The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) was enacted by Congress and signed into law in 2011. The impetus behind the law was to shift focus on foodborne illness from being one of reactionary to one of prevention. According to the Centers for Disease Control and Prevention, about 48 million people in the U.S. (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, and many of these instances are preventable.
The FDA has finalized seven rules to implement the act, and they are centered around the key principles of Prevention, Inspection and Compliance, Response, Imports and Enhanced Partnerships. With respect to transportation, regulations became effective in 2016, 2017 and 2018 that established requirements for shippers, loaders, carriers and receivers engaged in the transportation of human and animal food by truck or rail to use sanitary transportation practices to ensure food and feed safety. Below are several key elements of these rules as they apply to transportation companies.
Who is covered by the sanitary food transportation rule?
The rule applies to shippers, receivers, loaders and motor carriers and rail carriers that transport food in the United States, regardless of whether it is in interstate commerce. As defined under the federal Food, Drug and Cosmetic Act, “Food” means any food or constituents of food intended for consumption by humans or animals, which includes grain, grain products, flour, animal feed, pet food, animal feed ingredients and other agricultural products. FSMA rules only apply to foods regulated by the FDA, which is about 75% of the U.S. food supply. The other 25% is regulated by other agencies, such as the USDA, who oversees meat, poultry, and many dairy products. The FSMA rules also apply to shippers in other countries that transport food into the United States directly by rail or motor carrier conveyances if the food will be distributed or consumed in the United States. Additionally, companies involved in transporting food for export are covered until the shipment reaches a U.S. export port or the U.S. border.
There are several exemptions for:
- 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 (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.
What requirements apply to motor carriers?
The rule largely exempts motor carriers and rail carriers from the requirements unless the shipper and carrier have a written agreement (e.g., contractual arrangement) making the carrier or another party responsible, in whole or in part, for sanitary conditions during transportation. A “carrier” is defined as “a person who physically moves food by rail or motor vehicle in commerce within the United States.” Persons who transport food while operating as a parcel delivery service are excluded.
There are several obligations that trucking companies and railroads have under the rules, as well as shippers, receivers and loaders, to prevent food from becoming unsafe during transport. These include providing protection so food does not become cross-contaminated with non-food items in the same or a previous load, and to protect food from cross-contact (i.e., the unintentional contamination with a food allergen). The regulations also require truckers and railroads to consider the type of food being transported (e.g., human food, animal feed, pet food, etc.) and whether the product is a raw material, ingredient or a finished food when determining the conditions and controls to apply to the load.
Are there any additional requirements?
Shippers: To develop and implement written procedures to ensure vehicles and equipment used in transportation operations are in appropriate sanitary condition for the type of food being transported (i.e., will prevent the food from becoming unsafe during transport), unless they enter into a written agreement to confer those responsibilities with the carrier. In the event the latter occurs, the shipper needs to provide a one-time notification to the carrier, and, if necessary, to the loader of all sanitary specifications for the carrier’s vehicle and transportation equipment to ensure the food does not become contaminated during transport.
Loaders: Before loading food not completely enclosed by a container into a truck or railcar, the loader is to consider specifications, if any, provided by the shipper under a written agreement that the conveyance is in appropriate sanitary condition for the product being hauled (i.e., the conveyance is in adequate physical condition and free of visible evidence of pests and previous cargo that could cause the food to become contaminated during transport).
Vehicles and transportation equipment: The design and maintenance of vehicles and transportation equipment are such to ensure that they do not cause the food being transported to become unsafe.
Records: Records are to be created and maintained for shipper-to-carrier communications, written procedures, agreements and training. The retention periods for these records depends upon the type of record and when the covered activity occurred, but, except for training documentation, generally does not exceed 12 months.
Training: Motor carriers and rail carriers are required to train their personnel about potential food safety problems and basic sanitary transportation practices, and to maintain documentation of the training, but only if the carrier and shipper agree that the carrier is responsible, in whole or part, for sanitary conditions during transport. Shippers, receivers or loaders are not subject to training requirements.
Conclusion: With the exception or recordkeeping and training, most of the FSMA rules mirror typical industry best practices. Motor carriers should be careful to understand their contractual and regulatory obligations around sanitation and temperature monitoring to ensure food products remain safety over the course of the journey. Trailer tracking and periodical temperature monitoring may be a contractual requirement and should be carefully investigated.
- Final Rule on Sanitary Transportation of Human and Animal Food
- Fact Sheet of the Final Rule on Sanitary Transportation of Human and Animal Food
- Implementation Fact Sheet
- Training for Carriers covered by the Sanitary Transportation of Human and Animal Food Rule
- Food Safety Modernization Act Web Page