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Equipping Your Supply Chain for FSMA: Allocating Responsibilities under the FSMA Transportation Rule 

by Suzanne Trigg

Published: April, 2016

Submission: May, 2016


In the late 1980s, stories of garbage hauled in the same trucks regularly used to transport fruits and vegetables caused public outrage. Outbreaks of foodborne illnesses, including a salmonellosis outbreak that affected 224,000 consumers, have been attributed to contamination of transportation vehicles. Recently, a major U.S. foodservice distributor was penalized after its practice of storing seafood, milk and raw meat in unrefrigerated sheds was uncovered. 

To mitigate the food safety risks associated with transportation practices, Congress passed the Sanitary Food Transportation Act of 2005 (“SFTA”) and again addressed food transportation practices in the Food Safety Modernization Act of 2011 (“FSMA”). Earlier this month, in one of the final rules issued to implement FSMA, the FDA released its final rule on Sanitary Transportation of Human and Animal Food (“FSMA Transportation Rule” or “Rule”). The final FSMA Transportation Rule reflects the FDA’s response to many of the industry’s concerns, in that the FDA refocused its efforts on transportation practices that cause food safety risk, rather than also addressing practices that might lead to quality defects or spoilage of food products. 

Now is the time for food product manufacturers, processors, carriers, brokers, distribution centers, and others involved in food product and ingredient supply chains to determine what requirements apply to their business practices and to address how they will implement the FSMA Transportation Rule. After all, under the FSMA Transportation Rule, if transportation occurs under conditions that are not in compliance with the Rule, the food will likely be adulterated under the federal Food, Drug and Cosmetic Act. Responsible parties may be subject to fines and other liability. In addition, violations of the FSMA Transportation Rule may also support freight claims against carriers, or claims against other responsible parties in the supply chain alleging the negligence or other misconduct of a responsible party. 

Businesses (other than small businesses) must comply with the Rule in 2017. Small businesses (those with fewer than 500 full time employees or carriers that are not also shippers and receivers with less than $27.5 million in annual receipts) must comply with the Rule in 2018. Given the need to establish written procedures and update supply chain contracts, those affected by the Rule cannot afford to wait to begin implementing changes. 

Many companies are likely to find that though current procedures may need to be incorporated into contracts or otherwise formalized, many of the Rule’s requirements are flexible enough to adapt to the food industry’s current strategies for ensuring food safety during transportation. But as recognized by the FDA, companies are likely to find that there are new responsibilities, and therefore new costs, such as those associated with training and recordkeeping. 

What Activities are Covered? 

Through the final Rule, the FDA has clarified the parties, operations, and products that are subject to the FSMA Transportation Rule. To fully understand the scope of what is covered by the FSMA Transportation Rule, interested parties should note which activities and products are or are not covered by the Rule.

Transportation operations are broadly defined under the FSMA Transportation Rule to include “all activities associated with food transportation that may affect the sanitary condition of food including cleaning, inspection, maintenance, loading and unloading, and operation of vehicles and transportation equipment.” All transportation operations subject to the Rule must be conducted under such conditions and controls necessary to prevent the food from becoming unsafe. Conditions and controls necessary to prevent the food from becoming unsafe include segregation, isolation, or other protective measures to protect food: 

  • From cross-contact and contamination during transportation operations if transported in bulk vehicles or not completely enclosed by a container; 
  • From contamination by raw foods and nonfood items in the same load; and 
  • From unsafe temperature fluctuations. 

The following transportation operations are not covered by the FSMA Transportation Rule: 

  • Transshipping of food through the U.S. to another country; 
  • Transporting food that is imported to the U.S. for future export, and not consumed or distributed in the U.S.; or 
  • Food that is located in food facilities regulated only by the U.S. Department of Agriculture (“USDA”) under the Federal Meat Inspection Act, Poultry Products Inspection Act, or the Egg Products Inspection Act. 

Except for the above express exceptions, the requirements of the Rule apply whether or not the food is being offered for or enters interstate commerce. That is, food that is being transported from one processing facility to another for further processing would still be covered by the Rule. 

What Food Products are Covered? 

The Rule applies to transportation operations of food not completely enclosed by a container, which means “any food that is placed into a container in such a manner that it is partially open to the surrounding environment,” such as in an open wooden basket or crate, an open or vented cardboard box, or a vented plastic bag. The Rule also applies to food shipped in bulk, which comes into direct contact with the vehicle. The Rule’s requirements extended to food additives (except for food contact substances) and generally recognized as safe (“GRAS”) substances. 

Importantly, under the Rule, transportation operations do not include any activities associated with the transportation of food that is completely enclosed by a container unless that food requires temperature control for safety. The Rule further does not apply to transportation operations that include the transportation of compressed food gases or food contact substances (e.g., packaging materials). The FDA, noting that the temperature and time required for frozen food to become unsafe would result in significant quality issues before posing any safety risk, also stated that frozen food is not subject to the Rule.


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