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What’s required in FDA’s FSMA food transportation rule?

By David Fairfield, Senior Vice President of Feed Services

As mandated by the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) on April 6, 2016 published final regulations that establish requirements for shippers, loaders, carriers and receivers engaged in the transportation of human and animal food by truck or rail to use sanitary transportation practices to ensure food and feed safety.

Among the many operations covered by the rule are shippers, loaders, carriers and receivers involved with motor or rail vehicle transportation of raw agricultural commodities (e.g., grains and oilseeds), animal feed and feed ingredients, and human food and food ingredients.

The compliance date for the rule’s requirements was April 6, 2017 for “large” businesses. FDA defines a “large” business to be a business, other than a motor carrier that is not also a shipper and/or receiver, employing 500 or more persons and motor carriers having $27.5 million or more in annual receipts. The compliance date for other businesses covered by the rule that are not “large” is April 6, 2018.

The following are some common questions that have been posed to the NGFA about the rule, along with their answers.

 

  1. Q: Who is covered by FDA’s sanitary food transportation rule?

A: Generally, the rule applies to shippers, receivers, loaders and rail and motor carriers that transport food in the United States, regardless of whether the food is shipped in interstate commerce.  “Food,” as defined under the federal Food, Drug and Cosmetic Act, means any food or constituents of food intended for consumption by humans or animals. So, it encompasses grain, grain products, flour, animal feed and pet food, animal feed ingredients and other agricultural products.

The rules also apply to shippers in other countries that transport food into the United States (e.g., from Canada and Mexico) directly by rail or motor carrier conveyances if the food will be consumed or distributed in the United States. Companies involved in transporting food intended for export also are covered by the rule until the shipment reaches a U.S. export port or the U.S. border.

 

  1. Q: Who’s exempt from the rule?

A: The most significant exemptions are for: 1) shippers, receivers, loaders and carriers engaged in transporting food that have less than $500,000 in average annual revenue; 2) transportation activities conducted on a farm; 3) transported food that is completely enclosed by a container (such as containerized grain shipments), unless the food requires temperature control to maintain product safety; 4)  food transshipped through the United States to another foreign country; 5) transportation of food that is imported for future export, but which is neither consumed nor distributed in the United States; and 6) transportation of human food co-products intended for use as animal food without further processing. 

 

  1. Q: Does the rule apply to barge or vessel transportation?

A: No.

 

  1. Q: What requirements apply to rail carriers and truckers?

A: FDA’s final rule largely exempts rail carriers and truckers from the rule’s requirements unless the shipper and carrier have a written agreement (e.g., contractual arrangement) making the carrier or another party responsible, in whole or in part, for sanitary conditions during the transportation operation. The rule defines a “carrier” to mean “a person who physically moves food by rail or motor vehicle in commerce within the United States,” excluding persons who transport food while operating as a parcel delivery service. 

The NGFA has expressed major concerns to FDA that the way the final rule is written and structured, rail and truck carriers may be unwilling to enter into written agreements with shippers to assume responsibility for sanitary food transportation functions, even those that have become relatively routine practice (such as identifying the immediate previous load hauled or most recent cleaning of bulk vehicles), given the compliance obligations such agreements would create. The NGFA is engaged in active discussions with the agency and other stakeholders in attempting to address this significant issue. 

Importantly, however, there are several obligations that do apply to railroads and truckers – as well as to shippers, receivers and loaders – to utilize controls and operating conditions to prevent food from becoming unsafe during transport. This includes the requirement to provide adequate protection so food does not become cross-contaminated with non-food items in the same or a previous load, and to protect food from cross-contact (i.e., the unintentional contamination with a food allergen). FDA’s regulations also require railroads and truckers during their transportation operations to consider the type of food being hauled (e.g., human food, animal feed, pet food, etc.) and whether the product being transported is a raw material, ingredient or a finished food when determining the necessary conditions and controls to apply to the shipment.

 

  1. Q: What other requirement apply to businesses required to comply with the rule?
    Following is a general description of the rule’s other requirements:
  • Requirements for Shippers: Shippers are required to develop and implement written procedures adequate to ensure that vehicles and equipment used in transportation operations are in appropriate sanitary condition for the type of food being transported (e., will prevent the food from becoming unsafe during transport), unless they enter into a written agreement with the carrier to vest those responsibilities in the carrier. In the unlikely event that the latter occurs, the shipper is to provide a one-time notification to the carrier, and, if necessary, to the loader of all necessary sanitary specifications for the carrier’s vehicle and transportation equipment to ensure the food does not become contaminated during transport.   
  • Requirements for Loaders: Before loading food not completely enclosed by a container into a railcar or truck, the loader is to consider specifications, if any, provided by the shipper under a written agreement that the conveyance is in appropriate sanitary condition for the product being hauled (g., the conveyance is in adequate physical condition and free of visible evidence of pests and previous cargo that could cause the food to become contaminated during transport).
  • Vehicles and transportation equipment: The design and maintenance of vehicles and transportation equipment are to ensure that the vehicles and transportation equipment does not cause the food that it transports to become unsafe.
  • Records: Records are to be established and maintained for shipper-to-carrier communication, written procedures, agreements and training (required of carriers). The required retention time for these records depends upon the type of record and when the covered activity occurred, but except for training documentation, does not exceed 12 months.
  • Training: Rail and truck carriers are required to train their personnel about potential food safety problems and basic sanitary transportation practices, and to maintain documentation of the training, but only if the carrier and shipper agree that the carrier is responsible, in whole or part, for sanitary conditions during transport. No training requirements are imposed upon shippers, receivers or loaders.

Covered businesses should refer to the final rule for more detailed information. 

 

  1. Q: What are a shipper’s obligations under the rule concerning prior loads that have been transported on a conveyance?

     A:   During the rulemaking process, FDA initially proposed that shippers would be required to

obtain information about the prior three loads hauled on a conveyance and use that information when determining whether the conveyance was suitable for the shipper’s use.  

Significantly, however, based on stakeholder comments, FDA in its final rule eliminated the proposed requirement that shippers would need to obtain information about the prior three loads hauled on a conveyance when shipping bulk commodities. Instead, FDA established a final requirement that shippers of food transported in bulk are to develop and implement written procedures adequate to ensure that a previous cargo does not make the food unsafe. This means that the shipper is not required to obtain any information about prior cargoes that were hauled on the conveyance, and instead is obligated to take adequate measures, subject to FDA oversight, to ensure the safe transport of food to be placed in the conveyance.  At the shipper’s option, these written procedures can include reliance upon prior-load or conveyance clean-out information from the carrier; but again, this is not required.

 

  1. Q: How will FDA enforce the new requirements?

     A:  FDA has stated that it intends to use an “educate before and while we regulate” approach

to FSMA implementation, and says it will focus on supporting compliance through education in the initial months following the rule’s first compliance date. In doing so, FDA says that it expects inspections to begin later this year to ensure that shippers, receivers, loaders and carriers covered by the rule are complying with the requirements. The agency’s stated compliance goal when conducting the initial inspections will be to assess the industry’s level of readiness and, if deficiencies are found, to provide firms with the information they need to achieve compliance.

 

  1. Q: Where can more information about this rule and other FSMA-related requirements be found?

     A:  The NGFA recently issued an extensive guidance document on FDA regulations that

apply to the grain, feed and processing industry. The 79-page document may be found electronically on the NGFA Feed website.

 

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