The Food Safety Modernization Act promotes safety for the transportation of human and animal food.
The Sanitary Transportation of Human and Animal Food rule enacted by the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSM) is now final. It was published in the Federal Register on April 6, 2016. The rule further advances the FDA’s efforts to protect food from farm to table by helping to keep them safe from contamination during transportation.1
The rule builds on safeguards envisioned in the 2005 Sanitary Food Transportation Act (SFTA). Illness outbreaks resulting from human and animal food contamination during transportation, as well as incidents and reports of unsanitary transportation practices, have caused concerns about the need for regulations to help ensure that foods are transported safely. Learn more about the Sanitary Transportation of Human and Animal Food rule on the FDA website.
Who does the rule cover?
The Sanitary Transportation of Human and Animal Food rule applies to shippers, receivers, loaders and carriers who transport food in the US by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce.2 It also applies to:
- Persons, such as shippers, in other countries who transport food to the US directly by motor or rail vehicle (from Canada or Mexico), if the food will be consumed or distributed in the US.
- Persons, such as shippers, in other countries who transport food by ship or air and arrange for the transfer of the intact container onto a motor or rail vehicle for transport within the US, if the food will be consumed or distributed in the US.
- Companies involved in the transportation of food intended for export until the shipment reaches a port or US border.3
The rule does not apply to exporters who ship food through the US (for example, food being transported from Canada to Mexico) by motor or rail vehicle if the food does not enter US distribution.2
The following are also exempt from the rule:
- Shippers, receivers or carriers engaged in food transportation operations with an average annual revenue of less than $500,000.
- Transportation activities performed by a farm.
- Transportation of food that is transshipped through the US to another country.
- Transportation of food that is imported for future export and is neither consumed or distributed in the US.
- Transportation of compressed food gases (for example, carbon dioxide, nitrogen or oxygen) authorized for use in food and beverage products or food-contact substances.
- Transportation of human food byproducts for use as animal food without further processing, such as those sold directly to farmers to be fed to livestock. (Byproducts transported to facilities to be manufactured into feed or pet food are not exempt.)
- Transportation of food that is completely enclosed by a container, except food requiring temperature control for safety.
- Transportation of live food animals, except molluscan shellfish.3
Note: Please be aware of potential contamination risks when transporting to farms as mud, debris and manure can be transferred onto trucks or trailers.
The Sanitary Transportation of Human and Animal Food rule establishes requirements for:
- Vehicles and transportation equipment — The design and maintenance of vehicles and transportation equipment should not cause transported food to become unsafe. For example, vehicles and equipment should be adequately cleanable, suitable for their intended use and capable of maintaining temperatures necessary for safe transport.4
- Transportation operations — During transportation, measures should be taken to help ensure food safety, such as maintaining adequate temperature controls, preventing the contamination of ready-to-eat food from touching raw food, protecting food from contamination by non-food items in the previous or same load and protecting food from cross-contact, such as the unintentional incorporation of a food allergen.5
- Training — Carrier personnel should have documented training in sanitary transportation practices. It is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.6
- Records — Records of written procedures, agreements and training should be maintained. The required retention time for these records depends upon the type of record and when the covered activity occurred, but does not exceed one year.7
Key requirements for shippers
Shippers should develop and implement written procedures to help ensure that:
- Equipment and vehicles are in appropriate sanitary condition
- Previous cargo does not make food unsafe when transporting in bulk
- Adequate temperature control is maintained for food safety4
Key requirements for loaders
The loader must determine that:
- The transportation equipment is in appropriate sanitary condition before loading food that is not completely enclosed by a container.
- Each mechanically refrigerated cold storage compartment is adequately prepared for refrigerated transportation before loading food requiring temperature control.5
Key requirements for carriers
Transportation operations should accomplish the following:
- Assign competent supervisory personnel
- Conduct operations to help keep food from becoming unsafe during transportation
- Take measures to help prevent the cross-contamination of raw foods and non-foods by using techniques of load segregating, isolating or packaging
- Isolate, segregate or use other measures to help prevent contamination or cross contact of food not completely enclosed in containers or transported in bulk vehicles
- Take effective measures to help ensure the adequate transportation of food requiring temperature control for safety5
If a shipper transfers responsibility to the carrier, the carrier must have written procedures that:
- Specify practices for cleaning, sanitizing and inspecting vehicles used for food
- Describe how it will maintain and record temperature control as required by the shipper
- Describe how it will make provisions for the use of bulk vehicles, including maintaining information/records on the vehicle’s previous load and maintaining cleaning/wash records as required by the shipper5
The carrier is required to train personnel in sanitary transportation practices and have a documented certification of training. While there is no mandated length or syllabus for the certification training, suggested topics include:
- How to inspect trailers for signs of contamination and damage that may cause loss of temperature or allow contamination
- Load segregation, isolation and securement
- How to record and maintain temperature control
- Hand washing and general hygiene
- Food safety items that may be unique to the shipper’s or carrier’s specific operation
Recognizing that businesses, especially small businesses, may need more time to comply with the requirements, the FDA has adjusted compliance dates accordingly.
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 must comply two years after the publication of the final rule, making their compliance date April 6, 2018.
Other businesses that are not small and are not otherwise excluded from coverage must comply one year after the publication of the final rule, making their compliance date April 6, 2017.
Nationwide has experts in food and feed safety, as well as transportation safety. Contact your risk management consultant for more information. Also, continue to check the Seminars tab here on NSight Online for latest listings of food safety and transportation-related seminars.3
 21 CFR § 1.900. Who is subject to this subpart? US FDA.
 FSMA Final Rule on Sanitary Transportation of Human and Animal Food. US FDA. May 9, 2016.
 21 CFR § 1.906. What requirements apply to vehicles and transportation equipment? US FDA.
 21 CFR § 1.908. What requirements apply to transportation operations? US FDA.
 21 CFR § 1.910. What training requirements apply to carriers engaged in transportation operations? US FDA.
 21 CFR § 1.912. What record retention and other record requirements apply to shippers, receivers, loaders and carriers engaged in transportation operations? US FDA.