FSMA: Do You Know What You Are Responsible For?
Estimated reading time: 4 minutes
As of April 6, the FDA’s Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Foods became final. Though the rule has been in effect for large businesses since April 2017, small businesses (defined as shippers or receivers with fewer than 500 full-time employers, or carriers with less than $27.5 million in annual receipts) must now also be in full compliance.
While many companies have been compliant for years, others remain unprepared for the potential consequences of non-compliance. Whether you’re a shipper, broker, carrier, or receiver, below is a guide to the rule and several checklists to help you.
What is the FSMA Sanitary Transportation Rule?
This rule establishes comprehensive federal requirements designed to protect food from contamination while it is being transported by motor vehicle or rail within the United States. Standards address transportation vehicles, equipment, operations, communications, training, and record keeping.
There are four main components of the rule:
- Vehicles and Transportation Equipment. Along with their use and maintenance, vehicles and equipment must be designed to protect food while in transit. For example, they must be adequately cleanable and capable of maintaining specific temperatures.
- Transportation Operations. Measures such as adequate temperature controls, preventing ready-to-eat food from touching raw food, protecting food from contamination by non-food items, and protecting food from cross-contact with food allergens must be taken.
- Training. Carriers must provide training in sanitary transportation practices to all personnel engaged in transportation operations, and there must be documentation of the training. Training should cover potential food safety problems, basic sanitary transportation practices, and general responsibilities sunder FSMA regulations. The FDA offers a free, one-hour training module to help carriers meet this requirement, which you can access here.
- Records. Under FSMA, if it wasn’t documented, it didn’t happen. Shippers, 3PLs, and brokers must retain records demonstrating that they provided food safety specifications, temperatures, etc. for 12 months after the termination of the carrier contract. Carriers must retain training records for 12 months after the person identified in the record stops performing duties for which they were trained.
Shippers must determine and document the appropriate transportation operations for their products, and communicate those requirements to all parties across their supply chain. They must also provide an accurate Bill of Lading (BOL). Below are specific examples of shipper responsibilities.
- Develop and implement written procedures on temperature requirements and sanitation practices for different load types during loading, transportation, and unloading.
- Communicate all temperature-control, handling, and sanitary requirements to carriers in writing.
- Ensure all food-contact surfaces in vehicles are properly sanitized, corrosion-resistant, and free of chips or flakes.
- Inspect pallets and other equipment for any damage or conditions that may lead to contamination.
- Keep raw foods away from ready-to-eat foods or non-food items.
- Discuss with carriers how to handle any temperature violations or compromised loads.
Under FSMA, 3PLs and brokers are classified as shippers and assume the role and responsibilities of shippers. In other words, all the responsibilities outlined above apply to 3PLs and brokers as well. (If you skipped that section, go back and read it now.)
It’s imperative that brokers train their employees on these responsibilities. They must also have clear, documented procedures and policies in place for confirming whether partners are in compliance with FSMA rules. All brokers involved in moving food products should work closely with their shippers to fully understand all food safety protocols associated with their products so that they can pass that information onto the carrier.
Carriers are required upon request to provide information to shippers, brokers, loaders, and receivers regarding previous cargo hauled and provide confirmation of vehicle cleaning. They must also demonstrate that any refrigerated vehicle has been properly pre-cooled.
Carriers must be able to provide the following information to shippers, brokers, loaders, and receivers upon request:
- Where did the vehicle deliver previously?
- What commodities were previously hauled in the vehicle?
- When was the vehicle last cleaned (some shippers may even ask for wash-out receipts)?
- Are there any lingering odors in the vehicle?
- Can you demonstrate that a refrigerated vehicle has been properly pre-cooled?
- Do you have a temperature-monitoring system to manage temperature during transit?
- Can you confirm that temperature-sensitive cargo has little or no exposure to non-temperature controlled areas of the trailer?
The regulations require carriers to invest in process, equipment, and potentially new monitoring systems to ensure full compliance.
Receivers are required to provide washing facilities to vehicle operators if they will be handling, loading, or unloading any foods that are not completely enclosed. The receiver may also request proof of proper temperature-controls before accepting a load from a carrier.
The Risks of Non-Compliance: What You Don’t Know Can Hurt You
Ignorance of FSMA rules is no excuse for non-compliance. If food is not handled properly during transportation, companies could face criminal penalties. FDA record inquiries must be addressed within 24 hours, and failure to respond is considered a “prohibited act.” Companies that don’t take the necessary precautionary actions could find themselves in trouble with both the FDA and Department of Justice. Criminal penalties for violations include significant fines (up to $250,000 for an individual, or double that for organizations) and up to one year of imprisonment, so it’s critical to reduce exposure to liability.
When choosing transportation partners, make sure they are well-versed in FSMA with strict organizational processes in place to ensure all precautionary protocols are followed. At Capstone, we understand the critical role we play in compliance with the rule on Sanitary Transportation. We are prepared to address any of your food safety requirements head-on and have been doing so for years.