As one of the seven foundational rules of the Food Safety Modernization Act (FSMA), the Sanitary Transportation of Human and Animal Food rule has been dubbed the sleeper regulation among the new laws. The rule, whose origins are in the Sanitary Food Transportation Act of 2005, establishes guidelines to prevent practices that would increase contamination risk during the motor or rail transportation of food in the U.S. both intrastate and interstate.
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Explore This IssueDecember/January 2017
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Eliminating risk is always top of mind for a company’s lawyers and accountants, but recently finalized FSMA rules, including the Sanitary Transportation rule, have caused other company functions to increase their collaboration with their contacts at trading partner companies. Here are the top five things you may not have known about the Sanitary Transportation rule in order to comply.
- Every role has responsibilities. While all seven FSMA rules focus on the grower, manufacturer, retailer, and their facilities, the Sanitary Transportation rule also includes third-party transporation companies. The rule defines who among a supply chain’s participants are considered shippers, receivers, loaders, and carriers and calls out the responsibilities for each.
- Keep it cool and keep it clean. In keeping with FSMA’s overall intention, the Sanitary Transportation rule’s responsibilities are preventive in nature. Examples include ensuring temperature control during transportation and storage, and avoiding contamination of products by executing appropriate cleaning steps between shipments. As with all FSMA rules, there are exemptions and exceptions.
- Operating procedures in writing? Good, keep them for a while. Written agreements between all parties outlining standard operating procedures for transportation of a product are required records for this rule. The rule states records must be maintained 12 months beyond when the procedures are in use. These operating procedures should spell out the requirements for the container, from the design specifications to cleaning procedures to pre-cooling. And don’t forget, at each step along the container’s trip, documentation must be collected and maintained.
- You are responsible for stopping the truck or train. An additional provision added to the final rule places a requirement on all parties in the transportation process to stop the sale or distribution of a product if it has been determined that temperature controls have suffered a material failure or other conditions have been detected that render the product unsafe.
- Document your employee training. Similar to other FSMA rules, there is a training component that requires adequate training of all personnel engaged in transportation operations. They must be trained to identify and manage potential food safety problems, basic sanitary transportation practices, and carrier responsibilities. A key change here is the training of all personnel must be maintained in writing (or electronically) and be accessible to FSMA inspectors.
The FDA begins enforcing Sanitary Transportation in September 2017. Businesses, other than motor carriers who are not also shippers and/or receivers employing fewer than 500 people and motor carriers having less than $27.5 million in annual receipts, have to comply a year later.
The good news is there is a lot that can be done to prepare to comply. After identifying your company’s role in transportation, ensure proper procedures are in place, all personnel are properly trained, and all records are being maintained according to FSMA guidelines. Technology is available to address the market need for receiving, storing, sharing, and maintaining regulatory, audit, and insurance documentation all in one location. Since change doesn’t happen overnight, the time is now for shippers, retailers, distributors, and carriers to act in order to be prepared.
Fields is chairman and CEO of Park City Group, and is CEO of ReposiTrak. Reach him at firstname.lastname@example.org.