According to recent data from the Centers for Disease Control and Prevention, foodborne illness is a significant burden that affects nearly 48 million Americans per year, hospitalizing 128,000 and killing 3,000. In response, President Obama signed into law the Food & Drug Administration (FDA) Food Safety Modernization Act (FSMA) on January 4, 2011 to shift focus of federal regulators from responding to contamination to preventing it.

On June 6, 2016, the FDA FSMA rule on Sanitary Transportation of Human and Animal Food became final, advancing the FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failing to properly refrigerate food, clean trucks, and protect food.

Am I Covered by the Rule?

With some exceptions, the final rule applies to shippers, receivers, loaders, and carriers who transport food in the U.S. by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce. It also applies to persons in other countries who ship food into the U.S. directly by motor or rail vehicle (from Canada or Mexico), or by ship or air, and arrange for the transfer of the intact container onto motor or rail vehicle for transportation within the U.S., if that food will be consumed or distributed in the U.S.

Exceptions to the rule include, but are not limited to, transportation activities performed by a farm; shippers, receivers, and carriers engaged in food operations that have less than $500,000 in average annual revenue; transportation of completely enclosed food that doesn’t require temperature control; and transportation of food that is transshipped through the U.S. to another country.

How Long Do I Have to Comply?

Small businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts have until June 6, 2018 to comply.

Other businesses not considered small and that are not otherwise excluded from coverage began compliance on June 6, 2017.

Requirements of the Rule

There are four main requirements encompassed by the rule. First, the design and maintenance of vehicles and transportation equipment cannot cause the food that it transports to become unsafe. They must be adequately cleanable for their intended use and capable of maintaining temperatures necessary for the transport of food. Second, measures must be taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready-to-eat food from touching raw food, and protection of food from cross contamination. Third, training is required of carrier personnel in sanitary transportation practices and documentation of the training. This training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport. Lastly, records of written procedures, agreements, and training must be maintained for twelve months.

The FDAs Role

The FDA FSMA Food Safety Technical Assistance Network is already operational to provide a central source of information to support industry understanding and implementation of FSMA. The FDAs first round of inspections will assess the industry’s level of readiness, and if deficiencies are found, it will provide companies with the information they need to achieve compliance.