High-risk designation would be a recipe for disaster - The Packer

High-risk designation would be a recipe for disaster

05/23/2014 11:06:00 AM
Tom Karst

Tom Karst, National EditorTom Karst, National EditorIs there any way to overcome the distinction of being tabbed by the 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 phytonutrients 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 mentioned the comment period closed 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,” according to the request for comments.

The law also requires FDA to publish the list of high-risk foods on the website 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 the list 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.

Some of the factors that FDA will weigh as it determines what are high-risk foods include outbreak frequency, illness occurrence, severity of illness, the likelihood of microbial or chemical contamination, potential for the food to support pathogen growth, food consumption patterns and the probability of contamination and steps taken during manufacturing to reduce contamination.

The FDA also will look at health and economic factors, cost of illness and disabilities expected, according to the FDA notice.

One of Acheson’s colleagues at The Acheson Group, Jennifer McEntire, vice president and chief science officer, told me this week that the FDA is under no hard deadline to produce this rule, unlike the 2015 deadline for the produce safety rule and other major FSMA regulations.

Even so, she said the FDA’s designation of “high-risk” foods is drawing a lot of food industry attention.

She thinks that the way FDA has proposed their matrix of scoring risk, nearly all commodities could be labeled “high risk.”

“How will they draw the line between high risk and what is not?” she said.

The question of risk methodology that the FDA is currently seeking advice on is just a prelude to the main show.

Once the FDA actually identifies the specific food items that are high risk, watch out. Fortunes will be spent, I would think, in either keeping commodities off the “high risk” list or trying to extract them if they are shamed and named.

The FDA can only solve this by making every food high risk — or dumping the idea entirely. Since the latter isn’t likely, prepare for the former. High risk, yes, but consider the rewards!

tkarst@thepacker.com

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Produce Guy    
Texas  |  May, 28, 2014 at 07:06 AM

Great idea!! I am all for making our foods safer. Who isn't, right?? Now, has the FDA informed big store retailers and their customers that this will have a cost??

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