A.I.B. breaks down the Reportable Food Registry

by Erica Shaffer
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MANHATTAN, KAS. — The Food and Drug Administration’s Reportable Food Registry requires food and feed producers to report contaminated products to the F.D.A. via an electronic portal. But who must do the reporting and when has caused a lot of head scratching in the food industry.

“There’s a lot of confusion about this thing,” said Cliff Pappas, senior adviser for HACCP and quality system education for the AIB International. He said there are “still some things that people don’t understand at this date and time.”

Mr. Pappas moderated a webinar on the registry on Nov. 9. He said the Institute is considering additional webinars and other offerings such as a regional seminar to help with persistent questions about the registry regarding the concept of transfer, responsible parties and when a contaminated item must be reported. The burden is on industry to decide what to report into the registry. The stakes are high — failure to report an incident within 24 hours of being notified of the problem is a felony, Mr. Pappas said.

But what is a reportable food?

“A reportable food is an article of food other than dietary supplements or infant formula for which there is a reasonable probability that the use of or exposure to will cause adverse health consequences or death to humans or animals,” Mr. Pappas said.

This is essentially the definition of a Class 1 recall, he said. Most instances of Salmonella contamination would fall into a Class 1 recall because of the peanut butter and other recalls that occurred recently. Instances involving E. coli O157:H7, botulism, and hard particles 7 to 24 millimeters in size must also be reported into the registry, he added.

Undeclared allergens — if they include milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts or soybeans — must be reported into the system, Mr. Pappas said. For animal feed, elevated levels of heavy metals or melamine are considered by the F.D.A. to be reportable.

Infant formula and dietary supplements are not included as a reportable food because those items are regulated under a different section of the Food, Drug and Cosmetics Act. Also, food items under U.S. Department of Agriculture jurisdiction are exempt from the registry. Mr. Pappas said an exception to this would be if the food item under U.S.D.A. jurisdiction were transferred to a company under F.D.A. jurisdiction.

What does transfer or release to another person mean? A lot of things, it turns out, and it’s important for industry to know what transfer entails because it’s a determining factor in who must report the contaminated product to the registry. According to the F.D.A., transfer occurs when an article is released to another person, company, partnership, corporation, association or laboratory.

“If we release a product to a company, it could still be sitting on our warehouse floor, on our dock,” Mr. Pappas said. “Maybe we put it into their truck, but they have accepted the item itself — they have accepted ownership. “If at that point we find that there is an issue that puts it into a reportable food category — even though we could stop it immediately, never let it into the marketplace — it has been transferred and must in fact be reported to F.D.A.”

If a company retains ownership of a third-party warehouse, but the control over the distribution goes to that third-party warehouse, the item has been transferred, Mr. Pappas said.

So, if Company A transfers product to Company B and Company A discovers the product is contaminated, Company A must notify Company B and Companies A and B must report it to the registry, Mr. Pappas said. If Company B discovers the contamination, Company B must notify Company A, and Companies A and B must report the incident to the registry.

Keep adding companies to the chain, and it becomes increasingly difficult for industry to know who should be doing the reporting. But companies are responsible for knowing who should report the contaminated product and when to report it.

For example, suppose samples are taken from a food item and sent away for testing. The food item is then loaded onto a truck, which would take roughly two days to make delivery. In the meantime, the company receives the test results from the sample, and the results reveal a contaminant. The truck may be stopped, or resealed and returned to the location of shipment. However, the product must be reported into the registry even though the food never made it into the marketplace, Mr. Pappas said.

“It really does change dramatically the way that we would look at some of these activities around micro-testing when the product has been transferred or might be transferred to the second individual or the part other than the producing location,” he said.

Companies under F.D.A. jurisdiction would not be required to report a contaminated food product if three criteria are met:

 Adulteration originated with the responsible party;
 The adulteration was detected before transfer to another person; and
 The responsible party corrected the adulteration or destroyed or caused destruction of the product.

Mr. Pappas advised webinar participants to err on the side of caution when deciding which items to report.

“I would recommend to you that if there is any question in your mind, err on the conservative side,” he said. “Err on the idea of reporting it to the Reportable Food Registry.”

According to AIB International, 110 registrants logged into the session, but actual numbers are unclear because more than one person may have been sitting at a computer observing the webinar. FSM
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