The FDA Food Safety Modernization Act rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. The earliest compliance dates for some firms begin one year after publication of the final rule in the Federal Register.
This rule is one of seven foundational rules proposed since January 2013 to create a modern, risk-based framework for food safety. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads and failure to properly protect food.
The rule builds on safeguards envisioned in the 2005 Sanitary Food Transportation Act. Because of illness outbreaks resulting from human and animal food contaminated during transportation and incidents and reports of unsanitary transportation practices, there have long been concerns about the need for regulations to ensure that foods are being transported in a safe manner.
The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law.
Specifically, the FSMA rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training, and waivers.
With some exceptions, the final rule applies to shippers, receivers, loaders and carriers who transport food in the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce. It also applies shippers, in other countries who ship food to the United States 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 a motor or rail vehicle for transportation within the U.S., if that food will be consumed or distributed in the United States.
The rule does not apply to exporters who ship food through the United States (for example, from Canada to Mexico) by motor or rail vehicle if the food does not enter U.S. distribution.
Companies involved in the transportation of food intended for export are covered by the rule until the shipment reaches a port or U.S. border.
Specifically, the rule would establish requirements for:
Vehicles and transportation equipment: The design and maintenance of vehicles and transportation equipment to ensure that it does not cause the food that it transports to become unsafe. For example, they must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food.
Transportation operations: The measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready-to-eat food from touching raw food, protection of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact, i.e., the unintentional incorporation of a food allergen.
Training: Training 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.
Records: Maintenance of records of written procedures, agreements and training (required of carriers).
Certain businesses and activities are exempt from the rule, including:
– Shippers, receivers or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue.
– Transportation activities performed by a farm.
– Transportation of food that is transshipped through the United States to another country.
– Transportation of food that is imported for future export and that is neither consumed or distributed in the United States.
– Transportation of compressed food gases (e.g. carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products), and food contact substances.
– Transportation of human food byproducts transported for use as animal food without further processing.
– Transportation of food that is completely enclosed by a container except a food that requires temperature control for safety.
– Transportation of live food animals, except molluscan shellfish.