FDA Releases Final Rule on Sanitary Transportation of Human and Animal Food

Finalized Transportation Rules

Vehicles and transportation equipment.  Vehicles and transportation equipment must be designed and maintained to ensure transported food does not become unsafe. For example, this equipment must be appropriate and cleanable for their intended use and able to maintain temperatures necessary for the safe transportation of food.

Transportation operations. Operations during transportation must ensure food safety. This includes, but is not limited to 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 (the unintentional incorporation of a food allergen).

Training. Carrier personnel must be trained in sanitary transportation practices and training must be documented. Training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.

Records. Records must be kept of written procedures, agreements, and training (required of carriers). The required retention time for these records depends upon the type of record and when the covered activity occurred, but does not exceed 12 months.

What Significant Changes Were Made from the FDA’s Original Proposal?

• The definition of “transportation operations” has been changed to exclude: 
  • Transport of foods completely enclosed by a container (except food that requires temperature control for safety.) The original proposal stated that the proposal rule had specified that the enclosed foods must be shelf-stable, meaning safely stored at room temperature in a sealed container. 
  • The transport of “food contact substances,” which include coatings, plastics, paper, and adhesives as well as colorants, antimicrobials, and antioxidants found in packaging, and human food byproducts for use as animal food without further processing, such as those sold directly to farmers to be fed to livestock.

• The final rule clarifies that the intended use of the vehicle or equipment (transporting animal feed vs. human food) and the production stage of the food being transported (raw materials vs. finished products) are relevant in determining sanitary transportation requirements.

• Requirements for a temperature indicating or recording device during transport have been replaced with a more "flexible approach." Now, the shipper and carrier can agree to a temperature monitoring mechanism for foods that require temperature control for safety. 

• Carriers need to demonstrate requested temperature conditions were maintained only upon request rather than as a requirement for every shipment, as originally proposed.

• “Loaders” have been added as a covered party. A loader is defined as someone who physically loads food onto a vehicle. Before loading a food not completely enclosed by a container, the loader must determine that the transportation equipment is in appropriate sanitary condition. Also, before loading a food requiring temperature control, the loader must determine that each mechanically refrigerated cold storage compartment is adequately prepared for refrigerated transportation, including precooling, if necessary. 

• Primary responsibility for determining appropriate transportation operations now rests with the shipper, which may rely on contractual agreements to assign some of these responsibilities to other parties.

• If a covered person or company becomes aware of a potential failure of temperature control or any other condition that may render a food unsafe, that food must not be sold or distributed until a determination of safety is made. 

Compliance Tips

This is purely an FDA ruling enforceable by the FDA, similar state partners, and the USDA. This is not something the FMCSA has jurisdiction over, so state officers cannot issue citations for this new ruling. It is also not included in the FMCSRs.

Although, the FDA or an individual with proper authority could be spending time at the scales and using those facilities as a springboard to check compliance under FSMA. This tactic is not anything new and has been effectively used in the past for criminal interdiction, dyed fuel checks (IRS) and illegal alien checks (ICE). 

Make sure you understand the new ruling to avoid any costly citations and communicate with partners in order to determine how all parties will meet the new requirements. For further guidance, visit the FDA's FSMA page at http://www.fda.gov/fsma.