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Final FSMA Transportation Rule Excludes Food-Contact Substances

The U.S. Food and Drug Administration (FDA) Final Rule on the Sanitary Transportation of Human and Animal Food under the Food Safety Modernization Act (FSMA), issued on April 5, 2016, exempts food-contact substances. This rule provides for the sanitary transportation of food, and applies to shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in transportation operations concerning food. It includes requirements for vehicles and transportation equipment, transportation operations, training, record keeping, and FDA’s procedures for waiving the requirements of the rule. 

While FDA was not willing to exclude food-contact substances from the definition of “food” in the final rule, the Agency did agree that there is very low risk of food products becoming adulterated as a result of the unsanitary transport of food-contact substances and, thus, food-contact substances should be excluded from the rule. More specifically, “transportation operations” that trigger application of the rule’s requirements do not include the transportation of food-contact substances or food completely enclosed by a container (expect for packaged food that requires temperature control to ensure safety). Explaining the reason for this exclusion, FDA acknowledged in the preamble to the Rule that food-contact substances are protected during transportation with outer packaging, that the nature of food-contact articles make them inherently resistant to microbial contamination, that pathogens known to be deleterious to foods are not known to be a risk to food-contact substances, and that any pathogens that could be introduced to food-contact substances during transport would not likely survive the typically extreme processing conditions that food-contact materials undergo (e.g., curing, drying, and extrusion).

The Sanitary Transportation Rule is part of FDA’s implementation of the Sanitary Food Transportation Act of 2005) and the Food Safety Modernization Act of 2011 (FSMA).

© 2020 Keller and Heckman LLPNational Law Review, Volume VI, Number 97



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PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.