The Centers for Disease Control and Prevention estimates that about one in six Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne illnesses each and every year. To prevent food contamination during transportation, the Food and Drug Administration (FDA) proposed a new rule Friday. It is the seventh and final major directive in the scheme of the Food Safety Modernization Act (FSMA), which was signed into law on Jan. 4, 2011, and intended to ensure the safety and security of the nation’s food and feed supply.

“Certain shippers, carriers, and receivers engaged in transporting food by motor or rail vehicles would be required to follow common sense sanitary practices, such as properly refrigerating food, adequately cleaning vehicles between loads, and properly protecting food during transportation,” Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, wrote in an FDA blog post. The regulation also applies to those who ship food via international freight containers and then transfer the intact container once it has arrived in the U.S.

The FDA calculates the rule will cover 83,609 businesses, including both carriers and facilities. Yet there are many exceptions to the rule, such as shippers, receivers, or carriers that record less than $500,000 in total annual sales. The regulation also does not apply to those shipping food which will not be consumed or distributed in the U.S., nor does it apply to farms that transport fully packaged shelf-stable foods, live food animals, or raw agricultural commodities. An individual business may end up paying a substantial amount to implement the proposed regulation because it not only requires the cleaning and maintenance of vehicles but also compels businesses to train their employees and keep official records.

In fact, the FDA estimates the total first-year cost to be about $149.1 million (averaging $1,784 per business), while total annual costs thereafter might reach $30.08 million (averaging $360 per business). Food Shippers of America could not be reached for comment. “Truthfully, it’s uncommon for a foodborne illness to be caused by contamination during transportation,” Taylor commented in his blog post. “But we have received reports of unsanitary practices, and we want to minimize this potential source of illness.”

In order to properly enforce the rule, the FDA is proposing staggered implementation based on business size, ranging from one to two years after publication of the final rule, which will remain open to comments until May 31, 2014. “We’re all in this together. ...So let’s start talking about what we need to do to transport foods safely,” Taylor states in his blog post. “As with the other proposed rules, we will work with all stakeholders — including consumers, industry, and researchers — to ensure that what we’re proposing is practical and feasible while meeting our food-safety standards.”