hold primary responsibility for establishing sanitary conditions of transport under this rule unless the carrier has entered into a written agreement with the shipper to assume this responsibility,” Buckner said.

“The final rule also clarifies that the intended use of the vehicle or equipment — for example, transporting animal feed versus human food — and the production stage of the food being transported — such as raw materials versus finished product — are relevant in determining the applicable sanitary transportation requirements.

“Finally, if a person covered by the rule becomes aware of a possible failure of temperature control or any other condition that may render a food unsafe during transportation, that food must not be sold or distributed until a determination of safety is made.”

The FDA made clear is that it will work with the federal Department of Transportation to enforce the sanitary transportation rule.

“The agency will train its field staff on the new rule and — as required by the Sanitary Food Transportation Act of 2005 — will assist the Department of Transportation in developing procedures for DOT transportation safety inspections in order to identify suspected incidents of contamination or adulteration of food,” Buckner said during the conference call.

OOIDA’s safety and security operations director Doug Morris told Land Line Magazine earlier this year that truckers should not be surprised if FDA inspectors start showing up at weigh stations and other DOT inspection facilities.

“The FDA is going to be more proactive,” Morris told the magazine. “It may cause problems for those who aren’t keeping the required temperature settings or abiding by the rule. It could be a pretty bad situation if a load is declared in violation and could possibly be a total loss.

“There are exemptions in there, but most of the shippers have basically said that they’re not going to worry about the exemptions and just make sure that everyone is following the requirements.”

Key requirements of the new rule
The sanitary transportation rule establishes requirements for:

  • Vehicles and transportation equipment: The design and maintenance of vehicles and transportation equipment to ensure that it does not cause the food that it transports to become unsafe. For example, they must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food.
  • Transportation operations: The measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready to eat food from touching raw food, protection of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact.
  • Training: Training of carrier personnel in sanitary transportation practices and documentation of the training. This training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.
  • Records: Carriers must maintenance of records of written procedures, agreements and training. The required retention time for these records depends upon the type of record and when the covered activity occurred, but does not exceed 12 months.

Who is covered?
According to the FDA’s info sheet on the sanitary transportation rule, except for some exceptions, the final rule applies to shippers, receivers, loaders and carriers who transport food in the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce.

It also applies to shippers, in other countries who ship food to the U.S. directly by motor or rail vehicle from Canada or Mexico, or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the U.S., if that food will be consumed or distributed in the United States.

The rule does not apply to exporters who ship food through the United States, for example from Canada to Mexico, by motor or rail vehicle if the food does not enter U.S. distribution.

Companies involved in the transportation of food intended for export are covered by the rule until the shipment reaches a port or the U.S. border.

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