On April 6, 2016, the Food and Drug Administration (FDA) published in the Federal Register its long-awaited final rule on Sanitary Transportation of Human and Animal Food (Final Rule). The Final Rule is the sixth of seven final regulations that implement the Food Safety Modernization Act of 2011.
The final rule generally requires those engaged in the motor or rail transportation of human and animal food to use sanitary transportation practices to ensure the food is not transported under conditions that may render the food “unsafe,” i.e., adulterated. Although the final rule exempts certain transportation operations (e.g., sea vessel and air) and food, including food located in food facilities that are exclusively regulated by FSIS, FDA does not exempt meat and poultry products from the rule once they leave the FSIS-inspected establishment. FDA explains in the preamble to the final rule that even though FSIS requires its regulated entities to “address sanitation during transportation,” FSIS “does not have requirements that directly address transportation operations once they leave the FSIS-inspected facilities.”