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Bioterror rule on food and packaging records confounds

FDA’s requirements for recordkeeping and tracking of packaging and products appear unclear.

In what may be the understatement of the year, Leslye Fraser, director of the Food and Drug Admini-stration’s Office of Regula-tions and Policy, told an audience of food packagers in January that the new Bioterrorism Act’s recordkeeping requirements as they apply to packaging—which go into effect on December 9—“got to be a little complicated, I think, to understand.”

One thing is clear, though. Food manufacturers will have to be able to match up packaging purchased from suppliers with the outgoing shipments of food product packed in it—whether it’s shrink wrap, inner liner, can, bottle, carton, or other packaging.

Beyond that, confusion predominates. The FDA final rule doesn’t say how this “incoming-to-outgoing” link must be established. The rule does say that a food manufacturer must obtain certain information from a packaging supplier, including a lot number for the shipment if a lot number exists.

A food manufacturer must also record the name of the packaging supplier, a description of the packaging including brand name and specific variety, the date it was received, the quantity, and some contact information for the supplier. That information must be recorded at the time it is provided. If there is no lot number, the buyer must find another way to tie that packaging shipment to the outgoing packaged product. Similarly, the manufacturer must record the same type of information for the next company in the distribution chain who receives the food, such as a common carrier.

Records availability

That information must stay on file at the plant for six months to two years, depending on the potential for the product’s spoilage. If the FDA comes knocking, those records have to be produced within 24 hours.

“If the food product manufacturer, processor, or packer puts lot numbers, bar codes, whatever on the outside packaging of the finished product, that is up to them,” says Nega Beru, associate director of the Office of Plant and Dairy Foods at the FDA. Beru was the key FDA decision maker on the final rule issued last December. The FDA has not said whether that identifier on the outgoing product must be placed on the outer package, the bulk carton, or the pallet.

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