High-risk designation: recipe for disaster - The Packer

High-risk designation: recipe for disaster

05/22/2014 05:03:00 PM
Tom Karst

Tom KarstIs there anyway to overcome the distinction of being tabbed by Food and Drug Administration as a “high risk” food? Perhaps one fanciful marketing tack to consumers would go something like this:

 “Sure, our much-loved commodity X is called “high risk” by the FDA. But, it should be pointed out, it is also “high reward” as well. Big time phyto nutrients and vitamins are on board, along with the risk of salmonella and E. coli bacteria.”

 I kid, of course. Having your star-performing fruit or veggie tabbed a “high risk” food is absolutely the worst designation possible for a commodity group or shipper. In that context, I was visiting with one industry leader this week and he noted the comment period was closing May 22 on the FDA’s request for industry input on the agency’s methodology for its designation of high risk foods.

In its request for comments, the FDA pointed out the Food Safety Modernization Act requires the designation of high-risk foods.

“ Specifically, ..FSMA requires FDA to designate high-risk foods for which additional record keeping requirements are appropriate and necessary to protect the public health” the request for comments. The law also requires FDA to publish the list of high-risk foods on the Internet Web site of FDA at the time when FDA issues final rules to establish the additional record keeping requirements for high-risk foods.

So it is double whammy. Yes, you are a high risk food! And yes, you have extra record keeping requirements!

Former FDA official David Acheson, president and chief executive officer of Frankfort, Ill.-based The Acheson Group LLC, said in February the biggest challenge the FDA may face is the question whether a high-risk food can ever be classified as a low-risk food.

“Can you get fresh produce, or certain aspects of fresh produce, from a high-risk (list) to a lower risk?” he said. “That’s part of the challenge.”

No one in the food industry, including fresh produce, wants their commodity to be on the list of high-risk foods, of course. The FDA plans to publish a list of high-risk foods either before or at the same time it issues a proposed rule establishing record-keeping requirements for designated high-risk foods.

The FDA’s draft approach to identify high-risk foods uses several criteria to determine a total risk score, according to the notice. However, no commodities were identified as high-risk in the FDA’s initial document.


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