Does the Sanitary Transportation Regulation Require Seals for LTL Shipments?

FDA intends to enforce the adherence of industry to generally accepted best practices.

This question has come up frequently in our FSMA Sanitary Transportation workshop. Just as with all the parts of FSMA, the focus of the Sanitary Transportation of Human and Animal Food regulation is on addressing hazards that may be present throughout the food chain and assigning responsibility (liability) for preventing those hazards. There are very few specific requirements—most of it is couched in very general language, for flexibility on both sides (FDA's and industry's).

While the regulation does not specifically address locks or seals on trailers, the FDA has stated publicly that they intend to enforce the adherence of industry to generally accepted best practices. Sometimes, as in the case of certain animal food applications, the FDA has stated they will accept mild steel transports instead of stainless (as would typically be required for hauling food) because it's all about the risk, and mild steel is not a risk in those applications. What is the risk of an unlocked load to the food being hauled, and to the business being conducted? Maybe a seal or lock on an LTL can protect a significant investment from an identified hazard.

Generally, in most food hauling operations, seals or locks are required on trailers by businesses in order to protect their investments. They are also expected under GFSI-approved food safety management systems, used by most food manufacturers (which are private, voluntary standards, not regulatory). They are definitely required if you want to haul 100% juice under Juice HACCP and the JPA guidelines.

There are so few straightforward answers with FSMA. You must always look at your operation, your risks, and decide if controls are necessary. Document the basis for your decision, ensuring it is based on facts. If the FDA inquires, you must make your case for your decision. Do you feel comfortable defending it, all the way to a court of law if need be? If so, then stand by it.

If there are potential risks to food that is being hauled (don't forget about defense-type risks as well, like the truck being stolen or misrepresented) then you must take reasonable, industry-standard precautions to prevent those hazards from occurring.

Of course, you want to do this anyway because it is smart business.

The three waivers apply to businesses with transportation operations subject to State-Federal controls.

FDA issued a guidance to clarify that a waiver to the FSMA Sanitary Transportation covers retail food establishments that sell food for humans.

View the results for the FSMA Sanitary Transport IQ test.

The sixth FSMA rule will help ensure safe food in the transport of food from farm to fork.

Erika Miller has 10 years’ experience in the restaurant business, both front and back of house, where she worked her way up from washing dishes to waitressing. She learned the concept of food safety at a Servsafe food handling course during this time. Throughout her college career, she worked in several foodservice establishments. This experience has taught her the challenge and necessity of maintaining a safe food handling culture during times of peak production. Miller has experience as a quality assurance manager, as well as an analytical chemist. She understands the advanced instrumental analysis methods, such as gas chromatography and mass spectrometry, as well as microbiological testing methods commonly employed within the industry. She has an understanding of organic chemistry and takes a fact-based, scientific approach to system development and implementation.

Miller received her Bachelor of Science degree in chemistry from the University of Florida. A Tampa native, she is trained in and experienced with GMPs, HACCP, FSSC 22000, Internal Auditing/Risk Analysis and FSMA; including program design and implementation, facility compliance, and training. After a brief stint in aggregate quality assurance where she learned the basics of ISO and developed her first SOP manual, she entered the Florida Citrus industry (on the byproducts side), where she received further extensive training in the citrus industry. She has completed the FDA/FSPCA Preventive Controls Qualified Individual (PCQI) course. Miller has the unique ability to understand the scope of an operation and is able to logically develop a Food Safety Management System in a non-traditional food handling facility.