New FDA Rules & Regulations and Impact on Motor Carriers

Highlights of the Proposed Rule

Specifically, the proposed 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 contaminated.
• Transportation operations: The measures taken during transportation to ensure food is not contaminated, such as adequate temperature controls and separation of food from non-food items in the same load.
• Information exchange: Procedures for exchange of information about prior cargos, cleaning of transportation equipment, and temperature control between the shipper, carrier, and receiver, as appropriate to the situation. For example, a carrier transporting bulk liquid non-dairy foods would want to ensure that vehicles that have previously hauled milk will not introduce allergens into non-dairy foods through cross contact.
• Training: Training of carrier personnel in sanitary transportation practices and documentation of the training.
• Records: Maintenance of written procedures and records by carriers and shippers related to transportation equipment cleaning, prior cargos, and temperature control.
• Waivers: Procedures by which the FDA will waive any of these requirements if it determines that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health and that it is in the public interest.

Compliance Dates: The FDA’s final rule regarding human and animal food is expected to be published no later than March 2016

• Small Businesses — businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $25.5 million in annual receipts would have to comply two years after the publication of the final rule.
• Other Businesses — a business that is not small and is not otherwise excluded from coverage would have to comply one year after the publication of the final rule.

This proposed rule establishes requirements for vehicles and transportation equipment, transportation operations, training, and recordkeeping. For example, shippers would be required to inspect a vehicle for cleanliness or contamination prior to loading food that is not completely enclosed by its container. Operators of motor vehicles, railcars, and other equipment used in food transportation would be required to establish written procedures, subject to record keeping requirements, for cleaning their vehicles and transportation equipment. The FDA would be entitled to review these procedures and records.

The proposed rule also requires individuals who transport foods that require time/temperature control for safety to ensure the maintenance of the transportation cold chain during operations. This includes pre-cooling the vehicle, loading and unloading operations, and the transportation phase. The proposed rule would also establish procedures for the exchange of information about prior cargos, cleaning of transportation equipment, and temperature control between the shipper, carrier and receiver, as appropriate to the situation. Shippers would need this information to ensure adequate sanitation practices were used that would help prevent adulteration of transported products. For example, a carrier transporting bulk liquid non-dairy foods would want to ensure that vehicles that have previously hauled milk will not introduce allergens into non-dairy foods through cross contact.

Under the Carmack Amendment, motor carriers are liable for “actual loss” to property.  Now, a variation in temperature from an aggressive temperature standard, could represent such an actual loss, opening up carriers to additional losses.  In addition, as the adulterated product cannot be salvaged, freight losses would be deemed total losses, raising the dollar value of claims.

Motor Carriers should consider ways to insulate themselves from freight claims by putting a plan in place to implement constant temperature maintenance of their reefer units, as well as starting to communicate with their shippers and finding ways to address the issues. (For additional info: http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm)