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New FDA Final Rule on Food Safety Takes Effect


On April 6, 2017, new rules on the transportation of food products went into effect as part of the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA). Generally, the FSMA is the most sweeping reform of U.S. food safety laws since the 1940s and it imposes requirements on nearly every handler of food products. The goal of the FSMA is to prevent contamination as opposed to responding to it. In promulgating the FSMA, the FDA has been given new enforcement authority designed to achieve higher rates of compliance.

Specifically, the FSMA includes a final rule on the sanitary transportation of human and animal food that will apply to nearly all shippers and carriers, with some exceptions. The final rule focuses on a multitude of major categories, laid out below.

First, vehicles transporting temperature sensitive foods must now be equipped with the technology to measure and record temperature at any given time in order to demonstrate that a cold chain was maintained throughout the delivery process. The final rule leaves the determination of whether a food is temperature sensitive to the shipper. Additionally, there are no technical specifications required so long as the end goal of equipping the vehicles with temperature measurement devices that can be read at any time is met.

Second, a shipper is now required to develop written procedures that specify the pre-cooling temperature that the motor carrier vehicles must be set to before the food is placed in the vehicles as well as adequate temperature ranges for the transportation itself. The carrier must have the technology to maintain these stated temperatures and should develop a process to communicate temperature profiles during the transportation cycle.

Third, and not surprisingly, cleanliness is also emphasized in the final rule. Shippers now must implement further written procedures in order to prevent contamination of ready to eat food by raw food. Shippers are also required to provide hand-washing facilities to vehicle operators who will be handling unpackaged foods. Additionally, carriers are required to determine that a vehicle is in appropriate sanitary condition for the transport of food. This takes into consideration whether the vehicle is in adequate physical condition and free of visible evidence of pest infestation and previous cargo that could cause the food to become unsafe during transportation.

Fourth, the carrier must train its personnel in sanitary transportation practices and this training must also be documented. The FDA provides no specific sanitary transportation practices that must be included in training and therefore these are to be determined between the shipper and the carrier. Training should include how to deal with temperature violations that can occur during transportation or loading/unloading.

Fifth, retention of records is highlighted in the new final rule and shippers and carriers must maintain all of the transportation and training records mentioned above for a period of 12 months and also must make them available to any authorized party promptly upon request.

Food security, such as seals and locks, are not addressed by the final rule.

The FDA will be responsible for carrying out some of the inspections to ensure FSMA compliance, but the Department of Transportation will also establish procedures allowing its own agents, as well as state personnel, to perform inspections as well. Should the FDA determine that the requirements of the FSMA have not been met, it will consider a number of regulatory actions, including the issuance of advisory letters, seeking of injunctions, or filing of administrative actions.

Additionally, it is important to know who is and is not exempt from the new final rule. Below are the exempt entities and activities:

·         Shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue

·         Transportation activities performed by a farm

·         Transportation of food that is transshipped through the United States to another country

·         Transportation of food that is imported for future export and that is neither consumed or distributed in the United States

·         Transportation of compressed food gases (e.g. carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products), and food contact substances

·         Transportation of human food by-products transported for use as animal food without further processing

·         Transportation of food that is completely enclosed by a container except a food that requires temperature control for safety

·         Transportation of live food animals, except molluscan shellfish

For shippers, compliance will depend on attention to detail. Shippers should be sure to inform themselves of the different trailer designs and ensure they will meet FSMA requirements. Shippers should ensure foods are properly segregated and should feel comfortable tracing the transportation chain to ensure all food-contact surfaces are cleanable. Shippers should also inspect palettes and transportation equipment to ensure they are in good condition and will not lead to food exposure or contamination.

For carriers, compliance with the FSMA will undoubtedly be a team effort, requiring planners, dispatchers, and drivers to stay on the same page at all times when it comes to the transportation of perishable food products. If you have any questions about compliance, enforcement, or anything else related to the FSMA, please contact Peter Schurig or Kevin Coghill of the Setliff Law Transportation Team.

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