What Will the FDA’s FSMA Regulations Mean for Shippers
Every year 48 million Americans become ill from a food-borne illness, affecting one in six of us. Food-related illness hospitalizes an estimated 128,000 and 3,000 people die. This grim reality—from the Food and Drug (FDA) Administration—is the catalyst behind new regulations governing the transportation of mostly refrigerated food items, which take effect this year. The laws are part of a carefully crafted plan created by the FDA under a far-reaching program known as the Food Safety Modernization Act (FSMA) that launched in 2011.
These new laws, known as the Sanitary Transportation of Human and Animal Food or SFTA, apply to shippers, receivers, loaders, and carriers who transport food in the U.S. by motor or rail service, according to the FDA. For those of us in the supply chain and logistics industry, the SFTA has enormous implications on how you operate moving forward. Additionally, we all must be aware of the primary implementation dates in 2017.
The FDA says, “The final rule applies to persons, e.g., shippers, who ship food into the U.S.—directly by motor or rail vehicle (Canada or Mexico); and by ship or air.” The rule also applies to those who arrange the transfer of the container onto a motor vehicle or train.
Shippers, receivers or carriers with transportation operations less than $500,000 annually get off easy. Smaller operations do not have to comply with the rules, as do transportation activities performed by a farm, and food that is not consumed in the U.S. (exported food).
Finally, the FDA excludes food entirely enclosed by a container (except if requiring temperature control for safety), live food animals, except molluscan shellfish, compressed food gasses, food contact substances, and human food byproducts for use as animal food without further processing.
According to Refrigerated Transporter, “The new law gives the FDA the ability to focus on preventing food safety problems rather than just responding to contaminations. The agency was given new enforcement authorities to achieve higher rates of compliance with prevention. Some would even say the FDA was given unprecedented policing powers under FSMA.”
The big question is what does the implementation of SFTA mean for all of us on the frontline? What is changing and how should I organize my operations to comply with the new mandates? Let’s break it down.
Several new requirements will affect shippers, loaders, receivers and carriers.
Vehicles and Transportation Equipment
The new law places burdensome requirements on trucks and trailers. Specifically, the design, maintenance, and storage must be appropriate to prevent the food from becoming unsafe during transportation operations. For food requiring temperature control for safety, vehicles and transportation equipment must be equipped to provide adequate temperature control.
Also, steps must be taken to prevent food from becoming unsafe during transport such as presenting contamination of food through contact with raw food or food items. The steps include preventing any cross contact with food allergens and protecting food from contamination by previous cargo.
Contamination, for instance, can happen if a truck is hauling a load of potatoes in a trailer that had previously been filled with peanuts. The peanut-laced potatoes could cause a real danger to a consumer with a peanut allergy further down in the food chain. Moreover, if cross contamination happens, who’s responsible or liable? Well, SFTA covers that.
The rule states if a shipper, loader or receiver is aware of a temperature failure or other conditions that could cause harm to a food shipment, “shall not be sold or otherwise distributed.”
Also, if anyone in the supply chain is aware of a problem with the shipment, they must communicate with other parties. “To ensure the food isn’t sold, or unless it’s determined made by a qualified individual that the temperature deviation or other condition did not render the food unsafe,” says the FDA.
Training, Written Procedures and Record Keeping
The implementation of SFTA brings with it strict compliance rules on how companies must train its people, develop detailed written procedures and keep accurate records around the transportation of food items.
Carriers, for example, must have documented procedures on how its employees must care for trucks and trailers to maintain sanitary transport conditions. Accordingly, “The procedures must also describe how they will comply with the rule’s temperature control and bulk vehicle requirements.”
The first rules regarding SFTA are set to go into effect as early as this April (2017).
Need a 3PL to walk you through the implications of SFTA? Let’s talk about it.