Overview
The Food and Drug Administration’s (FDA) latest Food Safety Modernization Act (FSMA)-related final rule on the sanitary transportation of food gives food contact substance manufacturers reason to breathe a small sigh of relief, while other food transporters can take heart from additional flexibility under the rule. The final rule on the Sanitary Transportation of Human and Animal Food (Sanitary Transportation rule)1 establishes requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food to use sanitary transportation practices to ensure the safety of the food they transport. In a change from the February 2014 proposed rule, FDA has explicitly excluded food contact substances from the scope of the “food transportation operations” covered by the new regulations, and has significantly revised the rule for those who are covered to focus on transportation practices that could present a food safety problem, rather than simply spoilage concerns, and to provide additional flexibility in compliance requirements.
The Sanitary Transportation rule did not directly result from FSMA; rather, the rule implements the Sanitary Food Transportation Act of 2005, which required FDA to prescribe sanitary transportation practices to ensure that food transported by motor vehicle or rail is not transported under conditions that may adulterate the food.2 FDA has identified a number of practices that could result in food safety risks, such as the failure to properly refrigerate food, the inadequate cleaning of vehicles between loads, and the failure to properly protect food during transportation. Recognizing that the industry has worked hard to develop best practices for the safe transportation of food, this final rule facilitates continued reliance on those practices, while focusing on ensuring proper communication, assignment of responsibilities, and appropriate recordkeeping between all the parties involved.
These new requirements apply to shippers, receivers, loaders, and carriers who engage in food transportation operations in the United States using motor or rail vehicle (i.e., transportation by air and water generally is not covered)3 and have more than $500,000 in average annual revenue.4 With some important exceptions, the types of “food” covered under the rule represent the full scope of the foods regulated under the Federal Food Drug, and Cosmetic Act (FD&C Act), including animal food (pet food and feed for livestock), food additives, and dietary supplements. Notable exclusions are for: (1) food completely enclosed by a container (unless refrigeration is needed for safety); (2) compressed food gases; (3) food contact substances;5 (4) human food byproducts transported for use as animal food without further processing; and (5) live food animals, except molluscan shellfish.6 FDA also has “waived” requirements of the rule for the shipment of Grade A milk under the National Conference on Interstate Milk Shipments program and for permitted food establishments, such as restaurants, supermarkets, and home grocery delivery operations, where transported food is given directly to the consumer.
The exclusion of food contact substances from the final rule represents a significant win for industry, who had strongly argued to FDA that the inclusion of these products would represent a significant burden with no benefit because the very nature of food contact substances, as well as how they are processed and handled, presents virtually no risk of contamination. FDA recognizes these points in the final rule,7 and even notes that packaging is an effective preventive measure against the contamination of food.8
For those shippers, receivers, loaders, and carriers who transport covered products, the rule establishes requirements relating to:
- The design and maintenance of vehicles and transportation equipment
- The measures taken during transportation operations to ensure safety, such as appropriate temperature controls and load segregation
- The training of carrier personnel
- Required records for written procedures, agreements, and training
The compliance date for most companies is within one year after publication, i.e., April 6, 2017, but “small businesses,” which are businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts, have two years (i.e., April 6, 2018).
[1] 81 Fed. Reg. 20091 (April 6, 2016), available here. The final rule is effective June 6, 2016.
[2] Due to long delays in the development of the regulations for the Sanitary Food Transportation Act of 2005, Congress included in FSMA a provision mandating that FDA move forward with the implementation of the older law.
[3] Shippers using water or air transportation who arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the US are covered under the rule.
[4] This covers total annual revenues, using an average calculated on a rolling basis during the three preceding years, and adjusted for inflation.
[5] As defined in section 409(h)(6) of the FD&C Act.
[6] FDA also has excluded food that is transshipped or imported for export, and transportation activities by a farm.
[7] See Response 58, 81 Fed. Reg. at 20116.