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Compliance to FSMA’s Sanitary Transportation Rule took effect April 6. Are you ready for an inspection? A – Yes! I have everything ready in case FDA shows up. B – Sort of. I read the rule, but am still waiting on Guidance. C – No. I’m not even sure what applies to me! If you answered A – Congratulations! But you are probably one of the few who feel completely ready. In fact, you may even be a step ahead of FDA, who is still be ironing out a few of the wrinkles itself as it is currently in the process of training investigators to inspect firms for compliance with the rule. If you answered B or C – You’ll be happy to know that FDA intends to focus on Preventive Controls inspections first, so the agency doesn’t expect to begin to inspect to the Sanitary Transportation rule until “later this year,” likely in the fall. And, even then, following its mission to “educate before and while we regulate,” FDA has stated that “the objective of the first round of inspections will be to assess the industry’s level of readiness and, if deficiencies are found, to provide firms with the information they need to achieve compliance.” Keep in mind that the premise for this rule is to prevent food from becoming unsafe during transport. So, at a basic level the rule is focused on time/temperature controls, cross contamination of allergens or chemicals, and avoiding food contamination from “dirty” trucks. So, if you are shipping food that is fully enclosed (no air holes, etc.) and does not need temperature controls, the rule really does not apply to you. Also pay attention to the category you fall into. Are you a shipper, loader, carrier or receiver? Depending on what you do, you will have different responsibilities. The shipper has been defined as the entity that causes the food to be shipped – see below: Shipper means a person, e.g., the manufacturer or a freight broker, who arranges for the transportation of food in the United States by a carrier or multiple carriers sequentially. The shipper must specify to the carrier and, when necessary, the loader, in writing, all necessary sanitary specifications for the carrier’s vehicle and transportation equipment to ensure that vehicles and equipment used in its transportation operations are in appropriate sanitary condition for the transportation of the food, including any specific design specifications and cleaning procedures. The definitions and roles of the other entities can be found in the final rule. But in my opinion the shipper has, by far, the most work to do for compliance and the most onerous role for keeping records. Waivers, Exception, Exemptions. FDA also published three waivers on April 5 – the day before compliance took effect. The waivers focus on businesses that are subject to separate state-federal controls, so the rule is not needed to further protect those foods from becoming unsafe. These include: Businesses holding valid permits that are inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program, only when transporting Grade “A” milk and milk products. Food establishments (such as restaurants and grocers) authorized by the regulatory authority to operate when engaged as receivers, or as shippers and carriers in operations in which food is delivered directly to consumers, or to other locations the establishments or affiliates operate that serve or sell food directly to consumers. Businesses transporting molluscan shellfish (such as oysters, clams, mussels or scallops) that are certified and inspected under the Interstate Shellfish Sanitation Conference’s (ISSC) National Shellfish Sanitation Program (NSSP) and that transport the shellfish in vehicles permitted under ISSC authority. With some additional exceptions, the rule applies to shippers, receivers, loaders, and carriers who transport food in the U.S. by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce; and persons (e.g., shippers) in other countries who ship food into the U.S., for consumption or distribution, directly by motor or rail vehicle from Canada or Mexico, or by ship or air arranging for the transfer of the intact container onto motor or rail vehicle for transportation within the U.S. Exempt from the rule are shippers, receivers, loaders or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue; food transported by a farm, transshipped through the U.S. to another country, or imported for future export that is not consumed or distributed in the U.S.; compressed food gases; food contact substances; human food byproducts for use as animal food without further processing; completely containerized food unless it requires temperature control for safety; and live food animals, except molluscan shellfish. For small businesses – those employing fewer than 500 persons and motor carriers who are not shippers and/or receivers having less than $27.5 million in annual receipts – compliance is due April 6, 2018. FDA also intends to publish a Small Entity Compliance Guide later this year. With some entities, primarily carriers, being regulated by FDA for the first time, it is important that shippers understand that FDA is holding them primarily responsible for ensuring the requirements of the rule are met. When the carrier and shipper agree that the carrier is responsible, the carrier must provide and document personnel training. Compliance. Within the next few months, FDA intends to publish a free training module for carriers, however because training does not need to be FDA-approved or instructors certified, carriers also may train their own personnel or use external trainers. That said, FDA acknowledges that it may be difficult for carriers to document training until FDA training is available, so it is encouraging shippers to work with its carriers to ensure on complying with the rule. In addition to carrier training and its documentation, general requirements of the sanitary transportation rule include: Vehicles and transportation equipment must be designed and maintained so as to ensure the safety of the food it transports. Measures must be taken during transportation to ensure food safety (e.g., temperature controls, prevention of cross contamination and cross contact, etc.). Records must be maintained for shipper-to-carrier communication, written procedures, and agreements. As a final thought, FDA is indicating that they will enforce the Sanitary Transport Rule gradually and educate as they go. But keep in mind that even with that statement, the rule is the rule and the compliance dates are the compliance dates. So be ready to have at least the basics in place for compliance sooner rather than later. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance.


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