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SAFEGUARDS | Food NO. 079/16

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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. [1] 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.

SGS is committed to keeping you informed of regulatory news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions, including analytical testing, audits, certifications, inspections and technical support. We continually invest in our world class testing capabilities and state-of-the-art technology to help you reduce risks, and improve food safety and quality. For further information please visit our website. www.foodsafety.sgs.com.

For enquiries, please contact:

James Cook
Food Scientific and Regulatory Affairs Manager

t: +01 973 461 1493

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