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As we go to press, businesses that are not defined by FDA as small or are not otherwise exempt must now be in gear with the Food Safety Modernization Act (FSMA) Final Rule on Sanitary Transportation of Human and Animal Food, effective April 5, 2017.
The FDA defines as “small” shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts. These entities are scheduled for FSMA compliance by April 5, 2018.
Simply stated, the final FSMA Sanitary Transportation rule, proposed in January 2014 and issued April 5, 2016, requires those who transport perishable food, be it by motor or rail, land or sea, to use sanitary practices to ensure the food’s safety.
According to FDA, the rule establishes requirements in four key areas.
- Vehicles and transportation equipment. This focuses on the design and maintenance of vehicles and transportation equipment to ensure that they do not cause the food they transport to become unsafe. For example, they must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food.
- Transportation operations. This includes the measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready-to-eat food from touching raw food, protection of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact, such as the unintentional incorporation of a food allergen.
- Training. Training of carrier personnel in sanitary transportation practices and documentation of the training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.
- Records. Records include maintenance of written procedures, agreements, and training (required of carriers). The required retention time for these records depends upon the type of record and when the covered activity occurred, but does not exceed 12 months.
FDA notes that, with some exceptions, the final 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. It also applies to persons, for example, shippers, in other countries who ship food to the U.S. directly by motor or rail vehicle (from Canada or Mexico), or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the U.S., if that food will be consumed or distributed in the U.S.
The rule does not apply to exporters who ship food through the U.S. (from Canada to Mexico, for example) by motor or rail vehicle if the food does not enter U.S. distribution.
FDA designates eight exemptions to the Sanitary Transportation rule. These include 1.) shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue; 2.) transportation activities performed by a farm; 3.) transportation of food that is transshipped through the U.S. to another country; 4.) transportation of food that is imported for future export and that is neither consumed or distributed in the U.S.; 5.) transportation of compressed food gases (carbon dioxide, nitrogen, or oxygen authorized for use in food and beverage products, for example) and food contact substances; 6.) transportation of human food byproducts transported for use as animal food without further processing; 7.) transportation of food that is completely enclosed by a container, except a food that requires temperature control for safety; and 8.) transportation of live food animals, except molluscan shellfish.