US FDA Finalizes the FSMA Sanitary Transportation Rule
SAFEGUARDS | Food NO. 079/16
On April 6, 2016, the US Food and Drug Administration (US FDA) published the Sanitary Transportation of Human and Animal Food rule, the sixth of the seven core Food Safety Modernization Act (FSMA) rules.  This final rule will require those that transport human and animal food by rail or truck to adhere to best practices in food transportation.
As with all US FDA rules, there are some exceptions, but generally this rule applies to all shippers, carriers, loaders, and receivers transporting food in the United States (US) whether in intra or interstate commerce. This rule applies to those persons that transport food directly to the US, such as from Canada and Mexico.
The rule also applies to those shipping food in intact containers to the US via ship or air, that is transferred to rail or motor vehicle, providing the food is to be consumed in the US.
This rule does not apply to food being transported through the US for export out of the US, providing the product does not enter US commerce. For the shipping of food in the US, for export outside the US, this food is covered until it reaches the port or US border.
The key requirements are:
Vehicle and transportation equipment design and maintenance for the safe transport of food
Transportation operations to assure that food does not become abused or contaminated to render it unsafe
Training of carrier personnel in the safe transport of food, if shippers and carriers agree that the carriers are responsible for this
Record keeping of procedures, agreements and training of carrier personnel. These are to be kept as per the period of activity depending on the record, but for not more than a period of 12 months
This rule allows the US FDA to grant waivers, providing that the issuing of the waiver does not result in the unsafe transport of the food. The US FDA intends to issue the following waivers for those shippers, carriers and receivers who hold valid permits, and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety program, only when shipping Grade A milk products. The US FDA also will grant a waiver to food establishments holding valid permits issued by a relevant regulatory authority when engaged as receivers, shippers and carriers in operations in which food is relinquished to customers after being transported from the establishment. These establishments include, but are not limited to restaurants, supermarkets, and home grocery delivery operations.
The US FDA is reviewing a waiver for the transportation operations for molluscan shellfish for entities that hold valid state permits under the National Shellfish Sanitation Program.
Compliance dates for this final rule are established as two years, by April 6, 2018, for small businesses, defined as a shipper or receiver with fewer than 500 full time equivalent employees and a carrier with less than $27.5 million USD revenue. All other businesses not exempt or waived from this rule are required to comply in one year, by April 6, 2017.
Exemption from this rule:
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 and food contact substances
Transportation of human food byproducts 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
What does this mean for the food industry?
All shippers, carriers, loaders and receivers of food in the US will need to ensure their activities are compliant with the FSMA Sanitary Transportation of Human and Animal Food rule. With one year to comply (two years for ‘small businesses’), action should be taken now to ensure that operators have the necessary equipment, processes, training and record keeping measures in place in good time.
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