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New FDA Food Safety Rule Excludes Packaged Food

Volume 2, Issue 3
February 15, 2014
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The Food and Drug Administration on Jan. 31 proposed new regulations that when adopted will require shippers, carriers and receivers – including warehouses – to take certain steps to prevent the contamination of human and animal food during transportation and storage.

bagThe proposal marks the seventh major rule adopted to in implement the revised Sanitary Food Transportation Act that was enacted in 2005.

The new proposed rules establish criteria for sanitary transportation and storage practices, such as properly refrigerating food, adequately cleaning vehicles between loads, and properly protecting food during transportation.

Exempted from the rules are companies engaged in food transportation and storage that have less than $500,000 in annual sales.

The good news for many 3PL warehouse operators is that is not imposing the new requirements on the transportation and storage of fully-packaged shelf-stable foods. The International Warehouse Logistics Association had sought this change from an earlier version of the proposal.

The FDA rebuffed another change IWLA proposed when the agency defined a “receiver” as anyone who receives food after it’s transported, even if you are not the shipment’s final point of receipt. IWLA had noted that law holds a warehouse is not the owner of freight it stores for another company.

The FDA made it clear that the rules will apply to anyone who receives food after transportation, not just the ultimate consignee.

The rules also don’t apply to shippers, receivers or carriers engaged in transportation of food that is transshipped through the United States to another country, or to food imported for future export that is neither consumed nor distributed in the U.S.

However, the rules do apply to international shippers who transport food for U.S. consumption or distribution in an international freight container by air or ship, and who arrange for transfer of the intact container onto a truck or rail car in this country.

What It Means for You

The rules are intended to ensure that shippers, carriers and receivers who transport food items that the FDA says are at the greatest risk for potential contamination are following appropriate sanitary practices.

For example, the proposed rules require that shippers inspect a vehicle for cleanliness prior to loading food not completely enclosed in a container, such as fresh produce in vented boxes.

The rules would require that materials and workmanship used in design and manufacture of vehicles and transportation equipment for food to be suitable for that purpose and adequately cleanable.

The FDA said the equipment must be maintained “to prevent the food that they transport from becoming filthy, putrid, decomposed or otherwise unfit for food, or being rendered injurious to health from any source during transportation operations.”

The FDA would not consider pallets to be maintained in an appropriate sanitary condition if they are in such poor repair – for example, jagged wood edges — that they could damage food packaging, causing a loss of container integrity and increasing the potential for direct contamination.

The agency added that pallets used within food distribution centers must be cleaned and rotated or disposed of on a regular basis.

It is also proposed that the same Current Good Manufacturing Practice (CGMP) regulations for maintenance of equipment and utensils in food plants will apply to transportation equipment.

For foods requiring refrigeration the rules require the temperature be maintained in such a way that it will prevent such microbial growth.

The agency said it continues to receive reports of foods, such as meat and some seafood products, requiring temperature control being transported in unrefrigerated vehicles that are not equipped with insulated coolers and ice packs.

As a result, the proposed rules require proper insulation and ice packs be used when these foods are hauled in equipment lacking temperature controls.

Who Is Responsible?

Once transportation is complete, the carrier will be required to demonstrate to the shipper and if requested, to the receiver, that it maintained temperature conditions during transportation.

If the carrier and shipper agree in writing before transportation that the shipper is responsible for monitoring or assuring that the food was held under acceptable temperature conditions during the transportation operation, then the carrier is discharged from responsibility.

The shipper is also required to provide this same assurance to the receiver, and meet the same corresponding records requirements as the carrier would otherwise be, in circumstances where the shipper has assumed a responsibility that is normally borne by the carrier.

Applying equally to shippers, carriers and receivers, like warehouse operations, the proposed rules require that responsibility for ensuring operations are carried out in compliance with the law be assigned to competent supervisory personnel.

This provision mirrors a longstanding provision in the current CGMP regulations regarding the manufacturing, processing, packing, or holding of human food, the FDA noted.

In its examples of improper food handling, the agency included shell eggs left unattended for several hours on a loading dock on a warm day, and pasteurized citrus juice became spoiled during transport due to inadequate refrigeration.

Noting that temperature monitoring is not always practiced during loading and unloading of refrigerated and frozen foods, the FDA made it clear that it does not consider acceptable the staging and holding of any food subject to rapid growth of undesirable microorganisms in the absence of temperature control on a non-temperature controlled loading dock hours before a pickup.

Shippers and receivers must provide drivers who handle food not enclosed in a container during loading and unloading with access to a convenient hand-washing facility.

Anyone working in direct contact with food must conform to hygienic practices, including washing hands thoroughly and sanitizing if necessary.

The proposed preventive controls rules for animal food contain many similar provisions, including access to hand-washing facilities.

The entire FDA rulemaking can be found at:


Comments on the proposed rules are due by May 31. Public meetings on the proposal will be held in Chicago on Feb. 27; Anaheim, CA, on March 13; and College Park, MD, on March 20.

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