Last week FDA issued the final rule on Sanitary Transportation of Human and Animal Food, establishing requirements for shippers, loaders, motor/rail-vehicle carriers, and receivers to use sanitary transportation practices to ensure the safety of the food (for humans or animals) they transport. Specifically, the rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training and waivers. As are all the rules of FSMA, the rule is prevention- and risk-based, in that its goal is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food. The rule, which defines transportation as “any movement of food in commerce by motor vehicle or rail vehicle,” applies to food transported within the U.S., even if the food is not offered for/does not enter interstate commerce, and food that is imported to be consumed or distributed within the U.S. It does not apply to foreign shipments of food that are shipped through the U.S. without distribution in the U.S., or to transportation of food by ship or air within the U.S. because of limitations in the law. However, companies involved in the transportation of food intended for export are covered by the rule until the shipment reaches a port or U.S. border. FDA built flexibility into the rule, which implements the Sanitary Food Transportation Act of 2005 (2005 SFTA) as well as fulfilling requirements of FSMA, to allow the transportation industry to continue to use industry best practices for cleaning, inspection, maintenance, loading and unloading, and operation of vehicles and transportation equipment that ensure food safety. Key requirements of the rule include: Design and maintenance of vehicles and transportation equipment so as to be cleanable for their intended use and capable of maintaining temperatures necessary for food safety. Food safety ensured through adequate temperature controls, separation of ready-to-eat and raw foods, foods from non-foods, and food from allergenic cross-contact, etc. Documented training of carrier personnel in sanitary transportation practices for any operations in which it is agreed by the carrier and shipper that the carrier is responsible for sanitary conditions during transport. Maintenance of records of written procedures, agreements and carrier training for up to 12 months (based on rule specifications). Waivers and Exemptions Because FSMA allows FDA to waive transportation requirements if it determines that this will not result in unsafe food, the agency intends to publish waivers for two groups: Shippers, carriers and receivers shipping Grade A milk and milk products who hold valid permits and are inspected under the NCIMS Grade “A” Milk Safety program. Food establishments with valid regulatory-issued permits engaged as receivers, shippers and carriers when food is transported to customers from the establishment (e.g., restaurant, supermarket, and home-grocery deliveries), as these are regulated by the Retail Food Program. FDA is also continuing to review comments requesting a waiver for transportation operations for molluscan shellfish for entities that hold valid state permits under the National Shellfish Sanitation Program. Exempted are shippers, receivers, or carriers engaged in food transportation operations with less than $500,000 in average annual revenue, activities performed by a farm, and transportation of: Food transshipped through the U.S. to another country. Food imported for future export and is not consumed or distributed in the U.S. Compressed food gases and food contact substances. Human food byproducts transported for use as animal food without further processing. Food that is completely enclosed by a container unless it requires temperature control. Live food animals, except molluscan shellfish. Changes from the Proposed Rule FDA made several major revisions from the proposed to the final rule mainly in response to comments that focus the rule more narrowly on food safety and are consistent with existing safe transportation best practices, including: The definitions for parties covered by the rule have been simplified to make them all activity based, with “loader” added based on comments that this is a relevant segment that had not been identified. The definition of “transportation operations” is amended, such that additional transportation activities are not covered by the rule (e.g., food completely enclosed by a container, except that requiring temperature control, food contact substances, and human food byproducts transported for use as animal food without further processing). The provisions are changed to focus on food safety concerns, not adulteration as a result of spoilage or quality defects. Prescriptive requirements for temperature monitoring devices and continuous monitoring of temperature during transport is replaced with a more flexible approach allowing the shipper and carrier to agree to a temperature monitoring mechanism. The provision requiring the carrier to demonstrate temperature control to the receiver for every shipment requiring temperature control is removed, so that demonstration must be made only if the shipper or receiver requests it. The rule is revised to require that a person who is subject to the rule and becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, must take appropriate action to ensure that the food is not sold or otherwise distributed, unless a determination is made by a qualified individual that the condition did not render the food unsafe. The rule is revised to clarify that its requirements account for the fact that the intended use of the vehicle or equipment with respect to the transported food type (e.g., animal feed vs human food) and production stage (i.e., raw, ingredients, or finished product) is relevant in establishing the applicable sanitary transportation requirements. The rule is revised to primarily place the responsibility for determinations about appropriate transportation operations on the shipper. The shipper may rely on contractual agreements to assign some of these responsibilities to other parties if they agree to accept the responsibility. Compliance dates begin one year after publication (i.e., due April 6, 2017), with two years allowed for small businesses, defined as motor carriers with less than $27.5 million in annual receipts, and other businesses that are not also shippers and/or receivers employing fewer than 500 persons. 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. www.AchesonGroup.com
